Case 1:13-cv-01674-RGA Document 364 Filed 11/18/15 Page 1 of 4 PageID #: 10962
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAW ARE
`
`CA. No. 13-1674-RGA
`
`Consolidated
`
`C.A. No. 14-0422-RGA
`
`))))))))))))
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`))))))))))))
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`
`WATSON LABORATORIES, INC.,
`Defendant.
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`PAR PHARMACEUTICAL, INC., and
`INTELGENX TECHNOLOGIES CORP.,
`
`Defendants.
`
`PROPOSED FINDINGS OF FACT
`
`Pursuant to the Court’s instruction at the close of the November 3, 2015 at the close of
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`the November 2015 portion of the bench trial in the above-captioned matters, Plaintiffs Reckitt
`
`Benckiser Pharmaceuticals Inc., RB Pharmaceuticals Limited, and MonoSol Rx, LLC, hereby
`
`submit the following findings of fact in the following exhibits:
`
`Exhibit A:
`
`Plaintiffs’Proposed Findings of Fact regarding the validity of U.S. Patent
`
`No. 8,603,514;
`
`Exhibit B:
`
`Plaintiffs’Proposed Findings of Fact regarding infringement of U.S.
`
`Patent No. 8,017,150;and
`
`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

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`Case 1:13-cv-01674-RGA Document 364 Filed 11/18/15 Page 2 of 4 PageID #: 10963
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`Exhibit C:
`
`Plaintiffs’Proposed Findings of Fact regarding the validity of U.S. Patent
`
`No. 8,170,150
`
`Dated: November 18, 2015
`
`Respectfully submitted,
`
`/s/Daniel M. Attaway
`Mary W. Bourke (#2356)
`Dana K. Severance (#4869)
`Daniel M. Attaway (#5130)
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`(302) 252-4330 (Fax)
`mbourke@wcsr.com
`dseverance@wcsr.com
`dattaway@wcsr.com
`Attorneys for Plaintiffs
`
`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364 Filed 11/18/15 Page 3 of 4 PageID #: 10964
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`CERTIFICATE OF SERVICE
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`I hereby certify that on the 18th day of November, 2015 I caused the foregoing to be
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`electronically filed with the Clerk of the Court using CM/ECF which will send electronic
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`notification of such filing to all registered participants.
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`Additionally, I hereby certify that true and correct copies of the foregoing were caused to
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`be served on the following counsel of record via electronic mail:
`
`Daniel G. Brown
`Jennifer R. Saionz
`LATHAM & WATKINS LLP
`885 Third Avenue
`New York, NY 10022
`(212) 906-1200
`(212) 751-4864 (Fax)
`Daniel.brown@lw.com
`Jennifer.saionz@lw.com
`
`James K. Lynch
`LATHAM & WATKINS LLP
`505 Montgomery Street, Suite 2000
`San Francisco, CA 94111-6536
`(415) 391-0600
`(415) 395-8095 (Fax)
`Jim.lynch@lw.com
`
`Jennifer Koh
`LATHAM & WATKINS LLP
`12670 High Bluff Drive
`San Diego, CA 92130
`Jennifer.koh@lw.com
`
`James F. Hurst
`Michael K. Nutter
`Mr. Sharick Naqi
`Tyler G. Johannes
`WINSTON & STRAWN, LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`
`Emily C. Melvin
`LATHAM & WATKINS LLP
`330 North Wabash Avenue, Suite 2800
`Chicago, IL 60611
`(312) 876-7700
`(312) 993-9767 (Fax)
`Emily.melvin@lw.com
`
`Steven J. Fineman
`Katharine C. Lester
`RICHARDS LAYTON & FINGER, P.A.
`One Rodney Square
`920 N. King Street
`Wilmington, DE 19801
`(302) 651-7700
`(302) 651-7701 (Fax)
`fineman@rlf.com
`lester@rlf.com
`
`Michelle R. Ma
`LATHAM & WATKINS LLP
`140 Scott Drive
`Menlo park, CA 94025
`Michelle.ma@lw.com
`
`Counsel for Defendants Par Pharmaceutical,Inc.
`and IntelGenXTechnologies Corp.
`
`Melinda K. Lackey
`WINSTON & STRAWN, LLP
`1111 Louisiana Street, 25th Floor
`Houston, TX 7702-5242
`mlackey@winston.com
`
`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364 Filed 11/18/15 Page 4 of 4 PageID #: 10965
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`(312) 558-5600
`(312) 558-5700 (Fax)
`jhurst@winston.com
`mnutter@winston.com
`snaqi@winston.com
`tjohannes@winston.com
`
`Peter E. Perkowski
`David P. Dalke
`WINSTON & STRAWN, LLP
`333 S. Grand Avenue, Suite 3800
`Los Angeles, CA 90071
`pperkowski@winston.com
`ddalke@winston.com
`
`Megan C. Haney
`John C. Phillips, Jr.
