What the Justices Questioned
Justice Stephen Breyer sought to pinpoint how far a process could go and yet remain patentable. Could patentability apply to a method for determining when there is too little or too much fertilizer in a field? To Einstein’s E=mc2 equation?
“My question is: What has to be added to a law of nature to make it a patentable process?” Breyer said, best expressing the court’s conundrum in a question directed to Prometheus attorney Richard P. Bress of the law firm Latham & Watkins. “If you put too little in the answer to that question, I believe I can take things like E equals mc-squared and make them patentable. And if you put too much in, you are going to wreck your own case.”
Bress cited the court’s O’Reilly v. Morse decision (1853), where one Morse claim—use of electromagnetic force—was deemed too broad to patent because it could preempt many inventions never even thought of. However, the Morse code dot and dash signs were patentable as applied in the telegraph, since they represented a change in state of physical objects.
Another possible answer: In Diamond v. Diehr (1981), the Supreme Court upheld as patentable the execution of a process controlled by a computer program that applied a math formula that by itself was not patentable. That “machine-or-transformation” test was upheld by the Federal Circuit in In Re: Bilski (2008) but watered down by the high court in Bilski v. Kappos (2010), when it cautioned that the standard should not be the sole test but “a useful and important clue” of patentability; that may explain why Bress didn’t cite the case.
Mayo attorney Stephen M. Shapiro cited In Re: Bilski to argue that a patent cannot be used toward a broad preemption of a physical phenomenon—something Mayo and supporters accuse Prometheus of doing.
“Broad patents on natural biological relationships, which we consider the Prometheus patent to be, basically threaten the advancement of personalized medicine,” Roger D. Klein, M.D., chair of the Professional Relations Committee of the Association for Molecular Pathology, and director, Molecular Oncology Laboratory, Blood Center of Wisconsin, told GEN.
“You essentially give a monopoly over biological relationship, and then nobody else can come in and find out a better way to test for it,” Dr. Klein, who also attended the oral arguments, asserted. “And that stifles the advancement of personalized medicine, and it harms patients because it tends to increase costs and increase prices, and the patients don’t benefit from the efficiencies that would be gained by the introduction of novel methods.”
While Breyer’s basic question remained unanswered, Gerald J. Flattmann Jr., a partner in the intellectual property practice of the law firm Paul Hastings, said the closest anyone came to an answer was U.S. Solicitor General Donald B. Verrilli Jr. He noted that Section 101, which covers patentable subject matter, was an easier standard than Sections 102 and 103, which address whether a claim is novel and nonobvious, thus meriting patent eligibility.
“It only engendered more confusion with some members of the court,” Flattmann said—notably Chief Justice John Roberts and Justice Anthony Kennedy, who questioned if issues of novelty and nonobviousness should instead be addressed through Section 101.
Justices Sonia Sotomayor and Antonin Scalia, however, pursued lines of questioning that asked whether the patent so broadly preempted a physical phenomenon that Mayo and others could not offer a better metabolite test with more accurate numbers. Justice Elena Kagan, however, took an opposite line of questioning, asking whether the Prometheus patents were too broad and if the company wasn’t merely “point(ing) out a set of facts that exist in the world” and “claiming protection for something that anybody can try to make use of in any way.”
What will the Supreme Court decide in this much-watched molecular diagnostic lawsuit?
In Favor of Prometheus
In Favor of Mayo