IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB INCORPORATED and
`BAUSCH & LOMB PHARMA HOLDINGS
`CORP.,
`
`Plaintiffs,
`
`v.
`
`INNOPHARMA LICENSING, INC.,
`INNOPHARMA LICENSING, LLC,
`INNOPHARMA, INC. and INNOPHARMA,
`LLC,
`
`Defendants.
`
`Civil Action No. 1: 14-cv-00667 (JBS)(KMW)
`Civil Action No. 1:14-cv-04149 (JBS)(KMW)
`Civil Action No. 1:14-cv-05144 (JBS)(KMW)
`Civil Action No. 1: 15-cv-00335 (JBS)(KMW)
`Civil Action No. 1:14-cv-06893 (JBS)(KMW)
`Civil Action No. 1: 15-cv-03240 (JBS)(KMW)
`
`(Consolidated Actions)
`
`CONTAINS CONFIDENTIAL MATERIAL
`PURSUANT TO STIPULATED
`DISCOVERY CONFIDENTIALITY ORDER
`
`SUPPLEMENTAL OPENING EXPERT REPORT OF ROBERT 0 . WILLIAMS, ttl,
`PH.D. ON INNOPHARMA'S INFRINGEMENT AND OBJECTIVE INDICIA OF NON(cid:173)
`OBVIOUSNESS
`
`I.
`
`QUALIFICATIONS
`
`1.
`
`I, Robert 0. Williams, m, Ph.D., submit this report at the request of Plaintiffs
`
`Senju Pharmaceutical, Co., Ltd., Bausch & Lomb Incorporated, and Bausch & Lomb Pharma
`
`Holdings Corp. as an expert in the field of the design, evaluation and fonnulation of drug
`
`products. My qualifications in these areas, as well as other areas, are summarized in my expert
`
`reports dated December 28, 2015, and established by my curriculum vitae, which was attached
`
`as Appendix A to my December 28, 2015, expert reports.
`
`2.
`
`I am submitting this supplemental expert report in view of the supplemental
`
`expert reports by Dr. Adam C. Myers and Dr. Daryl S. Paulson dated January 11, 2016,
`
`regarding the stability of
`
`Prolensa ®product.
`
`Plaintiffs'
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`PAGE10F7
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`1
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`
`
`SENJU EXHIBIT 2255
`INNOPHARMA v SENJU
`IPR2015-00902
`
`

`
`II.
`
`DOCUMENTS AND INFORMATION CONSIDERED IN FORMING OPINIONS
`
`3.
`
`In forming my opinions, I had available the documents cited herein, the
`
`documents cited in my December 28, 2015, expert reports as well as the publications listed on
`
`my curriculum vitae. I also based my opinions on my professional and academic experience in
`
`the area of pharmaceutical formulation. I reserve the right to testify about these materials and
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`experience. To the extent I am provided additional documents or information, including any
`
`expert reports produced by lnnoPharma, I may offer further opinions. In addition to these
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`materials, I may consider additional documents and information in forming any rebuttal
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`opinions. Additionally, I may prepare demonstratives to illustrate any opinions I may present.
`
`III.
`
`STATEMENT OF OPINIONS EXPRESSED AND BASES AND REASONS
`THEREFOR
`
`4.
`
`I have reviewed the supplemental expert reports by Dr. Myers and Dr. Paulson,
`
`and I conclude that the opinions expressed in my opening expert reports dated December 28,
`
`2015, are consistent with these supplemental expert reports. To the extent I had referenced Dr.
`
`Myers or Dr. Paulson's expert reports in my opening expert reports, I reserve my right to rely on
`
`Dr. Myers and Dr. Paulson's supplemental expert reports as well as their expert reports dated
`
`December 24, 201 5.
`
`A.
`
`5.
`
`Plaintiffs' Prolensa® Product
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`Samples of Plaintiffs' Prolensa® product were tested for chemical stability and
`
`preservative efficacy using the test conditions specified in certain claims of the patents-in-suit.
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`A pot1ion of samples was used for unstressed (as received) analysis, and the remaining samples
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`were stressed in an oven for four weeks at 60° C. Samples from both the unstressed and stressed
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`conditions were evaluated for potency, i.e. chemical stability, and preservative efficacy. (See,
`
`e.g., Myers Supplemental Report; Paulson Supplemental Report.)
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`2
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`PAGE20F7
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`