`PHILLIPS, GOLDMAN & SPENCE, P.A.
`1200 N. Broom Street
`Wilmington, DE 19806
`mch@pgslaw.com
`jcp@pgslaw.com
`
`Counsel for Defendant Watson Laboratories,Inc.
`
`/s/Daniel M. Attaway
`Daniel M. Attaway (#5130)
`
`35321433
`
`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

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`Case 1:13-cv-01674-RGA Document 364-1 Filed 11/18/15 Page 1 of 6 PageID #: 10966
`Case 1:13—cv—O1674—RGA Document 364-1 Filed 11/18/15 Page 1 of 6 Page|D #: 10966
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`EXHIBIT A
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`EXHIBIT A
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`

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`Case 1:13-cv-01674-RGA Document 364-1 Filed 11/18/15 Page 2 of 6 PageID #: 10967
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`I.
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`Experts on the validity of the asserted claims of the ’514 Patent
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`1. Plaintiffs’expert,Dr.Robert Langer,is an Institute Professor at MIT,whose work
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`focuses on biomedical polymers and drug delivery systems.(Tr.467:1–16 (Langer).)He has
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`conducted extensive research related to cast films over decades.(Tr.468:11–469:13(Langer).)
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`2. Defendants’expert,Dr.S.Craig Dyar,has never made or tested a single pharmaceutical
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`cast film containing an active drug,nor authored any paper or made any presentation on cast
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`films.(Tr.at 355:2–7,355:20–356:2,356:22–357:17(Dyar).)
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`II.
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`The asserted claims of the ’514 Patent are not obvious
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`3. The asserted claims of the ’514Patent are entitled to a priority date of September 27,
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`2002.(D.I.353,Stipulated Facts Nos.37and 121.)
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`4. The asserted claims are directed to cast films.(JTX-002.)
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`5. A casting process involves (1)dissolving the polymer into a solvent and mixing;(2)
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`adding the active ingredient and mixing to form a dispersion;(3)casting the dispersion onto a
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`substrate;(4)drying into a film;and (5)cutting the film into dosage units and removing them
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`from the substrate.(Tr.473:15–474:10(Langer);see also id. at 319:5–320:19(Dyar).)
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`6. Many factors and forces may lead to disuniformity during a casting process.(Tr.484:19–
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`492:3(Langer);JTX-002at 2:19–26;3:33–4:6;4:51–64;11:15–49;22:65–67;36:61–67.)
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`7. If uniformity is lost at any point,it cannot be regained.(Tr.474:15–475:22(Langer).)
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`8. Asserted Claim 62requires,among other things,that “subsequent to casting and drying”
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`the uniformity of “substantially equally sized individual dosage units”does “not vary by more
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`than 10% of said desired amount of at least one active.”(JTX-002at claim 62.)
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`9. The prior art did not disclose any data showing drug content uniformity within ±10%
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`achieved in a final cast film.(See JTX-0187;JTX-0184;infra Fact Nos.10–12.)
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`10.The sole basis for Defendants’obviousness defense rests on an alleged combination of
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-1 Filed 11/18/15 Page 3 of 6 PageID #: 10968
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`the Chen reference (JTX-0187,“Chen”)and the Bess ’116Patent (JTX-0184,“Bess”),in light of
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`the knowledge of a person of ordinary skill in the art (POSA).(Tr.318:6–319:4(Dyar).)
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`11.Chen does not disclose “substantially equally sized individual unit doses which do not
`
`vary by more than 10% of said desired amount of said at least one active.”(JTX-002at claim 62;
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`Tr.504:5–521:11,522:18–524:2(Langer);id. at 370:2–10,336:12–337:7(Dyar);JTX-0187.)
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`a. Dr.Dyar concedes that the dissolution data in Figure 5of Chen does not indicate
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`what level of drug content uniformity was achieved in the Chen films.(Tr.at 370:2–10,336:12–
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`337:7(Dyar);JTX-0187at Fig.5.)
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`b. Even making assumptions most favorable to Defendants,Figure 5 shows Chen’s
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`films had greater than a ±10% variation in drug content uniformity.(Tr.504:5–521:11,522:18–
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`524:2(Langer);id. at 370:2–10,336:12–337:7,376:22–377:13(Dyar);JTX-0187at Fig.5.)
