By Kevin E. Noonan --
Two of the leaders among developing countries in challenging Western assumptions behind the TRIPS agreement and the WTO, Brazil and India, recently announced a further evolution of their national laws directed to implementing the provisions of that treaty.
Brasil's announcement concerns the administrative procedures governing the interaction between the Brazilian Patent Office (the Instituto Nacional da Propriedade Industrial or INPI) and its Public Health Service (the Agencia Nacional da Vigilancia Sanitaria or ANVISA). Under Brazilian law, ANVISA has the authority (and the responsibility) to grant prior consent to patent applications on pharmaceutical products and methods that were either pending or filed after December 15, 1999. This authority was part of the national enabling legislation under which TRIPS IP protection for pharmaceuticals became part of Brazilian law (Article 229-C); beforehand Brazilian patent law did not recognize pharmaceuticals as patentable subject matter. Although the statutory provisions requiring ANVISA's consent went into force on February 14, 2001, until now there were no established rules for an applicant to apply for ANVISA permission. The new rules, announced on June 23rd and coming into force on June 24th as Resolution No. 45, for the first time provide standardized administrative procedures for a pharmaceutical patent applicant to petition ANVISA for its consent that the applicant obtains a patent. This permission is now dependent, in part, on the patentability of the pharmaceutical or pharmaceutical method, as well as being grounded in public health concerns. The new rules are expected to reduce the extent to which ANVISA permission depends on the exercise of its discretionary authority. The rules provide applicants with the opportunity to submit documentary and other evidence, including prior art and counterpart granted foreign patents, as well as having provisions for interested third parties to submit evidence. The rules make a distinction between applicant- and third-party submissions in that third party submissions will not be published to the applicant. An adverse decision by ANVISA will not be made public, but upon notice to the applicant there is a 90-day term for filing a response. Appeals to the Full Board of Directors can be had within 60 days of any final decision. ANVISA's final decisions will be published in the Federal Patent Gazette. Once ANVISA's consent is obtained, the application is returned to INPI for patent grant.
Brasil's law gives the Public Health Service an effective veto on the patentability of any pharmaceutical or pharmaceutical method patent, and represents another example of developing countries obtaining the benefits of WTO membership while crafting national laws that de facto perpetuate a patent-unfriendly environment with regard to pharmaceutical patents. The danger to Western drug companies attempting to navigate national law in Brasil under its implementation of TRIPS is that ANVISA's veto permitted national interests to trump intellectual property protection, and hence was susceptible to political influence. After all, what Brasilian politician would risk being accused of harming (or worse, acting in a way that harmed) public health in Brasil in favor of a foreign drug company's intellectual property rights in Brasil. The best that can be said of Resolution No. 45 is that it has the potential to normalize the process of obtaining ANVISA approval for pharmaceutical and pharmaceutical method patents, and thus reducing to some degree the effects of political influence on the process. (Patent Docs thanks Brasilian associate Momsen Leonardos & Cia for alerting us to these developments and providing information about them.)
In India, the government has decided to grant innovator drug companies a hearing whenever an Indian company petitions for the government to grant a compulsory license on a patented drug. Compulsory licenses are available under Indian law (Patent Rules, Section 92A) for, inter alia, producing drugs for export to countries unable to produce the drug itself:
92A. (1) Compulsory license shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory license has been granted by such country or such country has, by notification of otherwise, allowed importation of the patented pharmaceutical products from India.
Explanation — For the purposes of this section, "pharmaceutical products" means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.
The specific instance involved in the government's decision is the petition by Natco Pharma, an Indian generic drug company located in Hyderabad, to manufacture Sutent® (sunitinib), an anticancer monoclonal antibody drug patented by Pfizer, and export it to Nepal, a country without the industrial infrastructure or capacity to make the drug itself. These rules implement the provisions of TRIPS and the Doha Declaration that permit a national drug company to seek a compulsory license to address a "public health crisis." However the law has been vague in defining the metes and bounds of what constitutes a "public health crisis," nor have the procedures and protocols for obtaining a license been definitively set forth under Indian law; one possible reason for this failure is that Natco is the only Indian generic drug company that has sought a compulsory license under the terms of Section 92A. Over Natco's protests, denied on July 4th, the Indian Patent Office decided that it would hear from Pfizer on the prudence of granting such a license.
It remains to be seen whether Pfizer's opportunity to be heard will have any substantive impact on the inclination of the Indian Patent Office to grant a compulsory license to Natco. In addition, other Western drug companies will be watching this decision, particularly Roche: Natco has also applied for a compulsory license to make and export to Nepal Roche's patented anticancer monoclonal antibody, Tarceva® (erlotinib).
For additional information regarding this and other related topics, please see:
• "More on Global Drug Patenting Crisis," August 14, 2007
• "Trying to Find a Solution to the Global Drug Pricing Crisis," July 16, 2007
• "Pharma Sanity Lacks Global Reach," July 13, 2007
• "Brasil Prevails in Dispute with Abbott over AIDS Drug Pricing," July 9, 2007
• "Worldwide Drug Pricing Regime in Chaos," May 9, 2007
• "A Modest Proposal Regarding Drug Pricing in Developing Countries," May 2, 2007
• "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries," May 1, 2007
Hi,
Strange that a law blog has a wrong map of a country. Please correct the map of India which shows the boundaries wrongly.
please refer to the official map at: http://www.india.gov.in/maps/indiaindex.php
thanks
Posted by: | July 21, 2008 at 01:03 PM
1:03 PM:
I am not sure what was exactly wrong with the previous map (other than the fact that it may have been tilted slightly). Nevertheless, I have changed to a different image.
Don
Posted by: Donald Zuhn | July 31, 2008 at 06:32 PM
The Indian map posted here is correct according to the United Nations and India.
Kashmir joined Indian Union in 1948, like approximately 600 hundred other kingdoms joined the Union, by a treaty between the king and the Indian Union.
However, most Pakistani maps and maps prepared in the US show north-western part of Kashmir as part of Pakistan. This part of Kashmir was occupied by invading Pakistan in 1948, which should be vacated by Pakistan under a UN resolution. Instead, Pakistan has been waging a terrorist war (or freedom fight??)from Pakistan Occupied Kashmir to get the rest of Kashmir from India.
Also, in 1962, China invaded and occupied part of India (in Kashmir).
These parts could be shown as disputed, as they belong to India but occupied by Pakistan and China.
Indian claim to the Kashmir has been well documented through treaties and UN resolutions.
Possession is 9/10 of the law!?
Posted by: The Indian Lawyer | August 13, 2008 at 06:42 PM