Tracking the Mayo Effect: Study Examines Personalized Medicine Patent Applications after SCOTUS DecisionApril 4, 2016

The US Supreme Court decided Mayo Collaborative Servs. v. Prometheus Labs. in 2012, effectively redefining the scope of patent eligible subject matter, particularly with respect to biotechnology and personalized medicine. Subsequent decisions by the Court in Myriad and Alice have confirmed what many prognosticators had predicted: a wide-spread broadening of the judicially-created exceptions to patent eligibility.  A new study in the Patently-O Patent Law Journal examines the practical effects of theMayo decision on personalized medicine patent applications pending at the USPTO.

Perhaps unsurprising to practitioners and patent owners in this technology area, the Mayo decision corresponded with a dramatic increase in rejections for lack of patent-eligible subject matter in applications relating to personalized medicine. However, even for those with first-hand experience, the data are a bit staggering: while only 15.9% of office actions issued in cases related to personalized medicine had rejections for lack of subject matter eligibility prior to the Mayo decision, 86.4% of office actions issued after the Mayo decision included such rejections.

Bernard Chao and Amy Mapes, An Early Look at Mayo’s Impact on Personalized Medicine, 2016 Patently-O Patent Law Journal 10.

The preliminary report based on the data does not include analysis of the ultimate outcome of these cases, or of the proportion of the rejections that were successfully overcome, which could be incredibly important in assessing the ultimate practical effects of the Supreme Court’s recent patent-eligibility decisions.

An additional interesting aspect of this study is the effect that the USPTO itself has had on applications through its implementation of examination rules and guidelines in response to the Supreme Court’s patent-eligibility decisions. The USPTO has put forth several versions of its examination guidelines, including revisions in response to both subsequent decisions and, importantly, in response to public feedback. Accordingly, the USPTO has had the benefit of input from experts in both patent practice and the technology area in crafting its approach to patent-eligibility, which may result in divergence from the Supreme Court and/or a change in the current trends.

As noted above, the Supreme Court’s decision in Mayo has been applied to other technology areas to remove patent-eligibility. Thus, these data may represent more broadly-felt changes in patent practice, and the effects in other technology areas (especially in computer and software-related technology) may be even more pronounced. In addition, a petition for certiorari was recently filed for review of the Federal Circuit’s decision in Sequenom v. Ariosa, which applied the Mayo decision to hold methods of detecting paternally-inherited cell-free fetal DNA (cffDNA) in the maternal bloodstream unpatentable.

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