Malini Aisola's blog
The USPTO-Pfizer collaboration to change India's laws on patents and test data
Submitted by Malini Aisola on 5. March 2010 - 19:10The 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.
USTR responds to Senator Wyden's letter on ACTA
Submitted by Malini Aisola on 2. March 2010 - 17:01Ambassador 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 WydenFOR IMMEDIATE RELEASE CONTACT: Jennifer Hoelzer (Wyden): (202) 224-3789
March 2, 2010Wyden Gets Some Answers on ACTA Negotiations
USTR Responds on Range of Issues, including Internet Access and Drug Sales
PhRMA pushes for data exclusivity in 2010 Special 301 comments
Submitted by Malini Aisola on 1. March 2010 - 18:11The 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.
Dec 9, 2009 Wikileaks documents related to the WHO EWG
Submitted by Malini Aisola on 21. January 2010 - 9:30On December 9, 2009, Wikileaks posted five sensitive documents related to the WHO Expert Working Group (EWG) on R&D Financing:
a non-public draft report of the WHO EWG a non-public Comparative Analysis done by the EWG the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Overview of the EWG Comparative Analysis an IFPMA summary slide on the EWG Draft Report
Open Letter to the WHO EB from Cecilia López Montaño, EWG member
Submitted by Malini Aisola on 17. January 2010 - 20:54The following is a letter sent by Cecilia López Montaño, a member of the WHO Expert Working Group on R&D Financing to the WHO Executive Board:
Bogotá. Colombia. January 15th 2010
Dear members of the Executive Board:
I am Cecilia López Montaño, senator of the Colombian Congress and member of the Expert Working Group on Research and Development Financing of the World Health Organization, in representation of the point of view of developing countries, I assume.
A closer look at the WHO EWG endorsed proposals on funding product development partnerships
Submitted by Malini Aisola on 14. January 2010 - 7:04The World Health Organization's Expert Working Group on R&D Financing spent scant attention on how to raise money, but showed considerable interest in how to spend it. The clear favorite approach is to give grants to product development partnerships -- the approach that has now become the most conventional approach, and one not surprisingly endorsed by the PDPs themselves, and also by the Gates Foundation and the IFPMA -- two groups that are often seen as devoted to protecting the status quo in terms of intellectual property and business models for innovation.
Senator Wyden's letter to the USTR on ACTA
Submitted by Malini Aisola on 7. January 2010 - 10:53Senator Wyden has written to the USTR posing 11 questions aiming to clarify the specific objectives of the Anti Counterfeiting Trade Agreement (ACTA). The next round of negotiations are scheduled to take place in Mexico during the week of January 25. The letter is available here.
EU proposal calls for deletion of "treaty" for persons with disabilities at SCCR 19
Submitted by Malini Aisola on 18. December 2009 - 5:23Below is the language of paragraph 7 of the draft conclusions of SCCR 19 contained in the "Draft Conclusions Version 2.0" document distributed this morning:
WIPO SCCR: CIS Statement in support of the WBU Treaty
Submitted by Malini Aisola on 16. December 2009 - 9:07Statement of the Centre for Internet and Society (CIS), Bangalore, on the matter of the Treaty for the Blind, Visually Impaired and other Reading Disabled, proposed by Brazil, Ecuador and Paraguay.
16th December, 2009
KEI, Richard Stallman and ORG ask EC to block Oracle's acquisition of MySQL
Submitted by Malini Aisola on 19. October 2009 - 17:05Today, Richard Stallman, Knowledge Ecology International (KEI) and the Open Rights Groups (ORG) sent a letter to Neelie Kroes, Commissioner for Competition for the European Commission expressing their opposition to Oracle's acquisition of MySQL as part of the proposed Oracle-Sun merger. The letter is available here.
