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Experimental use exception doesn’t apply to gene patents

Stephanie Huang, 2023 - J.D. Candidate, 2024, Fordham University School of Law “Silly Gene Patent is Not My Lover: A Retrospective Analysis of Myriad,” 34 Fordham Intell. Prop. Media & Ent. L.J. 160 (). Available at: https://ir.lawnet.fordham.edu/iplj/vol34/iss1/4 //DH

With respect to the pro-gene patenting argument that an experimental use exception for academic research exists (i.e., that patent owners may opt out of enforcing their patents against academic researchers conducting basic scientific research), there is no such equivalent for genetic testing.202 Using Myriad’s cease-and-desist crusade discussed in Part I as an example, patent owners tend to aggressively enforce their patent rights against both commercial competitors and academic researchers alike in the genetic testing space.203 This has had a detrimental impact on commercial testing activity.204 To avoid any potential trouble, a testing facility would most likely discontinue offering such services upon receiving a cease-and-desist letter because “diagnostics produce relatively low profits.”205 In fact, one study found that “twenty-five percent of clinical laboratories stopped performing a clinical genetic test because of patent concerns, and fifty-three percent did not develop a new test because of such concerns.”206 Because genetic testing in clinical settings also generates data from which “fundamental biological knowledge” may be gleaned, such inhibitory effects of gene patents on testing do in fact impact scientific progress.207

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