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For more information about this IP Law Alert,
please contact any Orrick's IP Partner
listed below. New York 666 Fifth Avenue tel 212-506-5000 Contacts: Robert M. Isackson Partner, East Coast IP Practice Leader Intellectual Property Phone: (212) 506-5280 Jennifer Gordon, Ph.D. Partner, Intellectual Property Practice Phone: (212) Orange
County 4 Park Plaza fax
949-567-6710 Contact: David E. Wang Partner,
Intellectual Property Practice tel:
(949) 852-7750 Silicon
Valley 1000 Marsh Road Contact: Elizabeth A. Howard, Ph.D. Partner,
Intellectual Property Practice tel: (650) 614-7316 |
June 2005Supreme Court Expands Definition And Protection Of Safe HarborMerck KGaA v. Integra Lifesciences I, LtdIn this Law Alert, we highlight the United States Supreme Court's Integra decision, which holds that new drug development is exempted under the safe harbor of section 35 U.S.C. § 271(e)(1), provided that a reasonable basis exists to believe that the new product could be the subject of a submission seeking regulatory approval. The section 35 U.S.C. § 271(e)(1) had previously been limited to exempt activity related to collecting information for submission to the FDA, for both pharmaceuticals and medical devices. In vacating the Federal Circuit decision, the Supreme Court broadened the protection afforded by the § 271(e)(1) safe harbor to include activities that reasonably could be related to the drug's submission for regulatory approval, whether such a submission actually occurs or not. Consequently, the § 271(e)(1) safe harbor is not limited to the testing of generic versions of patented pharmaceuticals or medical devices to obtain premarket approval, but may encompass new product development regardless of whether regulatory approval by the FDA is ultimately sought. The Court did not decide whether the safe harbor exempts use of “research tool” patented inventions. Therefore, the Supreme Court's ruling permits companies to make increased use of certain patented compounds, devices and methods under 35 U.S.C. § 271(e)(1) beyond that previously permitted by the Federal Circuit. Patented Compounds Protected Under Safe HarborThe Supreme Court held that the use of patented compounds in preclinical studies is protected under § 271(e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to such a submission. Invention At IssueThe invention at issue relates to the tripeptide sequence Arg-Gly-Asp, known as the “RGD peptide,” which promotes cell adhesion by attaching to receptors on the outer surface of certain endothelial cells. Dr. David Cheresh, a scientist at the Scripps Research Institute, discovered that blocking these same receptors inhibited angiogenesis, the process for generating new blood vessels. Subsequently, Merck agreed to fund the necessary experiments to satisfy, among other things, the FDA requirements for clinical trials after Dr. Cheresh and Scripps identified potential drug candidates. Scripps conducted experiments to evaluate specificity, efficacy and toxicity of several drug candidates for various diseases, to explain the mechanism by which the candidates worked and to determine which were effective and safe enough to warrant testing in humans. Many properties of the RGD peptide, as well as how it could be administered for optimum therapeutic effect, were examined. Integra owns the five patents at issue, all of which relate to the RGD peptide. When it learned of the Merck-Scripps agreement, it offered licenses to the patents-in-suit, which were declined. Integra then brought suit against Merck, Scripps and Dr. Cheresh for patent infringement in federal court in San Diego. At trial, the jury found Merck liable for infringing Integra’s patents. The jury further determined that Merck failed to show that its infringing activity was exempt pursuant to 35 U.S.C. § 271(e)(1). The district court denied Merck’s motion for judgment as a matter of law, explaining that the evidence was sufficient to show that the § 271(e) exemption did not apply. The Federal Circuit affirmed the finding of infringement and affirmed the denial of judgment as a matter of law on the ground that 35 U.S.C. § 271(e)(1)’s safe harbor did not apply because the Merck/Scripps work “was not clinical testing to supply information to the FDA, but only general biomedical research to identify new pharmaceutical compounds.” In other words, the Federal Circuit found the § 271(e)(1) exemption to encompass only those activities necessary to acquiring information for FDA approval, in this case the development of a generic copy of a patented pioneer drug already on the market, not new drug development activity. Judge Newman dissented, stating that the statute’s origins may have intended only to apply to registration of generic copies of drugs, but that the statute has been interpreted with broader scope to include laboratory experimentation and development of data for submission to the FDA. The Supreme Court vacated the Federal Circuit’s decision and remanded for further proceedings. The Court stated plainly “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 Food Drug and Cosmetic Act, finding the following protected by § 271(e)(1): · clinical and preclinical studies of patented compounds that are appropriate for submission to the FDA · studies intended to generate pharmacological, toxicological, pharmacokinetic and biological qualities of the drug in animals · studies intended to generate information regarding a “risk-benefit assessment of the appropriateness of the proposed [clinical] trial" · safety-related tests even if not compliant with FDA regulations Although the Court clearly conceded that “[b]asic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not ‘reasonably related to the development and submission of information’ to the FDA,” § 271(e)(1)’s exemption is broad enough to include, under certain conditions, “(1) experimentation on drugs that are not ultimately the subject of an FDA submission [and] (2) the use of patented compounds in experiments that are not ultimately submitted to the FDA.” Therefore, as long as there is a reasonable basis for believing the experiments will produce the types of information that are relevant to new drug applications, the use of patented compounds in preclinical studies are protected under § 271(e)(1). “Properly construed, § 271(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval: At least where a drugmaker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular biological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the ‘development and submission of information under . . . Federal law.’” Practical ImplicationsInterestingly, the question of whether § 271(e)(1)’s safe harbor exemption extends to patented “research tools” remains open. Research tools are compounds and processes that can assist in the discovery, identification, characterization and development of commercial products, (e.g., pharmaceuticals and biologics) but are not themselves readily marketable. The Federal Circuit indicated that § 271(e)(1) should be construed narrowly to avoid depriving research tools of the value of their patents. Here, however, the RGD peptides were not asserted to have been used as research tools and therefore the Court expressly declined to decide whether, or to what extent, § 271(e)(1) exempts from infringement the use of “research tools” in the development of regulatory information.
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