Page 1
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF NEW JERSEY
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`CIVIL ACTION NOS.:
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`15—335(JBS); 14—667(JBS);
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`14—4149(JBS); 14—5144(JBS)
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`SENJU PHARMACEUTICAL CO., LTD.,
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`BAUSCH & LOMB INCORPORATED, and
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`BAUSCH & LOMB PHARMA HOLDINGS
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`CORP.
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`Plaintiffs,
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`vs.
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`LUPIN, LTD. AND LUPIN
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`PHARMACEUTICALS,
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`INC.,
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`Defendants.
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`SENJU PHARMACEUTICAL CO., LTD.,
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`BAUSCH & LOMB INCORPORATED, and
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`BAUSCH & LOMB PHARMA HOLDINGS
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`CORP.,
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`Plaintiffs,
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`vs.
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`INNOPHARMA LICENSING,
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`INC.,
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`INNOPHARMA LICENSING, LCC,
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`INNOPHARMA,
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`INC., and
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`INNOPHARMA, LLC,
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`Defendants.
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`Job NO. NJ 2238419
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`SENJU EXHIBIT 2268
`Innopharma v Senju,
`IPR2015-00902 & IPR2015-00903
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`_Veritext Legal Solutions
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`973-410-4040
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`Page 1 of 173
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF NEW JERSEY
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`CIVIL ACTION NOS.:
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`15—335(JBS); 14—667(JBS);
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`14—4149(JBS); 14—5144(JBS)
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`SENJU PHARMACEUTICAL CO., LTD.,
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`BAUSCH & LOMB INCORPORATED, and
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`BAUSCH & LOMB PHARMA HOLDINGS
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`CORP.
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`Plaintiffs,
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`vs.
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`LUPIN, LTD. AND LUPIN
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`PHARMACEUTICALS,
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`INC.,
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`Defendants.
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`SENJU PHARMACEUTICAL CO., LTD.,
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`BAUSCH & LOMB INCORPORATED, and
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`BAUSCH & LOMB PHARMA HOLDINGS
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`CORP.,
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`Plaintiffs,
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`vs.
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`INNOPHARMA LICENSING,
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`INC.,
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`INNOPHARMA LICENSING, LCC,
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`INNOPHARMA,
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`INC., and
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`INNOPHARMA, LLC,
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`Defendants.
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`Job NO. NJ 2238419
`
`SENJU EXHIBIT 2268
`Innopharma v Senju,
`IPR2015-00902 & IPR2015-00903
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`_Veritext Legal Solutions
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`973-410-4040
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`Transcript of deposition taken
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`by and before Lisa Forlano, CCR, CRR, RMR,
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`Certificate No. XI01l43, at the offices of Alston &
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`Bird, LLP,
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`90 Park Avenue, New York, New York,
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`on Friday, February 26, 2016, Commencing at 10:38
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`a.m.
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`A P P E A R A N C E S:
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`Page 3
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`FINNEGAN, HENDERSON, FARABOW,
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`GARRETT & DUNNER, LLP
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`BY:
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`BRYAN C. DINER, ESQUIRE
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`TERRENCE KIM, ESQUIRE
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`901 NEW YORK AVENUE, NW
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`WASHINGTON, DC
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`20001-4413
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`(202) 408-4116
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`bryan.diner@finnegan.com
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`terrence.kim@finnegan.com
`ATTORNEYS FOR PLAINTIFFS
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`ALSTON & BIRD LLP
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`BY:
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`JOSEPH M.
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`JANUSZ, ESQUIRE
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`BANK OF AMERICA PLAZA
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`101 SOUTH TRYON STREET, SUITE 4000
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`CHARLOTTE, NORTH CAROLINA 28280-4000
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`(704) 444-1000
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`joe.janusz@a1ston.com
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`ATTORNEYS FOR DEFENDANT,
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`INNOPHARMA
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`JAMES ROBERTS, VIDEOGRAPHER
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`Page 4
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`PAGE
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`7
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`I N D E X
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`WITNESS
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`ROBERT C. CYKIERT, M.D.
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`By Mr. Diner
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`E X H I B I T S
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`1 2
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`3 4
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`10
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`Cykiert—1 Responsive Expert Report of Robert C.