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`c. The error bars in Chen Figure 5 represent one standard deviation from the mean
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`percentage of drug released,which means that only 68% of sample measurements would be
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`expected to fall within them.(Tr.278:7–10,378:7–15(Dyar);id. at 517:17–519:5(Langer).)
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`d. Chen uses the terms “homogeneity”and “uniformly”with regard to the dispersion in
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`the mixing tank before casting,but does not define the terms and also does not use them with
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`regard to the final film after casting and drying.(Tr.504:14–508:15(Langer);JTX-0187at 4:24–
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`32;15:19–23;17:7–11;20:19–20.)
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`e. Chen states that viscosity can impact muco-adhesive properties,but does not state or
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`suggest
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`that
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`the viscosity of a casting dispersion plays a role in achieving drug content
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`uniformity.(Tr.520:3–521:5(Langer);id. at 331:11–22(Dyar);JTX-0187at 13:1–2.)
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`12.Bess does not disclose “substantially equally sized individual unit doses which do not
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`vary by more than 10% of said desired amount of said at least one active.”(JTX-0184;see infra
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`2
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-1 Filed 11/18/15 Page 4 of 6 PageID #: 10969
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`Fact Nos.12a–b.)
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`a. Dr.Dyar did not identify any passage,figure,or data in Bess (including in Example
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`1)that he contended disclosed drug content uniformity of a final film,much less drug content
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`uniformity within ±10%.(Tr.358:23–359:5(Dyar).)
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`b. Example 1 of Bess does not disclose to a POSA drug content uniformity within
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`±10%.(Tr.604:4–611:8(Langer);JTX-0184at 12:42–13:40.)
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`13.Asserted dependent Claim 65further requires that the “variation of drug content is less
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`than 5% by weight per dosage unit.”(JTX-002at claim 65.)
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`14.The prior art did not disclose any data showing drug content uniformity within ±5%
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`achieved in a film.(JTX-002at claim 65;JTX-0184;JTX-0187;see infra Fact Nos.14a–c.)
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`a. Dr.Dyar did not contend any prior art reference disclosed how to achieve drug
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`content uniformity ±5%,as required by claim 65.(Tr.360:4–361:2(Dyar).)
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`b. Chen does not disclose a drug delivery composition wherein “said variation of drug
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`content is less than 5% by weight per film dosage unit.”(Tr.360:4–361:2(Dyar);JTX-0187.)
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`c. Bess does not disclose a drug delivery composition wherein “said variation of drug
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`content is less than 5% by weight per film dosage unit.”(Tr.360:4–361:2(Dyar);Tr.604:4–
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`611:8(Langer);JTX-0184.)
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`15.A person of ordinary skill in the art would have had no reason to combine Chen and Bess.
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`(Tr.387:18–388:20(Dyar);id. at 526:8–20(Langer);see JTX-0187;JTX-0184.)
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`a. Chen and Bess have conflicting teachings as to desired particle size.(JTX-0187at
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`2:17–20;JTX-0184at 11:50–65;Tr.387:18–388:20(Dyar).)
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`16.Dr.Dyar gave no explanation of how a POSA would allegedly modify Chen and Bess,or
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`combine them,to achieve the drug content uniformity of claims 62and 65.(Tr.318–319(Dyar).)
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`3
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Case 1:13-cv-01674-RGA Document 364-1 Filed 11/18/15 Page 5 of 6 PageID #: 10970
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`17.Contrary to Dr.Dyar’s assumption,POSAs viewed the prior art lack of data regarding
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`drug content uniformity as indicating the inability to obtain uniform pharmaceutical cast films.
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`(Tr.at 365:1–366:16(Dyar),id. at Tr.at 480:14–482:8(Langer);PTX 215at 1038.)
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`18.A POSA would not have had any reasonable expectation of success in developing a
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`pharmaceutical film with ±10% or ±5% drug content uniformity.(Tr.471:20–527:2(Langer);
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`see also Tr.338:7–12(Dyar).)
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`19.Changing an aspect of a casting process may lead to disuniformity at that or a later step;
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`the factors and process parameters must be carefully balanced.(Tr.490:16–493:9(Langer).)
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`20.A POSA would have understood that changing a step of the casting process to try to
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`make a film more uniform also risks altering other film properties,such as dissolution or release
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`kinetics.(Tr.490:16–493:9,620:8–621:4(Langer).)
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`21.Prior art,including the Leung ’298patent,taught away from the viscosity-based solution
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`of the ’514Patent.(Tr.at 524:14–5:25:23(Langer);JTX-183at 12:4–7.)
