Hatch-Waxman Safe Harbor: Lessons from Recent Court Precedent

We recently wrote an introductory overview of navigating the Common Law Research Exemption and the Hatch-Waxman Safe Harbor and an exploration of the application of the Common Law Research Exemption. Here, we take a closer look at the Hatch-Waxman safe harbor under 35 U.S.C. § 271(e)(1), particularly through treatment by the courts over the past decade. Even so, the courts have recognized that “‘[a]s far as the text [of the Safe Harbor] is concerned, . . . [it] is not plainly comprehensible on anyone’s view.’  Just so.” Blueallele Corp. v. Intellia Therapeutics, Inc., No. 24-791, 2024 U.S. Dist. (D. Del. Dec. 9, 2024) Our articles and others (see Chickos 2008) attempt to help navigators, but also show just how fact-intensive drawing the shoreline of the safe harbor can be.

UCB v. Catalent and the Scope of § 271(e)(1)

In UCB, Inc. v. Catalent Pharma Solutions, Inc., (E.D. Ky. May 12, 2021), UCB sought a preliminary injunction against Catalent, alleging infringement of its patent covering the compound lacosamide, the active pharmaceutical ingredient (“API”) in its drug VIMPAT^®. Catalent had imported and used lacosamide under contract with a third party (“Customer A”) in preparation for a new drug application to the Food and Drug Administration (FDA). Catalent attempted to invoke the § 271(e)(1) safe harbor. The court focused on whether Catalent’s importation and handling of lacosamide was “reasonably related” to Customer A’s FDA submission. The court adopted a broad and flexible interpretation of this standard, emphasizing several key points:

1. Precedent from the Federal Circuit and Supreme Court:
   • The court cited Momenta Pharms. v. Amphastar Pharms., 686 F.3d 1348 (Fed. Cir. 2012), and Merck KGaA v. Integra Lifesciences, 545 U.S. 193, 125 S. Ct. 2372, 162 L. Ed. 2d 160 (2005), to affirm that the safe harbor covers any activity that has a “reasonable basis for believing” it will produce information relevant to an FDA submission.
   • The court clarified that the use does not need to result in an FDA submission, only that there is a rational expectation that the data may be used for one.
2. Intent and Context Matter:
   • The court credited declarations from Catalent and Customer A indicating that the work performed was part of preparatory testing and formulation development for a future FDA submission.
   • The quantities of API used were consistent with non-commercial scale, supporting the claim that Catalent was not mass-producing but rather conducting tests and manufacturing samples to support regulatory approval.
3. Distinguishing from Commercial Activity:
   • UCB argued that the volume of imported lacosamide suggested commercial intent, but the court found this unpersuasive, noting that nearly all (99.9%) of the API was accounted for in Catalent’s testing or destruction records.
   • The court also distinguished Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265–6 (Fed. Cir. 2008) (declining to extend safe harbor to Proveris because the company “is not a patentee who would have been faced with a reduction of effective patent life caused by the FDA approval process, the reason being that the invention claimed in the … patent is not subject to the premarket approval required by the FDCA”). In that case, the product at issue—an Optical Spray Analyzer that measured the physical parameters of aerosol sprays used in nasal spray drug delivery devices—was not subject to FDA regulation. Here, instead, lacosamide is a drug product that requires FDA premarket approval.
4. Application of Shire:
   • The court relied heavily on Shire LLC v. Amneal Pharms. LLC, 802 F.3d 1301 (Fed. Cir. 2015), where the API supplier was found protected under the safe harbor because the material was used in preparing an ANDA.
   • Here, as in Shire, the third-party contractor (like Catalent) was not the NDA holder, but its role was integral to enabling the filing by Customer A, thus placing its conduct within the safe harbor.

Ultimately, the court concluded that Catalent’s importation, testing, and manufacturing of lacosamide were all activities reasonably related to the development of data for Customer A’s FDA submission. The decision reinforced the principle that the § 271(e)(1) safe harbor applies not only to the NDA/ANDA filers but also to third-party downstream suppliers, so long as their use is tied to the regulatory process. Thus, the safe harbor shielded Catalent from infringement liability, and UCB’s request for injunctive relief was denied due to lack of likelihood of success on the merits.

Allele Biotechnology’s Patent Battles with Regeneron and Pfizer

Two recent district court decisions involving Allele Biotechnology & Pharmaceuticals, Inc. further illustrate the reach and limits of the safe harbor. Allele filed separate patent infringement suits against Pfizer (along with its partner BioNTech) and Regeneron, alleging that their use of mNeonGreen, a fluorescent protein, in the development and testing of COVID-19 therapies was an act of infringement (see Allele Biotechnology & Pharms., Inc. v. Pfizer, Inc., No. 20-CV-01958-H-AGS, 2021 WL 1749903 (S.D. Cal. May 4, 2021) and Allele Biotechnology & Pharms., Inc. v. Regeneron Pharms., Inc., No. 20-CV-08255 (PMH), 2024 WL 4416811 (S.D.N.Y. Oct. 4, 2024), respectively). The Pfizer and Regeneron courts both found that the defendants failed to demonstrate that mNeonGreen is a “patented invention” for the purposes of § 271(e)(1).

