Posts Tagged: "Vanda v. West-Ward"

The USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance provides that if an abstract idea represented in one or more claim elements is integrated into a practical application by other limitations in the claim, then the claim as a whole would not be directed to a judicial exception and, as such, would be considered patentable under section 101. The revised guidance states that “a claim that integrates a judicial exception into a practical application will apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” This would seem to be in line with the public policy underlying the judicial exception of not allowing a claim to preempt all means of achieving a desired result. Often, patent claims are drafted such as to contain claim elements directed to desired outcomes as opposed to specific ways of achieving the desired outcomes. Claim elements directed only to desired outcomes have the effect of preempting all ways of achieving the desired outcome, and, as such, are considered to “monopolize the judicial exception”. The public policy behind the judicial exception seeks to prevent the monopolization of the judicial exception by a claim reciting only the desired outcome.

As we look ahead towards 2019, it is worth reflecting on several high-profile patent cases and brewing developments from the past year. Here are five lessons we learned from 2018 that may be useful in developing IP litigation strategies in 2019.

Proving inducement to infringe requires showing that the accused infringer possessed “specific intent” to infringe. In pharmaceutical cases, particularly those arising in the Hatch-Waxman framework, specific intent may be supplied by the wording of a drug label. Vanda sheds light on several issues relevant to inferring inducement to infringe based on a drug’s label. For example, can a label’s clear recommendations on ultimate dosage be negated by how a medical provider arrives at the dosage? Or, does finding specific intent require that every practitioner prescribe an infringing dose? Or, can evidence of substantial non-infringing use negate a finding of inducement when the drug’s label instructs performing the patented method?

On June 7, 2018, the USPTO issued new guidance to its examining corps in the form of a memorandum discussing the Federal Circuit’s April 13, 2018 decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Circ. 2018). The memo indicates that it is intended to “addresses the limited question of how to evaluate the patent eligibility of ‘method of treatment claims’ in light of the Federal Circuit decision in Vanda” and also states, perhaps in a nod to the leadership of new USPTO Director Andrei Iancu, that “[t]he USPTO is determined to continue its mission to provide clear and predictable patent rights in accordance with this rapidly evolving area of the law, and to that end, may issue further guidance in the area of subject matter eligibility in the future.”

In Vanda, Chief Judge Prost, one of the judges on the CellzDirect panel, dissented from the majority’s decision that found claims patent eligible for not being directed to a judicial exception in step one of the Mayo/Alice test. What differences between the claims in Vanda and those in CellzDirect led Judge Prost to dissent? Can these differences shed further light on the characteristics necessary for a claim to be found not directed to a patent-ineligible concept in step one?

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of the decision compares Vanda’s claims to those found ineligible for patent protection in the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012). While the ultimate patentability conclusions are opposite, the claims in Vanda and Mayo are very similar, highlighting the thin—and often unpredictable—line that divides eligible and ineligible subject matter. Generic drug manufacturers must account for this unpredictability in gauging their litigation risks.