Australia, Chile and New Zealand reply to UN Rapporteur for Right to Health on TPP complaints

KEI has recently learned that 6 of 9 countries ignored a UN Special Rapporteur request to respond to the March 22, 2011 complaint regarding the TPP. We are also disappointed in the comments from the three that did respond. The UN process for dealing with such complaints is somewhat bureaucratic and secretive. Among the three countries that did respond, Australia, Chile and New Zealand, all defended the secrecy of the TPP negotiating text and asserted that the TPP would not violate the right to health. Excerpts from the three countries that did respond follow, but note always that six countries including the United States did not respond, and that the United States was in fact the primary target of the complaint.

Australia on Transparency

The Australian Government has not kept the TPP negotiations secret.

Dr Emerson has instructed negotiators to provide candid and detailed information on negotiations and draft texts, to ensure stakeholders are well placed and sufficiently informed to enable them to make submissions and representations on issues of concern to them, as the negotiations continue. As you would be aware, negotiating text often contains a range of ambit claims. It has no status until it is agreed by all parties. The Australian Government is not convinced that publicly releasing contested text would assist informed public debate on the issues. It is not normal international practice in free trade agreement negotiations to make texts publicly available until they are agreed.

Australia on right to health

We are not able to comment on other countries’ positions but, from Australia’s perspective, the Government has made abundantly clear that Australia will not support provisions in trade agreements that constrain our ability to regulate legitimately on social, environmental or other important public policy matters, including healthcare.

Retaining the ability to ensure access to quality, affordable medicines for Australian consumers is a priority, and the Government would not accept an outcome in the TPP that would negatively impact upon the integrity of of Australia’s public health system.

Chile on Transparency

TPP member would like to add that, as in all past and future trade negotiations, countries involved have the right to keep offers, drafts texts and proposals confidential, as these documents reflect the positions of one and/or more countries that are engaged in a particular negotiation.

Chile on Right to Health

Finally, with respect to your final question, in the case of Chile, we would like to clarify that the main objective of the Ministry of Health of our country is to improve the levels of public health, by developing a harmonized health system that focuses on people and access to medicines. This system should strengthen the different factors that affect public health and also provide for an appropriate access to the health care system. Through this system, it will be possible to ensure the right to a higher standard of health in our country.”

New Zealand on Transparency

Trade negotiations, like most policy processes involving sensitive issues, have both a public and a private component. New Zealand’s practice on the specific issues of observer access and release of text has varied according to the circumstances of each negotiation. Large multilateral processes tend by their nature to be more open, often making it hard to reach agreement on sensitive issues. The general approach of New Zealand and other international parties in smaller trade negotiations whether bilateral or plurilateral, is not to allow observers into the negotiating room not to release texts until the signature. This is the practice followed in the TPP negotiation, but outside of these parameters we have made substantial efforts to engage with stakeholders at each step of the process.

I have also addressed the ‘secrecy’ question in detail above. New Zealand’s approach to the public and private components of trade and other policy processes in the TPP negotiations, including around access to texts, is consistent with international practice.

New Zealand on the Right to Health

On the question of accuracy, the preceding information shows that the picture set out in the allegations you cite bears little resemblance to the reality of New Zealand policy and practice, including in the TPP negotiation. With regard to the other specific questions you mention concerning patent procedure, ex officio border measures, monopolies for life-saving medicines and higher medicines prices, I should just repeat that no New Zealand government would consider becoming party to a negotiated outcome that called into question either the right to health or access to essential medicines.

United States on on Transparency

No response

United States on on Right to Health

No response

Commentary

The notion that secret negotiations are the norm is of course not true in terms of multilateral negotiations on intellectual property rights at WIPO or the WHO, or even WTO negotiations on intellectual property rights issues, but it is unfortunately the tradition in bilateral and regional trade agreements. The assertion by Australia, Chile and New Zealand that they do not or will not support barriers to access to medicine can be seen as lacking candor, given the nature of the proposals tabled by the United States on patents and drug pricing, and the likelihood of harmful measures being included in the final agreement, giving U.S. objectives and power in the negotiations.

Comment by KEI

The UN's Special Rapporteur Anand Grover asked nine countries to respond to specific allegations that the TPP would undermine the right to the highest standard of health. Only three governments bothered to respond, each defending the secrecy of the negotiations and lying about or minimizing the expected impact of the negotiation on access to medicines. Apparently the United States -- the leading target of the complaint and the most aggressive proponent of of high drug prices -- did not respond to Grover's July 19, 2011 letter [141]. In 2009, President Obama was awarded the Nobel Peace Prize, for "his extraordinary efforts to strengthen international diplomacy and cooperation between peoples." Apparently these "extraordinary efforts" do not extend to engagement with the UN's Special Rapporteur for the right to health on a topic that concerns life and death issues for millions of persons.

The responses by Australia and New Zealand on the issue of secrecy demonstrate how little each government respects its own citizens. When the Australian Government says it is "not convinced that publicly releasing contested text would assist informed public debate on the issues" you have to wonder how they arrive at this conclusion. Can you have an "informed public debate" on text that no one can see? New Zealand's statement that "in smaller trade negotiations whether bilateral or plurilateral . . . .not to release texts until the signature . . . is consistent with international practice" begs the question of whether or not the TPP can be considered one of the "smaller trade negotiations," and whether or not such secrecy is warranted at all for any trade agreement, or for every chapter and every paragraph in the TPP. As a practical matter, if Australia and New Zealand won't go on the record calling for the disclosure of the text, the Obama Administration will find it easy to maintain its policy of asymmetric access between big business and the public. We note that in the ACTA negotiations the European Parlliament forced the parties to disclose a copy of the negotiating text, and the Bush Administration published the entire text of the FTAA. Corporate lobbyists are always well informed, but public disclosure is done when governments recognize the legitimacy and value of an informed public.

James Love, Knowledge Ecology International, 27 September 2012.

Commentary by co-petitioners

The Chilean government’s answer to the UN Rapporteur for the Right to Health is ambiguous and misleading. In order to conceal the secret nature of the TPP negotiation and to ensure that no documentation is publicly available, the government declined to provide a clear answer. The fact is civil society has repeatedly requested access to TPP negotiating texts, but the Chilean government has denied access. In appeal, the Council for (Public) Transparency ordered the government to release supporting studies related to the negotiations, but it merely provided links to a few unrelated APEC documents dated back to 2009. But the answer is also misleading because it describes the role of Ministry of Health, but it omits the fact that the Ministry of Health has not been involved in negotiation in spite of the fact that several provisions of the TPP would seriously undermine access to medicines and public health in Chile.

Alberto Cerda Silva, Professor in Law, University of Chile Law School

Background

On 22 March 2011, Knowledge Ecology International (KEI), ten public interest groups and three law professors submitted a petition [142]to Anand Grover, the Special Rapporteur for the United Nations on the Right to Health.

A copy of the petition is available on the Internet here: http://www.keionline.org/node/1099 [142]

The Special Rapporteur was asked to intervene in a regional trade agreement named the Trans-Pacific Partnership (TPP) Agreement. In particular, the parties filing the complaint charge that the negotiations on intellectual property norms, in terms of process and substance, threaten and violate the right of hundreds of millions of persons to the enjoyment of the highest attainable standard of health.

At the time of the complaint, parties to the negotiations included the governments of Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, Vietnam and the United States. On 19 July 2011, the Special Rapporteur sent a communication separately to each of the nine governments drawing attention to the human rights concerns raised by the complainants. Australia, Chile and New Zealand were the only governments who responded to the Special Rapporteur's communique.

For the Special Rapporteur's communication to each of the nine countries, please click on the country links below.

• Australia [143]
• Brunei [144]
• Chile [145]
• Malaysia [146]
• New Zealand [147]
• Peru [148]
• Singapore [149]
• United States of America [141]
• Vietnam [150]

Please find the responses of Australia, Chile and New Zealand. It should be noted that none of the responses by these three countries provided satisfactory answers to the technical issues raised by the Special Rapporteur including the elimination of pre-grant opposition procedures, the elimination of Section 3(d) type patentability requirements that seek to prevent evergreening of patents, and requirement of parties to "provide ex-officio border measures with respect to in-transit goods that are suspected of using ‘confusingly similar’ trademarks (a separate category from counterfeit products)".

• Australia [151]
• Chile [152]
• New Zealand [153]

The major elements of the communication from the Special Rapporteur to each of the nine countries are reproduced below.

I have the honour to address you in my capacity as Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health pursuant to General Assembly resolution 60/251 and to Human Rights Council resolution 15/22.

In this connection, I would like to bring to your Excellency’s Government’s attention information I have received concerning According to the information received:

Since March 2010 several rounds of negotiations on the Trans Pacific Partnership (TPP) agreements have been held among the Governments of Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States and Vietnam. Intellectual property rights, including provisions for patents and the protection of regulatory test data on medical inventions, are reportedly on the agenda of the TPP negotiations.

It is alleged that the TPP negotiations have been conducted behind closed doors, without providing opportunities for persons, potentially affected by the TPP, to participate effectively and influence the outcome of the negotiations. Yet numerous entities from the private sector were allegedly provided with access to that information and could contribute to the negotiations.

Despite the alleged secrecy of the TPP negotiations, some information about the content of those negotiations was reportedly leaked. Accordingly, key parties to the negotiations proposed to eliminate ‘pre-grant opposition’ procedures. Those procedures are considered to be an important tool to prevent patent applicants from gaining patent monopolies based on weak or erroneous information, improve the quality and efficiency of patent office examinations, safeguard access to medicines and allow broad participation from civil society and other groups. It is alleged that alternative proposals discussed at the negotiations may not ensure the above-mentioned requirements and may limit the ability of developing countries to set patentability standards.

It is alleged that according to the negotiated TPP agreements parties would be required to provide ex officio border measures with respect to in-transit goods that are suspected of using ‘confusingly similar’ trademarks (a separate category from counterfeit products). In that context, it is alleged that differences in national policies on the standards for trademarks infringement involving medicines and geographically diverse trademark registrations would cause difficulties for legitimate generic manufacturers.

It is also alleged that some of the TPP’s intellectual property provisions would strengthen monopolies for life-saving medicines and create barriers for access to medicines. It is further alleged that new intellectual property standards would not only result in high prices for medicines but could also negatively impact the ability of developing countries to take positive steps towards ensuring the enjoyment of the right to health of their citizens.

I urge your Excellency’s Government to take all necessary measures to guarantee that the rights and freedoms of the aforementioned person(s) are respected and that accountability of any person guilty of the alleged violations is ensured. We also request that your Excellency’s Government adopts effective measures to prevent the recurrence of these acts.

Moreover, it is my responsibility under the mandates provided to me by the Human Rights Council, to seek to clarify all cases brought to my attention. Since I am expected to report on these cases to the Human Rights Council, I would be grateful for your cooperation and your observations on the following matters:

1. Are the facts alleged in the above summary of the case accurate?

2. Has a complaint been lodged?

3. Please provide the details, and where available the results, of any investigation, medical examinations, and judicial or other inquiries which may have been carried out in relation to this case. If no inquiries have taken place, or if they have been inconclusive, please explain why.

4. In the event that the alleged perpetrators are identified, please provide the full details of any prosecutions which have been undertaken; Have penal, disciplinary or administrative sanctions been imposed on the alleged perpetrators?

5. Please indicate whether compensation has been provided to the victim or the family of the victim.

I would appreciate a response within sixty days. I undertake to ensure that your Excellency’s Government’s response to each of these questions is accurately reflected in the reports I will submit to the Human Rights Council for its consideration.

Please accept, Excellency, the assurances of my highest consideration.

Anand Grover
Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health

Copyright Limitations and Exceptions: What does the secret TPPA text say?

[update: See: Leak of TPP text on copyright Limitations and Exceptions [158]]

This week, trade negotiators for the proposed Trans-Pacific Partnership Agreement (TPPA) are meeting in San Diego, where one are of focus concerns copyright policy. KEI earlier wrote to USTR with our concerns about the US proposals for copyright (see: http://www.keionline.org/node/1444 [159]). Today USTR published a blog, saying the "USTR Introduces New Copyright Exceptions and Limitations Provision at San Diego TPP Talks [160]." USTR said:

For the first time in any U.S. trade agreement, the United States is proposing a new provision, consistent with the internationally-recognized “3-step test," that will obligate Parties to seek to achieve an appropriate balance in their copyright systems in providing copyright exceptions and limitations for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. These principles are critical aspects of the U.S. copyright system, and appear in both our law and jurisprudence. The balance sought by the U.S. TPP proposal recognizes and promotes respect for the important interests of individuals, businesses, and institutions who rely on appropriate exceptions and limitations in the TPP region.

The United States is proposing this at the current round of TPP talks in San Diego. The proposal has benefited from the input of a wide range of stakeholders, and we look forward to discussing it further and sharing more information as the TPP negotiations progress.

I have not seen the USTR proposal, and have had some bad experiences in the past speaking about text I had not actually read. KEI’s concern is that if the 3-step test is introduced, at a minimum it just gives right holders two chances to knock something out (once at WTO, and once at TPPA). But it could be worse, if this is designed to apply to the many areas of the Berne and Rome conventions that are not now subject to the three step test.

Not all Berne exceptions are subject to 3-step test: Articles: 2(4,7), 2.bis, 10, 11, 11.bis(2-3), 13(1-2) and the Appendix are not subject to the 3-step test, and neither are the first sale doctrine (Article 6 of the TRIPS) or the control of anticompetitive practices in contracts (Article 40 of the TRIPS). Article 15(1) of the Rome Convention is also not subject to the three step test. Will the secret TPPA text change this?

