Patent law has already responded to limit human gene patents. For example, in 2005, the Court of Appeals for the Federal Circuit decided a case called in re Fisher that involved claimed "expressed sequence tags" (ESTs)-gene fragments rather than whole genes. Monsanto cited the usefulness of ESTs in locating whole genes in the maize genome, but the Federal Circuit rejected the claim to ESTs on the grounds that it lacked enablement and utility.
While in re Fisher made it more difficult to patent genebased inventions, the influential Supreme Court decision, KSR Inter not io ? al v. Tel eft ex, bytighteningthe nonobviousness requirement, has made it more challenging to patent inventions in all areas of technology. Furthermore, a renewed judicial interest in patents that implicate human thought may signal difficulties for patents claiming gene diagnostic tests.
Congress has also noted the anxiety over gene patenting, even considering amendments to the Patent Act that would effectively ban gene patents. In 2007, Congressman Xavier Becerra (D-CA) proposed the "Genomic Research and Accessibility Act." This bill would have provided that "no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies."
To date, genes remain patentable subject matter and gene patents remain potentially valid and enforceable. However, the future is now less certain in the face of increased judicial and Congressional scrutiny. In addition, empirical evidence suggests that issued gene patents are rarely asserted against others in litigation. The ACLU may have chosen a propitious moment to challenged Myriad's patents.
Thought Police
The ACLU's lawsuit against the USPTO and Myriad Genetics is something of a sequel. The organization previously filed an amicus brief in a high-profile Federal Circuit appeal called In re Bilski. This case considered an invention alleged to require a "mental step" capable of being carried out by a human mind. In the middle of the 20th Century, courts developed a judicial doctrine-"mental steps doctrine"-to limit patents whose claims implicated human thought. In 1951, the Court of Customs and Patent Appeals stated in its In reAbrams decision, "[i]t is self-evident that thought is not patentable."
In 2006, Supreme Court reversed its decision to decide an appeal on the patentability of method of medical diagnosis. The patent claim in Laboratory Corp. v. Metabolite Laboratories, was a method for detecting a deficiency of cobalamin or folate in warm-blooded animals based on "assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate."
The litigants agreed that "assaying a body fluid" referred to any test that detects an elevated level of total homocysteine. Furthermore, the inventors testified that "correlating" simply referred to a doctor recognizing an elevated level of homocysteine, a result that "would occur automatically in the mind of any competent physician." After the Federal Circuit found that claim 13 was not invalid, and that Laboratory Corp. had infringed it, the Supreme Court granted Laboratory Corp.'s petition for certiorari. The court limited the appeal to a single question:
"[w]hether a method patent... directing a party simply to 'correlate' test results can validly claim a monopoly over a basic scientific relationship... such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result."
Despite widespread anticipation of a decision definitively affirming or restricting "human thought" patents, the court declined to decide the case on the grounds that the writ of certiorari had been improvidently granted. This left the decision of the Federal Circuit intact. Justice Breyer wrote a blistering dissent, in which he argued that claim 13, and claims like it, should be unpatentable.
In the wake of the Supreme Court's non-decision, the lower courts decided a flood of cases involving patent claims alleged to involve thinking steps. Among these were the In re Comiskey and In re Bilski cases, both recently decided by the Federal Circuit. The latter invention involved "a method practiced by a commodity provider for managing (i.e., hedging) the consumption risks associated with a commodity sold at a fixed price." The Federal Circuit stated the legal issue they would decide as follows:
Whether the claimed subject matter is not patent-eligible because it constitutes an abstract idea or mental process; when does a claim that contains both mental and physical steps create patent-eligible subject matter?
To decide the case, the court articulated a "machine-ortransformation" test, declaring that "[a] claimed process is surely patent-eligible... if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." Neither applied in this case, and so the court held the claims to be unpatentable.
In re Bilski has important implications for medical diagnostic patents. Citing the in re Bilski decision in December 2008, the Federal Circuit, in Classen v. Biogen, affirmed a lower court's decision to invalidate patent claims on "evaluating and improving the safety of immunization schedules". The lower court found that "the correlation between vaccination schedules and the incidence of immune mediated disorders that Dr. Classen claims to have discovered is a natural phenomenon."
In another case decided last April, Ariad Pharmaceuticals v. Eli Lilly, the Federal Circuit found patent claims relating to modulating gene expression invalid for lack of adequate disclosure, and shed little light on patentable subject matter. Interestingly, Myriad Genetics considers the Prometheus v. Mayo appeal (which deals with patent claims covering methods of optimizing treatment of Crohn's disease) vital enough to its own interests that it has filed an amicus curiae brief urging the Federal Circuit to reverse the lower court's decision.
Allowing the patenting of "human thought" per se would clearly be problematic. As Dan Burk points out, "there would seem to be profound First Amendment implications to the concept of infringement by 'thinking patented thoughts'." The Supreme Court has just granted certiorari for in re Bilski, to clarify the patentability of inventions involving human thought, and to provide the sort of guidance it declined to provide in Laboratory Corp. Providing the Supreme Court actually renders a decision this time, the patentability landscape for biotechnological inventions may be altered significantly. A.T.
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