Supreme Court Of The United States Reversed The Federal Circuit On Method Claim For Treating Autoimmune Diseases Are Not Eligible For Patent Protection

Washington, D.C. – The United States Supreme Court has unanimously reversed a patent decision by the Court of Appeals for the Federal Circuit and has held that patent claims that are a “law of nature” are not patent eligible under 35 U.S.C. § 101. The decision built upon the Court’s 2010 decision in Bilski v. Kappos.

Patent lawyers for Prometheus Laboratories, Inc. of San Diego, California filed a patent infringement suit against Mayo Collaborative Services, doing business as Mayo Medical Laboratories of Rochester, Minnesota, alleging that Mayo infringed patent no. 6,355,623, Method of treating IBD/Crohn’s disease and related conditions wherein drug metabolite levels in host blood cells determine subsequent dosage and patent no. 6,680,302, Methods of optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders which have been issued by the US Patent Office.

The patents at issue involve claims over an observed correlation between certain blood tests and patient health, specifically the correlation between the level of certain drug metabolites in the patient’s blood and the patient’s symptoms of gastrointestinal disease. The Court of Appeals for the Federal Circuit had twice ruled in Prometheus’s favor. Oral arguments were held December 7, 2011 at the United States Supreme Court. The Court decision essentially held that Prometheus’s “invention” was not patentable because it was effectively a law of nature. In other words, the relationship between the dosages and the effect on patient health was a natural phenomenon and therefore, unpatentable.

We blogged a preview of this case in October. This ruling is being criticized by the patent bar as making the law less clear. In particular, Robert S. Sachs of Fenwick & West LLP is examining the decision in a series of blogs on Patently-O in which he examines “just some of the logical and legal errors in the Court’s decision.” Sachs commentary also suggests that numerous patents should now be found invalid.

Practice Tip: The Court’s decision has immediately changed protocol at the patent examination office. The US Patent Office has issued new guidelines to patent examiners which are available here.

This case was assigned number 10-1150 in the U.S. Supreme Court. Justice Breyer delivered the unanimous opinion of the Court.



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