Last week, in In re Bilski, No. 2007-1130, the United States Court of Appeals for the Federal Circuit, sitting en banc, articulated the test for whether a process is eligible for patent protection under section 101 of the Patent Act, 35 U.S.C. § 101. The majority opinion, joined by nine of the court’s twelve judges, relies heavily on decades-old Supreme Court precedent and rejects other tests, including State Street Bank’s “useful, concrete, and tangible result” inquiry. Although this case has been closely watched as a “business methods” patent case, the decision has profound implications for protecting inventions in life sciences. At the same time, it leaves open many questions that ultimately will determine the scope of section 101. The debate over what is patent-eligible subject matter has just begun.
As set forth in Bilski, a process is patent-eligible subject matter if it (1) is “tied to a particular machine or apparatus” or (2) transforms a particular article into “a different state or thing.” The court cautions that the claimed use of a specific machine or claimed transformation of an article must also “impose meaningful limits on the claim’s scope” and must not “pre-empt substantially all uses of [a] fundamental principle.” As a corollary, the recited machine or transformation must not consist merely of “insignificant extra-solution activity.” The “transformation must be central to the purpose of the claimed process.” Patent-eligible transformative processes include chemical and physical transformations of physical objects or substances.
While Bilski purports to clarify the test for analyzing the patent-eligibility of processes, many key questions remain unanswered: When is a process sufficiently tied to a particular apparatus or machine? When is the use of a recited machine more than “insignificant extra-solution activity”? When is the claimed transformation “central to the purpose of the claimed process”? When does a claimed invention foreclose substantially all uses of a fundamental principle, such as an algorithm or natural phenomenon? Does Bilski have implications for method of treatment claims? And what about non-process claims, such as claims to a peptide or polynucleotide that was isolated and purified from nature?
The Bilski court suggests, in a footnote, that its test is consistent with Justice Breyer’s dissent from dismissal of a petition for certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. 548 U.S. 124 (2006). In his dissent, joined by Justices Stevens and Souter, Justice Breyer states “[a]t most, respondents have simply described the natural law at issue in the abstract patent language of a ‘process.’ But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.” The claimed diagnostic process at issue comprised the steps of (1) “assaying a body fluid for an elevated level of total homocysteine” and (2) “correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.” Many commentators have noted that these claims were not well drafted and thus were not an appropriate vehicle for defining the scope of patent-eligible processes.
The precise boundaries of patent-eligibility for processes in the biotechnology and medical diagnostics fields may begin to emerge in two cases currently before the Federal Circuit. Classen Immunotherapies, Inc. v. Biogen IDEC, No. 2006-1634, which was argued in August 2007, raises the patent-eligibility question with regard to process claims directed to the risk-assessment of various vaccination schedules followed by immunization according to the lowest-risk schedule. The district court granted summary judgment of invalidity, reasoning that the immunization step is “insignificant post-solution activity” and the claims are “an indirect attempt to patent the idea that there is a relationship between vaccine schedules and chronic immune mediated disorders [and] . . . an attempt to patent an unpatentable natural phenomenon.” In Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403, the briefing of which was stayed pending the en banc review of Bilski, the claims are directed to measuring the metabolite levels in patients after administration of a drug and adjusting the drug dosage based on the measured metabolite levels to avoid toxic side effects. The district court granted summary judgment of invalidity on section 101 grounds, holding that the correlation of metabolite levels and toxicity is a natural phenomenon, and that the claims wholly preempt all practical use of the natural phenomenon. In these cases, the Federal Circuit may answer the questions of what constitutes preemption of substantially all uses of a fundamental principle and what constitutes more than “insignificant extra-solution” activity.
Faced with ambiguities in the Bilski test, innovators should be alert to its practical implications. First, there is now greater opportunity for accused infringers to assert section 101 defenses, and for licensees to bring section 101 challenges. While the focus of Bilski is patent-eligibility of process claims, litigants may well attempt to extend its preemption reasoning to composition claims that involve manifestations of nature. Second, Bilski will place a high premium on careful drafting of process claims to ensure that they properly recite patent-eligible subject matter. To avoid section 101 rejections, applicants will be well advised to draft diagnostic method claims to include the physical end-results of their claimed processes, such as claims reciting various diagnostic platforms on which a claimed test is performed. The Bilski decision also counsels in favor of separate independent claims for different physical end-results, or the use of a Markush claim format to group potential end-results within a single claim.
As a result of the Federal Circuit’s use of Bilski to limit patent subject-matter eligibility, many challenges lie ahead for companies in the biotechnology field, including particularly those involved with medical diagnostics, therapeutic methods, and personalized medicine. In the meantime, the section 101 debate will continue in district court patent challenges, ongoing Federal Circuit appeals and, quite possibly, the Supreme Court.