District Court Holds That 271(e)(1) Safe Harbor Protects Post-Filing Activities

A Massachusetts district court has granted summary judgment in favor of defendants Amphastar and Teva in a suit over a quality-control method patent for manufacture of the anticoagulant enoxaparin.

The two related suits were filed by plaintiff Momenta Pharmaceuticals, the first generic manufacturer of enoxaparin.  Momenta Pharm., Inc. v. Amphastar Pharm., Inc., No. 11-11681 (D. Mass.); Momenta Pharm., Inc. v. Teva Pharm. USA, Inc., No. 10-12079 (D. Mass.).  The suits were based on Momenta’s patent which was directed to a set of manufacturing control processes used to ensure that each batch of the drug included the necessary sugar chains.  Momenta alleged that the defendants infringed its patent by using the claimed methods their manufacture of enoxaparin.

In 2011, the district court granted Momenta a temporary restraining order and preliminary injunction preventing defendant Amphastar from marketing its product, finding that Momenta was likely to succeed on the merits.  On appeal, the Federal Circuit vacated the preliminary injunction, that Amphastar’s allegedly-infringing activities fell within the “safe harbor” provision of § 271(e)(1).  Momenta Pharm., Inc. v. Amphastar Pharm., Inc. 686 F.3d 1348 (Fed. Cir. 2012) [see previous post].

The Federal Circuit concluded that the safe harbor provision, which specifies that activities performed “solely for uses reasonably related to the development and submission of information under a Federal law” cannot infringe a patent, applied to even post-filing activities.  The Federal Circuit recognized that Congress used broad language that illustrated an intent that § 271(e)(1) apply to activities beyond those undertaken solely in order to gain ANDA approval.

Following the Federal Circuit’s decision (as well as the subsequent denial of cert. by the Supreme Court), both Amphastar and Teva moved for summary judgment based on § 271(e)(1)’s safe harbor.  The district court, granting both defendants motions for summary judgement, focused on the fact that Momenta’s Complaints expressly stated that defendants must infringe the ‘886 patent because the FDA requires them to perform the methods claimed by the ‘886 patent.  In doing so, the district court rejected Momenta’s arguments that (1) the safe harbor does not apply if the FDA has not mandated the use of the particular infringing test and (2) that defendants routine post-approval record keeping is not a “submission of information” under § 271(e)(1).  On the second point, the court cited to the Federal Circuit’s opinion, finding“the fact that the FDA does not in most cases actually inspect the records does not change the fact that the records are reasonably related to ‘submission’ of information to the FDA.”

The district court’s grant of summary judgment, as well as the earlier Federal Circuit opinion, represents a significant step in expanding the safe harbor in § 271(e)(1).  While this specific quality-control activity is unlikely to affect many pharmaceutical companies, this case may open the door to a safe harbor for additional post-filing activities.