Momenta Spars with Amphastar; Says Federal Circuit’s LOVENOX Safe Harbor Decision Must be Taken Up by the Supreme Court

By Kurt R. Karst –      

Earlier this week, Momenta Pharmaceuticals, Inc. and Sandoz Inc. (“Petitioners”) filed their reply to the brief filed late last month by Amphastar Pharmaceuticals, Inc. (“Amphastar”) opposing Petitioners’ petition the U.S. Supreme Court to review the August 3, 2012 judgment of the U.S. Court of Appeals for the Federal Circuit in Momenta Pharmaceuticals v. Amphastar Pharma., 686 F.3d 1348 (Fed. Cir. 2012).  In that case, a divided (2-1) Federal Circuit panel ruled that the scope of the Hatch-Waxman “safe harbor” provision at 35 U.S.C. § 271(e)(1) is broad and exempts from infringement any commercial activity where FDA requires that a record of that activity be maintained, even if no record is ever submitted to the Agency (see our previous post here).  Momenta contends that, unless the Supreme Court takes up the case, “[a]n intolerable state of confusion will persist . . . .”

As we previously reported, the case involves a generic version of LOVENOX (enoxaparin) and a method patent – U.S. Patent No. 7,575,866 (“the ‘866 patent”) – assigned to Momenta.  Momenta sued Amphastar in the U.S. District Court for the District of Massachusetts for patent infringement alleging that Amphastar infringed the ‘886 patent by manufacturing for commercial sale enoxaparin using the patented method.  Relying on the Federal Circuit’s decision in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), in which the Court held that 35 U.S.C. § 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained,” the District Court ruled that Amphastar’s activity fell outside of the “safe harbor” provision at 35 U.S.C. § 271(e)(1) and enjoined Amphastar from advertising, offering for sale, or selling its enoxaparin product.  (Classen was appealed to the Supreme Court, but the Court refused to hear the case after the U.S. Solicitor General filed an amicus brief urging the Court to deny certiorari.)

On appeal, the Federal Circuit disagreed with the District Court and vacated an injunction in the case.  The Federal Circuit explained in its August 2012 decision that it is not inconsistent with Classen “because the information submitted is necessary both to the continued approval of the ANDA and to the ability to market the generic drug,” and that in this case, “the submissions are not ‘routine submissions’ to the FDA, but instead are submissions that are required to maintain FDA approval. . . ,” thereby bringing them within the scope of the 271(e)(1) safe harbor.  In November 2012, the Federal Circuit denied a Petition for Rehearing en banc (see our previous post here), leading Momenta to petition the U.S. Supreme Court to review the case.  

Amphastar argued in its May 2013 opposition brief that Supreme Court review is neither necessary nor warranted.  Among other things, says Amphastar, Federal Circuit law is correct and consistent with precedent on the 271(e)(1) safe harbor, and the interlocutory posture and unique facts of the case make it a poor vehicle for Supreme Court review.  Not so fast, says Momenta:

The Federal Circuit’s legal ruling is both sweeping and wrong. . . . [T]he Federal Circuit has immunized post-approval, commercial activity this Court has never held protected by the Hatch-Waxman safe harbor. . . .  Taken to its logical conclusion, [the Federal Circuit’s decision] would immunize any commercial use of a patented invention for which a record must be kept documenting compliance with an already-approved manufacturing process. . . .  Nor would the majority’s interpretation necessarily be limited to immunizing manufacturing method patents.

Momenta goes on to explain how the Federal Circuit’s decision is unfaithful to the safe harbor statutory text and Supreme Court precedent in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) and Merck KGaA v. Integra Lifesciences, Ltd., 545 U.S. 193 (2005):

[T]he [FDC Act] expressly distinguishes between “submitting” information to the FDA and “maintaining” records for multiple purposes, including possible FDA inspection. . . .  Consistent with this statutory scheme, Section 271(e)(1) uses “submission,” not “maintain”—thereby exempting uses reasonably related to the development of information to obtain regulatory approval, while not immunizing post-approval infringing uses in the course of ordinary commercial activity.  Amphastar has no answer to this statutory distinction . . . .  If Congress had intended the remarkable departure from patent law created by the Federal Circuit’s immunization of post-approval, commercial use of patented inventions, the text of Section 271(e)(1) would have been much different.

The Supreme Court is expected to conference on the petition (Docket No. 12-1033) on June 20, 2013.