Some clarity to method of treatment claims from the Supreme Court?

April 29, 2020

Intellectual Property Alert

Author(s): Ravinderjit Braich, Ph.D.

When is a method of treatment not eligible for patent protection under section 101? When said method requires selectively administering treatment to some patients while withholding the treatment to other patients according to a divided Federal Circuit panel in INO Therapeutics LLC v. Praxair Distribution Inc.[i] The majority (Chief Judge Prost joined by Judge Dyk, Judge Newman dissented) affirmed a district court determination that claims directed to withholding inhalation of nitrous oxide to neonatal patients identified having hypoxic respiratory failure and having left ventricular dysfunction (LVD) were ineligible for patent protection.  The majority reasoned that a method of treatment claim that simply tells a doctor to hold back treatment is “not focused on changing the physiological state of the patient to treat the disease,” and such a “claim is directed to the natural phenomenon” and “involves only well-understood, routine, and conventional steps.”[ii]  The underlying rationale for the INO decision appeared to be the majority’s attempt to define a “method of treatment” claim as requiring a doctor to affirmatively take some action (e.g., administer a drug).  While Mallinckrodt and its subsidiary INO Therapeutics LLC filed a petition for certiorari, the Supreme Court denied Mallinckrodt’s petition,[iii] continuing its recent trend of not taking up patent-eligible subject matter cases.

Although this does not resolve the uncertainty created by the Alice/Mayo framework,[iv] the denial in the INO v. Praxair case does provide some guidance to patentees and applicants in the life sciences. The Supreme Court has effectively made claims that explicitly encompass withholding treatment to selected group of patients based on a diagnosis step ineligible for patent protection at this time. While not the outcome applicants and patent owners had hoped for, there is now at least some degree of direction as to what types of method of treatment claims clearly are not patent- eligible.

Even in light of this, successful prosecution of patent applications directed to method of treatment claims that rely on a diagnostic step can still be achieved.  Applicants can increase their chances by drafting their claims such that the treatment is not withheld from a selected patient. In other words, if treatment is to be withheld from a selected group, claims should not explicitly recite such a group.

  1. INO Therapeutics LLC v. Praxair Distribution Inc., 2018-1019 (Fed. Cir. Aug. 27, 2019), cert. denied, No. 19-1103 (April 6, 2020).
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  2. Id. at 9, 14.
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  3. INO Therapeutics LLC v. Praxair Distribution Inc., No. 19-1103 (April 6, 2020).
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  4. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) and the subsequent subject matter eligibility determination framework articulated in Alice Corp. v. CLS Bank International, 573 U.S. 2008 (2014).
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