Friday, September 05, 2008

CAFC affirms D NJ in Janssen v. Apotex concerning respiridone

In another post-MedImmune case on DJs, the CAFC said:

Defendant-Appellant Apotex, Inc. (Apotex) appeals the order of the United States
District Court for the District of New Jersey dismissing its declaratory judgment action
for noninfringement against Plaintiffs-Appellees Janssen Pharmaceutica, N.V. and
Janssen, L.P. (collectively Janssen). We affirm.
Apotex loses.

This is not a bad case to review to obtain background on the Hatch-Waxman Act.

The case was about the drug respiridone:

Janssen holds an approved NDA for its drug Risperdal® Oral Solution. The
Orange Book originally listed U.S. Patent Nos. 4,804,663 (’663 patent), 5,453,425 (’425
patent) and 5,616,587 (’587 patent) in connection with this NDA. The ’663 patent
covers the compound risperidone, which is the active compound in the drug Risperdal®
Oral Solution. The ’425 and ’587 patents cover specific aqueous solutions of
risperidone and methods for preparing these solutions. The ’663 patent expired on
December 29, 2007. However, the FDA granted Janssen an additional six months of
pediatric exclusivity pursuant to 21 U.S.C. § 355a, making June 29, 2008 the effective
expiration date of the ’663 patent.3 The ’425 and ’587 patents expire in 2014.

Of jurisdiction:

Whether an “actual controversy” exists that is sufficient to sustain federal subject
matter jurisdiction is a question of law this court reviews de novo. Teva Pharms. USA,
Inc. v. Novartis Pharms. Corp., 482 F.3d 1330, 1335-36 (Fed. Cir. 2007).


The Declaratory Judgment Act’s “actual controversy” requirement
“refers to the type of ‘Cases’ and ‘Controversies’ that are justiciable under Article III.”
MedImmune, Inc. v. Genetech, Inc., 127 S. Ct. 764, 771 (2007).
In MedImmune, the Supreme Court stated that a justiciable declaratory judgment
action exists when:

the facts alleged, under all the circumstances, show that there is a
substantial controversy, between parties having adverse legal interests, of
sufficient immediacy and reality to warrant the issuance of a declaratory


Jurisdiction over a declaratory judgment action must be present “at all stages of
review, not merely at the time the complaint is filed." Steffel v. Thompson, 415 U.S.
452, 459 n.10 (1974); see Benitec Austl., Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1344
(Fed. Cir. 2007) (“The burden is on the party claiming declaratory judgment jurisdiction
to establish that such jurisdiction existed at the time the claim for declaratory relief was
filed and that it has continued since.”); Int’l Med. Prosthetics Research Assocs., Inc. v.
Gore Enter. Holdings, Inc., 787 F.2d 572, 575 (Fed. Cir. 1986) (“[J]urisdiction over [] a
declaratory judgment action [must have] existed at, and has continued since, the time
the complaint was filed.”).

***An important point in the case -->

We agree with the parties that if Apotex had not stipulated to
the validity of the ’663 patent, then Caraco would have been controlling. However,
Apotex stipulated to the validity, infringement, and enforceability of the ’663 patent on
May 11, 2007. Therefore, while the harm that created a justiciable Article III controversy
in Caraco was present when Apotex filed its counterclaims on April 25, 2006, that harm
ceased to exist upon Apotex’s stipulation
Id. at 771 (citation omitted).


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