Lawsuits over laser patents raise serious issues for physicians, patients.

Apatent-infringement lawsuit filed against several Canadian physicians who perform refractive eye surgery continues to send shivers through the ranks of Canada’s ophthalmologists. Other physicians should be worried too, because this is an emerging trend. The 1995 suit by an American company, Visx, alleges that the physicians and 3 equipment manufacturers have infringed its Canadian patents for eye-laser technology, which date to 1988. Before the suit was filed, Visx asked for licence fees from physicians using the excimer-laser system. However, in its initial statement of claim the company demanded that the physicians stop using the technology and pay damages for unlicensed use. The physicians responded that they cannot be held accountable for patent infringement because they had purchased the laser technology from other manufacturers “freely thinking it could be used in good faith.” The lawsuit comes in the wake of growing popularity of laser surgery across the country. For example, at special clinics in Alberta and Saskatchewan approximately 4000 patients are treated annually. The surgery, known as photorefractive keratectomy, reshapes the cornea to reduce or eliminate myopia and end the need for eyeglasses or contact lenses. Canadian physicians were performing the procedure for 5 years before the US Food and Drug Administration gave its nod of approval in October 1995. The procedure, which is not covered by medicare, costs about $2200 per eye. Because the matter is currently before the court, it is not possible to discuss either the merits or the likely outcome of Visx’s case against Canadian physicians. However, there are issues surrounding the use of patented technologies that are of interest to physicians, as well as policy concerns that suggest legislative changes may be needed to clarify the law. The current court action draws attention to 2 contentious areas of patent law: • the general issue of granting patents for developments in medical technology; and • the availability of certain kinds of legal remedies when a patent has been infringed. Although it is generally understood that medical procedures and treatments cannot be patented in Canada, Canadian law remains unsettled. Methods for carrying out medical or surgical treatments are not specifically addressed in the definition of an inventive process that can be patented. Only through case law has it been determined that if the process is a “medical” treatment it cannot be patented. However, the technology or instruments used to provide a treatment can be patented. In the US, it is possible to patent both procedures and treatments and to require payment of royalties to the patent holder for alterations to procedures made during the evolution of medical knowledge. These patents grant a 20year monopoly over the use and teaching of medical and surgical procedures, techniques and processes, including methods of diagnosis, therapy and treatment. This has led to a proliferation of medical-procedures patents in the US, a trend that some observers think will undermine the long-standing tradition of open and critical exchange of scientific information. The patent issue has raised concerns in the US as well as Canada. A patent-infringement lawsuit in the US, which contributed to the controversy there and to physicians’ growing concern, may shed some light on the situation facing Canadian doctors because of the Visx lawsuit. The US case, which involved 2 New England ophthalmologists, was filed by Dr. Samuel Pallin against a colleague, Dr. Education