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Supreme Court to Review Patentability of Medical Diagnostic Patents

On June 20th the U.S. Supreme Court granted certiori in the case of Mayo Collaborative Services v. Promethius Laboratories, Inc. This patents at issue are: US Patent No. 6,355,623 and US Patent No. 6,680,302 which involve methods for treating certain gastrointestinal disorders such as inflammatory bowel disease (IBD), Crohn’s disease, and ulceritive colitus.  The patents involve methods for testing the patient’s blood for the presence of 6-thioguanie and administering a particular dosage of 6-meercaptopurine. The method also ensures that the administered drug is not toxic to the subject at the level administered.

Appellant Mayo (defendant in the case below) argues that these patents are invalid because they involve non-statutory subject matter. The question presented is:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

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