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Biomedicine

Doctors without Patents

Patent systems are challenged when proprietary rights clash with doctors’ sharing of health-care know-how.

The French government has frequently acted to protect its native commerce. France has subsidized its indigenous film industry to shield it against Hollywood competition; a French regulatory organization even went to court to insist that only French-grown sparkling wines bear the coveted name “champagne.”

Now a respected French institution is campaigning to protect its medical research community. Only this time, the case has implications far beyond the nation’s chauvinist interests. The Institut Curie, a top center for cancer research and treatment, announced recently that it will try to overturn a patent issued to a U.S. biotech firm conferring exclusive rights to breast cancer screening tests. Curie representatives contend they are combating “an unacceptable monopoly.”

The contested patent, granted last January by the European Patent Office to Salt Lake City-based Myriad Genetics, covers diagnostic tests using the BRCA1 gene to screen for a genetic predisposition to breast cancer (about one-half of inherited breast cancers are associated with this gene). Myriad Genetics won a similar U.S. patent in 1998 and now holds a broad patent portfolio over the BRCA1 gene in much of the world. What makes the case noteworthy is the core French argument: that Myriad Genetics’ monopoly on a diagnostic test runs counter to France’s “conception of public health.” It is a potent argument, and not just in France. The world’s patent systems face perhaps their most vexing challenges when proprietary rights clash with doctors’ age-old practice of freely sharing health-care know-how.

With support from the French Ministry of Health and Ministry of Research, the Institut Curie offers substantial evidence to bolster its claim. Dominique Stoppa-Lyonnet, head of oncological genetics, charges that Myriad’s unwillingness to license its technology means that French doctors wishing to screen their patients for predisposition to breast cancer must now send all DNA samples to Myriad for analysis. Myriad’s test costs some $2,500-more than three times the cost of existing French tests-and will preclude some 17 French laboratories from carrying out diagnostic research based on the results. Aside from the detriment to French patients, she says, “Giving in to this monopoly would bring about an intolerable loss of data and expertise for French laboratories.”

The Institut Curie also contends Myriad’s patent is too broad, covering existing as well as any future BRCA1-based screening techniques. European patent attorney Jacques Warcoin says the patent will thus stifle innovation in France. He also notes that identification of the BRCA1 gene was made possible by the work of many research teams, as well as with the collaboration of women from at-risk families. What’s more, that groundwork helped geneticist Mary-Claire King of the University of California, Berkeley, accomplish the key step of assessing 183 possible genetic markers for breast cancer and narrowing the list to one on chromosome 17. King published her team’s work in late 1990; on the strength of her findings, Myriad isolated the BRCA1 gene some four years later.

William Hockett, a Myriad spokesperson, dismisses such claims, saying, “Patents allow new technology to develop-in this case, very high quality tests.” Hockett notes that his firm doesn’t license its patent in order to offer “the highest-quality tests possible.” Quality control is paramount, he says, because screening tests influence critical decisions on patient care. Hockett also says it is “absurd” to charge that Myriad wants to stifle breast cancer research. He stresses that his firm is a major sponsor of such research, in part because-given the strength of its patent portfolio-“it benefits us directly.”

But Myriad’s statements do little to alter the real issue: namely, the clash between public health and proprietary claims on medical know-how. Traditionally, most patent systems distinguished between medical devices-like pacemakers-which can be patented, and medical procedures, such as the Heimlich maneuver, which have usually been freely shared by medical practitioners. Diagnostic tests, and even many drugs and vaccines, have fallen into an uncomfortable gray area: on the one hand they require some manufacturing (a feature often linked with patentability), while on the other hand they result increasingly from advances in the conceptual medical know-how that has been shared among doctors for at least the 2,000-odd years the Hippocratic oath has existed.

With the exception of the United States, some 80 countries, including every European Union nation, already exempt medical procedures from intellectual-property protection in order to safeguard the dissemination of new medical techniques and knowledge. As Europe grapples with diagnostic tests based on gene patenting, the gray area of useful medical knowledge grows. The Curie Institute’s legal action is an important protest. But more proactive work is needed to clarify appropriate limits on similar health-care claims. Ideally, a panel of stakeholders under the auspices of an international body like the World Health Organization ought to tackle the job. Without such a group, we will likely see many divisive fights like this one-needlessly restricting medical knowledge and potentially undermining the Hippocratic oath.

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