Myriad Genetics Receives Favorable Ruling on Gene Patentability

Myriad Genetics reported that a US federal appeals court has ruled that the company's composition of matter claims covering isolated DNA of the BRCA1 and BRCA2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.

The US Federal Circuit Court of Appeals upheld Myriad’s right to patent the isolated genes, BRCA1 and BRCA2, which are linked to hereditary breast and ovarian cancers. These genes serve as the basis for the intellectual property for the company’s BRACAnalysis test, a predictive test for assessing a woman’s risk for developing hereditary breast and ovarian cancer.

The key issue before the court related to the patentability of isolated DNA molecules and whether and to what degree such molecules are considered products of nature. Isolated DNA is a freestanding portion of a larger, natural DNA molecule. Isolated DNA has been cleaved or synthesized to consist of a fraction of a naturally occurring DNA molecule. Myriad contended that isolated DNA does not exist in nature and that isolated DNAs, unlike native DNAs, can be used as primers and probes for diagnosing cancer. The plaintiffs in this case, which included the Association for Molecular Pathology, contended that to be patent-eligible a composition of matter must also have a distinctive name, character, and use, making it “markedly different” from a natural product. In this case, the plaintiffs asserted that because isolated DNAs retain part of the same nucleotide sequence as native DNAs, they do not have any “markedly different” characteristics.

In ruling in favor of Myriad, the US federal appeals court agreed that “isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity,” said the court in its ruling. “While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. “For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules.”

Myriad supported the court’s decision. "We are very pleased with the favorable decision the Court rendered today which again confirmed that isolated DNA is patentable," said Peter Meldrum, president and CEO of Myriad Genetics, in a company press release. "Importantly, the Court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity."

Myriad owns or has exclusive license rights to 525 claims in 24 US patents relating to BRAC analysis testing. These patents contain multiple claims, including claims relating to compositions of matter on isolated BRCA1 and BRCA2 nucleic acids, compositions of matter on probes and primers, methods of detecting genetic mutations in the BRCA1 and BRCA2 genes, the use for diagnosing a predisposition to breast or ovarian cancer, and general molecular diagnostic technology applicable to BRAC analysis testing.

The genesis of the litigation dates back to 2009 when the Association for Molecular Pathology and other plaintiffs brought a lawsuit against Myriad in federal district court seeking a declaratory ruling that 15 claims of seven Myriad patents relating to the BRCA1 and BRCA2 genes were invalid.  The district court ruled against Myriad, and Myriad appealed the decision. In July 2011, a federal court of appeals reversed the district court’s decision in part, holding that nine composition claims relating to isolated DNA molecules and one method claim relating to screening potential cancer therapeutics were are patent-eligible, but affirmed the lower court’s decision that the remaining five method claims were patent-ineligible. In December 2011, the Association for Molecular Pathology and other plaintiffs in the case filed a petition for a writ of certiorari with the US Supreme Court of the United States seeking the Supreme Court’s review of the decision of the federal court of appeals. In March 2012, the Supreme Court granted the writ of certiorari and remanded the case back to a federal court of appeals for reconsideration in light of the US Supreme Court’s recent decision in Mayo v. Prometheus Laboratories, in which the US Supreme Court ruled that the relationship between the concentrations of blood metabolites and response to a therapeutic drug in two patents owned by Prometheus Laboratories were unpatentable.

In its ruling last week on upholding the patentability of isolated DNA molecules, the federal appeals courts also upheld that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is patent-eligible. The federal appeals court, however, ruled that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent-ineligible because such “claims include no transformative steps and cover only patent-ineligible abstract, mental steps,” said the court.