Mayo’s impact on patent applications related to biotechnology, diagnostics and personalized medicine

Abstract

On the sixth anniversary of Mayo, an empirical study examines the impact of the US Supreme Court decision on patent subject-matter eligibility and patent prosecution of biotech related patent applications before the USPTO. On March 20, 2012, nine judges of the US Supreme Cour t held unanimously that "Prometheus' patents set forth laws of naturenamely, relationships between c o n c e n t r a t i o n s o f c e r t a i n metabolites in the blood and the likelihood that a dosage of a t h i o p u r i n e d r u g w i l l p r o v e ineffective or cause harm" 1 .

One year after Vanda, are diagnostics patents transforming into methods of treatment to overcome Mayo-based rejections?

“…This figure is substantially higher than the allowance rate previously estimated for applications with a 35 USC 101 rejection citing Mayo (35.9%). 2 Additionally, in one of the three abandoned cases, the Vanda a r g u m e n t w a s s u c c e s s f u l i n overcoming the Mayo rejection.…”

“…Specifically, we address the following research questions: The method to answer these questions (Box 1) is derived from similar methods used to analyze the impact of Mayo and Myriad. 2,7,8,9 Results & Examples We identified 407 patent cases where applicants cited Vanda in their response to a USPTO office action containing a 35 USC 101 rejection citing Mayo.…”

“…1 This decision had a significant impact on the threshold of patentability for life sciences inventions, in particular those involving methods of detection, diagnosis, and treatment. 2 One of the outcomes of the Mayo ruling was a vaguely outlined twostep enquiry for determining patent subject matter eligibility. It came to be known as the Mayo/Alice test after it was refined in the subsequent US Supreme Court decision Alice Corp v. CLS Bank (Alice).…”

“…Far from settling the controversy surrounding patent subject matter eligibility, the application of the Mayo/Alice test has remained unclear and its results unpredictable. 2 In an attempt to promote consistent patent examination practices, the USPTO issued several examination guidance documents, providing instructions on the application of this test 3 . This guidance included a list of subject matter eligibility examples in the life sciences.…”

“…We hypothesised in a recent empirical study examining the impact of the Mayo decision that, after Vanda, patent applicants with a rejection for a claim directed to a method of diagnosis might seek to amend the claim during prosecution into a method of treatment claim. 2 This could be done, for example, by including a drug administration step based on the results gathered from the diagnostic test.…”