Lawyers for Minnesota's Mayo Clinic will appear before the justices of the U.S. Supreme Court Wednesday morning to argue that patents underlying a blood test are too broad and inhibit doctors from treating patients.
In a case that could have big implications for patent law, the high court will weigh whether the clinic infringed upon a patent held by Prometheus Labs San Diego.
Prometheus makes a blood test that helps doctors decide the proper dosage for a drug called thiopurine which is used to treated gastrointestinal illnesses. Mayo used that test until 2004 when the clinic created its own test, which it says was cheaper and faster. At that point, Prometheus sued for patent infringement and Mayo had to halt work on its test.
Mayo officials argue that companies do have a right to patent medical tests but said Prometheus's patent was much broader.
"The claim basically says that if our physician or our lab takes the blood, analyzes the blood and then thinks about the results, then they infringe the patent," said Jim Rogers, one of the Mayo Clinic's in-house patent lawyers.
The clinic's argument is that the Prometheus patent tries to include the test's results, so that no test, even if it uses a completely different approach, would fall outside the patent's scope.
John Singer, a patent lawyer for the Minneapolis intellectual property law firm Fish and Richardson which also represent the Mayo Clinic in the case, said patent law has an exemption for what's called "naturally observable phenomena." In other words, someone cannot patent something like Einstein's famous equation, E=MC² .
Singer said laboratory test results should fit squarely within that definition.
"You know, this is a natural thing your body does," he said. "But simply learning about that natural result, whatever your body does, that's what's claimed to be patent infringement."
Prometheus officials would not to comment about the case. Neither would PhRMA, the drug industry trade association that's written a brief backing the company's case.
But University of New Hampshire law professor Ann McCrackin said Prometheus's argument, which prevailed twice before the U.S. Court of Appeals D.C. Circuit, leans heavily on another idea that's part of patent law.
"In both instances, the court of appeals for the federal circuit says this case satisfies what we call the machine or transformation test," McCrackin said.
Under that test, to obtain a patent inventors have to prove that their invention must either be tied to a particular machine or must change materials into a "different state of being."
McCrackin, who also filed a friend of the court brief in this case in support of Prometheus, argues that the company's blood test meets that threshold because a process that looks at a chemical reaction in the blood is a transformation.
But more importantly, she said, Prometheus's patent covers a process: the set of steps needed to take the blood test.
"This case deals with the much bigger issue of when is a process eligible for a patent," McCrackin said.
The issue of patenting processes has started to draw a lot attention in legal and business circles.
Those patents often include software — which is one reason why a number of technology companies, including Verizon and Hewlett Packard have filed briefs in that support the Mayo Clinic's position.
McCrackin, who supports Prometheus's argument, said the stakes of this case are high for anyone who files a lot of patents.
"You very likely damage and hurt the potential patent protection for new technologies and fundamental new ideas to come in the future because we've now narrowed down the subject matter that can be eligible for a patent," she said.
Singer, the attorney for the Mayo Clinic, said the case could be extremely important to the medical profession.
"It will lay the framework in the medical setting, what is free for physicians to use in treating their patients and what is not," he said. "What can be patented and what can be not."
The Supreme Court is not expected to rule until next spring.