Case 2:18-cv-00734-CCC-MF Document 39 Filed 10/10/18 Page 1 of 1 PageID: 252
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`One Newark Center, 19th Floor
`Newark, New Jersey 07102
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` Tel: 973.690.5400 Fax: 973.466.2761
`www.rwmlegal.com
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`October 10, 2018
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`VIA CM/ECF
`Honorable Claire C. Cecchi, U.S.D.J.
`United States District Court
`50 Walnut Street
`Newark, New Jersey 07102
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`Dear Judge Cecchi:
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`Re:
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`Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.
`Civil Action No. 2:18-00734 (CCC)(MF)
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`This firm, along with Akin Gump Strauss Hauer & Feld LLP, represents plaintiffs in the
`above-referenced matter. Respectfully enclosed on behalf of all parties for Your Honor’s
`consideration is the Joint Claim Construction Statement pursuant to Local Patent Rule 4.3.
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`We thank the Court for its kind consideration of this submission. Should Your Honor
`have any questions, we are available at the Court’s convenience.
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`KJM/gd
`cc:
`All Counsel (via CM/ECF)
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`Respectfully,
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`s/Keith J. Miller
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`Keith J. Miller
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 001
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`Case 2:18-cv-00734-CCC-MF Document 39-1 Filed 10/10/18 Page 1 of 4 PageID: 253
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`IN THE UNITED STATED DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`JANSSEN PHARMACEUTICALS, INC.
`and JANSSEN PHARMACEUTICA NV,
` Plaintiffs,
` v.
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`TEVA PHARMACEUTICALS USA, INC.,
` Defendant.
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`Civil Action No. 2:18-00734 (CCC)(MF)
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`JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
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`Pursuant to Local Patent Rule 4.3 and the Court’s May 14, 2018 Scheduling Order (D.I. 29),
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`Plaintiffs Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV (collectively, “Janssen”) and
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`Defendant Teva Pharmaceuticals USA, Inc. (“Teva”) hereby submit their Joint Claim Construction
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`and Prehearing Statement concerning U.S. Pat. No. 9,439,906 (the “’906 Patent”).
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`I.
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`Construction of Terms
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`A.
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`Agreed Constructions
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`There are no terms for which the parties have agreed to a construction. The parties agree
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`that no terms, other than the one disputed term described below, are in need of construction.
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`B.
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`Disputed Terms
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`Pursuant to Local Patent Rule 4.3(b), attached as Exhibit A is a chart identifying the
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`single disputed claim term in this case, the parties’ respective proposed constructions for that
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`term, and the intrinsic and extrinsic evidence that each party intends to rely on in support of its
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`proposed construction or to oppose the other party’s construction. The parties may also rely on
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`any portion of the specification and prosecution history of the ‘906 Patent. The parties further
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`reserve the right to amend, correct, or supplement their claim construction positions and
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 002
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`Case 2:18-cv-00734-CCC-MF Document 39-1 Filed 10/10/18 Page 2 of 4 PageID: 254
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`supporting evidence for good cause. Janssen contends that the disputed claim term is definite
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`and able to be construed. Teva contends that the disputed term is indefinite and incapable of
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`being construed.
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`II.
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`Claim Terms Whose Construction Will Be Most Significant to the Resolution of the
`Case
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`Janssen’s position:
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`Janssen does not believe that construction of any claim term is necessary for resolution of
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`this case, or that any claim term is case dispositive. The construction of the disputed claim term,
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`which appears in two dependent claims, will not be case dispositive as to all asserted claims, and
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`at this stage, appears to be unlikely to be substantially conducive to promoting settlement.
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`Construction of the disputed claim term will simplify the issues for claims 17-21, because it will
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`address Teva’s contention that the claim term cannot be construed because it is insolubly
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`ambiguous.
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`Teva’s Position:
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`The disputed claim term pertains to claims 17-21 of the ‘906 Patent. Teva agrees that the
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`construction of the disputed claim term will not be case dispositive and appears to be unlikely to
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`be substantially conducive to promoting settlement. Furthermore, as the only issue is whether a
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`claim term renders claims 17-21 invalid as failing to comply with 35 U.S.C. §112, second
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`paragraph (indefiniteness), Teva believes that this dispute is more properly resolved based on a
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`full record following expert discovery.
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`2
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 003
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`Case 2:18-cv-00734-CCC-MF Document 39-1 Filed 10/10/18 Page 3 of 4 PageID: 255
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`III. Anticipated Length of Time Necessary for the Claim Construction Hearing
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`The parties believe that the Claim Construction Hearing can be completed in two hours of
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`attorney argument, divided evenly between Janssen and Teva. The parties agree that additional
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`time may be necessary if live expert witness testimony is presented at the Hearing.
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`IV.
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`Identification of Witnesses for the Claim Construction Hearing
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`The parties do not, at this time, intend to call any witnesses at the Claim Construction
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`Hearing.
