The USPTO, Federal Circuit and Congress each have taken recent steps to resolve uncertainty on subject matter eligibility under 35 U.S.C. § 101.

The USPTO has published guidance to provide more consistency during patent prosecution in assessing subject matter eligibility, but its effectiveness depends on whether the courts uphold patents issued in view of the guidance. The Federal Circuit recently declined to follow USPTO guidance, instead following its own precedent to invalidate patent claims. In light of this tension, support has been growing for a legislative solution, which may arrive soon.

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In contrast, Professor Mark Lemley from Stanford Law School testified that a more conservative approach that did not “eliminate two hundred years of legal doctrine” might provide more success in addressing problems in patent eligibility in life sciences while protecting against patent abuse in other areas.