Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 1 of 45 PageID #: 824
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`Civil Action No. 14-1171-GMS
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` (CONSOLIDATED)
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`))))))
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`
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`IN RE COPAXONE 40 MG CONSOLIDATED
`CASES
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`
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`JOINT CLAIM CONSTRUCTION CHART
`
`Pursuant to the Court’s Scheduling Order, the parties in the above-captioned matter
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`submit their Joint Claim Construction Chart for certain claim terms in U.S. Patent Nos.
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`8,232,250; 8,399,413; and 8,969,302. A copy of the Joint Claim Construction Chart is attached
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`as Exhibit A.1
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`During the meet and confer process, the parties reached an agreement on the construction
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`of the claim terms set forth in Section I of the attached chart. The parties jointly and respectfully
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`submit that, if the Court deems it appropriate, the Court include these agreed-upon constructions
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`in the ultimate claim construction order. In the alternative, the parties agree that these agreed-
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`upon constructions are binding between the parties.
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`Section II of the attached chart includes the parties’ proposed constructions of the
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`disputed claim terms with citations to the intrinsic evidence in support of their respective
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`proposed constructions. The parties have made a good-faith effort to include herein all known
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`support for their respective constructions, but reserve the right to supplement the attached chart
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`with additional intrinsic evidence and to rely on such evidence in their claim construction briefs.
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`1 Defendants’ position is that their proposed constructions shall not be construed or
`interpreted, and shall not work, operate or be urged or deemed in any way, as an admission by
`Defendants that any claim or claim limitation of the patents-in-suit is in compliance with the
`requirements of 35 U.S.C. §§ 101, 102, 103, or 112 or as a waiver by any Defendant of its right
`to assert in this action that any claim of the patents-in-suit is invalid for failure to comply with
`the requirements of 35 U.S.C. §§ 101, 102, 103, or 112.
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 2 of 45 PageID #: 825
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`Section III of the attached chart identifies claim terms that Defendants contend are not
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`limiting and Plaintiffs’ responses to these contentions.
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`Finally, Section IV of the attached chart contains constructions of the phrases in Section
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`III that the parties agree upon only if the court finds that the phrases are limiting. As explained
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`in Section III, however, Defendants maintain that the phrases are not limiting.
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`Dated: August 14, 2015
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`2
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 3 of 45 PageID #: 826
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`/s/ David M. Fry
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`David M. Fry (No. 5486)
`SHAW KELLER LLP
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`
`David M. Hashmall
`Elizabeth J. Holland
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`(212) 813-8800
`
`Daryl L. Wiesen
`John T. Bennett
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`
`William G. James
`GOODWIN PROCTER LLP
`901 New York Avenue, NW
`Washington, DC 20001
`(202) 346-4000
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`Attorneys for Plaintiffs Teva Pharmaceuticals
`USA, Inc., Teva Pharmaceutical Industries,
`Ltd., Teva Neuroscience, Inc. and Yeda
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`3
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`/s/ Stephen B. Brauerman
`Richard D. Kirk (No. 922)
`Stephen B. Brauerman (No. 4952)
`Vanessa R. Tiradentes (No. 5398)
`Sara E. Bussiere (No. 5725)
`BAYARD, P.A.
`222 Delaware Avenue, Suite 900
`Wilmington, DE 19801
`(302) 655-5000
`rkirk@bayardlaw.com
`sbrauerman@bayardlaw.com
`vtiradentes@bayardlaw.com
`sbussiere@bayardlaw.com
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 4 of 45 PageID #: 827
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`/s/ John C. Phillips, Jr.
`John C. Phillips, Jr. (No. 110)
`David A. Bilson (No. 4986)
`PHILLIPS, GOLDMAN & SPENCE, P.A.
`1200 North Broom Street
`Wilmington, DE 19806
`jcp@pgslaw.com
`dab@pgslaw.com
`
`Constance S. Huttner
`Beshoy M. Sharoupim
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 315-4430
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`Attorneys for DRL Defendants
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`/s/ Dominick T. Gattuso
`Dominick T. Gattuso (No. 3630)
`PROCTOR HEYMAN ENERIO LLP
`300 Delaware Avenue, Suite 200
`Wilmington, DE 19801
`(308) 472-7300
`DGattuso@proctorheyman.com
`William A. Rakoczy
`Deanne M. Mazzochi
`Rachel Pernic Waldron
`RAKOCZYMOLINOMAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`(312) 222-7543
`wrakoczy@rmmslegal.com
`dmazzochi@rmmslegal.com
`rwaldron@rmmslegal.com
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`Attorneys for Defendants Sandoz Inc.
