WASHINGTON _ A U.S. district court has issued a consent orderdismissing with prejudice a lawsuit brought by one ophthalmologistagainst another, claiming patent infringement. While the court ordermay have resolved a narrow issue of patent law, it apparently is notcooling the controversy between biotech manufacturers who opposeany restrictions on the patenting of new discoveries and the physiciancommunity which is backing a legislative ban on medical procedurepatents.

U.S. District Court Judge William Sessions III on March 28, 1996,entered a consent order invalidating the claims brought by SamuelPallin, medical director of the Lear Eye Clinic, of Scottsdale, Ariz.,who claimed patent infringement of a surgical procedure by JackSinger, another ophthalmologist, affiliated with the Lahey-HitchcockMedical Center, of Hanover, N.H. Pallin claimed in his lawsuit filedin 1993 that Singer infringed on his patent by using, teaching andwriting about the surgical incision.

Singer said after the court order was entered that his lawyers' fees,which were offset by several national physician organizations,exceeded $500,000.

Pallin, who had demanded Singer pay a royalty of between $2,500 to$10,00 per year, claimed victory after the court order was handeddown, issuing a press release stating his patent had "withstood a stifflegal challenge" and that 25 of his 29 patent claims "remain ineffect."

Dismissal of the Pallin-Singer lawsuit has energized the debate aboutwhether Congress should ban patents on medical procedures. Rep.Fred Ganske (R-Iowa) after the court order was handed down issueda letter to other House members, telling them the court decisionsupports the need for a Congressional ban on medical procedurepatents. Ganske has introduced legislation to ban this type of patents.

The biotech industry has a different take on the decision, claiming itreaffirms the right to patent any medical breakthrough. "The judge'sorder reaffirms the fact that an inventor should be able to apply forand receive patent protection for a new discovery," said RickBurgoon, general counsel for West Chester, Pa.-based Cephalon Inc."Patent holders have the right to sue for patent infringement."

Burgoon said Ganske's letter is not furthering efforts byrepresentatives of the biotech industry and the physician communityto reach a compromise on the scope of the proposed ban on medicalprocedure patents. "Those negotiations are still up in the air. Nosubstantive agreement has been reached," said Burgoon. He addedthat Sen. Bill Frist (R-Tenn.) has pledged his intention not tointroduce compromise legislation on the medical procedure patentissue until a compromise had been reached between the partiesinvolved. "Frist pledged his determination to protect the patent rightsof the biotech drug industry," Burgoon said.

Nancey McCann, director of government relations at the AmericanSociety of Cataract & Refractive Surgery, in Arlington, Va.,reiterated the intention of the ophthalmologists and other medicalgroups to reach a compromise with the biotech drug industry. "Wewant to resolve our differences and move on," she said. The societyleads a coalition of 15 medical specialty societies actively supportinga legislative ban on medical procedure patents. The coalition includesthe American Medical Association and American College ofSurgeons.

The controversy of medical procedure patents will be examined at ahearing early next month by the U.S. Patent and Trademark Office(PTO). Officials from that office have told Congress they oppose abill (HR 1127) sponsored by Ganske and former Rep. Ron Wyden(D-Ore.) that would ban patents on medical procedures.

At a hearing held by the House Judiciary Courts and IntellectualProperty Subcommittee (see BioWorld Today, Oct. 20, 1995, p. 1),Lee Skillington, director of the PTO's office of legislative andinternational affairs, told the subcommittee that any problems withthe patent system should be handled administratively not through newlegislation. n

-- Michele L. Robinson Washington Editor

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