The Federal Circuit’s recent decision in Assoc. for Mol. Pathology v. USPTO (informally referred to as the Myriad decision), provides some clarity to entrepreneurs and scientists working in the personalized medicine industry. The court overturned the district court decision and confirmed that isolated DNA molecules are patent-eligible subject matter as they “have a distinctive chemical identity and nature — from molecules that exist in nature.” The court did not limit patent eligibility to cDNA, as had been suggested by the U.S. government in its amicus curiae brief. Judge Kimberly Moore’s concurrence highlights an important policy further supporting the majority decision. The settled expectations of the biotechnology industry should not be taken lightly and deserve deference. Nevertheless, the court found some of the disputed method claims patent eligible and some not. The claims that included only steps of analyzing and comparing DNA sequences were found not to be patent eligible, whereas the claim that included steps of growing cells and determining their growth rate were patent eligible.
For those in the personalized medicine industry, the news that isolated DNA molecules remain patent eligible is good news. However, as genetic sequence data proliferates, we can anticipate a time in the not-too-distant future when new genetic variations will be found less often. In the post-genomic age, claims to isolated nucleic acid compositions having a defined sequence or polymorphism will become increasingly rare. Personalized medicine’s greatest innovations lie in teasing out the powers of sequence polymorphisms and marker panel expression levels to predict disease likelihood, severity, activity or therapy response. In the absence of composition claims, these innovations find patent protection through method claims.
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