Will the Supreme Court Review Safe Harbor Provisions for Post-Approval Activity?

Momenta Pharmaceutica and Sandoz recently petitioned the Supreme Court to review the Federal Circuit’s interpretation of the 35 U.S.C. § 271(e)(1) safe harbor provisions. The petition was filed in response to a Federal Circuit decision, issued in August 2012, overturning a Preliminary Injunction that prevented Amphastar from selling its generic version of enoxaparin, a low molecular weight version of heparin. Momenta Pharmaceuticals, Inc., et al. v. Amphastar Pharamceuticals, Inc. et al., 686 F.3d 1348 (Fed. Cir. 2012). The District Court had granted the P.I., in part, because it found Amphastar’s method of testing its product likely infringed Momenta’s patent.

Amphastar had been the first to file an ANDA for a generic version of enoxaparin, but only received FDA approval on September 19, 2011. Momenta’s ANDA had been submitted after Amphastar’s, but it received approval in July 2010, more than a year before Amphastar’s. In its first year, Momenta’s revenues from enoxaparin were in excess of $1 billion, and so Momenta was clearly motivated to prevent Amphastar from diluting its market.

Enoxaparin is made by breaking a heparin polysaccharide into smaller oligosaccharides, whose size distribution profile is dependent on the original mix of heparin molecules and the way in which the heparin molecule is broken down. Thus, enoxaparin contains not just a single molecule, but contains a mixture of molecules. The FDA’s approval of Amphastar’s enoxaparin was conditional on Amphastar testing its product to ensure that the mixture of molecules fell within certain parameters that the FDA required for bioequivalence. The Federal Circuit concentrated in its decision on the language of 35 U.S.C. § 271(e)(1):

[vision_pullquote style=”3″ align=”center”] It 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. [/vision_pullquote]

(emphasis added).

Momenta had argued that the safe harbor provisions did not apply because:

Amphastar’s allegedly infringing activity was post-approval and
other noninfringing methods were available.

Regarding Momenta’s first point, the Court refused to define the safe harbor provisions so narrowly that it was applicable only to the development of information submitted in an ANDA, stating that “under a Federal law” extended beyond the most barebones information required by the FDA, and instead encompassed all materials the FDA demands in the regulatory process. While Amphastar was not required to submit the product test data to the FDA, but only to retain it for a year after the expiration date of the batch, this was sufficient in the court’s eyes to being “reasonably related” to the development and submission of the information to the FDA. The Court distinguished Amphastar’s situation from Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1070 (Fed. Cir. 2011), where the infringing activity took place in studies evaluating the risk between the timing of childhood vaccinations and developing certain immune-mediated disorders. The Court decided that the activity in Classen was not related to regulatory approval, even though studies of this nature require the submission of certain formation to the FDA, e.g. information regarding adverse events, and so the safe harbor provisions did not apply.

Regarding Momenta’s second point, the Court simply pointed out that the statute does not mandate the use of a non-infringing alternative where one exists, and that the only limitation imposed by the statute on the infringing use be that it is “reasonably related to the development and submission of [the] information” required by Federal law.

Momenta’s petition to the Supreme Court claims that the Federal Circuit’s ruling is irreconcilable with Classen and that both this case and Classen are inconsistent with the text of the statute and the Supreme Court’s precedents. Additionally, Momenta argues that the Federal Circuit’s holding that “submitting information” includes “maintaining information” has the result that much manufacturing, testing and processing data all fall under the safe harbor provisions, rendering worthless many patents covering methods, compositions and packaging.

We expect that the Supreme Court will decide by June whether or not to grant certiorari and hear this case.