Fed. Cir. Limits Safe Harbor for Post-Approval Conduct


This article appeared on Law360 on November 17, 2015 and is reprinted with permission.

The Federal Circuit's Nov. 10 decision in Momenta Pharmaceuticals Inc. v. Teva Pharmaceuticals USA Inc. ("Momenta II"),[1] which reversed its earlier decision in Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc. ("Momenta I"), [2] is particularly significant. The decision not only narrows the scope of safe harbor protection for post-approval conduct but also seemingly eliminates such protection for research tools patents.

Momenta I

In MomentaI (and II), the facts demonstrated that the U.S. Food and Drug Administration had approved Amphastar's sales of genericLovenox provided that each commercial batch was tested before marketing to ensure that the product met rigid specifications. Although other testing regiments were available, Amphastar used Momenta's patentedassay to conduct these tests. The Federal Circuit affirmed the denial of Momenta's request for a preliminary injunction because it was "unlikely" that Momenta would succeed on the merits since Amphastar's conduct was protected by the safe harbor.[3]In rendering its decision, the court first needed to distinguish its earlier decision inClassenImmunotherapies Inc. v.BiogenIdec., which held that the safe harbor was limited to pre-approval conduct. [4] Judge Kimberly A. Moore, who had dissented inClassen, writing for the Momenta I majority stated: "The [Classen] studies themselves were not mandated by the FDA," and further, that "the patented methods were not insulated by the safe harbor because the studies did not facilitate marketing a generic drug by expedit[ing] development of information for regulatory approval.'"[5]Classen involved post-approval studies that monitored the effectiveness of vaccines. The studies were not required by the FDA, but once performed, the results were necessarily reported to the FDA.The Momenta I court held that "the scope of the safe harbor does not extend to information that may be routinely reported to the FDA, long after marketing approval has been obtained."[6] Indeed, according to Judge Moore, this ruling was not inconsistent with Classen because the submitted information "is necessary both to the continued approval of [the] ANDA and to [Amphastar's] ability to market the generic drug."[7] As such, the submissions were not "routine" as in Classen, but rather were "required to maintain FDA approval." [8] In summary, the court stated:

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."[9]

In sum, under Momenta I, it would appear that FDA-mandated, post-approval conduct (i.e., "activities … carried out to satisfy the FDA's requirements'") is by definition not "routine" and is therefore protected by the Hatch-Waxman safe harbor. This view was apparently changed in Momenta II.

It is also significant that the court, with then Chief Judge Randall Rader dissenting, held that safe harbor applies to research tools. Clearly, the Momenta patent, which covered an assay, was directed to a research tool. The dispute as to whether research tools are covered by the safe harbor stems from the U.S. Supreme Court's decision in Eli Lilly and Co. v. Medtronic Inc. [10] There, the court strongly suggested that the symmetry between Sections 271(e)(1) and 156 of the patent laws required that the safe harbor only applies to patents extendable under the latter section. Research tool patents, of course, are not extendable and thus, under this rationale, would not be subject to section 271(e)(1). The Supreme Court, however, recognized that this symmetry would not always exist:

[T]here may be some relatively rare situations in which a patentee will obtain the advantage of a [§156] extension but not suffer the disadvantage of the [§271 (e)(1)] noninfringement provision, and others in which he will suffer the disadvantage without the benefit. [11]

Decisions since Eli Lilly have been inconsistent on whether symmetry is required before the safe harbor applies. In Momenta I, the majority noted the Eli Lilly statement and flatly held that symmetry is not required between the two sections.[12] Yet, in Proveris Scientific Corp. v. Innovasystems Inc., the Federal Circuit, in essence adopted the symmetry approach, and as a result, held that research tool patents are not subject to the safe harbor.[13] The Proveris holding disregarded the court's earlier decisions in Abtox Inc. v. Exition Corp.[14] and Chartex Int'l PLC v. M.D. Personal Prods. Corp.,[15] which did not read the limitations of Section 156 into Section 271(e)(1). Yet, the Proveris decision has been followed by various district courts that have held that the safe harbor does not apply to research tools.[16] Other district courts have held the exact opposite.[17]

In Momenta II,[18] as applicable here, the Federal Circuit addressed two important issues: (1) whether the safe harbor covers "routine" post-approval testing; and (2) whether it covers research tools.

Momenta II

Research Tools

Addressing the second issue, the Federal Circuit, almost in passing, stated:

Despite the broad contours of the [safe harbor] exemption, some activities are outside its protection. … [R]esearch tools or devices that are not themselves subject to FDA approval may not be covered. Proveris Corp. v. Innovasystems, Inc. 1256, 1265-66 (Fed. Cir. 2008).[19]

This is the only “discussion” of whether the safe harbor covers research tools and the word "may" leaves the force of this statement somewhat uncertain. Yet, if research tools are not, in fact, covered, the court did not need to address the remaining safe harbor issue.

Research tools[20] are "not themselves subject to FDA approval," and related patents are therefore not extendable under Section 156. Thus, by citing Proveris, the Federal Circuit[21] has reinvigorated — and maybe settled — the ongoing debate on whether the safe harbor covers research tools.

