Intellectual Property

Changes Coming To Section 101 Patent Eligibility?

Senators have expressed a serious interest in patent reform -- that is, strengthening the rights of patent holders.

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Earlier this month, U.S. Senators Tillis (R-NC) and Coons (D-DE), the Chair and Ranking Member of the (newly revived) Senate Judiciary Subcommittee on Intellectual Property and Representatives Collins (R-GA), Ranking Member of House Judiciary, Johnson (D-GA), and Stivers (R-OH) released a “framework” on Section 101 patent reform. While legislative language has yet to drop, here are some quick thoughts on the “framework” document.

First, keep in mind Senators Tillis and Coons have both expressed a serious interest in patent reform and it’s always been clear that such reform would take the shape of strengthening the rights of patent holders. Indeed, according to Tillis, the senators requested re-instatement of the Subcommittee on IP to specifically address patent reform and both have been critical of SCOTUS decisions limiting patentability. In particular, Tillis and Coons have targeted Section 101, the portion of the Patent Act addressing subject matter eligibility and have already engaged stakeholders on this issue. The release of the framework document and much of the content is, therefore, not a surprise.

Over the past several years, SCOTUS has addressed patent subject matter eligibility in several cases, often unanimously reversing the Federal Circuit. For example, in Mayo v. Prometheus (a method of giving a drug to a patient then using measurements to determine whether the dosage needs to be increased or decreased was directed to natural law and not patentable subject matter); Association for Molecular Pathology v. Myriad Genetics (isolated DNA is a product of nature and, as such, ineligible for patent protection); and Alice Corp. v. CLS Bank International (computer-implemented process covering abstract ideas was not enough to transform a non-patentable idea into patentable subject matter), SCOTUS unanimously ruled against patent eligibility for the patents at issue. It is under this landscape that patent holders have lobbied Congress to “fix” the Patent Act, claiming that SCOTUS’s decisions are anti-innovation.

The released framework proposes to amend Section 101 by having a defined, closed list of subject matter that is not eligible for patent protection. In other words, everything would be subject-matter eligible for a patent unless it fell under a specific exclusion. The framework includes several categories of potential exclusions (though it says “might include” and we can certainly expect lobbying to narrow or remove some of these): 1) fundamental scientific principles; 2) products that exist solely and exclusively in nature; 3) pure mathematical formulas; 4) economic or commercial principles; and 5) mental activities. Some of these exclusions appear to target recent SCOTUS rulings on patent eligibility. For example, the isolated BRCA genes discovered in the Myriad Genetics case may not fit under the definition of “products that exist solely and exclusively in nature,” depending on how final language is crafted, since isolated DNA exists as part of a larger sequence in nature. Narrowly drawn exclusions could also target Mayo v. Prometheus and Alice Corp. The framework explicitly states an intention to also include a “‘practical application’ test to ensure that the statutorily ineligible subject matter is construed narrowly.” This approach would eliminate judicially created exceptions to subject matter eligibility through a closed and narrow list.

Another proposed change to Section 101 would be to focus eligibility solely on the utility requirement, removing the current requirement that the invention or discovery represent a “new and useful” process or article.   This change would lower the threshold for eligibility but would not eliminate the novelty requirement. Instead, once determined to be eligible, the invention or discovery would also need to demonstrate the conditions for patentability thresholds in Sections 102 and 103. Section 102 clearly establishes that the invention must meet a novelty standard. Section 103 provides the non-obvious requirement. Ultimately, this change may not make a huge difference since inventions that are not new could still be rejected under a Section 102 analysis.

While legislative language stemming from this framework will likely create greater clarity and could promote investment in the patent industry, exceptions cast too narrowly could potentially lock up fundamental building blocks that are currently not patent eligible (such as isolated DNA). Even with a narrow, closed list of non-patent-eligible subject matter, courts could still find that inventions or discoveries outside that list are not eligible based on Article I, Section 8, Clause 8 of the Constitution. The Constitutional rationale for the intellectual property system is “to promote the progress of science and useful arts,” which SCOTUS has repeatedly pointed out, serves as both a grant of Congressional power, as well as a limitation. If the closed list of exclusions are deemed to be too narrow, a Constitutional challenge could emerge.

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Krista L. Cox is a policy attorney who has spent her career working for non-profit organizations and associations. She has expertise in copyright, patent, and intellectual property enforcement law, as well as international trade. She currently works for a non-profit member association advocating for balanced copyright. You can reach her at kristay@gmail.com.

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