`and Momenta Pharmaceuticals, Inc.
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`/s/ Arun J. Mohan
`Frederick L. Cottrell, III (No. 2555)
`Arun J. Mohan (No. 6110)
`RICHARDS, LAYTON & FINGER, P.C.
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlf.com
`mohan@rlf.com
`Shannon M. Bloodworth
`PERKINS COIE LLP
`700 13th Street, NW
`Washington, DC 20005
`(202) 654-6204
`Attorneys for Mylan Inc., Mylan
`Pharmaceuticals Inc.
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`4
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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 5 of 45 PageID #: 828
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`/s/ Robert M. Vrana
`Melanie K. Sharp (No. 2501)
`Robert M. Vrana (No. 5666)
`Samantha G. Wilson (No. 5816)
`YOUNG CONAWAY STARGATT &
`TAYLOR LLP
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6681
`msharp@ycst.com
`rvrana@ycst.com
`swilson@ycst.com
`
`E. Anthony Figg
`Sharon L. Davis
`R. Elizabeth Brenner-Leifer
`Seth E. Cockrum
`Jennifer Nock
`ROTHWELL, FIGG, ERNST &
`MANBECK, P.C.
`607 14th Street, NW, Suite 800
`Washington, DC 20005
`(202) 783-6040
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`Attorneys for Synthon Pharmaceuticals Inc.,
`Synthon B.V, and Synthon s.r.o.
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`5
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`/s/ Richard L. Renck
`Richard L. Renck (No. 3893)
`DUANE MORRIS LLP
`222 Delaware Avenue, Suite 1600
`Wilmington, DE 19801-1659
`(302) 657-4900
`
`Anthony J. Fitzpatrick
`Vincent L. Capuano
`Christopher S. Kroon
`Carolyn A. Alenci
`DUANE MORRIS LLP
`100 High Street, Suite 2400
`Boston, MA 02110-1724
`(857) 488-4200
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`Attorneys for Amneal Pharmaceuticals LLC
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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 6 of 45 PageID #: 829
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`EXHIBIT A
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`EXHIBIT A
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 7 of 45 PageID #: 830
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`
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`I. AGREED-UPON CONSTRUCTIONS
`
`Patent Claim(s)
`’250
`6
`
`’250
`’302
`’250
`’413
`’302
`’250
`
`16, 17
`1, 10
`1, 15
`1, 16, 20
`3
`1, 15
`
`
`
`Claim Term
`“time to a confirmed
`relapse”
`“relapsing form of
`multiple sclerosis”
`“first clinical
`episode”
`
`Agreed-Upon Construction
`Time before a first confirmed relapse or between subsequent confirmed relapses.
`
`Secondary progressive multiple sclerosis with superimposed relapses, relapse-
`remitting multiple sclerosis and/or progressive-relapsing multiple sclerosis.
`A first clinical attack suggestive of multiple sclerosis.
`
`“clinically definite
`multiple sclerosis”
`
`A human that has had two clinical attacks suggestive of multiple sclerosis and
`clinical evidence of two separate lesions, or two clinical attacks suggestive of
`multiple sclerosis, and clinical evidence of one lesion and paraclinical evidence of
`another separate lesion.
`
`1
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 8 of 45 PageID #: 831
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`
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`II. DISPUTED TERMS AND PROPOSED CONSTRUCTIONS
`
`
`Patent Claim(s) Proposed Claim Terms
`
`’250
`’413
`’302
`
`1, 15, 19
`1, 19, 20
`1, 10
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`“comprising”/“comprises” No construction required; plain and
`ordinary meaning. If the Court construes
`the terms “comprising”/“comprises” in
`conjunction with the “regimen” terms in
`claims 1, 15, and 19 of the ’250 patent and
`1, 19, and 20 of the ’413 patent, and the
`terms “three subcutaneous injections [. . .]
`per week” and “subcutaneous injection [. .