The Pfizer court’s decision ultimately hinged more on procedural grounds than on the scope of the safe harbor itself. In Pfizer, defendants moved to dismiss, arguing that Allele’s infringement allegations were barred by the safe harbor since they used mNeonGreen (the alleged infringing product) to develop and test its SARS-CoV-2 vaccine candidates, which were subject to FDA regulatory submissions. While the court emphasized that “research tools” not subject to FDA premarket approval are generally not covered by the § 271(e)(1) safe harbor, it focused more on the fact that the safe harbor is an affirmative defense, and dismissal is only appropriate if the defense is clearly established on the face of the pleadings. Accepting Allele’s complaint allegations as true—that mNeonGreen is a research tool and not itself subject to FDA regulation—the court found that defendants failed to show that mNeonGreen qualified as a “patented invention” under § 271(e)(1) and denied defendants’ motion to dismiss claiming protection in the safe harbor.

The Regeneron court engaged more substantively with the inquiry of whether mNeonGreen is protected by the § 271(e)(1) safe harbor. Ruling in Allele’s favor on summary judgment, the court found that Regeneron’s use of mNeonGreen was not protected under the safe harbor. The court stressed that mNeonGreen is a research tool not itself subject to FDA regulation or approval despite Regeneron using mNeonGreen to (i) determine the effectiveness of various antibody candidates for potential inclusion in REGEN-COV (an antibody cocktail to treat COVID), (ii) test the potency of manufactured lots of REGEN-COV, and (iii) test the REGEN-COV antibodies against COVID-19 variants.

Although Regeneron used mNeonGreen to identify candidate antibodies and evaluate the performance of its product, the court found that these uses were not “reasonably related” to the development and submission of information under a federal regulatory law as required by § 271(e)(1). The ruling leaned heavily on the Federal Circuit’s precedent in Proveris, where the Court held that defendant’s OSA device used in the development of FDA regulatory submissions was not itself subject to the FDA premarket approval process, and thus, fell outside the safe harbor. As a result, Regeneron could not escape liability under the safe harbor and the court allowed Allele’s infringement claims to proceed.

Early Exit Possible, But Unlikely: Safe Harbor at the Motion to Dismiss Stage

Over the past five years, courts have occasionally addressed the safe harbor—an affirmative defense—at the motion to dismiss stage but have seldom conducted a substantive analysis at this stage.

• BlueAllele Corp. v. Intellia Therapeutics, Inc., No. CV 24-791, 2024 WL 5046278 (D. Del. Dec. 9, 2024) (denying motion to dismiss where plaintiff alleged that aspects of the accused gene editing technology did not need — and were not used for — FDA approval).
• Allergan, Inc. v. Revance Therapeutics, Inc., No. CV 21-1411-RGA, 2022 WL 2866723 (D. Del. July 21, 2022) (denying motion to dismiss where the complaint alleged that defendant was “actively building inventory” in preparation for “commercial launch” and finding that such allegation was “sufficient to support a plausible inference that [defendant] did not make and import the batches in question ‘solely for uses reasonably related to’ its FDA submission”).
• REGENXBIO Inc. v. Sarepta Therapeutics, Inc., No. CV 20-1226-RGA, 2022 WL 609141 (D. Del. Jan. 4, 2022) (denying motion to dismiss where defendant allegedly used patented cultured host cells to develop a SRP-9001 gene therapy product because, while SRP-9001 required FDA approval for marketing, the cultured host cells claimed in the at-issue patent and used by Sarepta to produce SRP-9001 do not; and declining to limit the holding of Proveristo the third-party supplier context).
• Wilson Wolf Mfg. Corp. v. Sarepta Therapeutics, Inc., No. CV 19-2316-RGA, 2020 WL 7771039 (D. Del. Dec. 30, 2020) (denying motion to dismiss where the complaint expressly alleged that certain of defendant’s infringing activities were not done to create information for submission to the FDA—i.e., that defendant had some batches of SRP-900 manufactured for use to develop, improve, and optimize its manufacturing process for commercialization purposes).
• Galderma Lab’ys, L.P. v. Medinter US, LLC, No. CV 18-1892-CFC-CJB, 2020 WL 871507 (D. Del. Feb. 14, 2020) (granting motion to dismiss claims of direct infringement where the complaint merely alleged that defendant used U.S. clinical trials and research data to market and sell U.S. manufactured DERMA VEIL in foreign countries and did not plausibly suggest that defendant was otherwise stockpiling DERMA VEIL for reasons unrelated to the clinical trial).
• Trutek Corp. v. Bluewillow Biologics, Inc., No. 2:21-CV-10312, 2022 WL 20689596 (E.D. Mich. June 2, 2022) (denying motion for leave to amend complaint and finding that defendant’s vaccines “plainly fall into the safe harbor provision” where the proposed amended complaint alleged that: (i) defendant “is currently developing vaccines”; the alleged infringing vaccines are in “ongoing” development and are “currently undergoing phased trials to determine safety and efficacy”; and defendant “has not yet realized revenue from sales of its vaccine products”).

As these recent cases indicate, the threshold showing to enter the safe harbor, particularly at the pleading stage, is high, as dismissal is only appropriate where the allegations in the complaint clearly and unequivocally establish safe harbor protection.

What’s Next?

The recent opinions above further reveal the challenges companies face when engaging in the activities required to bring a product governed by the Hatch-Waxman Act to market, including whether they can support a finding of infringement or even the allegation of infringement. We will continue to monitor developments that further define the scope and contours of the safe harbor.

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Author: stanciuc1
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