Case 1:14-cv-01515-SLR-SRF Document 96 Filed 12/10/15 Page 1 of 35 PageID #: 4352
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`1
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`ICEUTICA 2001
`Lupin v. iCeutica
`IPR2016-00399
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`

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`Case 1:14-cv-01515-SLR-SRF Document 96 Filed 12/10/15 Page 2 of 35 PageID #: 4353
`Case 1:14—cv—O1515—SLR—SRF Document 96 Filed 12/10/15 Page 2 of 35 Page|D #: 4353
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`TABLE OF CONTENTS
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`Page No.
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`I.
`
`II.
`
`INTRODUCTION ........................................................................................................... .. 1
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`NATURE AND STAGE OF THE PROCEEDINGS ...................................................... .. 2
`
`III.
`
`FACTUAL BACKGROUND .......................................................................................... .. 2
`
`A.
`
`State of the Art ..................................................................................................... .. 2
`
`l.
`
`2.
`
`3.
`
`Milling Has Long Been Used to Reduce Particle Size and
`Increase Drug Solubility and Bioavailability ........................................... .. 2
`
`iCeutica Filed Prior Patent Applications to Dry Milled
`Diclofenac Acid in 2005 and 2007 .......................................................... .. 3
`
`Iroko Admits Meiser Disclosed the Claimed Diclofenac Acid ............... .. 4
`
`B.
`
`The Patents—In-Suit .............................................................................................. .. 5
`
`l.
`
`The Shared Specification of the Patents .................................................. .. 5
`
`a.
`
`b.
`
`The Patents Disparage Wet Milling and Airjet Milling ............... .. 5
`
`The Inventors’ “Present Invention” ............................................. .. 6
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`2.
`
`3.
`
`Dissolution Testing in Example 14 of the Specification ......................... .. 7
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`The Asserted Claims ................................................................................ .. 8
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`IV.
`
`LEGAL STANDARD ...................................................................................................... .. 8
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`V.
`
`SUMMARY OF ARGUMENTS ..................................................................................... .. 9
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`VI.
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`ARGUMENT ................................................................................................................. .. 1 1
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`A.
`
`The Pharmaceutical Compositions Containing Diclofenac Acid ....................... .. 11
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`l.
`
`The Intrinsic Record Limits the Claims to Dry Milled
`Diclofenac Acid Compositions .............................................................. .. 11
`
`a.
`
`b.
`
`Dry Miiied Diclofenac Acid Is the “Present Invention” ............ .. 11
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`The Claimed Particle Size of Less Than 1,000 nrn
`Dictates the Particles Are Dry Milled Diclofenac Acid ............. .. l3
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`2
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`TABLE OF CONTENTS
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`(confd)
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`Page No.
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`2.
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`3.
`
`.P1.aintiffs 1.\/.[i.sunderstand Phillips’ l_I1Sti.‘L1C1£lOl1S Regarding the
`Use of Intrinsic Evidence to Limit Claim Scope ................................... .. 15
`
`Intrinsic and Extrinsic Evidence Confirms These Are Not
`
`Product—by—Process Claims .................................................................... .. 16
`
`B.
`
`. When Tested"
`.
`The Dissolution Test Embodied in the “Wherein .
`Clauses ............................................................................................................... .. 17
`
`l.
`
`The “Wherein .
`
`.
`
`. When Tested" Ciauses Deserve N0
`
`Patentable Weight .................................................................................. .. 1 8
`
`a.
`
`“Wherein .
`
`.
`
`. When Tested” Clauses Do Not Add
`
`Substance to the Claims ............................................................. .. 18
`
`b.
`
`c.
`
`. When Tested” Clauses Express Only
`.
`The “Wherein .
`an lntend.ed Result...................................................................... .. 19
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`The Dissolution Testing Is an Optional Condition in the
`Claims ........................................................................................ .. 20
`
`2.
`
`. When Tested”
`.