`.] three times per week [with at least one
`day between every subcutaneous
`injection]” in claims 1 and 10 of the ’302
`patent, “comprising”/“comprises” should
`have its plain and ordinary meaning of
`“including but not limited to” such that it
`allows additional treatments to be
`administered but does not open the
`glatiramer acetate regimen to allow more
`than three injections of glatiramer acetate
`per week.
`Intrinsic Evidence:
`’250 Patent Specification
`Col. 2, lines 47-51
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`The term “comprising” is an open-
`ended term that does not exclude
`additional, unrecited elements or
`method steps, and therefore means
`“including, but not limited to three
`subcutaneous injections of a 40 mg
`dose of glatiramer acetate over a
`period of seven days.”
`
`Intrinsic Evidence:
`Specification
`Common specification of the ’250,
`
`
`2 Plaintiffs and Defendants reserve the right to rely on the entire intrinsic record, including any portion of the specification,
`prosecution history and intrinsic prior art references cited therein, to support or rebut proposed claim construction positions. Plaintiffs
`and Defendants may also rely on intrinsic and extrinsic evidence identified by any party in support of their constructions; on expert
`testimony to rebut Plaintiffs’ and Defendants’ proposed meanings; and on expert testimony or other evidence, if any, offered by any
`party in support of their own claim constructions.
`
`2
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 9 of 45 PageID #: 832
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`
`
`Patent Claim(s) Proposed Claim Terms
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`’413, and ’302 patent: The entire
`common specification, including, for
`example, the ’250 patent at Abstract,
`1:67-2:3, 2:55-3:7, 4:3-13, 4:21-64,
`5:10-11, 5:20-33, 5:51-54, 16:25-45,
`17:24-18:6, and 18:19-26; the ’413
`patent at 16:26-36, 17:9-23, and 18:1-
`27; and the ’302 patent at 16:37-41,
`and 17:4-12. The entire specification
`supports Defendants’ construction at
`least because nothing in the
`specification limits the term.
`Prosecution History of Patent App.
`14/673,257
`3/30/2015 Substitute Preliminary
`Amendment at, e.g., 3
`5/22/2015 Office Action at, e.g., 4-6
`Summary of 6/17/2015 Examiner
`Interview at, e.g., 7-8
`6/25/15 Response to 5/22/2015 Office
`Action at, e.g., 2-3, 5, 19-20
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`Col. 4, lines 3-20
`Col. 8, lines 57-67
`Col. 9, lines 21-25 and 31-37
`Col. 16, lines 12-28 and 35-45 (claim 1)
`’413 Patent Specification
`Col. 2, lines 43-47
`Col. 3, line 66 to col. 4, line 15
`Col. 8, lines 52-62
`Col. 9, lines 15-19 and 24-30
`Col. 16, lines 2-18 and 26-36 (claim 1)
`’302 Patent Specification
`Col. 2, lines 43-47
`Col. 3, line 66 to col. 4, line 15
`Col. 8, lines 57-67
`Col. 9, lines 21-25 and 30-36
`Col. 16, lines 12-28
`’250 Patent File History
`5/14/12 Response to Office Action at 2, 4-
`5, 6-7, 9-10, 12, 17, and 19
`(TEVCOP00000191, TEVCOP00000193-
`194, TEVCOP00000196-197,
`TEVCOP00000199-200,
`TEVCOP00000202, TEVCOP00000207,
`and TEVCOP00000209)
`’413 Patent File History
`8/6/12 Response to Office Action at 2, 5-
`6, 8-9, 11-12, and 16 (TEVCOP00001729,
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`3
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 10 of 45 PageID #: 833
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`
`
`Patent Claim(s) Proposed Claim Terms
`
`’250
`’413
`
`1, 15, 19
`1, 19, 20
`
`“regimen of three
`subcutaneous injections
`[. . .] over a period of
`seven days with at least
`one day between every
`subcutaneous injection”
`
`
`
`“regimen of three
`subcutaneous injections
`[. . .] over a period of
`seven days with at least
`one day between every
`injection”
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`TEVCOP00001732-733,
`TEVCOP00001742-743,
`TEVCOP00001745-746, and
`TEVCOP00001750)
`’302 Patent File History
`12/9/13 Response to Office Action at 12-
`15 (TEVCOP00552798-801)
`8/5/14 Response to Office Action at 7-9,
`12-13, and 15 (TEVCOP00552839-841,
`TEVCOP00552844-845, and
`TEVCOP00552847)
`A continuous treatment requiring three
`and only three subcutaneous injections
`each and every week with at least one day
`between every injection.
