BackgroundWhile there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.Methodology/Principal FindingsWe read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents).We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.Conclusions/SignificancePolicies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active “life cycle management” or “evergreening” of patent portfolios in the industry.

Intellectual property law was once an arcane subject. Today it is at the center of some of the most highly charged political contests of our time. In recent years, college students, subsistence farmers, AIDS activists, genomic scientists, and free-software programmers have mobilized to challenge the contours of intellectual property (IP) law. Very recently, some from these groups have begun to develop a shared critique under the umbrella of "access to knowledge" (A2K). Existing accounts of the political economy of the field of IP have suggested that such a mobilization was unlikely. This Article takes the emergence of the A2K mobilization as an opportunity to develop a richer and less deterministic account of the contemporary politics of IP. It draws upon "frame mobilization" literature, which illuminates the role that acts of interpretation play in instigating, promoting, and legitimating collective action. The frameanalytic perspective teaches that before a group can act it must develop an account of its interests and theorize how to advance these interests. These acts of interpretation are both socially mediated and contingent. Ideas can be a resource for those engaged in mobilization, but one that is not fully in their control. Frames thus can lay the scaffolding for a countermovement even as they pave the way for a movement's success. Law is a key location for framing conflicts because it provides groups with symbolic resources for framing, and because groups struggle within the field of law to gain control over law's normative and instrumental benefits. Law thus exerts a gravitational pull on framing processes. Engagement with law can influence a group's architecture, discourse, and strategies, and can also create areas of overlapping agreement andas importantly-a language of common disagreement between opposing groups. The Article closes by suggesting some implications of this point, which should be of interest to those who design legal institutions and who engage in social mobilization. Most intriguing, perhaps, is the role it suggests that law may play in the creation of global publics and polities. A UT H OR. This Article has benefited greatly from the suggestions of more readers than I can thank here. I owe a special debt of gratitude to my colleagues at U.

The US Bayh-Dole Act encourages university patenting of inventions arising from publicly funded research. Lessons from three decades of US experience serve as a cautionary tale for those countries that may choose to emulate Bayh-Dole.

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The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need-meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development.