By Lisa Seachrist

Washington Editor

WASHINGTON — With the number of working days for Congress rapidly dwindling, Sen. Orrin Hatch (R-Utah) has urged Majority Leader Trent Lott (R-Miss.) to bring patent reform legislation that has been pending for almost a year to the full Senate for a vote.

Hatch, who sponsored the legislation, sent a letter to Lott on April 22, suggesting Lott bring the bill to the floor during Lott's scheduled High Tech Week May 3 through 9. However, controversy around issues unrelated to the biotech industry have slowed the bill's floor debut to date.

"This is an important issue for the Senator," a Hatch spokesperson said. "He continues to work to bring the bill to the floor."

The Omnibus Patent Act, S. 507, reforms operations at the Patent and Trademark Office (PTO) and restores patent term lost during delays at the office. The bill passed the Senate Judiciary Committee with a single dissenting vote on May 22, 1997, and has been awaiting consideration by the full Senate since then. In October, Hatch assembled five of the past six PTO commissioners to endorse the legislation and urge its uptake before Congress adjourned for the year.

Key Issue Restoring Patent Term

The most important issue for the biotechnology industry is restoring patent term. Since the enactment of the General Agreements on Tariffs and Trade (GATT) in 1994, 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 PTO.

While the typical patent is issued 18 months from the filing date, complex and often contested biotechnology patents can take as long as a decade to be issued. The entire time the patent is being considered by PTO, the patent term is ticking away. S. 507 restores time lost at PTO to guarantee that a patent has at least a 17-year life span.

"Increasingly, the tendency is to file [for a patent] very early in the drug development process," said Jeff Trewhitt, media spokeman for the Pharmaceutical Research and Manufacturers of America (PhRMA). "The average is that half of patent term is lost to the patent office and drug approval process. This bill needs to be passed."

Currently, the bill is being delayed by concerns over prior-use rights for inventors who have haven't patented their inventions. Some members of Congress say those inventors should be protected from finding themselves infringing on a patent filed after they have developed and used their invention.

Chuck Ludlam, vice president of government relations for the Biotechnology Industry Organization (BIO), said such issues aren't concerns for the biotechnology industry. Nevertheless, the delays are eating up precious time on a congressional schedule that has less than 30 working days remaining for the year.

"As a general point, this Congress doesn't have many more business days left," Ludlam said. "There are a lot of big issues floating around like the appropriations and a potential tobacco settlement. The rush is on right now to get our issues heard."

For that reason, BIO is flying in nearly 100 biotechnology executives Thursday to meet with members of Congress and their staffs on issues concerning the biotechnology industry including patent reform, securities litigation reform, the research and development tax credit and immigration quota issues.

The plan, Ludlam said, is for the executives to explain to the members the importance of restoring the patent term in the hopes that they would come to a time agreement — a limit on debate that prevents filibuster — in order to bring S. 507 to the floor.

A similar measure in the House, H.R. 400, passed in April 1997. *