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Food and Drug Administration v. Alliance for Hippocratic Medicine

Issues

Should the Court uphold the FDA’s modifications to the usage conditions of the drug mifepristone and defer to the FDA’s expertise before issuing preliminary relief, and do associations of doctors or medical groups have Article III legal standing to challenge the FDA's modifications due to safety concerns?

This case presents the Supreme Court with the issue of whether the Food and Drug Administration (“FDA”) can uphold its modifications to the usage guidelines of the drug mifepristone despite challenges from the Alliance for Hippocratic Medicine, who assert that these changes are capricious and unnecessarily elevate patient risk. Petitioner, the FDA, argues that Respondent, the Alliance for Hippocratic Medicine, lacks standing and that the FDA’s mifepristone-related decisions were based on solid clinical data and expert evaluations affirming the drug's safety and effectiveness. Respondent, the Alliance for Hippocratic Medicine, contends that it has standing and that the FDA's actions in 2016 and 2021 lack adequate safety studies and do not provide a cogent rationale for the modifications, thereby jeopardizing patient and healthcare provider safety. The Court's decision will determine whether mifepristone will stay subject to the lower court's injunction or if the FDA's decision to relax usage guidelines in 2016 and 2021 stands as justified.

Questions as Framed for the Court by the Parties

(1) Whether respondents have Article III standing to challenge the Food and Drug Administration’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use; (2) whether the FDA’s 2016 and 2021 actions were arbitrary and capricious; and (3) whether the district court properly granted preliminary relief.

In 1996, the United States Food and Drug Administration (“FDA”) received a new drug application (“NDA”) for the drug mifepristone from the Population Council.

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Mayo Collaborative Services v. Prometheus Laboratories, Inc.

Issues

Whether the possible “transformations” of body chemistry involved in giving  a patient prescription drugs  and testing the patient's blood for a naturally occurring correlation are enough to validate a patent for the correlation.

 

In this case, the Supreme Court will evaluate the validity of two patents held by Respondent Prometheus Laboratories. Prometheus had marketed a multistep medical test based on these patents, which describe the proper dosage range of powerful immunosuppressive drugs. However, after Petitioner Mayo Medical Laboratories announced its intention to market a competing medical test in 2004, Prometheus sued for patent infringement. Mayo now argues that the patents are invalid because they seek to monopolize a natural phenomenon, preempting all other uses of a naturally occurring correlation between metabolites and patient health. Prometheus, on the other hand, argues that the patents are valid because they involve concrete applications and cover patentable correlations, not just natural phenomena. The  decision in this case  may affect the cost and quality of patient health care, as well as the incentives for research and development in the medical industry.

Questions as Framed for the Court by the Parties

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

Petitioner Mayo Collaborative Services (“Mayo”) is a for-profit medical laboratory operating within the Mayo Clinic, a charitable institution providing medical education, research, and clinical care. See Brief for Petitioner, Mayo Collaborative Services at 8. The Mayo laboratory is recognized in particular for its treatment of autoimmune diseases, including gastrointestinal conditions like 

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