`If Given Patentable Weight, the “W’he1‘e.in .
`Clauses Must Include Lactose Monohydrate and Sodium Lauryl
`Sulfate .................................................................................................... .. 21
`
`C.
`
`“Median Particie Size,” “Volume Average Basis,” and “Median
`Particle Size on a Volume Average Basis” ........................................................ .. 22
`
`1.
`
`2.
`
`3.
`
`The Specification Defines “Median Particle Size” ................................ .. 22
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`Volume Average Basis .......................................................................... .. 23
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`Median Particle Size on a Volume Average Basis ................................ .. 26
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`D.
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`E.
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`“D(90) particle size” .......................................................................................... ..26
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`“Perceptible Pain Relief” and “Peak Pain Relief” ............................................. .. 26
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`VII.
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`CONCLUSION .............................................................................................................. .. 29
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`3
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`Case 1:14—cv—O1515—SLR—SRF Document 96 Filed 12/10/15 Page 4 of 35 Page|D #: 4355
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`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Abbott GmbH & Co., KG v. Centocor Ortno Biotech, Inc,
`
`No. 09-11340—PDS, 2011 WL 948403 (D. Mass. Mar. 15, 2011) ................................... ..13, 15
`
`Andersen Corp. v. Fiber Composites, LLC,
`474 F.3d 1361 (Fed. Cir. 2007) .............................................................................................. ..15
`
`Curtiss-Wright Flow Control Corp. v. Velan, Inc.,
`438 F.3d 1374 (Fed. Cir. 2006) .............................................................................................. ..15
`
`DDR Holdings, LLC V. Hofelscorn, L.P.,
`773 F.3d 1245 (Fed. Cir. 2014) .............................................................................................. ..28
`
`I-Iojfer V. Microsofi Corp,
`405 F.3d 1326 (Fed. Cir. 2005) ........................................................................................ ..19, 20
`
`Honeywell Int’l, Inc. 12. ITT Indus, Inc,
`452 F.3d 1312 (Fed. Cir. 2006) .................................................................................. ..11, 12, 29
`
`Honeywell Int’l, Inc. 1,’. US,
`609 F.3d 1292 (Fed. Cir. 2010) .............................................................................................. ..29
`
`Icon Outdoors, LLC 17. Core Res, Inc.,
`
`No. RDB—11-2967, 2012 WL 5521121 (D. Md. Nov. 14, 2012) ..................................... ..16, 17
`
`Intellectual Ventures I, LLC v. Canon Inc.,
`
`No. CV 13—473~SLR, 2015 WL 1458035 (D. Del. Mar. 27, 2015) ......................................... ..9
`
`Interval Licensing LLC v. AOL, Inc.,
`766 F.3d 1364 (Fed. Cir. 2014) cert. denied, 136 S. Ct. 59 (2015) ................................... ..9, 27
`
`Kinetic Concepts, Inc. 12. Blue Sky Med. Grp., Inc,
`554 F.3d 1010 (.Fed.. Cir. 2009) .............................................................................................. ..15
`
`Lizordteclt, Inc. v. Earth Res. Mapping Inc.,
`433 F.3d 1373 (Fed. Cir. 2006) .............................................................................................. ..12
`
`Minton v. National Ass’n ofSecurities Dealers, Inc,
`336 F.3d 1373 (Fed. Cir. 2003) .............................................................................................. ._19
`
`Nautilus, Inc. v. Biosig Instruments, Inc,
`134 S. Ct. 2120 (2014) ................................................................................................. ..9, 26, 29
`
`
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`4
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`

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`Case 1:14-cv-01515-SLR-SRF Document 96 Filed 12/10/15 Page 5 of 35 PageID #: 4356
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`TABLE OF AUTHORITIES
`
`(c0nt’d)
`
`Page N0(s).
