Supreme Court Declines Opportunity to Clarify Scope of Hatch-Waxman Safe Harbor

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The U.S. Supreme Court on Jan. 14, 2013, denied GlaxoSmithKline’s petition for certiorari seeking review of the Federal Circuit’s interpretation of the Hatch-Waxman safe-harbor provision at 35 USC 271(e)(1) in Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011). GSK sought reversal of the Federal Circuit’s holding that the scope of the safe harbor is limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions, and that 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.”

The Court’s decision follows the Solicitor General’s advice that the Classen case was not a good vehicle for review of the scope of the safe harbor, given its facts and in light of the Federal Circuit’s subsequent decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012). The Solicitor General endorsed the Federal Circuit’s narrow construction of Classen in the Momenta decision, as well as the court’s observation in Momenta that the “plain language of [35 USC 271(e)(1)] is not restricted to pre-approval activities.” In light of the Solicitor General’s brief, the Supreme Court’s decision to deny certiorari should not be taken as endorsement of the Classen court’s argument that the safe harbor is limited to pre-approval activities.

The Solicitor General’s arguments in its brief filed in the Classen case also suggest that further Supreme Court guidance may be needed regarding the scope of activities covered by the 271(e)(1) safe harbor for infringement “solely for uses reasonably related to the development and submission of information” to the FDA. The Momenta case squarely addressed this issue, and following the Federal Circuit’s Nov. 20, 2012, decision denying rehearing en banc in Momenta, further development of this issue is likely in 2013.

Further discussion of the briefing in connection with the petition for certiorari in Classen is provided below.

Supreme Court Briefing

GSK sought review of the Federal Circuit’s 2011 decision in Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011) holding that the 271(e)(1) safe-harbor provision is limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions, and that 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” [Classen Fed. Cir. Slip. Op. at 27]. In its Feb. 28, 2012, petition for certiorari, GSK argued that the divided panel of the Federal Circuit arbitrarily imposed extra-textual limitations on the safe-harbor provision of 35 USC 271(e)(1) [GSK petition at p. 2]. Respondent Classen urged the Court to deny certiorari, arguing that 271(e)(1) immunizes uses of the patented invention that are “solely directed to activities reasonably related to obtaining approval from the FDA to market generic drugs” in the pre-marketing phase of its development [Classen opposition brief at p. 8-9].

The Supreme Court invited the Solicitor General to file a brief to express the views of the United States in June 2012, and in its December 2012 amicus curiae brief, the Solicitor General urged the Supreme Court to deny certiorari [SG brief at p. 1].

Notably, the Solicitor General’s brief accepted that the Federal Circuit had erred in limiting the safe-harbor exemption to pre-marketing activities [SG brief at p. 10]. The Solicitor General’s brief characterized the Federal Circuit’s Classen decision to limit the safe harbor to pre-approval activities “misguided” and that “nothing in the statutory text warrants the court of appeals’ categorical exclusion of post-approval activity from the safe harbor.” [SG brief at p. 12].

Despite identifying this legal error, the Solicitor General’s brief identified three alternative grounds for denying certiorari. The Solicitor General explained first that even though the Federal Circuit erred in its interpretation of 35 USC 271(e)(1), the Supreme Court should not review the case, because the error was mollified by the Federal Circuit’s August 2012 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) (holding -- in contrast with the Federal Circuit’s Classen decision -- that post-approval activities performed for the FDA fall within the scope of the 271(e)(1) safe harbor).

The Solicitor General urged as a second ground to deny certiorari that the Supreme Court had left unsettled (in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)) the issue of whether the safe harbor even applies to the types of patented claims in Classen. And as a third ground, the Solicitor General argued that even under a proper construction of 271(e)(1), the Federal Circuit ultimately reached the correct result and had not erred in vacating the district court’s safe harbor ruling [SG brief at p. 19-23].


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