GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.

18-1976, 18-2023

Question(s) Presented

“The questions concern whether induced infringement can be used to nullify a provision of the Hatch-Waxman Amendments. Congress specified in Hatch-Waxman that when a drug is no longer patented and is FDA-approved for unpatented uses, a patent on one method of using the drug cannot be allowed to block the sale and use of the drug for the other, unpatented purposes. See 21 U.S.C. § 355(j)(2)(A)(viii). The statutory mechanism is a ‘carve-out’: a generic manufacturer can adopt a ‘skinny label,’ deleting the patented indication and labeling the product only for unpatented indications, and avoid claims that the label induces infringement. The questions are: Can the generic manufacturer nonetheless be held liable for induced infringement based on evidence that would be available in every carve-out case—the skinny label itself and product materials that describe the generic drug product as the AB-rated generic equivalent of the brand product, but do not even mention the patented method? And even if the generic manufacturer were found to have encouraged infringement, can it be held liable for infringement that it did not cause—e.g., if the direct infringer undisputedly did not see the communication that supposedly encouraged infringement?”

Selected Proceedings and Orders
August 5, 2021