Copyright 1996 PR Newswire Association, Inc. PR Newswire March 29, 1996, Friday "PALLIN PATENT CLAIMS INVALIDATED; PHYSICIANS FREE TO PERFORM SUTURELESS CATARACT SURGERY WITHOUT THREAT OF INFRINGEMENT LITIGATION" The American Society of Cataract and Refractive Surgery and the Lahey Hitchcock Clinic jointly issued the following: In a dramatic turn of events, a federal district judge entered a consent order today invalidating all claims at issue in Dr. Samuel Pallin's patent infringement action against fellow ophthalmologist, Jack A. Singer, M.D., and the Hitchcock Clinic of Dartmouth-Hitchcock Medical Center. Dr. Pallin's patent (No. 5,080,111) covers the shape and location of a sutureless incision that is widely used in cataract surgery. Dr. Pallin alleged that Dr. Singer infringed his patent by using, teaching, and writing about the incision. The order, which ends Dr. Pallin's claim of ownership of the procedure, was entered by Judge William K. Sessions, III, after a two-day hearing in the U.S. District Court in Burlington, Vermont. Dr. Pallin filed his much publicized action against Dr. Singer and the Clinic in 1993. The case, which is thought to be the first time one physician has sued another for violating a patent on a medical or surgical procedure has sparked enormous controversy within the health care community. It also has led to the introduction of federal legislation to ban or limit the enforcement of such patents. The American Society of Cataract and Refractive Surgery (ASCRS) and the American Academy of Ophthalmology assisted in the funding of Dr. Singer's defense. "This is a tremendously satisfying victory for Dr. Singer and the Clinic," said Dr. Stephen Plume, President of Lahey Hitchcock Clinic, the successor organization of the Hitchcock Clinic following its recent merger with the Lahey Clinic. "The court's order leaves no doubt that Dr. Pallin's patent claims were invalid and that there was never any basis for this suit," Plume said. "We are delighted with the outcome," said ASCRS President Charles D. Kelman M.D. "It is well known within the medical community that Dr. Pallin was not the first person to perform this kind of surgery. He never should have received a patent, and he never should have been allowed to enforce it against other physicians. This was the right legal result and the right result for society." If Dr. Pallin's suit had been successful, he could have sought royalties from some 2,000 other physicians who have reported using an incision similar to his patented procedure. At one time, Dr. Pallin had demanded that Dr. Singer pay a royalty between $2,500 to $10,000 per year. Any physician who used the procedure would have been a potential target for an infringement action if they refused to pay a licensing fee. Dr. Singer, who practices in Randolph, Vermont, expressed joy and relief with the court's order. "We have been totally vindicated," he said. "Physicians need to be able to practice medicine without the fear of a patent infringement suit hanging over their heads. It is my hope that our victory will deter others from bringing such actions. Our focus should be on developing new medical procedures for the benefit of our patients and society, not on personal financial gain," according to Singer. Judge Session's order includes the following provisions: 1. All patent claims at issue in the case are declared invalid. 2. Dr. Pallin is forbidden from enforcing any claim of the patent against the parties; against any other physician, health care provider, hospital, clinic or teaching institution; and against any other person or entity of any kind. 3. A finding that neither the Hitchcock Clinic nor Dr. Singer ever infringed the patent. ASCRS and the American Academy of Ophthalmology became involved in the litigation after defendants' first motion for summary judgment was denied. In addition to providing financial support to Lahey Hitchcock and Dr. Singer, they brought in the Washington office of Jenner & Block as lead counsel. Defendants' total litigation costs were nearly $500,000. The hearing on March 26 and 27 was held to determine the scope and validity of Dr. Pallin's patent claims. The hearing was originally scheduled for three days, but Judge Sessions issued his order after only two days of testimony and without hearing oral argument on the summary judgment motion. Such hearings are authorized by a recent federal court of appeals decision in Markman v. Westview Instruments' which is currently pending before the Supreme Court. Judge Sessions also permitted Singer and Hitchcock to file a new motion for summary judgment, which argued that the patent claims at issue in the case were invalid because the procedure claimed had been performed by other physicians, including Dr. Singer, before April 17, 1990, the date Dr. Pallin claims to have invented his patented "Chevron" incision. Ophthalmologists Dr. I. Howard Fine and Dr. Paul Ernest testified on behalf of the defense, as did Dr. Singer himself. Their testimony, and other evidence demonstrated that several other surgeons, including Dr. Singer, Dr. James Gills, Dr. Paul Ernest, and Dr. Michael McFarland, performed self-sealing surgery before Dr. Pallin claims to have invented the procedure he patented. The evidence included a photograph of the eye of one of Dr. Gills' patients who was operated on in March, 1990, a month before Dr. Pallin claims to have invented his procedure. The picture, taken recently with a photo silt lamp microscope shows that the incision used was exactly the same as the one disclosed in the patent. Dr. Pallin was cross examined for nearly a full day. His testimony confirmed that other surgeons performed the procedure before the date he claims to have invented it. Several other medical procedure patents have been issued in recent years, threatening the availability, quality, and affordability of health care in the United States, leading to considerable concern by medical associations and health care professionals generally. The American Medical Association has declared it unethical for physicians to obtain or enforce such patents. Two bills have been introduced in Congress, H.R. 1127, sponsored by Rep. Greg Ganske (R-Iowa) and former Rep. Ron Wyden (D-Ore.) and more than 120 other members of Congress, follows the lead of 80 other nations that ban the issuance of medical procedure patents, S. 1334, introduced by Sen. William Frist (R-Tenn), would prevent the enforcement of such patents against patients, physicians and their affiliated health care institutions, and other health care providers. ASCRS leads a coalition of 15 medical specialty societies that is actively supporting this legislative effort. The coalition includes the American Medical Association and the American College of Surgeons. "Legislation is clearly needed to protect other physicians from becoming the victims of baseless infringement suits," said David Karcher, Executive Director of ASCRS. "Health care providers should not have to spend half a million dollars for the right to use a new surgical procedure that has nothing to do with a drug or medical device." The consent order entered in the Pallin case is expected to bolster the medical community's effort to promote legislation to prevent the enforcement of patents for medical and surgical procedures against physicians and affiliated health care institutions. CONTACT: Nancey McCann, or Shelly Hedrick of the American Society of Cataract and Refractive Surgery, 703- 591-2220