Labeling and Induced Infringement in Pharma Patent Litigation and Protecting IP Rights

Description

A drug label may prove significant in Hatch-Waxman patent litigation, particularly concerning induced infringement of method-of-use patent claims.

35 U.S.C. 271(b) requires that the accused "actively induces infringement." As the Supreme Court explained several years ago in Global-Tech v. SEB (U.S. 2011), "actively induces infringement" means the accused knew of the patent and knew the induced acts were infringing. In Hatch-Waxman litigation, the patents listed in the Orange Book and the generic manufacturer's paragraph IV certification demonstrate the first prong of Global-Tech. The second prong of specific intent to induce infringement may be proven by the drug label instructions and information.

In Eli Lilly and Co. v. Teva Parenteral Medicines Inc. (Fed. Cir. 2017), the Federal Circuit found direct infringement attributable to physicians. The court found the defendants liable for inducing that infringement due to "evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishe[d] the requisite intent for inducement."

In Sanofi v. Watson (Fed. Cir. 2017), a case in which the claim tracked the label precisely, the Federal Circuit relied on the label in finding the specific intent required to encourage an infringing use. Evidence of substantial non-infringing uses was not relevant to the inducement inquiry.

In Vanda Pharm. v. West-ward Pharm. Int'l (Fed. Cir. 2018), the Federal Circuit found induced infringement based on the proposed label and explained how, in the Hatch-Waxman pre-launch context, actual past direct infringement does not have to be shown. Moreover, "patentees in Hatch-Waxman litigations asserting method patents do not have to prove that prior use of the NDA-approved drug satisfies the limitations of the asserted claims." The court also cited Sanofi when the alleged infringer tried to rely on evidence of substantial non-infringing uses.

In a precedential decision in GlaxoSmithKline L.L.C. v. Teva Pharmaceuticals USA Inc. (Fed. Cir. 2020), the Federal Circuit held that a generic pharmaceutical company could be liable for inducing infringement based on a skinny label. The decision could have a far-reaching effect on branded and generic drug manufacturers in their preparation of launching generics. In light of GSK, a skinny label alone is likely not enough to preclude induced infringement allegations.

Listen as our authoritative panel of patent attorneys discusses the implications of Lilly and label language for induced infringement. The Orange Book listed patent's label may be written so that the generic manufacturer is more vulnerable to a finding of induced infringement. The panel will offer guidance on strategic considerations and best practices for label language.