5 October 2018

Patent-Eligibility Of "Methods Of Treatment," And Possible Movement Toward Greater Eligibility

Recent judicial decisions and USPTO actions are aligning to clarify and increase the scope of patent-eligible subject matter.
United States Intellectual Property
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TAKEAWAY: Recent judicial decisions and USPTO actions are aligning to clarify and increase the scope of patent-eligible subject matter. Method of treatment claims, in particular, are now more clearly patent-eligible in certain circumstances.

No small amount of ink has been spilled over the fallout from the 2014 Supreme Court decision in Alice Corp. v. CLS Bank ("Alice") Alice Corp. v. CLS Bank International, 134 S.Ct. 2347 (2014). By increasing scrutiny of allegedly "abstract" claims, Alice led to a significant increase in patents and patent applications being found ineligible for patent protection under 35 U.S.C. 101. While many patent owners initially hoped that the impact would be largely confined to business method patents, new eligibility rejections have spread into software patents, and even mechanical devices. The situation has been exacerbated by the subsequent inscrutable case law concerning the definition of "abstract," leaving examiners, judges, and practitioners alike scratching their heads over the scope of eligibility.

The subsequent pushback did not just come from patent owners. The recently-appointed Director of the U.S. Patent and Trademark Office (USPTO) lamented that "the law itself is too complicated and not amenable to clear understanding or simple explanation," calling the Alice test a "tortured exercise." Various intellectual property groups have proposed legislation to clear the morass. And, in an unusual move, several Federal Circuit judges recently called for congressional intervention.

There is evidence that the pendulum has already begun to swing toward greater eligibility. The USPTO is currently working on added guidance to help clarify eligibility with examiners, which may cause a reduction in Section 101 rejections. A recent Federal Circuit decision in Berkheimer v. HP has spurred the Patent Office to require examiners to provide evidence, rather than merely assert, that a claim is "well-understood, routine, and conventional" if a claim is to be considered ineligible. See Berkheimer v. HP Inc., Case No. 2017-1437 (Fed. Cir. February 8, 2018).

In a win for the owners of medical devices and treatment methods, the Federal Circuit in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals recently held that a claim including treatment steps is not abstract, even if the claim contains natural relationships. See Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l Ltd., 2018 WL 1770273 (Fed. Cir. Apr. 13, 2018). In Vanda, the claims recite a method for treating a patient with a drug, where the dosage is varied based upon a determination of gene type. The USPTO concluded that "'method of treatment' claims that practically apply natural relationships should be considered patent eligible." Further, the USPTO stated that, for such applications, whether a technique is "well-understood, routine, or conventional" need not even be assessed.

Applicants with relevant subject matter for treatment methods, particularly those facing a 35 U.S.C. 101 rejection, might consider amending the claims to explicitly recite a method of treating a patient.

While it remains to be seen if this momentum will continue to build, some optimism from patent owners, especially owners of medical treatment techniques, seems warranted.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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