Copyright 1996 PR Newswire Association, Inc. October 1, 1996, Tuesday "President Signs Medical Patent Bill; Physicians Freed from Threat of New Medical Procedure Patent Lawsuits" The American Society of Cataract and Refractive Surgery (ASCRS) announced today that the spending bill passed by the U.S. Senate last night and signed into law by President Clinton provides relief for health care practitioners from the threat of legal action for performing patented medical procedures. The law includes a provision prohibiting enforcement against physicians of all medical procedure patents issued after the effective date of the legislation. Medical procedure patents confer ownership over medical procedures such as surgical incisions or other treatments not associated with a novel drug or device. An ASCRS-led coalition of medical societies fought for passage of the enforcement ban, which was championed in Congress by Rep. Greg Ganske (R-IA) and Sens. Bill Frist (R- TN) and Judd Gregg (R-NH). Ganske and Frist are both physicians who understand firsthand the importance of sharing medical information freely and openly. The Medical Procedure Patents Coalition was chaired by ASCRS and included the American Medical Association, the American College of Surgeons, and 13 other medical specialty societies opposed to medical procedure patents. Dr. Charles D. Kelman, President of ASCRS, hailed the enactment of the enforcement ban as a victory for patients. "This legislation will help ensure that new medical discoveries will be freely shared within the medical profession and widely available to our patients." The enforcement ban effectively resolves a growing problem in American medicine. An estimated 100 new medical procedure patents are now granted every month by the U.S. Patent and Trademark Office. In several cases patent holders have attempted to collect royalties from physicians who use these medical treatments. In one highly publicized case, Dr. Samuel Pallin sued Dr. Jack Singer and the Dartmouth-Hitchcock Clinic for using and teaching Pallin's patent incision for cataract surgery. ASCRS assisted Singer and the Clinic in defending this suit and in showing that other physicians had performed Pallin's procedure before his claimed invention date. The defendants obtained a consent order earlier this year invalidating the claims at issue in the case and preventing further enforcement of the Pallin patent. But this victory came at a high price: Dr. Singer and the Clinic incurred over a half million dollars in legal fees and costs, and Dr. Singer was forced to spend three years tied up in exhaustive litigation rather than treating patients, performing research, and writing articles. The new law would likely have prevented the enforcement of the Pallin patent, as well as other questionable patents that have been issued in recent years, including a patent for determining the gender of a fetus by reading an ultrasound and patented treatments for male impotence. Since medical breakthroughs traditionally result from a long series of incremental advances, rather than expensive clinical trials, it is unreasonable to claim "ownership" of a procedure and prevent the free use of such methods. Medical procedure patents not only violate the Hippocratic obligation that physicians be teachers and freely share their medical knowledge, they also pose a threat to patients since patent holders can restrict the licensure of medical procedures that would otherwise be widely available. Medical procedure patents can also deter physicians from using state-of-the-art procedures for fear of being sued for patent infringement. By banning enforcement of medical procedure patents against medical practitioners and related health care entities, the U.S. will join the more than 80 countries around the world that have outlawed the practice. Coalition members are listed below. American Society of Cataract and Refractive Surgery (chair) American Academy of Dermatology American Academy of Ophthalmology American Academy of Orthopaedic Surgeons American Academy of Otolaryngology - Head and Neck Surgery American Association of Neurological Surgery American College of Radiology American College of Surgeons American Institute of Ultrasound in Medicine American Medical Association American Society of Dermatologic Surgery American Society of Plastic and Reconstructive Surgery American Urological Association Association of American Medical Colleges Society of Cardiovascular and Interventional Surgery Society of Vascular Technology SOURCE American Society of Cataract and Refractive Surgery CONTACT: Nancey McCann or Michele Hedrick of American Society of Cataract and Refractive Surgery, 703-591-2220