Source: https://www.pharmapatentsblog.com/2018/05/08/federal-circuit-finds-anda-jurisdiction-before-piv-certification/
Timestamp: 2019-04-23 08:29:18+00:00

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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.
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.
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®.
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.
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.
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 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.

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