Given the fact that the WTO rules already provide for its own version of the 3-step test, there is no reason for the USTR to propose additional text within the TPPA, unless it wants to extend the jurisdiction of the 3-step to areas not covered by the WTO, or to provide right holders two opportunities to claim a particular exception is too favorable to users.

KEI has not seen the USTR proposal, which USTR claims "benefited from the input of a wide range of stakeholders." We intend to ask USTR for the text, and also the names of the stakeholders who were consulted on the text.

UPDATE. USTR is reportedly claiming it had previously shown the TPPA text on copyright exceptions to people outside of the USTR advisory board system. We are asking USTR for details on this.

More on the 3-step agreement.

This is an elaboration on the 3-step test in multilateral agreements. The 1996 WCT Copyright treaty has bad language on the 3-step test, but the WCT is not now part of the TRIPS agreement, and is only subject to dispute resolution via trade agreements outside of the WTO, like the TPPA.

If the WCT is referenced under the general provisions to the TPPA, you also get the 3-step test in the TPPA, subject, however, to the agreed upon statement regarding Article 10, which is helpful.

Note also that both Article 10 and the agreed upon statement regarding Article 10 the WCT were written in 1996, before the 2000 WTO decision on Section 110(5) of the United States Copyright Act. (See: World Trade Organisation Dispute Resolution Panel Report on Section 110(5) of the United States Copyright Act, http://www.wto.org/english/tratop_e/dispu_e/1234da.pdf [161]). The 2000 WTO panel decision presented a restrictive view of the WTO's version of the 3-step test (Article 13 of TRIPS), motivating a number of academics to argue for a new interpretation of the 3-step test that is more liberal. One influential expression of this view is the Declaration on a Balanced Interpretation of the "Three-Step Test" in Copyright Law. (http://www.ip.mpg.de/de/pub/aktuelles/declaration-threesteptest.cfm [162]).

The initial 3-step test was connected to Article 9 of the Berne Convention.

Berne Convention for the Protection of Literary and Artistic Works
Article 9
Right of Reproduction:
1. Generally; 2. Possible exceptions; 3. Sound and visual recordings

(1) Authors of literary and artistic works protected by this Convention shall have the exclusive right of authorizing the reproduction of these works, in any manner or form.

(2) It shall be a matter for legislation in the countries of the Union to permit the reproduction of such works in certain special cases, provided that such reproduction does not conflict with a normal exploitation of the work and does not unreasonably prejudice the legitimate interests of the author.

(3) Any sound or visual recording shall be considered as a reproduction for the purposes of this Convention.

A modified version appeared in the 1994 WTO TRIPS Agreement. Among other things, the TRIPS 3-step test was not specifically related to the reproduction right in the Berne Convention, and it replaced author with right holder, reflecting the more corporate focus of the TRIPS. It is also interesting to note that the provisions in the TRIPS concerning both patents and trademarks have different three-step tests, that give status to third parties.

1994 WTO Agreement On Trade-Related Aspects Of Intellectual Property Rights (TRIPS)

SECTION 1: COPYRIGHT AND RELATED RIGHTS
Article 13 Limitations and Exceptions

Members shall confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.

SECTION 2: TRADEMARKS
Article 17 Exceptions

Members may provide limited exceptions to the rights conferred by a trademark, such as fair use of descriptive terms, provided that such exceptions take account of the legitimate interests of the owner of the trademark and of third parties.

SECTION 5: PATENTS
Article 30 Exceptions to Rights Conferred

Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

Yet another version was included as Article 10 of the 1996 WCT.

WIPO Copyright Treaty
(adopted in Geneva on December 20, 1996)

Article 10 Limitations and Exceptions

(1) Contracting Parties may, in their national legislation, provide for limitations of or exceptions to the rights granted to authors of literary and artistic works under this Treaty in certain special cases that do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the author.

(2) Contracting Parties shall, when applying the Berne Convention, confine any limitations of or exceptions to rights provided for therein to certain special cases that do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the author.10

/10/ Agreed statement concerning Article 10: It is understood that the provisions of Article 10 permit Contracting Parties to carry forward and appropriately extend into the digital environment limitations and exceptions in their national laws which have been considered acceptable under the Berne Convention. Similarly, these provisions should be understood to permit Contracting Parties to devise new exceptions and limitations that are appropriate in the digital network environment.

It is also understood that Article 10(2) neither reduces nor extends the scope of applicability of the limitations and exceptions permitted by the Berne Convention.

The 3-Step test in FTA agreements

On January 1, 1994, the North American Free Trade Agreement between the United States, Canada, and Mexico (NAFTA) entered into force.

NAFTA
Article 1705: Copyright

5. Each Party shall confine limitations or exceptions to the rights provided for in this Article to certain special cases that do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.

The United States-Jordan Free Trade Agreement (FTA) entered into force on December 17, 2001. Note the NAFTA language referring to limitation and exceptions "to the rights provided for in this Article" became limitations and exceptions "to exclusive rights" in the US/Jordan FTA.

United States-Jordan Free Trade Agreement (FTA)
ARTICLE 4: INTELLECTUAL PROPERTY RIGHTS
Copyright and Related Rights

16. Each Party shall confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holders.

The United States-Chile Free Trade Agreement (FTA) entered into force on January 1, 2004. The US/Chile FTA brought back the reference to "limitations and exceptions to rights" language from NAFTA, and added a footnote 17 which provided a common understanding of how the 3-step test would be interpreted on certain issues.

United States-Chile Free Trade Agreement (FTA)
Article 17.5: Copyright

3. Each Party shall confine limitations or exceptions to rights to certain special cases which do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.17

/17/ Article 17.7(3) permits a Party to carry forward and appropriately extend into the digital environment limitations and exceptions in its domestic laws which have been considered acceptable under the Berne Convention. Similarly, these provisions permit a Party to devise new exceptions and limitations that are appropriate in the digital network environment. For works, other than computer software, and other subject- matter, such exceptions and limitations may include temporary acts of reproduction which are transient or incidental and an integral and essential part of a technological process and whose sole purpose is to enable (a) a lawful transmission in a network between third parties by an intermediary; or (b) a lawful use of a work or other subject-matter to be made; and which have no independent economic significance.

Article 17.7(3) neither reduces nor extends the scope of applicability of the limitations and exceptions permitted by the Berne Convention, the WIPO Copyright Treaty (1996), and the WIPO Performances and Phonograms Treaty (1996).

The United States-Singapore Free Trade Agreement (FTA) entered into force on January 1, 2004.

United States-Singapore Free Trade Agreement (FTA)

ARTICLE 16.4 : OBLIGATIONS COMMON TO COPYRIGHT AND RELATED RIGHTS

2. (a) Without prejudice to Articles 11(1)(ii), 11bis(1)(i) and (ii), 11ter(1)(ii), 14(1)(ii), and 14bis(1) of the Berne Convention for the Protection of Literary and Artistic Works (1971) (“Berne Convention”), each Party shall provide to authors, performers, producers of phonograms and their successors in interest the exclusive right to authorize or prohibit the communication to the public of their works, performances, or phonograms, by wire or wireless means, including the making available to the public of their works, performances, and phonograms in such a way that members of the public may access them from a place and at a time individually chosen by them. Notwithstanding paragraph 10, a Party may provide limitations or exceptions to this right in the case of performers and producers of phonograms for analog or digital free over-the-air terrestrial broadcasting and, further, a Party may provide limitations with respect to other non-interactive transmissions, in certain special cases provided that such limitations do not conflict with a normal exploitation of performances or phonograms and do not unreasonably prejudice the interests of such right holders.

[...]

10. Each Party shall confine limitations or exceptions to exclusive rights in Articles 16.4 and 16.5 to certain special cases which do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.

ARTICLE 17.5 : COPYRIGHT WORKS

ARTICLE 17.6 : PERFORMERS AND PRODUCERS OF PHONOGRAMS

3. (c) Each Party may adopt limitations to this right in respect of other non-interactive transmissions in accordance with Article 17.4.10, provided that the limitations do not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

The United States-Australia Free Trade Agreement (FTA) entered into force on January 1, 2005.

United States-Australia Free Trade Agreement (FTA)
ARTICLE 17.4 : COPYRIGHT

10. With respect to Articles 17.4, 17.5, and 17.6:

(a) each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder;

(b) notwithstanding sub-paragraph (a) and Article 17.6.3(b), neither Party may permit the retransmission of television signals (whether terrestrial, cable, or satellite) on the Internet without the authorisation of the right holder or right holders, if any, of the content of the signal and of the signal;

(c) unless otherwise specifically provided in this Chapter, nothing in this Article shall be construed as reducing or extending the scope of applicability of the limitations and exceptions permitted under the agreements referred to in Articles 17.1.2 and 17.1.4 and the TRIPS Agreement.

ARTICLE 17.6 : PERFORMERS AND PRODUCERS OF PHONOGRAMS

3. (a) Each Party shall provide to performers and producers of phonograms the right to authorise or prohibit the broadcasting or any communication to the public of their performances or phonograms by wire or wireless means, including the making available to the public of those performances and phonograms in such a way that members of the public may access them from a place and at a time individually chosen by them.

(b) Notwithstanding sub-paragraph (a) and Article 17.4.10, the application of this right to traditional free over-the-air (i.e., non-interactive) broadcasting, and exceptions or limitations to this right for such broadcasting activity, shall be a matter of each Party’s law.

(c) Each Party may adopt limitations to this right in respect of other non-interactive transmissions in accordance with Article 17.4.10, provided that the limitations do not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

The United States-Morocco Free Trade Agreement (FTA) entered into force on January 1, 2006.

United States-Morocco Free Trade Agreement (FTA)
ARTICLE 15.5: COPYRIGHT AND RELATED RIGHTS

11. (a) With respect to this Article and Articles 15.6, and 15.7, each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.
(b) Notwithstanding subparagraph (a) and Article 15.7.3(b), neither Party may permit the retransmission of television signals (whether terrestrial, cable, or satellite) on the Internet without the authorization of the right holder or right holders of the content of the signal, if any, and of the signal.

ARTICLE 15.6: COPYRIGHT

ARTICLE 15.7: RELATED RIGHTS

3. (a) Each Party shall provide to performers and producers of phonograms the right to authorize or prohibit the broadcasting or any communication to the public of their performances or phonograms, by wire or wireless means, including the making available to the public of those performances and phonograms in such a way that members of the public may access them from a place and at a time individually chosen by them.

(b) Notwithstanding subparagraph (a) and Article 15.5.11, the application of this right to traditional free over-the-air (i.e., noninteractive) broadcasting, and exceptions or limitations to this right for such activity, shall be a matter of each Party’s law.

(c) Each Party may adopt limitations to this right in respect of other noninteractive transmissions in accordance with Article 15.5.11, provided that the limitations do not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

The United States-Bahrain Free Trade Agreement (FTA) entered into force on January 11, 2006

United States-Bahrain Free Trade Agreement (FTA)
ARTICLE 14.4: OBLIGATIONS PERTAINING TO COPYRIGHT AND RELATED RIGHTS

10. (a) With respect to this Article and Articles 14.5 and 14.6, each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.

(b) Notwithstanding subparagraph (a) and Article 6.3(b), neither Party shall permit the retransmission of television signals (whether terrestrial, cable, or satellite) on the Internet without the authorization of the right holder or right holders of the content of the signal and, if any, of the signal.

ARTICLE 14.5: OBLIGATIONS PERTAINING SPECIFICALLY TO COPYRIGHT

ARTICLE 14.6: OBLIGATIONS PERTAINING SPECIFICALLY TO RELATED RIGHTS
3. (a) Each Party shall provide to performers and producers of phonograms the right to authorize or prohibit the broadcasting or any communication to the public of their performances or phonograms, by wire or wireless means, including the making available to the public of those performances and phonograms in such a way that members of the public may access them from a place and at a time individually chosen by them.

(b) Notwithstanding subparagraph (a) and Article 14.5.10, the application of this right to analog transmissions and free over-the-air broadcasts, and exceptions or limitations to this right for such activity, shall be a matter of domestic law.

(c) Each Party may adopt limitations to this right in respect of other noninteractive transmissions in accordance with Article 4.4.10, which shall not be prejudicial to the right of the performer or producer of phonograms to obtain equitable remuneration.

The CAFTA-DR (Dominican Republic-Central America FTA) entered into force for the United States and El Salvador, Guatemala, Honduras, and Nicaragua during 2006, for the Dominican Republic on March 1, 2007, and for Costa Rica on January 1, 2009. With the addition of Costa Rica, the CAFTA-DR is in force for all seven countries that signed the agreement.

CAFTA-DR (Dominican Republic-Central America FTA)

Article 15.5: Obligations Pertaining to Copyright and Related Rights

10 (a): With respect to Articles 15.5, 15.6, and 15.7, each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.

Article 15.7: Obligations Pertaining Specifically to Related Rights

3. (a) Each Party shall provide to performers and producers of phonograms the right to authorize or prohibit the broadcasting or any communication to the public of their performances or phonograms, by wire or wireless means, including the making available to the public of those performances and phonograms in such a way that

(b) Notwithstanding subparagraph (a) and Article 15.5.10, the application of this right to traditional free over-the-air noninteractive broadcasting, and exceptions or limitations to this right for such broadcasting, shall be a matter of domestic law.

(c) Each Party may adopt limitations to this right in respect of other noninteractive transmissions in accordance with Article 15.5.10, provided that the limitations do not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

The United States-Peru Free Trade Agreement (FTA) entered into force on February 1, 2009.

United States-Peru Free Trade Agreement (FTA)
Article 16.6: Related Rights

6. (a) Each Party shall provide to performers and producers of phonograms the right to authorize or prohibit the broadcasting or any communication to the public of their performances or phonograms, by wire or wireless means, including the making available to the public of those performances and phonograms in such a way that members of the public may access them from a place and at a time individually chosen by them.

