no subsequent applicant may rely on the undisclosed test or other data submitted in support of an application for marketing approval of new pharmaceutical products for a period of at least six years from the date of marketing approval in China. However, there is evidence that generic manufactures have, in fact, been granted marketing approvals by the State Food and Drug Administration (SFDA) prior to the expiration of this period, and in some cases, even before the originator's product has been approved. The United States looks forward to working with the SFDA and other relevant agencies to address this concern, including through on-going work in the JCCT.
In conclusion, the United States believes that continued bilateral dialogue and cooperation can lead to further progress in these and other areas. The United States will continue to put serious efforts into its joint work with China on IPR enforcement and protection strategies, innovation policies, and the range of other important IPR-related matters in this bilateral economic relationship, including through the JCCT and other fora.
India
India remains on the Priority Watch List in 2012. India made limited progress on IPR protection and enforcement in 2011, and its legal framework and enforcement system remain weak. The challenge of piracy over the Internet continues to grow, but the Copyright (Amendment) Bill 2010, which proposed partial implementation of the WIPO Internet Treaties and other reforms appears to have stalled. The United States continues to encourage India to promote a stable and predictable patent system that can nurture domestic innovation, including by resolving concerns with respect to the prohibition on patents for certain chemical forms absent a showing of increased efficacy. The United States recognizes India's recent efforts to address its patent application backlog, and urges India to take additional steps in this regard. The United States also urges India to continue to work to streamline its patent opposition proceedings. The United States will closely monitor developments concerning compulsory licensing of patents in India following the broad interpretation of Indian law in a recent decision by the Controller General of Patents, while also bearing in mind the Doha Declaration on TRIPS and Public Health found in the Intellectual Property and Health Policy section of this Report. The United States urges India to provide an effective system for protecting against unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products. The United States notes some improvements with respect to IPR enforcement, including reports of good cooperation of enforcement officials with some in the copyright industry, and increased use of judicial orders that have strengthened enforcement against pirated movies and music online. The United States encourages India to take additional steps to improve coordination with enforcement officials of certain state governments within India. The United States also continues to encourage India to address its judicial inefficiencies and to strengthen criminal enforcement efforts, including by imposing deterrent level sentences and giving IPR prosecutions greater priority. Finally, the United States commends India's recognition of the importance of innovation as part of its efforts to promote domestic manufacturing, and urges India to resist imposing discriminatory policies or other counterproductive measures in pursuit of that objective, and at the expense of adequate and
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