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More Biopharma Patent Murkiness Ahead

Executive Summary

Drug makers were hoping the Supreme Court would take up diagnostic manufacturer Sequenom Inc.'s appeal to better clarify US patent laws. But the high court on June 27 declined to hear the case – meaning there's more murkiness ahead in determining how solid the protections are for US innovators' intellectual property.

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Good, bad & uncertainty of new patent guidelines

Ever since the US Patent & Trademark Office (US PTO) issued guidance this past March aimed at addressing two Supreme Court rulings that rocked the life sciences sectors – Association for Molecular Pathology v Myriad Genetics and Mayo Collaborative Services v Prometheus Laboratories – unsatisfied patent lawyers and biopharmaceutical firms have eagerly awaited revisions to the agency's document.

US Capitol Capsule: Patent rejections expected to rise under post-Myriad guidelines

In laying down new guidelines for examining patent claims, the US Patent & Trademark Office (US PTO) has taken a broad interpretation of the US Supreme Court's unanimous ruling last June that declared a naturally occurring DNA segment is a product of nature and not patent eligible "merely because it has been isolated," legal experts said.

Patent 'mischief' lurks after Myriad

In declaring that isolated DNA is not patent eligible, but cDNA is, the US Supreme Court has left open the opportunity for mischief for further attempts to narrow or undermine the patentability of DNA genetic materials in a broader sense, said San Francisco lawyer Robert Sachs, a partner in the Intellectual Property Practice Group at Fenwick & West.

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