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ARTICLE · 10 JULY 2023

It's Time To Review Patent Eligibility For Diagnostic Methods

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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Life science companies invest substantial resources in research and innovation to drive medical advancement.

United StatesIntellectual Property
Kara Specht
Kara Specht
Yinan Liu, Ph.D.
Yinan Liu, Ph.D.
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Life science companies invest substantial resources in research and innovation to drive medical advancement. To maintain the momentum of innovation, it is crucial to ensure clarity and certainty in patent eligibility.

The US Supreme Court in Mayo Collaborative Servs v Prometheus Lab'ys (2012), ruled that the diagnostic patents in suit were invalid because they merely described the natural correlation between the drug's metabolite levels in the blood and its effectiveness. Following Mayo, the Supreme Court, in Alice v CLS Bank Int'l (2014), articulated a two-step test for examining patent eligibility under 35 U.S.C. § 101.

Under this test, a patent claim is ineligible if it 1) is directed to a patent-ineligible concept (such as laws of nature, natural phenomena, and abstract ideas), and 2) lacks elements sufficient to transform the claim into a patent-eligible application.

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