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`9
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`Cykiert, M D., on Objective Indicia of
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`Non—Obviousness
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`Cykiert—2 Adverse reactions to sulfites article 27
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`Cykiert—3 Bronuck Ophthalmic Solution document
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`31
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`PROLO333509 — PROLO3335l3
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`Cykiert—4 Topical Nonsteroidal Anti—inflammatory 47
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`Drugs and Cataract Surgery Article, 2159 — 2168
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`Cykiert-5 Document, PROLO080486 — PROLOO80492
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`Cykiert—6 Document, PROLOOBO493 — PROLOO80497
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`Cykiert—7 Acular information document,
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`PROLO332429 — PROL0332439
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`Cykiert—8 Voltaren Ophthalmic information
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`document, PROLO3324l4 - PROL0332418
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`Cykiert—9 Prolensa information document,
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`PROL0O802189 — PROLOO80224
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`74
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`75
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`77
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`98
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`Cykiert—1O Expert Report of Mark R. Prausnitz,
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`115
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`Ph.D., Regarding Secondary Considerations
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`Cykiert—11 WebMD document on Prolensa
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`126
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`Ophthalmic
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`E X H I B I T S
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`(CONTINUED)
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`Cykiert—12 Bromfenac Ophthalmic Solution 0.07%
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`130
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`Dosed Once Daily for Cataract Surgery document,
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`PROLO333854 — PROLO333862
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`Cykiert—13 Volume 14 from the Journal of the
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`137
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`American College of Nutrition, Number 3, June 1995
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`Cykiert—14 Article — Adverse reactions to
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`141
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`sulfites in drugs and foods, 1077 — 1080
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`Cykiert—15 Vol. 99, No. 2, February 1997 article 143
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`from the American Academy of Pediatrics, "Inactive"
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`Ingredients in Pharmaceutical Products: Update
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`(Subject Review)
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`VIDEO OPERATOR: Good morning, we're
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`now on the record.
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`Please note that the
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`microphones are sensitive and may pick up
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`whispering and private conversations.
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`Please
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`I
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`turn off all cellphones or place them away
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`from the microphones, as they can interfere
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`with the deposition audio. Recording will
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`continue until all parties agree to go off the
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`record.
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`My name is Jim Roberts representing
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`Veritext, with offices in Livingston, New
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`Jersey.
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`Today's date is February 26, 2016.
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`The time is approximately 10:38 a.m.
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`The deposition is being held at Alston & Bird,
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`located at 90 Park Avenue, New York City, New
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`York, and is being taken by counsel for the
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`Plaintiff.
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`The caption of the case is Senju
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`Pharmaceuticals, et al. versus Lupin, LTD., et
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`al.
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`The case is held in the US District
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`Court, District of New Jersey.
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`The name of
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`the witness is Robert C. Cykiert.
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`Counsel will please state their
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`——
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`appearances for the record.
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`MR. DINER: Bryan Diner with the law
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`firm of Finnegan Henderson, representing the
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`Plaintiff, Senju, et al. With me is my
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`colleague, Terrence Kim.
`MR.
`JANUSZ:
`doe Janusz of Alston &
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`Bird, representing the Innopharma defendants
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`and the witness,
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`today.
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`VIDEO OPERATOR: Our court reporter,
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`Lisa Forlano, also of Veritext, will please
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`swear in the witness.
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`ROBERT C. CYKIERT, M.D., having been
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`duly sworn, was examined and testified as
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`follows:
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`BY MR. DINER:
`
`Q
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`A
`
`Q
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`A
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`Q
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`Good morning, sir.
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`Good morning.
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`How are you today?
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`All right. Good.
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`How are you doing?
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`Fine,
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`thank you.
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`Can you please state
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`your full name and address for the record?
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`A
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`Sure. Robert Cykiert, 345 East 37th
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`Street, New York, New York 10016.
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`Q
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`Dr. Cykiert, have you been deposed
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`before?
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`A
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`Q
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`Yes,
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`I have.
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`Have you been deposed in an IP case
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`before?
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`By IP,
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`I mean intellectual property.
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`A
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`Q
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`No, not that I recall.
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`Okay.
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`I'll just go over a few ground
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`rules for today's proceeding, if that's fine with
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`you.
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`A
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`Q
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`Sure.
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`I kind of break them down into three
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`parts; my questions, your breaks, perhaps, or any
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`questions you have.
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`So first with regard to my
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`questions. My job is to ask the questions, your job
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`is to answer them, and to answer them truthfully and
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`accurately.
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`A
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`Q
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`Does that sound fair?
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`Yes.
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`Okay. With regard to breaks, any time
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`you feel you need a break, it's fine with us,
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`just
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`let us know.
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`If there is a question pending,
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`however,
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`I would just ask that you answer that
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`question and then we can take a break afterwards.
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`'
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`Is that fine?
