Research Exemptions and Nucleic Acid Patenting Goes to Trial

In Merck KGaA v. Integra Lifesciences I, Ltd., 125 S. Ct. 2372 (Jun. 13, 2005), the Supreme Court considered the scope of the exemption from patent infringement embodied in 35 U.S.C. § 271(e)(1). Under §271(e)(1), also referred to as the safe harbor provision, "[i]t shall not be an act of infringement to . . . use . . . 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 . . . use of . . . drugs." The Supreme Court, as an initial matter, held that "§271 (e)(1)'s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the [Federal Food, Drug, and Cosmetic Act]." Merck, 125 S. Ct. at 2380. As such, "the use of patented compounds in preclinical studies is protected under § 271(e)(1) as long as there is a reasonable basis for believing that the experiments will produce the types of information that are relevant to an [investigational new drug application] or [a new drug application]. Id. at 2383-84 (internal quotation marks omitted). Because the appeals court, (the U.S. Court of Appeals for the Federal Circuit ("Federal Circuit")), had applied a narrower construction of § 271 (e)(1), the Supreme Court vacated the judgment and remanded the decision to the Federal Circuit, where the case is now pending. See id. at 2384.

The second decision, In re Fisher, 421 F.3d. 1365 (Fed. Cir., Sept. 7, 2005), relates to the patentability of certain expressed sequence tags (ESTs). Affirming a decision by the U.S. Patent and Trademark Office's ("PTO") Board of Patent Appeals and Interferences, the Federal Circuit held that the claimed ESTs, which encode protein fragments in maize plants, lack specific and substantial utility, as required under 35 U.S.C. § 101, and that they are not enabled under 35 U.S.C. § 112, 1. See Fisher, 421 F.3d at 1367. Applying the Supreme Court's decision in Brenner v. Manson, 383 U.S. 519 (1966), the Federal Circuit held that the claimed ESTs were not supported by a specific and substantial utility "because Fisher does not identify the function for the underlying protein-encoding genes. Id. at 1376. The court also stated that the 2001 PTO Utility Examination Guidelines, applied in this case by the PTO, comport with its interpretation of the utility requirement of § 101. See id. at 1372.