Supreme Court Invalidates Claims to Naturally Occurring DNA: What Does This Mean for Gene Patents?

by Knobbe Martens
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Yesterday, the Supreme Court issued a decision in Association for Molecular Pathology v. Myriad Genetics regarding the patentability of genetic sequences.  In a unanimous decision, the Court determined that patent claims to naturally occurring DNA sequences were invalid, but also ruled that claims covering complementary DNA (cDNA) exon sequences were eligible for patent protection. 

The patents at issue claimed genetic sequences of the BRCA1 and BRCA2 genes, two genes whose mutations are associated with an increased risk of breast and ovarian cancer.  Myriad, the patentee, discovered the precise location and isolated the sequence of these genes, and obtained several patents on its discoveries.  One set of claims was directed to any type of isolated BRCA1 DNA that encoded a BRCA1 protein.  A second set of claims covered an isolated sequence of cDNA, a synthetic DNA sequence containing the “exon” regions that code for amino acids. 

The Supreme Court evaluated whether Myriad’s claims were eligible for patent protection under Section 101 of the Patent Act, which allows for protection of new and useful compositions of matter, but does not allow for the protection of naturally occurring phenomena.  The Court ruled that Myriad’s claims to any type of isolated DNA sequence were invalid, even where significant effort was required to isolate such sequences, because such sequences were naturally occurring and thus ineligible for patent protection.   

In contrast, the Court determined Myriad’s claims to cDNA sequences were eligible for patent protection under Section 101.  The Court found that the cDNA sequence was distinct from the naturally occurring DNA from which it was derived, was synthetically produced, and contained a sequence of exon regions that was not naturally occurring.  

This ruling is significant for its determination that composition claims to isolated DNA sequences are not eligible for patent protection if those isolated DNA sequences can be found in nature, and has the potential to impact a wide variety of patent claims to genetic sequences.    In addition, while the Supreme Court determined that cDNA claims satisfied the patent eligibility requirements of Section 101, it expressed no opinion as to whether these claims satisfied the additional requirements for patentability, such as novelty or nonobviousness. 

In view of Myriad, companies should evaluate their portfolios to assess how the Supreme Court’s pronouncements on patent eligibility may impact existing composition claims, not only in the area of genetic sequences, but also in other technologies involving the isolation of naturally-occurring products.  Companies should also review their existing claim strategy in view of the Supreme Court’s comments that techniques for gene isolation, as well as new applications of knowledge regarding genetic sequences, can be eligible for patent protection.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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