Awaking the Sleeping Dragon: The Evolving Chinese Patent Laws and its Implications for Pharmeceutical Patents

Part I of this Comment will discuss the development of the Chinese IP system and discuss why it has been ineffective in protecting pharmaceutical patents by comparing it to the US patent system. Part II analyzes the third amendment to the Chinese patent law and how it protects patents, particularly pharmaceutical ones, and deters counterfeiters from infringing upon the patents. Part II also presents different views on the effectiveness of the third amendment to protect patents. Part III argues that even though the third amendment is a great leap forward, pharmaceutical counterfeiting will continue to happen if the local governments do not cooperate with the central government in enforcing patent protection laws

The Value of Failures in Pharmaceutical R&D

We build a cumulative innovation model in which both success and failure provide valuable information for future research. To test this learning mechanism, we use a dataset covering outcomes of world-wide R&D projects in the pharmaceutical industry, and proxy knowledge flows with forward citations received by patents associated with each project. Empirical results confirm theoretical predictions that patents associated with successfully completed projects (i.e., leading to drug launch on the market) receive more citations than those associated to failed (terminated) projects, which in turn are cited more often than patents lacking clinical or preclinical information. We therefore offer evidence of the value of failures as research inputs in (pharmaceutical) innovationR&D competition, patent policy, pharmaceutical industry

The Value of Failures in Pharmaceutical R&D

We build a cumulative innovation model in which both success and failure provide valuable information for future research. To test this learning mechanism, we use a dataset covering outcomes of world-wide R&D projects in the pharmaceutical industry, and proxy knowledge flows with forward citations received by patents associated with each project. Empirical results confirm theoretical predictions that patents associated with successfully completed projects (i.e., leading to drug launch on the market) receive more citations than those associated to failed (terminated) projects, which in turn are cited more often than patents lacking clinical or preclinical information. We therefore offer evidence of the value of failures as research inputs in (pharmaceutical) innovation

Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance

Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review (“IPR”) proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation—particularly for discoveries made upstream in the innovation pipeline—thus imperiling the development of new drug therapies. But a fascinating solution has emerged: invoking tribal immunity to shield pharmaceutical patents from IPR before the Patent Trial and Appeal Board (“PTAB”). This serves two critically important objectives: promoting tribal self-sufficiency, and encouraging investment in life-saving and life-improving new drugs. Contractual partnerships between Native American tribes and pharmaceutical companies not only provide the tribes with a steady stream of royalty revenue, but also insulate biopharmaceutical patents from challenge in IPR proceedings through the invocation of long-established principles of tribal sovereign immunity. This Note is the first piece of scholarship to comprehensively analyze, and advocate for, the right to invoke tribal sovereign immunity in IPR proceedings

Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance

Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review (“IPR”) proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation—particularly for discoveries made upstream in the innovation pipeline—thus imperiling the development of new drug therapies. But a fascinating solution has emerged: invoking tribal immunity to shield pharmaceutical patents from IPR before the Patent Trial and Appeal Board (“PTAB”). This serves two critically important objectives: promoting tribal self-sufficiency, and encouraging investment in life-saving and life-improving new drugs. Contractual partnerships between Native American tribes and pharmaceutical companies not only provide the tribes with a steady stream of royalty revenue, but also insulate biopharmaceutical patents from challenge in IPR proceedings through the invocation of long-established principles of tribal sovereign immunity. This Note is the first piece of scholarship to comprehensively analyze, and advocate for, the right to invoke tribal sovereign immunity in IPR proceedings

TRIPS implementation and secondary pharmaceutical patenting in Brazil and India

This article compares national approaches toward secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures countries have enacted policies to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyze the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications, and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries’ approaches toward secondary patents need to be understood in the context of their broader approaches toward TRIPS implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s

"On the Failure of University-Industry Research Collaboration to Stimulate High Quality Research in Japan"

Using a panel of 30 Japanese chemical and pharmaceutical companies for the period of 1985 to 1998, we estimate the effects of university-industry research collaboration (UIC) on participating firms' research output. We find, as in other studies in the field, that UIC leads to more research output, in terms of the number of patents obtained. In contrast to the results for the U.S., however, we find no evidence that UIC significantly affects quality adjusted patents, that is, citation weighted patent counts. By looking finely at what part of the quality ladder of patents UIC stimulates, we find that UIC increases only those patents with a small number of citations, thus failing to affect the "average" quality of patents. Discussions of possible reasons for this finding are also offered.

Patents and pharmaceutical drugs : understanding the pressures on developing countries

This paper offers a discussion to the question of why there are pressures on developing countries for introducing and/or reinforcing patent protection to pharmaceutical drugs. Patent protection is an important component of a complex strategy developed by the research and development intensive pharmaceutical drug companies of industrial countries to meet market competition. For legal and economic reasons, patents are fundamental instruments for allowing the drug-inventing companies to appropriate the returns from their inventions. Patents sustain high prices, which in turn provide rents to undertake further research and development, which in turn allows the invention of new drugs, etc. In recent years, increasing drug regulations have implied that effective patent protection to the research and development intensive pharmaceutical drug companies has eroded. Furthermore, competition from the generic drug companies has increased quite significantly. Restoring patent protection in industrial countries and making developing countries introduce patent protection, has become part of research and development intensive pharmaceutical companies'strategies to regain market share.Industrial Management,Environmental Economics&Policies,Pharmaceuticals&Pharmacoeconomics,Real&Intellectual Property Law,Water and Industry

Product cycles, innovation and exports: A study of Indian pharmaceuticals

This paper sheds light on the product cycle and neotechnology theories of trade in the context of generic pharmaceuticals. The paper studies the export performance of 177 Indian pharmaceutical firms for the post- liberalization period 1991-2004. The results indicate that technology proxied by foreign patent rights has a positive impact on exports. This suggests that developing countries with innovation skills for process innovations are capable of penetrating international markets in the later stages of the product cycle by using patents, which were the barriers to trade in the early stages of the product cycle. Thus, Indian pharmaceutical firms adept at reverse-engineering of brandname drugs have an opportunity to enter the global generic market for off-patent drugs.Product cycle, Exports, Foreign patents, Pharmaceuticals

TRIPS implementation and secondary pharmaceutical patenting in Brazil and India

This article compares national approaches toward secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures countries have enacted policies to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyze the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications, and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries’ approaches toward secondary patents need to be understood in the context of their broader approaches toward TRIPS implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s