WASHINGTON _ The GATT treaty could carve years off patentsfor biotechnology products unless it is amended to ensure thatprotection lasts at least 17 years, the Biotechnology IndustryOrganization (BIO) told a hearing of the House Small BusinessCommittee last week.

The hearing was the latest in a long-running series of debates over theimpact of GATT (the General Agreement on Tariffs and Trade) onpatent issues.

Chuck Ludlam, BIO's vice president for government relations, saidGATT could trim protection for biotech products simply because itstarts the patent clock at the moment an application is filed, not whena patent is granted.

Under the new rule, the clock runs for 20 years from the time anapplication was filed. Under the old one, it ran for 17 years from thetime a patent was granted.

Thus, if patent review takes more than three years, it could mean thatbiotech products lose patent protection years before they might haveunder the old law, Ludlam told committee members.

"It all depends on how long it takes to process a patent application atthe PTO [U.S. Patent and Trademark Office]," he said. "We havehuge number of patents that take more than three years to processthrough the PTO. They are in jeopardy under this new rule."

The rule applies to all biotech enterprises, not just for-profit ones,Ludlam said. The underlying reason for the delay is the"extraordinary complexity of the applications" and the volume ofapplications the PTO must review each year _ factors which alsodrive up the cost of patent review.

The industry organization backs a remedy for the GATT situation:Amended implementation rules that would ensure a "diligent" patentapplicant would not lose patent protection for delays in theprocessing of an application when these delays are beyond theapplicant's control. Applicants that intentionally delay the processcould not obtain this relief.

Two bills, one submitted by Rep. Carlos Moorhead (R-Calif.) andanother by Sen. Orrin Hatch (R-Utah.), seek to amend the rule in thisway. Both bills are pending. n

-- Steve Sternberg Special To BioWorld Today

(c) 1997 American Health Consultants. All rights reserved.