Source: http://www.fdalawblog.net/2012/08/federal-circuit-rules-that-hatch-waxman-safe-harbor-is-quite-broad-in-dispute-over-enoxaparin-method/
Timestamp: 2019-04-23 02:56:46+00:00

Document:
We were eager to delve into the Federal Circuit’s recent 2-1 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Docket Nos. 2012-1062, -1103, -1104) concernng the scope of the Hatch-Waxman “safe harbor” provision at 35 U.S.C. § 271(e)(1), particularly in light of the Court’s prior decision in Classen Immunotherapies v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), which is on appeal to the U.S. Supreme Court (Docket No. 11-1078). Although the 2012 London Olympics captured most of our attention over the weekend, we did find some time to look over the decision. And we weren’t disappointed – at least insofar as the decision, and Chief Judge Randall Rader’s dissent, provided some legal entertainment.
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) 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 or veterinary biological products.
although the safe harbor provision permits otherwise infringing activity that is conducted to obtain regulatory approval of a product, it does not permit a generic manufacturer to continue in that otherwise infringing activity after obtaining such approval. . . . Here, the alleged infringing activity involves use of plaintiffs’ patented quality control testing methods on each commercial batch of enoxaparin that will be sold after FDA approval. Thus, it is not exempted under § 271(e)(1).
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.” . . . Limiting the scope of 35 U.S.C. § 271(e)(1) to just the submission of information pursuant to the [FDC Act] generally, or to the ANDA provision of the [FDC Act] in specific, would read words into the statute in violation of the express language chosen by Congress.
Moreover, while the statute does include a limitation – that the use must be “for uses reasonably related to the development and submission” – the term “reasonably related,” says the Court, citing and quoting Integra, “does not mean that the use of the patented invention must necessarily result in submission of information to the FDA.” Rather, “[a]s long as the accused infringer has a reasonable basis for believing that use of the patented invention might yield information that would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the ‘development and submission of information’ . . . .” (internal quotations omitted).
This case . . . fits well within Classen because the information submitted is necessary both to the continued approval of the ANDA and to the ability to market the generic drug. Here, the submissions are not “routine submissions” to the FDA, but instead are submissions that are required to maintain FDA approval. . . .
Under a proper construction of 35 U.S.C. § 271(e)(1), the fact that Amphastar’s testing is carried out to “satisfy the FDA’s requirements” means it falls within the scope of the safe harbor, even though the activity is carried out after approval. Unlike Classen, where the allegedly infringing activity “may” have eventually led to an FDA submission, there is no dispute in this case that Amphastar’s allegedly infringing activities are carried out to “satisfy the FDA’s requirements.” The district court’s interpretation of § 271(e)(1) was erroneous. Under the correct construction, Momenta cannot establish a likelihood of success on infringement and the preliminary injunction must be vacated.
The Federal Circuit also disagreed with Momenta’s argument that Amphastar’s testing is not protected under 35 U.S.C. § 271(e)(1) because there are non-infringing alternatives available that are endorsed by FDA.
Moreover, says Chief Judge Rader, the majority decision cannot be reconciled with the Federal Circuit’s Classen decision, and the “decision should instead request the entire court to resolve the issue en banc.” Although we’ve made such predictions before and they did not pan out (to our surprise), this Federal Circuit decision seems destined to further appeal.

References: v. 
 § 271
 v. 
 § 271
 § 271
 § 271
 § 271
 § 271