The EPO restored on appeal the controversial patent for the breast cancer gene filed by Myriad, but in a much more restricted form than before.
Scientists estimate that about ten percent of breast cancers are hereditary. Women who carry the BRCA1 gene face a 10-fold increased risk of contracting the disease by age 70.
Myriad, of Salt Lake City, Utah, created different kinds of diagnostic test kits, marketing them first in US and then in Canada.
In Europe, the company was granted three patents related to the BRCA1 gene in 2001, one covering cancer-related mutations, another for different methods of testing for those mutations, and a third for the gene itself.
The granting of the patents sparked uproar among European scientists, who argued that Myriad’s patents, and the way the company was administering them, would have a negative effect on innovation, push up health costs and deprive many women of the benefits of Myriad’s work.
In 2004 many researchers, including those in the genetics department of the Institut Curie in Paris, and counterparts elsewhere in Europe lodged a formal challenge to the Myriad patents.
They succeeded in getting the BRCA1 patents revoked but Myriad challenged the move. The verdict last week drew a line under the 14 year-long dispute.
“We would have preferred Myriad’s patents to have been revoked entirely but we are reasonably happy with the outcome,” said Dominique Stoppa-Lynnet, a professor of genetics at the Institut Curie.
Since 2004 other companies that have been granted patents on disease genes have licensed them, thus ensuring access and promoting widespread use. Myriad refused to adopt this business model, insisting that all samples from patients must be sent to its own laboratories in Utah, or to affiliated labs, for analysis.
The ruling last week forces Myriad to operate a looser licensing model for its BRCA1 patents, Stoppa-Lynnet said. “It means it won’t be possible for Myriad to have a monopoly [on testing].”
However, she added that there remains a lack of clarity, even after such a lengthy legal dispute, because EPO has reaffirmed Myriad’s patent for the gene mutation.
The EPO decision last week said the patent now relates to diagnostic methods for the detection of a predisposition for breast and ovarian cancer caused by a specific group of mutations of the gene, called frame shift mutations. It does not contain claims directed to the BRCA1 gene itself.