European patent office restores breast cancer gene patent

PARIS The European Patent Office on Wednesday restored on appeal a controversial patent for a breast cancer gene that had been withdrawn from a US biotech firm, but granting it in a more restricted form than before.
The final decision brings an end to a 14-year court battle in Europe pitting Myriad Genetics against an ad hoc consortium of research institutes supported by national governments.
Backed by pharmaceutical company Eli Lilly, Myriad obtained nine US patents in the mid-1990s on two genes -- BRCA1 and BRCA2 strongly associated with hereditary forms of breast and ovarian cancer in women.
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.
The company created different kinds of diagnostic test kits, marketing them first in United States and then in Canada.
In Europe, they were granted three patents related to the
BRCA1 gene in 2001, one covering cancer-related mutations, another different methods of testing for those mutations, and a third the gene itself.
Some European researchers worried that the patents were too broad, while public health officials objected to licensing agreements requiring that blood samples be sent back to Utah for the expensive tests.
"Governments, hospitals and researchers feared that Myriad's patents would stop research, drive up health costs and deprive women of appropriate care," said Richard Gold, a professor at McGill University in Canada and director of the Centre for Intellectual Property Policy.
Gold described the ruling Wednesday which defines the scope of the patent applying to diagnostic testing as a "partial victory" for Myriad that restores their exclusive rights, but only over half of the cancer-related mutations originally covered.
The decision handed down Wednesday said the patent only applies to diagnostics tools designed to find so-called "frame shift" mutations showing a predisposition for breast and ovarian cancer.
A frame shift mutation occur when there are too few or too many DNA building blocks, or nucleotides, in a genetic sequence, throwing off the ability of a gene to produce proteins.
"The problem in the Myriad case is not that they have a patent, but that they abused their monopoly," commented Dominique Stoppa-Lynnet, a professor of genetics at the Institut Curie in Paris who launched the legal challenge against the company in 2004.
"We would have preferred that the patent remain revoked. But the outcome is better than having the patent the way it was delivered in 2001," she told .
Messages left with Myriad headquarters in Salt Lake City requesting comment were not returned. For Gold, whose Centre has published a case study on Myriad, the patent office's decision "sends the right signal." "The court is saying 'we will grant the patent, but it is going to be narrowly related to what it is you discovered'," he said by phone.
Biotech companies first began patenting genes and genetic material in the 1980s. More than 20 percent of the 24,000 human gene patents granted since then have been in the United States.
A gene inside the human body cannot be patented. But once it is identified, removed and isolated, a company can apply for exclusive rights to exploit it for commercial purposes.