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Journal of Technology Law & Policy

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Document Type

Note

Abstract

This Note addresses the following question: Can a licensing agreement be drafted to preserve patentability of unknown genetic material before its specific use has been discovered?

To answer this question, the current utility standard set forth in 35 U.S.C. § 101 must be addressed. This standard does not allow patenting of genetic material without a defined specific use. To satisfy the specific utility requirement, a specific gene, promoter, or other use must be identified. Therefore, the genetic material mentioned above is not initially patentable because of 35 U.S.C. § 101 constraints.

Next, case law dealing with ambiguously drafted licensing agreements and 35 U.S.C. § 102(b) govern court decisions regarding this particular issue. This Note seeks to analyze current case law and to define the term commercial sale, and to distinguish a commercial sale from a license. However, inspection of the current case law provides little help in distinguishing a commercial sale from a license. Due to this discrepancy, this genetic material may be deemed on-sale and ultimately not patentable according to current patent law standards. Since this uncertainty exists between patent law and licensing, inventors will hesitate to license their material before filing a patent application. This reluctance to license their material will stymie “the [p]rogress of [s]cience and [the] useful [a]rts”—the very reason the U.S. patent system was founded.

Finally, to clarify this current ambiguity between licensing agreements and the on-sale bar, rules differentiating commercial sales and licenses have been proposed. Furthermore, these proposed rules allow for preservation of patentability if a licensing agreement is reached prior to the critical date set forth in 35 U.S.C. § 102(b) and no patent misuse is found.

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