The Supreme Court Rejects Patenting Some Isolated DNAs
The U.S. Supreme Court unanimously decided Assoc. Mol. Pathol. v. Myriad Genetics, No. 12-398 (2013) on June 13, holding that naturally occurring patent claims of Myriad Genetics relating to BRCA1 and BRCA2 gene DNA segments were patent-ineligible products of nature. "[S]eparating that gene from its surrounding genetic material is not an act of invention." The Court further held that complementary DNA, or cDNA, containing a nucleotide sequence that is not naturally occurring, by virtue of removal of non-coding intron sequences, is patent eligible. The Court expressly refrained from speaking to methods, applications of DNAs, or DNAs "in which the order of the naturally occurring nucleotides has been altered." The opinion reversed-in-part and affirmed-in-part the decision of the Court of Appeals for the Federal Circuit.
Although this decision pertained specifically to Myriad’s BRCA-related patents, it follows on the heels of decades of practice by the US Patent and Trademark Office (PTO) issuing patents with claims to isolated nucleic acids, and therefore potentially impacts many patent portfolios. The PTO already has issued a preliminary memo instructing examiners how to apply the decision to pending applications. We expect to see further guidance published by the PTO and further lower court decisions addressing whether Myriad affects the eligibility of other varieties of patent claims.
If you have questions or concerns relating to the ramifications of Myriad on your portfolio, please contact an attorney or agent in the biotechnology practice group.
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