In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman case, as the asserted patent did not issue until after the subject ANDA was filed, and plaintiffs filed their complaint before the ANDA was amended to include a Paragraph IV Certification that the asserted patent was believed to be invalid or not infringed.
The asserted patent claimed a method for treating schizophrenia patients with iloperidone, wherein one of two claimed dosage ranges is determined through an assessment of the patient’s genotype, as certain patients are unable to metabolize the drug efficiently.
The Court first addressed the question of jurisdiction, and found that the district court properly exercised jurisdiction over the case. In Hatch-Waxman cases, a drug company patent owner adds to the “Orange Book” a list of all patents covering their product. That list can be supplemented over time, as new patents covering the drug issue. A generic drug manufacturer seeking to launch a generic version of that drug must certify as part of its ANDA application, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that it believes that the proposed generic drug does not infringe a valid patent listed for that drug in the Orange Book. This is commonly called a “Paragraph IV Certification.” Under 35 U.S.C. § 271(e)(2), the filing of a Paragraph IV Certification is deemed an act of infringement of the listed patents.
At the time that West-Ward’s ANDA was filed, the asserted patent had not yet issued. After the patent issued, Vanda added it to the Orange Book and then filed suit against West-Ward. But by the time of suit, West-Ward had not amended its Paragraph IV certification to address the patent. Given that infringement was asserted under § 272(e)(2), and that the predicate Paragraph IV certification had not been filed, West-Ward argued that the Court did not have jurisdiction to hear the case. West-Ward later amended its Paragraph IV certification to add the asserted patent.
The Court held that, regardless of the merits of plaintiffs’ claims, they “arose under an Act of Congress relating to patents,” and “the want of an infringing act under § 272(e)(2) is a merits problem, not a jurisdictional one.” Relying on precedent finding infringement based on ANDA amendments, the Court then found that any missing act of infringement under § 272(e)(2) was provided by defendants’ post-suit Paragraph IV certification directed to the asserted patent. Therefore, the Court held, “[a] filer of an ANDA is… subject to a § 272(e)(2)(A) infringement claim on a patent that issues after the filing of the ANDA, but before FDA approval,” which the Court found to be consistent with § 272(e)(2)’s promotion of early resolution of disputes between patentees and generic drug manufacturers, as well as its legislative history. The Court noted in a footnote that the defendants did not move to dismiss the complaint at the pleadings stage for failure to state a claim.
The Court also affirmed the district court’s finding of induced infringement, reiterating its prior precedent holding that an ANDA applicant may induce infringement under § 272(e)(2) where its proposed labeling would, if approved and marketed, teach infringement of the claims. The Court distinguished its prior decision in Warner-Lambert on the grounds that that case involved a potentially infringing off-label use, while in the case at bar, the labeling itself would have taught infringement.
The Court also found that the asserted claims were patent eligible and not directed to a law of nature. The Court distinguished the claims at issue in Mayo v. Prometheus (U.S. 2012), which claimed a diagnostic technique comprising common-sense application of natural laws. Here, the Court found that the asserted claims were directed to a particular method of treating schizophrenia with specific dosages of iloperidone depending on genotyping results. Because the claims were directed to “a new way of using an existing drug,” rather than to simple observations of natural interactions, the Court held the claims patent-eligible. Judge Prost filed a dissenting opinion on this point, arguing that the claims’ recitation of specific dosages did not distinguish them from those at issue in Mayo, which recited specific blood concentrations of medication indicating a need to increase or decrease the dosage of that medication. Judge Prost argued that to the extent the majority found the prescribed dosages to embody an inventive concept, that inquiry should have been conducted not under the first prong of the Supreme Court’s Alice/Mayo analysis (whether the claims are “directed to” a natural phenomenon), but under the second (whether there is nonetheless an inventive concept).
The Court also affirmed the district court’s finding that the written description requirement was satisfied as to the claimed dosage range for poor iloperidone metabolizers, because it described a range of possible dosages that included the claimed dosage range. Reviewing the district court’s factual findings for clear error, the Court held that the “disclosure of a dose outside of the claimed range does not compel a finding that the asserted claims lack adequate written description.”
Finally, the Court affirmed the district court’s grant of injunctive relief. The district court had determined that injunctive relief under § 272(e)(4) was unavailable where the patent issued after the initial ANDA submission, but had ordered an injunction consistent with the relief described thereunder under its general equitable power. The Court found that the district court had erred and that injunctive relief under § 272(e)(4) was in fact appropriate, and affirmed the injunction on those grounds.
Opinion can be found here.
