iCeutica Pty Ltd. et al v. Lupin Limited et al
MEMORANDUM ORDER re: claim construction. Signed by Judge Sue L. Robinson on 2/29/2016. (nmfn)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ICEUTICA PTY LTD and
IROKO PHARMACEUTICALS, LLC,
LUPIN LIMITED and LUPIN
Civ. No. 14-1515-SLR
At Wilmington this ~day of February, 2016, having heard argument on, and
having reviewed the papers submitted in connection with, the parties' proposed claim
IT IS ORDERED that the disputed claim language of U.S. Patent Nos. 8,679,544
("the '544 patent"), 8,999,387 ("the '387 patent"), and 9,017,721 ("the '721 patent") shall
be construed consistent with the tenets of claim construction set forth by the United
States Court of Appeals for the Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303
(Fed. Cir. 2005), as follows:
1. "A pharmaceutical composition containing 18 mg of diclofenac acid" 1
and "a pharmaceutical composition containing 35 mg diclofenac acid." 2
Consistent with the parties' proposed constructions, the plain and ordinary meaning of
the limitation will apply. The specification states that "[t]he present invention relates to
Found in claim 1 of the '544 patent, claim 1 of the '387 patent, and claim 1 of the '721
Found in claim 6 of the '544 patent, claim 11 of the '387 patent, and claim 8 of the '721
methods for producing particles of diclofenac using dry milling processes as well as
compositions comprising diclofenac, medicaments produced using diclofenac in
particulate form and/or compositions, and to methods of treatment ... using a
therapeutically effective amount of diclofenac administered by way of said
medicaments." (1 :5-11 )3 The specification generally describes "methods of making
finely divided or sized drugs" such as dry milling, wet grinding/milling, and airjet milling,
as well as the limitations of such methods. Epistar Corp. v. Int'/ Trade Comm'n, 566
F.3d 1321, 1336 (Fed. Cir. 2009) (the Federal Circuit "recognizes that disparaging
comments alone do not necessarily show a manifest or express disavowal of the
criticized subject matter"). The specification presents dry milling of the biologically
active material 4 (3:56-62; 31 :39-32:22), the biologically active material (32:23-67), and
methods of administering pharmaceutical compositions (18: 14-22). The claims at issue
are directed to compositions and do not recite a specific process (i.e., dry milling) for
manufacturing the diclofenac acid particles. The court concludes that the specification
does not support defendants' additional language limiting the claims to "dry-milled
diclofenac acid." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir.
2004) (if a patent describes only a single embodiment, the claims of the patent must not
necessarily be construed as being limited to that embodiment "unless the patentee has
demonstrated a clear intention to limit the claim scope using 'words or expressions of
manifest exclusion or restriction"').
As the three patents-in-suit share a specification, references are to the '544 patent.
Indeed, during prosecution of the original application, the patentee selected the
process claims to prosecute, resulting in U.S. Patent No. 8,735,450 (not at issue here),
which discloses and claims compositions made by the dry-milling process.
2. "Wherein the unit dose when tested in vitro by USP Apparatus I (Basket)
method of U.S. Pharmacopoeia at 100 rpm at 37°C in 900 ml of 0.05% sodium
lauryl sulfate in citric acid solution buffered to pH 5.75 has a dissolution rate of
diclofenac acid such that at least [X]%, by weight, is released by [X] minutes" 5
and "wherein the unit dose has a dissolution rate of diclofenac acid such that at
least [X]%, by weight, is released by [X] minutes:" 6 "Wherein at least [X]%, by
weight, of diclofenac acid is released from the unit dose by [X] minutes as determined
by USP Apparatus I (Basket) method of U.S. Pharmacopeia at 100 rpm at 37°C in 900
ml of 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75" and "using
the methodology prescribed in the independent claims, the unit dose has a dissolution
rate such that at least [X]%, by weight, of diclofenac acid is released from the unit dose
by [X] minutes." According to the specification "[t]he process results in the biologically
active material having an improved dissolution profile[, which] has significant
advantages including the improvement of bioavailability of the biologically active
material in vivo." (24:35-39) The specification describes how to carry out the testing
method. (24:35-25:22, 54:12-67, example 14)
3. "The particles of diclofenac acid have a median particle size on a
volume average basis of" 7 and "the diclofenac acid has a median particle size, on
a volume average basis, of:" 8 "The diclofenac acid particles have a particle size
Found in claims 1 and 6 of the '544 patent, claims 1 and 11 of the '387 patent, and
claims 1 and 8 of the '721 patent.
