On June 13, 2013, the Supreme Court decided Association for Molecular Pathology v. Myriad Genetics, Inc. et al., holding that isolated forms of naturally occurring DNA segments are not eligible for patent protection. The decision changes the strategies for protecting inventions containing isolated, naturally occurring DNA, and may also have implications for inventions relating to other natural products.
Myriad Genetics provides genetic testing services to determine whether an individual has a mutation in the BRCA1 or BRCA2 gene associated with an increased risk of certain cancers, such as breast and ovarian cancer. Myriad owns or controls several patents relating to the BRCA1 or BRCA2 genes and to analytical methods involving the genes.
In 2009, several plaintiffs sued for a declaration that some claims in these patents are invalid, alleging that the claims were not directed to the types of subject matter eligible for patent protection under 35 U.S.C. § 101. The district court agreed with the plaintiffs, holding that all the challenged claims were invalid. That decision was appealed to the U.S. Court of Appeals for the Federal Circuit (“CAFC”), which agreed that some of the challenged method claims were unpatentable but held that the claims to isolated, naturally occurring DNA molecules (and to one of the patented methods) were patent-eligible under § 101.
Subsequently, the Supreme Court decided another important patent-eligibility case, Mayo v. Prometheus, and instructed the CAFC to reconsider its Myriad decision in view of Prometheus. As instructed, the CAFC issued a new opinion — largely identical to the initial opinion.
The Supreme Court accepted review of the CAFC’s new decision.
What the Supreme Court Said
- Claims to an isolated “naturally occurring DNA segment,” such as a claim to an isolated BRCA1 or BRCA2 gene, are not eligible for patent protection. Myriad’s claims directed to the isolated genes, or isolated portions of the genes, are unpatentable products of nature.
- The “extensive research” involved in discovering the genes did not render claims to isolated genes patent-eligible under § 101.
- Claiming “isolated” genes did not salvage Myriad’s claims, as the claims do not “rely in any way on the chemical changes that result from the isolation of a particular section of DNA,” but instead “focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”
- In contrast, Myriad’s claims to complementary DNA (cDNA), in which internal portions of the gene called “introns” have been omitted are patent eligible because the cDNA is not naturally occurring.
What the Supreme Court Did Not Say
- The Court expressed no opinion about the patentability of DNA molecules with an altered (non-naturally occurring) sequence of nucleotides, except for Myriad’s cDNA claims which were patent-eligible.
- The Court expressed no opinion in Myriad about the patentability of claims to inventions using knowledge about the genes, such as diagnostic or therapeutic methods.
- The Court expressed no opinion about the patentability of methods of manipulating genes.
Implications for Future Gene Patenting
Today, few companies rely solely on patenting naturally occurring DNA for competitive advantage. For example, the Human Genome Project was largely complete 10 years ago; those DNA sequences are “prior art” to any new patent applications. However, companies that rely at least in part on DNA patents should reevaluate their patent portfolios and IP strategies.
What You Need to Consider
Companies that rely on patents involving naturally occurring DNA sequences need to reassess their existing patent portfolios and consider readjusting how their inventions are claimed. For example, the Supreme Court suggested that the claims in Myriad were problematic because they did not focus on how the DNA was chemically different from that found in nature. Adding additional claim limitations focused on these chemical differences, in pending patent applications or in a post-grant proceeding, may prove necessary to fortify the claims against an invalidity challenge.
Companies whose patents or patent applications cover other substances that exist in living organisms in nature, such as proteins (e.g., hormones, antibodies, enzymes, etc.), oils, plant extracts, antibiotics and the like, should also revisit their patent strategies. Although the Supreme Court’s decision in Myriad related specifically to DNA, patent litigation defendants will likely attempt to use the Myriad decision to challenge the validity of any claim that covers pure or isolated versions of compounds that also occur in nature.
Importantly, methods of using DNA sequences and other naturally occurring substances remain patent-eligible under Myriad. While the methods still need to comply with the other requirements under § 101 (see Prometheus), companies developing therapeutics or diagnostics based on purified DNA, proteins or other natural materials that have not been synthetically modified should consider the role of method claims in their overall patent strategy.