WASHINGTON _ The U.S. Patent and Trademark Office (PTO) onMay 2, 1996, will hold a hearing on medical procedure patents, anissue that has split the medical community and biotechnology drugindustry.

The Clinton administration last summer told Congress it thoughtlegislation was unnecessary. But the American Medical Associationand a number of medical specialty societies are pressing Congress toenact HR 1127, which would prohibit the PTO from granting patentsfor medical procedures. (See BioWorld Today, August 18, 1995,p.1).

The administration's position has been embraced by theBiotechnology Industry Organization (BIO), which opposes grantingimmunity to physicians from the constructs of the patent system.

BIO is currently reviewing a compromise put forward by thephysician groups. "No compromise has been reached but nothing hasbeen rejected or accepted," a BIO spokesman said.

Word that the PTO would hold hearings came as Congress wasbeginning to consider patent legislation after taking a hiatus fordebate on budget reconciliation legislation.

The Senate at a hearing this week began its reassessment of two keyfederal statutes that afford drug manufacturers certain patent termprotections.

The debate is important to the biotech industry, which traditionallyhas been supportive of strong intellectual property protections. Patentterm protection is crucial, the industry says, to attract the enormousfinancial and scientific resources necessary to develop and testdiagnostic and therapeutic products.

In addition, the issue has renewed importance because of recentinitiatives from the FDA to define well-characterized biologicssimply by a physiochemical analysis and limited pharmacokineticstesting, perhaps producing classes of generic biotech drugs.

"If the FDA regulation prevails, it could signal a shift away from theconcept that every biotech drug is unique. Equivalent biologicals maybe created," explained Bruce Mackler, a partner in the Palo Alto,Calif.-based law firm of Fenwick & West.

Senate Judiciary Committee Chairman Orrin Hatch (R-Utah) onTuesday held hearings on patent term protections under the GATT(General Agreement on Tariffs and Trade) treaty at the request ofSen. David Pryor (D-Ark.), who sponsored an amendment to theGATT implementing legislation that was narrowly defeated by theSenate last December.

The GATT implementing legislation, enacted in June 1995, extendspatent term protection from 17 to 20 years. It also permits genericcompanies to go on the market 17 years after patent if they had madea substantial investment and would pay a royalty.

Pryor wants to eliminate the GATT "loophole" that he said permitsresearch drug companies to enjoy patent extension, resulting in amulti-billion dollar windfall to these manufacturers.

The issue of patent term protection under the GATT treaty ralliedpatient advocates. The Cystic Fibrosis Foundation told the committeethat "by rewarding ingenuity and encouraging innovation, patentprotection makes possible the investment of hundreds of millions ofdollars and years of time and effort in medical research," accordingto foundation President Robert Beall. The Autism Society of Americatestified that "while we certainly support patient access to lower-costtreatments for disease and disability rehabilitation, this short-termbenefit pales if it comes at the long-term expense of finding cures tolife-threatening illnesses," according to society president SandraKownacki.

Hatch's committee next week will conduct hearings on the DrugPrice Competition and Patent Term Restoration Act, also known asthe Hatch-Waxman patent law, named after its 1984 sponsors, Hatchand then-House Commerce Health Subcommittee Chairman HenryWaxman (D-Calif.). Hatch said those hearings will assess how thechanges that have occurred in the pharmaceutical marketplace overthe past 12 years have been affected by the statute.

A similar debate on the merits of amending GATT implementinglegislation is on hold in the House. Last summer Rep. CarlosMoorhead (R-Calif.), who chairs the House Judiciary Subcommitteeon Courts and Intellectual Property, held hearings on his patent termprotection bill (HR 1733), which assures inventors a 17-yearminimum for any issued patent that was delayed through no fault ofthe patent applicant. Also considered at that hearings was a billsponsored by Rep. Dana Rohrabacher (R-Calif.), which would amendthe GATT implementing legislation by establishing a patent term of20 years from date of filing or 17 years from the date it was granted,whichever was longer. (See BioWorld Today, May 30, 1995, p. 1.)No markup sessions to reconcile the differences between he two billshave been scheduled, according to a Moorhead spokesman. n

-- Michele L. Robinson Washington Editor

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