This week, The Prior Art takes a break from its usual surfing through federal court dockets in search of trolls and such to consider a potential landmark suit against the PTO. Association for Molecular Pathology, et al. v. United State Patent and Trademark Office, et al, 09-cv-04515, S.D. New York, filed 5/12/2009.
For nearly 30 years, the U.S. Patent and Trademark Office has been granting patents on portions of the human genome, a practice that has resulted in thousands of human genes -- as much as 20 percent of all human genetic material -- being patented.
This week, that practice came under a full-bore legal assault when groups representing more than 100,000 doctors and researchers, working together with lawyers at the Public Patent Foundation and the American Civil Liberties Union, filed suit against the PTO and Myriad Genetics, a Utah-based genetic testing company. It's a lawsuit two years in the making.
The suit's immediate goal is to invalidate seven patents that give Myriad the sole rights to administer tests and do research connected to a pair of genes closely connected to breast and ovarian cancer, BRCA-1 and BRCA-2 (pronounced "bracka-one" and "bracka-two"). Should the plaintiffs prove successful, though, their strike against the PTO would have far-reaching implications.
Dan Ravicher, the patent lawyer at the Public Patent Foundation who is working with the ACLU on the case, puts it bluntly: "The intention is to take down patents on human genes."
Myriad is a ripe target for several reasons. First, the patents it holds are on tests that diagnose breast and ovarian cancer. That got the attention of ACLU lawyers who focus on women's rights. Second, Ravicher says that -- unlike some corporate patent-holders that widely grant low-cost licenses to researchers -- Myriad has aggressively enforced its patents, making them particularly harmful.
"They have gone around and shut down researchers who are doing BRCA1 and BRCA2 research and providing clinical services," Ravicher says. "That includes universities like the University of Pennsylvania and New York University. They send cease and desist letters, and threaten to sue people."
Unlike other developed countries, the U.S. doesn't provide a "research exemption" in the context of patent infringement claims. The Federal Circuit has ruled that scientists and research institutions that violate patent rights can be hauled into court. That means that even though thousands of doctors and scientists regularly study human genes, they can't examine the BRCA genes without Myriad's permission. And, Ravicher adds, researchers who do get such permission -- and then perform genetic testing on patients as part of their research -- aren't allowed to share the test results with their patients. Instead, the research must refer those patients to Myriad to pay for the test results, which cost more than $3,000 apiece and aren't always covered by insurance.
Six named plaintiffs in the case are women who have been diagnosed with ovarian or breast cancer and have been unable to get proper treatment because of Myriad's patents. Lisbeth Ceriani, for example, is a single mother from Massachusetts who was diagnosed with breast cancer in May 2008; she can't get her blood samples processed by Myriad because they won't accept her coverage from MassHealth, a Medicaid insurance program for low-income people. Another plaintiff, 39-year-old Genae Girard, wanted a second opinion after she tested positive for a dangerous mutation under Myriad's test -- but because of Myriad's enforcement of its patent rights, she's unable to get that second opinion.
In a statement responding to the lawsuit, Myriad says it intends to vigorously defend its intellectual property rights in court, and believes its patents are valid and enforceable. It also notes that genetic patents granted by the patent office "cover a large number of life-saving pharmaceutical and diagnostic products."
While Myriad's behavior rankles researchers and public-interest lawyers, the patents it holds aren't unusual. The PTO has awarded tens of thousands of such patents, starting shortly after the Supreme Court's 1980 decision in Diamond v. Chakrabarty. In that case, the Court ruled by a 5-4 margin that a genetically engineered bacteria that broke down crude oil could be patented. The net result was that corporations were able to claim intellectual property rights in man-made living organisms. The Federal Circuit and PTO read the Chakrabarty ruling broadly, and began allowing patent grants isolated human gene sequences, and on a variety of tests that correlate genetic mutations with illnesses.
Since then, the PTO has regularly granted patent rights that cover "comparisons or correlations created by nature, but identified by a patent holder," says the complaint. Ravicher and his ACLU allies argue that doing so not only misreads the patent laws, but also violates the First Amendment: "This practice permits the patenting of laws of nature and abstract ideas and basic human knowledge or thought."
Getting patents on any part of the natural world has never been allowed. But patent lawyers have argued that isolated, purified gene sequences should be eligible for patenting, since such isolated sequences don't exist in the body, and the PTO, so far, has agreed. Patents have also been granted on the act of correlating specific mutations with diagnoses, giving monopoly rights to makers of some genetic tests.
This lawsuit directly attacks that line of reasoning, claiming that an "isolated and purified" human gene "performs the exact same function as a non-isolated and purified human gene in a person's body ... . Removing a product of nature from its natural location does not make it any less a product of nature.
To Ravicher, describing genes as "isolated and purified" in order to get patent rights in them is a thin legal fiction he aims to demolish.
"There hasn't been any public interest oversight of the patent system," says Ravicher, who also helps the Software Freedom Law Center fight against software patents. "It's been perverted to maximize corporate monopoly."
More coverage and links:
• Read the complaint here. Directors of the University of Utah Research Foundation are also named as defendants, since the University of Utah owns part or all of the patents at issue. Myriad holds the exclusive license to the patents.
• The New York Times covered the lawsuit and Myriad's response separately.
• Dennis Crouch at Patently-O isn't too interested in the debate over genetic patents: "The ones already patented will expire within the next decade -- most of them will expire before being put to any practical use."
• MSNBC has an (entirely unscientific) poll with about 1,500 respondents who are generally more upset than Crouch: a whopping 3 percent support genetic patents.
• Also at MSNBC, Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, says that after Myriad's patents were granted, the Canadian province of Ontario started doing its own BRCA testing, providing results eight weeks faster than Myriad for one-third the price. When Myriad threatened the province with lawsuits, the province's Health Minister told the company "to take a hike."
• Myriad's description of its BRCA tests.
• ACLU has a Web site on the BRCA lawsuits with photos & video of the plaintiffs.
This article first appeared in The Prior Art Blog on IP Law & Business.
