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 abusive litigation, and burdens legitimate applicants seeking to make patentability or freedom to operate determinations.

The United States looks forward to continuing to work with China to resolve these and other issues.

India

India remains on the Priority Watch List in 2013. In 2012, India made limited progress in improving its weak IPR legal framework and enforcement system. India enacted copyright amendments and published for comment draft rules to implement the Madrid Protocol and a draft National Intellectual Property Strategy, which proposes to create an enhanced IPR management system. In many areas, however, IPR protection and enforcement challenges are growing, and there are serious questions regarding the future condition of the innovation climate in India across multiple sectors and disciplines. The United States continues to urge India to reconsider how it can meet legitimate domestic policy objectives by fostering rather than undermining that innovation climate.

Patents & Regulatory Data Protection

The United States continues to encourage India to promote a stable and predictable patent system that can nurture innovation. As leading economies with a strong tradition of innovation, India and the United States can and should ensure supportive environments for innovators to achieve success and make significant contributions to economic growth in both countries. In that connection, the United States urges India to continue its recent efforts to address its patent application backlog and to streamline its patent opposition proceedings.

Recent actions by the Indian Government, however, have raised serious questions about the innovation climate in India and risk hindering the country's progress towards an innovation-focused economy. In the pharmaceutical sector, some innovators are facing serious challenges in securing and enforcing patents in India. The United States urges India instead to adopt policies that support both cutting-edge innovation to address important health challenges and a robust generic market.

For example, a patent system must encourage the development of inventions that meet the well-established international criteria of being new, involving an inventive step, and being capable of industrial application. The United States is concerned that the recent decision by India's Supreme Court with respect to India's prohibition on patents for certain chemical forms absent a showing of "enhanced efficacy" may have the effect of limiting the patentability of potentially beneficial innovations. Such innovations would include drugs with fewer side effects, decreased toxicity, or improved delivery systems. Moreover, the decision appears to confirm that India's law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application. 38