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`22.Drug content uniformity was widely viewed by POSAs to be a major obstacle to
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`pharmaceutical film development before the invention of ’514Patent.(Tr.472:24–473:4,494:2–
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`503:17(Langer);PTX 213at 191;PTX 212at 668;PTX 215.)
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`23.Prior to the invention of the ’514 patent,others had tried but failed to design
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`pharmaceutical films with the needed drug content uniformity,as recognized in multiple articles
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`in peer-reviewed journals,including an article by W atson’s own expert.(Tr.472:24–473:4,
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`494:2–503:17(Langer);PTX 213;PTX 215.)
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`24.Despite the long-felt need to develop a pharmaceutical film with drug content uniformity
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`sufficient to receive FDA approval,the prior art did not teach how to achieve drug content
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`uniformity for a pharmaceutical cast film.(Tr.472:24–473:14 (Langer);id. at 323:7–326:4,
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`4
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Case 1:13-cv-01674-RGA Document 364-1 Filed 11/18/15 Page 6 of 6 PageID #: 10971
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`360:4–362:9(Dyar);PTX 213at 191;JTX-002at 2:38–46.)
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`25.The first pharmaceutical cast film product was not approved until 2009.(D.I.353,
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`Stipulated Facts Nos.155;Tr.473:5–11(Langer).)
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`26.MonoSol’s discovery of why pharmaceutical films may show poor drug content
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`uniformity and its solution of the drug content uniformity problem have been praised in the
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`industry.(Tr.494:15–496:13,502:6–503:2(Langer);PTX 213at 191;PTX 210at 116.)
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`III.
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`The asserted claims of the ’514 Patent are not indefinite
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`27.A POSA would understand that the “cast film”of claim 62is a film made by the casting
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`process.(Tr.527:16–528:9(Langer);JTX-002.)
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`28.A POSA would understand the “film-forming matrix”of claim 62is able to flow and has
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`viscosity prior to drying.(See infra Fact Nos.28a–c,30.)
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`a. Claim 62,and the specification of the ’514Patent,explain the “film-forming matrix”
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`is “flowable”and “capable of being dried.(Tr.528:10–529:21,530:23–532:10(Langer);JTX-
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`002at claim 62;5:49–6:2;30:34–37.)
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`b. The specification describes the “wet casting process”and drying of “wet-cast films.”
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`(Tr.530:7–531:15;JTX-002at Abstract;9:10–14;22:26–30;25:21–31;28:51–55.)
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`c. The specification discusses the viscosity of the film-forming matrix.(Tr.532:11–
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`532:21(Langer);see, e.g.,JTX-002at 23:36–39;24:57–64.)
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`29.A POSA would not understand claim 62to require the final dried cast film to still flow or
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`have viscosity.(Tr.527:3–533:4(Langer);id. at 388:21–389:20;(Dyar);JTX-002.)
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`30.Dr.Dyar admitted the examples in Chen “show a flowable matrix,”even though the films
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`in Chen are dried.(Tr.342:4–9(Dyar).)
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`31.A POSA would have understood the scope of the asserted claims of the ’514Patent with
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`reasonable certainty.(Tr.527:3–533:4(Langer);see JTX-002.)
`5
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Case 1:13-cv-01674-RGA Document 364-2 Filed 11/18/15 Page 1 of 6 PageID #: 10972
`Case 1:13—cv—O1674—RGA Document 364-2 Filed 11/18/15 Page 1 of 6 Page|D #: 10972
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`EXHIBIT B
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`EXHIBIT B
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-2 Filed 11/18/15 Page 2 of 6 PageID #: 10973
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`I.
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`W atson’s ANDA Product Infringes Claims 1 and 4of the ’150 Patent
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`1. Claim 1 of the ’150 patent
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`is directed to a film product comprising a “polymer
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`component”in which there is, among other things, lower molecular weight (MW) polyethylene
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`oxide (“PEO”) having an average MW in the range of 100,000–300,000 and higher MW PEO
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`having an average MW in the range of 600,000–900,000. (JTX-1 at claim 1;D.I. 156 at 8–9.)
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`2. A person of ordinary skill in the art (“POSA”) would understand the “molecular weight”
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`ranges in claim 1 to refer to viscosity average MWs. (Tr. 131:5–24, 134:11–135:22 (Mathias);id.
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`at 263:710, 285:1–5 (McConville);id. at 640:7–642:11, 675:15–676:6 (Prud’homme).)
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`3. Watson concedes that its proposed ANDA product meets all limitations of claims 1 and 4
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`besides the limitation requiring the higher MW PEO. (Joint Statement of Admitted Facts, ¶¶107–
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`17 (D.I. 353);Tr. 243:4–22 (McConville).)
