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Mayo Collaborative Services v. Prometheus Laboratories, Inc. Decision

On Tuesday, March 20, 2012, the U.S. Supreme Court issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In a unanimous decision, the Supreme Court sided with Mayo and held that method claims involving administering a drug to a patient and determining the effect were not patentable subject matter. The court concluded that the method was directed to a “law of nature” and therefore not patentable.

Prometheus’ patented methods included two steps: (a) “administering” a drug that provides the thiopurine to a subject; and (b) “determining” the levels of the drug’s metabolites created in the subject. Presumably the invention identified likely harm or ineffectiveness of the drug based on the determined metabolite levels.

The Supreme Court addressed the question of whether the claims do significantly more than simply describe a natural relationship. The court’s response to that question was “no.” The Manual of Patent Examining Procedure §2105 (8) provides that laws of nature are not patentable and correspondingly claims that merely recite processes of nature are likewise not patentable. In this case, Prometheus’ claim attempts to identify the correlation between the presence of a drug metabolite to the effectiveness of the administered drug. However, a compound introduced into a biological system will produce metabolites naturally as the compound is utilized or degraded by the system. Consequently, without more the claim merely recites the natural effect of metabolism. In this case, the patented claims did not add enough to these correlations to qualify as patent eligible processes.

Beyond this the court also postulated that such claims if allowed would likely foreclose more future inventions than the underlying discovery could reasonably justify. As it related to Prometheus’ patent claims, the court noted “they tie up the doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the imprints he has drawn using the correlations. And they threaten to inhibit the development of more refined treatment recommendations (like that embodied in Mayo’s test), that combine Prometheus correlations with later discovered features of metabolites, human physiology or individual patient characteristics.”

The impact of the court’s decision on the fields of pharmaceuticals and biotechnology remains unclear. However, it may change the order in which the court hears infringement cases. Prior to this decision, the courts had considered the Plaintiff’s infringement cause of action first in a lawsuit, later deciding the Defendant’s counter complaint that the claims are invalid. Now the threshold issue in patent enforcement may turn first on whether the patent claims are valid before deciding whether there has been an infringement of issued claims.

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