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The phannaceutical industry is among the most politically powerful business sectors in the United States today. This article describes how this industry has successfully entrenched its power, with attention to four sources of power: property power. vertical power over politics, ideational power, and material power. Attempts to reform the industry must grapple with these forms of power, which are not easily separated and which, in the current environment, tend to reinforce one another. [ABSTRACT FROM AUTHOR]

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue--Loturne 11, Issue 1--captures that event. The following article represents the second of four panels. This panel asked, "Should the U.S. government actively assert its own patents?" The panel was moderated by Christopher Morten, Deputy Director of NYU Law's Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical Technology Transfer at the U.S. Army Medical Research and Development Command, Professor Amy Kapczynski of Yale Law School, Donna Meuth, Associate General Counsel and Lead Attorney of the U.S. Intellectual Property Department of Eisai, and Zain Rizvi, a policy researcher at Public Citizen who focuses on pharmaceutical innovation and access to medicines. [ABSTRACT FROM AUTHOR]

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available. [ABSTRACT FROM AUTHOR]

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]

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a "taking" of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US's most important state and federal health care programs. [ABSTRACT FROM AUTHOR]

The article focuses on U.S. Food and Drug Administration's mission as both a producer of balanced information about drugs and a validator of information on drugs. Topics discussed include analysis of right-to-try law, and First Amendment litigation regarding drug marketing for the same; enactment of 21st Century Cures Act for governing drug approval; and laws governing drug pricing in the country.

The Blueprint for Transparency at the FDA recommends that the FDA proactively release more clinical trial data. We show that the FDA possesses the legal authority to act on this recommendation, and describe several reasons that the agency should do so. In particular, the primary existing route for researchers to obtain access to this data, the Freedom of Information Act (FOIA), has important limits, as our own recent experience shows. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

When policymakers and academics think about designing optimal innovation incentives, they almost exclusively limit their considerations to various types of reward incentives--that is, innovation "carrots." But in this Article, we show that, under specific circumstances, innovation "sticks"--potential penalties for failures to innovate--can play valuable roles in our innovation policy, either alone or in conjunction with innovation carrots. We also provide examples of several innovation sticks that have already been used with apparent success, including the federal Corporate Average Fuel Economy standards. Finally, we apply our approach to a new area--the problem of car fatalities--to illustrate the potential of innovation sticks to yield substantial social benefits. Our model suggests that a relatively simple system of yardstick penalties could help reduce national auto fatalities by as much as 20 percent simply by bringing laggard entities (such as companies and states) up to the median. [ABSTRACT FROM AUTHOR]

The article focuses on neoliberalism in property law in the U.S. in 2015. Topics include the development of intellectual property (IP) law in the U.S., neoliberalism in welfare, and the public-goods problem, which describes the lack of state-back property rights. Information is provided on public procurement.

In IP scholarship, patents are commonly understood as more efficient than other approaches to innovation policy. Their primary ostensible advantage is allocative: as a form of property rights, patents act as a conduit between market signals and potential innovators, ostensibh' guiding investment toward inventions with the most social value. Existing accounts recognize that, in practice, signals of social value that patents facilitate may be attenuated because of, for example, transaction costs and limits on the scope and length of patent rights. We show here, however, a different problem with the conventional allocative account. The appropriability mechanism patents rely on, namely excludability, operates in asymmetrical ways for different kinds of information goods. While scholars have noted that patent systems fail to create goods whose value is difficult to appropriate in consumer markets, this fact has not been fully appreciated in the literature, nor have its implications for the standard justification for patents. Through derailed examples in the health context we show that some kinds of information goods will be much more difficult to exclude than others. Importantly, there is no reason to expect that the ease of exclusion will be correlated with social value. The analytic point that emerges is generalizable: patents themselves can have distortive effects, stemming from structural features of exclusion rights. Unlike the problem of attenuation, the problem of asymmetric nonexcludability cannot be resolved by increasing patent scope or length. Because excludability is variabk along a continuum, property rights in information, even if formally perfected, and even assuming away conventional transaction costs, will create asymmetrical demand for different kinds of information goods. This argument provides an important new justification for alternatives to patents such as government funding and gives us new insights about how to allocate such funding. It also reinforces the need for a comparative institutional approach to innovation policy, and for incorporating into our debates currently unrecognized implications that patents may have for values such as privacy and free speech. [ABSTRACT FROM AUTHOR]

Background: While 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 Findings: We 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/Significance: Policies 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. [ABSTRACT FROM AUTHOR]

