In Gene Patent Case, Company Vows to Fight

May 13, 2009, 5:18 pm
By JOHN SCHWARTZ


Today’s New York Times has a story about a novel lawsuit filed in federal court on Tuesday that challenges the notion that genes can be patented.
The lawsuit (available for download as a .pdf) was filed by a coalition of plaintiffs drawn together by the American Civil Liberties Union, and includes individual cancer patients and large professional organizations of geneticists and pathologists. The thrust of the suit concerns patents issued to a Utah company, Myriad Genetics, having to do with genes associated with an increased risk of breast cancer and ovarian cancer.
Myriad declined to comment yesterday, saying simply that it had not had time to review the complaint in the case. Today, the company’s general counsel, Richard Marsh, provided an general oral statement in response to the filing of the suit.
Mr. Marsh said:
Myriad understands that a lawsuit has been filed that challenges the legality and constitutionality of granting gene patents. However, Myriad has not yet been served in this matter. We intend to vigorously defend our intellectual property rights, if served in the lawsuit.
It is our understanding that the core issue in the complaint revolves around the patenting of genes. Since a landmark U.S. Supreme Court decision in 1980 relating to gene patenting, the U.S. Patent and Trademark Office has granted tens of thousands of genetic and genetic-related patents, which cover a large number of life-saving pharmaceutical and diagnostic products. Myriad’s patent portfolio includes both “genetic” patents and patents on surrounding technologies required for testing.
We have rights to 23 granted U.S. patents which cover a number of important aspects related to the detection of mutations in the BRCA1 and BRCA2 genes. These patents cover not only isolated gene sequences, but also methods of isolating, analyzing and detecting mutations. Myriad strongly believes its patents are valid and enforceable, and will be upheld by the courts.
The statement raised eyebrows at the A.C.L.U., however, where the attorney Christopher A. Hansen noted that the case Mr. Marsh appears to be referring to, Diamond v. Chakrabarty, upholds the decision to grant a patent of an organism that was a human-made: a genetically engineered bacterium, not a naturally occurring DNA sequence. “We are talking about a real apples and oranges situation,” Mr. Hansen said. “Chakrabarty doesn’t change our view one iota,” he said, adding that “it strongly reinforces our view” because the opinion in the case underscores the notion that “laws of nature, physical phenomena, and abstract ideas” lie beyond the patent realm.
This case has, of course, just begun, and many twists and turns can be expected along the way, and predicting the outcome of cases is a fool’s game. For the plaintiffs, this represents a chance to ask the courts for what is essentially a do-over on broad decision about granting gene patents that they believe was mistaken from the start.
Harry Ostrer, director of the human genetics program at the New York University School of Medicine and a plaintiff in the case, said in an interview, “I don’t completely know whether I’m brave or foolhardy on this one,” to go up against long-established patent law with a legal challenge. “When we had a small group of plaintiffs, it felt more foolhardy than brave,” he said. Now, he said, the group of plaintiffs has grown to include organizations that represent more than 100,000 scientists, pathologists and geneticists, and “I think they feel they’re fighting the Spanish Civil War,” and want to have been part of the fight.
When reminded that the Spanish Civil War didn’t go especially well for many members of the Abraham Lincoln Brigade, he laughed and said, “Our guys were deemed heroic by Hemingway.” Perhaps, he said, “some day, people will write novels about the Myriad plaintiffs and how foolhardy they were.”