Case 1:14-cv-01515-SLR-SRF Document 140 Filed 02/29/16 Page 1 of 5 PageID #: 6768
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`ICEUTICA PTY LTD and
`IROKO PHARMACEUTICALS, LLC,
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`Plaintiffs,
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`v.
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`LUPIN LIMITED and LUPIN
`PHARMACEUTICALS, INC.,
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`Defendants.
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`Civ. No. 14-1515-SLR
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`MEMORANDUM ORDER
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`At Wilmington this ~day of February, 2016, having heard argument on, and
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`having reviewed the papers submitted in connection with, the parties' proposed claim
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`construction;
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`IT IS ORDERED that the disputed claim language of U.S. Patent Nos. 8,679,544
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`("the '544 patent"), 8,999,387 ("the '387 patent"), and 9,017,721 ("the '721 patent") shall
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`be construed consistent with the tenets of claim construction set forth by the United
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`States Court of Appeals for the Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303
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`(Fed. Cir. 2005), as follows:
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`1. "A pharmaceutical composition containing 18 mg of diclofenac acid" 1
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`and "a pharmaceutical composition containing 35 mg diclofenac acid."2
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`Consistent with the parties' proposed constructions, the plain and ordinary meaning of
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`the limitation will apply. The specification states that "[t]he present invention relates to
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`1 Found in claim 1 of the '544 patent, claim 1 of the '387 patent, and claim 1 of the '721
`patent.
`2 Found in claim 6 of the '544 patent, claim 11 of the '387 patent, and claim 8 of the '721
`patent.
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`1
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`ICEUTICA 2004
`Lupin v. iCeutica
`IPR2016-00397
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`Case 1:14-cv-01515-SLR-SRF Document 140 Filed 02/29/16 Page 2 of 5 PageID #: 6769
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`methods for producing particles of diclofenac using dry milling processes as well as
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`compositions comprising diclofenac, medicaments produced using diclofenac in
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`particulate form and/or compositions, and to methods of treatment ... using a
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`therapeutically effective amount of diclofenac administered by way of said
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`medicaments." (1 :5-11 )3 The specification generally describes "methods of making
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`finely divided or sized drugs" such as dry milling, wet grinding/milling, and airjet milling,
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`as well as the limitations of such methods. Epistar Corp. v. Int'/ Trade Comm'n, 566
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`F.3d 1321, 1336 (Fed. Cir. 2009) (the Federal Circuit "recognizes that disparaging
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`comments alone do not necessarily show a manifest or express disavowal of the
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`criticized subject matter"). The specification presents dry milling of the biologically
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`active material4 (3:56-62; 31 :39-32:22), the biologically active material (32:23-67), and
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`methods of administering pharmaceutical compositions (18: 14-22). The claims at issue
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`are directed to compositions and do not recite a specific process (i.e., dry milling) for
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`manufacturing the diclofenac acid particles. The court concludes that the specification
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`does not support defendants' additional language limiting the claims to "dry-milled
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`diclofenac acid." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir.
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`2004) (if a patent describes only a single embodiment, the claims of the patent must not
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`necessarily be construed as being limited to that embodiment "unless the patentee has
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`demonstrated a clear intention to limit the claim scope using 'words or expressions of
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`manifest exclusion or restriction"').
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`3 As the three patents-in-suit share a specification, references are to the '544 patent.
`4 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.
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`2
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`Case 1:14-cv-01515-SLR-SRF Document 140 Filed 02/29/16 Page 3 of 5 PageID #: 6770
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`2. "Wherein the unit dose when tested in vitro by USP Apparatus I (Basket)
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`method of U.S. Pharmacopoeia at 100 rpm at 37°C in 900 ml of 0.05% sodium
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`lauryl sulfate in citric acid solution buffered to pH 5.75 has a dissolution rate of
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`diclofenac acid such that at least [X]%, by weight, is released by [X] minutes"5
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`and "wherein the unit dose has a dissolution rate of diclofenac acid such that at
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`least [X]%, by weight, is released by [X] minutes:"6 "Wherein at least [X]%, by
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`weight, of diclofenac acid is released from the unit dose by [X] minutes as determined
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`by USP Apparatus I (Basket) method of U.S. Pharmacopeia at 100 rpm at 37°C in 900
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`ml of 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75" and "using
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`the methodology prescribed in the independent claims, the unit dose has a dissolution
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`rate such that at least [X]%, by weight, of diclofenac acid is released from the unit dose
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`by [X] minutes." According to the specification "[t]he process results in the biologically
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`active material having an improved dissolution profile[, which] has significant
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`advantages including the improvement of bioavailability of the biologically active
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`material in vivo." (24:35-39) The specification describes how to carry out the testing
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`method. (24:35-25:22, 54:12-67, example 14)
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`3. "The particles of diclofenac acid have a median particle size on a
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`volume average basis of" 7 and "the diclofenac acid has a median particle size, on
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`a volume average basis, of:"8 "The diclofenac acid particles have a particle size
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`5 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.
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`3
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`Case 1:14-cv-01515-SLR-SRF Document 140 Filed 02/29/16 Page 4 of 5 PageID #: 6771
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`diameter that divides the population in half such that 50% of the population is greater
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`than or less than said particle size diameter as determined on an equivalent spherical
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`particle volume basis measured after particle size reduction but before preparing the
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`unit dose." The specification defines "median particle size" "as the median particle
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`diameter as determined on an equivalent spherical particle volume basis. Where the
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`term median is used, it is understood to describe the particle size that divides the
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`population in half such that 50% of the population is greater than or less than this size."
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`(22:2-8) The specification explains that the "median particle size" is determined on a
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`particle volume basis. (16:39-40, 17:52-53, 33: 12-13) Further, "laser diffraction ... is
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`commonly used to measure particle size from 100 nm to 2000 micron, by calculat[ing] a
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`volume distribution of equivalent spherical particles .... " (21 :44-50) Contrary to
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`defendants' argument that the language "volume average basis" in the claims renders
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`them indefinite, the court concludes that the entire limitation, viewed in light of the
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`specification, would "inform those skilled in the art about the scope of the invention with
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`reasonable certainty."9 Nautilus, Inc. v. Biosig Instruments, Inc.,_ U.S._, 134
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`S.Ct. 2120, 2129 (2014) (citations omitted).
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`4. "Perceptible pain relief110 and "peak pain relief:" 11 "An observable
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`decrease in pain by a patient" and "the maximum observable decrease in pain by a
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`patient." The specification describes efficacy studies for the treatment of pain. (61 :32-
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`9 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
`1J1J 9-12)
`1° 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.
`11 Found in claims 23-24 of the '544 patent.
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`4
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`Case 1:14-cv-01515-SLR-SRF Document 140 Filed 02/29/16 Page 5 of 5 PageID #: 6772
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`69:28, example 16) The court acknowledges defendants' argument that perception of
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`pain is dependent on the individual enrolled in the study. However, the methods
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`described in the specification are standardized approaches used in industry. 12 (61 :35-
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`39) Plaintiffs' expert13 explained that:
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`[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.
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`(D.I. 109 at~ 32)
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`5. The court has provided a construction in quotes for the claim limitations at
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`issue. The parties are expected to present the claim construction consistently with any
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`explanation or clarification herein provided by the court, even if such language is not
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`included within the quotes.
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`12 "[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."
`13 Extrinsic evidence.
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`5