Following through on its plan announced earlier this month, Momenta Pharmaceuticals recently filed a petition for a writ of certiorari in Momenta v. Amphastar. As we reported previously, the Federal Circuit's decision in this case appears to conflict with its 2011 decision in Classen v. Biogen IDEC. Both cases concern the scope of the "safe harbor" under 35 U.S.C. 271(e)(1), which exempts certain activities that otherwise would amount to patent infringement.
Recapping briefly, in Classen, the patent owner accused its competitors of infringing patents claiming methods of immunization. Specifically, Classen alleged that the defendants' post-approval studies of vaccines were infringing activities, and the defendants argued that their participation in the vaccine studies was reasonably related to the FDA requirement to report adverse events to FDA, and was therefore encompassed by the safe harbor. In a 2-1 decision, the Federal Circuit found in favor of Classen, holding that 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."
In Momenta, the patent owner accused its competitors of infringing patents claiming methods of analyzing enoxaparin. More specifically, Momenta argued that the defendants' post-approval testing of commercial batches of enoxaparin infringed its patent. The defendants, on the other hand, argued that their activities were reasonably related to the FDA requirement to perform quality-control testing on commercial batches of their product, and were therefore protected by the safe harbor. This time, in another 2-1 decision, the Federal Circuit found in favor of the defendants. The majority distinguished Classen:
Here, the submissions are not "routine submissions" to the FDA, but instead are submissions that are required to maintain FDA 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 FDA's requirements."
The defendants in Classen petitioned the Supreme Court, and the Court asked the Solicitor General to file a brief setting forth the views of the United States government. In its brief, the Solicitor General recommended that the Court deny review, stating that the case "would provide a poor vehicle for the Court to consider the application of Section 271(e)(1) to post-approval activities." On January 14, the Court denied cert in Classen, perhaps with an eye toward taking the Momenta case instead.
In its cert petition, Momenta frames the question presented as follows:
Whether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as "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."
Momenta asserts in its petition that the Federal Circuit's decisions in Classen and Momenta are irreconcilable, and that both are "fundamentally wrong." Momenta argues, for instance, that "[h]ad Classen been applied in this case, Amphastar's use of Momenta's patented invention would not have been exempted from infringement. Amphastar uses Momenta's patented method in the course of routine post-approval, commercial manufacturing of its drug, not to obtain pre-marketing approval." Momenta further argues that both Classen and Momenta are inconsistent with the statutory text and Supreme Court precedents, including the Court's most recent case interpreting the safe harbor, Merck v. Integra.
Finally, Momenta argues the scope of the safe harbor "is an issue of exceptional, immediate importance to the pharmaceutical industry." According to Momenta, "The Federal Circuit's diametrically opposed interpretations of Section 271(e)(1) have created immense uncertainty in a trillion-dollar industry that develops life-saving and life-enhancing drugs." Further, Momenta states, "the Federal Circuit's ruling in this case could shield from infringement any approved activity by a pharmaceutical company for which the company must maintain a record for possible future FDA inspection. This could render numerous method, composition, and packaging patents completely worthless."
Hat tip to Alex MacCormick for the news that Momenta filed its cert petition.