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`A program or systemic plan of
`treatment that does not exclude
`additional, unrecited elements or
`method steps, and therefore means
`“including, but not limited to three
`subcutaneous injections of a 40 mg
`dose of glatiramer acetate over a
`period of seven days with at least one
`day between every injection.”
`Defendants moreover assert that the
`phrase Teva identified for
`construction is an inappropriate
`“term” for construction; it is a partial
`clause. The term “regimen” should be
`construed alone to mean “a program
`or systemic plan of treatment.”
`
`4
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 11 of 45 PageID #: 834
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`
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`Patent Claim(s) Proposed Claim Terms
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`Intrinsic Evidence:
`’250 Patent Specification
`Col. 2, lines 47-51, “Disclosed is an
`effective low frequency dosage regimen of
`GA administration to patients suffering
`from a relapsing form of multiple
`sclerosis, including patients who have
`experienced a first clinical episode and
`have MRI features consistent with
`multiple sclerosis.”
`Col. 4, lines 3-20, “This invention
`provides a method . . . comprising
`administering to the human patient three
`subcutaneous injections of a
`therapeutically effective dose of glatiramer
`acetate over a period of seven days with at
`least one day between every subcutaneous
`injection so as to thereby alleviate the
`symptom of the patient.
`In another embodiment, there are three
`injections for every seven days and there
`must be at least one day between each
`injection. In a further embodiment,
`possible injection schedules include Day
`1, Day 3, Day 5; Day 1, Day 3, Day 6;
`Day 1, Day 3, Day 7; Day 1, Day 4, Day
`6; Day 1, Day 4, Day 7; Day 1, Day 5,
`Day 7; Day 2, Day 4, Day 6; Day 2, Day
`4, Day 7; Day 2, Day 5, Day 7; or Day 3,
`Day 5, Day 7.”
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`Intrinsic Evidence:
`Specification
`Common specification of the ’250,
`’413, and ’302 patent: The entire
`common specification, including, for
`example, the ’250 patent at Abstract,
`1:67-2:3, 2:47-51, 2:55-3:7, 4:3-13,
`4:21-64, 5:10-11, 5:20-33, 5:51-54,
`9:30-36, 16:12-45, 16:25-45, 17:24-
`18:6, and 18:19-26; and the ’413
`patent at16:26-36, 17:9-23, and 18:1-
`27. The entire specification supports
`Defendants’ construction at least
`because nothing in the specification
`limits the term.
`Prosecution History of the ’250 patent
`2/14/12 Office Action at, e.g.,
`TEVCOP00000100-104
`5/8/2012 Examiner Interview
`(TEVACOP00000189)
`5/14/2012 Response to 2/14/2012
`Office Action and 5/8/2012 Examiner
`Interview at, e.g.,
`TEVACOP00000191-193, 196-202.
`
`Prosecution History of ’413 Patent
`2/6/12 Office Action at, e.g.,
`TEVACOP00001706-1712
`8/6/12 Response to 2/6/12 Office
`
`5
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 12 of 45 PageID #: 835
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`Patent Claim(s) Proposed Claim Terms
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`Action at, e.g., TEVACOP00001729,
`1742-43, 1745-46.
`Final Office Action, dated October
`10, 2012 at, e.g., TEVCOP00002761-
`2762
`Prosecution History of Patent App.
`14/673,257
`3/30/2015 Substitute Preliminary
`Amendment at, e.g., 3
`5/22/2015 Office Action at, e.g., 4-6
`Summary of 6/17/2015 Examiner
`Interview at, e.g., 7-8
`6/25/15 Response to 5/22/2015 Office
`Action at, e.g., 2-3, 5 19-20
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`Col. 8, lines 57-67, “A . . . study . . . to
`assess the efficacy, safety and tolerability
`of Glatiramer Acetate (GA) injection 40
`mg/ml administered three times weekly by
`subcutaneous injection over placebo in a
`double-blind design.
