The San Diego Intellectual Property Law Association (SDIPLA) is one of two groups that have filed an amicus curiae brief urging reversal of the District Court's summary judgment decision in Ariosa Inc v. Sequenom, Inc. (The brief from the other amicus, the Biotechnology Industry Organization, BIO, will be the subject of a future post.) The SDIPLA's position in its brief is not surprising (particularly in view of the violence with which the District Court treated established principles of patent law); what is surprising is that only two amici have shared their views with the Federal Circuit.
(In an unusual procedural aside, certain of the appellees refused to consent to these amicus filings, ostensibly because addressing the issues in the brief would require a 60-day extension of time for filing their responsive brief. The tactic worked, with the Federal Circuit granting the amici's motions for leave to file their briefs and appellees' motion for extension of time. Their responsive brief is now due May 5, 2014.)
Turning to the substance, the SDIPLA's brief poses three questions the Federal Circuit should address in the appeal:
1. Does a claim to a diagnostic use of a known process or known composition of matter that is statutorily patent eligible under 35 U.S.C. §101 become nonstatutory when the use is a new use of the known process or known composition of matter for the limited purpose of detection of a product of nature or natural phenomenon?
2. Is it relevant to the question of statutory patent eligibility of the claim of question 1 that the claimed process satisfies the machine-or-transformation test for statutory patent eligibility of a process?
3. Can a claim to a new diagnostic use of a known process or known composition of matter that is statutory patent eligible under 35 U.S.C. §101 be deemed preemptive of a product of nature or natural phenomenon when the new use of the known process or known composition of matter is limited to the detection of the product of nature or natural phenomenon?
In proposing answers to these questions, the amicus brief recites claim 1 of U.S. Patent No. 6,258,540 as being representative of the claims at issue:
A method for detecting a paternally inherited nucleic acid of fetal origin performed on a serum of plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
The brief argues that 35 U.S.C. § 100(b) expressly specifies that the term "process" used in § 101 encompasses "a new use of a known process, machine, manufacture, composition of matter, or material" (emphasis in brief). The claims at issue fall within the scope of this definition, being either a new use of a known process (amplification and detection of cffDNA) or a new use of an old composition of matter (naturally occurring cffDNA) (or both). The brief asserts that amplification and detection of DNA is patent eligible (assuming it could satisfy the other requirements of the statute); the brief cites the numerous patents granted to various aspects of in vitro amplification including, inter alia, U.S. Patent No. 4,683,195. The brief also argues (with less force) that plasma or serum would also be patent eligible; in a footnote the amicus notes that plasma and serum must be separated "by the intervention of man" and that plasma and serum have properties that differ from blood, thus satisfying the requirements of Diamond v. Chakrabarty not disturbed by either Mayo v. Prometheus or AMP v. Myriad. However, the brief makes the more interesting argument that, following the District Court's reasoning, claims to amplifying and detecting DNA that are patent eligible become less patent eligible when narrowed to a specific application of the technology (here, detecting cffDNA). Established patent law would be "eviscerated if a diagnostic process which, when broadly claimed, would be patent eligible if the requirements of novelty and unobviousness were satisfied becomes ineligible for patenting when narrowed if that narrowing involves applying the process to the new use of detecting a hitherto unknown product of nature or natural phenomenon, in this case the presence of cffDNA of paternal origin in maternal blood."
Amicus also argues that the claims of the '540 patent satisfy the "machine or transformation" test, which the brief argues is "a useful and important clue . . . for determining whether some claimed inventions are processes under §101," citing Bilski v. Kappos. The "substantial manipulation" required in the practice of the invention likewise provide "yet further clues to the patentability of the claims" and "justify[] recognition of the patent eligibility of the '540 patent claims."
The tension between the Supreme Court's Mayo decision and its earlier Diamond v. Diehr precedent is recited by the brief with regard to "the rigid application of the language of [Parker v.] Flook and Mayo which'"stands in stark contrast to the observation in Diamond v. Diehr [] that '[it] is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be patentable.'"
The brief then walks through earlier Supreme Court precedent related to the patent eligibility of process claims. These include Cochrane v. Deener (which the brief cites as the first decision recognizing that a new process can be patent eligible even if "not limited to any special arrangement of machinery"); Funk Bros. Seed Co. v. Kalo Inoculant Co. (which the brief distinguishes from the claims at issue because the '540 patentees "did not seek to patent this phenomenon but instead patented a process which, as the record in this case clearly reflects and the District Court acknowledges, takes advantage of the knowledge of that natural phenomenon by applying it to a new and very useful end, the detection of a cffDNA of paternal origin in the maternal blood" and noted that even the Funk Bros. Court recognized that claims to applications of natural phenomena were patent eligible); and Diehr. In particular, the brief cites the portion of the Myriad decision where Justice Thomas noted with approval the patent eligibility of applications of the patentees' knowledge of the BRCA genes and the relationship of mutations in those genes to an increase propensity for developing cancer. And the brief distinguishes the claims at issue from the claims invalidated by the Supreme Court in Mayo, on the grounds that nothing in the claims at issue in Mayo other than the natural law was inventive and in fact was well known and extensively practiced in the prior art.
These arguments lead this amicus to propose a rule, that "a process claim which is directed to a new diagnostic use of a known process and/or known composition of matter that are otherwise eligible for patenting under §101 be itself considered patent eligible in the circumstance where the diagnosis is specifically directed to the detection of a previously unknown natural product or natural phenomenon of diagnostic significance." The predicted consequence is that "[a]doption of such a standard of patent eligibility will also do much to further and incentivize innovation to discover and exploit new diagnostic tools without restricting other applications of the product of nature or natural phenomenon such innovation reveals, all of which is to the substantial benefit of the public."
