Broader patents, lesser care: Avoiding fear of infringement

The U.S. Supreme Court should strike down a ruling on "correlation" patents that threatens to turn physicians into violators just for doing their work.

Posted April 17, 2006.

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There are enough hassles that can interfere with patient-physician relationships. Worrying about patent infringement should not be added to the list. And yet that could happen, depending on how the U.S. Supreme Court rules, likely this summer, in the case of Laboratory Corp. of America v. Metabolite Laboratories Inc.

The central issue of the lawsuit is whether a company may patent not only a specific technique or product, but also the correlation between a substance in the human body and a disease. In this case, it is the association between elevated levels of homocysteine indicates and a vitamin B12 or folic acid deficiency. In other words, a ruling by the Supreme Court saying a correlation is patentable -- as two lower courts have ruled -- means naturally occurring phenomena are patentable.

A specific process for testing is legitimately patentable. But a royalty payment shouldn't be required when "any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result," according to a friend-of-the-court brief written by the AMA, the American College of Medical Genetics, the American College of Obstetricians and Gynecologists, the Assn. for Molecular Pathology, the Assn. of American Medical Colleges and the College of American Pathologists.

This ends up interfering with the physician-patient relationship in several ways. At the moment of ordering a test, a physician would be forced to consider the following questions: Do I have to send this test to a specific lab that has the patent on the relationship I'm trying to discover? Do I have to pay a royalty merely for reading the result? Is there a way I can take care of my patient without infringing on a patent?

But outside the office, the result of expanding patents to include correlation of scientific evidence -- often, what physicians already know -- is that a chilling effect is put on scientific research, lest someone interfere with a patent. Or, research doesn't get to the physicians because laboratories and others are now dissuaded from disseminating information widely. "In short, patents on scientific principles interfere with the development of medical advances and the provision of effective patient care," according to the brief.

The concern over patents gone wild isn't just in medicine. The threat of legal exposure for violating patents that never should have been approved also has the likes of IBM and American Express weighing in with physician groups on the side of LabCorp.

Some analysts believe the Supreme Court accepted this case because of so-called "patent squatters," small firms specializing in holding questionable patents, who seek large settlements from successful companies.

Critics of the current patent mess often point to Research in Motion's agreement to pay $612.5 million to a small patent-holding company rather than risk a judgment that threatened to shut down its BlackBerry personal digital assistant system.

This isn't the first time the AMA has stepped in on a patent matter. The Association successfully lobbied Congress to pass a law in 1996 that exempted physicians from liability for direct infringement for "the performance of a medical or surgical procedure on a body."

The legislation grew out of a federal case, Pallin v. Singer, in which one doctor sued another for violating his patent of a surgical procedure. But the law specifically exempts any medically related patent that involves drugs, lab work or biotechnology activity -- any medical procedure not performed directly on a person.

Metabolite and its co-plaintiff, Competitive Technologies, received a $7.8 million judgment (including attorneys fees) against LabCorp. But the companies have said in court papers they don't plan to collect royalties from doctors who violate the patent.

Still, even if doctors never directly feel the sting of such a ruling, they will feel it by never hearing of scientific advances they should know about. Or, another company might well decide to order physicians to pay royalties for what common sense would otherwise suggest is the appropriate practice of medicine.

Already, physicians have to deal with insurers or other third parties inserting themselves unjustly between physicians and patients regarding care. The U.S. Supreme Court should not add fear of patent infringement to the list.

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