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 Section 2(j) of India's Patents Act sets forth the criteria for patentability. An "invention" under the Act is any product or process that is novel, has an inventive step, and is capable of industrial application. Section 3(d) of India's Patents Act states, in relevant part, that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" is not considered to be an "invention" under Indian law. As noted in the 2014 Special 301 Report, the Indian Supreme Court 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 continues to have concerns that Section 3(d) of India's Patents Act, as interpreted, may have the effect of limiting the patentability of potentially beneficial innovations. Such innovations could include drugs with fewer side effects, decreased toxicity, improved delivery systems, or temperature or storage stability. In practice, India has already applied this standard to deny patent protections to potentially beneficial innovations, some of which enjoy patent protection in multiple other jurisdictions. In addition, the United States supports patent systems that incorporate efficient patent procedures and foster high-quality patents; as such, the United States urges India to improve and streamline its patent opposition procedures as it adopts and implements the Draft IPR Policy. 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. This has the ensuing effect of impeding an applicant's ability to make investments and conduct business in India.

Second, while emphasizing our continued commitment to the Doha Declaration on the TRIPS Agreement and Public Health, as discussed in the Intellectual Property and Health section of this

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