Myriad Further Limits Patent Eligibility

by William K. Merkel, PhD, JD
Volume 12, Issue 2 (Summer 2013)

The recent decision of the US Supreme Court in Assoc. Mol. Pathol. v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013) continued the Court’s efforts to clarify those innovations eligible for patent protection. Myriad unanimously held that “isolated” BRCA1/2 DNAs were patent ineligible under 35 USC § 1 01 while BRCA1/2 complementary DNAs (cDNAs) were patent eligible under that statutory provision. In considering patent eligibility, the Court proposed a test for isolated DNAs that balances incentives and impediments to innovation arising from patent protection, without placing any weight on whether the innovation relates to nature or to an abstract idea. The Court concluded that the mere act of isolating DNA segments claimed in terms of their genetic information was insufficient to render the claims patent eligible. Although the full effect of Myriad won’t be fully known for some time, it is already apparent that reliance expectations developed over 30 years have been upset. Taking a closer look, Myriad discovered the BRCA1 and BRCA2 genes and their influence on the risks of breast and ovarian cancers. Myriad also located these genes in the human genome, isolated the genes, and determined the sequences of several alleles, or versions, of these genes, with some alleles associated with higher cancer risks than others. This led Myriad to develop and market a diagnostic test for assessing breast and ovarian cancer risk, and to seek patent protection for the technology. Myriad refused to license the technology to competitors, which led to a declaratory judgment suit against Myriad. The district court granted summary judgment to the challengers, holding that Myriad’s isolated BRCA1/2 DNA claims and BRCA1/2 cDNA claims were invalid for patent ineligibility under 35 USC § 101. For reasons not relevant to the patent eligibility of DNA composition claims, the Court of Appeals for the Federal Circuit (CAFC) had two cracks at this case on appeal, and both times it held that isolated BRCA1/2 DNAs and BRCA1/2 cDNAs were patent eligible. On its own second review of the case, the US Supreme Court unanimously and finally decided the appeal of summary judgment, holding isolated BRCA1/2 DNAs patent ineligible, but BRCA1/2 cDNAs patent eligible...

Merkel WK. Myriad Further Limits Patent Eligibility. BioProcess J, 2013; 12(2): 37-41.

Posted online August 1, 2013.