WASHINGTON _ The House on Monday passed byvoice vote legislation already approved by the Senate thatwould make it easier for biotechnology firms to winprocess patents by modifying the test for obtaining them.

The slim bill, HR 587, is only a handful of pages long butit has been a long-sought objective for biotech industrylobbyists. Similar legislation passed the Senate threetimes and the House once.

David Beier, vice president of government affairs forSouth San Francisco-based Genentech Inc., lobbied forthe bill for six years. "The legislation is the result of ahigh degree of cooperation between the industry, U.S.Patent and Trademark Office [PTO] and Congress," hetold BioWorld Today.

"The bill underscores the importance of strongintellectual property protection and a clear, coherentunderstanding of the rules for patent protection. Inaddition, the bill recognizes that the biotech industry hasunique intellectual property needs," Beier said.

"The bill plugs a potential loophole. By getting a processpatent on the manufacturing process, biotech companieswill be able to enforce at the border a product that wasmade overseas using a U.S.-patented process," said LisaRaines, vice president of government relations forGenzyme Corp., located in Cambridge, Mass.

"We eliminated this loophole before there was a seriousthreat to biotech business," she told BioWorld Today.

The Biotechnology Industry Organization (BIO) calledthe bill an "effective means of protecting technologypatented in the U.S. from unfair foreign competition," ina statement issued early this year. The bill enables abiotech firm to petition the U.S. International TradeCommission to issue an exclusion order to prevent entryof the foreign product.

When HR 587 was reported out of the House JudiciaryCommittee last June, bill sponsor Rep. Carlos Moorhead(R-Calif.) said the legislation was necessary to end theadministrative limbo in which PTO had found itself afterthe courts handed down two conflicting decisions aboutprocess patients. (See BioWorld Today, June 8, 1995, p.1.)

The legislation is supported by the Clinton administrationand is expected to be signed into law soon.

Medical Procedure, Gene Therapy Patents Banned?

Far more controversial is legislation that would banpatents on medical procedures and perhaps gene therapy,according to BIO, whose members are split on the issue.The organization's spokesman said BIO would notcomment for the record any further.

The House Judiciary Courts and Intellectual PropertySubcommittee today will hear from representatives of theAmerican Medical Association and biotech companies tosee if they have been able to craft a compromise on HR1127, introduced by Reps. Greg Ganske (R-Iowa) andRon Wyden (D-Ore.) that would ban the PTO fromissuing any patents for a medical procedure or technique.

The AMA is allied with a number of powerful physiciangroups to enact HR 1127 which it sees as necessary toblock physicians who would seek patents on medicalinnovations that could restrict the unfettered diffusion ofa new technology or therapy into medical practice.

However, BIO said that any restrictions on the patentingof medical therapies is unacceptable.

BIO announced its opposition to the bill butrepresentatives from individual companies are workingbehind the scenes to see if a compromise is possible.Richard Burgoon, patent counsel at Cephalon Inc., ofWest Chester Pa., in the past few weeks has floatedalternatives to HR 1127 that may meet the concerns oforganized medical groups.

Sen. Bill Frist (R-Tenn.) is expected to offer acompromise version of the Ganske-Wyden bill aimed atobtaining the support of BIO and the physician groups,according to Randy Fenninger, a lobbyist for the AmericaUrological Association, which actively supports the banon medical procedures.

But a Frist aide, Kathy Fine, describes BIO andphysicians' groups as "at an impasse" and doubted if theywould rally immediately behind a Frist compromise.

Fenninger said that Ganske and Wyden have indicatedthey would throw their support behind the Frist bill.Today's hearing will reveal whether BIO and thephysician organization can do the same.

Patent term legislation also is a controversy inside thebiotech industry. At issue are two bills sponsored byReps. Moorhead and Dana Rohrbacher (D-Calif.) thatdefine patent term protection differently.

While Rohrbacher has accumulated a larger number ofco-sponsors, his aides said, Moorhead's bill also hassupport on the committee. How support coalesces aroundthe two bills will be seen on Nov. 1, 1995, when TheHouse Judiciary Courts and Intellectual PropertySubcommittee has a hearing on the legislation. n

-- Michele L. Robinson Washington Editor

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