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`A
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`Q
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`Yes.
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`Okay. And to the extent that you have
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`any questions of a question that I've asked or are
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`unclear about something, please let me know and I'll
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`be happy to either clarify or rephrase the question.
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`Is that okay?
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`Yes.
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`And if I ask a question and you answer
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`A
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`Q
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`it, I'll assume that you understood the question.
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`Is that fine?
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`Q
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`Yes.
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`Okay.
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`Is there any reason why you
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`cannot testify today truthfully and accurately?
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`A
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`Q
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`No, no reason.
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`I'd like to mark the first exhibit.
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`(Responsive Expert Report of Robert C.
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`Cykiert, M.D., on Objective Indicia of
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`Non—Obviousness was marked Cykiert—1 for
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`16 I
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`identification.)
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`BY MR. DINER:
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`Q
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`Okay.
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`Now, Dr. Cykiert,
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`the court
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`reporter has just handed you a document that is
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`entitled, Responsive Expert Report of Robert C.
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`Cykiert, M.D., on Objective Indicia of
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`Non—Obviousness.
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`Is what has been marked as Cykiert
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`Exhibit 1 your expert report,
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`including any exhibits
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`or appendices that you have submitted in this case?
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`A
`Q
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`I'm sorry.
`What's the question?
`Is this the expert report that you have
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`submitted in this matter?
`
`A
`
`Q
`
`Yes, it looks like it.
`
`Okay.
`
`Can you please turn to the page
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`in your expert report after page 31.
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`I
`I
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`!
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`A
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`Q
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`at the top?
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`A
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`Q
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`A
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`Q
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`Okay.
`
`On that page do you see the signature
`
`Yes.
`
`Is that your signature?
`
`Yes, it is.
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`Now, on the next page, which actually
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`doesn't have a page number,
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`there's another
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`signature.
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`Is that your signature as well?
`
`A
`
`Q
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`Yes.
`
`Now,
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`if you hold these two pages open
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`together,
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`I think as you are doing presently,
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`the
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`page after page 31 has a date of February 3 at the
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`top.
`
`A
`
`Q
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`Do you see that?
`
`Yes.
`
`The next page actually has a date of
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`February 1, 2016 at the top.
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`Do you see that?
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`A
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`Q
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`Yes.
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`Do you know why you have two signature
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`pages with two different dates.
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`A
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`Yeah, apparently I signed it without
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`5,
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`looking at the date and later I was told it was the
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`wrong date,
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`so I had to re—sign it again with the
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`correct date.
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`Q
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`And which one is the correct date that
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`you re—signed?
`
`A
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`Q
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`I believe it was February 1.
`
`Okay.
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`So you signed the report on
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`February 1, but February 3 was the date indicated
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`13' when you signed it?
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`14 '
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`A
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`Apparently it was the wrong day.
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`I
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`believe I signed it actually on February 1, but I
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`didn't notice that it had the wrong date printed on
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`it, February 3,
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`so I was asked to re-sign it with
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`the correct date.
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`Q
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`Okay.
`
`Thank you.
`
`Who prepared your expert report in this
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`case?
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`A
`
`Q
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`A
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`Q
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`I prepared it.
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`Did you prepare it by yourself?
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`I prepared it with the attorneys.
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`Okay.
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`Now, at the end of your report,
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`does it contain a copy of your CV?
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`A
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`Q
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`of today?
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`Yes, it does.
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`And is this CV current and accurate as
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`A
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`I think it's accurate to within
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`probably about six months or so.
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`Q
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`Okay.
`
`Is there anything that you would
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`like to add to your CV that's not presently in it?
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`A
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`Q
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`Nothing right now that I can think of.
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`Okay. And your curriculum vitae lists
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`your current, relevant professional experience,
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`correct?
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`A
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`Yes.
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`14
`15-
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`Q
`Dr. Cykiert,
`in what areas do you
`consider yourself an expert?
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`A
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`I'm an ophthalmologist and I have
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`special expertise in what's called the anterior
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`segment of the eye, which is the front of the eye,
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`which includes things like cataract surgery, cornea,
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`external disease, any diseases, conditions, problems
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`I
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`or complications or surgeries of the front part of
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`the eye.
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`Q
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`You're not an expert on any of these
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`conditions in the posterior part of the eye?
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`A
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`The posterior part of the eye is
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`connected to the front of the eye, so I'm also, as
`
`an ophthalmologist, an expert on all parts of the
`
`eye, front to back, but
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`I have specific fellowship
`
`training in the anterior segment of the eye.