`Methods: The study is designed to select
`three days a week for injection. Three
`injections are administered for every seven
`days and there must be at least one day
`between each injection.”
`Col. 9, lines 21-25, “Study Design:
`Eligible subjects are randomized in a 2:1
`ratio (40 mg:placebo) and assigned one of
`the following three treatment arms: 1. 40
`mg s.c. GA three times weekly . . .”
`Col. 9, lines 31-37, “Subjects successfully
`completing the study are offered the
`opportunity to enter into an open label
`extension in which all subjects will
`continue treatment with 40 mg/ml GA
`dose. This is done until the 40 mg/ml GA
`dose is commercially available for the
`treatment of relapsing remitting multiple
`sclerosis (RRMS) patients or until the
`development of this dose regimen is
`stopped by the Sponsor.”
`Col. 16, lines 12-28, “ . . . the subject
`application discloses an effective low
`frequency dosage regimen of GA
`
`6
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 13 of 45 PageID #: 836
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`
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`Patent Claim(s) Proposed Claim Terms
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`administration to patients suffering from a
`relapsing form of multiple sclerosis,
`including patients who have experienced a
`first clinical episode and have MRI
`features consistent with multiple sclerosis.
`Based on the performance of the dosage
`regimen in these studies, the
`administration of three s.c. injections over
`a period of seven days with at least one
`day between every injection is also
`expected to work in the treatment of
`patients who have experienced a clinically
`isolated syndrome (CIS).”
`Co. 16, lines 35-45 (claim 1)
`’413 Patent Specification3
`Col. 2, lines 43-47
`Col. 3, line 66 to col. 4, line 15
`Col. 8, lines 52-62
`Col. 9, lines 15-19 and 24-30
`Col. 16, lines 2-18 and 26-36 (claim 1)
`’250 Patent File History
`5/4/12 Response to Office Action at 2 and
`4-5 (TEVCOP00000191 and
`TEVCOP00000193-194)
`5/14/12 Response to Office Action at 6-7
`and 10 (TEVCOP00000196-197 and
`
`
`3 The specifications of the ’250 and ’413 patents are the same, and the intrinsic evidence cited in the specification of the ’413
`patent in this section is the same as intrinsic evidence cited above for the ’250 patent.
`
`7
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 14 of 45 PageID #: 837
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`Patent Claim(s) Proposed Claim Terms
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`TEVCOP00000200): “As amended the
`claims cannot be reasonably construed to
`read on only a single seven day period of
`administration, at least because the claims
`as amended require a ‘regimen.’”
`5/14/12 Response to Office Action at 9
`(TEVCOP00000199): “The Examiner’s
`position is based on the view that the
`claims are so broad as to read on a therapy
`consisting of three, and only three
`administrations of glatiramer acetate, the
`three administrations occurring in a single
`seven day period. Applicant submits that
`this is an unreasonably broad claim
`construction which a person skilled in the
`art would not reach. Rather, a person
`skilled in the art would interpret the claims
`as being directed at a dosage regimen at
`least because the claims recite ‘so as
`thereby alleviate the symptom.’”
`5/14/12 Response to Office Action at 9-10
`(TEVCOP00000199-200): “In light of
`this, a person of ordinary skill in the art
`would clearly understand that recitation of
`administering to the human patient a
`therapeutically effective regimen of three
`subcutaneous injections over a period of
`seven days with at least one day between
`every subcutaneous injection defined a
`regimen for therapeutic effect.”
`
`8
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 15 of 45 PageID #: 838
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`
`
`Patent Claim(s) Proposed Claim Terms
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`5/14/12 Response to Office Action at 12
`(TEVCOP00000202): “Flechter et al.,
`which teaches alternate day administration
`cannot anticipate a ‘regimen’ requiring
`administration 3 times during a seven day
`period because the treatment protocol of
`Flechter et al. results in four
`administrations every other successive
`seven day period.”
`5/14/12 Response to Office Action at 17
`(TEVCOP00000207): “As discussed
`above, the alternate day administration of
`Flechter et al. does not anticipate the
`claimed ‘regimen’. The dosage regimen
`of Flechter et al. is alternate days; the
`regimen of Cohen et al. is daily. In
`contrast, the claimed dosage regimen
`requires less frequent administration than
`either Flechter et al. or Cohen et al.; ‘three
`subcutaneous doses . . . over a period of
`seven days … .’”
