Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd.

Case Name: Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. Apr. 13, 2018) (Circuit Judges Prost, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by Prost, C.J.) (Appeal from D. Del., Sleet, J.) 

Drug Product and Patent(s)-in-Suit: Fanapt® (iloperidone); U.S. Patent No. 8,586,610 (“the ’610 patent”)

Nature of the Case and Issue(s) Presented: The ’610 patent related to a method of treating schizophrenia patients with iloperidone wherein the dosage range was based on the patient’s genotype. Iloperidone could cause QT prolongation, which could lead to severe cardiac problems. A certain genotype was associated with poor metabolization of iloperidone. Thus, the patent taught administration of a dose of iloperidone to patients with that specific genotype (“poor metabolizers”) lower than the dose administered to patients with a genotype associated with normal metabolization of the drug.

Fanapt was approved for the treatment of patients with schizophrenia. Vanda sued West-Ward alleging patent infringement based on the filing of an ANDA for a generic version of Fanapt. After a bench trial, the district court found that the ’610 patent was valid and infringed. West-Ward appealed to the Federal Circuit arguing: (i) under 35 U.S.C. § 217(e)(2), the district court did not have subject matter jurisdiction over an action based on a patent that had not yet issued at the time the ANDA was filed; (ii) there could be no act of infringement under 35 U.S.C. § 271(e)(2) where an ANDA was filed before the asserted patent issuesd (iii) Vanda failed to prove the requisite direct infringement and specific intent prongs of induced infringement; (iv) the asserted claims were not directed to patent-eligible subject matter under § 101; (v) the claims were invalid for lack of adequate written description; and (v) the district court’s award of injunctive relief was improper.

Why Vanda Prevailed: Jurisdiction: West-Ward argued that the district court lacked subject-matter jurisdiction over an action in which the asserted patent issued after the ANDA was filed. Further, it argued that jurisdiction was lacking because the complaint was filed before West-Ward made a Paragraph IV certification to that patent. The Federal Circuit held that the district court had subject matter jurisdiction over the case because claims made under 35 U.S.C. § 271(e)(2) “necessarily arise under an Act of Congress relating to patents.” Further, the Federal Circuit noted that “West-Ward’s arguments relating to whether there was a qualifying act of infringement raised potential merits problems, not jurisdictional ones.” The Federal Circuit also held that there was subject matter jurisdiction over Vanda’s § 271(e)(2) infringement claims even though Vanda filed suit before West-Ward filed its Paragraph IV certification.

Infringement: The Federal Circuit first addressed whether, separate from the jurisdictional question, an infringement claim under 35 U.S.C. § 271(e)(2)(A) could lie where the asserted patent were to issue after the ANDA was filed. West-Ward argued that infringement claims under § 271(e)(2)(A) could only be based on patents that issued before the filing of an ANDA. The Federal Circuit disagreed, holding that an ANDA filer was subject to § 271(e)(2)(A) infringement claims on patents that issued after the filing of the ANDA but before FDA-approval.

Next, the Federal Circuit addressed the district court’s finding of induced infringement. Direct infringement and specific intent were the predicates to a finding of induced infringement. West-Ward argued that the district court erred by finding that the language in the proposed label constituted direct infringement, and instead must have found instances of actual past infringement by physicians. The Federal Circuit held that a patentee need not prove an actual past instance of infringement by a physician to establish § 271(e)(2)(A) infringement. A patentee could satisfy its burden of proof on the predicate direct infringement “by showing that if the proposed ANDA product were marketed, it would infringe the [asserted] patent.” Here, the Federal Circuit found that the district court’s analysis of the proposed label to assess potential direct infringement was proper.

With respect to intent, West-Ward argued that Vanda failed to prove that the proposed label would encourage a physician to perform each step of the claimed methods and that a substantial number of non-infringing uses precluded a finding of specific intent as a matter of law. The Federal Circuit held that the district court did not err in finding that the label recommended performing the infringing steps and that there was  no “substantial noninfringing use” exception for induced infringement as there was for contributory infringement. Thus, the Federal Circuit affirmed the district court’s finding of induced infringement.

Patent Subject Matter Eligibility: West-Ward argued that the asserted claims were ineligible under § 101 because they were directed to a natural relationship between iloperidone metabolism and QT prolongation. The Federal Circuit disagreed, finding that the asserted claims were not directed to the relationship itself, but to an application of that relationship. Based on the results of a genotyping test, the claims require the treating doctor to administer different doses of iloperidone. Thus, the Federal Circuit noted that “the ’610 patent claimed a new way of using an existing drug that was safer for patients because it reduced the risk of QTc prolongation.”

Written Description: West-Ward argued that the district court erred in finding that the claims were not invalid of lack of adequate written description because the ’610 patent did not contain experiments with the claimed doses for poor metabolizers and reported data that did not support the claimed poor-metabolizer dose range. Based on the trial record, the Federal Circuit found that the district court did not clearly err, and that the test results reported in the ’610 patent specification adequately supported the claims.

Injunctive Relief: The Federal Circuit held that the district court erred in concluding that injunctive relief pursuant to § 271(e)(4) was unavailable to Vanda, but found that the district court’s grant of injunctive relief was nonetheless supported by § 271(e)(4). The court noted that § 271(e)(4) “contains no carve out for patents that issue after the date of submission of the original ANDA.” Based on the statutory language, the court held that upon a finding of patent infringement under § 271(e)(2), the district court must order remedies in accordance with § 271(e)(4). Thus, the court affirmed the district court’s grant of injunctive relief.

In a dissenting opinion, Chief Judge Prost states that she would find the asserted patent claims invalid for describing a law of nature. In particular, Chief Judge Prost took issue with the majority’s efforts to distinguish the Mayo case from the facts here. “Although I agree with the majority’s reasoning that the district court had jurisdiction under the Hatch-Waxman Act, I would not reach the issues of written description, infringement, and injunctive relief because I would find the ’610 patent claims ineligible subject matter.”