SCOTUS Bolsters Skinny Labels; USPTO, CAFC Squeeze Patent Scope
The Supreme Court bolstered 'skinny-label' generics against induced infringement claims, while the USPTO and Federal Circuit created new hurdles for patent enablement and obviousness-type double patenting in life sciences.
The U.S. Supreme Court, in Hikma v. Amarin, has significantly bolstered the 'skinny label' pathway for generic drugs by holding that induced infringement requires affirmative conduct encouraging a patented use, not just routine commercial statements of generic equivalence. This raises the bar for brand-name patent enforcement. Concurrently, patent prosecution strategy faces a squeeze from two other fronts. The USPTO's Appeals Review Panel has endorsed the 'anti-harassment' rationale as a standalone basis for obviousness-type double patenting (ODP), creating uncertainty that now awaits a clarifying Federal Circuit ruling in In re Ablynx. At the same time, the Federal Circuit is applying the Supreme Court's Amgen precedent to heighten enablement and written description standards under 35 U.S.C. § 112, making it harder to secure broad genus claims. Recent decisions show that even method-of-treatment claims require robust data to be upheld. For life sciences clients, these developments demand an immediate review of litigation strategies, patent portfolio management, and claim-drafting practices to adapt to the shifting landscape. The outcome of the Ablynx appeal is the next key development to watch.