Unique Issues Facing Brand-Compounder Patent Litigation, Law360

Partners Michael Abernathy and Christopher Betti and associate Michael Sikora co-authored an Expert Analysis article for Law360 discussing key differences between traditional Hatch-Waxman Act litigation and emerging patent disputes between branded pharmaceutical companies and compounding pharmacies.

The authors analyze how patent enforcement dynamics shift outside the Hatch-Waxman framework, particularly where compounded products are already on the market and actual damages, jury trials, and injunction standards come into play. The article also covers regulatory considerations under Section 503A, FDA shortage determinations, and strategic implications for both branded companies and compounders navigating intellectual property risk.

Read the full Law360 article >>