`
`So
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`many conditions that affect the front of the eye
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`also have an effect on the back of the eye, which
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`7 I
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`I'm an expert on as well.
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`Q
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`Any other areas of ophthalmology that
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`you would consider yourself an expert
`
`in other than
`
`what you just stated?
`
`A
`
`Basically it depends how you define
`
`expert. What do you mean by "expert"?
`
`Q
`
`Well, do you have an expertise in any
`
`other areas of ophthalmology other than what you
`
`just described?
`
`A
`
`I have numerous areas of expertise
`
`within ophthalmology. Again, depending on how you
`
`define "expert," I have special super expertise in
`
`the front part of the eye, but I'm also an expert on
`
`the back of the eye,
`
`the middle the eye,
`
`the sides
`
`of the eye and every disease and condition of the
`
`eye.
`
`Q
`
`Okay. Are you an expert
`
`in the field
`
`of pharmacy?
`
`A
`
`That I'm not an expert
`
`in, no.
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`Q
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`A
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`Q
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`Have you ever practiced pharmacy?
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`No,
`
`I have not.
`
`Are you an expert
`
`in the area of
`
`pharmacology?
`
`A
`
`Q
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`No,
`
`I'm not an expert in pharmacology.
`
`And neither are you an expert in
`
`pharmacokinetics?
`
`A
`
`Q
`
`I am not an expert
`
`in pharmacokinetics.
`
`Nor are you an expert
`
`in
`
`pharmacodynamics, right?
`
`A
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`I'm not an expert in pharmacodynamics.
`
`But
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`I should say that I know certain things about
`
`all those things that you mentioned simply because
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`part of ophthalmology is treating conditions,
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`diseases with various drugs which required me to
`
`know a bit about pharmacy, pharmacokinetics and
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`pharmacodynamics.
`
`Q
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`But as you stated, you don't consider
`
`yourself an expert in those areas, correct?
`
`A
`
`Again, depending on how you define
`
`"expert," I would say with my definition of expert,
`
`I'm not an expert in those, as I previously stated.
`
`Q
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`That's fine.
`
`Dr. Cykiert, have you ever conducted
`
`any research on any bromfenac—containing product?
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`A
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`Q
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`No,
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`I have not.
`
`Have you ever conducted any research on
`
`any tyloxapol—containing product?
`
`A
`
`Q
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`No,
`
`I haven't.
`
`Are you an expert
`
`in chemistry, using
`
`your definition of an expert?
`
`A
`
`Well,
`
`I majored in chemistry in
`
`college,
`
`so I do have basic fundamental knowledge of
`
`:
`
`chemistry, especially how it applies to the eye and
`
`diseases of the eye, but I wouldn't consider myself
`
`an expert in that.
`
`Q
`
`Thank you. Would you consider yourself
`
`an expert in chemical stability testing of aqueous
`
`liquid preparations?
`
`A
`
`Q
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`That I'm not an expert in.
`
`Have you ever conducted any chemical
`
`stability testing on an aqueous liquid preparation?
`
`A
`
`Q
`
`A
`
`Q
`
`Patent?
`
`A
`
`Q
`
`A
`
`No,
`
`I haven't.
`
`Are you an expert
`
`in patent law?
`
`No,
`
`I'm not.
`
`Are you a named inventor on any U.S.
`
`Yes,
`
`I am.
`
`How many, approximately?
`
`One patent.
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`Q
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`A
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`And what does it deal with?
`
`It's a patent that blocks radiation
`
`from cellphones.
`
`Q
`
`A
`
`Q
`
`So not
`
`involved in ophthalmology,
`
`then?
`
`No, it's not.
`
`Are you a named inventor on any pending
`
`U.S. Patent applications?
`
`A
`
`Q
`
`Could you repeat that?
`
`Sure. Are you a named inventor on any
`
`pending U.S. Patent applications?
`
`A
`
`Q
`
`No.
`
`You mentioned you have at least one
`
`patent. Are you comfortable reading patent claims?
`
`A
`
`Q
`
`What do you mean by am I comfortable?
`
`Let me back up a minute.
`
`Do you know
`
`what I mean by a patent claim?
`
`A
`
`Sure.
`
`Okay. When you read patent claims, do
`Q
`you feel you understand them?
`
`A
`
`Yes.
`
`Q
`
`So,
`
`then, are you comfortable in
`
`reading patent claims?
`
`A
`
`Q
`
`them?
`
`I can read them, certainly.
`
`And can you read them and understand
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`Q
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`A
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`It depends what the patent is about.
