Originally published in Bio-Science Law Review - November 2012.

On 20 March 2012, in Mayo Collaborative Servs v Prometheus Labs, Inc., the Supreme Court of the United States invalidated diagnostic treatment process claims for effectively claiming the laws of nature underlying the claimed invention. To reach this decision, the court reviewed the ‘guideposts’ set by its previous guidance regarding patent eligibility, and compared the claims-at-issue with those previously considered by the court. In Mayo, the court erected a new guidepost, one with particular relevance for the medical community, as the decision specifically addresses medical diagnostic treatments, but also one which may impact the general patentability of any invention that relies upon laws of nature or natural correlations to describe that invention.

Some patent attorneys in the United States fear that the court’s invalidation of the medical diagnostic patents at-issue may unduly limit the patentability of future innovation in the medical community. This fear, in some respects, has already come to fruition in that a US District Court recently used Mayo’s guidance to invalidate claims drawn to methods and systems for selecting a therapeutic regimen, as discussed further below.

Further, while the effect of Mayo is not yet clear, and may not be for years, another concern is that the court unduly expanded the patent eligibility doctrine beyond its ascribed ‘screening function’ and blurred the distinction between patent eligibility and the concepts of anticipation and obviousness.

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