(b) Notwithstanding subparagraph (a) and Article 16.7.8, the application of this right to analog transmissions and free over-the-air broadcasts, and exceptions or limitations to this right for such activity, shall be a matter of each Party’s law.

(c) Any limitations to this right in respect of other noninteractive transmissions shall be in accordance with Article 16.7.8 and shall not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

Article 16.7: Obligations Common to Copyright and Related Rights

8. With respect to Articles 16.5 through 16.7, each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.

9. Notwithstanding Articles 16.7.8 and 16.6.6(b), no Party may permit the retransmission of television signals (whether terrestrial, cable, or satellite) on the Internet without the authorization of the right holder or right holders of the content of the signal and, if any, of the signal.

The U.S.-Korea trade agreement entered into force on March 15, 2012.

U.S.-Korea trade agreement
ARTICLE 18.4: COPYRIGHT AND RELATED RIGHTS

Footnote 11 to Article 18.4.1.

/11/ Each Party shall confine limitations or exceptions to the rights described in paragraph 1 to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder. For greater certainty, each Party may adopt or maintain limitations or exceptions to the rights described in paragraph 1 for fair use, as long as any such limitation or exception is confined as stated in the previous sentence.

10. (a) With respect to this Article and Articles 18.5 and 18.6, each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.

ARTICLE 18.5: COPYRIGHT
ARTICLE 18.6: RELATED RIGHTS

ARTICLE 18.6: RELATED RIGHTS

3. (c) Each Party may adopt limitations to this right in respect of other noninteractive transmissions in accordance with Article 18.4.10, provided that the limitations do not prejudice the right of the performer or producer of phonograms to obtain equitable remuneration.

Beijing treaty on audiovisual performances, adopted by the Diplomatic Conference on June 24, 2012

Beijing treaty on audiovisual performances

Article 1 Relation to Other Conventions and Treaties

(3) This Treaty shall not have any connection with treaties other than the WPPT, nor shall it prejudice any rights and obligations under any other treaties1,2.

/fn 1/ Agreed statement concerning Article 1: It is understood that nothing in this Treaty affects any rights or obligations under the WIPO Performances and Phonograms Treaty (WPPT) or their interpretation and it is further understood that paragraph 3 does not create any obligations for a Contracting Party to this Treaty to ratify or accede to the WPPT or to comply with any of its provisions.

/fn 2/ Agreed statement concerning Article 1(3): It is understood that Contracting Parties who are members of the World Trade Organization (WTO) acknowledge all the principles and objectives of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and understand that nothing in this Treaty affects the provisions of the TRIPS Agreement, including, but not limited to, the provisions relating to anti-competitive practices.

Article 13 Limitations and Exceptions

(1) Contracting Parties may, in their national legislation, provide for the same kinds of limitations or exceptions with regard to the protection of performers as they provide for, in their national legislation, in connection with the protection of copyright in literary and artistic works.

(2) Contracting Parties shall confine any limitations of or exceptions to rights provided for in this Treaty to certain special cases which do not conflict with a normal exploitation of the performance and do not unreasonably prejudice the legitimate interests of the performer /9/.

/fn 9/ Agreed statement concerning Article 13: The Agreed statement concerning Article 10 (on Limitations and Exceptions) of the WIPO Copyright Treaty (WCT) is applicable mutatis mutandis also to Article 13 (on Limitations and Exceptions) of the Treaty.

/fn 10/ Agreed statement concerning Article 15 as it relates to Article 13: It is understood that nothing in this Article prevents a Contracting Party from adopting effective and necessary measures to ensure that a beneficiary may enjoy limitations and exceptions provided in that Contracting Party’s national law, in accordance with Article 13, where technological measures have been applied to an audiovisual performance and the beneficiary has legal access to that performance, in circumstances such as where appropriate and effective measures have not been taken by rights holders in relation to that performance to enable the beneficiary to enjoy the limitations and exceptions under that Contracting Party’s national law. Without prejudice to the legal protection of an audiovisual work in which a performance is fixed, it is further understood that the obligations under Article 15 are not applicable to performances unprotected or no longer protected under the national law giving effect to this Treaty.

See also

Joint statement from EFF, Knowledge Ecology International, Public Knowledge, and Public Citizen. http://keionline.org/node/1453 [163]

From a December 2011 WTO meeting: Rachel Marusak Hermann, IP Experts Focus On 3-Step Test In Copyright, Discuss Way Forward [164], IP-Watch.

Wikipedia on the Berne three step test. [165]

Max Planck Declaration on the Three Step Test [162].

KEI letter to USTR regarding TPPA copyright provisions

The governments of Brunei, Chile, New Zealand, Singapore, Australia, Malaysia, Peru, Vietnam and the United States are negotiating a multilateral free trade agreement known as the Trans-Pacific Partnership Agreement (TPP). The negotiations are being conducted with considerable secrecy, even though they address many issues of great interest to the general public. The Agreement will cover many topics, including intellectual property rights, the pricing of pharmaceutical drugs, and the rights of investors to sue states over policies and actions that impact their investments. USTR has indicated that Mexico and Canada will be joining the negotiations later this year. The next round of negotiation takes place in San Diego, California from July 2-10, 2012. USTR will be hosting a Direct Stakeholder Engagement event on Monday, July 2, 2012.

The USTR web page on the negotiation is: http://www.ustr.gov/tpp/ [166]. The KEI web page on the negotiation is http://keionline.org/tpp [167], and contains links to many documents and the web pages of other NGOs following the negotiation.

On June 26, 2012, KEI sent a letter to USTR addressing copyright, the primary focus of intellectual property chapter discussions during the San Diego round.

A copy of the letter, which is available here [4], addresses the following points:

• The TPPA IPR text is too restrictive as regards temporary reproductions
• The TPPA IPR text should not ban parallel of importation of copyrighted works
• The TPPA should not legislate the term of copyright protection.
• The TPPA should not create a separate cause of action for circumvention of a TPM
• The TPPA should not require “substantial evidence” for legitimate limitations and exceptions to TPMs
• Robust user rights are needed for the placeholders for limitations and exceptions
• TPPA should not propose TRIPS plus damages for copyright
• KEI Comments on the General Provisions and the treaties to which parties must sign

KEI notes from Eighth Round of TPPA Negotiations

Krista Cox wrote these notes on September 13, 2011, reporting on the eighth round of negotiations for the Trans-Pacific Partnership Agreement (TPPA).

The round began on 6 September 2011 in Chicago, IL and continued through 15 September. Official stakeholder engagement was limited to 9-11 September, with a reception on the 9th, a "platform" for presentations on the 10th, and a 45 minute briefing to stakeholders on the 11th. Notably, during this round, USTR tabled the remainder of its proposals for the IP chapter, including controversial provisions relating to data protection for pharmaceutical products, patent linkage and patent term extensions. We believe that all substantive IP proposals from the parties have now been tabled.

Chief TPPA negotiators for Chicago round, September 11, 2011. Photo by Krista Cox.

Stakeholder Platform
On Saturday, 10 September, a broad range of stakeholders, including industry, NGOs and academics, were given the opportunity to present. However, because of the length of this negotiating round and consecutive days of negotiations, some negotiators indicated that they would not attend the presentations. For the negotiators that did attend, because the platforms were split across three rooms with simultaneous presentations occurring, they had to choose which presentations to attend. Although most of the IP presentations occurred in the same room, there were some on medicines that occurred simultaneously in another room.

I presented on areas where USTR's proposal for the IP chapter could be inconsistent with current U.S. law [52] and impede current legislative areas to reform areas of known concern.

Professor of Law from Duke University, James Boyle, gave an excellent and entertaining presentation on the need for evidence-based proposals in the TPPA, such as the US proposal to extend copyright to life plus seventy years. He also noted that IP protection is not always needed to provide incentives to "invent." For example, he noted, business methods were created long before patents because greed and fear provided sufficient motivation.

It was unfortunate that Boyle only received 10 minutes to speak when the majority of presenters were allotted twenty minutes. KEI ceded half its time slot to Boyle after being told by USTR (when we requested a time slot for Jamie Boyle a couple days after platform registration had closed) that the presentations would end at 6:20 p.m. and that slotting additional platforms after that would be too late. USTR suggested that we allocate some of our time to Boyle, which we did. However, after receiving the schedule shortly before the negotiating round began, three presentations were slated for 6:20 p.m. or later, and given my prior communication with USTR, I presume that these were late registrants. The three presenters included: BIO, Nucor Corporation and the U.S. Chamber of Commerce. Additionally, Ed Gresser from the Alliance for Healthcare Competitiveness did not present, but instead was replaced by a presenter from Johnson & Johnson. I find it extremely unfortunate that a full time slot could not be allocated to an academic (and that our own time slot was shortened) given that representatives from the private, corporate sector were given full time slots late in the day.

Some other notable presenters on IP or access to medicines included: Electronic Frontier Foundation (EFF), Public Knowledge (PK), Free Software Foundation, HAI Peru, Public Citzen, the Motion Pictures Association of America (MPAA), Internet NZ, PhRMA, American University's Program on Information Justice and Intellectual Property (PIJIP), the Center for Policy Analysis on Trade and Health, the American Medical Association and Sharon Treat, a Maine state representative.

Stakeholder Briefing
At the stakeholder briefing on 11 September, Chief Negotiator for the US, Barbara Weisel, began with a statement that "the courtship is over, the bloom is off the rose, now is the time for the work that will make the marriage between our countries work" and indicated that negotiations had moved into the more difficult sections, covering the more sensitive issues. However, she remained optimistic and stated that the partners were committed to moving to the APEC summit in Honolulu in November. When pressed, she admitted that she does not know what the November document or statement will look like, and that the negotiators will have to take stock after the next round of negotiations in Lima in October.

With regard to substantive issues, Weisel indicated that the US would table the remainder of its intellectual property text during the Chicago round of negotiations, but that some other chapters, such as labor, still had outstanding text. Peru also stated that it would table text in a future round, specifically noting that horizontal issues would be presented in the next round of negotiations in Lima.

When specifically asked about USTR's remaining IP text and the May 10, 2007 agreement [168], Weisel said that she would not comment on the US proposal. She stated that a USTR white paper on medicines would be publicly released the following day. Additionally, when specifically pressed about TRIPS-plus proposals, Weisel claimed that her office did not think of proposals in terms of being TRIPS-plus or not TRIPS-plus. Responding to a question on whether the US has presented any evidence to support its TRIPS-plus proposals, Weisel said that the parties don't necessarily discuss "philosophy" or engage in academic debates during the negotiations.

The New Zealand chief negotiator commented that text on state owned enterprises (SOEs) had not yet been tabled. Earlier in the week, KEI learned that USTR did have text ready to present on SOEs, but after calling in the U.S. Chamber of Commerce for a debriefing on 7 September, the U.S. Chamber reportedly asked USTR not to table the text because they were unhappy with the precedence the text could set, indicating yet another example where trade policy is dictated by the private sector.

Transparency, or the lack thereof, continues to be a deep concern for NGOs and academics. At the Vietnam round of negotiations, the Vietnamese Chief Negotiator indicated that each country could determine for itself whether to release the text. Since then, several individuals have requested the text from their home country, but have been denied. In Chile, the refusal to release the text was accompanied by a letter stating that all countries had signed an agreement at the outset of negotiations agreeing to keep negotiating text confidential. We note that the leaked copy of the US IP Chapter [5] references guideline "1.4(b)" in classifying the document. When asked whether the countries could release the text of the memorandum of understanding signed between all nine trading partners, Weisel said that it was an issue that would have to be discussed.

With respect to the release of the actual text, Weisel stated that release would not happen. She asserted that USTR had been more transparent and actively engaged with its stakeholders than in any other negotiation. Despite repeated stakeholder comments that the process in other negotiating fora have been much more transparent and open, Weisel maintained that the TPPA negotiations have been transparent.

The chief negotiator from Malaysia said that he was not sure that there was any text in the TPPA for the protection of indigenous people.

Intellectual Property Concerns
On 12 September 2011, USTR tabled the remainder of its intellectual property chapter text, including the controversial provisions on data protection for pharmaceutical products, patent linkage and patent term extensions. In conjunction with its new text, USTR also distributed a public white paper [169] on access to medicines. Although we had been led to believe that this white paper would defend USTR's positions on its newly tabled text, the paper contains little substance and does not describe the text of these provisions.

As noted above, Weisel refused to comment on the substance of the proposals. However, based on the information contained in the USTR white paper and discussions with USTR officials including Stan McCoy, data protection for pharmaceutical products, patent linkage and patent term extensions are all on the table as being included as protections that would be provided where companies register their drug within a certain time "window." McCoy called the USTR proposal an "enhancement" from the May 10, 2007 deal, claiming that the new proposal would incentivize innovators to register their products in developing countries and that patients in these countries would then have access to drugs they would not have in the past. However, as noted by KEI and other groups [170], USTR's proposal is really something that benefits big pharma rather than actually improving access to affordable medicines in developing countries.

Additionally, it has been reported that differential treatment of countries has not been proposed for IP and the US proposal would apply to all TPPA trading partners. Because of the late tabling of the text (just one day prior to the conclusion of the IP negotiations for this round), it does not seem that the new USTR proposals would be discussed during the Chicago round as many negotiators wanted time to carefully analyze the new text.

As a whole, it appears that there is growing and vocal opposition to USTR's aggressive IP positions. It seems like the four countries that already have free trade agreements with the US--Australia, Chile, Peru and Singapore--may be unwilling to go beyond that which is already contained in their existing FTAs. Some other countries who do not currently have FTAs with the U.S., such as New Zealand and Vietnam, have reportedly also been vocal in opposing the U.S. positions. It seems as though Chile and New Zealand may have moved to a common position (they had each tabled separate IP chapter proposals previously) and their position may be joined by other countries. It seems as though some are still waiting to see what Peru's current positions are given somewhat recent election of President Humala (who had campaigned against the US-Peru FTA).