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`4. Watson’s proposed ANDA product uses a commercial grade of PEO manufactured by
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`Dow Chemical and sold commercially as Polyox N80. (Tr. 113:12–24 (Mathias);PTX-49 at
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`WAT-SUB-0016282).
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`5.
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`In manufacturing Polyox N80, Dow mixes numerous separate batches of PEO. (Tr.
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`114:1115:13, 122:14–21, 174:617 (Mathias);JTX-41 at 2).
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`6. To determine whether a PEO sample contains sets of a lower average MW PEO and a
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`higher average MW PEO, it is necessary to analyze the molecular weight distribution of PEO in
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`the sample using gel permeation chromatography (GPC). (Tr. 114:20–119:17 (Mathias);id. at
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`193:23–195:2 (Yau).)
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`a. Watson’s expert, Dr. McConville, admits that if presented with an unknown sample
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`of PEO, he would be unable to say whether it has two average molecular weights without having
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`it analyzed by a polymer scientist like Dr. Wallace Yau. (Tr. 288:11290:1 (McConville).)
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`1
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Case 1:13-cv-01674-RGA Document 364-2 Filed 11/18/15 Page 3 of 6 PageID #: 10974
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`b. Although the Court rejected Defendants’two “bottle”argument in claim construction
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`(D.I. 156 at 8–9), Dr. McConville bases his position on a contention that claim 1 requires a drug-
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`maker to mix two or more commercial grades (bottles) of PEO. (Tr. at 284:12–286:6, 255:23–
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`256:16 (McConville).)
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`7. GPC is the standard analytical technique for determining the MW distribution of PEO.
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`(Tr. 115:20119:17 (Mathias);id. at 194:14195:2, 230:615 (Yau).)
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`8. GPC provides a precise measure of MW distribution, permitting calculation of the
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`viscosity average MWs found in the sample by well-known techniques. (Tr. 198:11199:5
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`(Yau);id. at 117:9–118:12 (Mathias).)
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`9. Dr. Wallace Yau, a respected researcher highly skilled in GPC analysis, had a GPC
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`analysis conducted on Polyox N80 in accordance with industry standards. (Tr. 119:15121:22,
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`150:3–15 (Mathias);id. at 193:23–197:7 (Yau).)
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`10. GPC analysis of Polyox N80 reveals it is polydisperse with a wide unimodal distribution
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`of MWs, including higher MW PEO. (Tr. 117–122, 151–152 (Mathias);id. at 203:1–7 (Yau).)
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`11. Literature shows that a combination of multiple grades of lower and higher average MW
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`samples of PEO has a unimodal distribution with the high degree of polydispersity exhibited by
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`the Polyox N80 grade. (Tr. 122:14–124:6 (Mathias);JTX-31.)
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`12. Dow scientists who authored the L’Hote Gaston paper concluded that combining two sets
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`of higher and lower average MW PEOs did not result in a bimodal distribution, but rather a
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`unimodal distribution. (JTX-31 at 5 and Fig. 2.)
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`a. Dr. McConville, who admits he is not an expert in polymers (Tr. 290:22–291:7), cited
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`no support for his assertion that a combination of a lower average MW PEO and a higher
`
`average MW PEO would yield a bimodal distribution. (See Tr. 277:12–282:6 (McConville).)
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`2
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`Case 1:13-cv-01674-RGA Document 364-2 Filed 11/18/15 Page 4 of 6 PageID #: 10975
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`b. Dr. McConville’s assertion that a combination of a lower average MW PEO and a
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`higher average MW PEO would yield a bimodal distribution is directly contradicted by the
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`findings of the L’Hote Gaston paper. (JTX-31 at 5 and Fig. 2;Tr. 122–124 (Mathias.).)
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`13. Figure 2 of the L’Hote Gaston paper shows that when the Polyox 205 grade (identified as
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`having an “approximate”average MW of 600,000) and Polyox N-12K (identified as having an
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`“approximate”average MW of 1,000,000), see JTX-30 at 15, 16, were combined together, GPC
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`analysis of the sample produced a unimodal distribution having a similar MW distribution as the
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`Polyox 1105 grade (identified as having an “approximate” average MW of 900,000). (Tr.
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`122:15124:6 (Mathias);JTX-31 at 1, 4, & Fig. 2;JTX-30 at 15, 16.)
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`14. The broad unimodal distribution of MWs seen in the GPC analysis of samples of Polyox
`
`N80 is consistent with the presence of a mixture of lower and higher MW PEOs having different
`
`average MW, as shown in the L’Hote Gaston paper. (Tr. 117:9–21, 121:23124:6 (Mathias);
`
`compare PTX-526E (distribution for N80 sample tested by Dr. Yau), with JTX-31 at 4, Fig. 2.)
