The Safe Harbor Under 271(e)(1): Is Post-Approval Activity "Routine"?

Executive Summary

On November 10, 2015 the Federal Circuit issued its opinion in the companion cases of Momenta Pharms., Inc. v. Teva Pharms. USA Inc. and Momenta Pharms., Inc. v. Amphastar Pharms., Inc. (Momenta II). Both cases have been closely watched for their potential impact on the current scope of safe harbor protection under 35 U.S.C. § 271(e)(1) and this decision, in the Amphastar case specifically, signals a narrowing of that scope, at least with respect to post-approval regulatory activity involving use of a patented invention.

In sum, while the Federal Circuit’s 2012 decision in Momenta Pharms, Inc. v. Amphastar Pharms., Inc. (Momenta I) held that use of a patented invention for post-approval, FDA-mandated, commercial-release, quality control testing fell within the scope of the safe harbor, the Federal Circuit has now reversed course on that holding, finding instead that Amphastar’s testing and FDA submissions are “routine” and that, per Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir. 2011), the safe harbor “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.”

The decision focuses the safe harbor question relating to post-approval activity on whether such activity can be characterized as “routine.” If the answer is yes, § 271(e)(1) does not apply.


Momenta is the assignee of U.S. Patent No. 7,575,886, which is directed to a process used to ensure that each batch of the generic anticoagulant enoxaparin meets certain quality standards. Per FDA requirements, generic manufacturer Amphastar must test each batch of its approved generic enoxaparin before commercial distribution and sale. Amphastar further must maintain the records of such testing in the event the FDA requests such information. Amphastar utilizes the ‘886 patented process to accomplish this FDA-mandated quality control testing.

In September 2011, Momenta sued Amphastar for infringement of the ‘886 patent and moved for a preliminary injunction to prevent ongoing infringement during the course of the suit. The district court granted Momenta’s request for a preliminary injunction based on its belief that Amphastar’s quality control batch testing infringed the ‘886 patent.

Amphastar immediately appealed and the Federal Circuit, in an opinion written by Judge Moore, found that, under the plain language of § 271(e)(1), nothing precluded the safe harbor from extending to post-approval activities so long as such activities were “reasonably related to the development and submission of information” to the FDA. Further, the court determined that Amphastar’s submissions to the FDA were “anything but routine” but rather “implicate[d] Amphastar’s very ability to continue its FDA approval for its ANDA and to continue manufacturing and marketing enoxaparin under its ANDA.” Accordingly, the Federal Circuit held that § 271(e)(1) extended to Amphastar’s activities and that “the district court incorrectly concluded that Momenta was likely to succeed on the merits of its infringement claim.”

The case proceeded in the district court and Amphastar moved for summary judgment of no infringement based upon the protections of the safe harbor, which the district court granted. Momenta appealed. In a relatively rare act by the court, after hearing oral argument on the parties’ briefs, the Federal Circuit requested the position of the United States government on the question of “whether performing a process and retaining process records after initial FDA approval for the purposes of demonstrating compliance with FDA requirements is protected by the safe harbor of § 271(e)(1) if that activity also has a commercial purpose.” The United States responded in the negative.

Federal Circuit Decision

On first glance it seems that the question presented to the Federal Circuit by Momenta’s appeal in this case is the exact same question that was presented to the same court back in 2012 when Amphastar appealed the grant of the preliminary injunction. In many respects the expectation was that the outcome would be the same. In fact, however, the outcome was not the same and the Federal Circuit justified this, in part, by distinguishing between the depth of the factual record presented in the instant appeal and the very limited record present at the preliminary injunction stage.

In addition, though acknowledging that, per the “law of the case” doctrine, a court will generally not revisit an issue once decided in a litigation, the court clearly reminded us all that “findings of fact and fact-intensive conclusions of law made by a court in the preliminary injunction context are not binding.” So, this Federal Circuit panel (which included Judge Moore herself) did not feel bound by its prior decision in Momenta I. This rationale gave the court the latitude to reverse its course.

On the factual record presented in the Momenta II appeal, the court concluded that Amphastar’s submissions are appropriately characterized as “routine.” Utilizing dictionary definitions of the word “routine” and no doubt considering the detailed summary provided by the United States’ amicus brief in characterizing Amphastar’s quality control testing as “routine,” the court held that “the routine quality control testing of each batch of generic enoxaparin as part of the post approval, commercial production process is not ‘reasonably related to the development and submission of information’ to the FDA, and it was clearly erroneous to conclude otherwise.” Of course, the court was careful to point out that not all post-approval activity is “routine” and that activities such as application for supplemental NDAs or post-marketing studies may still fall well within the safe harbor.

This decision was plainly laced with policy concerns as the Federal Circuit recognized that the Momenta I conclusion would result in “manifest injustice” and that no other court prior to Momenta I extended safe harbor immunity to activities relating to ongoing commercial manufacture and sale.

The Impact

This decision is important both for its impact on Momenta I and its lack of impact on Momenta I. Judge Moore’s opinion in Momenta I is generally thought to have facilitated a wide expansion of the scope of safe harbor – clarifying in no uncertain terms that § 271(e)(1) is not limited to generic approval activity only, and that the plain language of the statute is broad enough to encompass any activity so long as that activity is reasonably related to the development and submission of information pursuant to a federal law. Under such an expansive read, the safe harbor would easily extend not only to post-approval activities but to a host of other activities as well.

This decision reigns in this scope, but only to the extent it conflicts with Classen’s explicit prohibition on use of § 271(e)(1) to cover “information that may be routinely reported to the FDA” after approval. Thus, we now have a “routine” test for post-approval activity. However, the decision says nothing about the otherwise broad scope of § 271(e)(1) with respect to non-“routine” uses of patented inventions in the course of developing information to be submitted under a federal law. Though the Federal Circuit easily walked away from its characterization of Amphastar’s testing in Momenta I as “anything but routine,” Judge Moore’s expansive reading of the safe harbor in that case remains untouched.

And one last note!

Many clients ask about the extension of safe harbor to use of “research tools” – patented inventions that are not themselves subject to regulatory approval but are used nonetheless in testing or screening for drug development purposes and whose use clearly leads to the development and submission of information in the approval process. The Federal Circuit chose its words carefully because this issue remains an open question: “In addition, research tools or devices that are not themselves subject to FDA approval may not be covered.”