Horizon Therapeutics is currently in early talks with several major pharmaceutical companies about a potential sale, in today's bite-sized hospital and health industry news from the District of Columbia and Illinois.

• District of Columbia: The U.S. Court of Federal Claims (CFC) ruled in favor of Gilead Sciences in a patent suit against CDC over the HIV drug Truvada. In the suit, the federal government argued that Gilead did not compensate CDC for its role in researching Truvada's use as a preexposure prophylaxis (PrEP). In the decision, which was unsealed last week, senior U.S. Judge Charles Lettow said CDC violated three material transfer agreements when it failed to promptly notify Gilead that the agency had filed patents related to using Truvada to prevent HIV. Although CDC first applied for a patent in 2006, it did not inform Gilead until 2014. In addition, Lettow concluded that Gilead has "sufficiently proven that it suffered reliance, restitution and expectation damages," although a dollar amount was not stated. In a statement, a spokesperson for Gilead said the company was satisfied with the decision, which "emphasizes that Gilead was a key part of the collaboration that resulted in the government's PrEP patents." Currently, a similar patent infringement lawsuit between the U.S. government and Gilead is underway in a Delaware federal court, and a jury trial has been scheduled for May 2023. (Brittain, Reuters, 12/1; Kansteiner, Fierce Pharma, 12/2)

• District of Columbia: HHS last week issued a new proposed rule revising the 340B Administrative Dispute Resolution (ADR) process, which was established in a 2020 final rule. According to HHS, the proposed rule will better align with statutory requirements in the Affordable Care Act. Under the proposed rule, a more conventional administrative process would be established for ADR; the ADR panel structure would be revised to include 340B subject matter experts from the Health Resources and Services Administration's Office of Pharmacy Affairs; align the ADR process with statutory provisions on diversions, duplicate discounts, and overcharges; and more. In addition, the proposed rule notes that disputes between 340B covered entities and drug companies that are subject to federal court review would not be eligible for the ADR process until the court process is completed. Comments on the proposed rule are due by Jan. 30, 2023. (AHA News, 11/29)

• Illinois: Horizon Therapeutics, which develops treatments for rate and immune diseases, last week said that it is in preliminary discussions with several pharmaceutical companies about a potential sale. According to Horizon, Amgen, Johnson & Johnson's (J&J) Janssen Global Services, and Sanofi have all expressed takeover interest. However, J&J later said it did not intend to make an offer for Horizon. So far, Amgen and Sanofi have continued to express interest and said that any offer would be cash only. According to the Wall Street Journal, Horizon currently has a value of almost $18 billion and could sell for well over $20 billion. Although a deal is not guaranteed, if the Horizon sale does happen before the end of the year, it could be the largest health care acquisition in 2022. Any possible bidders are required to announce whether they will make an offer for the company by Jan. 10, 2023. (Dummett/Cooper, Wall Street Journal, 11/29; Silverman, STAT, 12/5)