Federal Circuit Summaries

Before Prost, Lourie and Hughes. Appeal from the United States District Court for the District of Delaware.

Summary: When another patent for a drug issues after an ANDA is filed, there can still be jurisdiction for an infringement lawsuit and a finding of infringement of that patent even when the ANDA is not amended until after the lawsuit is filed.

West-Ward Pharmaceuticals (“West-Ward”) filed an ANDA seeking approval to manufacture and sell a generic version of Vanda Pharmaceuticals’ (“Vanda”) drug for treating schizophrenia patients with iloperidone. At the time West-Ward filed the ANDA, Vanda only had one patent listed in the Orange Book for its drug. After the ANDA was filed, Vanda filed suit alleging infringement of its patent. While the first suit was pending, Vanda obtained a second patent for its drug and filed a second infringement lawsuit. After the second lawsuit was filed, West-Ward amended its ANDA to assert that the second issued patent was invalid and/or not infringed. The two lawsuits were consolidated. The district court determined that the asserted patent claims were infringed through inducement and not invalid. West-Ward appealed.

The Federal Circuit first addressed whether the district court had jurisdiction over the second filed lawsuit when the second patent was issued after West-Ward filed the ANDA and where Vanda sued West-Ward for infringement before West-Ward amended its ANDA to submit a Paragraph IV certification for the second patent. The Federal Circuit found that there was jurisdiction, in part, because Vanda’s complaint alleged West-Ward infringed the second patent under 35 U.S.C. § 271(e)(2)(A) by filing the ANDA. The mere fact that West-Ward had not submitted a Paragraph IV certification for the second patent until after Vanda filed suit did not establish that there was no justiciable controversy.

Next, West-Ward argued there was no infringement of the second patent because the patent was issued after the ANDA was filed and Vanda sued for infringement before West-Ward submitted a Paragraph IV certification. The Federal Circuit held that amendments to an ANDA can constitute an act of infringement. The Federal Circuit also addressed the issue of induced infringement. West-Ward argued that Vanda failed to satisfy its burden of proving the predicate direct infringement. However, Vanda 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). This section makes it possible for a patent owner to have a court determine if a drug were put on the market would it infringe.

The Federal Circuit then looked at whether the asserted claims were patent-eligible. West-Ward argued that the asserted claims were ineligible under § 101 because they were directed to a natural relationship between iloperidone, CYP2D6 metabolism and QT prolongation. The Federal Circuit determined that the claims were patent eligible because they “are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.”

Accordingly, the Federal Circuit affirmed the district court’s decision and grant of injunctive relief. Judge Prost dissented, arguing that the asserted patent claims are directed to a law of nature and therefore constitute ineligible patent subject matter.