The April/May issue of IP Law & Business featured a story about Robert Shafer, a Stanford University researcher whose free HIV database had become embroiled in a patent dispute that led Shafer to believe medical method patents are out of control.
Since that story’s publication, groups representing most of the American medical establishment have become involved in two major patent cases that turn on the same question that Shafer confronted: just what kinds of "technology" should be eligible for patent protection?
One of those cases, Prometheus Laboratories v. Mayo Collaborative Services et al., is now headed to the Federal Circuit; oral arguments are scheduled for August 5. Amicus briefs filed on both sides show clearly the divide between the patent bar and medical professionals on this issue.
At issue in Prometheus are tests that measure levels of metabolites produced by the body after a person takes thiopurine drugs, which are typically used to treat Crohn’s disease and other inflammatory bowel conditions. Knowing those levels helps doctors assess how well a patient is responding to thiopurine treatment. The drug dosage may be modified depending on whether the metabolite levels are too high or low.
Prometheus claims it alone is legally allowed to perform the tests that measure those metabolites. The company is the exclusive licensee of two patents—6,355,623 and 6,680,302—that it says cover the testing.
These aren't genetic tests. But the same doctors' groups that joined a highly publicized lawsuit to eliminate human-gene patents object to Prometheus' patents, which they say cover something that is part of basic science. Prometheus and several other medical-testing companies (including Myriad Genetics, the defendant in the anti-human-gene-patent suit) have built their businesses in large part by guarding monopoly rights to tests that only they perform. That model, their opponents say, hurts researchers and patients.
Michael Watson, executive director of the American College of Medical Genetics, is among those who is sharply critical of the testing companies. His group is a signatory to an amicus brief [PDF] supporting the Mayo Clinic in the Prometheus suit and a plaintiff in the ACLU suit against Myriad.
"They tell anybody else delivering the test to cease and desist," Watson says of the testing companies. Sometime, he claims, these companies will go so far as to send blood samples to a university lab for testing, then put the lab on notice for infringement if it does perform the requested tests.
"It's so out of character with the new way testing develops," Watson says. "It’s contrary to where technology is going, and we’re seeing worrisome impacts."
The Mayo Clinic developed its own thiopurine-related test that measured the same metabolites but relies on different “warning” levels to determine when a change in drug dosage in needed. In June 2004, Mayo announced it would begin using its own test and would also offer that test for sale to others. Prometheus responded by suing Mayo for patent infringement on June 15, 2004.
The clinic considered the thiopurine test important enough—and the Prometheus patents dangerous enough—that it chose to fight the suit. Mayo is represented by Fish & Richardson.
"The patents are based on observations of the laws of nature," says David Herbert, chief administrative officer for Mayo Medical Laboratories. "We chose to make a stand." Such "observational" patents increase costs, slow innovation, and worsen patient care, he says. "It doesn’t allow the test to be performed close to the bedside, and there's no ability to have second opinions."
In 2005, the Southern District of California district court found on summary judgment that Mayo’s test did infringe the Prometheus patents. More motions and cross motions followed. Last year, the court issued an order [PDF] in favor of Mayo, ruling that the infringed patents-in-suit are invalid because they merely recite a natural phenomenon—the correlation of thiopurine drug use and certain metabolite levels.
Prometheus appealed that decision to the Federal Circuit, which prompted the dueling amicus briefs from the doctors' groups like Watson’s (on behalf of Mayo) and the American Intellectual Property Law Association, which favors Prometheus [PDF]. Mayo's test is still on hold while the appeal is pending.
AIPLA, the main patent lawyers' professional group, argues in its brief that the Prometheus test should be eligible for patent protection, because it meets the Bilski machine-or-transformation standard. The (natural) metabolites are created, AIPLA argues, "from the physical transformation of a drug provided as part of a process created by man."
The brief goes on to argue that in ruling for Mayo, district court Judge John Houston was overreacting to a dissent written by three Supreme Court justices in the 2006 LabCorp v. Metabolite case. While the court’s majority dismissed that case for technical reasons, a vocal minority argued that the full court should have taken it up in order to consider limiting the scope of what can be patented.
