“That’s an Invention?”
All these patents confront medical specialists with a profusion of private claims on methods, observations, and other knowledge that in the past doctors freely used and shared. Specialists from urologists to eye surgeons have received patent infringement threats.
In one of the best-known cases, several years ago radiologists around the country received letters attempting to exact royalties on a patent covering a technique for determining the sex of a fetus at 12 to 14 weeks with ultrasound. The patent-still valid-boils down to visually distinguishing fetal male genitalia from female. Many in the field derided the claim. As Chris Merritt, a radiologist at the Ochsner Clinic in New Orleans, puts it: “It’s like saying you have a secret method for distinguishing the gender of patients when they take their clothes off for a physical. That’s an invention?”
This claim, however, never reached the stage of litigation. The American College of Radiology publicly condemned the claim. Later the patent holder, obstetrics and gynecology specialist John D. Stephens of San Jose, California, withdrew his royalty demands.
The inherent complexities of the biomedical knowledge economy are probably not going to be resolved by the patent examiners alone. Patent examiners are seldom medical practitioners, and they typically base their decisions on searches of published work aimed at finding whether anyone has previously reported a procedure or treatment. But published works are often a poor reflection of the unfolding state of medical knowledge; as a result, the examiners grant patents for many procedures that are not novel or even noteworthy. Many ownership claims cover skills most hospitals expect doctors to learn during their medical residencies, skills one generation of doctors has traditionally passed to the next.
For instance, almost all surgical residents are taught how to suture the stomach to the intestines (to treat bleeding ulcers or stomach cancer); a physician owns a patent on a technique for this procedure. Similarly, cosmetic surgeons around the world know how to make slits in a skin graft to expand it; another physician holds a patent covering a technique for this procedure. Still another doctor owns the simple procedure of treating iron deficiency by administering iron under the tongue.
Given the thousands of procedures doctors perform every day, “the proliferation of patents on medical and surgical procedures becomes a frightening prospect,” says Robert Portman, a patent lawyer at the Washington, D.C. firm Jenner & Block. It could “wreak havoc on the delivery of medical services.”
Portman litigated one of the most publicized of the recent medical patent cases. The case generated widespread attention to the issue when it came to trial in 1995-and it helped inspire congressional legislation in 1996. In 1992 Arizona eye surgeon Samuel Pallin received a patent on a type of incision, used in cataract operations, that required no stitches to heal. Once Pallin received the patent, he demanded royalties from fellow eye surgeon Jack Singer, who also used the procedure and had written about it in medical journals. Pallin threatened to force Singer to stop using the technique unless Singer paid.
To Pallin, the patent reflected his rightful intellectual property. “We don’t think of it as greedy when a scientist gets a royalty for coming up with a new [drug] compound. It is ridiculous to say that this is any different,” he retorted to the Wall Street Journal after medical professional societies criticized him for his private ownership claim.
But to Singer, the patent was an affront. An eye surgeon at the Hitchcock Leahy Clinic at Dartmouth Medical College in New Hampshire, Singer had already perfected the procedure in his own practice. He did not patent it. In fact, he taught it to his students and shared it at symposia with other doctors from around the world. Singer maintains that he and many other eye surgeons had developed this type of stitchless incision simultaneously.