Will Prometheus Prevail?
A Prometheus amici said the company’s patents involve more than a law of nature or observation. Juhasz Law Firm PC argued that subject matter patentability under 35 U.S.C. §101 can be determined by the existence of either a physical link or virtual link to physical or tangible objects.
Paul R. Juhasz, president of Juhasz Law, told GEN the physical-virtual standard was supported by two Supreme Court cases: Diamond v. Diehr; where software that manipulated a specific physical object was patentable; and O’Reilly v. Morse (1853), where the Morse code dot and dash signs were patentable to the extent they were applied in the telegraph, since they represented the change in state of physical objects from switches to clicks; one Morse claim, though—use of electromagnetic force—was deemed too broad to patent.
Diamond was cited in two Federal Circuit life science cases: Myriad’s lawsuit (Association for Molecular Pathology v. US Patent and Trademark Office) and Classen Immunotherapies v. Biogen Idec, where a Federal Circuit majority on August 31 upheld two of three Classen patents. “Classen is a case that, in my view, addresses the concern of the Supreme Court with regard to extra-solution activity” expressed in Bilski v. Kappos, Juhasz said.
In Classen the court maintained that while a transformation to gather data toward a body of knowledge was not patentable, a transformation “putting this knowledge to practical use” is. Classen’s physical-virtual standard also complements the transformative-step standard applied by a three-judge Federal Circuit panel that earlier this year upheld Myriad’s gene claims and methods of screening for cancer compounds as patentable– but not claims for mutation analysis.
Myriad seeks to protect seven patents related to breast cancer susceptibility genes 1 and 2 and its method for analyzing sequences of those genes for mutations associated with breast cancer against a legal challenge by several medical associations and individual doctors, aided by the American Civil Liberties Union (ACLU) and Public Patent Foundation.
The ACLU weighed in on Prometheus v. Mayo via amicus, arguing that the case “raises fundamental issues regarding freedom of thought and scientific inquiry centering around First Amendment values. What Prometheus seeks to monopolize through its patents is the right to think about the correlation between thiopurine drugs and metabolite levels and the therapeutic consequences of that correlation. Granting Prometheus or any other patent holder a monopoly on abstract ideas is incompatible with a constitutional regime that protects freedom of thought.”
Three tech giants—Microsoft, Intel, and EMC—urged the Supreme Court to affirm a “basic standard for patent eligibility focusing on the use of certain means to create a useful practical result in the physical world” but not technology-based or “rigid” standards such as machine-or-transformation.
The high court will likely set that “basic standard.” If Bilski v. Kappos is any guide, the court’s standard can be expected not to rely on the rigidity of a single test but on some combination of tests grounded in precedent and designed to advance life science innovation.