Are research tools protected from patent infringement under the Hatch-Waxman safe harbor, section 271(e)(1)? While different courts have reached different conclusions on this question, one recent district court decision answered it with a resounding “No.”
The safe harbor was enacted to overrule Roche Prods., Inc. v. Bolar Pharm. Co.There, the Federal Circuit held that Bolar’s use of Roche’s patented product in conducting tests to prepare its FDA application infringed Roche’s patent, even though Bolar would not market its competing product until after Roche’s patent expired. The practical implication of this decision is that even after its patent expired, a patentee such as Roche would continue to enjoy market exclusivity, while a competitor such as Bolar begins the tests necessary to seek FDA approval. This, in effect, not only extended the patent’s term but also delayed introduction of competing products.
Section 271(e)(1) was enacted to address this situation. It exempts companies from certain acts of patent infringement by creating the so-called safe harbor that allows them to use a “patented invention” “solely for uses reasonably related to the development and submission of information [to the FDA].” To compensate patentees for allowing this otherwise infringing conduct, and, further, for the loss of patent term during the FDA review period, section 156(a) was simultaneously enacted. This section permits patentees to extend the life of certain patents – not all patentable inventions, but only those patents covering a product subject to FDA review, or a method of manufacturing or using such product – for up to five years. Since the two sections were both enacted as part of the Hatch-Waxman Act, some courts have held that they operate in tandem, i.e., only patents covering products, or methods of manufacture or use subject to FDA review are extendable under section 156(a) and subject to safe harbor protection. This concept requires “symmetry” between the two sections.
Allele v. Pfizer
Allele alleged that Pfizer’s use of Allele’s mNeon Green product, a florescent protein used in Pfizer’s research, development and testing of its SARS-COV-2 vaccine candidates, infringed Allele’s U.S. Patent No. 10,221,221 (“the ‘221 patent”). Allele argued that the invention – a research tool – was not a “patented invention” under section 271(e)(1). Pfizer responded that all of the alleged acts of infringement were undertaken to develop information for submission to the FDA to gain approval of its vaccine. Thus, it reasoned that, even if the ‘221 patent covered a research tool, the safe harbor applied. The key issue was whether research tools are encompassed by section 271(e)(1).
The court began its analysis by noting that Allele’s argument was “primarily based” on the Federal Circuit’s decision in Proveris. There, the accused product was an Optical Spray Analyzer (“OSA”) that itself was not subject to FDA approval, but was used to conduct tests that were submitted to the FDA to gain approval of a drug delivery device, which was itself subject to FDA approval. The Allele court summarized the issue in Proveris as “whether section 271(e)(1) immunizes the manufacture, marketing, or sale of [defendant]’s OSA, which is used in the development of FDA regulatory submission, but is not itself subject to the FDA premarket approval.” Continuing, the Allele court recognized that Proveris held that “section 271(e)(1) safe harbor does not immunize the OSA from infringement.”
The Allele court noted that Proveris provided two reasons for its holding. First, “because the OSA device was not subject to FDA premarket approval, the device was ‘not within the category of entities for whom the safe harbor provision was designed to provide relief.’“ Second, because the invention in the ‘221 patent was not subject to FDA premarket approval, it could not be extended under section 156(a); thus, it was not a “patented invention” within section 271(e)(1).
In this regard, Proveris held that the Supreme Court interpreted the term “patented invention” in section 271(e)(1) as including all products listed in section 156(f) to create a “perfect product fit” between the two sections, i.e., “symmetry.” Section 156(f), as relevant here, covers drug products and medical devices, not research tools.
In addressing the second reason, the Allele court noted that Proveris had been cited with approval by the Federal Circuit in Momenta Pharms., Inc. v. Teva Pharms. USA Inc.(“‘research tools or devices that are not themselves subject to FDA approval may not be covered’ by section 271(e)(1)”) and followed by various district courts.
Allele court rejected Pfizer’s reliance on Classen Immunotherapies, Inc. v. Elan Pharms., Inc., which involved a research tool, because Classen did not specifically consider whether the patent-in-suit was covered as a research tool or whether the patent was a “patented invention” under section 271(e)(1). The court also distinguished Abtox, Inc. v. Exitron Corp., on which Pfizer had also relied. That case, decided before Proveris, involved a medical device that was subject to an FDA “abbreviated approval process,” whereas Allele’s patented invention was not. In this regard, the court found that Abtox actually supported Allele’s position that only inventions subject to FDA review were covered by safe harbor protection.
Lastly, the court did “not find persuasive” Pfizer’s reliance on Teva Pharms. USA, Inc. v. Sandoz Inc., which held that research tools were encompassed by safe harbor, because Teva  did not address the holding in Proveris that because the patent-in-suit was not subject to FDA approval, it was not a “patented invention” under section 271(e)(1).
The decision on the motion to dismiss in Allele is unlikely to be the final word on the safe harbor issue. Indeed, the court noted that Pfizer may raise this defense at a “later stage” of the proceedings. It does, however, provide a thorough and thought-provoking analysis of the safe harbor issue and should be considered when evaluating the applicability of safe harbor protection to research tools.
 “Research tools” are “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. 72,090,72092 n.1 (Dec. 23, 1999).
CompareIsis Pharms. Inc. v. Santaris Pharma A/S Corp., No. 3:11-CV-2214-GPC-KSC, 2014 WL 2212114 (S.D. Cal. May 28, 2014) (Safe harbor does not encompass research tools), with Teva Pharms. USA, Inc. v. Sandoz Inc. No. 09-CV-10112 KBF, 2013 WL 3732867 (S.D.N.Y. July 16, 2013) (Safe harbor encompasses research tools).
Allele Biotechnology & Pharms., Inc. v. Pfizer, Inc., No. 20-CV-01958-H-AGS, 2021 WL 1749903 (S.D. Cal. May 4, 2021) [hereinafter “Allele” and “Pfizer”].
 The legislative history of the Act indicates that Congress was focused on delayed generic competition. The Act, as interpreted by the courts, however, covers all drug development programs. See Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892, 897 (Fed. Cir. 2015).
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Mr. Coggio is of counsel to the New York office of Fish & Richardson P.C. He has extensive law firm experience as a senior trial attorney and counselor and has litigated disputes across a wide range of technologies with a particular focus in chemical, pharmaceutical, medical device, and biotechnology. He has also been involved in cases...