Ass’n for Molecular Pathology v. United States Patent and Trademark Office, 2011 U.S. App. LEXIS 15649 (Fed. Cir. July 29, 2011) (LOURIE, MOORE, concurring in part; BRYSON, concurring in part and dissenting in part) MyriadGenetics07292011.fc
Major issues: claims to isolated genes; claims to comparing gene sequences to detect cancer; Bilski; patent eligible subject matter
In a much-watched case, known generally by the name of the patent owner, Myriad Genetics, a Federal Circuit panel addressed Section 101 issues concerning claims to isolated DNA and to methods of screening for cancer by DNA testing. The panel also addressed the issue whether the plaintiffs, “an assortment of medical organizations, researchers, genetic counselors, and patients” had “standing under the Declaratory Judgment Act to challenge Myriad’s patents.”
On standing, the Federal Circuit held that “at least one plaintiff,” a doctor, had standing. On the merits, the majority distinguished between claims to isolated genes and screening by cell growth rates and claims to methods of comparing DNA sequences. The former but not the latter were for patent eligible subject matter.
Pertinent to this decision is the Supreme Courts June 20, 2011 grant of certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, CPLRG 0071 (Fed. Cir. 2010), which involves Section 101 issues on patent claims concerning medical diagnostics.
UPDATE: The Supreme Court reversed in the Prometheus case. See CPLR 0079. On March 26, 2012, the Supreme Court remanded the Myriad Genetics case. Thereafter, on August 16, 2012, the Federal Circuit, in a divided panel decision, affirmed its prior approach. Myriad2012.fc Thus, applying Mayo, the majority held that the “composition claims to `isolated” DNA molecules” did not “cover patent-ineligible products of nature under § 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter.” It also held that the “method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells” as not “directed to a patent-ineligible scientific principle.” However, it held that the “method claims directed to `comparing’ or `analyzing’ DNA sequences are patent ineligible” because the “claims include no transformative steps and cover only patent-ineligible abstract, mental steps.”
Patents. At issue were seven patents. U.S. Pat. No. 5,747,282; U.S. Pat. No. 5,837,492; U.S. Pat. No. 5,693,473;U.S. Pat. No. 5,709,999; U.S. Pat. No. 5,710,001; U.S. Pat. No. 5,753,441; U.S. Pat. No. 6,033,857. USPatNo5747282 USPatNo5837492 USPatNo5693473 USPatNo5709999 USPatNo5710001 USPatNo5753441 USPatNo6033857
District Court. A district court held the challenged claims in the patents unpatentable under Section 101. See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010).
Isolated DNA Molecules. The majority held that “composition claims to `isolated’ DNA molecules” were not to “patent-ineligible products of nature under § 101” because “the molecules as claimed do not exist in nature.” An example of such a claim was claim 1 of the ‘282 patent: “An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”
The mutations in the human “BRCA1” and “BRCA2” genes were “associated with a predisposition to breast and ovarian cancers.”
The majority reasoned, inter alia, that isolated DNA was, by virtue of how it is obtained, chemical distinct from natural DNA: it is not merely “purified.” The majority rejected a dissenting judge’s analogy to “snapping a leaf from a tree”: “[N]o one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity.”
Method of Screening by Comparing Cell Growth Rates. The majority also upheld that a method claim to “screening potential cancer therapeutics via changes in cell growth rates” as not drawn “to a patent-ineligible scientific principle.” An example of such a claim was ‘282 patent claim 20:
20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
The majority noted that “the claim includes transformative steps, an `important clue’ that it is drawn to a patent-eligible process. Bilski, 130 S. Ct. at 3227. Also,
the claim is not so “manifestly abstract” as to claim only a scientific principle, and not a patent-eligible process. See Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859, 869, CPLRG 0072 (Fed. Cir. 2010). The claim does not cover all cells, all compounds, or all methods of determining the therapeutic effect of a compound. Rather, it is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic. Moreover, the claim is tied to measuring a therapeutic effect on the cells solely by changes in the cells’ growth rate. The claim thus presents “functional and palpable applications” in the field of biotechnology. Id. at 868; see also Prometheus, 628 F.3d at 1355 (“[T]he claims do not preempt all uses of the natural correlations; they utilize them in a series of specific steps.”).
Methods of Comparing or Analyzing DNA Sequences. In contrast, the majority held not patentable “claims directed to “comparing” or “analyzing” DNA sequences.” An example of such a claim was claim 1 of the ‘999 patent.
1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises  comparing a first sequence selected from the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.
Those claims “include[d] no transformative steps and cover[ed] only patent-ineligible abstract, mental steps.”
“[The claims] recite nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position.
The majority distinguished Prometheus (which was written by the same judge, Judge Lourie).
[In Prometheus,] the court held that because the metabolite levels could not be determined by mere inspection, the determining step necessarily required a transformation: `Some form of manipulation … is necessary to extract the metabolites from a bodily sample and determine their concentration.
Myriad’s claims, in contrast, do not include the step of “determining” the sequence of BRCA genes by, e.g., isolating the genes from a blood sample and sequencing them, or any other necessarily transformative step. Rather, the comparison between the two sequences can be accomplished by mere inspection alone. Accordingly, Myriad’s claimed methods of comparing or analyzing nucleotide sequences fail to satisfy the machine-or-transformation test, and are instead directed to the abstract mental process of comparing two nucleotide sequences. The claims thus fail to claim a patent-eligible process under § 101.”