On June 7, 2018 the United States Patent and Trademark Office (USPTO) issued a new Memorandum that clarifies its view of Subject Matter Eligibility, under 35 U.S.C. § 101, regarding the patentability of Personalized Medicine discoveries.

The Memorandum was prompted by the Federal Circuit’s recent Vanda decision, where the Court provided its own insights as to the Subject Matter Eligibility of Personalized Medicine patent claims. [1] The claims in Vanda recited a method of treating a patient suffering from schizophrenia with the drug, iloperidone, and included specific steps, such as administering iloperidone to the patient in an amount guided by the genotype of the patient, which can predict the rate of drug metabolism. The Court summarized Vanda by stating: “The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship.”
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For those of you who may have lost hope regarding the patentability of personalized medicine discoveries, here’s some encouragement.  Recently the Federal Circuit affirmed the validity of a patent directed to a method of treating schizophrenia, which is based on genetic testing of the patient. Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., Nos. 2016-2707, 2016-2708, 2018 WL 1770273, —F.3d — (Fed. Cir. Apr. 13, 2018).  The Court found that the claims of U.S. Patent No. 8,586,610 were patent eligible and not drawn to a law of nature under 35 U.S.C. § 101.  Claim 1 is representative and is shown below:
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dnaiStock_000024754431_LargeThe patentability of genes is under scrutiny all over the world.

Several weeks ago, the High Court of Australia shed light upon the patentability of nucleic acids (D’Arcy v. Myriad Genetics Inc.). Similar to the situation in the U.S. for 35 U.S.C. §101, the High Court found that an isolated nucleic acid coding for a mutant BRCA1 protein was not patentable subject matter.
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