Federal Circuit Narrows the Scope of the Section 271(e)(1) Research Exemption
Proveris Scientific Corp. v. Innovasystems, No. 2007-1428 (Fed. Cir. 2008)
35 U.S.C. § 271(e)(1) states:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . 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 or veterinary biological products.
This statute, passed as part of the Hatch-Waxman Act in 1984, provides a "safe harbor" from claims of patent infringement based on activities related to the pursuit of FDA approval of drug products. For example, it exempts ANDA applicants from allegations of patent infringement based on R&D done for the purpose of establishing bioequivalence.
Proveris Scientific owns U.S. Patent No. 6,785,400, which is directed to a system and apparatus for characterizing aerosol sprays used in drug delivery devices, such as nasal spray pumps and inhalers. Innova makes and sells a device that, although not itself subject to FDA approval, is used in connection with FDA regulatory submissions. Specifically, the device is used to measure the physical parameters of aerosol sprays used in nasal drug delivery devices.
Proveris filed suit against Innova, alleging infringement of the '400 patent. As part of its defense, Innova invoked the safe harbor provision of section 271(e)(1). Innova argued that its allegedly infringing activities are immunized because its device is used by third parties solely for the development and submission of information to the FDA. At trial, the district court ruled as a matter of law that Innova could not avail itself of section 271(e)(1). In an opinion released yesterday, the Federal Circuit affirmed the district court.
Innova argued on appeal that it is entitled to the benefit of section 271(e)(1) because it offered to sell its device only to pharmaceutical companies and the FDA, and that its device was used exclusively in relation to applications for FDA approval. Proveris responded that the section 271(e)(1) safe harbor is applicable only to products that are subject to patent term extensions under 35 U.S.C. § 156(f)--namely, drug products, medical devices, food additives, and color additives. According to Proveris, section 271(e)(1) does not immunize infringement of patents on laboratory or manufacturing equipment.
The Federal Circuit framed the issue as this: "whether section 271(e)(1) immunizes the manufacture, marketing, or sale of Innova's device, which is used in the development of FDA regulatory submissions, but is not itself subject to the FDA premarket approval process."
The court concluded that section 271(e)(1) provides no such immunity, reasoning that Congress did not intend for section 271(e) to apply to parties like Innova, whose device is not subject to FDA premarket approval, and who therefore faces no regulatory barriers to market entry upon patent expiration.
The Federal Circuit explained that its conclusion "achieves the same kind of fit, or symmetry" that the Supreme Court spoke of in the Eli Lilly v. Medtronic case, which also dealt with section 271(e)(1). According to the court, "Because Proveris's patented product is not subject to a required FDCA approval process, it is not eligible for the benefit of the patent term extension afforded by 35 U.S.C. § 156(f). At the same time, because Innova's device also is not subject to a required FDCA approval process, it does not need the safe harbor protection afforded by 35 U.S.C. § 271(e)(1)."
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