Post-Approval Conduct

The Federal Circuit in Momenta II did not limit the safe harbor to pre-approval activities — a disputed issue in Classen. But, while "post-approval studies" can fall within the section, whether such uses are "reasonably related" to a Section 271(e)(1) submission requires "more critical analysis in the post-approval context."[22] The court noted that no case until Momenta I extended the safe harbor to encompass ongoing, post-approval commercial activities.[23] It also stressed that the safe harbor was directed to seeking FDA approval — not post-approval conduct. In sum, post-approval use of a patented invention may still be protected, but such instances are limited:

The routine record retention requirements associated with testing and other aspects of the commercial production process contrast with non-routine submissions that may occur both pre- and post-approval, such as the submission of investigational new drug applications ("INDs"), new drug applications (NDAs"), supplemental NDAs, or other post-approval research results. … The routine quality control testing of each batch of generic enoxaparin as part of the post approval, commercial production process is therefore not "reasonably related to the development and submission of information" to the FDA, and it was clearly erroneous to conclude otherwise.[24]

Thus it seems that seeking changes or additions to an existing FDA filing would not be "routine."


Some conflict exists between Classen, Momenta I and Momenta II. While the submissions in Classen were not required, i.e., mandatory, and thus merely "routine," the submissions in Momenta were required by the FDA. Therefore, under the Momenta I court's reasoning, Momenta's post-approval conduct should have been protected. But the Momenta II court reconsidered its earlier decision and decided that the quality control test at issue was a "habitual" or "regular" part of the production process, and not related to obtaining FDA approval.[25]

In summary, the Momenta II decision indicates that: (1) Section 271(e)(1) may not apply to research tools (at least for now); (2) the safe harbor is not limited to pre-approval conduct; (3) post-approval conduct will be "more critically analyzed" than pre-approval conduct; and (4) the type of post-approval conduct subject to the safe harbor protection may be restricted to conduct "required" by the FDA to obtain, alter, or supplement an existing filing.

[1] App. Nos. 2014-1274, 1277 (Nov. 10, 2015 Fed. Cir.).[2] 686 F.3d 1348 (Fed Cir. 2012).[3] Id. at 1361.[4] 659 F.3d 1057, 1070 (Fed. Cir. 2011).[5]Momenta I, 686 F.3d at 1357.[6] 1358 (emphasis added).[7] Id.[8] Id.[9] Id. at 1359. Chief Judge Rader dissented, see id. at 1361, arguing, inter alia, that the safe harbor is limited to pre-approval activities. See id. at 1362-63.[10] 496 U.S. 661 (1990).

[11] Id. at 671-72.

[12] Momenta I, 686 F.3d at 1361. In Momenta I, then Chief Judge Rader cited Proveris and endorsed the symmetry analysis between § 271(e)(1) and § 256. See id. at 1371 (Rader, J., dissenting).

[13] 536 F.3d 1256, 1265 (Fed. Cir. 2008).

[14] 122 F.3d 1019, 1030 (Fed. Cir.) opinion amended on reh'g, 131 F.3d 1009 (Fed. Cir. 1997).

[15] 5 F.3d 1505, at *4 (Fed. Cir. 1993).

[16] See, e.g., Isis Pharm., Inc. v. Santaris Pharma A/S Corp., No. 11CV02214, 2012 WL 4111157, at *4 (S.D. Cal. Sept. 19, 2012); PSN Illinois, LLC v. Abbott Labs., No. 09 C 5879, 2011 WL 4442825, at *5 (N.D. Ill. Sept. 20, 2011).

[17] See, e.g., Sandoz Teva Pharm. USA, Inc. v. Sandoz Inc., No. 09 CIV. 10112, 2013 WL 3732867, at *7 (S.D.N.Y. July 16, 2013), appeal dismissed (Sept. 5, 2013), appeal dismissed (Nov. 20, 2013).

[18] The Momenta II decision did not address the holding in Momenta I that the "submission" requirement of section 271(e)(1) was satisfied even though the testing results-at-issue were not actually submitted to the FDA. Nor did the court address the ruling that the alleged infringer was not required to choose a non-infringing alternative to the patented invention, assuming one was available.

[19] Slip Op. at 14 (emphasis added).

[20] The National Institutes of Health defines "research tools" as "tools that scientists use in the laboratory including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines." 64 Fed. Reg. 72, 090, 72,092 n.1 (Dec. 23, 1999).

[21] Judge Dyk dissented in part, but "join[ed] the majority opinion insofar as it holds that 35 U.S.C. 271(e)(1) safe harbor does not immunize Amphastar's accused use of the [Momenta] patent in its manufacturing process." Slip Op. dissent at 2.

[22] Slip Op. at 17.

[23] But see Wesley Jensen Corp. v. Bausch & Lomb, Inc., 235 F. Supp. 2d 370, 376 (D. Del. 2002) (safe harbor not limited to pre-approval conduct).

[24] Slip Op. at 17. See also Classen Immunotherapies, Inc. v. Elan Pharm., Inc., 786 F.3d 892, 897 (Fed. Cir. 2015) (noting that "in the post-approval context it may be less straightforward to determine whether an accused infringer’s use of a patented invention was "solely for uses reasonably related to the development and submission of information" under the FDCA). The Classen court held that post-approval studies conducted to secure changes to a drug label were subject to the safe harbor. See id. at 897-98.

[25] Slip. Op. at 16-17.