Blog Big Molecule Watch July 26, 2022

Supreme Court Cert Petitions on Skinny Label Inducement and Written Description Issues

On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK method-of-use patent, despite having a “skinny” label carving out the sole patented indication.  According to Teva, the question presented is “[i]f a generic drug’s FDA-approved label carves out all of the language that the brand manufacture has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourage infringement of those carved-out uses?”  Teva asserts that the decision below “eviscerates the key element of inducement liability:  the requirement that a plaintiff prove active steps to encourage direct infringement.”  Teva states that the Hatch-Waxman Act specifically permits generic manufacturers to carve-out a patented indication, to allow them to “launch skinny-labeled products without fear of crippling liability.”  According to Teva, the decision below “effectively nullifies a Congressional enactment created specifically to encourage precisely what Teva did here: bring a low-cost generic drug to market labeled for unpatented uses.”

Biogen also has a pending cert petition with the Supreme Court, filed on June 14, 2022, seeking review of a split Federal Circuit decision that invalidated a patent covering their multiple sclerosis drug TECFIDERA® for lack of written description.  The Federal Circuit held that the patent was invalid because the patent’s claim of a “therapeutically effective dose” is not properly supported because the specification only provided “a single passing mention” of the optimal dosage, without support from clinical data.  According to Biogen, the question presented is—“[i]s 35 U.S.C. § 112’s requirement that a patent specification ‘contain a written description of the invention’ met when the specification describes the invention, or must the specification also disclose data that demonstrates the claimed invention is ‘effective’ and emphasize the claimed invention by singling it out and describing it more than once?”  Biogen argues that the Federal Circuit erred by requiring a patent specification to prove—rather than just describe—the claimed effect.

The parties supporting Biogen’s cert petition include the American Chemical Society, the New England Legal Foundation, and the industry groups PhRMA and BIO.  The parties urged the Supreme Court to grant cert and review the written description standard, which they claim is too stringent under the Federal Circuit’s interpretation.  They explain that the standard would bar many therapeutics from being patented and stifle innovation because it necessitates the need for clinical data before a company is able to seek a patent.

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