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]

Human rights frameworks afford everyone the right to health and the right to enjoy the benefits of scientific progress and its applications. Both come together to create state obligations to ensure access to medicines and other health technologies. Though the impact of patents on access to high-quality, affordable medicines and health technologies has been well described, there has been little attention to the impact of trade secrecy law in this context. In this paper, we describe how trade secrecy protection comes into conflict with access to medicines--for example, by preventing researchers from accessing clinical trial data, undermining the scale-up of manufacturing in pandemics, and deterring whistleblowers from reporting industry misconduct. The paper proposes measures to diminish the conflict between trade secrecy and health that are consistent with international law and will advance health without undermining innovation. [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]

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 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]