Friday, January 05, 2018

Apotex prevails at the CAFC in case about extended release dosage forms of cyclobenzaprine hydrochloride

The decision of Judge Robinson of D. Delaware in APTALIS v. Apotex was vacated :

In this Hatch-Waxman case, Apotex Inc. and Apotex
Corp. appeal from the district court’s claim construction of
“extended release coating” and its finding that Apotex’s
product infringes U.S. Patent Nos. 7,790,199 and
7,829,121. We conclude that the district court erred by
not construing the term “extended release coating” to
require a continuous outer film, as taught by the intrinsic
evidence. Accordingly, we vacate the infringement finding
and remand for further proceedings.


When construing claims, “there is sometimes a fine
line between reading a claim in light of the specification,
and reading a limitation into the claim from the specification.”
Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d
1182, 1186 (Fed. Cir. 1998). This case tiptoes that line.
The specification does not provide a lexicographic definition
of “coating,” and the prosecution history contains no
clear and unmistakable disavowal of claim scope. Nonetheless,
Apotex contends that the intrinsic evidence would
have taught an ordinarily skilled artisan at the time of
the invention that an “extended release coating” is limited
to a continuous outer film, not simply “[a] layer of any
substance that is applied onto the surface of another.”
For the reasons explained below, we agree and adopt
Apotex’s proposed construction of “extended release
coating” as “a continuous outer film applied onto the
surface of the active-containing core to provide an extended
release of the active core.” See Appellants Br. 21.

Of the issue

The specification bolsters our conclusion that the extended
release coating must be a continuous outer film.
See Phillips, 415 F.3d at 1315 (“[T]he specification ‘is
always highly relevant to the claim construction analysis.’”
(internal citation omitted)). First, every embodiment
in the specification that discusses a coating describes a
process in which the water insoluble polymer coating is
external to the active-containing core. See, e.g., ’199
patent col. 4 ll. 15–17 (“ER Beads can be produced by
applying a functional membrane comprising a water
insoluble polymerThe prosecution history offers additional support for
construing “extended release coating” to require a continuous
outer film. See Markman v. Westview Instruments,
Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc) (“To
construe claim language, the court should also consider
the patent’s prosecution history, if it is in evidence.”).
During prosecution of the ’199 patent, the applicants
submitted a declaration from Dr. James W. McGinity.
The Declaration summarizes Dr. McGinity’s interview
with the examiner during the prosecution of a related
patent application that shares the same specification as
the asserted patents. alone or in combination with a water
soluble polymer onto IR Beads.”);


Finally, Aptalis contends that the prosecution history
is irrelevant to the claim construction question here
because there is no clear and unmistakable disavowal of
claim scope. Our precedent does not support this proposition.
We have stated that “[a]ny explanation, elaboration,
or qualification presented by the inventor during patent
examination is relevant, for the role of claim construction
is to ‘capture the scope of the actual invention’ that is
disclosed, described, and patented.” Fenner Invs., Ltd. v.
Cellco P’ship, 778 F.3d 1320, 1323 (Fed. Cir. 2015) (quoting
Retractable Techs., Inc. v. Becton, Dickinson & Co.,
653 F.3d 1296, 1305 (Fed. Cir. 2011)). Although the
prosecution history may lack the clarity imbued by the
specification, it “can often inform the meaning of the
claim language by demonstrating how the inventor understood
the invention and whether the inventor limited
the invention in the course of prosecution, making the
claim scope narrower than it would otherwise be.” Phillips,
415 F.3d at 1317. Accordingly, even in the absence of
a clear and unmistakable disavowal, we conclude that the
prosecution history can be evaluated to determine how a
person of ordinary skill would understand a given claim


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