RULING COULD AFFECT OUTSTANDING PATENT CASES

A U.S. Supreme Court ruling exempting biomedical research from federal patent infringement rules is expected to have widespread ramifications on outstanding patent cases, particularly those in which research activities fell into a "gray area," according to an attorney.

The Supreme Court ruled unanimously that the "Bolar Amendment," which provides safe harbor from patent infringement claims, allows biomedical research using patented compounds "as long as there is a reasonable basis for believing" the studies will yield information that could be used for an FDA drug application. The Bolar Amendment was implemented in 1984 as part of the Hatch-Waxman Act.

The Bolar statute clearly "provides a wide berth for the use of patented drugs in activities related to the federal regulatory process," the court stated. "Properly construed, [the statute] leaves adequate space for experimentation and failure on the road to regulatory approval." The decision vacated a 1996 ruling by the U.S. District Court for the Southern District of California, which had limited the application of the patent exemption. That decision was upheld by the U.S. Court of Appeals for the Federal Circuit in June 2003.

The court's markedly broad view of the Bolar provision should come as good news to pharmaceutical manufacturers, which had been closely watching the case. Among the industry groups praising the decision was the Generic Pharmaceutical Association, which said the ruling will give drug developers much-needed flexibility.