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`Dated: October 10, 2018
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`Respectfully Submitted,
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`___s/ Keith J. Miller_______________
`Keith J. Miller
`Justin T. Quinn
`Michael J. Gesualdo
`ROBINSON MILLER LLC
`One Newark Center, 19th Floor
`Newark, NJ 07102
`(973) 690-5400
`kmiller@rwmlegal.com
`jquinn@rwmlegal.com
`mgesualdo@rwmlegal.com
`
`Matthew A. Pearson
`Barbara L. Mullin
`Angela Verrecchio
`AKIN GUMP STRAUSS HAUER & FELD
`LLP
`Two Commerce Square
`2001 Market St., Suite 4100
`Philadelphia, PA 19103
`(215) 965-1200
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`_____s/ Liza M. Walsh_________
`Liza M. Walsh
`Christine I. Gannon
`William T. Walsh, Jr.
`WALSH PIZZI O’REILLY FALANGA LLP
`One Riverfront Plaza
`1037 Raymond Boulevard, Suite 600
`Newark, NJ 07102
`(973) 757-1100
`lwalsh@walsh.law
`cgannon@walsh.law
`wwalsh@walsh.law
`
`Jeanna M. Wacker
`Christopher T. Jagoe
`Mira A. Mulvaney
`Gregory Springsted
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
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`3
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 004
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`Case 2:18-cv-00734-CCC-MF Document 39-1 Filed 10/10/18 Page 4 of 4 PageID: 256
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`Attorneys of Plaintiffs Janssen
`Pharmaceuticals, Inc. and Janssen
`Pharmaceutica NV
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`Attorneys for Defendant Teva Pharmaceutical
`USA, Inc.
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`4
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 005
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`Case 2:18-cv-00734-CCC-MF Document 39-2 Filed 10/10/18 Page 1 of 5 PageID: 257
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`Exhibit A
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 006
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`Case 2:18-cv-00734-CCC-MF Document 39-2 Filed 10/10/18 Page 2 of 5 PageID: 258
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`Exhibit A – Claim Term in Dispute and the Parties’ Proposals
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`Claim Term
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`Janssen’s Proposed Construction and Support
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`Teva’s Position and Support
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`“average particle size
`(d50) of from about
`1600 nm to about 900
`nm”
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`Claims 17 and 19
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`average particle size (d50) means about 50% of the
`particles have a diameter of less than the d50 when
`measured by art-known conventional techniques
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`“the average particle size (d50)” is in the range of
`from about 1600 nm to about 900 nm
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`The claim term is insolubly ambiguous. In view of
`this claim term, claims 17 and 19, and their
`respective dependent claims, when viewed in light
`of the specification and prosecution history, fail to
`inform those of skill in the art about the scope of the
`claimed invention with reasonable certainty.
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`Intrinsic Evidence:
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`906 Patent at 7:21-44; Claims 17 and 19.
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`U.S. Patent No. 6,555,544 at 5:15-25; 8:43-9:44.
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`Extrinsic Evidence:
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`WO 2007/117661 A2 at [51].
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`US 2004/0258757 A1 at [0002-0006], [0014-0015].
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`US 2006/0159766 A1 [0002-0003], [0129-130].
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`US 2007/0148252 A1 [0124], [0142].
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`A. Jillavenkatesa, S.J. Dapkunas, L.S.H. Lum. NIST
`Recommended Practice Guide, (2001) Special
`Publication 960-1, Particle Size Characterization,
`Chapter 6: Size Characterization by Laser Light
`Diffraction Techniques at 125-137.
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`Pharmaceutical Preformulation and Formulation –
`Practical Guide from Candidate Drug Selection to
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`Intrinsic Evidence:
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`‘906 patent specification, at e.g., 7:21-41
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`‘906 patent file history
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`Extrinsic Evidence:
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`Allen, Particle Sampling and Powder Size
`Determination, Ch. 2 (2003).
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`Britain, What Is the “Correct” Method to Use for
`Particle-Size Determination?, Pharmaceutical
`Technology (2001).
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`Burgess et al. Particle Size Analysis: AAPS
`Workshop Report, Cosponsored by the Food and
`Drug Administration and the United States
`Pharmacopeia, The AAPS Journal, 6(3): article 20
`(2004).
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`Sinko, Martin’s Physical Chemistry and
`Pharmaceutical Sciences, 5th Ed. Ch. 19 (2006).
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`2
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 007
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`Case 2:18-cv-00734-CCC-MF Document 39-2 Filed 10/10/18 Page 3 of 5 PageID: 259
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`Exhibit A – Claim Term in Dispute and the Parties’ Proposals
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`Claim Term
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`Janssen’s Proposed Construction and Support
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`Teva’s Position and Support
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`Commercial Dosage Form (2004 ed.), Chapter 6:
`Solid Dosage Forms at 182-186.
