Bioethics and Patent Law: The Case of Myriad

Myriad’s gene patents for breast cancer screening

BRCA-1 and BRCA-2 are two genes linked to susceptibility for breast and ovarian cancer (hence their acronyms). The risk of falling ill increases if these genes show certain mutations. Identifying the mutations is therefore important for diagnosis and for monitoring higher-risk women. Myriad Genetics Inc., in collaboration with the University of Utah, were the first to sequence the BRCA-1 gene, and applied for patent protection in 1994. Together with the University of Utah Research Foundation and the United States of America, Myriad holds U.S. patents 5747282 and 5710001 on the isolated DNA coding for a BRCA-1 polypeptide and on a screening method. In 1997, together with the Centre de Recherche du Chul in Canada and the Cancer Institute of Japan, they received patent protection on an isolated DNA sequence, asserting rights over a number of mutations in the gene (U.S. Patent 5693473). Further patent applications were filed on the second gene, BRCA-2, in the U.S. and in other countries (US Patents 5837492 and 6033857).

Technical challenge and ethical objections

These patents were controversial. Oppositions were filed against the European patent (EP 705902) on the isolated BRCA-1 gene by, among others, Switzerland’s Social Democratic Party; Greenpeace Germany; the French Institut Curie; Assistance Publique-Hôpitaux de Paris; the Belgian Society of Human Genetics; the Netherlands, represented by the Ministry of Health; and the Austrian Federal Ministry of Social Security. The opponents challenged the patent on the basis of the European Patent Convention’s patentability criteria, arguing that the claimed invention lacked novelty, inventive step and industrial application, and that the patent failed to disclose the invention sufficiently for a person skilled in the art to carry it out.

Underlying the technical grounds for opposition were deeper ethical and policy concerns. In addition to the continuing questions about patenting inventions derived from the human genome, the Myriad case raised concerns about the potentially limiting effects of the patents on further research, on the development of new tests and diagnostic methods, and on access to testing. While the considerable medical benefits of the cancer screening...