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
