By Kevin E. Noonan --
The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval activities are properly within the scope of the Hatch-Waxman "safe harbor" (as set forth in 35 U.S.C. § 271(e)(1)). This was the question presented to the Court:
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.
The case below, styled Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. involved a District Court's determination that U.S. Patent No. 7,575,886 was not infringed by Teva nor by Amphastar and additional defendants in companion cases decided together. The claims at issue were directed to enoxaparin, an anticoagulant drug marketed since 1993 under the brand name Lovenox®. Momenta marketed the first generic version of the drug and sought to block additional generic entrants by asserting the '866 patent, which claimed methods for ensuring that each batch of the drug met quality standards. The District Court held that co-defendant Amphastar's activities alleged by Momenta to infringe the '886 patent fell within the scope of the § 271(e)(1) safe harbor as being "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . ." under the statute.
The Federal Circuit vacated the District Court's grant of summary judgment in Amphastar's favor, in an opinion by Judge Wallach joined by Judge Moore and by Judge Dyk, who also dissented in part on other aspects of the decision. The majority relied on its interpretation of the "purpose" of the statute from the legislative history:
[Section 271(e)(1)] provides that it is not an act of patent infringement for a generic drug maker to import or to test a patented drug in preparation for seeking FDA approval if marketing of the drug would occur after expiration of the patent . . . . This section does not permit the commercial sale of a patented drug by the party using the drug to develop such information . . . . The information which can be developed under this provision is the type which is required to obtain approval of the drug. . . . The purpose of sections 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement [emphasis in opinion].
The opinion noted that while the contours of the safe harbor have been deemed broad (citing, inter alia, Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005), Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir. 2011), and AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1027 (Fed. Cir. 1997)), the safe harbor is not without boundaries. These exceptions include research tools not subject to FDA approval (Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265–66 (Fed. Cir. 2008)) and information "routinely reported" to the FDA post-approval (citing Classen). Earlier, the Federal Circuit had affirmed denial of Momenta's motion for preliminary injunction on the grounds that the movant was unlikely to prevail, but in light of a fuller record than had been available at the preliminary injunction stage, the Court was convinced that the FDA submissions relied upon by Amphastar were sufficiently "routine" that they fell outside the scope of the § 271(e)(1) safe harbor. The opinion contrasted the routine nature of the submissions made based on the use of Momenta's method with "non-routine submissions that may occur both pre- and post-approval, such as the submission of investigational new drug applications ('INDs'), new drug applications ('NDAs'), supplemental NDAs, or other post-approval research results." Because Amphastar's submissions using Momenta's patented technology were routine, they were not "reasonably related to the development and submission of information" as required by the statute to qualify for the safe harbor, and the District Court's decision to the contrary was clearly erroneous in the Federal Circuit's opinion. This decision was based in part on the panel's apprehension that deciding in Amphastar's favor would "result in manifest injustice" because it would be the first case to have § 271(e)(1) encompass "activities related to ongoing commercial manufacture and sale." The majority's conclusion was supported by the Federal government as amicus, wherein "the government argued that the routine use of a patented testing process in the commercial manufacture of a drug is not 'reasonably related to the development and submission of information to [the] FDA' and thus not shielded from liability by § 271(e)(1).'"
Denial of certiorari does not connote agreement by the Court, of course, but until the Court decides to address this issue the question of what activities are not within the safe harbor remains unclear, particularly with regard to ones such as safety testing that are performed post-approval.