`
`Inc. v. Pride S013, LLC,
`Not Dead Yet
`N0. 13 C 3418, 2015 WL 5829761. (N.D. E11. Oct. 5,2015) ............................................ ..19, 20
`
`On Demand Mach. Corp. v. Ingram Indus.,
`442 F.3d 1331 (Fed.. Cir. 2006) .............................................................................................. ..13
`
`Phillips 12. A WH Corp,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ...................................................................... ..passim
`
`Renishaw, PLC 12. Marposs .S‘oc1'er'a’ per Azfonf,
`1581-".3d 1243 (Fed. Cir. 1998) .............................................................................................. ..20
`
`.S*cIn0fi—/iventis US., LLC v. S-rmdoz, Inc., et al.,
`345 F. App’x 594 (Fed. Cir. 2009) ........................................................................................ ..16
`
`Texas’ Digifal SyS., Inc. v. Telegenix, Inc,
`308 F.3d 1193 (Fed. Cir. 2002) .............................................................................................. ..15
`
`Texas Irzstruments Inc. v. US. Int"! Trade Comm ‘:1,
`988 F.2d. 1165 (Fed. Cir. 1993) ............................................................................................. ..18
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 112 ................................................................................................................... ..pass:'m
`
`MFEP§2111.04 .......................................................................................................................... ..18
`
`-iV...
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`5
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`I.
`
`INTRODUCTION
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`Through this suit, Plaintiffs are attempting to recapture subject matter that they ded.icated.
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`to the public long ago. Plaintiffs’ own PCT applications, which are prior art, not only disciosed
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`nanoparticle formulations of diclofenac acid, but also disclosed that such fonnulations had
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`advantages over conventional compounds including more rapid therapeutic action or lower dose.
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`Plaintiff lroko admitted as much in an SEC filing. There is nothing novel or inventive about
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`nanoparticle formulations of diclofenac acid or methods of administering those formulations.
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`Plaintiffs’ patent suit against Lupin hinges on a claim interpretation that is contradicted
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`by the specification and by the claims themselves. To capture nan—dry milled diciofenac
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`particles in the claims, Plaintiffs ask. this Court to reject the inventors’ plain and repeated
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`declaration in the specification that
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`the invcntion—the “present invention”~is dry milled
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`diclofenac acid. Plaintiffs ignore the 305 experiments and 12 examples in the specification of
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`dry milled drug products and the complete absence of any experiments or examples to products
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`produced by other milling methods.
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`Instead, Plaintiffs claim that the inventors disclosed other
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`types of milling in the specification, including airjet milling and wet milling. Bu.t Plaintiffs
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`never tell the Court that the inventors mentioned those methods only in the Background Section
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`and then, only to denigrate them for their inabiiity to achieve the particles sought and claimed by
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`the inventors. Plaintiffs must be heid to the inventors’ representations that their invention is dry
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`milled diclofenac acid. Plaintiffs’ claims cannot inciude subject matter they did n.ot invent and
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`that they actually considered impossible.
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`Moreover, Plaintiffs’ attempt
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`to dress up their claims by tacl<;i.n.g on run—of-the~mill
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`dissolution tests fails to impart patentable weight. The “wherein .
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`.
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`. when tested” clauses
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`embodying the dissolution tests are not entitled to patentable weight, as they simply state the
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`results that fiow naturally from well—known, standard test conditions.
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`-1-
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`6
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`6
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`II.
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`NATURE AND STAGE OF THE PROCEEDINGS
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`Lupin agrees with the Nature and Stage of the Proceedi.ngs set forth by Plaintiffs in their
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`Opening Brief. See D.I. 67 at 2.
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`III.
`
`FACTUAL BACKGROUND
`
`A.
`
`State of the Art
`
`1.