(The dissent indicates that justices Stephen Breyer and John Paul Stevens, as well as retiring Justice David Souter, clearly favor limiting what can be patented. Hal Wegner, the Foley Lardner partner who writes a popular patent newsletter, calls the authors of this brief the "notorious Breyer three.")
The AIPLA brief also argues that the Prometheus test is an example of "personalized medicine," and that such a strategy "maximizes effectiveness of treatment, minimizes adverse effects, and ultimately saves time, money, and lives….Patent protection is essential for continuing investment and innovation in the field of personalized medicine."
The medical groups, which also include the American Medical Association, take an opposing view, arguing that Prometheus claims ownership of something that occurs naturally: the well-known fact that higher or lower levels of the metabolites in question go together with different treatment regimens.
There is no "post-solution activity" and no treatment method specified by the patents, the medical groups argue. Further, they say, the fact that the correlation is noted after the patient takes a man-made drug is irrelevant.
Allowing such patents not only misreads patent laws, but raises ethical concerns for physicians, this argument continues: "Physicians have longstanding obligations to advance and share useful medical knowledge with patients and physicians." Patents on basic scientific principles "threaten to stifle innovation and raise the costs of medical treatment." And claiming exclusive rights to "scientific facts," such as the correlation that Prometheus purports to own, actually harms research and personalized medicine rather than helping it, the doctors argue.
Prometheus argues that its patents represent more than mere "correlations," since its test includes machines, blood samples, and dosage decisions. The company's lawyers from Latham & Watkins also argue that the Mayo Clinic isn't making a stand on principle—rather, it hopes to make money by blowing off Prometheus's patent rights.
"Mayo argues that the patents-in-suit randomly ensnare doctors who do nothing more than inadvertently hear about them," write Prometheus lawyers in the appeal brief. Those concerns "ring particularly hollow," the brief says, since Mayo hopes to "produce and sell a multimillion dollar laboratory test, the economic value of which would derive entirely from Prometheus's invention."
The case "is about the infringing business plans of Mayo's for-profit diagnostic laboratory, and no doctor is going to order and pay for Mayo’s planned test inadvertently," they write.
Rather than allow a company to patent a test and guard monopoly rights to performing it in-house, Michael Watson and his colleagues would prefer to see companies recoup what they spend on developing new testing products by licensing or selling those tests to labs around the country.
Watson says he hears regularly from geneticists who would happily try to create new tests or improve an existing one, but won’t do so because of patent issues. Companies like Prometheus and Myriad, Watson says, are creating "monopolized service laboratories that preclude getting second opinions."
"If you can't look at parts of the genome [because of patents], it has negative influences on the practice of medicine," says Watson. "And the potential impact is higher in the future."
That, he says, is because the next important advances in the field of genetics are going to involve more comprehensive tests that can analyze the entire human genome. Watson predicts that these tests will be available for $1,000 or less. But they run the risk of infringing many patents like those owned by Myriad or Prometheus. And the cost of busting a patent through litigation can run as high as $2 or $3 million—a costly fight that most university or research labs aren’t ready to take on.
Doctor's groups have already had some success getting Congress's attention on the issue. In 2007, U.S. Rep. Xavier Becerra (D-Los Angeles) introduced legislation that would ban gene patents altogether. "This cannot be what Watson and Crick intended,” he said at the time, referring to the scientists credited with figuring out the structure of DNA. The bill ultimately died, but Watson says that his group is keeping its legislative options open.
Prometheus Laboratories, Inc. v. Mayo Collaborative Services, et al. 04-cv-1200, S.D. California.
- District Court Summary Judgment order in favor of Mayo Clinic [PDF]
- Medical groups amicus brief in support of Mayo Clinic [PDF]
- AIPLA amicus brief in support of Prometheus [PDF]
- Prometheus Appeal Brief [PDF]
- Prometheus Reply to Mayo Appeal Brief [PDF]
Image: Wikimedia / Jan Cossiers