On June 13, 2013, the U.S. Supreme Court issued its highly awaited ruling in Ass’n for Molecular Pathology v. Myriad Genetics, Inc. (the “Myriad case”), unanimously holding that isolated, naturally occurring DNA was not patent eligible, but affirming the patent eligibility of synthetically created cDNA. The Court’s decision affirmed in part and reversed in part the Federal Circuit's holding that both isolated DNA and cDNA were patent eligible under 35 U.S.C. § 101.
In light of the Court’s decision in Myriad, applicants and patentees may wish to evaluate their DNA and/or diagnostic portfolios for risk of potential § 101 challenges by third parties.
For pending and new applications, include claims covering the cDNA of a gene of interest. Applications should include descriptive support for specific cDNA sequences and/or enumerate modifications that distinguish claimed DNA molecules from molecules isolated from natural sources.
For issued patents, patent owners should confirm that their issued claims include claims to nucleic acid molecules that do not occur in nature (e.g., cDNA). If necessary, patent owners may file a reissue application introducing such claims.
For new applications, include claims having different claim strategies (e.g., method claims to use of DNA that satisfy the Prometheus requirements).
Myriad has patents with issued claims to isolated DNA coding for BRCA1, BRCA2, and variants that increase the risk of ovarian and breast cancer (e.g., “[a]n isolated DNA coding for a BRCA1 polypeptide," which has "the amino acid sequence set forth in SEQ ID NO:2.”).
These patents were based on work that Myriad and its institutional collaborators at the University of Utah had performed to identify variant BRCA1 and BRCA2 sequences as biomarkers for increased risk of ovarian and breast cancer.
The patent eligibility of Myriad’s claims had been challenged in district court. The district court ruling was appealed to the Federal Circuit and then to the Supreme Court. In light of its Prometheus opinion, the Supreme Court remanded the case for further review to the Federal Circuit, where the patent eligibility of the claims covering isolated DNA sequences and cDNA was upheld. Because the second Federal Circuit ruling mirrored its previous ruling, the Supreme Court took the case on certiorari, as expected.
The Supreme Court Decision
Two types of claims were at issue before the Supreme Court: (1) composition claims directed to isolated DNA molecules and (2) composition claims directed to complementary DNA (“cDNA”), which does not occur in nature. The Court did not consider method claims involving DNA sequences.
The Court found that isolating DNA molecules was not sufficient to confer patent eligibility, because “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.” The Court found that “Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.” The Court found that merely isolating the genes was not sufficient to render the isolated BRCA1 and BRCA2 genes patent eligible.
The fact that cDNA does not occur in nature persuaded the Court that cDNA is patent eligible. The Court reasoned that “the lab technician unquestionably creates something new when cDNA is made.” As a result, cDNA is not a “product of nature” and is patent eligible under § 101.
In light of the Court’s decision in Myriad, applicants and patentees may wish to evaluate their DNA and/or diagnostic portfolios for risk of potential § 101 challenges by third parties, particularly in light of the new post-grant review proceedings instituted by the America Invents Act (see our Alert on this here). For pending and new applications, inclusion of claims covering the cDNA of a gene of interest is advisable. To satisfy the Myriad requirements, patent applicants should include descriptive support for specific cDNA sequences and/or enumerate modifications that distinguish claimed DNA molecules from molecules isolated from natural sources. For issued patents, patent owners should confirm that their issued claims include claims to nucleic acid molecules that do not occur in nature (e.g., cDNA). If necessary, patent owners may file a reissue application introducing such claims.
The Supreme Court’s decision demonstrates the value of presenting different types of claims within a single application. Interestingly, as the Court noted, method claims were not implicated by the decision. For example, diagnostic claims using DNA biomarkers are not excluded from patent eligibility by the Myriad ruling. It is expected that such method claims would be patent eligible, so long as they satisfy the Prometheus requirements (e.g., including active and/or transformative steps, such as extraction, sequencing, or other processing steps).
It remains to be seen what effect this decision will have on biotech and pharma innovation, but going forward the Myriad ruling restricts the patent protection available to owners of DNA-based technologies.