District Judge Nathaniel Gorton denied a plaintiff’s motion for leave to amend its infringement contentions, finding the amendments, if allowed, would be “futile.” This eventful case involves Amphastar Pharmaceuticals’ alleged infringement of Momenta Pharmaceuticals’ patent covering procedures related to an anticoagulant drug marketed as Lovenox (generically known as enoxaparin). Momenta filed suit in September, 2011, days after Amphastar received FDA approval for its generic enoxaparin. Then, in October, 2011, the Court granted a preliminary injunction against Amphastar, and Amphastar quickly appealed.  As the case proceeded in the District Court, the Federal Circuit stayed the preliminary injunction, pending appeal, and ultimately vacated the grant of preliminary injunction.

Before Judge Gorton was Amphastar’s motion for summary judgment of non-infringement arguing that Amphastar’s activities fell under the safe-harbor provision of 35 U.S.C. § 271(e)(1). Also before Judge Gorton was Momenta’s request for leave to amend its infringement contentions (retroactive leave, as it turns out Momenta had already served the two amendments without seeking leave).

The Court first addressed Amphastar’s summary judgment motion. Momenta had initially accused two of Amphastar’s processes: the “Approved 15-25%” procedure, which Amphastar used at the time of FDA approval, and the “Revised 15-25%” procedure, which Amphastar adopted after FDA approval. Finding both fell under the § 271(e)(1) safe harbor because the procedures were related to collecting the information required by laws concerning FDA approval, the Court granted summary judgment of non-infringement for both.

That left Momenta’s motion for leave to amend. Momenta accused two additional procedures in its amended infringement contentions: the “DBB test” and the “Batch-to-Batch” procedure. The Court found “DBB test,” which was very similar to the two “15-25%” procedures, would also fall under the § 271(e)(1) safe harbor because the FDA actually required Amphastar to perform it as part of the FDA approval application. With respect to the “Batch-to-Batch” procedure, the Court concluded because the procedure “simply involves comparing data that has already been produced [,]  it cannot possibly require repeating all of the steps of the [asserted patent] that would be required for infringement.” Accordingly, the Court denied Momenta’s motion to amend its contentions “because the proposed amendments would be futile in any event.” Momenta has appealed to the Federal Circuit.