The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA approval. Section 271(e)(1) exempts certain pharmaceutical-related activities from patent infringement, stating that “[i]t shall not be an act of infringement to make, use, or sell 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.” The safe harbor has previously been interpreted to include a wide array of pre-approval activities, but the scope of post-approval activities encompassed by § 271(e)(1) is less clear. The Federal Circuit held in November 2015 that the safe harbor does not extend to post-approval bioequivalence testing required by the FDA. Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610 (Fed. Cir. 2015). 

Several drug manufacturers, including Momenta and Amphastar, sought to market generic versions of enoxaparin, an anticoagulant sold under the brand name Lovenox®. The FDA made ongoing ANDA approval contingent upon bioequivalence testing for each generic enoxaparin batch to show conformance with the United States Pharmacopeia (“USP”) standard. The dispute underlying the Momenta decision arose because Momenta alleged that Amphastar’s enoxaparin bioequivalence testing infringes its U.S. Patent No. 7,575,886. Accordingly, Momenta sued Amphastar two days after Amphastar received FDA approval to market generic enoxaparin.

The Federal Circuit rejected Amphastar’s argument that the bioequivalence testing did not infringe Momenta’s patent because it is protected by the § 271(e)(1) safe harbor. The appellate court relied primarily on an earlier decision holding that the safe harbor “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011). Applying that holding to Amphastar’s post-approval bioequivalence testing, the Federal Circuit concluded that “[t]he information generated as each batch of drug substance is tested is routinely (i.e., habitually, regularly, and repeatedly) recorded and retained,” and thus not within the scope of the safe harbor. The court noted that a contrary conclusion “would result in manifest injustice” by expanding § 271(e)(1) “to encompass activities related to ongoing commercial manufacture and sale.”

Amphastar and additional generic drug manufacturers accused by Momenta have asked the Supreme Court to review the Federal Circuit’s decision. They argue that the Federal Circuit’s categorical exclusion of “routine” testing from the safe harbor is nowhere supported in the statutory text, and furthermore conflicts with Supreme Court precedent mandating that the safe harbor be broadly construed to cover the “entire statutory scheme of regulation.” They further argue that bioequivalence testing of enoxaparin satisfies the requirements of the safe harbor, as it is performed “solely” for purposes “reasonably related” to the “development and submission of information” to the FDA. In their view, the categorical exclusion of bioequivalence testing required by the FDA for ongoing approval will create “road blocks to lower-cost generic drugs,” an issue that “is of ever-growing importance given the increasing prevalence of biologics, and hence biosimilar generics.” 

Momenta counters that Amphastar’s post-approval bioequivalence testing is not “solely” and “reasonably related to the development and submission of information” to the FDA. Momenta argues that while Amphastar is legally required to retain batch testing records for at least one year, the information generated is used to select enoxaparin batches for commercial sale, not to make an affirmative submission to the FDA. Moreover, Momenta asserts that Amphastar and other generic competitors are not required to use Momenta’s patented process, but could use any “suitable means” to test generic enoxaparin batches.  

The Supreme Court’s decision as to whether to grant certiorari is not expected until October of this year.

UPDATE (October 3, 2016) – The Court denied Amphastar’s petition for certiorari.