`
`Milling Has Long Been Used to Reduce Particle Size and Increase
`Drug Solubility and Bioavailability
`
`Milling, also referred to as grinding, has been used for decades to reduce the particle size
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`of poorly-soluble drug compounds,
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`in order to increase the drug’s solubility, and hence its
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`bioavaiiability. Amiji ll 21.1 Bioavailability is the degree to which a drug compound becomes
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`available to a target tissue in the body, and depends, to a large extent, on the drug’s ability to
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`dissolve in the small intestine. Amiji ti 18; IA22 (l:l9—23).3 Reducing the particle size of the
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`drug increases the overall surface area of the administered dose of the drug. Amiji ii 20. Dry
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`milling and wet milling are two methods that have been employed to reduce particle size; the
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`distinction being simpiy that wet milling is perfonned in a iiquid medium, whereas dry milling
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`“Should be understood to refer to miiling in at ieast the substantial absence of liquids.” JA33
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`(2324-25). Wet and dry milling each have benefits and drawbacks; one drawback of wet milling
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`is that flocculation, or the clumping together of milled particles, prevents production of particles
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`below a certain size. Amiji ii 21.
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`In 1993, Samejima addressed poor solubility and poor bioavailability by reducing drug
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`particle size through dry milling. Specifically, Samejiina disclosed dry milling naproxene (an
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`1 Lupin’s brief is supported by the co11currcntiy—f1l.ed declaration of Dr. Mansoor Amiji,
`Ph.D., R.Ph., an expert in the field of nanoparticle pharmaceutical formulations.
`
`3 All references to the shared specificati.on are to the ’544 patent (JAl -JA57).
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`7
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`NSAID like diciofenac) to “preferably less than 1 },un [L000 nm]” to improve dissolution,
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`solubility, and bioavailability. Ex. 6 (Samejima, 2:43-45, 4:l4—45).3
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`In 2007, Kesisoglou er at’. explained that “nanosizing,” or “the reduction of the active
`
`pharmaceu.tical ingredient (API) particle size down to the sub—micron range," wouid improve
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`dissoiution of a drug. Ex. D (Kesisoglou at 632). Kesisoglou stated that particle size reduction
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`had been employed in the pharmaceutical industry for decades, but “recent advances in milling
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`technology and our understanding of such colioidal systems have enabled the production of AP1
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`particles of 100-200 nm size in a reproducibie manner.” In’. At the time of the patents, one of
`
`ordinary skill weil knew that reducing a drug’s particie size wouid increase its surface area, and
`
`thereby increase its solubility and bioavailability. Amiji 1l‘|] 22-24.
`
`2.
`
`iCeutica Filed Prior Patent Applications to Dry Milled Diciofenac
`Acid in 2005 and 2007
`
`iCeutica is one of two Plaintiffs in this case and is also the assignee of the patents.
`
`iCeutica previously filed two PCT patent applications directed to dry milled diclofenac acid.
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`In
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`2005, iCeutica flied PCT Application No. PCT:’AU2005/00l_977 (Ex. 4, “Payne”).
`
`In 2007,
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`iCeutica fried PCT Application No. "PCT/AU2007/000910 (Ex. 5, “M'eiser”). Both Payne an.d
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`Meiser are prior art to the patents-in-suit.
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`Payne and Mei_ser both disparage the use of wet milling to reduce a drug’s particle size,
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`and do so with identical language, stating: “[W]et grinding may be employed to reduce particie
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`size, but flocculation restricts the lower particle size limit to 10 microns (10,000 nm)" and “[t]he
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`wet milling process [] is prone to contamination, thereby leading to a bias in the pharmaceutical
`
`art against wet milling.” Ex. 4 (Payne at 213-6); EX. 5 (Meiser at 2). Both iCeutica applications
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`3 Numbered exhibits refer to Lupin exhibits attached to the concurrently—filed Declaration
`of Benjamin Anger; iettered exhibits refer to Plaintiff exhibits attached to the Declaration of
`Elizabeth Flanagan (D.l. 68).