`5/14/12 Response to Office Action at 19
`(TEVCOP00000209): “Furthermore, the
`claimed invention is directed to a regimen
`that is less frequent than alternate day
`therapy. As discussed above, Flechter et
`al. increased the time between
`administrations by 24 hours, i.e. from 24
`to 48 hours. The claimed dosage regimen
`requires yet longer spans without
`treatment. For example, in some instances
`
`9
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`

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`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 16 of 45 PageID #: 839
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`Patent Claim(s) Proposed Claim Terms
`
`’302
`
`1, 10
`
`“three subcutaneous
`injections [. . .] per week”
`
`
`
`“subcutaneous injection
`[. . .] three times per week
`[with at least one day
`between every
`subcutaneous injection]”
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`Plain and ordinary meaning but in no
`way limited to three and only three
`injections per week.
`Defendants moreover assert that the
`phrase identified by Teva for
`construction is an inappropriate
`“term” for construction; it is a partial
`clause.
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`there will be a span of three consecutive
`days without treatment, e.g. when
`treatment occurs on days 1, 3 and 7 or on
`days 1, 5 and 7, or even instances where
`there are two spans of two consecutive
`days without treatment, e.g. when
`treatment occurs on days 1, 4 and 7.”
`’413 Patent File History
`8/6/12 Response to Office Action at 2, 5-
`6, 8-9, 11-12, and 16 (same evidence
`identified above in file history of ’250
`patent) (TEVCOP00001729,
`TEVCOP00001732-33,
`TEVCOP00001742-743,
`TEVCOP00001745-746, and
`TEVCOP00001750)
`A continuous treatment requiring three
`and only three subcutaneous injections
`each and every week [with at least one day
`between every injection].
`
`10
`
`

`
`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 17 of 45 PageID #: 840
`
`
`
`Patent Claim(s) Proposed Claim Terms
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`Intrinsic Evidence:
`’302 Patent Specification4
`Col. 2, lines 43-47
`Col. 3, line 66 to col. 4, line 15
`Col. 8, lines 57-67
`Col. 9, lines 21-25 and 30-36
`Col. 16, lines 12-28
`’302 Patent File History
`12/9/13 Response to Office Action at 12-
`15 (TEVCOP00552798-801)
`8/5/14 Response to Office Action at 7
`(TEVCOP00552839): “Rather, one
`skilled in the art would clearly interpret
`the claims as being directed at a dosage
`regimen. Presently presented claim 34
`recites ‘three subcutaneous injections of a
`40 mg/ml dose of glatiramer acetate per
`week’ (emphases added). Applicant
`submits that, as amended, the claims
`cannot be reasonably construed to read on
`only a single seven day period of
`administration.”
`8/5/14 Response to Office Action at 8
`(TEVCOP00552840): “In light of this,
`one of ordinary skill in the art would
`clearly understand that the recitations of
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`Intrinsic Evidence:
`Specification
`The entire specification of the ’302
`patent including, for example, the
`’302 patent at 16:37-41, and 17:4-12.
`The entire specification supports
`Defendants’ construction at least
`because nothing in the specification
`limits the term
`Prosecution History of ’302 Patent
`7/9/13 Office Action at, e.g., 3-8.
`12/9/13 Response to 7/9/13 Office
`Action at, e.g., 6-15
`2/5/14 Final Office Action, at e.g.,
`p.3-5
`8/5/14 Response to 2/5/14 Final
`Office Action at, e.g., 3-9
`Prosecution History of Patent App.
`14/673,257
`5/22/2015 Office Action at, e.g., 4-6
`Summary of 6/17/2015 Examiner
`Interview at, e.g., 7-8
`6/25/2015 Response to 5/22/2015
`Office Action at, e.g., 2-3, 19-20.
`
`
`4 The specifications of the ’250, ’413, and ’302 patents are the same, and the cites to the specification of the ’302 patent in this
`section are the same as those cited above for the ’250 and ’413 patents.
`
`11
`
`

`
`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 18 of 45 PageID #: 841
`
`
`
`Patent Claim(s) Proposed Claim Terms
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`‘administration to the human patient of
`three subcutaneous injections . . . per
`week’ in claim 34 and ‘subcutaneous
`injections injection by the human patient .
