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Negative test result by using rapid test device for COVID-19As we approach the second year of the COVID-19 global pandemic, diagnostic testing has become a gateway governing the ability to participate in “typical” activities of daily life. While not fail-safe, COVID-19 diagnostic tests are presently the best available means to assess whether an individual is infected with the coronavirus that causes COVID-19 and could spread this virus to others. As a society, we have been forced to rely upon these diagnostic tests to engage in the behaviors of the pre-COVID world. From spending the holidays with family to crossing state lines, frequent COVID testing is now strongly encouraged, if not required. As a result, our access to the world is tied to proffering a biological sample to confirm we do not presently carry coronavirus.

Despite the real-world import of diagnostic testing, patent law has evolved to seemingly discount the importance of innovation in diagnostic testing. And at this point, diagnostic testing could be viewed as presumptively ineligible for patent protection in view of recent decisions interpreting 35 U.S.C. §101, the statute governing patent‑eligible subject matter. Indeed, following the U.S. Supreme Court’s landmark decision in Mayo v. Prometheus in 2012, the Federal Circuit’s judges have expressed a deep concern that there is “a per se rule that diagnostic kits and techniques are ineligible.” Athena Diagnostics, Inc. v. Mayo Collaborative Servs., 927 F.3d 1333, 1354 (Fed. Cir. 2019).

But recent Federal Circuit precedent has given some hope that, through the use of artfully‑drafted claim language, diagnostic tests may still be eligible for patenting. And in view of the central importance of diagnostic testing to the present COVID-19 crisis, the policy considerations that underlie strengthening innovation incentives in the diagnostic space have become more compelling and more urgent.

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