April 16, 2018

Hold the Mayo: Specific Method of Treatment for Specific Patients using a Specific Compound at Specific Doses to Achieve a Specific Outcome Is Patent-Eligible Subject Matter

By Bryan K. Wheelock, Principal

In Vanda Pharmaceuticals Inc. v. West-ward Pharmaceuticals International Limited, [2016-2707, 2016-2708] (April 16. 2018), the Federal Circuit affirmed the district court’s determination that claims 1–9, 11–13, and 16 of U.S. Patent 8,586,610 are infringed and not invalid.

The Federal Circuit noted that inducement can be found where there is evidence of active steps taken to encourage direct infringement, which can in turn be found in advertising an infringing use or instructing how to engage in an infringing use. Thus, it can be found where there is evidence of active steps taken to encourage direct infringement, which can in turn be found in advertising an infringing use or instructing how to engage in an infringing use.

The Federal Circuit rejected West-ward’s argument that the proposed label was insufficient to find inducement, without an underlying direct infringer, because, in an ANDA case, infringement is statutorily defined as filing or amending the application, not by selling a product.

The Federal Circuit also found that the district court did not clearly err in finding that the proposed label recommends performance of all the claimed steps, finding that potential noninfringing uses do not preclude a finding of specific intent to induce infringement.

Regarding subject matter eligibility, the Federal Circuit rejected West-ward’s argument that the claims were similar to the the claims found patent ineligible in Mayo. First, the claims in Mayo were not directed to a novel method of treating a disease. Instead, the claims were directed to a diagnostic method based on the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. This relation was a consequence of the ways in which thiopurine compounds are metabolized by the body — entirely natural processes. And so a patent that simply describes that relation sets forth a natural law. In contrast, the Federal Circuit found the instant claims were directed to “a new way of using an existing drug” that is safer for patients.

Second, the Federal Circuit found that, unlike the claim in Mayo, the present claims do not tie up the doctor’s subsequent treatment decision. The claim in Mayo did not go beyond recognizing a need to increase or decrease a dose — it could be infringed even if the doctor did not actually change the treatment. In other words, the claim in Mayo did not involve using the natural relationship.

In contrast, the claims in suit recite the steps of carrying out a dosage regimen based on the results of genetic testing. Thus the claims do not broadly tie up the doctor’s subsequent treatment decisions.

The Federal Circuit analogized the case to CellzDirect, where the claims were not directed to an observation or detection, but to a method of preserving cells. There, the natural ability of the subject matter to undergo the process did not make the claim “directed to” that natural ability. The Federal Circuit also distinguished Myriad, where the court noted that method claims and patents on new applications of knowledge about particular genes were not implicated by its decision, noting the claims fall squarely within categories of claims not implicated by its decision.

The Federal Circuit concluded that the claims were directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. They are different from Mayo because they recite more than the a natural relationship; instead, they recite a method of treating patients based on this relationship.

The Federal Circuit affirmed that the district court clearly erred in finding that the patent sufficiently discloses the claimed invention.

Finally, the Federal Circuit agreed that 35 U.S.C. § 271(e)(4) supports the injunctive relief granted by the district court.