On January 7, 2005, the United States Supreme Court agreed to accept review of the decision in Merck KGaA v. Integra Lifesciences I Ltd., 331 F.3d 860 (Fed. Cir. 2003). The Supreme Court is expected to determine whether the drug-research safe harbor (35 U.S.C. 271(e)(1)) protects pre-clinical research using patented technology to develop and identify new drugs.
According to 35 U.S.C. 271(a), "whoever without authority makes, uses, offers to sell, or sells any patented invention ... during the term of the patent therefore, infringes the patent." In 1984, an exemption to that rule was enacted: "It shall not be an act of infringement to make, use, offer to sell, or sell ... 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." 35 U.S.C. 271(e)(1).
Integra sued Merck for patent infringement related to research funded by Merck. Merck’s 271(e)(1) safe harbor defense was presented to the jury. The jury returned a verdict of infringement, and that the safe harbor exemption was not applicable.
Merck appealed, and the Federal Circuit affirmed the liability ruling, narrowly interpreting the safe harbor provision. The majority found that since the "focus of the entire exemption is the provision of information to the FDA," an "otherwise infringing activity must reasonably relate to the development and submission of information for FDA’s safety and effectiveness approval process" to qualify for the exemption. The exemption "does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process." The decision drew a distinction between clinical and pre-clinical research, and indicated that pre-clinical drug research and development should automatically be excluded from the safe harbor provision.
Merck petitioned the Supreme Court to hear the case, and presented the following question:
Under 35 U.S.C. 271(e)(1), it is generally not an act of infringement to use a patented invention "solely for uses reasonably related to the development and submission of information under a Federal law" regulating the manufacture, use, or sale of drugs. The question presented is whether the court of appeals erred in limiting that exemption to clinical studies designed to provide information for Food and Drug Administration approval of a new drug.
The Solicitor General, on request from the Supreme Court, reviewed the matter and indicated that certiorari should be granted, stating that the Federal Circuit’s decision incorrectly narrows the safe harbor provision of 271(e)(1) by excluding pre-clinical studies from its protection. As such, the Federal Circuit’s decision is likely to restrict the development of new drugs. The solicitor general advocated review "because of the immediate adverse impact that the court of appeals’ decision is likely to have on important medical research, an impact that is magnified by the Federal Circuit’s exclusive national jurisdiction over patent appeals."
In addition, Foley & Lardner attorneys, Harold C. Wegner, Stephen B. Maebius and Rouget F. Henschel will be filing an amicus brief with the Supreme Court on behalf of a pharmaceutical client.
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