Biologics Blog

Lawmakers Release Framework for Section 101 Reform

On April 17, 2019, several lawmakers from the Senate and House of Representatives released a bipartisan, bicameral framework for statutory reform of 35 U.S.C. § 101.  The framework was released about two months after the revival of the Senate Judiciary Subcommittee on Intellectual Property.  For the past several years, innovators, the Patent Office, and even judges on the Federal Circuit have raised concerns that Section 101 has become a runaway law for invalidating patents that reflect genuine advances in science and technology.  The revival of the Senate subcommittee and the release of this framework indicate that Capitol Hill has heard, and is moving towards a response to, these concerns. 

The framework was announced by U.S. Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.), respectively Chair and Ranking Member of the Senate Judiciary Subcommittee on Intellectual Property, and Representatives Doug Collins (R-Ga.), Ranking Member of the House Judiciary Committee, Hank Johnson (D-Ga.), Chair of the House Judiciary Committee’s Subcommittee on Courts, Intellectual Property and the Internet, and Steve Stivers (R-Ohio).  Tillis and Coons have been meeting with industry representatives since December 2018 to discuss Section 101 reform.  “The release of this framework comes after multiple roundtables and extensive discussions with stakeholders who would be affected by reforming Section 101. Senator Coons and I look forward to receiving feedback from the release of this framework and encourage anyone who might potentially be affected to contact our office and offer us input,” Senator Tillis said in a press release.   

The framework is a simple outline for Section 101 reform.  It calls for defining, in the statute, “a closed list” of “exclusive categories” of subject matter that would be ineligible for patent protection.  The examples provided include “[f]undamental scientific principles,” and “products that exist solely and exclusively in nature.”  To ensure a fresh start, the reform would “[s]tatutorily abrogate judicially created exceptions” to patent eligibility.  Acknowledging the possibility of using clever draftsmanship to circumvent these exclusive categories, however, the framework states that the reform would “[e]nsure that simply reciting generic technical language or generic functional language does not salvage an otherwise ineligible claim.”  Responding to concerns that recent case law has blurred the lines between Section 101 other statutory requirements for patenting, the framework says that under the reform, patent eligibility would be determined “without regard to considerations properly addressed by 102, 103, and 112.” 

Although the one-page framework has a long way to go before it leads to new law, the bipartisan proposal signals that the wheels of change to Section 101 have been set in motion.  The proposed abrogation of “judicially created exceptions” to patent eligibility in favor of a closed list of enumerated statutory exclusions and the explicit separation of Section 101 requirements from those of other patent provisions are no doubt a relief to stakeholders who have been fighting for patent eligibility reform.  But open questions remain.  For example, as more detailed legislative proposals take form in the coming months, stakeholders in the life sciences space will be paying close attention to how diagnostic method patents—like those invalidated in Athena v. Mayo or even more recently in Cleveland Clinic v. True Health—would fare under a new Section 101 patent eligibility framework.

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