`. . three times per week’ in claim 43 define
`dosage regimens.”
`8/5/14 Response to Office Action at 9
`(TEVCOP00552841): “Flechter et al.,
`which teaches alternate day administration
`cannot anticipate a regime requiring
`administration 3 times per week because
`the treatment protocol of Flechter et al.
`results in four administrations every other
`week. Thus, when given their broadest
`reasonable interpretation, Flechter et al.
`does not anticipate the instant claims.”
`8/5/14 Response to Office Action at 12
`(TEVCOP00552844): “The hypothetical
`combination of Flechter et al. and Cohen
`et al., even if proper, would yield alternate
`day 40mg GA, not ‘three subcutaneous
`injections of a 40 mg/ml dose of
`glatiramer acetate per week’ as required
`by claim 34 (emphases added).”
`8/5/14 Response to Office Action at 13
`(TEVCOP00552845): “As discussed
`above, the alternate day administration of
`Flechter does not anticipate the claimed
`regimen. The dosage regimen of Flechter
`et al. is alternate days; the regimen of
`
`12
`
`

`
`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 19 of 45 PageID #: 842
`
`
`
`Patent Claim(s) Proposed Claim Terms
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`Cohen et. al. is daily. In contrast, the
`claimed dosage regimen requires less
`frequent administration than either
`Flechter et al. or Cohen et al.;
`‘administration to the human patient of
`three subcutaneous injections . . . per
`week’ as in claim 34 and ‘subcutaneous
`injection by the human patient . . . three
`times per week’ as in claim 43.”
`8/5/14 Response to Office Action at 15
`(TEVCOP00552847): “The claimed
`invention is directed to a regimen that is
`less frequent than alternate day therapy.
`As discussed above, Flechter et al.
`demonstrates a marked decrease in
`efficacy when reducing the frequency of
`GA administration. Flechter et al.
`increased the time between
`administrations by 24 hours, i.e. from 24
`to 48 hours. The claimed dosage regimen
`requires yet longer spans without
`treatment because it calls for only three
`injections per week.”
`’250 Patent File History
`5/14/12 Response to Office Action at 6-7,
`9-10, 12, 17, and 19 (TEVCOP00000196-
`197, TEVCOP00000199-200,
`TEVCOP00000202, TEVCOP00000207,
`and TEVCOP00000209)
`’413 Patent File History
`
`13
`
`

`
`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 20 of 45 PageID #: 843
`
`
`
`Patent Claim(s) Proposed Claim Terms
`
`’250
`
`5
`
`“brain atrophy”
`
`Defendants’ Proposed Construction
`and Intrinsic Evidence2
`
`A reduction in brain volume over
`time.
`Intrinsic Evidence:
`The ’250 Specification
`The ’250 patent at 4:33-34; 12:19-20,
`46-49; 13:43-44; 13:66-14:5; 14:62–
`15:4
`PCT/US2008 /013146, at 26:14-27:3
`(’413 Patent file history at
`TEVCOP_1524.)
`Bjartmar & Fox, Drugs of Today,
`38(1):17-29 (2002), at 22 (’413 Patent
`file history at TEVCOP_2446.)
`
`Teva’s Proposed Construction and
`Intrinsic Evidence2
`8/6/12 Response to Office Action at 8-9,
`11-12, and 16 (TEVCOP00001742-743,
`TEVCOP00001745-746, and
`TEVCOP00001750)
`The loss of brain tissue.
`
`Intrinsic Evidence:
`’250 Patent Specification
`Col. 12, lines 19-20 and 46-49, “Brain
`atrophy as defined by the percentage
`change from baseline to month 12 (end of
`placebo-controlled phase) in normalized
`gray matter volume and in normalized
`white matter volume.”
`Col. 13, line 66 to col. 14, line 5
`Col. 14, line 62 to col. 15, line 4,
`“Treatment with 40 mg s.c. GA three
`times weekly significantly reduces brain
`atrophy as defined by the percentage
`change from baseline to month 12 in
`normalized gray matter volume and in
`normalized white matter volume.
`Treatment with 40 mg s.c. GA three times
`weekly is at least as effective as 20 mg s.c.