`
`Okay.
`
`If it's a patent in ophthalmology or
`
`related to ophthalmology I feel very comfortable
`
`reading it and understanding it.
`
`Q
`
`A
`
`Q
`
`Very good.
`
`Thank you.
`
`Are you an expert
`
`in clinical testing?
`
`No,
`
`I'm not.
`
`Have you ever conducted any clinical
`
`testing with a pharmaceutical product?
`
`A
`
`Q
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`No,
`
`I don't believe I have.
`
`And so that would include not having
`
`conducted any testing, clinical testing with an
`
`ophthalmic product, correct?
`
`A
`
`Q
`
`Correct.
`
`In connection with your opinions in
`
`this matter, did you conduct any testing comparing a
`
`bromfenac —— comparing bromfenac—containing
`
`compositions?
`
`A
`
`Q
`
`No,
`
`I did not.
`
`And you understand that Prolensa is a
`
`bromfenac—containing composition, correct?
`
`A
`
`Q
`
`Yes.
`
`-
`
`And you understand that Xibrom is a
`
`bromfenac—containing composition?
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`A
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`Q
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`Yes.
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`And you also understand that Bromday is
`
`Page 18
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`a bromfenac-containing composition, correct?
`
`A
`
`Q
`
`Yes.
`
`You did not conduct any comparative
`
`testing between Prolensa and Bromday, correct?
`
`A
`
`Q
`
`That's correct,
`
`I did not.
`
`Nor did you conduct any comparative
`
`testing between Prolensa and Xibrom, correct?
`
`A
`
`Q
`
`I did not.
`
`Were you instructed not to conduct any
`
`comparative testing among bromfenac—containing
`
`compositions?
`
`MR.
`
`JANUSZ:
`
`I'11 caution the witness
`
`not to reveal the substance of any
`
`communication with counsel.
`
`I think that ——
`
`let me just read the question.
`
`MR. DINER:
`
`I'll agree that if he
`
`answers it yes or no it's not a waiver of any
`
`privilege.
`
`MR.
`
`JANUSZ: That's fine.
`
`THE WITNESS:
`
`I'm sorry, could you
`
`repeat that question.
`
`BY MR. DINER:
`
`Q
`
`Were you instructed not to conduct any
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`comparative testing among bromfenac—containing
`
`compositions?
`
`A
`
`Q
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`No.
`
`Would you please turn to page 3 of
`
`Cykiert Exhibit 1, which is your expert report.
`
`I'd like to refer you to the bottom of
`
`7'
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`the prior testimony section.
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`Do you see that?
`
`Yes.
`
`Go to the first bullet point.
`
`I think
`
`A
`
`Q
`
`it indicates cases in the last five years in which
`
`you have provided expert testimony;
`
`is that correct?
`
`A
`
`Q
`
`Yes.
`
`The first case in the first bullet
`
`point, Chery versus Malik.
`
`Do you see that?
`
`Yes.
`
`What was your role in that case?
`
`I believe that was a medical
`
`A
`
`Q
`
`A
`
`malpractice case.
`
`Q
`
`A
`
`Q
`
`And what was your role?
`
`I was an expert.
`
`And what was your role as an expert
`
`in
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`24 I
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`that case?
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`25
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`A
`
`I don't remember the details of that
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`case right now.
`
`Q
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`Do you remember, generally, what kind
`
`of expert opinions you provided in the case as a
`
`general matter?
`
`A
`
`Q
`
`A
`
`Q
`
`That case I don't recall.
`
`Thank you. That was in 2015, correct?
`
`Right.
`
`Okay.
`
`How about
`
`the next case,
`
`Gallimore versus Allison. What was that case about?
`
`well.
`
`case?
`
`A
`
`Q
`
`A
`
`Q
`
`correct?
`
`A
`
`Q
`
`A
`
`Q
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`A
`
`Q
`
`A
`
`Q
`
`That's a medical malpractice case as
`
`And you appeared as an expert
`
`in that
`
`I don't think I appeared in that.
`
`You provided testimony in that case,
`
`Yes.
`
`In what capacity?
`
`As a defense expert.
`
`Did you provide testimony at trial?
`
`No, not at trial.
`
`Did you provide deposition testimony?
`
`NO.
`
`So what kind of prior testimony did you
`
`offer in this case that led you to list this in this
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`category?
`
`A
`
`I don't know exactly the name, but it's
`
`a court document that's submitted to the Court.
`
`It
`
`might be perhaps a summary judgment document or some
`
`attestation type of document.
`
`I don't recall the
`
`details of it.
