University of Southern California

Within Subject Matter Eligibility—A Disease and a Cure

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Article by Allen K. Yu
From Volume 84, Number 2 (January, 2011)

Ever since the Supreme Court pronounced in Diamond v. Chakrabarty that “Congress intended statutory [patentable] subject matter to include anything under the sun that is made by man,” the thrust of subject matter eligibility has been broadly to include all subject matters that are not “laws of nature, physical phenomena, and abstract ideas.” In essence, subject matter is eligible for protection under the patent laws if it is man-made and is ineligible if it is a part of nature. Such a definition of subject matter eligibility is, unfortunately, unhelpful in the biomedical context. A basic discovery involving a new pathological pathway, for example, represents an advancement of both basic knowledge about nature as well as basic know-how in diagnosing and treating human diseases. A successful isolation of a gene, protein, or cell represents a triumph both for our understanding of nature as well as our ability to diagnose and treat human diseases. This Article argues that subject matter eligibility should neither be a mere prohibition against the patenting of nature and abstract ideas, a mere pseudorequirement to enforce other patentability requirements, nor a mere exercise in the statutory interpretation of 35 U.S.C. § 101, but a unique constitutional requirement to ensure that the patenting of eligible subject matter promotes the useful arts. To take into account the cost side of patenting, eligibility may be defined in part as a prohibition of the patenting of “basic tools of scientific and technological work.” To ensure that knowledge that can be provided freely to the public is not unwittingly removed from the public, eligibility may be defined in part by distinguishing “inventions” from “discoveries,” as viewed from a person skilled in the art. To accentuate the role patents play in a nation’s larger Industrial Policy, eligibility may be limited to “industrial applications” and “technology” that are the purview of Industrial Policy. This Article emphasizes the importance of viewing the patent regime not just as a property system, but as part of a larger regulatory regime for promoting innovations.

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