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`8
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`
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`also disparage another type of milling, airjet milling, for an inability to reduce particle size to
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`less than “about 1 to about 50 microns (1,000-50,000 nm). Ex. 4 (Payne at 2:3-6); Ex. 5 (Meiser
`
`at 2). After disparaging wet milling and airjet milling in the Background Section, both iCeutica
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`applications disclose their invention as a dry milling process that allegedly reduces the particle
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`size of various drug compounds, including diclofenac acid, to less than 1000 nm, to increase the
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`drug’s solubility and bioaVailability.4 See, e. g_, Ex. 4 (Payne, 1:25-26, 17:1-4, 26 Table 1, 42:9-
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`43:26, Claim 36); Ex. 5 (l\/leiser, 6-7, 27-28); An1iji.1l'll 24-28.
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`3.
`
`Iroko Admits Meiser Disclosed the Claimed Diclofenac Acid
`
`lroko, iCeutica’s parent company and a plaintiff in this case, filed an 17-1 Prospectus with
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`the Securities and Exchange Commission (SEC) in 2013. Ex. 13 (Prospectus). The Prospectus
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`describes Zorvolex® as “a novel formulation of diclofenac, developed using the SoluMatrixTM
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`technology platform” and states that “zorvolexw consists of diclofenac acid as the sole active
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`ingredient.” Id. at 89. The Prospectus states that Payne discloses iCeutica’s “first generation
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`milling technology and resulting products” and Meiser discloses the “second generation milling
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`technology and resulting products." Id. at U3. The Prospectus then states that “SoluMatrixTM
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`Technology Platform is currently based on our second generation technology (Poitfolio (ii))
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`[Meiser].°° Id. Under the heading SoluMatrixT“ Technology Platform, the Prospectus states that
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`“{t]he methods described in [Meiser] applications can be used to prepare Zorvol.exTM.
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`.
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`. .” Id. at
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`115.
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`4 Plaintiffs’ Opening Brief espouses that the patented diclofenac acid formulations allow
`a “decrease in dose” over the traditional diclofenac salt formulations. D.I. 67 at 1. But, as
`discussed in this
`section, Meiser and Payne both previously disclosed diclofenac acid
`formulations having particle sizes less than 1000 nm, and Meiser specifically taught that the
`formulations “exhibit advantages over conventional compounds by way of, for example, more
`rapid therapeutic action or lower dose.” Ex. 5 (Meiser at 7) (emphasis added).
`
`9
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`Taken together,
`
`.l.r.oko‘s statements concede that Zorvolex
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`® is made by the methods
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`disclosed in Meiscr. By iisting the patents in the FDA’s Orange Book under Zorvolex®, lroko
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`asserts that Zo1volex® is also covered by the patent claims. With lro.ko’s listing the patents in the
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`Orange Book, and lroko’s concession that Zowolex® is made by methods disclosed in Meiser,
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`iroko acknowiedges that the diclofenac product claimed in the patents is disclosed in Meiser.
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`The Prospectus also concedes that the Solulvlatrix Technology “uses a dry milling process to
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`reduce the drug particle size.” Id. at 3 (emphasis added).
`
`B.
`
`The Patents—In—Suit
`
`In 2010, iCeutica tiled another PCT application directed to dry milling, with the word-
`
`for—word disparagement of wet milling and airjet milling found in Payne and Meiser. This 2010
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`PCT Application No. PCT/AU2010/00047} is the parent application of the patents—in—suit.
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`1.
`
`The Shared Specification of the Patents
`
`a.
`
`The Patents Disparage Wet Milling and Airjet Milling
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`The patents share a common specification, in which the inventors purport to address the
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`same solubility and bioavailability issues that Payne and Meiser previously addressed. For
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`example, both Payne and Meiser state that “[p]oor bioavailahility is a significant probiem
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`encountered in the development of therapeutic compositions, particularly those compounds
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`containing a bioiogically active compound that is poorly soluble in water at _physioIog.ical pH.”
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`Ex. 5 (Meiser at l); Ex. 4 (Payne at 1). The patents—in—suit contain nearly identical langu.age.
