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Guideline Change

The US Patent and Trademark Office has issued a set of revised guidelines that Ed Silverman at Pharmalot says may make it easier for biotechs and drug makers to receive patents.

The initial guidelines, Silverman notes, were released in March in response to the Supreme Court's rulings in Association for Molecular Pathology v. Myriad that isolated DNA cannot be patented and in Mayo v. Prometheus that a test correlating metabolites to drug dosage cannot be patented, and they aimed to help examiners determine what is and what is not patent eligible.

But, industry trade groups argued that these guidelines were too restrictive and Leanne Rakers, an intellectual property attorney at the Harness Dickey law firm, tells Silverman that "[t]he guidance went beyond what the Supreme Court was saying in those cases."

These revised guidelines instead instruct examiners to take a more "integrated approach," Silverman says. As he notes, under these new guidelines, a patent describing a "combination of two or more materials with different characteristics than what exists in nature may be eligible. This was unlikely to be considered eligible for a patent according to the March guidelines."

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