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 Court recently explained, in the case of patent applications for pharmaceuticals and other chemicals:

The amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions …. [O]n reading [section 2] with section 3(d) it would appear that the Act sets different standards for qualifying as 'inventions' things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold higher, by virtue of [section 3(d)]. … [I]n case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation.

The United States is concerned that section 3(d), as interpreted, may have the effect of limiting the patentability of potentially beneficial innovations. Such innovations would include drugs with fewer side effects, decreased toxicity, improved delivery systems, or temperature or storage stability. In practice, this standard has already been applied to deny patent protections to potentially beneficial innovations, some of which enjoy patent protection in multiple other jurisdictions.

Even after a product receives a patent, Indian law continues to pose challenges to the enjoyment of that IPR protection.

First, the United States supports patent systems that incorporate efficient patent procedures and foster high-quality patents, and, in that connection, urges India to improve and streamline its patent opposition procedures. Specifically, under India's patent regime, the same interested person may, at minimal cost, challenge a patent through both pre-grant and post-grant opposition proceedings on any of eleven enumerated grounds, including by citing the same grounds in both pre- and post-grant challenges. As a result, applications can be tied up in costly challenge proceedings for years, all the while running the potential term of the patent which begins from the application filing date, thus impeding an applicant's ability to make investments and conduct business.

Second, while bearing in mind the Doha Declaration on TRIPS and Public Health, discussed in the Intellectual Property and Health Policy section of this Report, the United States also continues to monitor developments concerning compulsory licensing of patents in India. The United States urges India to provide greater transparency about its ongoing inter-ministerial process that is considering over a dozen patented medicines as candidates for government-initiated compulsory licenses, and urges India to allow opportunities for input by rights holders, as appropriate, with respect to decisions concerning compulsory licenses.

In addition, the United States continues to be concerned with the rationale underlying a decision by India's Controller-General of Patents to grant a compulsory license under Section 84 of India's Patents Act (which allows private parties to initiate proceedings seeking a compulsory

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