FDAnews Drug Daily Bulletin


June 2, 2006

An influential lawmaker held a hearing recently on the pharmaceutical industry's efforts to implement a new patent review procedure that would set a limited time period for patent challenges.

The hearing, held by the Senate's Judiciary Subcommittee on Intellectual Property, addressed the current patent review structure, with an eye toward implementing reforms that are meant to increase patent protections for the pharmaceutical industry. During the hearing both Sen. Patrick Leahy (D-Vt.), the ranking member of both the committee and the subcommittee, and Philip Johnson, Johnson & Johnson's chief patent counsel, called for a limited review of patents after they've been approved.

The hearing was held as part of a debate over calls for stronger patent protections, which includes a bill by Rep. Lamar Smith (R-Texas) that would expand U.S. Patent and Trade Office (PTO) patent review authority. Industry opponents believe the bill's lack of a time limit for making the patent challenges could undermine patent protections.

Currently, courts and the PTO have jurisdiction to review challenges to existing patents. But industry officials believe the PTO review is unduly restrictive because of limitations on when patents can be challenged and the fact that once a party challenges a patent it is prevented from making another challenge in the future.