Cardiology Pharmaceuticals

SCOTUS Rules Against Amgen in PCSK9 Patent Dispute

The U.S. Supreme Court ruled against Amgen in its PCSK9 inhibitor patent dispute with Sanofi and Regeneron that was intended to revive patents for Amgen’s cholesterol-lowering drug, Repatha. 

The unanimous ruling brings closure to a decade-long battle between PCSK9 leader Amgen and its rivals Sanofi and Regeneron Pharmaceuticals (Sanofi‘s U.S. distributor), which will remain free to market their Praluent PCSK9 in the U.S. 

The Supreme Court upheld a 2021 federal appeals court decision that invalidated two Amgen patents, finding that they didn’t satisfy “enablement” requirements. In other words, the patents were too broad and weren’t detailed enough to allow a skilled scientist to recreate the invention. 

Amgen’s Supreme Court case argued that the lower courts set an inappropriately high bar for “enablement,” its patents didn’t have to detail every possible claim, and the patents actually are enabled because “scientists can make and use every functional antibody” if they follow Amgen’s “roadmap” or “conservative substitution.”

  • However, the Supreme Court disagreed, stating that “the more one claims, the more one must enable” and that Amgen “failed to enable all that it has claimed.”
  • Justice Neil Gorsuch’s statement added that Amgen sought to “monopolize . . .  every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors,” covering far more functional antibodies than the 26 involved in Repatha’s amino acid sequences.

Sanofi and Regeneron’s Praluent PCSK9 inhibitor has a similar mechanism as Repatha. Both use laboratory-produced antibodies to block the PCSK9 inhibitor protein, which limits liver cells’ ability to remove LDL-C from the blood. However, Praluent and Repatha use different chemical combinations.

  • Amgen’s Repatha remains the market leader with $1.3B in global sales last year, far more than Praluent’s $530M globally ($130M in the U.S. via Regeneron), although neither of the PCSK9 inhibitors have achieved what some viewed as their potential.

Insiders suggest that the ruling could have a broad impact on the pharmaceutical industry, protecting against what some see as patent overreach, while encouraging innovation. 

  • The ruling also has specific implications for pharma’s $160B antibody segment, with similarly long lists of antibody patent holders that are disappointed by this ruling (AbbVie, GSK, Biogen, Bristol Myers Squibb) and other pharma companies that are celebrating the court’s decision (Pfizer, Bayer, AstraZeneca, Genentech, J&J).

The Takeaway

Although this ruling doesn’t bring tangible changes to the PCSK9 inhibitor segment in the short term, the court’s narrower patent enablement definition could open the door for more antibody drugs targeting cardiovascular and other diseases.

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