IP Law Daily Infringement finding, injunction affirmed in dispute over generic drug for treating schizophrenia
Friday, April 13, 2018

Infringement finding, injunction affirmed in dispute over generic drug for treating schizophrenia

By Thomas Long, J.D.

In a split decision, the U.S. Court of Appeals for the Federal Circuit has affirmed a decision of the District of Delaware holding, after a bench trial, that pharmaceutical makers West-Ward Pharmaceuticals International Limited and West-Ward Pharmaceuticals Corp. (collectively, "West-Ward") induced infringement of asserted claims of a patent for method for treating schizophrenia. The appellate court also agreed with the district court’s determination that the patent-in-suit was not invalid, and it affirmed the district court’s grant of injunctive relief to the patent’s owner, Aventisub LLC, and its exclusive licensee, Vanda Pharmaceuticals Inc. The district court had jurisdiction over the plaintiffs’ Hatch-Waxman Act infringement claims even though the patent-in-suit issued after West-Ward applied for approval of its generic product, because it had amended its application to assert that the patent was invalid. The patent did not claim ineligible natural phenomena, but instead a novel method of treating a disease, according to the court. The claims contained sufficient written description. West-Ward’s proposed product label encouraged physicians to carry out all of the steps of the asserted patent claims and therefore induced infringement. Finally, the district court properly issued an injunction under 35 U.S.C. §271(e)(4). Chief Judge Sharon Prost wrote in dissent, opining that the patent-in-suit was directed to an ineligible law of nature (Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International Ltd., April 13, 2018, Sleet, G.).

Patent-in-suit; infringement dispute. The plaintiffs asserted that West-Ward infringed U.S. Reissue Patent No. 39,198 ("the ’198 patent") and U.S. Patent No. 8,586,610 ("the ’610 patent"). The ’198 patent was not at issue on appeal. The ’610 patent related to a method of treating schizophrenia patients with iloperidone wherein the dosage range is based on the patient’s genotype. The plaintiffs made and sold a brand-name iloperidone treatment, Fanapt®. This drug, called an "atypical antipsychotic," had fewer side effects than other antipsychotics. West-Ward’s predecessor-in-interest, Roxane Laboratories Inc., filed an Abbreviated New Drug Application (ANDA) seeking approval to make and sell a generic version of Fanapt® in various strengths, for the treatment of schizophrenia. The proposed ANDA label was substantially identical in all material respects to the Fanapt® label. At that time, the ’198 patent had not yet expired, and the ’610 patent had not yet issued. The plaintiffs filed suit for infringement of the ’198 patent. When the ’610 patent issued, the plaintiffs filed another infringement suit, which the court consolidated with the suit over the ’198 patent. West-Ward provided notice to Vanda that it had amended its ANDA to include a Paragraph IV certification that the ’610 patent was invalid and/or not infringed.

Trial court findings. Following a bench trial, the district court found that West-Ward’s proposed products induced infringement of the asserted claims of the ’610 patent, but they did not contributorily infringe them. The court held that West-Ward’s submission of a paragraph IV certification for the ’610 patent was an act of infringement. The district court also held that the asserted claims were not invalid under Section 101 (patent-ineligible subject matter), Section 103 (obviousness), or Section 112 (lack of written description). Finally, the district court enjoined West-Ward from making and selling its ANDA product prior to the expiration of the ’610 patent. The district court stated that it was granting the injunction under its general equitable powers because, in its view, injunctive relief under Section 271(e)(4) was not available because of the timing of the issuance of the ’610 patent and the filing of West-Ward’s ANDA. West-Ward appealed to the Federal Circuit.

Jurisdiction. West-Ward argued that 35 U.S.C. §271(e)(2) did not create a basis for subject matter jurisdiction over Vanda’s infringement claims because the ’610 patent had not issued when the ANDA was filed. West-Ward contended that a Hatch-Waxman Act-based claim for Section 271(e)(2) infringement can only be based on patents that have issued before an ANDA is filed. The Federal Circuit agreed with Vanda that the district court had jurisdiction over this case. 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). West-Ward’s arguments relating to whether there was a qualifying act of infringement raised potential merits problems, not jurisdictional issues, the appellate court said. Moreover, an actual controversy had existed between the parties from the time when the suit was commenced.

Infringement. The Federal Circuit first addressed whether, beyond the jurisdictional question, a claim for infringement of the ’610 patent under 35 U.S.C. §271(e)(2)(A) can lie when the ’610 patent issued after the original ANDA was submitted, and Vanda sued West-Ward for infringement of the asserted claims prior to West-Ward submitting a Paragraph IV certification. The Federal Circuit held that it could. Although the court agreed with West-Ward that only an issued patent can give rise to a valid infringement claim under Section 271(e)(2)(A), it disagreed that that conclusion precluded Vanda’s infringement claim. The ’610 patent was a patent "for a drug … the use of which is claimed in a patent," 35 U.S.C. §271(e)(2)(A), as contemplated in the Act even though it issued after West-Ward filed its ANDA. West-Ward subsequently amended its ANDA to include a Paragraph IV certification for the ’610 patent after it issued. The infringement analysis under Section 271(e)(2)(A) required consideration of the amended ANDA, the court said, and amendments to an ANDA, including a Paragraph IV certification for a later-issued patent, can constitute an act of infringement under Section 271(e)(2)(A). This holding served the Hatch-Waxman Act’s purpose of facilitating the early resolution of patent disputes between generic drug makers and pioneering brand-name drug companies, in the court’s view. The court noted that the Act’s provisions regarding stays of FDA approval took into account amendments to ANDAs.