Other Points of Interest

USTR head Ron Kirk and Chicago Mayor Rahm Emanuel at a September 9 TPPA stakeholder event. Photo by Krista Cox.

Ambassador Ron Kirk and current Mayor of Chicago (and former White House Chief of Staff to President Obama) Rahm Emmanuel both attended the reception on 9 September and provided some opening remarks. Ambassador Kirk seemed quite confident that a framework would be announced at the November APEC meeting. The reception was sponsored by a number of companies including Microsoft.

A number of demonstrations and civil society activities occurred during the first week of negotiations. On Labor Day hundreds of labor activists gathered in Grant Park to protest the TPPA, including Ben and Jerry from Ben & Jerry's Ice Cream. They announced the collection of 20,000 postcards protesting the TPPA, some of which were personally delivered by Arthur Stamoulis of Citizens Trade Campaign to Ambassador Kirk at the reception. On Wednesday, AIDS activists joined together to "close" the entrance of the Hilton hotel, where negotiations occurred, declaring it a crime scene because of the deadly impact the agreement could have as a result of the aggressive IP provisions that will make it more difficult for generic drugs to enter the market. Jennifer Flynn from HealthGAP hand-delivered the recently released Malaysian Declaration on TPPA and Access to Medicines [171] to Barbara Weisel at the stakeholder briefing.

Finally, a few notes on future rounds. The Peruvian Chief Negotiator stated that the next round of negotiations will also be an extended round. The dates are now set for 19-28 October. A Peruvian IP negotiator stated that the second week of negotiations will be held at the Marriott hotel in Lima, Peru. The APEC summit in Honolulu in November will not be a negotiating round for the TPPA. It does sound like there will be an "abbreviated" round of negotiations following APEC that will take place in Malaysia in December, with rumors that the next round after that will be in Australia in January. Dates and cities for the Malaysian and Australian rounds have yet to be confirmed.

Leak of TPP text on copyright Limitations and Exceptions

Below is a leak of the negotiating text from the TPP trade agreement, on copyright limitations and exceptions. For some additional context on this issue, see: "What does the secret TPPA text say about copyright exceptions?" http://keionline.org/node/1451 [172],
"Berne Exceptions not subject to 3-step test" http://keionline.org/node/1518 [173], and the Peter Jaszi, Michael Carroll and Sean Flynn statemen: http://infojustice.org/archives/26799 [174].

Note that the US and Australia are both presenting very restrictive text, and Peru and Singapore are both willing to accommodate the bad language. For example, see:

"US/AU oppose: Paragraph 1 permits a party to carry forward and appropriately extend into the digital environment limitations and exceptions in its domestic laws. Similarly, these provisions permit a Party to devise new"

and

93 Negotiator’s Note: SG/PE: Can accept both versions of paragraph 1.

What was presented by USTR with great fanfare as language on "balance in providing limitations and exceptions" is preceded with this language which actually makes the TPPA more restrictive than the TRIPS or the WCT: "Subject to and consistent with paragraph (1)."

Among other things, this puts copyright exceptions for "criticism, comment, news reporting, teaching, scholarship and research" under a restrictive 3-step test, even in the areas where the Berne Convention and the TRIPS have different standards for exceptions, such as fair practice, or a total green light.

The leaked text follows:

Article QQ.G.16: Limitations and Exceptions

[US:
1. [US/AU: With respect to this Article [(Article 4 on copyright) and Article 5 and 6 (which deal with copyright and related rights section and the related rights section)], each Party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance, or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.]

2. Subject to and consistent with paragraph (1), each Party shall seek to achieve an appropriate balance in providing limitations or exceptions, including those for the digital environment, giving due consideration to legitimate purposes such as, but no limited to, criticism, comment, news reporting, teaching, scholarship and research.92]

[NZ/CL/MY/BN/VN propose; AU/US oppose93: 1. Each party may provide for limitations and exceptions to copyrights, related rights, and legal protections for technological protections measures and rights management information included in this Chapter, in accordance with its domestic laws and relevant international treaties that each are party to.]

[US/AU propose: With respect to this Article and Articles 5 and 6, each party shall confine limitations or exceptions to exclusive rights to certain special cases that do not conflict with a normal exploitation of the work, performance or phonogram, and do not unreasonably prejudice the legitimate interests of the right holder.]

2. [NZ/CL/MY/BN/VN propose; US/AU oppose: Paragraph 1 permits a party to carry forward and appropriately extend into the digital environment limitations and exceptions in its domestic laws. Similarly, these provisions permit a Party to devise new] [US/AU propose; NZ/CL/MY/BN/VN oppose: its understood that each party may, consistent with the foregoing, adopt or maintain] exceptions and limitations for the digital environment.]

---
92 [US: For purposes of greater clarity, a use that has commercial aspects may in appropriate circumstances be considered to have a legitimate purpose under paragraph 2]
93 Negotiator’s Note: SG/PE: Can accept both versions of paragraph 1.

Note that Australia is not shown asking for this provision that they have in their current AU/US/FTA

(c) unless otherwise specifically provided in this Chapter, nothing in this Article shall be construed as reducing or extending the scope of applicability of the limitations and exceptions permitted under the agreements referred to in Articles 17.1.2 and 17.1.4 and the TRIPS Agreement.

USTR is putting US Fair use exceptions at risk, by creating a situation where Berne Articles: 2(4,7), 2.bis, 10 and 10bis provide special flexibility, but for which USTR proposes be put under the 3 step test in the TPP. The US/AU proposal is also narrowing the flexibilities for related rights, and making compulsory licenses or liability rules more difficult -- something important for solutions to the orphan works problem.

Dear Congress: WHY IS THIS NEGOTIATING TEXT KEEP SECRET FROM THE PUBLIC?

Leaks are hard to come by, and do not invite as much scrutiny as official versions that are shared with the public.

• August 3, 2012, Carolina Rossini, New leaked TPP text puts fair use at risk [175], EFF.
• August 5, 2012. Megan Geuss, Leaked: US proposal on copyright's limits. A TPP draft looks more restrictive than some had hoped [176]. Ars Technica
• August 6, 2012. Juha Saarien, Australia pushes for restrictive copyright in TPP. Sides with US in closed-door battle [177]. ITnews for Australian Business
• August 6, 2012. DJ Pangburn. New copyright proposal threatens right to parody, commentary, even reporting [178]. Death and Taxes.
• August 6, 2012. Mike Masnick. TPP Text On Fair Use Leaks; US Proposals Are Really About Limiting Fair Use, Not Expanding It. from the unfortunate dept [179]. TechDirt.com
• August 6, 2012. Kimberlee Weatherall, copyright expert and associate professor in Sydney University's Faculty of Law, Are we still America’s deputy IP sheriff in the Asia-Pacific? [180] Crikey
• August 6, 2012. Zach Walton TPP Leak Shows That The U.S. Wants To Restrict Fair Use [181]. Webpronews
• August 7, 2012, Peter Martin, Time to come clean on US bedfellow, minister [182], The Sydney Morning Herald
• August 7, 2012. Peter Martin, Emerson chasing deals that look like sellouts [183], Sydney Morning Herald.
• August 7, 2012. Suzanne Tindal. Australia jumping off a copyright cliff with TPP [184]. Znet
• August 7, 2012. Michael Geist. TPP Fair Use Proposal Leaks Raising Concerns About New Restrictions [185].
• August 7, 2012. John Hilvert. Govt rejects copyright limit claims in TPP talks [186]. ITnews
• August 7, Terry Hart. Three Step Turnaround [187]. The Copyright Alliance. Terry Hart doesn't know much about the topic (such as which exceptions are actually subject to the 3-step test in different agreements), but has strong opinions.

Members of Congress and Governors backing PhRMA/BIO, calling for 12 years data protection for biologic drugs in TPP

While the GOP and Democratic conventions highlight the differences between the parties, there are some bipartisan issues, and one of the biggest is taking care of corporate interests.

PhRMA has published a "Note To Media On Elected Officials Support For 12 Years of Data Protection In TPP [188]". These are the letters from Members of Congress that PhRMA cites as supporting their position, calling for a requirement of 12 years of exclusive rights for test data protection in the TPP negotiations. Note that PhRMA/BIO support is deeply bipartisan, including many Democratic liberals such as Ed Markey, Patty Murray, John Kerry, etc.

The level of engagement by members of Congress and governors the 12 year test data issue illustrates both how dependent upon and corrupted by corporate campaign money is the Congress, and how little U.S. political figures care about people living in developing countries, where this policy [189] is expected to have the greatest harm.

August 10, 2012. Eight US Governors (Arkansas, Colorado, Iowa, Massachusetts, New Jersey, North Carolina, Oklahoma, Washington) write President Obama calling for 12 years of protection for biologics test data in TPP.
http://phrma.org/sites/default/files/2351/2012tppbiologicslttfromgovsfinal.pdf [190]
This is a quote from the letter:

Given the substantial complexities of bringing biologics to market and the significant investment required to establish, and sustain development, it is critical that the TPP include 12 years of biologics data protection as found in U.S. law.

Among those signing the letter were five democrat (Mike Beebe D-Arkansas, John Hickenlooper D-Colorado, Deval Patrick D-Massachusetts, Bev Perdue D-North Carolina, Chris Gregoire D-Washington) and three GOP (Terry Branstad R-Iowa, Chris Christie R-New Jersey, Mary Fallin R-Oklahoma) governors.

August 6, 2012. Letter from Senator Claire McCaskill to President Obama, calling for 12 years of biologics data protection in TPP.
http://phrma.org/sites/default/files/2351/tppletterobamabiologicsfinal.pdf [191]

July 13, 2012. Letter from eight democratic members of Massachusetts Delegation to House of Representatives calling for 12 years of biologics test data protection in TPP. Signing the letter were Ed Markey (D, MA-7), Richard E. Neal (D, MA-2), John W. Olver (D, MA-1), James P McGovern (D, MA-3), John F. Tierney (D, MA-6), Stephen Lynch (D, MA-9), Niki Tsongas (D, MA-5), William Keating (D, MA-10).
http://phrma.org/sites/default/files/2351/7-13-2012madelegationletterrebiologicsintpp.pdf [192]

July 12, 2012. Letter from Senators Patty Murray (D-WA) and Maria Cantwell (D-WA), calling for "robust intellectual property rights for biologics" including 12 years of biologics data protection in TPP.
http://phrma.org/sites/default/files/2351/murraycantwelltppbiologicsletter071212.pdf [193]

May 11, 2012. Sen. Menendez (D-NJ) Letter calling for 12 years of test data protection for biologcs in TPP.
http://phrma.org/sites/default/files/2351/menendezletteronipprotectionsintpp051112.pdf [194]

May 4, 2012. TPP Letter from Senators Kay Hutchison (R-TX) and John Cornyn (R-TX), calling for 12 years for biologics data protection in TPP.
http://phrma.org/sites/default/files/2351/lettertoambkirk-biologicsintpptexas4may2012.pdf [195]

May 3, 2012. Letter from Senators Tom Carper (D-DE) and Chistopher Coons (D-DE), calling for 12 years for biologics data protection in the TPP. http://phrma.org/sites/default/files/2351/carper-coonstppiplettermay2012.pdf [196]

2011

September 12, 2011. Letter from 37 members of the US Senate, beginning with Senators Hatch and Kerry, to Ambassador Kirk, calling for 12 years of data protection for biologics in TPP.
http://phrma.org/sites/default/files/2351/11-09-12hatch-kerrytoambkirkre-tppbiologics.pdf [197]

From the letter:

As you are aware, U.S. law provides for a 12-year term of regulatory data protection for biologics and we believe that should serve as the baseline for the administration’s objectives for this aspect of the negotiation. This 12-year term was the result of careful deliberations in which the U.S. Congress arrived at a bipartisan consensus taking into account and weighing many factors. It is our view that the agreed upon term of protection best supports the Congress’ goals of maintaining the nation’s competitiveness as the leading innovator of biologics products, increasing the number of high-value jobs, and improving access to safe and affordable medicines by creating a clear pathway for the regulatory approval of biosimilar drugs.

Because intellectual property rights are a cornerstone for job creation and American competitiveness, we urge you to ensure that the U.S. negotiators are given clear instructions to attain this negotiating objective.