`
`15. While Dow reports the “approximate”average MW of Polyox N80 as 200,000, Dow
`
`assigns this value to any samples having a wide range of viscosity readings made using a
`
`viscometer, and acknowledges it “may not be directly comparable”to other measurements such
`
`as those using GPC. (Tr. 130–131, 134, 144:23–145:2 (Mathias);JTX-30 at 15, Table 1, n. 1.)
`
`16. Viscosity measurements made using a viscometer are less precise than GPC analysis and
`
`cannot provide a MW distribution for a sample;such measurements provide only a single
`
`average value for the entire sample regardless of its components or their MW distribution. (Tr.
`
`115:20–117:21 (Mathias);id. at 194:14–195:12 (Yau).)
`
`a. Viscosity measured using a viscometer (i.e., rheological viscosity) can be used to
`
`quickly determine if a sample of Dow’s Polyox material falls within the manufacturer’s
`
`3
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-2 Filed 11/18/15 Page 5 of 6 PageID #: 10976
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`specification for the commercial grade, but it cannot indicate if a sample contains discrete sets of
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`lower average MW and higher average MW PEOs, as required by claim 1. (See JTX-30 at 15
`
`and JTX-33 at 391 (rheological measurement for Polyox N80 should be between 55–90 or 55–
`
`115 cps); Tr. 115:20117:21 (Mathias); id. at 194:14195:2 (Yau); id. at 647–651
`
`(Prud’homme).)
`
`17. Polymer scientists commonly analyze a unimodal distribution obtained through a GPC
`
`analysis by partitioning the data into discrete sets, allowing them to consider separately different
`
`components of the sample. (Tr. 124:7–127:6 (Mathias);JTX-76 at 1951;JTX-40 at 193.)
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`18. A POSA would be able to partition a MW distribution obtained by GPC analysis to
`
`determine whether there are two averages meeting the requirements of the claims. (Tr. 124:11–
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`129:7 (Mathias);id. at 197:8–199:5 (Yau).)
`
`19. Partitioning the MW distribution of a sample of PEOs at 600,000 would be an
`
`appropriate starting point for a POSA analyzing whether a film contains the lower and higher
`
`average MW PEOs of claim 1. (Tr. 127:7–128:14, 155:15–156:18 (Mathias).)
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`20. Because the claim requires fractions in two ranges and the lower average MW component
`
`must be about 60 percent of the polymer component or greater, partitioning the sample at the
`
`lower end of the upper range (600,000 daltons) has the greatest likelihood of determining
`
`whether or not a sample has PEO components meeting the limitations of claim 1. (Tr.
`
`127:7128:14, 181:20183:15, 184:9185:14 (Mathias).)
`
`21. When GPC data on Polyox N80 is partitioned at 600,000, it demonstrates the presence of
`
`a set of lower average MW PEO having a viscosity average MW of 100,000 and making up
`
`about 98% of the sample, and a set of higher average MW PEO having a viscosity average MW
`
`of 900,000 and making up about 2% of the sample. (Tr. 128:18131:4 (Mathias);PTX-526.)
`
`4
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-2 Filed 11/18/15 Page 6 of 6 PageID #: 10977
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`a. The ’150 Patent, in claims 1 and 4 and throughout the specification, refers to average
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`MW of PEOs in increments of 100,000. (See JTX-1 at claims 1 and 4, 50:10–35.)
`
`b.
`
`It is understood in the industry that a commercial polymerization processes for the
`
`manufacture of PEO result
`
`in substantial batch-to-batch variation and that measurement
`
`techniques also have variability, so POSAs consider PEOs in increments of average MW having
`
`1 or 2 significant digits. (Tr. 130:15131:4 (Mathias);199:14–200:14 (Yau);JTX-30 at 15;JTX-
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`33 at 391.)
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`c. The raw value of 900,318 mathematically calculated for the higher average MW PEO
`
`from GPC data would be understood to represent PEO having a viscosity average MW of
`
`900,000. (Tr. 128:18131:4 (Mathias);id. at 199:14–200:14 (Yau);PTX-526G–J.)
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`d. The raw value of 95,895 mathematically calculated for the lower average MW PEO
`
`from GPC data would be understood to represent PEO having a viscosity average MW of
`
`100,000. (Tr. 128:18131:4 (Mathias);PTX-526G–J.)
