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What are Mayo and Myriad?

What are Mayo and Myriad? Image

Starting with Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S.Ct. 1289 (2012) and continuing into subsequent cases, the Supreme Court has articulated a two-part analytical framework for determining whether a claim is patent-eligible under 35 U.S.C. § 101.  First, it must be determined whether the claim is directed to one of the three judicial exceptions: laws of nature, natural phenomena, or abstract ideas.  If not, the claim is eligible under 35 U.S.C. § 101.  If the claim is directed to one of the three judicial exceptions, it is next necessary to determine whether the claim as a whole amounts to “significantly more” than the judicial exception itself.  This “significantly more” analysis requires one to analyze whether the recited steps or elements, taken alone or in an ordered combination, transform the claim into patent-eligible subject matter.

Mayo dealt with one of three long-established judicial exceptions to patentability under 35 U.S.C. § 101: laws of nature.  The Mayo Court held that methods of administering a thiopurine drug, detecting metabolites of that drug, and determining whether to change the dosage based on the detected level of metabolite were simply reciting a law of nature and were not patent eligible subject matter.

In Association for Molecular Pathology v. Myriad Genetics, 133 S.Ct. 2107 (2013), the Court expanded on Mayo to deal with a different judicial exception: natural phenomena (or “products of nature”).  The Court in Myriad held that naturally-occurring DNA segments, even when isolated from their natural environments, were products of nature and were not patentable subject matter.  In contrast to naturally-occurring DNA segments, however, the Court in Myriad indicated that cDNA (DNA lacking the naturally-occurring non-coding introns) was patent eligible subject matter since such cDNA does not occur in nature.

Mayo and Myriad are each landmark rulings that disrupted long-standing judicial and USPTO precedent, and significantly changed the landscape for obtaining and enforcing patents in the life sciences industry.  Under Mayo and Myriad, claims to both diagnostic methods per se and isolated genes that occur naturally in cells are unpatentable under 35 U.S.C. § 101.  Given the transformational change these cases have effected, it will be interesting to watch how these holdings are applied by lower courts and the USPTO to other life science examples.