The field of intellectual property (IP) law today is focused, as the name itself advertises, on one particular institutional approach to scientific and cultural production: IP. When legal scholars explain this focus, they typically do so with reference to the virtues of price. Because price gives us a decentralized way to link social welfare to the production of information, IP is alleged to be more efficient than other approaches. The dominant mode of IP scholarship begins here and then addresses questions internal to IP law--for example, how broad or narrow should exceptions to IP rights be? But the internalism that characterizes the field of IP cannot, as I show, be justified by the value of efficiency. Economics offers us no a priori reason to assume that IP is more efficient than other possible approaches, most prominently government procurement and commons-based production. If we take the invitation that economists offer us to think external to IP, we also gain new insights about the implications of values other than efficiency for the choice between different institutional approaches to scientific and cultural production. We see, as I argue, that using price to guide scientific and cultural production--which is to say, using IP--may have costs not only for efficiency, but also for distributive justice and informational privacy. The IP approach is in tension with the value of distributive justice because reliance upon price may yield not only unjust distribution of existing information resources but also unjust production of future information resources. The IP approach is in tension with the value of information privacy because relying on price to generate information facilitates the desire, the demand, and perhaps the capacity for price discrimination. That, in turn, generates an impulse for the extensive collection of personal information. Both government procurement and commons-based production plausibly offer more promise than does IP in both distributive justice and privacy terms, and they may be no less efficient than IP. Giving full scope to all three of these values thus requires us to telescope out from the internalism that characterizes the field, and to countenance a broader role for commons-based production and government procurement. In the field of IP, I conclude, we should pay less attention to IP and more to the alternatives. [ABSTRACT FROM AUTHOR]

The article discusses the effect of Trade-Related Aspects of Intellectual Property (TRIPS) Agreement for the enforcement of high minimum standards of intellectual protection (IP) protection in India. TRIPS is the most important part of IP treaties, which requires the of the World Trade Organization (WTO) to adopt and enforce high minimum standards of IP. TRIPS also serves as the harmonizing force for formal flexibility in pharmaceuticals sector in the country.

This commentary offers a response to the Sonderholm, Bird, and Flynn et al. articles, and argues that the current innovation crisis requires more ambitious approaches, as well as a serious consideration of alternative mechanisms for R&D such as prizes. [ABSTRACT FROM AUTHOR]

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 frame- analytic 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 and- as 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. [ABSTRACT FROM AUTHOR]

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.

Deals with same-sex privacy and the limits of anti-discrimination law in the U.S. Discussion on sex-based bona fide occupational qualification (BFOQ); Assessment of the failure of same-sex privacy doctrine to meet the stringent requirements established for BFOQ; Examination of reasoning which justifies the exclusion of same-sex privacy norms from gender norms.

Discusses the attempt of the U.S. Department of Defense (DoD) to bring an end to the conflict between the military and law schools through the Solomon Amendment passed by U.S. Congress in 1994. Ways to criticize both the Solomon Amendment and the DoD enforcement campaign; Emphasis on education; View of modern university founder Wilhelm von Humboldt on universities.

The author reflects on the Trans-Pacific Partnership Agreement (TPP) under negotiations by 12 Pacific Rim countries, including Australia, New Zealand, and the U.S. Topics discussed include the TPP's implications for a wide range of health policy issues, from medicine prices to tobacco regulation, concerns raised by groups like Medecins sans Frontieres and Oxfam against the TPP, and the draft chapters of the TPP, including those on intellectual property and investor-state dispute settlement.

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.

We live in a time of interrelated crises. Economic inequality and precarity, and crises of democracy, climate change, and more raise significant challenges for legal scholarship and thought. "Neoliberal" premises undergird many fields of law and have helped authorize policies and practices that reaffirm the inequities of the current era. In particular, market efficiency, neutrality, and formal equality have rendered key kinds of power invisible, and generated a skepticism of democratic politics. The result of these presumptions is what we call the "Twentieth-Century Synthesis": a pervasive view of law that encases "the market" from claims of justice and conceals it from analyses of power. This Feature offers a framework for identifying and critiquing the Twentieth-Century Synthesis. This is also a framework for a new "law-and-political-economy approach" to legal scholarship. We hope to help amplify and catalyze scholarship and pedagogy that place themes of power, equality, and democracy at the center of legal scholarship. [ABSTRACT FROM AUTHOR]

This article analyzes the spread of intellectual property in trade agreements. We explain how the integration of intellectual property with international trade rules led to the globalization of pharmaceutical patenting, and then how additional provisions related to pharmaceutical products have been introduced by regional and bilateral trade agreements. We describe the additional 'TRIPS-Plus' rules contained in recent trade agreements, which go beyond the requirements of the World Trade Organization's TRIPS Agreement, and explain the potential challenges that they may create for developing countries. We draw attention to the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, with particular emphasis on the importance of timing. Depending on when countries began allowing drugs to be patented, TRIPS-Plus provisions have different effects; and when pharmaceutical patenting has been in place for more countries for more time, the effects of TRIPS-Plus provisions will change again. [ABSTRACT FROM AUTHOR]

Editorial. Comments on the role of universities in promoting the patenting of life-saving medicines and technologies. Benefits of patents; Need to develop better patenting strategies; Reasons cited for universities not opting for patenting.

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]

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.