Pharmaceutical Legal and Regulatory Trends To Watch in 2024
This article highlights several notable legal and regulatory developments in 2023 and discusses developments that will continue to shape the pharmaceutical industry in 2024.
January 12, 2024 at 10:03 AM
8 minute read
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 standard for enablement in the context of antibody genus claims and declined to disturb Federal Circuit decisions regarding written description and induced infringement in the context of skinny labels.
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 and the use of "march-in" rights under Bayh-Dole.
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