December 2001

Doctors without Patents

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

By Seth Shulman

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.