I found 4 signatures not legible. Among the 33 that I could make out, there were 13 Democrats and 20 Republicans, including both senators from eight states (CA, DE, IN, MA, MS, NJ, WA, WY). Among those signing, in the order they appear on the letter, are: Orrin G. Hatch (R-UT), John F. Kerry (D-MA), John Kyl (R-AZ), Kay R. Hagan (D-NC), Roy Blunt (R-MO), Barbara Ann Mikulski (D-MD), Scott P Brown (R-MA), Robert Menendez (D-NJ), Marco Rubio (R-FL) , Maria Cantwell (D-WA), [signature illegible], Tom Carper (D-DE), Robert Portman (R-OH), Dianne Feinstein (D-CA), Dan Coats (R-IN), Patty Murray (D-WA), Michael B. Enzi (R-WY), Bob Casey, Jr. (D-PA), Chris Coons (D-DE), Barbara Boxer (D-CA), John Boozman (R-AR) , [signature illegible], Pat Roberts (R-KS), Frank R.Lautenberg (D-NJ), Dick Lugar (R-IN), Roger Wicker (R-MS), Mark Kirk (R-IL), John Barrasso (R-WY), [signature illegible], Kay Baily Hutchison (R-TX), Mike Crapo (R-ID), Chuck Grassley (R-IA), John Thune (R-ND), Jack Reed (D-RI), [signature illegible], Thad Cochran (R-MS), James Inhofe (R-OK),

September 12, 2011. Senators Mark Udall (D-CO) and Michael Bennet D-CO), calling for 12 eyars of biologics data protection in TPP.
http://phrma.org/sites/default/files/2351/bennetudalllettertoustrregardingbiologics09-12-11.pdf [198]

July 27, 2011. 40 members of House of Representatives call for 12 years of biologics data protection in TPP.
http://phrma.org/sites/default/files/2351/ttpbioletterfinal072711.pdf [199]

May 27, 2011 TPP Letter from Governors of seven states (Colorado, Connecticut, Delaware, Maryland, Massachusetts, North Carolina and Washington State) calling for "very strong" intellectual property protections for biopharamceutical sector.
http://phrma.org/sites/default/files/2351/2011tpplettertopresidentfromgovernors-52711.pdf [200]

May 17, 2011. 28 Members of US Senate, beginning with Senators Hatch and Cantwell, call for "high standards" for IPR protection in TPP, modeled after KOR/US FTA.
http://phrma.org/sites/default/files/2351/20110517finalhatchcantwellletter.pdf [201]

February 18, 2011. Representative Donald A. Manzullo (R, IL-16), on TPP IPR protections, focusing also on New Zealand pricing of pharmaceutical drugs.
http://phrma.org/sites/default/files/2351/tppmanzulloletter.pdf [202]

February 14, 2011. 18 members of House Judiciary Committee ask for "highest level of protection" in TPP IPR Chapter, based upon KOR/US FTA.
http://phrma.org/sites/default/files/2351/021411housesignedtppletter.pdf [203]

US Senators on record supporting 12 years of protection for biologics data in TPP

1. Bennet, Michael, D, CO, September 12, 2011 (Colorado Senators letters)
2. Boxer, Barbara, D, CA, September 12, 2012 letter with 37 Senators
3. Cantwell, Maria, D, WA, July 12, 2012 letter, and September 12, 2012 letter with 37 Senators
4. Carper, Tom, D, DE, May 3, 2012, and September 12, 2012 letter with 37 Senators
5. Casey, Jr., Bob, D, PA, September 12, 2012 letter with 37 Senators
6. Coons, Chris, D, DE, May 3, 2012, and September 12, 2012 letter with 37 Senators
7. Fienstein, Dianne, D, CA, September 12, 2012 letter with 37 Senators
8. Hagan, Kay R., D, NC, September 12, 2012 letter with 37 Senators
9. Kerry, John F., D, MA, September 12, 2012 letter with 37 Senators
10. McCaskill, Claire, D, MO, August 6, 2012 letter
11. Menendez, Robert, D, NJ, May 11, 2012, and September 12, 2012 letter with 37 Senators
12. Mikulski, Barbara Ann, D, MD, September 12, 2012 letter with 37 Senators
13. Murray, Patty, D, WA, July 12, 2012 letter, and September 12, 2012 letter with 37 Senators
14. R.Lautenberg, Frank, D, NJ, September 12, 2012 letter with 37 Senators
15. Reed, Jack, D, RI, September 12, 2012 letter with 37 Senators
16. Udall, Mark, D, CO, September 12, 2011 (Colorado Senators letters)
17. Barrasso, John, R, WY, September 12, 2012 letter with 37 Senators
18. Blunt, Roy, R, MO, September 12, 2012 letter with 37 Senators
19. Boozman, John, R, AR , September 12, 2012 letter with 37 Senators
20. Brown, Scott P., R, MA, September 12, 2012 letter with 37 Senators
21. Coats, Dan, R, IN, September 12, 2012 letter with 37 Senators
22. Cochran, Thad, R, MS, September 12, 2012 letter with 37 Senators
23. Cornyn, John, R, TX, May 4, 2012 letter
24. Crapo, Mike, R, ID, September 12, 2012 letter with 37 Senators
25. Enzi, Michael B., R, WY, September 12, 2012 letter with 37 Senators
26. Grassley, Chuck, R, IA, September 12, 2012 letter with 37 Senators
27. Hatch, Orrin G., R, UT, September 12, 2012 letter with 37 Senators
28. Hutchison, Kay Baily, R, TX, May 4, 2012 letter, and September 12, 2012 letter with 37 Senators
29. Inhofe, James, R, OK, September 12, 2012 letter with 37 Senators
30. Kirk, Mark, R, IL, September 12, 2012 letter with 37 Senators
31. Kyl, John, R, AZ, September 12, 2012 letter with 37 Senators
32. Lugar, Dick, R, IN, September 12, 2012 letter with 37 Senators
33. Portman, Robert, R, OH, September 12, 2012 letter with 37 Senators
34. Roberts, Pat, R, KS, September 12, 2012 letter with 37 Senators
35. Rubio, Marco, R, FL, September 12, 2012 letter with 37 Senators
36. Thune, John, R, ND, September 12, 2012 letter with 37 Senators
37. Wicker, Roger, R, MS, September 12, 2012 letter with 37 Senators
38. [signature illegible], September 12, 2012 letter with 37 Senators
39. [signature illegible], September 12, 2012 letter with 37 Senators
40. [signature illegible], September 12, 2012 letter with 37 Senators
41. [signature illegible], September 12, 2012 letter with 37 Senators

Notes from meeting with USTR on the TPP IPR chapter

Today USTR provided some additional insight into negotiations of a regional, Asia-Pacific trade agreement, known as the Trans-Pacific Partnership (TPP) Agreement. The USTR web page on the TPP negotiations is http://www.ustr.gov/tpp [28]. At present, the TPP negotiators include Australia, Brunei Darussalam, Chile, New Zealand, Peru, Singapore and Vietnam. Japan and Canada have expressed interest in joining the negotiations, and USTR clearly would like to design an agreement that will be open to other countries. Our discussions focused on the intellectual property chapter in the agreement. According to USTR, the only text that has been tabled for the IP chapter concerns trademarks and general provisions -- the patents, copyrights, test data and enforcement sections of the IP chapter are being designed now. USTR expects a number of health related issues to be raised in the upcoming Santiago Chile meeting in February 2011.

USTR said the IP chapter for the TPP would harmonize IPR obligations strictly upwards.

The lead negotiator for the TPP is Barbara Weisel. The deputy lead negotiator is David Bisbee. Among other things, David Bisbee has written notes on how to influence USTR [204]. The chapter lead for intellectual property rights is Stan McCoy.

The Obama Administration has developed a policy on transparency for the TPP negotiations which apparently does not involve any commitments to sharing the text with the general public, even after it has been given to all member countries in the negotiation and to hundreds of corporate insiders on the USTR advisory board system.

The TPP negotiations will involve substantive intellectual property right norms, as well as norms for the enforcement of those rights. Unlike ACTA, the TPP will be subject to a dispute resolution process, which means that the U.S. and other countries will be subject to "fines" if they are not in compliance with the agreement.

The TPP is a unique bilateral for the U.S. in that it involves countries with very different levels of development, and as a consequence, there is considerable interest in the "architecture" of the intellectual property chapter.

In today's meeting, KEI and others pressed the USTR on a number of issues relating to access to medicine. Among other things, USTR was asked to insure that developing countries would benefit from the flexibilities in agreements regarding access to medicine that were negotiated between the House Democrats and the Bush White House in May 10, 2007. (See: here [168], and here [205]). The Obama Administration understands that public health, development and consumer groups want the May 10, 2007 agreement to be a starting point for health safeguards, but they were not giving any reassurances that this would be the case.

After being told the Obama Administration would not consider anything that lowered IPR norms in the TPP negotiations, and only measures that raised norms, KEI reminded USTR has the Clinton and Bush Administration both were willing to lower IPR norms, when they were persuaded it was appropriate. This included:

• President Clinton's December 1, 1999 speech to the WTO [206] endorsing new changes in U.S. trade policy to address concerns over access to medicines.
• President Clinton's Executive Order 13155 [207]of May 10, 2000, concerning Access to HIV/AIDS Pharmaceuticals and Medical Technologies.
• President Bush's decision to agree to the November 14, 2001 Doha Declaration on TRIPS and Public Health.
• President Bush's decision to accept the waiver to 31.f of the TRIPS agreement on 30 August 2003.
• President Bush's July 16, 2004 agreement between USTR and Canada [208] to modify NAFTA to allow exports of medicines under compulsory licenses.
• President Bush's May 10, 2007 agreement on the bipartisan New Trade Policy [209], which eliminated patent extensions, eliminated linkage of drug registration and patents, and relaxed test data protection for the Peru Free Trade Agreement.

For the Obama Administration to claim that it can only harmonize upwards is really disappointing, given the promises that Obama made during his presidential campaign.

On other topics, KEI pressed USTR to not only respect current U.S. legal norms, but also the flexibility of the U.S. Congress to change those norms. One example of this was the legislative proposal to eliminate exclusive rights for test data protection [210] in cases where there is a conflict with medical ethics.

Related: US Industry IP memo for the TPP negotiations leaked [211]

Patents and Doctors, and the USTR TPP text

The recently obtained US draft text [59] for the intellectual property rights chapter for the Trans-Pacific Partnership Agreement (TPP) contains provisions that go far beyond the requirements of international agreements as well as the standards of US law itself. One particular area of concern involves the broad definition of patent eligible subject matter that fails to provide for any exception from patentability for surgical methods or procedures. Nor does the draft language contain any exception for the enforcement of surgical method patents. This failure to include such exceptions not only implicates significant ethical problems for surgeons, but is inconsistent with US law.

Under US patent law, certain exclusions apply limiting enforcement of particular patents.

35 U.S.C. 287 [212]. Limitation on damages and other remedies; marking and notice.
(c)(1) With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

While the US does not provide an exception for the patent eligibility of a surgical method, patent law does limit enforcement of these patents against medical practitioners who perform medical or surgical procedures. Surgeons who perform patented surgical methods are therefore not liable for patent infringement on these activities.

Consistent with this exception, the Australia-United States Free Trade Agreement (AUSFTA) allows for a surgical method exclusion from patentability. The text of the AUSFTA allows for:

2. Each Party may only exclude from patentability: (a) inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law; and (b) diagnostic, therapeutic, and surgical methods for the treatment of humans and animals.

Although the AUSFTA provided for an surgical method exclusion from patentability, no similar provision exists within the USTR's proposed TPP text. In fact, draft Article 8.2(b) apparently requires that patents be made available for surgical methods:

Each Party shall make patents available for inventions for the following:
(a) plants and animals, and
(b) diagnostic, therapeutic, and surgical methods for the treatment of humans or animals.

The US draft TPP language on patentability provides a narrow exclusion that does not explicitly cover surgical methods. Draft Article 8.3 reads:

Each Party may only exclude from patentability inventions, the prevention within its territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law.

The TPP draft also fails to exclude surgical methods from patent enforcement, thus opening surgeons who use patented surgical methods up to patent infringement liability. This lack of exception for surgical methods creates ethical problems for surgeons treating patients best served by a patented technology.

The USTR's draft provisions in the TPP are therefore inconsistent with US law. Both US patent law and the AUSFTA contain provisions allowing for exceptions from patentability or patent infringement for surgical methods. The lack of a similar provision in the TPP text effectively ignores current, applicable US law.

As KEI has noted repeatedly, when the USTR keeps the draft text of these trade agreements secret, the public is prevented from giving policy makers informed and effective feedback on the flaws of various proposals. The lack of surgical methods exception is an example of how the policy of secrecy can create problems.

Pending U.S. Court Cases on Intellectual Property and Their Relation to the Trans-Pacific Partnership Agreement (TPPA)

**Updated 19 March 2013, after the Supreme Court released its opinion in Kirtsaeng ruling to permit parallel importation of copyrighted works**

The Supreme Court's docket on intellectual property and related matters has been substantial this term, as well as recent years. Many interesting cases are also making their way through the Federal Courts of Appeals. Between last term and the current term, cases before the Supreme Court related to access to knowledge and access to medicines have included the parallel importation of copyrighted goods, patentability of human genes, patentability of self-replicating technology, the patent eligibility of certain method patents, the interplay of antitrust law and patent law in pay-for-delay cases, among others. The Supreme Court may also elect to grant certiorari in other cases, including the parallel importation of patented goods. Amongst the U.S. Courts of Appeals, a number of patent and copyright cases, including several fair use cases are currently being heard.

How the Trans-Pacific Partnership Agreement (TPPA) will affect these cases remains to be seen. However, the question of why the USTR has put forth proposals in some of these contentious areas while U.S. law remains undecided or unclear remains. Some of the issues in the U.S. proposals for the intellectual property chapter of the TPPA will be directly addressed by U.S. courts in the coming months; those cases pending before the Supreme Court this term will be decided before the Court recesses in June. While not exhaustive, brief coverage of court cases that may be relevant to the TPPA follow:

Pending Cases:
Kirtsaeng v. John Wiley and Sons (Supreme Court of the United States)
Parallel importation of copyrighted goods.

This case involves exhaustion of rights [213], also known as the first sale doctrine, of copyrighted goods. In this case, Kirtsaeng purchased textbooks from Thailand then resold them in the United States. The publisher filed suit alleging copyright infringement based on a theory that exhaustion of rights do not apply to foreign made works. There is currently a three-way split of authority in the United States on whether national exhaustion or international exhaustion of rights apply to copyrighted goods in the United States. The Third Circuit asserted that international exhaustion applies, the Ninth Circuit found that exhaustion occurs only after the right holder authorizes a first sale within the United States, and the Second Circuit found that exhaustion never applies to foreign made works. The Supreme Court heard oral arguments this fall and is expected to settle this split of authority by the time the Court recesses in June. This case is highly relevant to the TPPA negotiations because the U.S. proposed a ban on parallel importation of copyrighted works. If the Supreme Court rules in favor of Kirtsaeng, finding that exhaustion of rights apply even to sales abroad, the ruling would come in direct conflict with the U.S. proposal for the TPPA.