`
`Q
`
`A
`
`Q
`
`Such as a Declaration perhaps?
`
`Right, a Declaration, correct.
`
`Okay. And did you say that this case
`
`dealt with medical malpractice as well?
`
`A
`
`Q
`
`Yes.
`
`Okay. There are six more cases on your
`
`list, beyond the Gallimore versus Allison case.
`
`Were all of those medical malpractice cases?
`
`A
`
`Q
`
`Yes.
`
`And let's just go to this Cifuentes
`
`versus Staciu case.
`
`Do you recall what your role
`
`was in that case?
`
`A
`
`Q
`
`expert?
`
`A
`
`Q
`
`Yes,
`
`that one I appeared in court.
`
`And were you testifying in court as an
`
`Yes.
`
`And what generally was the subject
`
`matter of your testimony?
`
`A
`
`It was a complication during cataract
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`surgery.
`
`Q
`
`Okay. And which side in the litigation
`
`did you represent?
`
`A
`
`Q
`
`I represented the doctor.
`
`So you were offering your opinions in
`
`defense of a malpractice suit brought against the
`
`doctor?
`
`A
`
`Q
`
`Yes.
`
`Dr. Cykiert,
`
`is CME an abbreviation for
`
`cystoid macular edema?
`
`A
`
`Q
`
`Yes, it is.
`
`If I refer to cystoid macular edema
`
`today as CME, will you understand what
`
`I mean?
`
`A
`
`Q
`
`presume?
`
`A
`
`Q
`
`Yes.
`
`And that will be easy for both of us,
`
`I
`
`Yes, that's a nice abbreviation.
`
`Is it correct that Prolensa is approved
`
`for post-operative treatment of inflammation and
`
`pain after cataract surgery?
`
`A
`
`Q
`
`Yes.
`
`Now, Prolensa is not approved for
`
`treatment of CME, correct?
`
`A
`
`That's not the official approval,
`
`that's correct.
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`Q e
`
`or oth
`
`It doesn't have any approval, official
`
`rwise for CME, correct?
`
`MR.
`
`JANUSZ: Objection, vague.
`
`THE WITNESS: Well, approval by whom?
`
`BY MR.
`
`DINER:
`
`Q
`
`A
`
`Q
`
`By the FDA.
`
`Not by the FDA, no.
`
`Does it have approval by anyone for the
`
`treatment of CME?
`
`A
`
`It has approval by many doctors who use
`
`it for
`
`that purpose off label, which is perfectly
`
`accept
`
`able.
`
`Q
`
`Administering compounds off label is
`
`accept
`
`able?
`
`A
`
`Q
`
`A
`
`Q
`
`Yes.
`
`Is that what you're saying?
`
`Right.
`
`What is your basis for that?
`
`MR.
`
`JANUSZ: Objection, calls for
`
`speculation.
`
`THE WITNESS: That's commonly
`
`understood that certain medications have uses
`
`other than the official FDA approval.
`
`BY MR.
`
`DINER:
`
`Q
`
`And do you often administer ophthalmics
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`off label?
`
`A
`
`It depends on what you mean by "often."
`
`It depends on the ophthalmic, it depends on the
`
`patient's condition.
`
`It depends on numerous
`
`factors.
`
`Q
`
`Have you administered ophthalmics off
`
`label before?
`
`A
`
`Yes,
`
`I have, as have thousands of other
`
`ophthalmologists every day.
`
`Q
`
`Are you familiar with the ophthalmic
`
`Voltaren?
`
`A
`
`Q
`
`Yes.
`
`Is it approved by the FDA for the
`
`treatment of CME?
`
`A
`
`Q
`
`No, it's not.
`
`In fact,
`
`there are no ophthalmic NSAIDs
`
`that are approved by the FDA for the treatment of
`
`CME, correct?
`
`A
`
`Q
`
`Correct.
`
`And there are no ophthalmic NSAIDS
`
`approved by the FDA for the prevention or
`
`prophylaxis of CME, correct?
`
`A
`
`Q
`
`Correct.
`
`Do you draw a distinction between
`
`treatment in prophylaxis with respect to CME?
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`A
`
`Q
`
`A
`
`Yes,
`
`there is a distinction.
`
`What is it?
`
`Well, broadly, prevention means putting
`
`a patient on a drug to try to prevent a condition
`
`from occurring. And treatment is the condition or
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`disease already exists and you're using a drug to
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`try to cure or treat that disease or condition.
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`Q
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`And the explanation you just gave as
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`between prophylaxis and treatment would similarly
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`apply to the prophylaxis and treatment of CME?
