FDAnews
www.fdanews.com/articles/98392-house-passes-patent-reform-bill-concerns-remain-within-industry

House Passes Patent Reform Bill, Concerns Remain Within Industry

September 12, 2007

The House voted 220-175 to pass a patent reform bill despite opposition from the White House and industry.

The Patent Reform Act, H.R. 1908, and its Senate counterpart, S. 1145, will make the pharmaceutical marketplace “much more friendly for [patent] infringers,” according to Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood.

The House acted on H.R. 1908 Sept. 7, despite a letter from House Republican leadership to Speaker Nancy Pelosi (D-Calif.) asking her to continue to work on the bill instead of scheduling it for “quick consideration.” The Senate and House judiciary committees passed the Patent Reform Act, S. 1145 and H.R. 1908, in July.

BIO opposes the bill because it “puts at risk a whole host of innovators,” Greenwood said during a meeting with reporters. He added that he was concerned H.R. 1908 could later be included in an omnibus bill, such as an appropriations bill, without undergoing debate and negotiations on the Senate floor.

The Bush administration does not support a provision in the bill that would limit a court’s discretion in determining damages to compensate for a patent infringement, according to a statement of policy from the White House Office of Management and Budget. While the administration supports passing patent modernization legislation, it will oppose H.R. 1908 until the provision is revised, the office said.

The Generic Pharmaceutical Association (GPhA) also has “significant concerns” over the House bill, GPhA President and CEO Kathleen Jaeger said. The group opposes a provision in the bill that would codify the inequitable conduct defense, she added.

BIO did support some of the bill’s provisions when it passed the committees. The House committee adopted an amendment that would revoke the ability of defendants to use best mode as a defense in patent infringement cases, which BIO praised. Sen. Arlen Specter (R-Pa.) proposed a similar amendment in the Senate version, but it was voted down.

Greenwood also praised the House committee’s decision to remove the second window from the post-grant review provision. The provision would have allowed a petitioner to request a review of a patent upon receiving a notice of infringement or if the petitioner can prove the patent causes significant economic harm, even after a year of the patent’s issuance, during the second window.

“The second window would extend the opportunity to challenge a patent, diminishing its value and reducing incentives for investment,” Greenwood said at the time.

A copy of the bill is available at thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.01908:. — Emily Ethridge