`GA daily administration at reducing brain
`atrophy as defined by the percentage
`change from baseline to month 12 in
`normalized gray matter volume and in
`normalized white matter volume.”
`
`14
`
`

`
`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 21 of 45 PageID #: 844
`
`
`
`
`III. TERMS DEFENDANTS CONTEND ARE NOT LIMITING
`
`
`Patent Claim(s)
`
`’250
`
`1
`
`Claim Terms
`Defendants Contend
`Are Not Limiting
`“alleviating a symptom of
`relapsing-remitting
`multiple sclerosis”
`
`Teva’s Response/Proposed
`Construction and Intrinsic Evidence
`
`Defendants’ Intrinsic Evidence that
`Phrases Are Not Claim Limitations
`
`This term constitutes a claim limitation
`and, other than the construction of
`“alleviating” set forth in Section I, does
`not require construction; plain and
`ordinary meaning.
`Intrinsic Evidence:
`’250 Patent Specification
`Col. 2, lines 55-64
`Col. 4, lines 3-12
`Col. 16, line 46 to col. 17, line 13 (this
`preamble phrase serves as an antecedent
`basis for the term “wherein alleviating a
`symptom comprises . . .” in dependent
`claims 2 and 4-11).
`’250 Patent File History
`5/14/12 Response to Office Action at 8-9
`(TEVCOP00000198-199):
`“Specifically, the Examiner alleged that
`the claims encompass a method of
`alleviating a symptom of multiple
`sclerosis by administering ‘as few as
`three subcutaneous injections of 40mg of
`glatiramer acetate (a.k.a. copolymer-1)
`on alternate days [during] a one week
`period’ . . . The Examiner further alleged
`
`Defendants’ intrinsic evidence listed
`below applies to each of the phrases in
`this Section III.
`
`U.S. Provisional App. No. 61/274,687
`p. 27, ll. 15-26; p. 30, ll. 1-31; p. 31, l. 2
`– p. 32, l. 13
`Specification (common to all patents)
`e.g., ’250 patent, 12:8-55; 12:55-67;
`13:45 – 14:5; 14:6 – 15:50
`Prosecution History of ’250 Patent
`2/14/12 Office Action, ¶¶ 2, 4, 6
`(TEVCOP00000100-104)
`5/14/12 Applicant Arguments/Remarks
`Made in Response to 2/14/12 Office
`Action, pp. 6-10; 12; 14-16; 18-19
`(TEVCOP00000196-200, -204-206, -
`208-209)
`Prosecution History of ’413 Patent
`2/6/12 Office Action, ¶¶ 2, 4, 6
`(TEVCOP00001706-1710)
`8/6/12 Applicant Arguments/Remarks
`Made in Response to 2/6/12 Office
`Action, pp. 7-9; 11-13; 15-18
`
`15
`
`

`
`Case 1:14-cv-01171-GMS Document 88 Filed 08/14/15 Page 22 of 45 PageID #: 845
`
`
`
`Patent Claim(s)
`
`Claim Terms
`Defendants Contend
`Are Not Limiting
`
`Teva’s Response/Proposed
`Construction and Intrinsic Evidence
`
`Defendants’ Intrinsic Evidence that
`Phrases Are Not Claim Limitations
`
`that neither the specification nor the art
`of record provides evidence that a
`benefit has been shown, or can
`reasonably be predicted, to result from
`administration of as few as three doses of
`glatiramer acetate; and that the applicant
`has not demonstrated measurable benefit
`from the administration of only three
`doses of glatiramer acetate.
`Applicant’s Response
`In response, applicant respectfully
`traverses. The Examiner’s position is
`based on the view that the claims are so
`broad as to read on a therapy consisting
`of three, and only three administrations
`of glatiramer acetate, the three
`administrations occurring in a single
`seven day period.”
`5/14/12 Response to Office Action at 12-
`20 (TEVCOP00000202-210)
`6/15/12 Notice of Allowance
`(TEVCOP00001161-165)
`This term constitutes a claim limitation
`and, other than the construction of
`“tolerability” set forth in Section I, does
`not require construction; plain and
`ordinary meaning.
`
`(TEVCOP00001741-743; -745-747; -
`749-752)
`