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`Q
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`That's correct.
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`Other than for the treatment
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`post—operatively of inflammation and pain after
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`cataract surgery, Prolensa is not approved for
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`anything else, correct?
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`things you mentionedn
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`Q
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`Now,
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`the approved indication on the
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`Prolensa label is not limited to cases where the
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`patient is unable to receive corticosteroid
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`treatment due to allergy, correct?
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`A
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`Q
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`Could you repeat that again?
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`Sure.
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`The approved indication on the
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`Prolensa label is not limited to cases where the
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`patient is unable to receive corticosteroid
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`treatment due to allergy;
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`is that correct?
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`That's correct.
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`And the approved indication on the
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`Prolensa label is not limited to cases where the
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`patient has diabetes, correct?
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`That's correct.
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`Are you familiar with the term "sulfite
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`sensitivity" with regard to ophthalmics?
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`A
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`Yes.
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`Are asthmatics a class of people that
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`could have sulfite sensitivity?
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`A
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`Asthmatics can and so can anybody else.
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`Some people are allergic to sulfites.
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`Q
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`When someone is allergic to sulfites,
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`how does that manifest itself clinically?
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`A
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`Just like any allergy,
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`there are
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`various manifestations.
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`Sometimes it could just be
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`itching of the skin.
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`Some people can get hives.
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`Some people can get respiratory problems,
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`they have
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`difficulty breathing, and in the most severe cases
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`they can have what's called anaphylaxis, which is a
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`severe life—threatening reaction where they can't
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`breathe,
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`their blood pressure drops,
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`their heart may
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`even stop.
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`So there's a broad spectrum of allergic
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`reactions that can occur with sulfite.
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`Q
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`And in the context of ophthalmics,
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`this
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`issue of sulfite sensitivity, was that known for
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`sometime?
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`MR.
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`JANUSZ:
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`I'll just object to the
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`scope.
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`Go ahead.
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`BY MR. DINER:
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`Q
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`A
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`You can answer.
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`That's been known for a while. Several
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`drops contain that, and we know some patients have
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`sulfite allergies.
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`Q
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`Was it known prior to 2003 that
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`there -- some people who were sulfite sensitive in
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`the context of taking ophthalmics, for example?
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`MR.
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`JANUSZ:
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`Same objection.
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`THE WITNESS:
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`I can't tell you
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`specifically what year the sulfite allergy
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`issue came up with in ophthalmics.
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`I'm not
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`sure why you picked 2003, but
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`I couldn't tell
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`you exactly what year,
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`so I can't answer that
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`accurately.
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`MR. DINER:
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`I'd like to mark the next
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`document, please.
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`(Adverse reactions to sulfites article
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`was marked Cykiert—2 for identification.)
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`THE WITNESS: Thanks.
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`BY MR. DINER:
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`Q
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`Now, Dr. Cykiert,
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`the court reporter
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`has just handed you a publication to Yang, et al.,
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`and it is entitled, Adverse Reactions to Sulfites.
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`It's a couple—page document.
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`You can take a look at
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`it and let me know when you're ready and I'll ask
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`you some questions.
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`A
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`Do you want me to read the entire
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`document before you ask me questions?
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`Q
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`Well, how about I ask you some
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`questions, and to the extent you need to refer to
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`the document in greater detail you should feel free
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`to do so.
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`A
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`Q
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`Okay.
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`Now,
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`just a few moments ago you were
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`talking about anaphylactic shock,
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`I believe.
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`Do you recall that?
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`Yes.
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`You see in that first paragraph of this
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`A
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`Q
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`article on the first page,
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`left—hand column, it says
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`—— second sentence,
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`In the United States more than
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`250 cases of sulfite—re1ated adverse reactions,
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`including anaphylactic shock, asthmatic attacks,
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`urticaria and angioedema, nausea, abdominal pain and
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`diarrhea, seizures and death have been reported.
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`Do you see that passage?
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`A
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`Yes.
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`MR.
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`JANUSZ: Object to scope here as
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`well.
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`BY MR. DINER:
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`Q
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`Now,
`
`in the context of what we were
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`talking before about sulfite sensitivity and some of
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`the manifestations of sulfite sensitivity, does the
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`list that I just read include some of the
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`sensitivity?
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`MR.
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`JANUSZ:
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`Same objections.
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`THE WITNESS:
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`I mentioned earlier all
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`these things that are listed in this article
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`before I saw the article.
