Scope of safe harbor provisions of Hatch-Waxman Act still unclear

The question of the extent to which the "safe harbor" against infringement that is part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by the different conclusions arrived at by the Court of Appeals for the Federal Circuit in Classen Immunotherapies, Inc. v. Biogen IDEC and Momenta Pharmaceuticals, Inc. v. Amphastar Inc. The issue once again came before the court in Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., in a decision handed down last month. The decision provides another example of the court setting forth the contours of the scope of the safe harbor, particularly with regard to activities performed by a generic drug maker to ensure quality control and other aspects of drug making post approval.

The case involved a district court's determination that U.S. Patent No. 7,575,886 was not infringed by Amphastar and additional defendants. 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 granted summary judgment (i.e., as a matter of law not dependent on the facts before it) in defendants’ favor that their activities were protected under the safe harbor.

The Federal Circuit reversed. The court’s decision was based on its appreciation of the purpose of the statute according to 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 notes that while the boundaries of the safe harbor have been deemed to be wide and expansive (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 any boundaries at all. These exceptions to the compass of the safe harbor provisions 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). Even though the Federal Circuit had earlier affirmed the district court’s denial of Momenta's motion for preliminary injunction on the grounds that the patentee was unlikely to prevail, here the court held that they were considering a fuller record than had been available at the preliminary injunction stage. That record was enough to convince the court that the FDA submissions relied upon by Amphastar were sufficiently "routine" that they fell outside the scope of the safe harbor and thus Amphastar would be liable for infringement.

The opinion contrasts 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. This determination 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 the safe harbor encompass "activities related to ongoing commercial manufacture and sale."

In a footnote the opinion sets out the views of the 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).'" While the decision is consistent with these sentiments, there is nothing in the opinion indicating that the government's views formed any basis for the opinion.

The Supreme Court has not weighed in on this question for more than 10 years (in the Merck v. Integra case) and there has been sufficient disagreement by the Federal Circuit judges that the court may take review of this issue if asked. It seems likely that any measure taken by a generic manufacturer to ensure safety of the drugs it markets will be deemed by the High Court to be within the safe harbor; while patent rights are variably respected by courts the issue of public safety (and the political necessity of reducing drug prices) is likely to be paramount.