Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was sufficient to establish infringement in the ANDA context. Here, we highlight the Federal Circuit’s threshold decision that the district court correctly exercised ANDA jurisdiction under the Hatch-Waxman Act, even though the patent had issued after the ANDA was filed and the ANDA action was brought before a Paragraph IV certification had been made.

Procedural Background

In 2013, West-Ward filed an ANDA that sought FDA approval to market a generic version of Vanda’s Fanapt® (iloperidone), an atypical antipsychotic approved for treatment of schizophrenia. West-Ward’s ANDA included a Paragraph IV certification for U.S. Reissue Patent No. 39,198, which was listed in the Orange Book for Fanapt®. In response, on November 25, 2013, Vanda filed a first patent infringement action against West-Ward, asserting the ‘198 patent.

The patent at issue in Vanda, U.S. Patent No. 8,586,610, was granted on November 19, 2013. On June 16, 2014, Vanda filed a second infringement action against West-Ward alleging infringement of the ’610 patent under 35 U.S.C. § 271(e)(2). That was before the ’610 patent was listed in the Orange Book and before West-Ward provided a Paragraph IV certification against the ’610 patent.

After the 2014 action was commenced, on January 15, 2015, the ’610 patent was listed in the Orange Book for Fanapt®, and, on May 6, 2015, West-Ward provided a Paragraph IV certification against the ’610 patent.

The 2013 and 2014 actions were consolidated and proceeded to trial. As summarized in the Federal Circuit decision:

Following a bench trial, the district court found that West-Ward’s proposed products induce infringement of the asserted claims of the ’610 patent, but do not contributorily infringe them. …. The court held that West-Ward’s “submission of a paragraph IV certification for the ’610 [p]atent is an act of infringement” and that Vanda’s expert Dr. Alva “practiced the steps of the ’610 [p]atent claims” with Fanapt®.

While the district court concluded that relief under 35 U.S.C. § 271(e)(4)(A) was unavailable because the ANDA was filed before the ’610 patent issued, it granted injunctive relief under its “general equitable power.”

The Federal Circuit Determination on Jurisdiction

The Federal Circuit decision was authored by Judge Lourie. Judge Hughes and Chief Judge Prost joined in the jurisdiction decision. (Chief Judge Prost dissented from the subject matter eligibility decision.)

Although this is our third article on Vanda, this is the first issue Federal Circuit addressed. Since jurisdiction is a threshold issue, the court had to decide whether the district court had jurisdiction over the 2014 action, even though it was brought under the Hatch-Waxman Act (35 U.S.C. § 271(e)(2)) before a Paragraph IV certification had been made.

The statute at issue provides:

(2)It shall be an act of infringement to submit—
(A) an [ANDA] application …. for a drug claimed in a patent or the use of which is claimed in a patent …
*****
if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug, veterinary biological product, or biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

In supplemental briefing submitted at the direction of the Federal Circuit, Vanda argued that “its allegations of infringement under 35 U.S.C. § 271(e)(2) created subject matter jurisdiction in the district court under 28 U.S.C. § 1331 and § 1338(a), and presented a justiciable controversy.”

In contrast, West-Ward argued that “§ 271(e)(2) infringement can only be based on patents that have issued before an ANDA is filed,” and that even if the Paragraph IV certification was amended to include the asserted patent, the District Court’s jurisdiction was not proper because the certification was not made before the 2014 action was filed.

The Federal Circuit agreed with Vanda. The court cited its 2012 decision in AstraZeneca Pharm. LLP v. Apotex Corp. for the proposition that “[w]hen patentees pursue [§ 271(e)(2)] . . ., their claims necessarily arise under an Act of Congress relating patents.” The Federal Circuit further explained that jurisdiction is “met once a patent owner alleges that another’s filing of an ANDA infringes its patent under § 271(e)(2), and this threshold jurisdiction determination does not depend on the ultimate merits of the claims.” The Federal Circuit reasoned:

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).

The Federal Circuit rejected West-Ward’s timeline-based arguments, characterizing them as being directed to the merits of the case rather than jurisdiction. On that point, the court cited the Supreme Court opinion in Caraco Pharm. Labs, Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012), which described “[t]he want of an infringing act [under § 271 (e)(2)] [as] a merits problem, not a jurisdictional one.”

The Federal Circuit also determined that the fact that West-Ward had filed the ANDA and Vanda had sued created an actual controversy between the parties. The court explained that “[t]he mere fact that West-Ward had not submitted a Paragraph IV certification for the ’610 patent until after Vanda filed suit does not establish that there not was a justiciable controversy over which the court could exercise jurisdiction.”

Thus, the Federal Circuit concluded that the district court’s exercise of jurisdiction was proper under § 271(e)(2). (The court did not reach alternate arguments concerning declaratory judgment jurisdiction.)

Hatch-Waxman Complaints

The statute at issue, § 271(e), refers to Paragraph IV certifications in paragraph (5), but that paragraph creates declaratory judgment jurisdiction over an action brought by the ANDA filer if the patent owner fails to bring suit within 45 days. On the other hand, paragraph (2) refers to submission of an ANDA, but makes no reference to Paragraph IV certifications. This decision emphasizes that patent owners always should consider including a claim based on § 271(e)(2) in a complaint against an ANDA filer, even if the patent issued after the ANDA was filed, has not yet been listed in the Orange Book, and even if the patent has not been the subject of a Paragraph IV certification.