Regulatory Test Data
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.
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.
WIPO Symposium on the Evolution of the Regulatory Framework of Test Data
Submitted by thiru on 2. February 2010 - 8:25As 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: http://www.wipo.int/edocs/mdocs/mdocs/en/wipo_ip_lss1_ge_10/wipo_ip_lss1...
WIPO Symposium (February 8, 2010): Evolution of the Regulatory Framework of Test Data
Submitted by thiru on 12. January 2010 - 8:07On February 8, 2010, the World Intellectual Property Organization (WIPO) will hold a " Symposium on the Evolution of the Regulatory Framework of Test Data – From the Property of the Intellect to the Intellect of Property".
