By Lisa Seachrist

Washington Editor

WASHINGTON - The House of Representatives overwhelmingly passed H.R. 1907, which would restore patent term lost as a result of the passage of the General Agreements on Tariffs and Trade (GATT) in 1994.

The House suspended its Rules, which then prohibited any amendments, and voted 376 to 43 to pass the bill that restores, on a day-for-day basis, patent term lost due to delays at the U.S. Patent and Trademark Office (PTO). In addition, the legislation provides for re-examination to reduce costly patent litigation, and calls for some publication of patents once an inventor files for the patent.

The Senate must now introduce similar legislation if patent reform is to become law.

"The House has sent a very clear message to the Senate," said Chuck Ludlam, vice president of government relations at the Biotechnology Industry Organization (BIO). "We had 206 Republicans and 170 Democrats vote for this bill. This is as good as it gets in a House that isn't known for its bipartisanship."

Patent reform has been an issue for the biotechnology industry since GATT was passed in 1994. Efforts to pass patent reform in the 105th Congress were met with great divisiveness. So much so that in the waning days of that Congress, Senate Majority Leader Trent Lott (R-Miss.) refused to bring the issue to the Senate floor for a vote without a time agreement that would have prevented filibuster. (See BioWorld Today, May 11, 1998, p. 1.)

Sen. Orrin Hatch (R-Utah), chairman of the Senate Judiciary Committee, championed the patent reform effort in the Senate in the 105th Congress. While his spokeswoman said the senator remains committed to the issue, he has been reported to be waiting for the House to act before introducing legislation.

"We needed tremendous momentum in the House to launch it in the Senate," Ludlam said. "In 1997 this was a fairly divisive issue. This year they are sending a very different message."

The problem with the current patent system for the biotechnology industry is that since the enactment of GATT, U.S. patents no longer provide 17 years of exclusivity from the time of issuance. Companies and inventors now have 20 years exclusivity from the date they file their patent at the PTO.

While the typical patent comes through in 18 months, complex and highly contested biotechnology patents can languish for years - as long as a decade. The entire time the patent is being considered by the PTO, the patent term is ticking away.

"The patents at greatest jeopardy are the most valuable because they're the most likely to be contested," Ludlam said. "Some of those patents would end up with only five to 10 years of patent term left. This bill is incredibly important for breakthrough patents."

Ludlam noted that with biotech's need for capital formation as a lifeline to survival, a company's patent estate is sometimes the only true value it has. Protecting that estate is paramount. H.R.1907 provides for a day-for-day restoration of patent term for time lost at the PTO that isn't the fault of the patent applicant.

"We really wanted this exact wording because we are hoping to get restoration of patent term for delays at FDA, too," Ludlam said.

Ludlam credited Rep. Howard Coble (R-N.C.), chair of the Judiciary Committee, with masterfully negotiating and navigating the bill through the House. Ludlam also had high praise for Rep. Dana Rohrabacher (R-Calif.), a one-time opponent to patent reform, who favored a return to the 17-year patent system. Ludlam said Rohrabacher really focused on the restoration of patent term and that his pressure gave BIO the leverage to lobby for the day-for-day extension of patent term.