Safe Harbor Provision Case Not Selected for Supreme Court Review

Thumbnail image for Thumbnail image for supremecourt.pngEarlier this week, the U.S. Supreme Court denied GlaxoSmithKline’s certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)’s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention “solely for uses reasonably related to the development and submission of information under [federal drug laws],” does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that “§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration.” Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)’s safe harbor and explained that Classen held that 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.”

As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK’s petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit’s Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court’s interpretation of the provision.

Not everyone shares the Solicitor’s belief that Momenta sufficiently clarified the temporal scope of the safe harbor. The Supreme Court’s decision to deny cert has left some in the pharmaceutical industry uneasy about postmarketing activity. Many feel that, absent Supreme Court guidance, a decision about whether postmarketing activity is found to be infringing will depend on the specific panel of the Federal Circuit selected to hear a particular case.

Those uneasy with the current state of the law may not have to wait too long, as Momenta has claimed that it will file a certiorari petition seeking review of the Federal Circuit’s decision. And for those hoping the Supreme Court adopts the Momenta approach and finds the safe-harbor provision protects postmarketing activity, there is precedent for the Court adopting a broad reading of 35 U.S.C. § 271(e). In Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), the Supreme Court held that the safe-harbor provisions covered medical devices, and in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), the Court held that preclinical studies of patented compounds could find protection under § 271(e).