The granting of secondary use patents in the pharmaceutical industry has become more prominent after the negotiations of the TRIPS Agreement in 1995. More and more secondary use patents have been granted, especially in developed countries. But, on the flip side, some firms tend to take advantage of secondary use patents in order to extend the exclusivity period. This can generated concerns among the policy makers worldwide. As a result of this, obtaining secondary use pharmaceutical patents has become a arduous process.
Scenario in developing countries
Traditionally, pharmaceutical patents have been one of the most controversially debated issues in concern with intellectual property protection, strikingly more in developing countries. In the process of negotiations of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, the protection of pharmaceutical products was opposed by developing countries as they were of the opinion that strong patent protection would obstruct the development of domestic pharmaceutical industry and would impede access to to drugs. The TRIPS agreement made it mandatory for all members of the WTO to grant patents with a statutory lifetime of 20 years from the patent application, also to pharmaceutical compounds.1
Nonetheless, many developing countries have a relatively more restrictive approach than developed countries when it comes to granting of pharmaceutical patents. While it is required by TRIPS to grant patent protection to processes as well as products in "all fields of technology", the agreement gives substantial freedom to define the standards of patentability.2 This provision has been used by developing countries, for example, India to impose limits on the granting of secondary pharmaceutical patents.
Inspite of universalization of pharmaceutical patenting by TRIPS, developing countries have exploited the substantial freedom given to them to define patentability standards by trying to restrict the granting of secondary patents.
The Glivec Patent Saga
Section 3(d) of the Indian Patent (Amendment) Act, 2005 was heavily criticised with the development of the Novartis case. Patent protection was not granted by the Supreme Court to a life-saving cancer drug known as Gleevec. The decision was based on the reasoning that the drug did not show any "enhanced efficacy" or any "therapeutic effect" as was required to be shown when obtaining secondary patent protection for the new use of an already existing drug. This section was seen to exclude incremental innovation which was violative of the provision laid down by the TRIPS Agreement. Apart from this, the scope of the term efficacy was not Cleary defined and was seen to be extremely vague. The court also failed to provide the rationale as to why the subject matter lacked enhanced efficacy. Accordingly, due to this interpretation, any kind of incremental innovation will not be capable of obtaining patent protection in India.3
Conclusion
Compared to developed countries, developing countries like India, Paraguay, Argentina, etc seem to have much more stringent laws regarding the granting of secondary pharmaceutical patents. Historically, developed countries have been much more liberal in granting such patents, but with time they haveshown an inclination towards a more stringent approach toward new pharmaceutical forms. In the years to come, there is risk that the policies in developing as well as developed countries will favour generic entries into the market, and this in turn could create a scarcity in matters of money and motivation for innovation thereby affecting the investment in research and development of new drugs.4
The Indian regime, though in compliance with the TRIPS Agreement, is seen to hamper the spirit of the TRIPS Agreement by imposing the "therapeutic efficacy" clause which is not only arbitrary but also evidently excludes incremental innovation. This additional requirement of the new form having therapeutic efficacy is outside the scope of the TRIPS Agreement (i.e the invention must be novel, involving an inventive step and must have industrial application). Due to this, a cause for concern arises with respect to those countries which try to seek protection and market their products in the Indian market.
Providing patent protection to secondary use medical claims has it's own set of impediments, but granting secondary use pharmaceutical patents would help for drug repurposing. Providing protection for such claims would assist in further interest and returns on investments made by pharmaceutical companies.
Footnotes
1 Even then, various provisions which allow signatories to impose restrictions on use and granting of patents on pharmaceuticals such as compulsory licensing and price controls are incorporated in the TRIPS Agreement.
2 TRIPS Article 27.3(a) allows countries to exclude therapeutic and diagnostic methods from patentability, which offers another legal justification for excluding new uses of existing drugs from patentability.
3 AIR 2013 SC 1311.
4 Susan Fyan, Pharmaceutical Patent Protection and Section 3(D): A Comparative Look at India and the U.S., 15 Va. J.L. & Tech. 198 (2010).
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