United States District Court, D. Delaware
Alza Corp. and Janssen Pharmaceuticals Inc., Plaintiffs,
Amneal Pharmaceuticals of New York, LLC and Amneal Pharmaceuticals LLC Defendants.
Defendants filed Abbreviated New Drug Application No. 207515
and a Major Complete Response Amendment with the FDA seeking
to sell a generic version of Concerta, Plaintiffs filed for
infringement of U.S. Patents No. 8, 163, 798 and No. 9, 144,
549. (D.I. 2). Defendants request judgment on the pleadings
under Federal Rule of Civil Procedure 12(c). The contested
claims are of two basic types: (1) those that cover
non-osmotic and osmotic dosage forms and (2) those that cover
only osmotic dosage forms.
the first category of claims, claims that cover both osmotic
and non-osmotic dosage forms, Defendants seek judgment on
collateral estoppel grounds. Previously, the District of
Delaware invalidated similar claims for lack of enablement, a
decision affirmed by the Federal Circuit. This portion of
Defendants' motion is dismissed as moot because
Plaintiffs have agreed not to assert claims covering
non-osmotic dosage forms. (D.I. 30 at p. 2).
the second category of claims, claims only covering osmotic
dosage forms, Defendants seek judgment based on
argue that "osmotic dosage form" claims
"unambiguously" require both a "semipermeable
membrane" and a "push layer." (D.I. 22 at p.
18). This construction resolves the infringement analysis,
Defendants argue, because the ANDA product does not include a
push layer. Defendants argue their proposed definition
is obvious from the patent itself and is the one mandated by
the Federal Circuit's opinion in Alza Corp. v. Andrx
Pharmaceuticals, LLC, 603 F.3d 935 (Fed Cir. 2010).
Thus, formal claim construction is unnecessary.
the requirement of a "push layer, " I do not read
the cited portions of the specification as
"unambiguously" requiring osmotic dosage forms to
be construed as including a push layer. Defendants cite
column 3, lines 50 to 54 of the '798 patent, and the
corresponding part of the '549 patent, to support their
claim construction argument. (D.I. 22 at p. 18). In that
part, the specification discusses the prior art and describes
a "sophisticated type of osmotic device"
that includes two layers, one a push layer. ('798 Patent,
col. 3, 1. 38) (emphasis added). Far from making
Defendants' proposed construction unambiguously correct,
this language supports the argument that a push layer is only
in certain types of osmotic devices, not all. Defendants also
cite embodiments of osmotic dosage forms in the specification
with a push layer to require one. (D.I. 40 at pp. 7-9). At
this stage, without formal claim construction, I decline to
read a limitation into the claim language from the
further argue that Alza requires me to construe
osmotic dosage forms to include a push layer. Specifically,
Defendants cite footnote 1 that reads:
Osmotic dosage forms are dosages with a "push"
layer comprising osmotically effective solutes-i.e.,
substances that dissolve and, as fluid is imbibed through the
semipermeable pill wall, swell and push against the
deliverable drug formulation. The pill wall is semipermeable,
meaning that it is permeable to the passage of external
fluids into the compartment, but is substantially impermeable
to the passage of a drug agent or excipients outward. The
drug itself exits via an orifice, which constitutes the
"passageway" through the wall for delivering the
drug from the pill, so as to gradually increase drug
concentration in the body.
Non-osmotic dosage forms within the scope of the claims
include "oral tablets and capsules" with
sustained-release dosage forms suitable for producing
ascending release rates, where the release rate is as
determined by an appropriate in-vitro dissolution test.
Non-osmotic dosage forms do not have a "push"
Alza, 603 F.3d at 937 n. 1. There are three problems
with Defendants' position.
the Federal Circuit was not engaging in, nor reviewing, claim
construction. The district court had never construed
"osmotic dosage form." See Alza Corp. v. Andrx
Pharm. LLC, 2007 WL 6137000 (D. Del. Oct. 5, 2007). In
the best case for Defendants, footnote 1 could be
characterized as a drive-by claim construction, cf.
Arbaugh v. Y & H Corp., 546 U.S. 500, 511 (2006)
(characterizing "unrefined disposition" as
"drive-by jurisdictional rulings"), but footnote 1
is not even that. Instead, it appears the court was doing
just what the court said it was doing, that is, providing
the Federal Circuit did not cite, nor suggest it was relying
on, the specification or any other intrinsic evidence (or
extrinsic evidence for that matter) for its description of
osmotic dosage forms. This makes sense because, again, the
court was not engaged in claim construction.
the description of osmotic dosage forms described in footnote
1 was not necessary to the court's holding. In
Alza, the parties did not contest the meaning of
osmotic dosage forms. 603 F.3d at 939. The parties stipulated
that osmotic dosage forms were enabled. The enablement
dispute focused exclusively on non-osmotic dosage forms.
Id. The enablement analysis did not reference a push
layer for delineating what was enabled and what was not
enabled. See Id. at 939, 941. Instead, the
enablement analysis was focused on the cursory nature of the
single paragraph reference in the specification to ways of
using non-osmotic dosage forms. Id. at 941.
believe this case requires claim construction and probably
expert testimony before a finding on infringement can be
these reasons, Defendants' motion for judgment on the
pleadings is DISMISSED ...