`
`See JA22 0:15-19).
`
`The patents copy verbatim,
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`in the Background Section, Payne’s
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`and Meiser°s
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`disparagement of wet milling and airjet milling. JA22 (1:44-51). The patents further disparage
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`wet miliing in the Summary of the lnvention Section: “[W]et grinding techniques utiiizing water
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`10
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`10
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`.
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`. are incapable of being applied to [highly water—soluble drug compounds], as the particles
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`dissolve appreciably in the solvent.” Id. (l 8:64-67).
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`b.
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`The Inventors’ “Present Iiiventioir”
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`The inventors represent throughout the specification, without equivocating, that their
`
`invention is the diclofenac particles produced by dry milling—that is, dry milled. diclofenac acid.
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`The first sentence, under the h.eadin.g FIELD OF THE INVENTION, states: “The present
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`invention relates to methods for producing particles of diclofenac nsing dry milling processes
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`.
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`.
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`.
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`.’° Id. (1 15-6) (emphasis added). The first sentence under the heading SUMMARY OF THE
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`INVENTION states: “[T]he “present invention is directed to the unexpected finding that
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`particles of a biologically active material can be produced by dry milling processes at
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`c.onin1erciai scale.” lA23 (3:44-4'7) (emphasis added). Under the heading “Commercial Scaie,”
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`the patents continue: “The present invention is directed to the unexpected finding that particles
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`of a biologically active material can be produced by dry milling processes as described herein
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`at cornm.ei‘ci.al sc-aie.” lA33 (24:14-17) (emphasis added). The patents include an entire section
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`entitled “Dry Milling,” which states in the first sentence: “In the dry milling process of the
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`present invention .
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`.
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`. .”
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`Id. (31 :39) (emphasis added).
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`The patents include
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`12 examples (Examples 1-12)
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`that
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`involve processing drug
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`compounds to produce nanopaiticle formulations; all 12 examples use dry milling technology to
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`produce dry milled nanoparticies.
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`IA-44-47 (46:55—52:55); Amiji TI 50. The patent figures show
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`tabulated results of 305 experiments performed as part of the examples, all of which involve dry
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`milling the active drug compound. alone, with surfactants or with grinding matrices. See Figures
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`IA, 1B, 1C, 1D, 1E, 1F, lG, 2A, 3A, 4A, 5A, 6A, 6B, 6C, 7A, 8A, 9A, 9B, 10A, 11A, & 12A.
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`None of these examples or experiments involves wet milling or airjet milling, consistent with the
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`inventors’ disparagement of these techniques. Amiji “F” 50-51.
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`-5-
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`‘I1
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`11
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`Case 1:14-cv-01515-SLR-SRF Document 96 Filed 12/10/15 Page 12 of 35 PageID #: 4363
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`
`2.
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`Dissolution Testing in Example 14 of the Specification
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`Example 14 is important to the construction of the claims because it contains the
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`dissolution test that is part of the “wherein . . . when tested” clause of each independent claim.
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`Example 14 describes the comparative in vitro dissolution testing of “nanoformulations of the
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`invention” against a “commercial reference” diclofenac product. JA48 (54:11-67). Example 14
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`is the only example of dissolution testing in the patents.
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`The diclofenac capsules tested in Example 14 are prepared as described in Examples 13a
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`and 13b and were originally dry milled as samples W, X, and Y in Example 9. JA47-48 (52:57–
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`67; 53:30–37; 54:17-22). Figure 9b, partially reproduced below, shows that diclofenac samples
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`W, X, and Y were dry milled with 84% lactose monohydrate and 1% sodium lauryl sulfate
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`referred to as SDS, or sodium dodecyl sulfate in the figure.
