The U.S. Supreme Court ruled on June 13, 2013, in a unanimous opinion, that naturally occurring, isolated DNA is not eligible for patent protection under 35 U.S.C. § 101, but that synthetically created genetic material (e.g., cDNA) is patent eligible.

Myriad scientists identified the location and sequence of the human BRCA1 and BRCA2 genes. More importantly, mutations in these genes were discovered by Myriad to greatly increase an individual’s risk of developing breast and ovarian cancer.

Myriad holds several patents covering this technology, and the patents at issue in this case are directed to isolated BRCA1 and BRCA2 genetic sequences, including isolated DNA and cDNA sequences that code for BRCA1 and BRCA2. The patents gave Myriad the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, and Myriad enforced these patents to preclude others from isolating and sequencing these genes as part of a diagnostic test for susceptibility to breast and ovarian cancer. Myriad’s patents are also directed to method claims for a cell-based assay for screening putative cancer therapeutics. These method claims were held patentable by the Federal Circuit and were not at issue before the Supreme Court.

Myriad's Patent Validity Challenged

Several doctors, patients, and advocacy groups sued Myriad for invalidity of its patents under 35 U.S.C. § 101. The U.S. District Court for the Southern District of New York invalidated Myriad's patent claims to isolated DNA molecules, but the Federal Circuit, noting that its decision was consistent with the longstanding practice of the U.S. Patent and Trademark Office (USPTO), reversed that decision and held that claims directed to isolated DNA were patent eligible.

In its decision, the Supreme Court holds that the extracted and isolated DNA is merely a "product of nature," putting it squarely within the court's patent eligibility exception. The court noted that, although Myriad's technology was a "medical breakthrough" inasmuch as it found important and useful genes, "extensive effort alone is insufficient to satisfy the demands of § 101."

Myriad argued that the USPTO's past practice of awarding gene patents was entitled to deference. The court dismissed this argument, noting that the United States had taken a position in the case that isolated, naturally occurring DNA was not patent eligible under 35 U.S.C. § 101.

Implications of Ruling

The court’s decision in Myriad is intended to be a narrow one. Justice Clarence Thomas, writing for the court, made sure to note that method claims, new applications of knowledge relating to BRCA1 and BRCA2 genes, and naturally occurring nucleic acid molecules that have been altered were not at issue in the case.

One immediate and significant impact of the Myriad decision will be its affect on licensors of gene patents. Licensees of such patents may choose to avoid payment of royalties based on the invalidity of certain claims pursuant to Myriad. In these situations, patent holders should review affected patents in their portfolios to determine if corrections can and should be made to bolster the patent eligibility of the claimed subject matter. These potentially valuable corrections may be effected through the use of continuation and/or reissue applications. If a reissue application may be required, patent holders should consult a patent attorney experienced in post-issuance practice.

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