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

Personalized Medicine “Method of Treatment” Claims Held Patent-Eligible

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., 2018 WL 1770273 (Fed. Cir. Apr. 13, 2018) (Prost (dissenting), LOURIE, Hughes) (D. Del.: Sleet) (4 of 5 stars)

Fed Cir affirms Hatch-Waxman bench judgment of infringement and validity. Vanda’s patent relates to a method of treating schizophrenia, and is listed in connection with Vanda’s Fanapt (iloperidone) product.

Subject matter jurisdiction: The district court did not err in exercising jurisdiction over the present case. The district court had subject matter jurisdiction over the case per § 271(e)(2)(A), notwithstanding the asserted Vanda patent (the ’610 patent) issued after West-Ward’s original ANDA, and Vanda filed its complaint prior to West-Ward submitting its Paragraph IV certification for the ’610 patent. “Vanda’s complaint alleged that West-Ward infringed the ’610 patent under 35 U.S.C. § 271(e)(2)(A) by filing the ANDA. Nothing more was required to establish the district court’s subject matter jurisdiction pursuant to 28 U.S.C. § 1338(a).” Op. at 10. The opinion reasons that arguments over whether there was a pre-complaint qualifying act of infringement “raise potential merits problems, not jurisdictional issues.” Id. The opinion also notes that there was a clear actual controversy between the parties throughout the case.

Infringement: The district court did not err in reasoning that West-Ward’s submission of its Paragraph IV certification for the ’610 patent was an act of infringement under § 271(e)(2). The opinion rejects West-Ward’s argument that that subsection only concerns the patents listed at the ANDA’s filing. Per Ferring, 764 F.3d 1382 (Fed. Cir. 2014), amendments to an ANDA are relevant to the infringement analysis, and “amendments to an ANDA, including a Paragraph IV certification for a later-issued patent, can constitute an act of infringement under § 271(e)(2)(A).” Op. at 14. “A filer of an ANDA is therefore subject to a § 271(e)(2)(A) infringement claim on a patent that issues after the filing of the ANDA, but before FDA approval.” Id. at 15.

The district court also did not err in finding inducement by West-Ward in connection with its proposed label. The opinion notes that it was not necessary for Vanda to identify an actual past instance of a doctor practicing every claim step (Vanda had identified such a doctor, but West-Ward was attacking Vanda’s proof as to the doctor’s actions). Per Bristol-Myers Squibb, 69 F.3d 1130 (Fed. Cir. 1995), and Warner-Lambert, 316 F.3d 1348 (Fed. Cir. 2003), § 271(e)(2)(A) permits proving hypothetical infringement (i.e., if the drug were put on the market, it would infringe), as the allegedly infringing product is not yet on the market. The district court’s determination that West-Ward’s label “recommends” physicians performing the claimed steps was appropriate, and the opinion finds no clear error in the finding of induced infringement on independent claims. The opinion does not analyze the infringement analysis for dependent claims, as such error would be harmless, citing TiVo, 516 F.3d 1290 (Fed. Cir. 2008). Because the district court’s analysis turned on recommendations in the label itself, off-label cases like Warner-Lambert are not on point. The opinion also rejects West-Ward’s argument for substantial noninfringing uses, as such uses are not a defense to inducement.

Subject matter eligibility: The district court correctly determined that Vanda’s claims were directed to patent-eligible subject matter, though it erred in its application of the two-step test of Alice, 134 S. Ct. 2347 (2014), and Mayo, 566 U.S. 66 (2012). Applying Alice/Mayo step one, Vanda’s claims were not directed to a patent-ineligible concept. The opinion discusses how representative claim 1 described treatment of schizophrenia by (1) determining a certain patient genotype by taking a sample and performing an assay, and (2) administering “specific dose ranges of iloperidone depending on the patient’s CYP2D6 genotype.” Op. at 28. Unlike the patent-ineligible claims in Mayo, Vanda’s claims were specifically directed to the application of a drug to treat a particular disease. The opinion describes how method of treatment claims like Vanda’s, unlike the claims in Mayo, was of confined reach that limited preemption concerns and did more than simply “tell engineers to apply a known natural relationship or to apply an abstract idea with computers.” Op. at 29. As in CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016), this is a case where the claims did not just observe or detect a natural process, but created a new, useful method. “[T]he natural ability of the subject matter to undergo the process does not make the claim ‘directed to’ that natural ability.” Op. at 31 (quoting CellzDirect). Myriad, 569 U.S. 576 (2013), is not contradictory, as that opinion specifically did not address “method claims” or “patents on new applications of knowledge about particular genes.”

Written description: The district court did not clearly err in determining that Vanda’s patent adequately described the claimed dosages. The opinion discusses how the patent reports and describes test results covering the claimed range, and Vanda offered interpretive expert testimony. The Fed Cir also declines to reach one variation of West-Ward’s written description attack as it was presented for the first time on appeal, citing Singleton, 428 U.S. 106 (1976), and HTC, 667 F.3d 1270 (Fed. Cir. 2012).

Injunctive relief: The district court correctly determined that an injunction was available to Vanda, though the district court erred in its determination of the basis for such an injunction. “[U]pon a finding of patent infringement under § 271(e)(2), the district court must order remedies in accordance with § 271(e)(4).” Op. at 37. The opinion rejects West-Ward’s argument that a letter from the FDA in a separate matter was contradictory. That letter merely confirmed that the thirty-month statutory stay of approval was unavailable because, in that case, Vanda’s patent information had not been submitted before the ANDA filing date. The district court had wrongly held that injunctive relief was unavailable under that subsection, but had entered the injunction under its “general equitable power.” Op. at 7–8. Because the injunction had a sufficient statutory basis, affirmance was appropriate notwithstanding the district court’s legal error. The opinion rejects West-Ward’s argument that Vanda had an obligation to file a cross-appeal to obtain appellate review of the district court’s rejection of § 271(e)(4) as a basis for the injunction. Per El Paso Natural Gas, 526 U.S. 473 (1999), and Radio Steel, 731 F.3d 840 (Fed. Cir. 1984), Vanda was permitted to argue for any basis of affirmance that did not enlarge its rights under the judgment or require amendment.

Dissent: Chief Judge Prost would have found Vanda’s claims directed to patent-ineligible subject matter. “The majority relies on the claims’ recitation of specific applications of the discovery underpinning the patent to find no natural law is claimed. But it conflates the inquiry at step one with the search for an inventive concept at step two. Once the natural law claimed in the ’610 patent is understood in a manner consistent with Mayo, what remains fails to supply the requisite inventive concept to transform the natural law into patent-eligible subject matter.” Dissent at 1–2.