WASHINGTON _ The Biotechnology IndustryOrganization (BIO) is attempting to reach a compromisewith the American Medical Association (AMA) andseveral key physician specialty organizations onlegislation that would ban patents on medical proceduresand, possibly, gene therapy.

The AMA is lobbying hard for HR 1127, introduced byReps. Greg Ganske (R-Iowa) and Ron Wyden (D-Ore.)that would ban the U.S. Patent and Trademark Office(PTO) from issuing any patents for a medical procedureor technique.

BIO has countered that the bill sets a "dangerousprecedent for other bills which might be offered toweaken our patent system," according to a BIO positionpaper. BIO also has told Congress that the bill wouldeffectively ban gene therapy patents.

The Clinton administration has not developed a formalposition on HR 1127.

The Ganske-Wyden bill already has 100 co-sponsors,including the chairman of the House JudiciaryCommittee, Rep. Henry Hyde (R-Ill.), who has finaljurisdiction over the bill, the chairmen of the House Ways& Means and Commerce Committees and both panel'shealth subcommittees. Rep. Carlos Moorhead, who chairsthe Judiciary Subcommittee on Courts and IntellectualProperty, has agreed to hold hearings on HR 1127 on Oct.18, 1995.

Several BIO members, led by Richard Burgoon, patentcounsel at Cephalon Inc., of West Chester, Pa., havefloated an alternative to HR 1127 they hope addresses theconcerns of organized medical groups.

Possible Senate sponsors of HR 1127 asked the physicianspecialty groups and BIO to sit down together andattempt to turn out a compromise, according to RandyFenninger, a lobbyist for the American UrologicalAssociation, which actively supports the ban on medicalprocedure patents.

Make Process Patents The Exception

BIO proposed that HR 1127 be amended by exceptingprocess patents from the ban on medical procedurepatents. This exception would address the concerns raisedby biotech and pharmaceutical manufacturers bypermitting method of use patents "for drugs andbiotechnology processes subject to FDA review,"according to the BIO compromise. Limitations onenforcement are preferable to BIO because this approachwould "neutralize strong opposition" by its members,according to the BIO compromise.

BIO is concerned that any talk about compromise wouldinflame those BIO members who are ideologicallyopposed to any restrictions on patents. Efforts atcompromise "may seem inconsistent with prior statementand actions against medical procedure patents," states theBIO proposal to amend HR 1127.

Any possible compromise reached between BIO andorganized medicine will have to breach deep divisions.Both camps are ideologically committed to theirpositions. The AMA's House of Delegates last Junepassed a resolution that questioned the ethics andeconomic effect of medical patents.

"Since the time of Hippocrates, physicians have relied onan open exchange of information without expectation offinancial reward for advancing medical sciences," saidJohn Glass, chair of the AMA's Council on Ethical andJudicial Affairs.

The AMA also is concerned that once procedures becomepatented, a physician would not be able to use theprocedure without obtaining a license. If the patent holderwere to restrict the number of licensees or charge a highprice for licensing, then the patent holder would placesignificant barriers to access to needed treatment, theAMA stated in June.

It All Started With Samuel Pallin

Much of the AMA's and other medical groups' interest inmedical procedures can be traced to a 1993 patentenforcement lawsuit brought by Samuel Pallin. He suedthe Lahey Hitchcock Clinic and another physician forallegedly infringing on his patent on performing aspecific type of ophthalmologic surgical incision. WhenPallin requested a royalty between $2,500 and $10,000per year, the Hitchcock Clinic sued and sought tooverturn Pallin's patent as unenforceable, according tothe BIO position paper.

The Pallin case is not the only patent infringement legalaction, said Fenninger. Several specialists around thecountry have sent letters to physicians requesting them topay a royalty when performing a medical procedure forwhich the specialist claims a patent. Fenninger said oneobstetrician-gynecologist in California is seeking a patenton the way he read an ultrasound to determine a fetus'ssex.

Calling the recent flash of patent infringementcontroversies a convergence of "greed and continuedcommercialization of U.S. medicine," Fenninger said thelarger number of specialty groups backing the legislationillustrates the widespread support for a ban on additionalpatents. In addition to the AMA, the legislation issupported by the American College of Surgeons,American College of Radiology, American Academy ofOrthopedic Surgeons, American College of Obstetricians& Gynecologists and American Society of Cataract andRefractive Surgery.

BIO's public posture in opposition to HR 1127 has beenso strident that it may have alienated several members ofCongress, said Nancy McCann, lobbyist for the cataractsurgeons.

BIO on July 18, 1995 circulated a letter and analysis toeach member of Congress that explained the bill's"devastating impact on the biotechnology industry."

The BIO analysis prompted bill sponsor Ganske to issue a"Dear Colleague" letter to each member of the House inwhich he disputed each of BIO's contentions, includingthat the bill would ban gene patents. n

-- Michele L. Robinson Washington Editor

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