Intellectual Property Law Firm Florida

DNA and Method Patents With Simple Steps – One Patentable, The Other Non-Patentable Abstract Idea

The Federal Circuit Court of Appeals (the Court that hears all patent appeals) again waded into the murky waters of what is a non-patentable method (a simple abstract idea) and what is a patentable process, machine, article of manufacture, composition of matter, or any improvement thereof.  DNA, when chemically manipulated by a human, is patentable but the method of comparing or analyzing DNA sequences is an abstract idea which is not patentable under the Patent Act.  Ass’n for Molecular Pathology v. U.S. Patent and Trademark Ofc. and Myriad Genetics, Inc., Case No. 2010-1406 (Fed. Cir. Aug. 16, 2012) (available here).

Under the Patent Act, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101.  The Court began by noting that the patent laws would be given wide scope. Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010); Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980); Promethens Labs Inc. v. Mayo Collaborative Servs., 628 F.3d 1947 (Fed Cir. 2010), rev’d, 132 S. Ct. 1289 (2012) and remanded.

Plaintiffs challenged under §101 Myriad’s composition claims directed to “isolated” DNA molecules, its method claims directed to “analyzing” or “comparing” DNA sequences, and its claim to a method for screening potential cancer therapeutics. Myriad argued that an isolated DNA molecule is patent eligible because it is, as claimed, “a nonnaturally occurring manufacture or composition of matter” with “a distinctive name, character, and use.” The Patent Office (USPTO) argued that DNA molecules engineered by man, including the claimed cDNAs,9 are patent-eligible compositions and have been for decades.

The Court stated that one distinction between nonpatentable products of nature and patentable human-made inventions for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature.

The parties in Myriad did not dispute that Myriad’s claimed isolated DNAs “exist in a distinctive chemical form — as distinctive chemical molecules — from DNAs in the human body, i.e., native DNA.”  Per the Court, Myriad’s “isolated DNA, in contrast, is a free-standing portion of a larger, natural DNA molecule,,” the BRCAI gene, isolated BRCAI and BRCA2.  “Although isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body.”

Claim 2 of Myriad’s ’282 patent is narrower than claim 1 and creates a new chemical entity which “is the work of human transformation, requiring skill, knowledge, and effort.” Slip opn. P. 52, citing Mayo, 132 S. Ct. at 1294.  “In this case, the PTO has issued patents relating to DNA molecules for almost thirty years.”   To dirive the point home, the Court stated: a “patent directed to isolated DNA molecules recite patent-eligible subject matter under § 101.”

Myriad’s method or process claims did fare as well as the isolated DNA claims.  “Claims to ‘comparing’ or ‘analyzing’ two gene sequences fall outside the scope of § 101 because they claim only abstract mental processes.”  Citing Benson, 409 U.S. at 67. “This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: one looks at the first position in a first sequence; determines the nucleotide sequence at that first position; looks at the first position in a second sequence; determines the nucleotide sequence at that first position; determines 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 alteration; and repeats the process for the next position.”

Finally, the Court turned its attention to Myraid’s “screening” claims, holding them patentable subject matter under the Patent Act.  “Lastly, we turn to claim 20 of the ’282 patent, directed to a method for screening potential cancer therapeutics via changes in cell growth rates of transformed cells… Claim 20 recites a method that comprises the steps of (1) growing host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, (2) determining the growth rate of the host cells with or without the potential therapeutic, and (3) comparing the growth rate of the host cells.”

“By definition, however, performing operations, even known types of steps, on, or to create, novel, i.e., transformed subject matter is the stuff of which most process or method invention consists …. Furthermore, 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. Accordingly, we hold that claim 20 of the ’282 patent recites patent-eligible subject matter under § 101.”

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