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`
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`In Example 14, one 18 mg capsule of diclofenac acid (sample W) and one 35 mg capsule
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`of diclofenac acid (a combination of samples X and Y) were subjected to a dissolution test
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`according to USP section <711> and under the following test conditions: Apparatus I (basket)
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`method; stir speed of 100 rpm; dissolution media of 0.05% sodium lauryl sulfate and citric acid
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`solution buffered to 5.75 pH; volume of 900 mL; temperature of 37°C; and measurement
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`intervals of 15, 30, 45, and 60 minutes, and an additional measurement at “infinity,” defined as
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`15 additional minutes at a higher rotation speed. JA48 (54:22-30).
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`-7-
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`12
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`

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`The results of the dissolution testing are shown in Table 14a of the patents.
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`Id. (54:35-
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`50). The claimed dissolution percentages (82%, 91%, 94%, 95%) are found only in this table.
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`3.
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`The Asserted Claims
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`Plaintiffs have asserted all 24 claims of each patent against Lupin.5 All independent
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`ciaimsewhether the method claims in the ”387 patent or composition claims in the ’544 and
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`"721 patents——include three limiting elements: (1) the pharmaceutical composition: “a [solid
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`oral] unit dose of a pharmaceutical composition containing {X} mg of diciofenac acid”; (2) the
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`dosage amount: [X] is either 18 mg or 35 mg of diclofenac acid; and (3) the particle size. All
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`independent claims also include an additional, fourth, non—limiting clause:
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`(4) the “wherein .
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`.
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`.
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`when tested” clause: optionally performing a dissolution test on the diclofenac acid under
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`specific and well—known test conditions.
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`IV.
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`LEGAL STANDARD
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`Claim construction is grounded in the ordinary meaning of the claims as understood by a
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`person of skill in the art at the time of the invention. See Philfips v. AWH Corp, 415 F.3d 1303,
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`1313 (Fed. Cir. 2005) (en banc). A skilled artisan Views the claim terms in the context of the
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`“intrinsic” evi_dence—the claims, the specification, and the prosecution history.
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`Id.
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`“{T]he
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`context in which a term is used in the asserted claim can be highly instructive.” Id. at 1314.
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`The claim terms “must be construed so as to be consistent with the specification, of
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`which they are part.” Id. at 1316 (internal quotation marks and citation omitted). The correct
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`construction “can only be determined and confirmed with a full understanding of what the
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`inventors actually invented and intended to envelop with the claim.”
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`In’. (internal quotation
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`marks and citation omitted).
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`in this regard, “ftlhe construction that stays true to the claim
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`5 Lupin has requested that Plaintiffs limit the asserted claims to a reasonable number, but
`Plaintiffs have, thus far, refused to do so.
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`13
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`13
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`

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`language and most naturally aligns with the patcnt’s description of the invention will be, in the
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`end, the correct construction.” Id.
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`Consistent with Phillips’ requirement to align the terms with the patent‘s description,
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`“the specification may reveal an intentional disclaimer, or disavowal, of claim scope by the
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`inventor.” PI’?-i[.iI'pS, 415 F.3d at 1316. When this happens, “the inventor has dictated the correct
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`claim scope, and the inVentor’s intention, as expressed in the specification,
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`is regarded as
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`dispositive." Id.
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`A patent must “conclude with one or more claims particuiarly pointing out and distinctly
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`claiming the subject matter which the applicant regards as his invention." 35 U.S.C. § 1 12 1] 2
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`(2000). “[A] patent is invalid for indefiniteness if its claims, read in light of the specification
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`delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those
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`skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc, 134
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`S. Ct. 2120, 2124 (2014). “it cannot be sufficient that a court can ascribe some meaning to a
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`patent's claims[.l°" See id. at 2130 (emphasis in original). “The claims, when read in light of the
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`specification and the prosecution history, must provide objective boundaries for those of skill in
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`the art.” See Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014) cert.
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`denied, 136 S. Ct. 59 (2015). Claim terms may be found indefinite at the claim construction
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`stage and this Court has previously done so. Intellectual Ventures I, LLC V. Canon Inc, No. CV
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`13-473-SLR, 2015 WL 1458035, at *2 (D. Del. Mar. 27, 2015).
