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A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically covered by patents held by private firms, and priced without regard to the public's investment. The Bayh-Dole Act provides a possible remedy, but its scope is limited. [ABSTRACT FROM AUTHOR]

High drug prices are creating serious health and fiscal problems in the United States today. This reality is vividly illustrated by recently approved medicines to treat Hepatitis C. These new medicines can cure nearly everyone with this potentially fatal infection and may even enable the elimination of this disease. But the drugs' sticker price--close to $100,000-- has meant that very few patients who could benefit from them can access them. This Article describes an approach, available under existing law, to bring about transformative reductions in the prices of these medicines, at least for federal programs and possibly beyond. Under 28 U.S.C. § 1498, the U.S. government can buy generic versions of these medicines at less than 1% of their list price plus a reasonable royalty. This power has received almost no academic attention, despite the fact that it is regularly used by the government in other sectors, including defense. Indeed, though it has now been forgotten, the federal government relied on this provision numerous times to procure cheaper generic drugs in the 1960s. We recover this history and show how § 1498 can once again be used to increase access to life-saving medicines, addressing several important interpretive questions about the application of the provision along the way. We also offer the first sustained efficiency defense of this approach. This power, we show, can be analogized to the eminent domain power over land and similarly justified as a means to address hold out problems. We show that courts or agencies can fashion damages remedies that provide robust returns to investment, and so protect dynamic incentives while permitting radical improvements in static efficiency. Our remedy involves some risk, as do all policy innovations. But the status quo is so deeply dysfunctional--with millions of Americans unable to benefit from medicines that could halt the spread of a major disease--that the case for action is overwhelming. [ABSTRACT FROM AUTHOR]

The article presents the authors' perspective on the effect of adopting a law styled after the U.S. Bayh-Dole (BD) Act of 1980, which promotes the patenting of publicly funded research, in developing countries. They contends that it is unclear that the positive impacts of BD in the U.S. would arise in developing countries due to the absent multiagency federal pluralism, the practically oriented universities and other features of the U.S. research system in these countries.

Discusses an open licensing approach for university innovations. Impact of patents and other exclusive rights on global access and research and development gaps; Models and lessons of commons-based production; Role of universities in biomedical research.

The article offers the author's insights on the landmark ruling of India's Supreme Court on the Novartis v. Union of India and Others case regarding the patent law 2.0, which can align innovations in pharmacy medicine with the health needs of the public. The author discusses the disadvantage of patents and the problems that arise on wrong kind of patent protection. She mentions that the decision of the court indicates that India can denied drug patents despite the U.S. approval.

This Viewpoint discusses legislative efforts at the state level to monitor or regulate drug prices and reviews legal challenges raised by industry in response to these efforts. [ABSTRACT FROM AUTHOR]

This Viewpoint uses the legal dispute between Amgen and the US Food and Drug Administration (FDA) regarding the FDA’s denial of market exclusivity for cinacalcet to discuss the FDA policy granting 6 months of market exclusivity as an incentive for manufacturers to conduct efficacy and safety studies in child populations. [ABSTRACT FROM AUTHOR]