New USPTO Guidance on Subject Matter Eligibility Shines Ray of Hope for those Seeking Method of Treatment Claims

On June 7, 2018, the United States Patent and Trademark Office (USPTO) issued a memorandum to the Examining Corps detailing the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West Ward Pharmaceuticals (887 F.3d 1117).

At issue were claims directed to methods of treating a patient having schizophrenia with iloperidone, a drug known to affect the heart’s rhythm in patients having a particular genotype. The Court found the claims to be patent eligible under 35 U.S.C. § 101 because they are not “directed to” a judicial exception.

In particular, the Court distinguished these claims from those of Mayo Collaborative Servs. v. Prometheus Labs., Inc. (566 U.S. 66 (2012)) because the Mayo claims were not “method of treatment” claims that recited a step of administering a drug to a patient to treat a condition. The Mayo claims, as a whole, were determined to be directed to gathering information about a natural relationship whereas the Vanda claims are interpreted as directed to the practical application of a natural relationship by inclusion of a step requiring a doctor to administer iloperidone to treat schrizophrenia.

Given this interpretation, the Court found that the Vanda claims are not directed to the patent-ineligible natural relationship between the gene and the risk of heart rhythm disruption so there was no need to move to the second step of determining if the patent claims “something more” than that natural phenomenon.

The USPTO memorandum stressed this finding, instructing the Examining Corps that:

“(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible under Step 2A of the USPTO’s subject matter eligibility guidance; and (2) it is not necessary for ‘method of treatment’ claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S.C. § 101.

This should be welcome news to patent applicants since Step 2B analysis can be complicated and it is often unclear what constitutes “something more.” Furthermore, this guidance will help those seeking patent protection for methods of treating diseases or disorders by providing a framework to structure their claims.


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