The question of to what extent genes are patentable will be argued before the Supreme Court on April 15. The Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics may finally settle a long-standing controversy.

This whole brouhaha has to do with U.S. Patent Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.  The composition claims cover two “isolated” human genes, BRCA1 and BRCA2 and certain mutations in these genes associated with a predisposition to breast and ovarian cancers. Representative composition claims include claims 1, 2, and 5 of the ’282 patent:

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2.  The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

Patentable Subject Matter

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 Supreme Court has consistently construed § 101 broadly, explaining that “[i]n choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope.” Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (quoting Chakrabarty, 447 U.S. at 308).

Supreme Court  precedents provide three judicially created exceptions to § 101’s broad patent-eligibility principles: “laws of nature, physical phenomena, and abstract ideas.”

Here, the Plaintiffs challenge Myriad’s composition claims directed to “isolated” DNA molecules and method claims directed to “analyzing” or “comparing” DNA sequences under § 101.

Composition Claims: Isolated DNA Molecules

Myriad argues that an isolated DNA molecule is patent eligible because it is, as claimed, “a nonnaturally occurring composition of matter” with “a distinctive name, character, and use.”

The Plaintiffs argue that claims to isolated DNA molecules fail to satisfy § 101 because such claims cover natural phenomena and products of nature. The Plaintiffs assert that to be patent eligible a composition of matter must also have a distinctive name, character, and use, making it “markedly different” from the natural product.

Petition for Certiorari

The petition for certiorari requesting that the Supreme Court review the constitutionality of the matter posed the following questions:

Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing (“isolating”) the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions:

1. Are human genes patentable?

2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?

3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision inMedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its  patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

The Supreme Court has granted certiorari only on question 1.

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  1. […] (For a helpful synopsis of patent law with relation to the Myriad case, also check out Patent Barista.) […]

  2. […] Ass’n for Molecular Pathology v. Myriad Genetics Oral Arguments Set for Monday, April 15, 2013 […]