Amgen v. Sanofi: The U.S. Supreme Court Reviews Patent Enablement.

On June 18, 2023, the U.S. Supreme Court in the matter of Amgen, Inc. et al. v. Sanofi, et al.1 unanimously upheld the 2021 decision of the U.S. Court of Appeals for the Federal Circuit,2 striking down as overbroad Amgen's patent claim to an entire functional genus of monoclonal antibodies. Amgen's patent claims were not limited to antibody structure or antibody amino acid sequences. This is significant because Amgen's patent claims did have amino acid sequences, but they were directed to the epitope.

The US Supreme Court and Affirmative Action: The Negative Impact on the Physician Workforce.

PURPOSE: Maintaining admissions of underrepresented students to medical schools is essential to securing a diverse health care workforce. Empirical evidence indicates that minority patients may prefer practitioners of their own race. The recent US Supreme Court decision concerning affirmative action makes this goal more difficult, but medical schools can still work within the language of the law to redouble their efforts to seat a diverse class of medical students. METHODS: We examined the literature correlating the availability of minority physicians and the health outcomes of the patients they serve. We also examined the literature on race-conscious policies of medical schools intended to address the shortage of minority physicians considering the benefits achieved through a diverse field of health care workers. We also examined the law and the recent US Supreme Court opinion, including the application of equal protection principles, to suggest strategies to seat a diverse class of students within the scope of the law. FINDINGS: Institutions have maintained the status quo of disparate distributions of professions by race through structural biases that also limit access to medical schools. The new US Supreme Court decision is expected to exacerbate this disparity unless medical schools engage in admissions protocols that actively solicit the character and unique abilities that each of the applicants can offer to contribute to the medical school and the health care profession. IMPLICATIONS: The new US Supreme Court mandate is likely to create challenges for medical schools in their efforts to recruit and seat minority applicants. The mandate provides little discussion, suggesting a lack of understanding of the downstream public health consequences to patients if medical school applicants are denied the benefits of race-conscious admissions policies. Nevertheless, the language of the US Supreme Court's opinion may provide a viable path forward, at least with respect to medical schools where the need for a diverse pool of health care practitioners is particularly compelling.

Reining in Costs of Kidney Dialysis: US Supreme Court Offers Hope to End Predatory Pricing.

PURPOSE: Two for-profit dialysis providers control >70% of the US kidney dialysis market. They use their excessive market power to force private insurers to pay nearly 4 times the Medicare rate, earning exorbitant profits for themselves at the expense of the health care system. Both the legislative and judicial systems have been called on to address this inequity, so far without success. METHODS: We examined the history of this issue as set forth in official Centers for Medicare & Medicaid Services, US Department of Health and Human Services, Federal Trade Commission, and other regulatory documents as well as court filings and opinions. We analyzed the legislative efforts to address the problem and the judicial response. FINDINGS: We found that most efforts, to date, have failed. However, a 2022 US Supreme Court decision helps illuminate a path forward, in large part by defining the limits of judicial intervention. IMPLICATIONS: We identify a path forward that would separate the monopolistic players using a multipronged effort involving US Department of Justice, Federal Trade Commission, Office of Inspector General, and states attorneys general. We also caution that, based on our research, the providers could challenge further efforts by deciding to withdraw services in certain areas or refuse to do business with certain insurers, resulting in patients having difficulty accessing dialysis.

Bakke Redux - Affirmative Action and Physician Diversity in Peril.

This article examines the legal arguments that may lead the Supreme Court to overrule precedent and strike down affirmative action in university admissions. Given the critical importance of a diverse physician workforce for our Nation's health care system, the potential reversal of affirmative action admission programs in medical schools may have severe negative consequences. This article discusses the implications for health care should the Court issue an opinion restricting or eliminating affirmative action in higher education.

Law Journals, Biomedical Journals, and Restraint of Trade.

Law journals permit submission of scholarly manuscripts to multiple journals concurrently, but biomedical journals strictly forbid submission of manuscripts to more than one journal at a time. Law journals may then compete for the publication of manuscripts. This article examines whether the single-submission requirement of biomedical journals may constitute restraint of trade in violation of Section 1 of the Sherman Antitrust Act.

Icosapent ethyl: scientific and legal controversies.

Icosapent ethyl (Vascepa) is a purified preparation of the omega-3 fatty acid eicosapentaenoic acid, which is marketed by Amarin Pharma based in Ireland. The product was initially approved by the US Food and Drug Administration for the use of a high dose (4 g/day) in the treatment of hypertriglyceridaemia. On the basis of the results of the REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl Intervention Trial), the agency later granted a label extension to include the additional indication of a reduction in risk of cardiovascular events in persons with serum triglyceride levels of 150 mg/dL or greater and established cardiovascular disease or diabetes. Data supporting the efficacy of omega-3 fatty acids in the prevention of cardiovascular disease have been inconsistent and controversial. The story of the development of icosapent ethyl has been fraught with challenges, including the invalidation of six core patents on the product, and recently, the completion of a new clinical trial, STRENGTH (Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia), that directly contradicts REDUCE-IT and calls into question whether icosapent ethyl is actually effective in the secondary prevention of cardiovascular events. This article traces the course of the development of this fascinating product and discusses its complex medical, regulatory and legal history, which is still continuing to unfold.