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`TEVAPALI0000936-1001 at 941, 943-944.
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`TEVAPALI0001516-653 at 575, 630, 633-642.
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`TEVAPALI0002878-886 at 882.
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`TEVAPALI0003588-601 at 592.
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`TEVAPALI0000497-720 at 523-529, 531, 535-536.
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`TEVAPALI0001286-1305 at 290-299.
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`TEVAPALI0001403-491 at 408-420, 425-427, 430-
`440, 482, 484.
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`TEVAPALI0001059-122 at 100-101.
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`TEVAPALI0014343-360.
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`JANUS00031407-438.
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`JANUS00031439-471.
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`JANUS00031665.
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`JANUS00031765-852 at 765-784.
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`JANUS00017819-890 at 861-862.
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`Yang, et al. Colloid Characterization by
`Sedimentation Field-Flow Fractionation, J. Colloid
`Interface Sci., 92(1), 81-91 (1983).
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`Yang, Handbook of Fluidization and Fluid-Particle
`Systems (2003).
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`Loh et al. Overview of milling techniques for
`improving the solubility of poorly water-soluble
`drugs, Asian Journal of Pharmaceutical Sciences 10,
`255-274 (2015)
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`Khadka et al. Pharmaceutical particle technologies:
`An approach to improve drug solubility, dissolution
`and bioavailability, Asian Journal of
`Pharmaceutical Sciences 9, 304-316 (2014)
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`Hickey et al. Physical Characterization of
`Component Particles Included in Dry Powder
`Inhalers. I. Strategy Review and Static
`Characteristics, J Pharm Sciences 96(5), 1282-1301
`(2007)
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`Skoog et al., Principles of Instrumental Analysis,
`Ch. 34 (2007)
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`The United States Pharmacopeia 30: The National
`Formulary 25, “Light Diffraction Measurement of
`Particle Size” p.163-166; “Particle Size Distribution
`Estimation by Analytical Sieving” p.318-329 (May
`1, 2007)
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`3
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 008
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`Case 2:18-cv-00734-CCC-MF Document 39-2 Filed 10/10/18 Page 4 of 5 PageID: 260
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`Exhibit A – Claim Term in Dispute and the Parties’ Proposals
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`Claim Term
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`Janssen’s Proposed Construction and Support
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`Teva’s Position and Support
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`The European Pharmacopoeia “Particulate
`Contamination: Sub-visible Particles” p. 300-302;
`“Particle Size Analysis by Laser Light Diffraction”
`p.311-313; “Optical Microscopy” p.323-327 (6th
`ed. 2007)
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`Remington, The Science and Practice of Pharmacy
`21 Ed. Ch. 37 (2005)
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`Mingard et al., Good Practice Guide for Improving
`the Consistency of Particle Size Measurement,
`National Physical Laboratory (2009).
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`JANUS00001977-JANUS00002064
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`JANUS01587765-JANUS01587845
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`If necessary, Teva may offer expert testimony
`regarding the level of skill in the art, the knowledge
`of a person of ordinary skill in the art, and the
`meaning of the claim term as understood by a
`person of ordinary skill in the art.
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`JANUS00031472-537 at 475, 480, 484-497.
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`Teva Canada Limited’s Non-Binding Claim
`Construction dated July 25, 2018.
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`FDA Guidance on Q6A Specifications: Test
`Procedures and Acceptance Criteria for New Drug
`Substances and New Drug Products: Chemical
`Substances.
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`ICH Harmonised Tripartite Guideline
`Specifications: Test Procedures and Acceptance
`Criteria for New Drug Substances and New Drug
`Products: Chemical Substances Q6A.
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`Intrinsic and extrinsic evidence identified or relied
`on by Teva.
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`Janssen reserves the right to rely on expert
`testimony of Dr. Diane J. Burgess, a Distinguished
`Professor of Pharmaceutics at the University of
`Connecticut. Dr. Burgess is expected to testify
`about the level of skill of a person of ordinary skill
`in the art of the claimed inventions and that the term
`“average particle size (d50) of from about 1600 nm
`to about 900 nm” has a commonly understood
`meaning to a person of ordinary skill in the art at the
`time of the invention. Dr. Burgess is also expected
`to testify that there are well-known, conventional
`techniques in the art for measuring average particle
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`4
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 009
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`Case 2:18-cv-00734-CCC-MF Document 39-2 Filed 10/10/18 Page 5 of 5 PageID: 261
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`Exhibit A – Claim Term in Dispute and the Parties’ Proposals
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`Claim Term
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`Janssen’s Proposed Construction and Support
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`Teva’s Position and Support
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`size (d50) and that a person of ordinary skill in the
`art would be aware of such techniques.
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`5
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`Mylan v. Janssen (IPR2020-00440) Ex. 1028 p. 010
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