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`6.
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`According to Dr. Myers' supplemental expert report, the average percent recovery
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`of bromfenac free acid for samples that were stressed was 99.8%.
`
`(See, e.g., Myers
`
`Supplemental Report.) These chemical stability results further support my opinion, consistent
`
`with the opinion provided in my opening expert reports, that Plaintiffs' Prolensa® product is a
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`stable aqueous liquid preparation that has sufficient resistance to degradation to be formulated
`
`and maintained for ophthalmic use, as described in the claims of the '290, '13 1, '813 and '606
`
`patents. These chemical stability results also support my opinion, consistent with the opinion
`
`provided in my opening expert reports, that Plaintiffs' Prolensa® product contains tyloxapol in an
`
`amount sufficient to stabilize bromfenac, as described in the claims of the '290, '13 1, '81 3
`
`and '606 patents.
`
`7.
`
`According to Dr. Paulson's supplemental expert report, the following test
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`results were obtained for preservative efficacy of the unstressed and stressed samples (see, e.g.,
`
`Paulson Supplemental Report):
`
`Or&llnlsrn
`
`S. aureus
`
`P.
`ai!IUginoro
`
`C.
`albiC(UIS
`
`A. niger
`
`Condition
`Unstressed
`
`Str~l!d
`
`tJnstres$1!d
`
`Stressed
`Unstressed
`Stressed
`Unstreued
`Stressed
`
`Inoculum
`Count
`
`1.97667 l( 106
`
`1.7070 )( 106
`
`3.3953 X lr:f
`
`8.8837X lOs
`
`28
`<LOOxl01
`
`CeU Count (CFU/mLl
`D:aY$ After Inoculation
`:n
`1
`14
`1
`-
`<1.00X101 <LOOx 101 <1.00x101
`...
`<l.IX)J( 10 I
`<L00x10~ 400x101
`<LOOxlat
`..•
`<l...OOx 101
`<1.00xl01 <L00x 101 <1.00x101
`-
`<L{)O X 101
`<LOOxl01
`<1.00xl01
`<LOO x10t
`--
`-
`"< 1.00 X 10' < LOOX 10~ <LOOxlot
`--
`-
`<.1,00 x101 < 1.ooxur <1.00xlot
`-·
`...
`<1.00xl01
`<l.OOx 101 <1.00x101
`-
`-·
`<l.OOxl01 <l.OOx 101 <t.OOx 101
`
`8.
`
`It is my opinion, consistent with the opinion provided in my opening expert
`
`reports, based on the preservative efficacy test results above, that Plaintiffs' Prolensa® product,
`'
`under both unstressed and stressed conditions, satisfies the EP-criteria B of the European
`
`3
`
`
`
`PAGE30F7
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`

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`Pharmacopoeia, as described in claims 26-30 of the '290 patent and claims 28-30 of the '606
`
`patent. Furthermore, because the Court construed "US Pharmacopoeia" in claims 25-29 of
`
`the '13 1 patent as "EP-criteria B of the European Pharmacopoeia," it is further my opinion that
`
`Plaintiffs' Prolensa® product, under both unstressed and stressed conditions, satisfies the EP-
`
`criteria B of the European Pharmacopoeia, as described in claims 25-29 of the '131 patent. The
`
`above preservative efficacy results, moreover, further support my opinion, consistent with the
`
`opinion provided in my opening expert reports, that Plaintiffs' Prolensa ® product is a stable
`
`aqueous liquid preparation that has sufficient preservative efficacy to be formulated and
`
`maintained for ophthalmic use, as described in the claims of the '290, '131, '813 and '606
`
`patents. Moreover, the claim charts in Appendices G-K identify the claims of the patents-in-suit
`
`that cover Plaintiffs' Prolensa® product and support that coverage with reference to each claim
`
`element.
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`4
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`PAGE 4 OF 7
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`5
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`PAGE 5 OF 7
`PAGE 5 OF 7
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`IV.
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`COMPENSATION
`
`13.
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`I will be compensated for my time preparing for and testifying in this matter at the
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`rate of $600/hour. No part of my compensation is contingent upon the outcome of this matter or
`
`any issue in it.
`
`V. PRIOR EXPERT TESTIMONY
`
`14.
`
`During the past four years, I have testified as an expert in the following cases:
`
`AstraZeneca and Pozen v. Dr. Reddy's (CA 11-cv-02317-JAP-DEA), Lupin (CA 11-cv-04275-
`JAP-DEA), Actavis (CA 3:13-cv-03038-JAP-DEA), Mylan (CA 3:13-cv-04022-JAP-DEA)
`
`Horizon US and Jagotec v. Actavis Pharma (C.A. No. 1:13-cv-01524-NLH-JS)
`
`Depomed, Inc. v. Actavis Elizabeth LLC, Watson Laboratories, Inc., Incepta Pharmacetuicals Co.
`Ltd (C.A. 3:12-cv-01358-JAP-TJB); Impax Laboratories, Inc., Par Pharmaceutical, Inc. (C.A.
`3:12-cv-02154-JAP-TJB); Zydus Pharmacetuicals Inc., Cadi/a Healthcare Ltd. (C.A. 3:12-cv-
`02813)
`
`Shionogi & Co., Ltd. Versus Sandoz Inc. and Hospira Inc.
`(FL W)(LHG))
`
`(C.A. No. 3: 12-cv-07907
`
`Kremers Urban/Schwarz Pharma v. AAI Pharma (C.A. No. 02-cv-09628 (BSJ)
`
`Wyeth Holdings Corporation and Wyeth-Ayerst Lederle LLC (Pfizer) v. Sandoz Inc. (C.A. No.
`90-955 (LPS))
`
`6
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`PAGE 6 OF 7
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`

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`Ferring B. V. v. Watson Laboratories, Inc. eta/. (3:11-cv-00481-RCJ-VPC) and Apotex, Inc. et al.
`(C. A. No. 3: 11-CV -00485-RCJ-VPC)
`
`Pfizer Inc. v. Fresenius Kabi USA, LLC (Tygacil ANDA Litigation) (C.A. No. 1: 13-cv-01893-
`SLR)
`
`Shionogi & Co., Ltd. Versus Sandoz Inc. and Hospira Inc. (C.A. No. 3: 12-cv-07907
`(FLW)(LHG)
`
`Abbott Laboratories, LTD and Takeda Pharmaceuticals America Inc. v. the Minister of Health
`and Mylan Pharmaceuticals ULC (Canadian Federal Court File No.: T-1451-11)
`
`Jarrow Formulas Inc. v. Now Health Group, Inc., Soft Gel Technologies Inc. v. Jarrow
`
`Formulas Inc., (C.A. No. CVl0-8301 PSG (JCx)
`
`1112/2016
`Date
`
`Robert 0. Williams Ill, Ph.D.
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`7
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`PAGE 7 OF 7