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`V.
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`SUMMARY OF ARGUl\/TENTS
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`1.
`
`The claim term “a pharmaceutical composition containing 18 [35] mg of
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`diciofenac acid” is properly construed to include “dg milled diciofenac acid.” Throughout the
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`specification, the inventors repeatedly declared that the “present invention” is the dicloifenac
`
`14
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`14
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`

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`particles produ.ced by dry milling——that is, d.ry miiled diclofenac acid: “The present invention
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`relates to methods for producing particles of diciofenac using dry milling processes.” All
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`claims require a particle size of less than 1000 nm, and dry milling is the only disclosed method
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`for achieving the particle size. The inventors even disparaged other methods of milling in the
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`Background Section, because those methods cannot achieve the particle sizes recited in the
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`claims. The law prohibits Plaintiffs from recapturing claim scope once disclaimed.
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`2.
`
`The recited dissolution test, as embodied in the “‘vNi'l(“IT€l]"l
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`.
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`. .whcn tested” clauses
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`shouid not be afforded patentabie weight. The test fails to provide any substance to the claimed
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`methods of administering diclofenac acid, or to the claimed compositions of diclofenac acid.
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`In
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`operation and outcome, the _performance of this test is divorced from the other claim elements.
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`Indeed, perfonnance of the test is recited as optional, "because the claims recite only that “when
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`tested,” the diclofenac acid wili attain a certain dissolution.
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`The claims do not require
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`performance of the test as part of the “method for treating pain” in the ’387 patent, or as part of
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`the “unit dose” composition in the ‘S44 and ’72E patents.
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`3.
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`Ail independent claims include the terms “median particles size” and “volume
`
`average basis” to describe the particle size measurement. “Median particle size” is defined in the
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`specification; “volume average basis,” however, appears only in the claims and fails to inform
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`those skilled in the art, with reasonable certainty, about the scope of the invention, and therefore
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`renders the claims invalid as indefinite under 35 U'.S.C. § 112, ii 2.
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`4.
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`The ‘‘[)(90) particle size” terms are properly construed, based on the specification
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`as the diameter at which 90% of the particles have a smaller particle diameter when measured on
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`a paiticie volume basis. Piaintiffs’ proposed construction would unnecessarily import a timing
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`requirement into the claims.
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`-10-
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`15
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`15
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`

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`5.
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`Finally, several dependent claims also include subjective limitations related to
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`“_perce_ptibie pain relief and “peel: pain relief" such that these claim terms lack defined claim
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`scope and are thus also invalid as indefinite under 35 U.S.C. § ll2, ll 2.
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`VI.
`
`ARGUMENT
`
`A.
`
`The Pharmaceutical Compositions Containing Diclofenac Acid
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`All independent claims recite “a pharmaceutical composition containing 18 [or 35] mg of
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`diciofenac acid,” which should be construed to mean “a pharmaceutical composition containing
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`18 [35] mg of dry milled diclofenac acid.”
`
`1.
`
`The Intrinsic Record Limits the Claims to Dry Milled Diclofenac Acid
`Compositions
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`Reading the claims, specification, and prosecution history, one of ordinary skill would
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`have understood the inventors to have intentionally disclairned all forms of diclofenac acid
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`except dry milled diclofenac acid.
`
`a.
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`Dry Milled Diclofenac Acid Is the “Present Invention”
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`Under headings FIELD OF T INVENTION and SUIVIMARY OF THE INVENTION,
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`and elsewhere throughout the specification, the inventors defined their “present i.n'vent.ion” as the
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`diclofenac particles produced by dry inilling—that is, dry milled diclofenac acid.
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`In just one of
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`many instances, the first sentence of the patent defines the “present invention” as “methods for
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`producing particles of diclofenac using dry milling processes .
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`.
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`.
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`.”
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`’544 patent, 125-6
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`(emphasis