Report (See Section I), the United States also continues to monitor India's application of its compulsory licensing law. The United States requests clarity from the Government of India regarding the compulsory license decision-making process as it affects U.S. stakeholders. Although the government has issued only one compulsory license under Section 84 of India's Patents Act, India has made clear in other policy statements that it views compulsory licensing as an important tool of industrial policy for green technologies, with the potential to be applied more regularly across economic sectors. Specifically, India has, in the past, promoted compulsory licensing in its National Manufacturing Policy as a mechanism available for government entities to effectuate technology transfer in the clean energy sector.
In the UNFCCC negotiations, India continues to identify patents as obstacles to the dissemination of climate change technologies, pressing for outcomes that would potentially undermine incentives for innovation, such as patent protection and competitiveness conditions that are critical parts of the response to climate change and other environmental challenges. Despite India's claims, there is significant empirical evidence demonstrating that green technology patents promote innovation and technology transfer. Supported by its patent system, India has become a leading global manufacturer in several green technology sectors, with Indian companies leading global R&D efforts in this sector. India need only create a truly enabling environment in its market, with the features of openness, predictability, consistency, and fairness, and the investment, technology transfer, and innovation on which India's further development depends, will follow.
The United States also notes with concern the continuing challenges involved with the enforcement of patent rights in India, including challenges that some patent holders reportedly face in securing injunctions against firms that manufacture patented inventions without authorization from the patent holder. In addition, when approving such marketing without authorization, Indian state governmental authorities reportedly do not have a mechanism to confirm whether the item to be manufactured is under patent. Recent cases such as Merck v. Glenmark and Cipla v. Roche illustrate this problem and underscore the need for greater regulatory coordination between officials in state and central governments.
Finally, the United States continues to urge India to provide an effective system for protecting against unfair commercial use, as well as the unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products. Without these types of protections, companies in India reportedly are able to copy certain pharmaceutical products and seek immediate government approval for marketing based on the original developer's data. The United States notes the potential to address this issue as part of the First Draft of India's National IPR Policy, which describes protection of undisclosed information as an "important area of study and research for future policy development." The United States understands that the issue of agricultural chemical data protection may be considered by the Indian Parliament under the Pesticides (Amendment) Bill.
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