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Why is it a big mistake to link funding of R&D costs with drug prices?:

USTR pressures Taiwan on pricing and reimbursement of pharmaceuticals and medical devices

This from USTR's 2010 Trade Policy Agenda and 2009 Annual Report:

The USPTO-Pfizer collaboration to change India's laws on patents and test data

The United States Patent and Trademark Office has a joint program with Pfizer to fund and manage seminars in India on "misconceptions of evergreening" and "the importance of regulatory data protection and patent linkage." KEI has submitted a FOIA request to USPTO on this topic, and received a small installment of documents on Friday. Attached to this blog are 4 pages of documents that we received from two meetings held in Mumbai, India on September 9, 2009. Ten journalists and 15 NGOs attended the meetings.

Six Myths about the treaty for people with disabilities that should be debunked next week?

Next week (March 8-12) delegates from various developing countries will gather in Washington, DC for a week long "INTERNATIONAL TRAINING FOR DEVELOPING COUNTRIES AND COUNTRIES IN TRANSITION ON EMERGING ISSUES IN COPYRIGHT AND RELATED RIGHTS AND ISSUES PERTAINING TO BLIND AND VISUALLY IMPAIRED PERSONS" co-organised by the US Copyright Office and WIPO. We hope that at least 6 Myths about the treaty for people with disabilities proposed by Brazil, Ecuador and Paraguay will be clearly debunked once and for all during the training.

Senator Leahy patent reform bill out of step with ACTA provisions on patent damages

On March 4, 2010, the Senate Judiciary Committee released its new "compromise bill" on patent reform. Senator Leahy described the objectives of the bill as follows:*

"we wanted to improve patent quality and the operations at the [Patent and Trademark Office], and address runaway damage awards that were harming innovation. We are close to a compromise that will address these issues."

Indian NGOs confront GWU Law School efforts to push maximalist IPR norms in India

The ties between Universities and businesses are often complex and blurred. Private companies or trade associations fund research and seminars, and have consulting relationships with faculty members, trying to shape public policy and judicial decisions on a wide range of issues. A particularly interesting industry/university connection concerns something called the "India Project," that is associated with the George Washington University (GWU) Law School.

KEI looks at USTR letter to Wyden, and conflicts between ACTA and patent reform

On January 6, 2010, Senator Ron Wyden sent a letter to the USTR asking a number of questions about the U.S. negotiating objectives in ACTA. On February 28, 2010, USTR responded. The USTR response focused mostly on the official U.S. "asks," rather than the state of the negotiating text, which also reflects also the views of other parties. For this reason, the USTR letter to Wyden only tells part of the story about what ACTA may do.

USTR responds to Senator Wyden's letter on ACTA

Ambassador Ron Kirk has issued a response to Senator Wyden's letter dated January 6, 2010. The official press release from Senator Wyden's office follows:

U.S. Senator Ron Wyden

FOR IMMEDIATE RELEASE CONTACT: Jennifer Hoelzer (Wyden): (202) 224-3789
March 2, 2010

Wyden Gets Some Answers on ACTA Negotiations

USTR Responds on Range of Issues, including Internet Access and Drug Sales

Copyright lobby (IIPA) demands that USTR punish governments who 'consider' mandating open source software

On February 18, 2010, the International Intellectual Property Alliance (IIPA), a trade association whose members include the Business Software Alliance (BSA), the Motion Picture Association of America (MPAA) and the Recording Industry Association of America (RIAA) prepared a 498 page submission to the Office of the United States Trade Representative (USTR) detailing their concerns with 39 countries or territories which the IIPA believed were not providing adequate and effective protection of their

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 swpat.org.

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:

SUBMISSION OF GLOBAL HEALTH ORGANIZATIONS:

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.

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