Several notable legal and regulatory developments in 2023 have and will continue to shape the pharmaceutical industry in 2024. First, the Supreme Court weighed in on the "skinny label" case between GSK and Teva Pharmaceuticals. Teva was asking the high court to reverse a $235 million loss to GSK in a patent dispute over a generic heart drug, but the court declined the case.

In addition, the current administration announced new regulatory objectives and initiatives with implications for the pharmaceutical industry, including announcements regarding the use of artificial intelligence (AI) in drug development, and concerted efforts from the White House and Federal Trade Commission to lower prescription drug costs through challenges to the propriety of patents listed in the FDA Orange Book.

Supreme Court decisions

In May of 2023, in Amgen v. Sanofi, the Supreme Court unanimously affirmed the Federal Circuit's decision that Amgen's asserted patent, covering a wide range of antibodies, were invalid for lack of enablement. Defendant Sanofi argued Amgen's broad claims were not enabled based on the patent's disclosure, particularly because the claims were written to capture antibodies based on their function—namely, all antibodies capable of binding to two different molecules—rather than their specific structure.