Search

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 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]

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]

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]

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]

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 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.

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.

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]

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.