Review of Granted Compulsory Licences
Legislators recognise that exceptions and limitations may be established to help the achievement of the ultimate goal under patent law. However, exceptions and limitations are made to keep the interest balance between the patentee and the public, including the potential competitors of the patentee. Such interest balance would be obtained when patentees are restrained from asserting their exclusive rights against some acts that have no substitution effects on the patented products and, at the same time, are conducive to the disclosure of and access to the patent to enhance the technological development. This inference is supported by Art. 30 of the TRIPS Agreement, after which limited exceptions can be allowed in patent law provided that they “do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”.
Compulsory Licensing of Patents: The Bayer/Natco Case
On 9th March 2012 the Indian Controller of Patents granted the first compulsory licence in India. Indian generics producer Natco Pharma Ltd. has been granted the right to produce and sell in India Bayer’s patented medicine “Sorafenib”, which is useful for treating advanced stage liver and kidney cancer. After a brief introduction on compulsory licenses under the TRIPS Agreement and the Paris Convention, the author verifies whether the decision of the Controller of Patents satisfies the conditions set forth by the these international treaties in relation to compulsory licenses. He concludes inter alia that the ruling might be in violation of the non discrimination principle enshrined in Article 27(1) TRIPS. General comments are also made about the role of compulsory licensing in guaranteeing the availability of patented products to a wide range of consumers and in general the transfer and dissemination of the associated technology.
Access to generic antiretrovirals: inequality, intellectual property law, and international trade agreements.
The governments of numerous low- and middle-income countries are currently instituting rules that strengthen changes in domestic intellectual property legislation, often made to conform to the mandates of "free" trade agreements signed with the United States. These measures frequently include intellectual property provisions that extend beyond the patent law standards agreed upon in recent World Trade Organization negotiations, which promised to balance the exigencies of public health and patent holders. In this paper, we analyze the concern that this augmentation of patent law standards will curtail access to essential medicines, particularly as they relate to the AIDS pandemic. We critically examine the potential threats posed by trade agreements vis-à-vis efforts to provide universal access to antiretroviral medications and contend that the conditioning of economic development upon the strengthening of intellectual property law demands careful attention when public health is at stake. Finally, we examine advocacy successes in challenging patent law and conclude that greater advocacy and policy strategies are needed to ensure the protection of global health in trade negotiations.