Momenta Pharm., Inc. v. Amphastar Pharm., Inc.

Safe harbor provision of Hatch-Waxman allows post-approval batch testing.

October 16, 2012

GENERICally Speaking

Case Name: Momenta Pharm., Inc. v. Amphastar Pharm., Inc., Case No. 2012-1062, 686 F.3d 1348 (Fed. Cir. Aug. 12, 2012) (Circuit Judges Moore, Rader, and Dyk presiding; Opinion by Moore; Dissent by Rader.) (Appeal from D. Mass., Gorton, J.)

Drug Product and Patent(s)-in-Suit: Lovenox® (enoxaparin); U.S. Pat. No. 7,575,886 (“the ’886 patent”)

Nature of the Case and Issue(s) Presented:  Momenta is the assignee of the ’886 patent that generally relates “to methods for analyzing heterogenous populations of sulfated polysaccharides, e.g. heparin [and] . . . LMWH [e.g. enoxaparin.]”  Amphastar, the first-to-file ANDA applicant, submitted its ANDA in March of 2003, and subsequently became involved in protracted patent litigation with Sanofi-Aventis as a result of its filing.  Amphastar eventually gained approval to manufacture and sell generic enoxaparin on September 19, 2011.  Although Amphastar filed its ANDA application first, Momenta was the first company to bring its generic enoxaparin to the marketplace, having been approved by the FDA to market its product in July of 2010.  Momenta sued Amphastar two days after it received its FDA approval.  Momenta alleged infringement of the ‘886 patent, which claimed a method for analyzing an enoxaparin sample for the presence or amount of non-naturally occurring sugar.  Momenta argued that Amphastar included its patented method-of-analysis in Amphastar’s process for manufacturing enoxaparin.

Momenta filed motions for a temporary restraining order and a preliminary injunction seeking to prevent Amphastar’s generic product from entering the marketplace, both of which the district court granted.  Amphastar filed interlocutory appeals to the Federal Circuit in relation to the issuance of the preliminary injunction as well as two denials for relief from the preliminary injunction, pursuant to 28 U.S.C. § 1292.  The Federal Circuit majority held that Amphastar’s testing of its generic product fell within the safe harbor provision of the Hatch-Waxman Act, and vacated and remanded the district court’s opinion. 

Why Amphastar Prevailed:  At issue was whether the district court had construed the safe harbor provision too narrowly.  The lower court agreed with Momenta’s argument that the safe harbor provision did not apply because Amphastar’s testing procedure concerned post-approval activity, and also because the FDA did not require the use of the procedure that was claimed in the ’886 patent.

The Federal Circuit first determined whether the language of the safe harbor statute was plain and unambiguous.  It held that the statute was not ambiguous, and that Congress could not have been clearer in its choice of words: As long as the use of the patented invention is solely for uses “reasonably related” to developing and submitting information pursuant to “a Federal law” regulating the manufacture, use, or sale of drugs, it is not “an act of infringement.”  Although the provision was enacted in the context of the ANDA approval process, the court noted that the text of the safe harbor provision did not reference the portion of the Federal Food, Drug and Cosmetic Act describing ANDA requirements.  The court pointed to the fact that when Congress wanted a provision to specifically address the ANDA approval process it specifically mentioned it, and provided 35 U.S.C. § 271(e)(2)(A) as such an example.

Applying its construction of the safe harbor provision, the court determined that Amphastar’s use of the testing method was for the purpose of complying was compliant with FDA regulations.  The court reasoned that FDA regulations require that all records associated with a produced batch of drugs, including the subject batch records, “be retained for at least 1 year after the expiration date of the batch.”  21 C.F.R. § 211.180(a).   The court concluded that because the FDA may require Amphastar to produce such batch records for the FDA’s inspection upon request, the batch tests fell within the safe harbor’s definition of submission of information under a federal law.

The court also dispensed with Momenta’s secondary argument that Amphastar could have used other, non-patented tests in order to ascertain batch purity.  Judge Moore noted that there was nothing in the safe harbor provision that mandated the use of non-infringing alternative uses when one existed.  She concluded that the only limitation in the safe harbor provision was that the use must be reasonably related to the development and submission of information pursuant to a federal law regulating the manufacture, use, or sale of drugs or veterinary biological products.

In Judge Rader’s lengthy dissent, he took issue with the majority’s failure to address the voluminous and clear legislative history behind the safe harbor provision.  First, he addressed the fact that the stated purpose of the safe harbor provision was to legislatively overrule the Federal Circuit’s holding in Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984).  In that case, the court held that experimental use of a drug product before the expiration of a patent claiming the drug product constituted infringement, even if the only purpose of the experimentation was to seek FDA approval for commercial sale of the drug after the patent had expired.  Without the exception, a brand manufacturer would gain a short extension after the patent expired as generic manufacturers attempted to get up to speed in manufacturing the drug.  The safe harbor provision would allow generic competitors to experiment with formulating the drug and to enter the market immediately upon expiry of the relevant drug patent.  The dissent also noted that there was ample support in the legislative history to support the contention that the safe harbor provision should only apply to experimental uses made in relation to pre-marketing approval.  In stark contrast to the legislative history, Judge Rader found that the majority’s interpretation of the statute would result in continuous, commercial infringing sales by Amphastar during a portion of the life of a valid patent held by Momenta.  Judge Rader also took the majority to task for supporting its opinion on the fact that Amphastar had availed itself of the safe harbor provision because the FDA could potentially request its batch records for the production of the generic drug.  Retention, Judge Rader noted, is the complete and exact opposite of submission.

This decision raises potential conflicts with Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011).  In Classen, Judge Rader joined the majority opinion finding no safe harbor; Judge Moore dissented.

Back to Top