Breast-cancer test case could shape future of medical patents
Published Friday, July 20, 2012 8:22AM EDT
Last Updated Tuesday, May 14, 2013 8:29AM EDT
A case that's going before a federal appeals court in the U.S. today could have major implications for biotechnology companies working on important tests and treatments for the most complicated diseases.
The case involves a biotechnology company called Myriad Genetics inc., which wants to hold onto its patent on BRCA1 and BRCA2 gene variants -- two key genetic mutations that can signal a woman's risk of developing breast or ovarian cancer.
Myriad wants to remain the exclusive U.S. commercial provider of screening tests for both genes.
The American Civil Liberties Union argues that would limit not only on scientific research, but also health care options for women.
Marguerite Ethier, an intellectual property lawyer with the Toronto-based law firm Lenczner Slaght, says this is the most high-profile case the courts have seen so far on the tricky area of genetic patents.
She says the way it stands now, any woman who wants to find out if she has one or both BRCA mutations has to go through Myriad. No other lab can run its own test for the mutations nor double-check the accuracy of Myriad's test.
“They effectively have a monopoly over diagnostic testing for those mutations,” Ethier told CTV’s Canada AM Friday.
She notes that the monopoly has a time limit. The patent will eventually expire and the monopoly will end.
“But during the period of the monopoly, there is less access to diagnostic treatment for potential patients of these diseases,” Ethier says.
The situation is not unique, she says. There are currently patents on thousands of gene mutations in the U.S. and Canada, because the biotech industry depends on “intellectual property” rules to underpin its work.
Patents on genetic mutations are meant to protect those companies that pour a lot of money into discovering the mutations and the role they play in diseases and treatments. If every company could ride the coattails of those efforts, companies might never recover their initial investments.
“The biotech industry has structured itself on the assumption that these patents were going to be granted and would be upheld – which, until recently, had been correct,” she said
“So a lot of the research and development money has gone into these tests based on those assumptions.”
In 2010, a Federal Circuit court judge ruled against Myriad in the BRCA variant cases, but the next year, the U.S. Court of Appeals for the Federal Circuit upheld the patents.
Then, in March 2012, the Supreme Court set aside that finding because a separate case had found that there should be some limits on patents for diagnostic tests using genetic material.
The Supreme Court ordered the Federal Circuit Appeals Court to reconsider the Myriad dispute in light of that decision.
Arguments in the case begin today though a ruling is not expected until late summer.