A US District Court has ruled that claims in seven patents supporting a widely used genetic test for inherited breast and ovarian cancer susceptibility are invalid.
The decision is likely to be challenged in a legal appeal — but if upheld, it could have huge implications for the biotechnology industry. It also stands in stark contrast to a 2008 decision by the appeals board of the European Patent Office, which supported the patents (see 'Europe to pay royalties for cancer gene').
The latest ruling, delivered on 29 March, is the result of a lawsuit brought in May 2009 against Myriad Genetics, based in Salt Lake City, Utah, and the University of Utah Research Foundation, which hold the patents on the BRCA1 and BRCA2 genes. Mutations on BRCA1 and BRCA2 are responsible for most hereditary breast and ovarian cancers. A woman who tests positive on Myriad's BRCA test has on average an 82% risk of developing breast cancer in her lifetime and a 44% risk of developing ovarian cancer, according to the company.
The patents, which Myriad has actively enforced, grant the company the exclusive right to perform diagnostic tests on the two genes. The company charges over $3,000 for its BRACAnalysis test. In 2009, Myriad's revenues from molecular diagnostics grew by 47% to $326.5 million. BRACAnalysis accounts for the lion's share of those revenues.
The plaintiffs in the case included individual physicians and patients as well as the Association for Molecular Pathology and the American College of Medical Genetics; they were represented by the American Civil Liberties Union (ACLU) and the New York–based Public Patent Foundation. The American Society of Human Genetics and the American Medical Association also filed briefs in support of the plaintiffs' challenge to the patents.
The plaintiffs called the patents illegal on the basis that they restrict both scientific research and patients' access to medical care and that patents on human genes violate patent law because genes are "products of nature".
In his written opinion, Judge Robert Sweet of the US District Court for the Southern District of New York excluded from consideration the plaintiffs' arguments on the stifling of research and patient access. But he nonetheless ruled that both Myriads' composition and method claims are invalid under the law, disagreeing, for instance, with Myriad's argument that the purification of a natural product like a gene necessarily renders it patentable
"The summary judgment is a first step but a very important one," says Mary-Claire King, a geneticist at the University of Washington in Seattle, who discovered BRCA1 in 1990. "Opening genetic testing for BRCA1 and BRCA2 to the competitive marketplace of new genomic technologies would be good for breast and ovarian cancer patients, their families, and their physicians."
"Today's ruling is a victory for the free flow of ideas in scientific research," says Chris Hansen, a staff attorney with the ACLU First Amendment Working Group. "The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."
Patently appealing
But industry watchers were taken aback by the ruling, as many had expected it to go in the other direction. "There is a lot of case law in support of gene patents," says Junaid Husain, senior medical technology analyst at Soleil Securities, a New York–based investment advisory firm. "If you deny those patents, you are potentially putting a lot of companies and their technologies at risk."
Jim Greenwood, the president and CEO of the Biotechnology Industry Organization, a Washington-based lobby group, called the decision "only a preliminary step" in the legal process. He also challenged the court's reasoning, arguing that "preparations of isolated and purified DNA molecules, which alone can be put to use in these ways, are patentable because they are fundamentally different from anything that occurs in nature".
Myriad immediately promised to appeal the ruling, arguing that the judge did not follow legal precedent in the matter and had ignored the intention of the US Congress that the Patent Act should be broadly applied."We are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation," commented Peter Meldrum, Myriad's president and CEO, in a statement.
He noted that 16 of Myriad's 23 patents on BRCA remain valid and said the company does not expect the ruling to affect its business operations.
However, in trading before the opening of the NASDAQ stock market on 30 March, shares of Myriad Genetics (MYGN) declined 9.2 percent, to $22.60, after closing at $24.90 the previous day.