WASHINGTON _ Biotechnology firms, fearful that the GeneralAgreement on Tariffs and Trade (GATT) would chisel years frompatent protection, on Thursday praised a congressional decision thatmay spell relief.
The GATT implementing legislation, passed in December 1994,starts the patent clock ticking on the date a patent application is filed,rather than on the date it is approved. In essence, this means delays inapproval by the U.S. Patent and Trademark Office (PTO) couldwhittle away corresponding years of patent protection.
Responding to these concerns, the House Judiciary Committee'ssubcommittee on Courts and Intellectual Property on Wednesdayagreed to amend the law.
The amendments would extend the patent term to compensate fortime lost due to legal and administrative challenges filed during theapproval process.
The decision marks a hard-won victory by the BiotechnologyIndustry Organization (BIO), which has campaigned for two years topersuade the House subcommittee to consider amending the law. Theamendments were introduced by the subcommittee chairman, Rep.Carlos Moorhead (R-Calif.), and Rep. Patricia Schroeder (D-Colo.),both of whom sponsored the original bill to amend the GATTimplementing legislation.
Chuck Ludlam, BIO's vice president for government relations, said,"the strengthened Moorhead-Schroeder bill addresses our concerns.It is a rational, reasonable approach that protects the diligent patentapplicant and improves the patent system for the 21st Century."
GATT implementing legislation is designed to harmonize U.S. patentlaw with the terms of the GATT agreement, which extends patentprotection for a minimum of 20 years from the date an application isfiled. In contrast, the U.S. implementing legislation _ as originallyadopted _ established patents lasting a maximum of 20 years fromthat date.
"If we can't amend that law we're stuck with the term that wasoriginally adopted, which is harmful to biotech," Ludlam said.
Still, the fate of the Moorhead-Schroeder bill is anything but certain,at least during this congressional session.
Congress will adjourn in early October. With holidays and recesses,that leaves about three months on the legislative calendar forCongress to adopt the Moorhead-Schroeder bill and the BIO-sponsored amendments to it. As matters stand, President Clinton isexpected to sign the bill, Ludlam said.
"We want to pass the amendments now, because we believe they willreassure our capital markets that the GATT patent terms will notadversely affect our member companies," he said. "GATT's patentterm directly affects capital formation and that is why this is such ahigh-priority issue for us.
"Patent term is money. That's the bottom line."
For the most part, biotech representatives expressed satisfaction withthe congressional decision.
"From my viewpoint, it's a very good thing," says Michele Cimbala,a biotech attorney with Sterne, Kessler, Goldstein & Fox, inWashington.
"Biotechnology applications tend to take longer than others becausethis is a relatively new area of patent law," Cimbala said. "They arethe cases in which the patent term would be most severelycompromised by a long interference or appeal. The Moorhead-Schroeder bill would allow applicants to recover significantly moretime than the current statute would."
"We welcome these changes," said Janet Hasek, manager of patentprosecutions and trademarks for Genentech Inc., of South SanFrancisco. "They give us back patent-term protection that we wouldotherwise lose due to GATT."
Robert Blackburn, vice president and chief patent counsel for ChironCorp., of Emeryville, Calif., also lauded the committee's action, buthe noted that some major questions remain to be resolved.
"We're encouraged that the committee has backed off from someDraconian limits on patent-term protections," said Blackburn, whowrote legislative language incorporated into the amendments.
But Blackburn added the committee let stand language from theoriginal bill that could still make it difficult for companies to obtainpatent extensions under some circumstances.
"Another critical aspect of the industry's ability to support this billwill be a clarification [stating] that an applicant qualifies for anextension if any adverse PTO decision is reversed on appeal _ evenif some of the PTO objections are sustained," he said.
Ludlam said these and other details remain to be resolved, and thatBIO already has begun to address them with various legislators. n
-- Steve Sternberg Special To BioWorld Today
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