Supreme Court Overturns Personalized Medicine Patents, Creating Confusion In Diagnostics Realm
This article was originally published in The Gray Sheet
High court rules the processes covered by two patents to determine proper drug dosages based on metabolite concentrations do not transform unpatentable natural laws into patent-eligible applications.
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While the mobile health sector and digital health in general is poised for a major boom, a 2014 case, Alice Corp. v. CLS Bank International, continues to be a major hurdle for manufacturers wanting to patent their software. While there are some recent positive trends, attorneys recommend caution and proactive steps to make the best of the current patent environment.
Development of products derived from natural sources will be deterred by PTO’s factor-based approach to patent eligibility, firms contend, noting special concern about examples given in the office’s recent guidance document.
Concerns over patents, the anticipated regulatory oversight over complex tests, and reimbursement and evidence development characterized the continued upheaval in the diagnostics industry over the past year. However, genomics tools and technologies continue to be refined and introduced commercially, and companies with a sharp marketplace focus are showing they can still rise to the top.