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`22. The higher MW PEO will have a disproportionately large impact on the functional
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`properties of a sample due to entanglement of the larger molecules. The approximately 2% of the
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`higher average MW fraction in Polyox N80 will impact the properties of a film, and is not
`
`considered merely stray. (Tr. 112:19, 169:13–170:17, 136:2–138:6 (Mathias);JTX-40 at 1, 3.)
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`a. Dr. McConville’s testimony that the approximately 2 percent higher MW fraction is a
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`“stray”amount rests on his assertion, as a non-expert in polymers, that claim 1 requires at least
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`10 percent of the high MW fraction, a limitation unsupported by any intrinsic evidence,
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`literature, or principles of polymer chemistry. (Tr. at 274:1–276:3, 290:22–291:7 (McConville).)
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`23. The low MW PEO in Watson’s ANDA Product constitutes 86% of the polymer
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`component. (Tr. 135–136 (Mathias).)
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`5
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-3 Filed 11/18/15 Page 1 of 6 PageID #: 10978
`Case 1:13—cv—O1674—RGA Document 364-3 Filed 11/18/15 Page 1 of 6 Page|D #: 10978
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`EXHIBIT C
`
`EXHIBIT C
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
`
`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

`
`Case 1:13-cv-01674-RGA Document 364-3 Filed 11/18/15 Page 2 of 6 PageID #: 10979
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`(A) The Asserted Claims Are Not Indefinite
`
`1.
`
`Defendants contend that the claims 1 and 10 of the ’150 Patent are indefinite because
`
`“molecular weight”could refer to different measurements of average molecular weight (“MW”).
`
`2.
`
`Claims 1 and 10 are directed to film products containing a polymer component that
`
`comprises a lower MW polyethylene oxide (“PEO”) having a MW in the range of 100,000-
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`300,000 and a higher MW PEO having a MW in the range of 600,000-900,000. (Tr. at 637-638,
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`663-669, 689-690 (Prud’homme);JTX-0001 at 57:36-54 and 58:29-46);Tr. at 675:15-676:6
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`(Prud’homme);Id. at 164:7-11 (McConville).)
`
`3.
`
`Dr. Prud’homme, a Princeton University professor, past president of the U.S. Society of
`
`Rheology, and former Chair of Dow’s Technical Advisory Board on Material Science, which
`
`advised the company on materials including PEO, explained, a person of ordinary skill in the art
`
`(“POSA”) would understand from the ’150 Patent’s claims, specification, and file history that the
`
`term “molecular weight”refers to viscosity average MW. (Tr. at 635:18-636:9, 640:7-
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`642:11(Prud’homme);JTX-0010).
`
`4.
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`The ’150 Patent specification identifies the PEO used in referenced experiments as
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`“[a]vailable from Dow Chemical Company.”(Tr. at 429:23-430:7 (Amiji);Id. at 641:6-11
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`(Prud’homme);Id. at 253:13-254:11 (McConville);JTX-0001 at 48:41-58).
`
`5.
`
`The Flick reference discussed in the file history of the ’150 Patent, which disclosed the
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`Dow Chemical (Union Carbide) commercial grades, conveyed to a POSA that the “Approximate
`
`Molecular Weight”that Dow reports for a grade of PEO is correlated with a viscosity range.
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`(JTX-0033 at 8;JTX-0004 at 1063-1064, 1073;Tr. at 641:12-642:11 (Prud’homme).)
`
`1
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-3 Filed 11/18/15 Page 3 of 6 PageID #: 10980
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`6.
`
`A POSA would understand from the Flick reference and older Dow brochures that
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`viscosity average MW is the type of MW measurement relevant in the ’150 Patent. (Tr. at
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`641:12-642:11, 646:4-24 (Prud’homme).)
`
`7.
`
`Viscosity average MW is the most common measure of MW in this context. (Tr. at
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`454:10-19 (Amiji);Id. at 646:4-24, 675:15-24 (Prud’Homme);Id. at 254:7-11 (McConville).)
`
`8.
`
`Because the ’150 Patent and file history point to viscosity average MW, a POSA would
`
`not read the claims of the ’150 Patent to refer to number average MW, z-average MW, or weight
`
`average MW, which are not mentioned in the patent or file history. (Tr. at 642:2-646:3
`
`(Prud’homme);Id. at 255:7-12 (McConville).)
`
`9.
`
`Additionally, the POSA would regard number average MW and z-average MW as clearly
`
`inapplicable because they cannot be measured experimentally, and skews results: in the case of
`
`number average MW towards very low MW species and in the case of z-average MW toward
`
`ultra-high MW species.
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`(Tr. at 643:16-645:13 (Prud’homme).)
`
`10.
