Source: https://www.carlsoncaspers.com/district-court-holds-that-271e1-safe-harbor-protects-post-filing-activities/
Timestamp: 2019-04-26 08:56:31+00:00

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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.
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.

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