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S4 | MONDAY, APRIL 13, 2015 | Litigation
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Nature-Based Claims
And the Patent-Eligibility Landscape Post-‘Mayo’ and ‘Myriad’
BY ROBERT GUNTHER, CHRISTOPHER NOYES AND OMAR KHAN
The Supreme Court recently decided two cases in which the central question was whether certain patent claims involving natural materials and biomolecules constituted patent eligible subject matter under 35 U.S.C. §101. In Mayo Collaborative Services v. Prometheus Laboratories,1 the U.S. Supreme Court held that patent claims to “relationships between concentra- tions of certain metabolites in the blood and the likelihood that a dosage ... will prove ineffective or cause harm” are not patent eligible because they generally recite a law of nature, and the addition of cer- tain claim steps directed to “well understood, routine, conventional activity” does not change that con- clusion. In Association for Molecu- lar Pathology v. Myriad Genetics,2 the court held that “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”
Shortly after the Supreme Court’s decision in Myriad, the Patent Office published the 2014 Interim Guidance
on Patent Subject Matter Eligibil-
ity (Guidance), which sets forth a three-step inquiry for evaluating the
patent eligibility of claims involving
natural and biologic material.3 The
Patent Office’s Guidance also pro-
vides illustrative examples of pat-
ent eligible, and ineligible, claims involving natural principles and/or products, including claims directed
to various nature-based bacterial mixtures, genetically modified bac-
teria, nucleic acids, purified proteins, anti- bodies and food.
While the PTO is still soliciting public feed- back and continuing to grapple with the pro-
ROBERT GUNTHER and CHRISTOPHER NOYES are partners, and OMAR KHAN is counsel, at Wilm- er Cutler Pickering Hale and Dorr in New York. JEFFREY COLEMAN, an associate, assisted in the preparation of this article.
spective effects of Mayo and Myriad, federal district courts and the Federal Circuit have been contributing to a growing body of case law that is likely to decide the fate of exist- ing patent claims involving natural materials and biomolecules. In this article, we review recent cases applying Mayo and Myriad and examine how courts have analyzed the patent eligibility of compositions reflecting genetic information (e.g., certain primers, man-made mutations and clones)4 and method claims involving natural materials and biomolecules
(e.g., certain methods for correlating, ampli- fying and sequencing DNA).5
The Section 101 Threshold
Section 101 of the Patent Act is the sole tool for assessing whether a claim is directed to patent eligible subject matter.6 Discoveries of “new and useful ... composition[s] of matter, or any new and useful improvement thereof” are patent eligible.7 Laws of nature, natural phenomena, and abstract ideas, however,
are not.8 The Supreme Court has long held that these three “judicial exceptions” cannot pass the §101 threshold.9
In Mayo, the patents at issue claimed processes to help doctors treat patients with autoimmune dis- eases and, specifically, to determine whether a given dosage level of thio- purine drugs is too low or too high by identifying correlations between metabolite levels and the likelihood that the drug would be effective The Supreme Court found that the claims did not constitute eligible subject matter because they “set forth laws of nature—namely, rela- tionships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove inef- fective or cause harm.” The court concluded that although the patents recited additional steps in addition to the law of nature, the additional steps were insufficient to transform the character of the claims into pat- ent-eligible subject matter, because those steps “consist of well under- stood, routine, conventional activity already engaged in by the scientific community [which], when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.”
The Supreme Court in Myriad faced the question of whether Myriad’s patents—which claimed the genetic sequence of two genes involved in breast cancer, BRCA1 and BRCA2—were directed at “new and useful” compositions of matter, or if they were instead directed at “naturally occurring phenomena.” The court held that Myriad did not create or alter any genetic informa- tion encoded in the BRCA genes, and Myriad’s success in isolat-
ing the genes by separating them from the genome by breaking chemical bonds was not enough to save the claims. Synthetically cre- ated cDNA was held to be patent eligible, however, because its exons-only chemical structure is not naturally occurring.
Compositions Encoding Gene Information
Primers. Primers are short sequences of synthetic DNA complementary to a specific