Teva Pharma. USA, Inc. v. Sandoz, Inc.

Granting motion to dismiss because Defendants’ acts were protected by the safe harbor provision of §271(e)(1)

Fall 2013

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Teva Pharma. USA, Inc. v. Sandoz, Inc., Civ. No. 09-10112 (KBF); 10-7246 (KBF), 2013 U.S. Dist. LEXIS 99121 (S.D.N.Y. July 16, 2013) (Forrest, J.)

Drug Product and Patent(s)-in-Suit: Copaxone® (glatiramer acetate); U.S. Pat. Nos. 6,514,938 (“the ’938 patent”), 7,074,580 (“the ’580 patent”), 7,163,802 (“the ’802 patent”), and 7,615,359 (“the ’359 patent”)

Nature of the Case and Issue(s) Presented:  Sandoz and Mylan filed ANDAs seeking to market generic Copaxone, which includes the active ingredient glatiramer acetate, a mixture of polypeptides. To receive FDA approval, Mylan and Sandoz must demonstrate that the polypeptides in their ANDA products have the same molecular weight characteristics as the polypeptides that constitute glatiramer acetate. Teva’s patents-in-suit relate to polypeptide markers that are suitable for calibrating chromatographic columns to measure the molecular weight characteristics of glatiramer acetate. The complaints alleged that defendants used Teva’s patents in preparing their respective ANDAs and sought declaratory relief for defendants’ future use of Teva’s patents when defendants market and distribute their ANDA products. Defendants filed a motion to dismiss under Fed. R. Civ. P. 12(b)(6) claiming that their use of Teva’s patents while preparing their ANDA products was protected by the safe harbor provisions of 35 U.S.C. § 271(e)(1). Defendants also argued that the claims against their future use should be dismissed under Fed. R. Civ. P. 12(b)(1) because there was no case or controversy. Defendants are now utilizing different technology and have committed not to use the technology claimed in the Teva patents. The court granted defendants’ motion on both issues.

Why Defendants Prevailed:  Defendants prevailed on the Rule 12(b)(6) motion because the court found that their actions were protected by the safe harbor provision. The court construed the term “patented invention” in 35 U.S.C. §271(e)(1) to cover the technology that is disclosed in the Teva patents. Relying on the Federal Circuit’s decision in Momenta Pharms., Inc. v. Amphastar Pharms. Inc., 686 F.3d 1348 (Fed. Cir. 2012), the court determined that the safe harbor provision allows for the elective use of patented technology as long as it serves to produce information required under federal law. The court also found that the Supreme Court’s explicit endorsement of the jury instruction in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) compelled the same result. The Supreme Court approved a jury instruction stating that the generic manufacturer “does not need to show that the information gathered from a particular activity was actually submitted to the FDA” to be afforded the safe harbor protections. In the instant case, Teva alleged that Sandoz and Mylan used the claimed markers to contribute to the generation of information relevant to their ANDAs. Teva argued that the phrase “patented invention” limits the scope of the safe harbor provision. Teva asserted that Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008) and PSN Ill., LLC v. Abbott Labs., 09 Civ. 8579, 2011 U.S. Dist. LEXIS 102088 (N.D. Ill. Sept. 20, 2011) compel a different result. The court did not find these cases relevant. First, Proveris cannot be read so narrowly as to require that the “patented invention” exclude patented testing devices.  According to the court, Proveris stands for the proposition that “when a ‘patent invention’ is not used solely for developing information and submission, that invention in connection with that use is not covered by the safe harbor.” Second, the PSN decision was either wrong or irrelevant.

With respect to the Rule 12(b)(1) motion concerning defendants’ future use, the court found that while there may have been a case or controversy at the outset of the case, any case or controversy is now mooted. Defendants submitted letters to the Court representing that they will not use Teva’s patents, except in the remote and unlikely event that the FDA requires them to do so.

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