**Update: On 19 March 2013, the Supreme Court released its opinion in the Kirtsaeng case. In a 6-3 decision, the Court ruled that the first sale doctrine applies not just to domestically manufactured works, but also to those made abroad. The Court thus applies international exhaustion principles rather than national exhaustion, permitting the parallel importation of works. The Court's ruling is therefore in conflict with the U.S. proposal in the TPPA. Further analysis of the Court's decision is available here [214].**

Association for Molecular Pathology v. Myriad Genetics (Supreme Court of the United States)
Patent eligibility of human genes and isolated DNA.

This case [215] surrounds the patent eligibility of human genes [216]and isolated DNA, specifically the BRCA1 and BRCA2 genes associated with an individual's susceptibility to breast and ovarian cancer. As a result of the upstream patenting on the BRCA genes, the right holder, Myriad Genetics has a monopoly over diagnostic testing for mutations on these genes and patients cannot obtain second opinion testing despite the fact that Myriad's initial test failed to find known mutations and also had a known error rate, particularly for patients of non-European ancestry. The Supreme Court will hear oral arguments on 15 April 2013, with a decision expected by June. Notably, this case follows after the Supreme Court ordered the case re-heard by the Federal Circuit following its unanimous 2012 ruling in Mayo v. Prometheus [217], a case where the Supreme Court invalidated certain method claims on a diagnostic test. Although the issue of gene patenting is not expressly addressed n the TPPA, the U.S. has proposed very low patentability standards and also would require patents for diagnostic, therapeutic and surgical methods [218] despite the fact that patenting for these categories are not required by TRIPS and have not been required by any previous U.S. free trade agreement.

Cambridge University Press v. Becker (11th Circuit)
Fair use of e-reserve system in a university.

In the present case, Georgia State University provided students access to copyrighted materials through electronic systems and over the internet, without permission from the rightholders. Publishers sued the university for the e-reserves system, alleging copyright infringement. The district court found fair use to apply in 70 of 75 cases (largely based on the amount of the work used) and that there was no copyright infringement. The district court noted that the four fair use factors (1) purpose and character of the use; 2) nature of the copyrighted work; 3) amount and substantiality of the portion used in relation to the copyrighted work as a whole; and 4) effect of the use upon the potential market for or value of the copyrighted work) must be taken together, rather than viewed in isolation. The case is currently being appealed to the 11th Circuit. With respect to the TPPA, the U.S. has proposed the three-step test [1] and while it references "criticism, comment, news reporting, teaching, scholarship and research," these elements must be "subject to and consistent with" the three-step test. In other words, the U.S. has proposed the three-step test without providing appropriate protections for those limitations or exceptions that are not subject to the thee-step test, such as the list of Berne exceptions [219]. Some may argue that the U.S. fair use system on its face would not comply with the three-step test as a WTO panel has interpreted the test. However, the exceptions found to be "fair use [220]," including in this e-reserves case, may be saved despite potential failure to comply with the three-step test because many "fair use" exceptions in the United States could actually fall under a specific Berne exception, such as the exception for teaching and education. However, if the U.S. proposed text on limitations and exceptions for the TPPA is accepted without adequate protection for those exceptions that fall outside the three-step test, much of what is considered to be "fair use" in the United States may come under attack as failing to comply with the three-step test.

Authors Guild v. Hathitrust (2d Circuit)
Orphan works, fair use in digitization, fair use for visually impaired or disabled.

The appeal in this case involves issues of orphan works, fair use of a digitization project, and fair use for persons who are blind or disabled. The court below did not rule on the orphan works project, an initiative to make available to University faculty and students full-text copies of orphan works, due to the suspension of the project pending a change in policy for identifying orphan works (the court judged this issue to be not ripe for review). The district court did rule on the two fair use issues. It first found that making copies of entire works can be transformative fair use when done, for example, to make the work searchable; even wholesale copies of works can be termed fair use when the copy serves a different function as the original. The court thus found that the project of digitizing the work to enhance search capabilities to be fair use. The lower court also found that digitizing works for to provide access for persons who are visually impaired or have other disabilities falls under the Chafee Amendment (permitting accessible format works without permission of the rightholder) and is also transformative fair use. Significantly, the district court noted that "I cannot imagine a definition of fair use that would not encompass the transformative uses made by Defendants' MDP and would require that I terminate this valuable contribution to the progress of science and cultivation of the arts." Like the Cambridge v. Becker case, this case turns on the fair use exceptions permitted by U.S. copyright law and the U.S. proposal in the TPPA requiring all exceptions to comply with the three-step test (and restrictive interpretation by the WTO panel) could come into conflict with court findings of fair use.

CLS Bank v. Alice (Federal Circuit)
Presumption of patent validity.

One issue in this case, currently on appeal to an en banc sitting of the Court of Appeals for the Federal Circuit, involves when presumption of patent validity applies. Although 35 U.S.C. 282 provides for a presumption of patent validity, this presumption might only apply to questions of fact and not questions of law. As a result, questions arising under 35 U.S.C. 101, that is questions of subject matter eligibility may fall outside this presumption. The court has an opportunity determine in this case whether presumption of patent validity applies in a case about whether a particular patent-at-issue is patent-eligible under the law; Supreme Court precedent suggests that the presumption of validity does not apply to patent subject matter eligibility questions. The U.S. proposal in the TPPA provides that "each Party shall provide for a rebuttable presumption that a patent is valid, and shall provide that each claim of a patent is presumed valid independently of the validity of the other claims." However, the weight of precedent suggests that the U.S. exempts the question of subject matter eligibility from the presumption.

Organic Seeds v. Monsanto (Federal Circuit)
Remedies for patent infringement, injunctions.

A group of organic farmers in the present case sought declaratory judgment that they would not be sued for patent infringement should they be contaminated by Monsanto's patented, genetically modified seeds (Monsanto has reportedly sued a farmer previously for patent infringement when seeds inadvertently ended up on his farm through contamination). Because Monsanto's genetically modified seeds are so ubiquitous, the chances of unintended contamination is high. In addition to other claims asserted, the farmers in the case stated that Monsanto would not be entitled to any remedy even if the patents were held to be valid, infringed and enforceable because no economic injury would occur to Monsanto and that the public interest does not support the grant of injunction. Depending on how the U.S. proposal is interpreted, it is possible that the outcome of this case could conflict with the U.S. proposal for the TPPA (if the U.S. proposal on injunctive relief is interpreted as requiring an injunction in all cases of infringement).

Additional information on these and other cases, including parallel importation of patented goods [221], patent exhaustion [222] of self-replicating technology [223], and the interplay of antitrust law and patent law [224] is available here [225].

TPP IP text would restore right to sue surgeons and other medical professionals for patent infringement. Why?

Kista Cox on a provision in the TPP trade negotiation that would restore right to sue surgeons and other medical professionals for patent infringement. The US law (35 USC 287(c)) was changed after lawsuits were filed against surgeons performing certain procedures in eye surgery. USTR and USPTO have been asked to protect this exception in the TPP Intellectual Property Chapter, but have not done so.

In patent law, many countries have excluded "therapeutic and surgical methods for the treatment of humans." This is either done by excluding the patentability of the subject matter, or by providing a limitation on the remedies for infringement.

The language that USTR and USPTO have proposed for the TPP would eliminate the flexibility found in the WTO TRIPS Agreement to "exclude from patentability . . . diagnostic, therapeutic and surgical methods for the treatment of humans or animals."

Article 27
Patentable Subject Matter [226]

3. Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

The US law permits patents to be granted, but not enforced against a "medical practitioner or against a related health care entity" (see definition below). The US law, sought by the AMA, would permit patent owners to seek damages and other remedies from manufacturers of devices used in surgery, but not against the surgeon or the other medical practitioners or health care entities, for performing a procedure.

The US proposals in the TPP do not permit exceptions to either the granting of patents on the subject matter or the enforcement of the patents against a "medical practitioner or against a related health care entity."

For more on this issue, see: Patents and Doctors, and the USTR TPP text (http://keionline.org/node/1093 [218] )

35 U.S.C. 287 Limitation on damages and other remedies; marking and notice.

(c)

• (1) With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.
• (2) For the purposes of this subsection:
• (A) the term "medical activity" means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.
• (B) the term "medical practitioner" means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.
• (C) the term "related health care entity" shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.
• (D) the term "professional affiliation" shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.
• (E) the term "body" shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.
• (F) the term "patented use of a composition of matter" does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.
• (G) the term "State" shall mean any state or territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
• (3) This subsection does not apply to the activities of any person, or employee or agent of such person (regardless of whether such person is a tax exempt organization under section 501(c) of the Internal Revenue Code), who is engaged in the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), where such activities are:
• (A) directly related to the commercial development, manufacture, sale, importation, or distribution of a machine, manufacture, or composition of matter or the provision of pharmacy or clinical laboratory services (other than clinical laboratory services provided in a physician's office), and
• (B) regulated under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Clinical Laboratories Improvement Act.
• (4) This subsection shall not apply to any patent issued based on an application the earliest effective filing date of which is prior to September 30, 1996.

(Amended Aug. 23, 1988, Public Law 100-418, sec. 9004(a), 102 Stat. 1564; Dec. 8, 1994, Public Law 103-465, sec. 533(b)(5), 108 Stat. 4989.)
(Subsection (c) added Sept. 30, 1996, Public Law 104-208, sec. 616, 110 Stat. 3009-67.)
(Amended Nov. 29, 1999, Public Law 106-113, sec. 1000(a)(9), 113 Stat. 1501A-589 (S. 1948 sec. 4803).)

The complete Feb 10, 2011 text of the US proposal for the TPP IPR chapter

KEI has obtained the February 10, 2011 US government draft of the intellectual property chapter of the Trans-Pacific Partnership Agreement (TPP).

http://keionline.org/sites/default/files/tpp-10feb2011-us-text-ipr-chapter.pdf [12]

The text is marked to be "protected from unauthorized disclosure," and the USTR is seeking to classify the document until four years from entry into force or the close of the negotiations. The document has been distributed to all member states particpating in the TPP negotiations, so it is not secret from any of the parties in the negotiations. The document may also be subject to review by the hundreds of corporate insiders who serve on USTR advisory boards. It is, however, secret from the taxpayers and voters who live in the United States, and people everywhere who are going to live under the new norms. In this case, the secret text involves tough new rules for patents, copyright and related rights including broadcaster rights and expressions of folklore, digital rights management information, trademarks, domain names, geographic indicators, regulatory test data for pharmaceutical drugs and agricultural products. There are also more than 15 pages of oblgiations regarding the enforcement of those rights, including criminal sanctions against infringers.

KEI objects to the policy of making the negotiating text of intellectual property agreements secret, particularly when the documents are distributed to all parties in a negotiations, and thus are only secret from the public. The Congress needs to intervene and require that such texts be made public routinely.

This Document Contains TPP CONFIDENTIAL Information
MODIFIED HANDLING AUTHORIZED*
Derived From: Classification Guidance
dated March 4, 2010
Reason: 1.4(b)
Declassify on: Four years from entry into force of the TPP agreement or, if no agreement enters into force, four years from the close of the negotiations.
* This document must be protected from unauthorized disclosure, but may be mailed or transmitted over unclassified e-mail or fax, discussed over unsecured phone lines, and stored on unclassified computer systems. It must be stored in a locked or secured building, room, or container.

Some quick examples of norms pushed by USTR

Copyright

• Copyright damages shall consider the suggested retail price or other legitimate measure of value submitted by the right holder.
• (art. 4.5) The term of protection of a work (including a photographic work), performance, or phonogram is to be calculated:
  • on the basis of the life of a natural person, the term shall be not be not less than the life of the author and 70 years after the author’s death;
  • on a basis other than the life of a natural person, the term shall be: (i) not less than 95 years from the end of the calendar year of the first authorized publication of the work, performance, or phonogram, or (ii) failing such authorized publication within 25 years from the creation of the work, performance, or phonogram, not less than 120 years from the end of the calendar year of the creation of the work, performance, or phonogram.
• Would eliminate any possibility of parallel trade in copyrighted books, journals, sheet music, sound recordings,
  computer programs, and audio and visual works (i.e., categories of products in which the value of the copyrighted
  material represents substantially all of the value of the product) (art. 4.2, and footnote 11)
• Each Party shall establish or maintain a system that provides for pre-established damages, which shall be available upon the election of the right holder
• Requires criminal enforcement for technological measures beyond WIPO Internet Treaties, even when there is not copyright infringement (art. 5.9)
• Impose a legal regime of ISP liability beyond the DMCA standards (art. 16.3)
• Requires legal incentives for service providers to cooperate with copyright owners in deterring the unauthorized storage and transmission of copyrighted materials; (art. 16.3.b.vi.A)
• Requires identifying internet users for any ISP, going beyond U.S. case law (art. 16.3.b.xi)
• Includes the text of the controversial US/KOREA side letter on shutting down web sites

Public Health

• No mention of Doha Declaration on TRIPS and Public Health or WHO Global Strategy on Public Health, Innovation and Intellectual Property.
• Pharmaceutical Products:
  2. [Placeholder for provisions related to data protection for pharmaceutical products]
  3. [Placeholder for provisions related to patent linkage]
  4. [Placeholder for provisions related to patent term/data protection relationship]
  5. [Placeholder for definitions of “new pharmaceutical product” and “new agricultural
  product”]
• 5. [Placeholder for “Bolar” provision] (art. 8.5)

Agriculture

• Parties agree to sign the International Convention for the Protection of New Varieties of Plants, 1991
• 10 years of exclusive rights in agricultural chemcial test data (art. 9.1)

Patents

• Parties agree to Patent Cooperation Treaty and the Patent Law Treaty
• Patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the known efficacy of that product. (art. 8.1)
• Requires patent for second use (art. 8.1)
• In civil and administrative proceedings involving patents, each Party shall provide for a rebuttable presumption that a patent is valid, and shall provide that each claim of a patent is presumed valid independently of the validity of the other claims.
• [Placeholder for provisions concerning patent term restoration/adjustment] (art. 8.6)
• Where a Party provides proceedings that permit a third party to oppose the grant of a patent, a Party shall not make such proceedings available before the grant of the patent. (art 8.7)
• USTR proposal in TPP:
  

  Each Party may only exclude from patentability inventions, the prevention within its territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law. (art. 8.3)

  Which is more restrictive than the text of AUSFTA, which reads:

  2. Each Party may only exclude from patentability: (a) inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law; and (b) diagnostic, therapeutic, and surgical methods for the treatment of humans and animals. [emphasis added]

• Each Party shall provide that a claimed invention is industrially applicable if it has a specific, substantial, and credible utility. (art. 8.12) Depending upon how you read this sentence, which also relates to Article 8.1, it either limits or expands the type of inventions that must be patented. The expansion of the obligation to grant patents would happen if the text is seen as a definition of industrially applicable.

