[P]ost-approval studies that are "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs" fall within the scope of the § 271(e)(1) safe harbor.
On August 3, 2012, in Momenta Pharms., Inc. v. Amphastar Pharms., Inc., the U.S. Court of Appeals for the Federal Circuit (Rader, Dyk, Moore*) vacated and remanded the district court's preliminary injunction enjoining Amphastar from infringing U.S. Patent No. 7,575,886, which related to methods for analyzing heterogeneous populations of sulfated polysaccharides, e.g. heparin and enoxaparin marketed as Lovenox, a drug that prevents blood clots. The Federal Circuit stated:
"The issuance of a preliminary injunction . . . is a matter of discretion for a district court. That discretion, however, is not absolute and must be reviewed in light of the equitable standards governing the issuance of injunctions." To determine whether a preliminary injunction is appropriate, the district court weighs factors including "(1) whether the movant has sufficiently established a reasonable likelihood of success on the merits; (2) whether the movant would suffer irreparable harm if the injunction were not granted; (3) whether the balance of hardships tips in the movant's favor; and (4) the impact, if any, of the injunction on the public interest." Id. The grant of a preliminary injunction can be overturned "by showing that the court made a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings." As the party seeking the injunction, the burden is on Momenta to establish it is entitled to this extraordinary relief. In order to prove a likelihood of success on the merits, Momenta must prove that Amphastar likely infringes its patent. Conversely, if Amphastar establishes that Momenta is unlikely to succeed on its claim of infringement, a preliminary injunction is likely not appropriate.
In its opposition to the preliminary injunction, Amphastar argued, among other things, that its testing falls within the scope of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1). Section 271(e)(1) indicates that "[i]t shall not be an act of infringement to ... use ... a patented invention . . . 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 . . . ." The district court found that "the alleged infringing activity involves the use of plaintiffs' patented quality control testing methods on each commercial batch of enoxaparin that will be sold after FDA approval." While acknowledging that Amphastar's use of the patented method was for the purpose of developing information to submit to the FDA, the district court nevertheless concluded that the safe harbor does not apply to Amphastar's testing: "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."
Although the Hatch-Waxman safe harbor provision was enacted in the context of the then-novel ANDA approval process, 35 U.S.C. § 271(e)(1) does not reference the portion of the Federal Food, Drug, and Cosmetic Act describing the ANDA requirements, e.g., 21 U.S.C. § 355(j). Instead, Congress used more flexible and expansive language to define the scope of § 271(e)(1), referring generally to "the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." This broad language unambiguously applies to submissions under any federal law, providing that the law "regulates the manufacture, use, or sale of drugs." Limiting the scope of 35 U.S.C. § 271(e)(1) to just the submission of information pursuant to the Federal Food, Drug, and Cosmetic Act generally, or to the ANDA provision of the Federal Food, Drug, and Cosmetic Act in specific, would read words into the statute in violation of the express language chosen by Congress.
Unlike the closely related infringement provision, 35 U.S.C. § 271(e)(2), Congress did not link the safe harbor to the submission of an application for approval under the Federal Food, Drug, and Cosmetic Act. We cannot change the statutory language. We will not import the limitation of § 271(e)(2) into § 271(e)(1). The statute here applies to any use of a patented invention as long as the use is "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). . . . The scope of the Hatch-Waxman safe harbor does not stop at activities reasonably related to development of information submitted in an ANDA. Instead, the safe harbor applies "to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." As long as the allegedly infringing use is "for uses reasonably related" to the development and submission of that information it is not an act of infringement, regardless of where that requirement resides in the law.
Amphastar, as a generic drug manufacturer under an ANDA, cannot sell a batch of enoxaparin unless it has established that its strength and quality is consistent with the standards set forth in the relevant official compendium. FDA regulations require that all records associated with a produced batch of drugs, including these batch records, "be retained for at least 1 year after the expiration date of the batch." These records "shall be readily available for authorized inspection" by the FDA at any time. We think that the requirement to maintain records for FDA inspection satisfies the requirement that the uses be reasonably related to the development and submission of information to the FDA. It is not disputed by the parties that these records are produced in order to develop and submit to the FDA proof that the Amphastar products comply with a Federal law. The fact that the FDA does not in most cases actually inspect the records does not change the fact that they are for the "development and submission of information under a Federal law." Thus, we consider this information "submitted" for purposes of the statute. We turn then to the question of whether these submissions are within the safe harbor.
Here, the submissions are not "routine submissions" to the FDA, but instead are submissions that are required to maintain FDA approval. Amphastar is required to conduct a laboratory determination of identity and strength of the active ingredient for each batch of enoxaparin. This test must be done according to the patented methods described in an official compendium, in this case the United States Pharmacopeia (USP). Moreover, as described above, FDA regulations require that all such batch records "be retained for at least 1 year after the expiration date of the batch," and that such records "shall be readily available for authorized inspection" by the FDA at any time. Failure to comply with these requirements could result in suspension or revocation of Amphastar's ANDA approval to market the drug. Furthermore, such testing is "a condition for [the drug's] approval and release" into commerce, thus acting as a predicate to the ability to market the ANDA-approved drug to the public. The submissions to the FDA in this case are anything but "routine" -- they implicate Amphastar's very ability to continue its FDA approval for its ANDA and to continue manufacturing and marketing enoxaparin under its ANDA. [T]he information here is not generated voluntarily by the manufacturer but is generated by FDA requirements the manufacturer is obligated under penalty of law to follow. Under such circumstances, the information can be said to have been gathered solely for submission to the FDA and [not]primarily for non-FDA purposes. While Momenta urges us to adopt the pre-/post- approval distinction used by the district court, we cannot . . . . We therefore hold that post-approval studies that are "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs" fall within the scope of the § 271(e)(1) safe harbor.
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