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`BY MR. DINER:
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`Q
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`Okay. And at the bottom of the first
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`page it indicates that this article was published on
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`November 1, 1985;
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`is that correct?
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`A
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`Q
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`Right.
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`Uh—huh. And if you look at the
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`paragraph bridging the first and second page --
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`sorry, strike that.
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`If you look at the second column of the
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`first page, you see where it identifies six
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`sulfiting agents?
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`JANUSZ:
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`Same objection.
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`THE WITNESS: What do you mean by
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`sulfiting --
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`BY MR. DINER:
`
`Q
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`Let me refer you to the second column,
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`second full paragraph on the first page. There it
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`talks about a number of different sulfites
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`identified in various products.
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`Do you see that,
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`the different
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`sulfites?
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`A
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`Q
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`Yes.
`
`Okay. And sodium sulfite is listed
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`there, correct?
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`MR.
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`JANUSZ:
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`Same objection.
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`THE WITNESS: Where is sodium sulfite
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`listed?
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`l8_ BY MR. DINER:
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`Q
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`A
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`not sure --
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`The fifth line down.
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`Could you point to the paragraph?
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`I'm
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`Q
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`Sure.
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`That paragraph.
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`Yeah.
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`Yeah.
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`It says six sulfiting agents.
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`Q
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`And one of the six sulfiting agents
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`includes sodium sulfite, correct?
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`MR.
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`JANUSZ:
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`Same objection.
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`THE WITNESS: Yes,
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`that is listed
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`there.
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`BY MR. DINER:
`
`Q
`
`And you're familiar with the ophthalmic
`
`Bronuck, correct?
`
`A
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`Q
`
`that correct?
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`Yes,
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`I am.
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`And Bronuck contains sodium sulfite;
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`is
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`MR.
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`JANUSZ:
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`Same objection.
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`THE WITNESS:
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`I'd have to see the
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`packet insert to be sure.
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`(Bronuck Ophthalmic Solution document
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`PROL0333509 — PROLO333513, was marked
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`Cykiert—3 for identification.)
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`BY MR. DINER:
`
`Q
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`Now, Dr. Cykiert,
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`the court reporter
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`has just handed you a document marked as Cykiert
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`Exhibit 3, bearing Bates numbers PROLO33509 through
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`513.
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`Following up on my last question and your last
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`answer,
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`I would direct you to the second page of
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`Cykiert Exhibit 3,
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`the left—hand column at the top.
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`You see the box that identifies the composition of
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`Bronuck?
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`A
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`Q
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`Yes.
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`Okay. And back up a minute. Would you
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`agree that this translation appears to be the
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`package insert information concerning the ophthalmic
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`formulation known as Bronuck?
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`A
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`Are you asking me to vouch that the
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`translation is correct?
`
`Q
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`A
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`Q
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`No.
`
`Oh.
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`I'm asking you to let me know if you
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`agree that this appears —— that Cykiert Exhibit 3
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`appears to be the prescribing information for
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`141 Bronuck.
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`Yes.
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`Okay. And back to the left—hand column
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`of the second page, do you see that box towards the
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`top identifying the ingredients in Bronuck?
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`A
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`Q
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`Yes.
`
`Do you see next to additives a list of
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`additives in Bronuck?
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`A
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`Q
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`Yes.
`
`Do you see that it —— strike that.
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`Bronuck, according to this document,
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`contains sodium sulfite, correct?
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`MR.
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`JANUSZ: Objection, scope.
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`THE WITNESS:
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`It says dry sodium
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`sulfite.
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`BY MR. DINER:
`
`Q
`
`Okay.
`
`Can you go back to Cykiert
`
`Exhibit 2, please? Now, Cykiert Exhibit 2
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`identifies that sulfites, such as sodium sulfite,
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`can be used in ophthalmics. And if it will help you
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`to answer the question I'll refer you to the bottom
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`of page 1 and the paragraph bridging the right-hand
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`column to the top of the second page of Cykiert
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`Exhibit 2.
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`BY MR. DINER:
`
`MR.
`
`JANUSZ: Objection, scope.
`
`THE WITNESS: Yes,
`
`I see that.
`
`Q
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`Okay. And it indicates that —— strike
`
`that.
`
`So this document indicates that it was
`
`known in November of 1985 that adverse reactions to
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`sulfites, such as sodium sulfite, could occur in
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`ophthalmic eye drops, correct?
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`MR.
`
`JANUSZ: Objection, scope and to
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`the extent it mischaracterizes the document.
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`THE WITNESS: Yeah,
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`I didn't read the
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`whole document, but it says in the first
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