United States: Consider Patent Infringement Risk When Testing or Conducting Studies on Medical Products

Originally published Spring 2004

Prior to the Drug Price Competition and Patent Term Restoration Act of 1984, most any use of a patented invention without permission from the patent owner was an infringing act. A competing product utilizing the patented invention could not be made, used, or sold in the United States while the U.S. patent was in force without infringing the patent. Even the process of obtaining FDA regulatory approval for a drug or medical device had to wait until the patent expired. Due to the FDA’s pre-market approval requirements for drugs and medical devices, and the associated delay in obtaining that approval, drugs and medical devices could not be marketed or made publicly available until long after the patent expired. The patent owner’s patent rights thus were effectively extended beyond the expiration of the patent.

In 1984, Congress amended the patent statute to account for the FDA approval delay. The patent statute now provides a "safe harbor" against patent infringement for making, using, offering for sale, selling, or importing 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". Notwithstanding this statutory language that, on its face, includes only drugs and veterinary biological products, federal courts have long held that it also includes medical devices.

Activities that fall within the safe harbor are addressed in a recent decision by the Court of Appeals for the Federal Circuit, Integra Life Sciences I v. Merck. The decision indicates that Integra owns a U.S. patent related to a short segment of fibronection, a component of biological tissues to which cells adhere, having the sequence arg-gly-asp (RGD peptide). RGD peptides promote cell adhesion by interacting with receptors on the cell surface. Investigators at the Scripps Research Institute discovered that RGD peptides may be useful in treating certain diseases such as cancer by blocking the cell receptors to which RGD peptides bind. By blocking the receptors on cells that form blood vessels, it was recognized that the extension of blood vessels into tumors might be impaired, thereby starving rapidly dividing tumor cells.

Merck, recognizing the importance of the discovery for cancer therapy, hired Scripps and its investigators to identify drugs that might inhibit new blood vessel growth. Merck and Scripps entered into an agreement whereby Merck would fund the "necessary experiments to satisfy the biological bases and regulatory (FDA) requirements for the implementation of clinical trials" with a cyclic RGD peptide identified by the investigators or a derivative thereof. Integra learned of the agreement, and following unsuccessful licensing negotiations with Merck, sued Merck in federal district court for infringement of Integra’s patent related to the RGD peptides.

After the district court’s determination that Merck’s activity did not fall within the safe harbor, Merck appealed to the Federal Circuit. The Federal Circuit agreed with the district court and found that Merck’s activity was infringing and did not fall within the safe harbor. The Federal Circuit indicated that the safe harbor applies "solely for uses reasonably related to the development and submission of information under a Federal law." In interpreting this statutory language, the Federal Circuit indicated that Merck’s activity was "pre-clinical" and "down the chain of experimentation to embrace development and identification of new drugs that will, in turn, be subject to FDA approval" in the future.

In its Integra decision, the Federal Circuit appears to permit clinical testing to supply information to the FDA (although the decision does not define what clinical testing means) but not pre-clinical testing such as "general biomedical research to identify new pharmaceutical compounds." Such pre-clinical testing does not fall within the safe harbor and so constitutes patent infringement if covered by an unexpired U.S. patent. The Federal Circuit characterized "general biomedical research" in which the FDA has no interest as "the hunt for drugs that may or may not later undergo clinical testing for FDA approval." The Federal Circuit indicated that the Scripps work sponsored by Merck was not "solely for uses reasonably related . . . [to] . . . clinical testing" for the FDA, adding that the safe harbor provision "does not reach any exploratory research that may rationally form a predicate for future FDA clinical tests."

Although the facts of the Integra case relate to drug development, it seems possible that the same reasoning about what does and does not fall within the safe harbor would apply to the activities of companies developing medical devices.

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