General Enforcement Obligations

• Each Party shall provide ex officio border measures with respect to imported, exported, or in-transit merchandise, or merchandise in free trade zones, that is suspected of being counterfeit or confusingly similar trademark goods, or pirated copyright goods (art. 14.4)
• Requires adopting compensation for infringement without actual damages (art.12.3 and 4)
• For copyright and trademark, criminal punishment would apply even to non-for-profit infringement (art. 15.1)
• In determining damages for infringement of intellectual property rights, its judicial authorities shall consider, inter alia, the value of the infringed good or service, measured by the suggested retail price or other legitimate measure of value submitted by the right holder. (art. 12.3.b)

Consumer Protection and Competition Safeguards

Weak, meak or Missing

Comment

Overall, the USTR proposal for the TPP intellectual property chapter would:

(1) include a number of features that would lock-in as a global norm many controversial features of U.S. law, such as endless copyright terms.
(2) create new global norms that are contrary to U.S. legal traditions, such as those proposed to damages for infringement, the enforcement of patents against surgeons and other medical professional, rules concerning patents on biologic medicines, disclosure of information from ISPs, etc. (We will work on a detailed list).
(3) undermine many proposed reforms of the patent and copyright system, such as, for example, proposed legislation to increase access to orphaned copyrighted works by limiting damages for infringement, or statutory exclusions of "non-industrial" patents such as those issued for business methods.

These are complicated and important issues that have impact on people's lives. The publication of the text, via a leak, will allow people who have the expertise and interest in the subjects to provide analysis and feedback on the proposals. The decision to make make this document secret from the public undermines the legitimacy of the TPP negotiations, and predictably strengthens special interests at the expense of the public. Of course, we have seen such secrecy before from USTR, but we thought the Obama Administration would change things. The topics covered by the TPP IPR Chapter to go the heart of access to medicine, food and knowledge, and the freedom to use knowledge and innovations. The contempt for democratic processes and the arrogance of those that insist on secret global norm setting is shocking.

For more on the transparency issue, see the July 22, 2009 NGO letter to the United States Trade Representative (USTR) [227], recommending the USTR and other federal agencies reduce secrecy and increase transparency in negotiations that involve global norms for knowledge governance.

UN Rapporteur for the Right to Health asked to intervene in the TPP negotiation

The following groups and individuals have written to Anand Grover, the Special Rapporteur for the United Nations on the right of everyone to the enjoyment of the highest attainable standard of health, to lodge a complaint about the Trans Pacific Partnership (TPP). The TPP is a regional free trade agreement being negotiated by the governments of Brunei, Chile, New Zealand, Singapore, Australia, Malaysia, Peru, Vietnam and the United States.

The basis for the appeal is described in the attached memorandum [228]

http://keionline.org/sites/default/files/r2h_anand_grover_tpp_22march201... [228]

The complaint was filed by the following organizations and individuals:

• James Love, Thiru Balasubramaniam, Krista Cox and Manon Ress on behalf of Knowledge Ecology International
• Edward Low on behalf of the Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
• German Holguin Zamorano on behalf of Latin American and Caribbean(LAC)-Global Alliance for Access to Medicines
• Roberto Lopez on behalf of Acción Internacional por la Salud (HAI) Peru
• Dr Patricia Ranald on behalf of the Australian Fair Trade and Investment Network
• Jose Teran on behalf of Acción Internacional por la Salud (HAI) Ecuador
• Francisco Rossi on behalf of IFARMA Foundation - Colombia
• German Holguin Zamorano on behalf of Mision Salud, Colombia
• Alejandra Alayza on behalf of Peruvian Network for Fair Globalisation - RedGE
• Health Action International (HAI) Europe
• Acción Internacional por la Salud (HAI) Latin America and the Caribbean
• Alberto Cerda Silva, Professor of Law, University of Chile Law School
• Allen Black Jr., Adjunct Professor of Law, University of Pittsburgh
• Jane Kelsey, Professor of Law, University of Auckland

A press release about the filing follows:

UN Special Raporteur on right to health asked to intervene in TPP Trade negotiation

March 22, 2010

FMI (See contact details below)

March 21, 2011. Eleven public interest advocacy groups and three law professors have submitted a petition to Anand Grover, the Special Rapporteur for the United Nations on the right of everyone to the enjoyment of the highest attainable standard of health. A copy of the petition is available on the Internet here: http://www.keionline.org/node/1099 [142]

The Special Rapporteur has been asked to intervene in a new regional trade agreement named the Trans-Pacific Partnership (TPP) Agreement. In particular, the parties filing the complaint charge that the negotiations on intellectual property norms, in terms of process and substance, threaten and violate the right of hundreds of millions of persons to the enjoyment of the highest attainable standard of health.

Parties to the negotiation now include the governments of Brunei, Chile, New Zealand, Singapore, Australia, Malaysia, Peru, Vietnam and the United States. However, it is expected that attempts will be made to extend the norms to a much wider group of trading partners. Moreover, given economies of scale, any agreement that shrinks the market for legal generic medicines will have an adverse impact on consumers everywhere.

The TPP agreement, is being negotiated behind a veil of secrecy, underming the ability for the persons who will be affected by the norms to participate effectively in efforts to influence the outcome of the negotiations. The lack of access to information is not universal, however, as some corporate interests have special access to information about the negotiations that is not available to the general public.

A recent leak of a copy of the United States government's proposal for a chapter on intellectual property rights has revealed the negotiation is addressing the most sensitive issues in the area of access to medicine, including such items as the standards for granting patents on medical inventions, patent extensions, the exclusive rights in regulatory test data, restrictions on the “in-transit” shipments of legitimate generic drugs, and other topics.

The Commission on Human Rights resolution 2002/31 provides the Special Rapporteur for the right to health the mandate to issue an urgent appeal or allegation letter to Governments based on reliable information on alleged violations of the right to health. The Special Rapporteur can write to the Government(s) concerned, "either together with other special procedure mandates or independently, inviting comment on the allegation(s), seeking clarifications, reminding a Government of its obligations under international law in relation to the right to health, and requesting information, where relevant, on steps being taken by the authorities to redress the situation in question."

Communications from the Special Rapporteur to the concerned Government(s), either in the form of an Urgent appeal or an allegation letter are confidential at an initial stage. Once the summary of letters and the response of the of the concerned Government(s) are enclosed into addendum 1 of the Human Rights Council's annual report, then this information becomes public.

The organizations and individuals signing the petition include:

• James Love, Thiru Balasubramaniam, Krista Cox and Manon Ress on behalf of Knowledge Ecology International
• Edward Low on behalf of the Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
• German Holguin Zamorano on behalf of Latin American and Caribbean(LAC)-Global Alliance for Access to Medicines
• Roberto Lopez on behalf of Acción Internacional por la Salud (HAI) Peru
• Dr Patricia Ranald on behalf of the Australian Fair Trade and Investment Network
• Jose Teran on behalf of Acción Internacional por la Salud (HAI) Ecuador
• Francisco Rossi on behalf of IFARMA Foundation - Colombia
• German Holguin Zamorano on behalf of Mision Salud, Colombia
• Alejandra Alayza on behalf of Peruvian Network for Fair Globalisation - RedGE
• Health Action International (HAI) Europe
• Acción Internacional por la Salud (HAI) Latin America and the Caribbean
• Alberto Cerda Silva, Professor of Law, University of Chile Law School
• Allen Black Jr., Adjunct Professor of Law, University of Pittsburgh
• Jane Kelsey, Professor of Law, University of Auckland

The following are quotes from some of the persons signing the petition, listed in alphabetical order.

Allen Black, Adjunct Professor of Law, University of Pittsburgh “It is the duty of the Government to protect health and human safety. However, the currently proposed trade agreement simply ignores health and human safety. Worse if implemented, it will actually deny life saving medicines to those most in need. It is unconscionable that the U.S. would ever promote such an agreement because it sacrifices lives without any benefit other than increased revenues for U.S. corporations.”

Alberto Cerda Silva, Professor in Law, University of Chile Law School “The TPP compromises public health, particularly in developing countries, by requiring the adoption of measures that create serious obstacles for access to medicines, such as restrictions on the shipment of generic goods in transit to developing countries, patents for new uses of older drugs, and the linkage of patents to drug registration in markets where regulators are not well equipped to evaluate patent claims. The TPP draft goes beyond any Free Trade Agreement in force; in fact, countries like Australia, Chile, New Zealand and Peru would be required to re-update its domestic law to comply with the obligations imposed by the American draft of the TPP.”

Edward Low, Positive Malaysian Treatment Access & Advocacy Group (MTAAG+) “HIV patients in Malaysia used to be on Duovir, a generic antiretroviral drug imported from India under a compulsory license. However, the government's switchback to the branded Combivir increased the government's treatment cost 6 fold and impeded the antiretroviral roll out plan. Thus, we have first hand knowledge of the curtailing of TRIPS flexibilities as it is a matter of life and death for the HIV community. The TPP aims to impose patent linkage to drug registration, data exclusivity and undermine Malaysia's sovereign right to determine patentability criteria. The net result of the TPP will result in more unaffordable drugs just waiting for the poor at the grave.”

James Love, Director, Knowledge Ecology International.. “The text the United States has already tabled in the TPP negotiation is an aggressive attack on the modest flexibilities that developing countries now have to protect the poor. But the many placeholders suggest the worst is yet to come. USTR is telling groups that it plans to abandon the May 10, 2007 compromise on access to medicine – an agreement between Democrats in the House of Representatives and the George W. Bush White House. The Obama Administration is showing that it is no friend to poor people living in developing countries. The Obama Administration is also trying to lock into a global agreement the most anti-consumer aspects of US law, making it much more difficult or impossible to introduce needed reforms to protect US consumers. The notion that governments have to act to control health care costs is undermined by the White House policy proposals in the TPP.”

Krista Cox, Staff Attorney, Knowledge Ecology International. “The manner in which the Trans Pacific Partnership has been negotiated erodes the human rights to access to information and participation in public affairs. The secrecy of these negotiations effectively works against the interests of marginalized groups, such as women children, and those living in extreme poverty, who will be greatly affected by enactment of the TPP. The TPP violates human rights, particularly the right to health. While States have a positive obligation to protect this right, in part by promoting better access to medicines and medical treatment, the United States has done the opposite by placing economic policy and intellectual property interests above the basic human rights to life and health.”

Roberto Lopez, Acción Internacional por la Salud (HAI) Peru. “The TPP would enact TRIPS plus norms that would compromise Peruvians' right to health. The prohibition on pre-grant opposition and the proposed granting of new use patents undermines Peruvian policy space in taking measures to protect public health and promote access to medicines.”

Thiru Balasubramaniam, Geneva Representative, Knowledge Ecology International. “The intellectual property rights chapter as proposed by the United States imposes a one-size fits all straightjacket which vitiates the discretion afforded to WTO members in the TRIPS Agreement, and re-affirmed in the Doha Declaration on the TRIPS Agreement and Public Health, the WHO Global Strategy on Public Health, Innovation and Intellectual Property. The TPP text would prohibit pre-grant opposition procedures for patents while mandating the granting of new uses for older drugs for developing countries including Peru, Malaysia and Vietnam. As noted in the March 15, 2011 UNAIDS/WHO/UNDP Policy brief on Using TRIPS flexibilities to improve access to HIV treatment: 'The decision on whether a new form of a known substance can be patented has major implications for many drugs used in HIV care, now and in the future.'”

For more information, please contact:

Krista Cox, krista.cox@keionline.org [229], +1.202.332.2670

Thiru Balasubramaniam, thiru@keionline.org, +41.76.508.0997

News stories and blogs

• 12 April 2011, Shiow Chin Tan, Pacific free-trade agreement 'threat to generic drugs' [230] SciDev.Net
• 30 March 2011, Health Advocates File Petition with U.N. Over Proposed Trade Agreement Among Several Countries [231], Kaiser Daily Global Health Policy Report
• 29 March 2011, John Zarocostas, Trade talks on patent protection violate right to health, allege advocacy groups [232], British Medical Journal
• 28 March 2011, William New, Call Issued for UN Intervention In Trans-Pacific Regional Pact [233], IP Watch
• 25 March 2011, Adam Behsudi, U.S. TPP IPR Proposal Accused of Violating Human Rights for Health [234], Inside U.S. Trade
• 25 March 2011, UN Special Rapporteur on the Right to Health asked to intervene in TPP Trade negotiation [235], International Federation of Health and Human Rights Organisations
• 23 March 2011, IP Provisions in Trans-Pacific Partnership Negotiations Raise Public Health Concerns [236], Bridges Weekly, Volume 15 Number 10.
• 23 March 2011, Koichi Kameda, UN Rapporteur for the Right to Health asked to intervene in the TPP negotiation [237], a2k Brasil
• 22 March 2011, UN Rapporteur for the Right to Health asked to intervene in the TPP negotiation [238], New Zealand Not for Sale

US Industry IP memo for the TPP negotiations leaked

Knowledge Ecology International (KEI) has received a copy of U.S. industry demands on the Intellectual Property chapter of the Trans-Pacific Partnership Agreement (TPP) [28]negotiations. A draft letter from US industry to USTR has been leaked and is available here [239].

