Supreme Court Declines to Review Scope of Section 271(e)(1) Safe-Harbor

Earlier this week, the United States Supreme Court denied Amphastar Pharmaceutical’s petition for certiorari regarding the scope of the safe-harbor of 35 U.S.C. § 271(e)(1), a provision that generic drug and biosimilar makers often rely upon to shield their manufacturing and testing activities from claims of patent infringement.  The case is Amphastar Pharmaceuticals, Inc. et al. v. Momenta Pharmaceuticals, Inc. et al. (S. Ct. Dkt. No. 15-1402), and involves Amphastar’s generic version of Sanofi’s Lovenox® (enoxaparin sodium), which Momenta accuses of infringing Momenta’s patented methods of analysis.

In July 2013, the District Court of Massachusetts granted summary judgment of non-infringement in favor of Amphastar upon finding that Amphastar’s use of certain quality control test methods as part of its process for manufacturing enoxaparin could not infringe Momenta’s claimed methods of analysis because such activity was protected from infringement by the Section 271(e)(1) safe-harbor.  Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 962 F. Supp. 2d 348 (D. Mass. 2013).  Section 271(e)(1) provides that “[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”  The District Court based its decision, in part, on the Federal Circuit’s previous interpretation of the safe-harbor provision in the very same case, in which the Federal Circuit vacated the District Court’s grant of a preliminary injunction against Amphastar’s sale of its generic product because the majority of the panel concluded, based on the preliminary injunction record, that the post-approval testing that Amphastar carried out to “satisfy the FDA’s requirements” was protected by the safe-harbor from Momenta’s claims of infringement.  See Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348, 1357-61 (Fed. Cir. 2012).  The Supreme Court declined to review that decision.

In December 2015, the Federal Circuit vacated the District Court’s judgment of non-infringement.  “With the benefit of additional briefing in the current appeals, which reflects the full district court record developed by all parties after the preliminary injunction phase,” the Federal Circuit concluded that Amphastar’s “routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process is … not ‘reasonably related to the development and submission of information’ to the FDA, and it was clearly erroneous to conclude otherwise.”  Momenta Pharm., Inc. v. Teva Pharm. USA, Inc., 809 F.3d 610, 620 (Fed. Cir. 2015).

In May 2016, Amphastar filed a petition for certiorari, presenting the following question: “Whether the safe harbor protects a generic drug manufacturer’s bioequivalence testing that is performed only as a condition of maintaining FDA approval and is documented in records that must be submitted to the FDA upon request.”  Amphastar argued, among other things, that the Federal Circuit had wrongly imported a categorical exclusion of “routine” testing into the safe-harbor that was nowhere supported by the statutory language.  Momenta opposed the petition.  On Monday, the Supreme Court denied Amphastar’s petition without further comment.

The action between Momenta and Amphastar is still pending in the District Court (Civil Action No. 11-CV-11681).  A jury trial is scheduled for July 10, 2017.