Inducement. Turning to the merits, the court concluded that the district court did not clearly err in finding induced infringement. According to the court, in a Hatch-Waxman case, such as this one, the patent owner did not need to prove an actual past instance of direct infringement by a physician to establish infringement under 35 U.S.C. §271(e)(2)(A). Therefore, it was not necessary to show that West-Ward’s expert administered the infringing drug to a patient. Rather, Section 271(e)(2)(A) made it possible for the patent owner to have the court determine whether, if a particular drug were put on the market, it would infringe the relevant patent. Therefore, Vanda was able to satisfy its burden to prove direct infringement—a predicate to establishing inducement—by showing that if the proposed ANDA product were marketed, it would infringe the ’610 patent. The district court made factual findings that the proposed label "recommends" that physicians perform the claimed steps, and its analysis of the proposed label to assess potential direct infringement by physicians was proper, the Federal Circuit said. The district court’s findings regarding the label’s recommendations were not in error. Furthermore, because the proposed label itself recommended infringing acts, even if the proposed ANDA product had "substantial noninfringing uses," West-Ward may still be held liable for induced infringement. Therefore, the district court’s judgment of infringement by inducement was affirmed.

Subject-matter eligibility. West-Ward argued that the asserted claims are ineligible under 35 U.S.C. §101 because they were directed to a natural relationship between iloperidone, the metabolism of a gene known as CYP2D6, and prolongation of the time between the Q and T waves of the heart rhythm ("QTc prolongation"). According to West-Ward, the claims added add nothing inventive to those natural laws and phenomena. The court disagreed. The claims of the ’610 were directed to a novel method of treating a disease, not to natural phenomena. Although the inventors recognized the natural relationship cited by West-Ward, they did not claim that relationship, but rather an application of it. The claims here required a treating doctor to administer iloperidone in specific dosages, depending on the result of a genotyping assay. The specification further highlighted the significance of the specific dosages by explaining how certain ranges of administered iloperidone correlated with the risk of QTc prolongation. Thus, the court explained, the ’610 patent claims described a new way of using an existing drug that was safer for patients because it reduced the risk of QTc prolongation. The court also stated that the claims did not carry a risk of preemption because they did not "tie up" the doctor’s subsequent treatment decisions.

Written description. West-Ward argued that the asserted claims were invalid for lack of written description because nothing in the ’610 patent demonstrated possession of the claimed dosage ranges for poor and non-poor CYP2D6 metabolizer genotypes. In the Federal Circuit’s view, the district court did not clearly err in finding that the ’610 patent contained adequate written description for the claimed "12 mg/day or less" dosage range for poor metabolizers. The patent reported relevant test results and explained that patients can be more safely treated with iloperidone if the dose of iloperidone is adjusted based on the CYP2D6 genotype of each patient. It also included examples of such doses. West-Ward waived its written description challenge with respect to non-poor metabolizers by failing to properly present it to the trial court, the appellate court said.

Injunctive relief. West-Ward argued that the injunctive relief ordered by the district court was not supported by the court’s "general equitable power," and the lack of jurisdiction or an infringing act under 35 U.S.C. §271(e)(2) precluded upholding the injunctions under 35 U.S.C. §271(e)(4). The Federal Circuit disagreed, holding that 35 U.S.C. §271(e)(4) supported the injunctive relief granted by the district court. The district court had properly held that Vanda had established infringement of the ’610 patent under Section 271(e)(2). The injunction provisions of Section 271(e)(4) contained no carveout for patents that issued after the date of submission of the original ANDA. Although the district court erred in concluding that the remedies pursuant to Section 271(e)(4) were unavailable, the court granted Vanda injunctive relief consistent with those remedies. Accordingly, the Federal Circuit affirmed the grant of injunctive relief.

Dissenting opinion. Chief Judge Sharon Prost dissented, stating that she would find the asserted patent claims invalid as directed to a law of nature. Chief Judge Prost also argued that the claims did not contain additional material supplying a requisite inventive concept to transform the natural law into patent-eligible subject matter.

The case is Nos. 16-2707 and 16-2708.

Attorneys: Nicholas P. Groombridge (Paul, Weiss, Rifkind, Wharton & Garrison LLP) for Vanda Pharmaceuticals Inc. Kenneth G. Schuler (Latham & Watkins LLP) for West-Ward Pharmaceuticals International Ltd. and West-Ward Pharmaceuticals Corp.

Companies: Vanda Pharmaceuticals Inc.; Aventisub LLC; West-Ward Pharmaceuticals International Ltd.; West-Ward Pharmaceuticals Corp.

MainStory: TopStory Patent FedCirNews

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