How Amgen Lost the PCSK9 Patent War
19 hours ago
- #supreme-court
- #biotechnology
- #patent-law
- Amgen sued Sanofi and Regeneron in 2014 over ownership of PCSK9 cholesterol drugs, but lost the Supreme Court case in 2023.
- Amgen's patents claimed broad rights to millions of antibodies, but only provided detailed information for 26, violating patent law's enablement requirement.
- Regeneron developed alirocumab independently using a different method, but Amgen claimed it infringed their patents due to similar biological effects.
- Amgen initially won in court, but the Federal Circuit reversed the decision, citing inadequate enablement for the broad patent claims.
- The Supreme Court unanimously ruled against Amgen, emphasizing that broad patent claims require equally broad disclosure.
- Despite legal defeat, Amgen gained a commercial advantage due to delays, with evolocumab outselling alirocumab by $1.5 billion annually by 2023.
- Competition led to price reductions (from $14,000 to $5,850 annually) and improved patient access to PCSK9 inhibitors.
- Amgen faced antitrust consequences, including a $406 million damages award for anticompetitive practices.
- The case highlights the tension between rewarding innovation and preserving competition in biotech patents.
- Policy suggestions include tiered exclusivity periods, net price growth caps, and tax incentives to balance innovation and competition.