The U.S. Supreme Court agreed to review a lower ruling in which a patent held by Integra LifeSciences Holdings prevented Germany’s Merck KGaA from conducting conduct "head-start" exploratory research for future applications into a potential new anticancer drug, even if the drug could not feasibly be marketed until after the patent expired in 2006.
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 government has argued that the Federal Circuit decision (see 331 F.3d 860, 66 USPQ2d 1865 (Fed. Cir. 2003)) incorrectly suggests that Section 271(e)(1) is limited to "clinical" research, which the FDA regards as trials on humans. However, in determining whether to permit clinical trials, the FDA considers pre-clinical research, including pharmacological and toxicological studies of the drug involving laboratory animals or in vitro.
To read the Federal Circuit opinion in this case, click here.
To read the government amicus brief, click here.
Update:
For more on Merck v. Integra, see Dennis Crouch’s Patently Obvious blog for an outstanding review of the case and the flood of amicus briefs pouring into the Supreme Court.