6 Found in claims 2-5 and 7-10 of the '544 patent, claims 6-8 and 16-18 of the '387
patent, and claims 3-5 and 10-12 of the '721 patent.
7 Found in claims 1 and 6 of the '544 patent.
8 Found in claims 1-4 and 11-14 of the '387 patent and claims 1-2, 8-9, 15-18 and 23-24
of the '721 patent.
diameter that divides the population in half such that 50% of the population is greater
than or less than said particle size diameter as determined on an equivalent spherical
particle volume basis measured after particle size reduction but before preparing the
unit dose." The specification defines "median particle size" "as the median particle
diameter as determined on an equivalent spherical particle volume basis. Where the
term median is used, it is understood to describe the particle size that divides the
population in half such that 50% of the population is greater than or less than this size."
(22:2-8) The specification explains that the "median particle size" is determined on a
particle volume basis. (16:39-40, 17:52-53, 33: 12-13) Further, "laser diffraction ... is
commonly used to measure particle size from 100 nm to 2000 micron, by calculat[ing] a
volume distribution of equivalent spherical particles .... " (21 :44-50) Contrary to
defendants' argument that the language "volume average basis" in the claims renders
them indefinite, the court concludes that the entire limitation, viewed in light of the
specification, would "inform those skilled in the art about the scope of the invention with
reasonable certainty." 9 Nautilus, Inc. v. Biosig Instruments, Inc.,_ U.S._, 134
S.Ct. 2120, 2129 (2014) (citations omitted).
4. "Perceptible pain relief 110 and "peak pain relief:" 11 "An observable
decrease in pain by a patient" and "the maximum observable decrease in pain by a
patient." The specification describes efficacy studies for the treatment of pain. (61 :32-
Extrinsic evidence. Indeed, the parties' experts agree that measurements calculated
on a volume basis are known to one of skill in the art. (D. I. 108 at 1J1l 27-39; D. I. 125 at
Found in claims 21-22 of the '544 patent, claims 23 and 24 of the '387 patent, and
claims 19-22 of the '721 patent.
Found in claims 23-24 of the '544 patent.
69:28, example 16) The court acknowledges defendants' argument that perception of
pain is dependent on the individual enrolled in the study. However, the methods
described in the specification are standardized approaches used in industry. 12 (61 :3539) Plaintiffs' expert 13 explained that:
[P]hysicians in the field have been using the terms "perceptible pain relief'
and "peak pain relief' consistently in this manner for years. These pain
relief terms are not novel to Plaintiffs' clinical study of the Zorvolex® drug
products. In fact, many clinical studies of nonsteroidal anti-inflammatory
drugs, like diclofenac acid, utilized the terms "perceptible pain relief' and
"peak pain relief" to assess the pain relief of patients undergoing
treatment. The use of "peak pain relief" and "perceptible pain relief' in the
field is consistent with their description in the clinical efficacy study
disclosed in the specification of the patents-in-suit.
5. The court has provided a construction in quotes for the claim limitations at
issue. The parties are expected to present the claim construction consistently with any
explanation or clarification herein provided by the court, even if such language is not
included within the quotes.
"[A] Phase 2, Phase 2, Randomized, 35 Double-Blind, Single-Dose, Parallel-Group,
Active- and Placebo-Controlled Study of Diclofenac Nanoformulation Capsules for the
Treatment of Pain After Surgical Removal of Impacted Third Molars."
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