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.

Editorial. April 17, 2006.

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?