Biotechnology advocates said Friday industry concerns overprotection of intellectual property rights have been eased with arewrite of a controversial legislative proposal banning patents onmedical procedures.
The ban was included in an amendment to a House spending bill forthe Commerce, Justice and State departments and the legislation wassent to the Senate before the August recess.
Although the measure was designed to prevent patents on medicalactivities, such as cataract surgery, the Biotechnology IndustryOrganization (BIO) warned the amendment was worded so vaguely itcould be applied to inventions such as biological drugs anddiagnostics as well as gene therapy.
The patent ban was supported by the American Medical Association(AMA), which argued assigning intellectual property rights toprocedures, such as surgery, could limit their availability.
Rep. Greg Ganske (R-Iowa), a member of the commerce committee,attached the amendment to the House appropriations bill. In theSenate _ which last week had not yet approved its version of thespending bill _ the patent ban is sponsored by Sen. Bill Frist (R-Tenn.).
Although Ganske said his amendment did not affect patentable drugs,machinery, devices, diagnostics and biological products, he and Fristasked BIO and AMA members to work together over the Augustrecess to recommend a method of ensuring that legitimate inventionswere not inadvertently threatened.
As a result, the amendment and legislative record were rewritten toexempt biotechnology patents, said BIO's president, Carl Feldbaum.
In particular, the measure was changed so it would not baninfringement for "the use of a patented machine, manufacture, orcomposition of matter in violation of such patent; the practice of apatented use of a composition of matter in violation of such patent; orthe practice of a process in violation of a biotechnology patent."
Although BIO's concerns were satisfied, the industry group will notsupport the amendment. Feldbaum said he told the bill's backers BIOalso would not oppose the measure.
By tacking the amendment onto the appropriations bill it wouldprevent the U.S. Patent and Trademark Office from spending funds toissue patents for surgical and medical procedures during the nextyear.
The medical activities patent ban was spurred by a court fightinvolving a doctor who sued another physician for infringing a patenton a cataract surgical procedure. The federal courts ultimatelyrejected the plaintiff's patent claims.
BIO and pharmaceutical industry representatives said the originalGanske amendment was so broad it would have created confusion inits application and would have resulted in more litigation.
Little Chance For FDA Reform
Other legislation closely monitored by biotechnology advocates isFDA reform, which has little chance of passage in the 104thCongress.
The House and Senate have decided to adjourn for the Novemberelections Sept. 27, 1996, instead of Oct. 4, 1996, as originallyscheduled. If there's no action on FDA reform in the next threeweeks, the proposals will have to wait for the 105th Congress to beseated next year.
In the Senate BIO is backing a bill by Sen. Nancy Kassebaum (R-Kan.) called the FDA Performance and Accountability Act. In theHouse, the industry group supports the Drugs and Biologics ReformAct of 1996 sponsored by Richard Burr (R-N.C.). Burr's proposal issimilar to Kassebaum's legislation.
Kassebaum has been allocated time to bring her bill to the Senatefloor. But Feldbaum said few legislators are pushing for a vote onwhat they perceive as an issue that may generate too muchcontroversy in this presidential election year.
"We are making a last ditch effort to get the bill in play," Feldbaumsaid, "by sending letters to every legislator."
Feldbaum admits it's a long shot. "If this were a basketball game withone minute left," he said, "we'd be down five points, in need of acouple of three-pointers and maybe a judicious foul call." n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.