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Cataract Surgery Lawsuit Sparks Fight Over Medical Patents

March 25, 1995

WASHINGTON (AP) _ Dr. Samuel Pallin wants fellow doctors to acknowledge him as an inventor of no-stitch cataract surgery _ by paying royalties every time they make his patented frown-shaped cut on a patient’s eyeball.

He has sparked an uproar by U.S. doctors who say patenting the way they practice medicine is unethical and drives up health care costs. They’ve persuaded Congress to consider outlawing the practice.

``The ramifications of this ... boggle the mind,″ said Dr. David Karcher, chief of the American Society of Cataract and Refractive Surgery.

At issue is patenting the actual steps a doctor takes to diagnose or treat a patient.

A California doctor, for example, got a patent on determining the sex of a fetus by scrutinizing the proper spot on an ultrasound for ``external genitalia.″ He has demanded royalties from hundreds of obstetricians, who argue that’s equivalent to patenting how to tell the right hand from the left on an X-ray.

About 500 urologists have been charged licensing fees for treating impotence with penile drug injections, an idea critics say has been around for decades.

Pallin is suing some Vermont eye surgeons for patent infringement, and, if he wins, plans to charge ophthamologists about $5 for every no-stitch slice made on the million Americans who seek cataract surgery each year.

Pallin argues his cut actually saves money, because a single suture costs $17. And he says these techniques are true inventions no less deserving of the 17 years of royalties a patent confers than a new drug is.

``I was the lucky one to come up with the right answer,″ said Pallin, a Sun City, Ariz., ophthamologist. ``If it turns out I do profit from it, I won’t complain or apologize.″

But Pallin’s lawsuit, the first over these ``methods patents,″ sparked a fight by the American Medical Association and a cadre of doctors’ groups. They contend physicians independently uncover surgical or diagnostic improvements and have an ethical obligation to share them quickly, while patents delay that information sharing and pass royalty costs to patients.

``There are very few revolutionary techniques, most are evolutionary,″ said Dr. Jack Singer of the Dartmouth-Hitchcock Medical Center, the subject of Pallin’s suit. ``Patenting medical methods goes against the way medicine is taught and passed down in the entire world.″

Prompted by the doctors’ arguments, lawmakers later this year will consider outlawing methods patents. ``We think we’ve got a chance to stop this economic Balkanization of medical research,″ said Rep. Ron Wyden, D-Ore., who introduced the legislation with Rep. Greg Ganske, R-Iowa, a plastic surgeon.

More than 20 countries forbid methods patents. U.S. law says any invention that is novel, has utility and is not obvious can be patented. In 1954, it began allowing medical methods patents.

But only recently have doctors sought and begun enforcing such patents. Traditionally, they get credit for new techniques when their research is published in international medical journals. Colleagues offer improvements, and surgeons adopt and adapt the procedures based on the public dialogue.

In April 1990, Pallin made a tiny cut on a patient’s eyeball that allowed him to slide out a cataract before eye fluid sealed the cut without stitches. But the nation’s leading eye journal called it old news. Indeed, a March 1990 medical newspaper reported that an Arkansas surgeon had successfully performed no-stitch cataract removal that January, and Singer says he has surgical notes showing he too was working on a variation.

A stung Pallin argued his cut was better, sought a patent _ and won. Now he’s suing Singer, who popularized the frown cut, for patent infringement.

No trial date has been set, and experts don’t know whether the courts will settle the issue before Congress, where the mood has been to expand patent rights.

Patents have always helped businesses foster investments in new technology that otherwise might be too risky to fund _ and medicine is no exception, said Atlanta patent attorney Bill Needle. ``If you start to erode that which can be patentable, where do you stop?″ he asked.

Medicine is unique, argues Chicago patent attorney Ronald Wanke, who represents the physicians’ groups. Doctors constantly search for better methods to improve patients’ outcome, evolutions that have never needed a patent’s financial incentive, he contends.

``I’m not 100 percent sure what’s best for medicine,″ acknowledged Pallin. But, ``I defy you to to explain to me what logical reason there is to draw a line between patenting a medical device and a method.″

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