In a big win for drug researchers, the Supreme Court ruled today that a scientist may infringe on a competitor's patent early in the drug development process. But by remaining silent on another issue, the Court left unanswered the contentious question of whether basic research with patented materials is exempt from infringement suits.
The court was reviewing a 9-year old patent infringement case. Central to the issue was a 1984 law exempting research "reasonably related" to the Food and Drug Administration (FDA) drug approval process. The intent of the law is to foster basic research for developing new medicines. In the case, Scripps Research Institute cell biologist David Cheresh was found by a jury in 2000 to have infringed a patent on a surface peptide during cancer studies. Merck KGaA, unrelated to the US firm Merck & Co., had teamed with Cheresh on the research and argued that the 1984 law made him exempt from a patent suit. But a federal appeals court sided with patent holder Integra 3 years ago that Cheresh's work was "preclinical" and not tied to FDA approval of any drug. In the process, that court narrowed the scope of so-called "FDA exemption" and stunned the biotech community.The Supreme Court today rejected such a narrow view, saying that research even untied to a specific drug approval effort could be eligible for the FDA exemption. As for the Merck and Integra, the high court sent that dispute back to the appellate level with new instructions for the judges. "This is a big win for discovery drug companies," said biotech attorney Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP in Chicago. "It says that activities that they would want to undertake like using biotech research tools for drug discovery are not categorically excluded from the exemption."What the court didn't say was as important as its decision. Researchers had worried the court would comment on--and possibly narrow--the legal exemption from infringement suits for basic science. But on that the court was silent, leaving it up to congress to clarify the issue. "I'm a little relieved they didn't say anything bad," said Joshua Sarnoff, assistant director of the Glushko-Samuelson Intellectual Property Law Clinic at American University's Washington College of Law in Washington, D.C.