Federal Circuit Judges Spar over Post-FDA-Approval Application of Hatch-Waxman Safe Harbor

| September 4, 2012

Momenta Pharma v. Amphastar Pharma

August 3, 2012

Panel:  Rader, Dyk and Moore.  Opinion by Moore.


Momenta sued Amphastar for infringement of Momenta’s drug testing method.  Amphastar argued that its use of Momenta’s patented method for testing Amphastar’s commercial batches is covered by the exception to infringement for activities related to FDA regulatory review under the “safe harbor” provision of section 271(e)(1). The District Court issued a preliminary injunction against Amphastar, holding that the “safe harbor” is limited to pre-FDA approval activities.  The Federal Circuit vacates the injunction.  Amphastar’s activities took place after FDA marketing approval of Amphastar’s product, but the plain language of the statutory “safe harbor” covers all uses of a patented invention that are “reasonably related” to submission of information under FDA regulatory review.  Since Amphastar’s manufacturing batch testing was mandated by FDA for commercialization, and not “routine” information gathered “voluntarily,” Amphastar’s use of Momenta’s patented method is exempted by the “safe harbor.”


New drugs and some medical devices are subject to a lengthy regulatory approval process by the Food and Drug Administration (FDA).  This regulatory review period usually runs parallel to the term of a patent on the new drug or medical device, which tends to reduce the patentee’s opportunity to recoup investments through protected sales between FDA marketing authorization and expiration of the patent.  Conversely, commercialization of generic products would tend to be delayed until long after expiration of a drug or medical device patent, because competitors would have to wait until after expiration of the patent to engage in the activities required for FDA review of a generic product.

To balance these distortions, the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) instituted, on the one hand, a patent term extension for new drugs or medical devices subject to FDA regulatory approval, and on the other hand, an exception from infringement for some activities related to the FDA regulatory review of competing products.  Specifically, the “safe harbor” provision of section 271(e)(1) exempts from infringement activities that would otherwise infringe a patented invention but are performed “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs…” (35 U.S.C. 271(e)(1)).  This exception to infringement makes it possible for a generic manufacturer to start experiments and studies necessary for FDA review without waiting for the patent expiration.

In this case, the patentee Momenta had obtained FDA authorization to market a first generic version of the drug enoxaparin covered by a Sanofi-Aventis patent.  After Amphastar subsequently obtained FDA authorization for a second generic version, Momenta sued Amphastar for infringement of Momenta’s patent on a drug sample analysis method.  Momenta alleged that FDA requires testing of each commercial batch of enoxaparin, and that Amphastar’s testing of its drug’s commercial batches infringes Momenta’s patent.

The District Court agreed with Momenta and granted a preliminary injunction against Amphastar.  The District Court held that the “safe harbor” of section 271(e)(1) is intended to cover pre-FDA approval and does not extend to activities after obtaining FDA approval.  Amphastar appealed to the Federal Circuit.

Recently, in Classen Immunotherapties, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), a panel of the Court of Appeals for the Federal Circuit (CAFC) decided that the safe harbor does not apply to “information that may be routinely reported to the FDA long after marketing approval has been obtained.” The information at issue in Classen was a record of studies on possible side-effects of a vaccine.  FDA requires reporting of adverse side effects.

This time, a different CAFC panel finds that the statute broadly covers “any use” as long as the use is “reasonably related” to the submission of information under FDA regulatory review, whether pre- or post-approval by FDA.  The CAFC panel takes pain to distinguish Classen by noting that the batch testing performed by Amphastar is not “routine.”  Unlike in Classen, “the information here is not generated voluntarily by the manufacturer,” but Amphastar’s use of Momenta’s patented method “implicate[s] Amphastar’s very ability to continue its FDA approval for its ANDA and to continue manufacturing and marketing enoxaparin under its ANDA.”  Since Amphastar is required to maintain batch testing records in the case of a possible FDA inspection, the panel finds that Amphastar’s use of Momenta’s patented testing process is still within the “safe harbor” as defined by the broad statutory language of section 271(e)(1).

A dissent by Chief Judge Rader strongly criticizes this broad reading of the safe harbor under section 271(e)(1).  The dissent sees this decision as contrary to Classen, to the legislative history of the Hatch-Waxman Act, and to the promotion of technological innovation.

Takeaway: Judge Moore, who authored the majority opinion in this case, had dissented in Classen, whereas Judge Rader, who was in the majority in Classen, is now the dissenter.  With such conflicting views among CAFC judges, the uncertainty about the contours of the safe harbor is bound to endure, at least until the Federal Circuit takes up the issue “en banc” or the Supreme Court resolves the issue (a petition for certiorari in Classen is currently pending).

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