The letter was prepared by the Intellectual Property (IP) Task Force of the U.S. Business Coalition for TPP, that represents a cross-sectoral group of US companies and business groups including the Pharmaceutical Research and Manufacturers of America (PhRMA), the US Chamber of Commerce, and the Motion Picture Association of America (MPAA). The metadata from the MS Word file identifies the author as Anissa Whitten*, a former Department of State Foreign Affairs Officer who now works for the MPAA.

According to the letter, Industry is asking the US government for a number of TRIPS plus, WCT plus and ACTA plus provisions:

- To seek the highest possible IP protection from TPP negotiating parties.
- To built upon existing FTAs and use the US/Korea Free Trade Agreement as a baseline. Although the letter does not specifically mention the May 10, 2007 compromise that included important public health flexibilities in the US/Peru FTA, US Industry is clearly demanding the US government to reject the compromise as the basis for negotiations.
- To go beyond the Anti-Counterfeiting Trade Agreement (ACTA). For instance, it states that the TPP should outlaw camcording in theaters, despite the fact that the ACTA made it optional for countries to have criminal penalties for camcording.

The letter asks the US government to pay special attention to geographical indications, WIPO 1996 Internet Copyright Treaties, patent protection for software, test data protection, pharmaceutical reimbursement policies and IPR enforcement.

The provision on test data protection reads as follows:

Provide Robust and Effective Protection of Innovators’ Data. Innovative industries, including biopharmaceutical and agrochemical companies, expend tremendous effort and resources conducting research to demonstrate the safety and efficacy of their life-saving and life-enhancing inventions. Patent protection, which runs concurrent with data protection, does not protect the effort and investment needed to prove safety and efficacy of these products. Unless the data developed to prove a product’s safety and efficacy is effectively protected, companies are unable to recoup the significant investment required to generate the data and the costs of launching a product. As such, it is critical that the TPP ensure the robust and effective protection of innovators’ data.

With regarding to digital works and the Internet, the paper calls for a definition of commercial scale which is not tied to the profit motive of the infringer:

Commercial scale. The TPP must reflect the reality that right holders are harmed when illegal content is posted to the Internet with or without charge to the downloader and acknowledge harm to the infringed party rather than profit motive or the commercial purpose of the infringer.

The industry wants the agreement to mandate longer copyright terms:

Extended term of protection for copyrights to match US law. There is an unmistakable global trend toward extending the term of copyright protection. The TPP must reflect this reality, preventing a potential irritant to international trade that results from divergent terms among trading partners.

Relevant to the US consideration of the Hague Convention on the Choice of Court Agreements, and to many consumer protection concerns, the industry calls for the TPP to focus on the role of contracts.

Contractual rights. The TPP should affirm that all right holders are allowed to exercise economic rights in their own names and that any person acquiring or holding such economic rights by virtue of a contract must be able to exercise those rights and enjoy fully the benefits derived from those rights.

The industry wants the TPP to mandate software patents:

The language of the TPP agreement needs to be strengthened to specifically require providing patent protection for computer implemented inventions.

The main area where transparency is mentioned is in connection with the ability of the industry, including large drug companies and other health care providers, to have deeper access to the decision making process of regulators, including regulators who set prices.

The US industry position contrasts the New Zealand government position leaked last week [240] that challenges the overprotection of intellectual property, particularly in the areas of copyright and patents and asks the TPP patent and copyright provisions be no more stringent than existing WTO TRIPS global standards.

For more information on the TPP negotiations, see:

• American University PIJIP website on TPP [241].
• USTR website on TPP [28]
• Public Citizen's web page on TPP [64]

* From a MPAA bio: "Anissa Whitten is Vice President of International Affairs and Trade Policy for the Motion Picture Association of America (MPAA). Ms. Whitten works with federal government agencies and Congress to reduce foreign trade barriers and improve protection of intellectual property in foreign markets for the U.S. motion picture, television programming and home video industries. Prior to joining MPAA, she worked in the State Department’s Bureau of Economic and Business Affairs as State’s expert on trade in services, representing the Department at World Trade Organization and free trade agreement negotiations. Her other policy portfolios included government procurement, trade capacity building, cultural diversity, and temporary entry. Whitten entered the State Department as a Presidential Management Fellow from the US Department of Labor’s Bureau of International Labor Affairs."

USTR New Exclusive Right for Copyright Holders: Importation Provision in the Trans Pacific Partnership Agreement (TPPA)

At the recently completed Vietnam round of negotiations for the Trans-Pacific Partnership Agreement (TPPA), once again, no official text of negotiation was released. Therefore, we still need to speculate about its status, relying in part on a three-month-ago leaked version of the intellectual property chapter [59] proposed by the Office of the United States Trade Representative (USTR).

This proposal includes a requirement that negotiating parties provide copyright holders the exclusive right to authorize importations, for "categories of products in which the value of the copyrighted material represents substantially all of the value of the product."

Article 4: Copyright and Related Rights

2. Each Party shall provide to authors, performers, and producers of phonograms the right to authorize or prohibit the importation into that Party’s territory of copies of the work, performance, or phonogram made without authorization, or made outside that Party’s territory with the authorization of the author, performer, or producer of the phonogram.fn.11

fn.11 With respect to copies of works and phonograms that have been placed on the market by the relevant right holder, the obligations described in Article [4.2] apply only to books, journals, sheet music, sound recordings, computer programs, and audio and visual works (i.e., categories of products in which the value of the copyrighted material represents substantially all of the value of the product). Notwithstanding the foregoing, each Party may provide the protection described in Article [4.2] to a broader range of goods.

The USTR introduced is proposal on intellectual property to negotiating parties at the round hosted in Chile, last February. Regarding copyright, much of the proposal is drafted as an upgrade of the Digital Millennium Copyright Act (DMCA), by adopting norms for the liability of online service providers, and the legal protections of technological protective measures and digital rights management information. However, some aspects of the proposal go well beyond the DMCA; including the proposal to require the granting to right holders of copyright and neighboring rights the exclusive economic right to control the importation of legitimate copies of works.

What does an exclusive right for importation mean?

Copyright holders already control reproduction, public performance and execution, modification, and distribution of works, and can decide where, when, and how distribute their works. However, in some countries, they are not able to control the importation of a legitimate acquired work from another country -- a practice known as parallel trade [242], one example of the principle of the exhaustion of rights, or the first sale doctrine.

If the US proposal to the TPPA IP chapter is accepted, right holders would be able to prevent third parties from importing legitimacy copies of works from one country to another, without authorization.

Currently, no multilateral international instrument on intellectual property grants to copyright holders an exclusive right to control the importation of works, so parallel importations are possible. Indeed, the World Trade Organization's Agreement on Trade Related Aspects of Intellectual Property (TRIPS) [243] specifically eliminates the possibility of litigating dispuites over parallel trade, or any other aspect of the exhausion of rights.

Article 6 - Exhaustion

For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.

Even the ACTA agreement includes, as a footnote to the Chapter on Border measures, this text:

It is to be understood that there shall be no obligation to apply the procedures set forth in this section to goods put on the market in another country by or with the consent of the right holder.

Thus, under all important global norms for intellectual property, copyrighted goods can be provided simultaneously through two or more legitimate channels of distribution. The lack of an exclusive right to control importations facilitates the circulation of goods, favors a more intense competition among distributors, and benefits consumers in the importing country.

Right owners typically oppose parallel trade in copyrighted goods, because they prefer to control and segment their markets.

Conferring an exclusive economic right on importation is controversial not only because of its damage for competition and consumers, but also because of conflicts with domestic law in the United States and other TPPA-negotiating countries.

The U.S. Copyright Act sets forth the exclusive rights of copyright holders, but it makes no mention to an exclusive right to control the importation of works (Sec. 106 [244]). In fact, because of the silence of the Copyright Act, the U.S. Supreme Court has been required to answer the issue of controlling importation. In the Costco case, the well-known retailer sold copyrighted watches legitimately acquired in foreign markets without authorization of its right holder, who opposed that commercialization. To be clear, those were not "counterfeit" goods, but legitimate goods made by the right holder but initially intended for foreign markets. Unfortunately, last December, the U.S. Supreme Court adopted a tie-vote decision [245], which, according to the "Affirmance by an Equally Divided Court" doctrine, leaves the previous decision of the lower appellate federal court standing without resolving the raised constitutional issue. In sum, the Copyright Act does not resolve the issue and the Supreme Court has neither, but the USTR is attempting to change the existing flexibility.

If granting exclusive right on importation is controversial in the U.S., it is even more problematic for countries that have embraced free flow of (copyrighted) goods and services. In recent years, some TPPA negotiating parties have adopted international exhaustion of rights into their domestic laws, which means right holders do not control international free flow of their works; this is the case, for example, of Australia [246], Chile [247], Malaysia [248], New Zealand [248], and Singapore [249]. Sacrificing consumers’ interest is highly problematic for those countries, because they cannot enjoy any advantage of scale economies. The New Zealand case illustrates the situation of those countries.

In 1998, New Zealand adopted the Copyright (Removal of Prohibition on Parallel Importing) Amendment Act 1998 [250]. The law embraced international exhaustion of rights, allowing parallel importations. In spite of being allowed by the TRIPS Agreement, in 1999, the USTR included New Zealand in the Watch List of the Special Report 301 [251] because of the parallel importations. As a result of the USTR pressure, in 2003, New Zealand introduced some limitations in its Copyright Act [252], mainly in favor of films. Successive analysis has been conducted by the government respect to the parallel importation. In 2005, a government report [253]found that lifting the ban on parallel importations has not affected the investment in and promotion of New Zealand creative sector, but improved choices and quality of services to retailers and consumers through increased competition, a result similar to Australia.

The case of New Zealand shows how parallel importations are particularly important for smaller economies. Almost all the countries involved in the TPPA negotiations are comparative small economies, including Chile and Australia. However, even in the U.S., this new right would clearly affect consumers and retailers, by increasing their access cost and limiting their business opportunities. USTR has aligned itself with the right holders.

The USTR’s proposal on this new exclusive rights for exportation will meet resistance from negotiators of those economies that have adopted international exhaustion of rights. After all, this is a decision that the TRIPS Agreement reserves to domestic law of the WTO-members (article 6 [254]). It would thus be interesting to know, what evidence or "studies" support the decision by the USTR to include an exclusive right for controlling importation in the TPP negotiations? And, how does it affect competition, and what wiil be the harm to consumers? How will the right be enforced in a digital environment, like the Internet?

Segmentation of markets and differences in national incomes

To the extent that copyright owners make the case that it is appropriate to segment markets between higher and lower income countries, in order to make copyrighted goods like films, books or computer games more affordable in developing countries, the agreement could be implemented in a more pro-competition manner. Specifically, the barriers to parallel trade could be limited to parallel trade from low income countries to high income countries, but be permitted between high income countries, and from high income markets to low income markets. Indeed, this proposal was explored by CPTech (the previous name for KEI), in 2002, in the context of a WTO negotiation on cross border movements on pharmaceutical drugs, and in various Congressional proposals concerning parallel trade for pharmaceutical drugs.

Alberto Cerda [255], Research Associate, KEI

Appendix

Perhaps also relevant for US negotiators are the provisions in 19 USC 1337 concerning imports of goods that infringe copyrights (and other intellectual property rights). Here it is worth noting that under current U.S. law, it is possible to import even infringing works without the permission of the right owner, a possibility not provided for in the US proposal for legitimate copyrighted goods imported via parallel trade.

TITLE 19 CHAPTER 4 SUBTITLE II
Part II—United States International Trade Commission
§ 1337. Unfair practices in import trade

. . .

(a) Unlawful activities; covered industries; definitions
(1) Subject to paragraph (2), the following are unlawful, and when found by the Commission to exist shall be dealt with, in addition to any other provision of law, as provided in this section:
[snip]
(B) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that—
(i) infringe a valid and enforceable United States patent or a valid and enforceable United States copyright registered under title 17; or

. . .
(d) Exclusion of articles from entry
(1) If the Commission determines, as a result of an investigation under this section, that there is a violation of this section, it shall direct that the articles concerned, imported by any person violating the provision of this section, be excluded from entry into the United States, unless, after considering the effect of such exclusion upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such articles should not be excluded from entry. The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry.

. . .

(l) Importation by or for United States
Any exclusion from entry or order under subsection (d), (e), (f), (g), or (i) of this section, in cases based on a proceeding involving a patent, copyright, mask work, or design under subsection (a)(1) of this section, shall not apply to any articles imported by and for the use of the United States, or imported for, and to be used for, the United States with the authorization or consent of the Government. Whenever any article would have been excluded from entry or would not have been entered pursuant to the provisions of such subsections but for the operation of this subsection, an owner of the patent, copyright, mask work, or design adversely affected shall be entitled to reasonable and entire compensation in an action before the United States Court of Federal Claims pursuant to the procedures of section 1498 of title 28.

What best describes Obama Administration rationale for secrecy of tabled TransPacific Partnership Agreement IPR texts?