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PhRMA pushes for data exclusivity in 2010 Special 301 comments

The Pharmaceutical Research and Manufacturers of America (PhRMA) 2010 Special 301 submission (a 200 plus page document) systematically lists in great detail, grievances against 41 countries for, in its view, the insufficient implementation and enforcement of national IP legislation.

A primary focus of attention and frequent "area of concern" in the submission is the inadequate protection of pharmaceutical regulatory data. Regulatory data refers to test and clinical trial data generated by drug developers and submitted as requisite evidence of safety and efficacy for the successful registration of a product. While data protection can take many forms, data exclusivity regimes grant a period of exclusive rights to the originator during which generic manufacturers are banned from relying on the original data to meet registration standards of safety and efficacy. In its submission, PhRMA relentlessly advocates for, indeed makes demands of several countries to implement data exclusivity provisions that go far beyond their obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

As noted by KEI and others in submissions to USTR, a number of public health and development NGOs have been highly critical of data exclusivity regimes, citing the large barriers to the introduction of generic medicines, and the conflicts between data exclusivity and medical ethics, when generic firms are required to replicate experiments with humans where the results of trials are already known. KEI will focus on the issue of pharmaceutical test data protection in its testimony on the Special 301 list on March 3, 2010.

Below are country-specific statements on this subject from PhRMA's submission:

PhRMA has singled out THAILAND by recommending that it be identified as a Priority Foreign Country
In 2007, implementing Ministerial regulations of the Trade Secrets Act of 2002 were issued by the Thai FDA. While the regulations provide trade secret protection that prohibits disclosure of confidential information, the regulations fail to prohibit the Thai FDA or generic drug applicants, for a fixed period of time, from relying on the originator’s regulatory data to approve generic versions of the originator’s product. That protection (referred to as Data Protection) should be established by Thailand to ensure unfair commercial use of innovators’ data does not occur.

PhRMA encourages Thailand to (1) implement new regulations that do not permit generics producers to rely directly or indirectly on the originators’ data, unless consent has been provided by the originator, for the approval of generic pharmaceutical products during the designated period of exclusivity; (2) bring Thailand’s regulations in line with international best practices by making clear that trade secret protection is provided to all confidential material whenever it is received by officials; (3) extend data protection to new dosage forms, new indications, etc; and (4) require Thai FDA officials to protect information provided in confidence by the originator by ensuring that information is not improperly made public or made available for use or reliance by a subsequent producer of a generic pharmaceutical product.

KEI notes on the EU leak of the ACTA text

On 12 February 2010, the Council of the European Union distributed a table drawn up by the Commission Services, outlining the positions of various counties regarding civil enforcement and the special requirements relating to the Internet. A copy of this 44 page document was leaked on March 1, 2010, and is attached to this blog. A text version of the table is available from

Global Health Organizations Submission to USTR Special 301

On February 18, 2010, 12 NGOs working on Access to Medicines submitted joint comments to the 2010 Special 301 Process

The submission is available here.

And a summary below:


KEI comments on U.S.T.R. Special 301

KEI is one of several public health groups working with Sean Flynn on filing comments in the current U.S.T.R. request for comments on the Special 301 process (Federal Register Notice USTR-2010-0003-0129). In addition, KEI filed these comments:

KEI comments on Special 301

18 February 2010

KEI provides the following comments regarding the 2010 Special 301 Review, including but not limited to the Identification of Countries Under Section 182 of the Trade Act of 1974.

Our comments include the following points:

Billy Tauzin's 2008 compensation from PhRMA was $4,476,157

Billy Tauzin announced today that he will be stepping down as President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) at the end of June 2010.

PhRMA's 990 Tax Return Form, Schedule J-1 shows the amount Tauzin was compensated in 2008:

Base compensation: $2,055,445
Bonus & incentive compensation: $692,875
Other reportable compensation: $159,412
Deferred compensation: $1,556,960
Nontaxable benefits: $11,465

Total: $4,476,157

Rethinking compulsory licensing for export: WTO members hold informal consultations on Paragraph 6 implementation

Friday, 12 February 2010

Around 100 Members of the World Trade Organization attended informal consultations today in Room E (a mainstay of the green room consultations) to discuss the implementation of Paragraph 6 mechanism which was created to be an "an expeditious solution" for "WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector" that faced difficulties in in "making effective use of compulsory licensing under the TRIPS Agreement".

PCT Patent Filings per million residents

The use of the patent system is quite different from country to country. The following table provides the number of WIPO PCT patent filings, by country of origin, from January 2005 to November 2009, per million residents.* The source of the data on PCT filings is the February 2010 version of the WIPO Statistics Database. (WIPO notes the 2009 data are provisional and incomplete). The PCT counts are based on the international filing date and the country of residence of the first named applicant.

WIPO PCT filings down in 2009

A February 8, 2010 WIPO press release states:

International patent filings under WIPO's Patent Cooperation Treaty (PCT) fell by 4.5% in 2009 with sharper than average declines experienced by some industrialized countries and growth in a number of East Asian countries.

PhRMA's grants to US organizations in 2008

In the United States, tax exempt non-profit organizations are subject some some requirements for financial disclosure via the IRS form 990, which is available to the public. The disclosure requirements cover most U.S. based trade associations, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the trade association for some 28 "member" companies.

WIPO SCP 14: Summary of the Chair


SCP/14/9 Rev.


DATE: January 29, 2010



Fourteenth Session
Geneva, January 25 to 29, 2010


Agenda Item 1: Opening of the Session

WIPO Symposium on the Evolution of the Regulatory Framework of Test Data

As mentioned, before WIPO is holding a symposium on February 8, 2010 on the "Evolution of the Regulatory Framework of Test Data - From the Property of the Intellect to the Intellect of Property". The symposium will be held from 9:30 AM to 5 PM in Room B of WIPO headquarters.

The program of the symposium can be found here:

Deadlock at 14th session of the WIPO Standing Committee on the Law of Patents (SCP)

After a around 10 hours of informal consultations today, it appears that the 14th session of the WIPO Standing Committee on the Law of Patents (SCP) has not reached consensus on new items for the Committee's consideration. From sources close to the negotiation, much of the wrangling dealt with whether to preserve the non-exhaustive nature of the list of issues identified at SCP 12 and SCP 13.

Suggestions by Asian Like-Minded Countries on Future Work of the WIPO Standing Committee on the Law of Patents (SCP)

The members of the "Asian Like-Minded Countries" group are: India, Indonesia, Iran and Pakistan.

Agenda 8: Future Work

1. [Following a proposal by the Chair,] the Committee

(a) reaffirmed that the non-exhaustive list of issues identified at the twelfth session of the SCP held in June 2008, and updated at its 13 session, would remain open for further elaboration and discussion at its next session(1);

SCP 14: Draft text on Future Work

Around 4:20 PM CET, the following draft text was made available for for Member States' consideration. Currently, the countries are in informals considering the following text.

Around 5:50 PM, a draft text entitled "Suggestion by Asian Like-Minded Countries" was made available.

Among the key amendments suggested was the following language:

"Comments of Member States and Observers would be reflected in annexures appended to the respective studies"

Knowledge Ecology International statement on Opposition Systems WIPO SCP 14

The following intervention was delivered by KEI at the 14th session of the Standing Committee on the Law of Patents (SCP) on the item related to opposition systems.

January 27, 2010

Knowledge Ecology International statement on 7(f): Opposition Systems

Thank you Mr Chair, for providing Knowledge Ecology International (KEI) with the opportunity to provide some thoughts on the Committee's work on opposition systems.

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