`
`As concerns weight average MW, a POSA would in any event have understood weight
`
`average MW to be correlated with and numerically close to viscosity average MW for the PEO
`
`recited in the asserted claims (i.e., within approximately 10%). (Tr. at 645:19-646:3, 660:11-21)
`
`11.
`
`Dr. Prud’homme also explained that viscosity average MW was not only a well-
`
`established measure of average MW (indeed, the most common such measure), but was used in
`
`the field to describe polymer average MW at the time of the invention. (Tr. at 641-642, 645-646,
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`649, 652-653,675- 679 (Prud’homme).)
`
`12.
`
`Nor are Defendants persuasive in pointing to the “approximate”MW reported by Dow
`
`for a particular grade of its PEO, such as Polyox N-80, as determinative of the viscosity average
`
`MWs. First, Dow does not report the actual average MW on a per sample basis: instead, Dow
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`2
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-3 Filed 11/18/15 Page 4 of 6 PageID #: 10981
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`provides a nominal MW that it assigns if a sample falls within a wide range of viscosities as
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`measured by a viscometer. (Tr. at 647:4-651:21 (Prud’homme);see also JTX-0030 at 15).)
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`Second, Dow’s “approximate”MW provides no information about the array of MWs of the PEO
`
`in the sample, which would be necessary to determine whether the claim limitations are met.
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`(Tr. at 652:11-654:1, 655:9-656:11 (Prud’homme).) Third, Dow employed its “approximate”
`
`MW simply as a release or qualification measurement to allow customers to confirm that a given
`
`sample was is the right viscosity “ballpark”and representative of what one would expect to see
`
`in a sample of, for example, Polyox N80. Dow did not use its “approximate”or nominal MW to
`
`indicate a precise MW. (Tr. at 647-651, 681-683 (Prud’homme);see also JTX-0030 at 15).)
`
`13.
`
`As Dr. Prud’homme explained, to ascertain whether a particular sample meets the lower
`
`and higher MW range limitations of the ’150 patent, a POSA would understand that it would be
`
`necessary to use gel permeation chromatography (“GPC”) to analyze the distribution of MWs of
`
`PEO present in the sample and determine whether the sample has the lower and higher average
`
`MW PEO set forth in the asserted claims. (Tr. 652:11-654:1, 655:9-656:11)
`
`14.
`
`In any event, Dow does not provide viscosity average MW information for individual
`
`samples or batches, let alone information about the array of MW observed in a sample. As Dr.
`
`Prud’homme explained, to ascertain whether a particular sample meets the lower and higher MW
`
`range limitations of the ’150 patent, a POSA would understand that a sample would need to be
`
`arrayed by MW using gel permeation chromatography (“GPC”), which can be used to calculate
`
`viscosity average MW.
`
`(Tr. 647:4-654:1, 655:9-656:11 (Prud’homme).)
`
`15.
`
`Based on the intrinsic evidence and a POSA’s knowledge of PEO, a POSA would
`
`understand the boundaries of the claims of the ’150 Patent with reasonable certainty. (Tr. at
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`661:3-12 (Prud’homme).)
`
`3
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`TEVA EXHIBIT 1014
`TEVA PHARMACEUTICALS USA, INC. V. MONOSOL RX, LLC
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`

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`Case 1:13-cv-01674-RGA Document 364-3 Filed 11/18/15 Page 5 of 6 PageID #: 10982
`
`(B) The Asserted Claims Are Not Obvious
`
`16.
`
`Defendants’assertion of obviousness is based solely on the contention that a patent
`
`application published on February 17, 2005 (Yang) is prior art to the ’150 Patent and rendered
`
`the asserted claims of the ’150 Patent obvious. (Tr. at 440:17-22, 448:2-8, 452:7-17 (Amiji).)
`
`17.
`
`Yang is the parent application of the ’150 Patent;the ’150 Patent was filed as a divisional
`
`of Yang following a restriction requirement, and has the same inventors and assignee. (JTX-
`
`0001 at 1;JTX-0178 at 1;JTX-0004 at 1174-1175;see Tr. at 463:5-464:20 (Amiji)).
`
`18.
`
`The ’150 Patent claims priority to U.S. Provisional Application No. 60/473,902 (the ’902,
`
`Application), which was filed on May 28, 2003 and shares the same “Detailed Description of the
`
`Invention”in relevant part. (JTX-0249 at 1, 2, 30, 31, 81;JTX-0001 at 17:52-58, 18:11-28,
`
`51:39-45, claims 1 and 10;Tr. at 668:10-669:18 (Prud’homme)).
`
`19.
`
`The asserted claims of the ’150 Patent have priority to the May 2003 f