UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`AKORN, INC.
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`Petitioner
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`SENJU PHARMACEUTICAL CO., LTD.
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`MITSUBISHI CHEMICAL CORPORATION
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`Patent Owner
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`Case IPR2015—01205
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`Patent 6,114,319
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`DECLARATION OF DIANE PANG REGARDING AUTHENTICATION OF
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`MAXIDEX® 0.1 % (DEXAMETHASONE OPHTHALMIC SUSPENSION)
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`SENJU-MITSUBISHI 2091
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`IPR2015-01205
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`U.S. Patent No. 6,114,319
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`Declaration of Diane Pang
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`Exhibits Referenced In This Declaration
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`A
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`Printout of “maxidex (NDA # 013422)” search results
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`from “Dru s I FDA” database
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` Label for Maxidex® 0.1% (dexamethasone ophthalmic
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`susension
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`IPR2015-01205
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`U.S. Patent No. 6,114,319
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`Declaration of Diane Pang
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`1, Diane Pang, am an attorney at O’Melveny & Myers LLP.
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`Exhibit A is a true and correct copy of the search results for “maxidex
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`(NDA # 013422)” that I obtained from the “Drugs@FDA” database on June 22,
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`2016.
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`Exhibit B is a true and correct copy of the Maxidex® 0.1%
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`(dexamethasone ophthalmic suspension) Label that I obtained from the
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`“Drugs@FDA” database on June 22, 2016.
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`4.
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`I declare under penalty of perjury under the laws of the United States
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`that the foregoing is true and correct. This declaration is executed this E day of
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`June, 2016, at Newmrt Beach, California.
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`2%’2 /éfflezg
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`Dian Pa g
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`Exhibit A
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`Druge@Fr.'A: FDA Approved Drug Products
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`H".'IlIi F. H I
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`A lo I ln[$l.‘:
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`Medic-.aiDevicee Radiation-Emitting Products Veccinea.Biooci&Biologica Animalaivelerlnary
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`cosmetics
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`0 FDA Home 0 Drug Databases 0 Drugs@FDA
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`Back to Search Results
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`Back in Overview
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`FAQ i lnatructiona | Gloaaary | Contact Ua
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`cngmicgi ‘nip.
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`Hgvigw ciguificgugn
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`MAXIDEX
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`(NDA) 013422
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`or-zxmemnsone
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`ALCON
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`June 20. 1962
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`0 There are no Therapeutic Equivalents
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`0 Approval Hlatory. Letters, I‘-levlewe, and Related Documents
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`0 Label Infon-nation
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`Products on Application {NDA) #013422
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`Click on a column header to re-eort the table:
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`Active ingredients
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` DEXAMETHASONE fl SUSPENSION!DFlOPS:OPHTHALMiC
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`Ierlrellng
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`Back to Top | Back to Previous Page | Back to Drugs@FDA Home
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`h'iip:.I‘."www.aocessdaiafda.gov.‘sr:ripis;'Cdcr.’drugsaifdeJindex.r:fm'?fus:aciion=Scarc|1,DrugDctail5[6,-22.’20I6 l1:34:4l AM]
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`lmp:l:'www.aocessdII1.fth.govlsc:ipIslcderldrugsalfdaIindex.cftn?f\|seacIion=Search.DrugDelIils[6.f2?."20l6 11:34:41 AM]
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`Exhibit B
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`NDA 13-422/SLR-035
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`Page 3
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`Package Insert
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`Maxidex°
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`0.1 % (dexamethasone ophthalmic suspension)
`Sterile
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`DESCRIPTION: MAXlDEX® 0.1 % (dexamethasone ophthalmic suspension) is an adrenocortical
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`steroid prepared as a sterile topical ophthalmic suspension. The active ingredient is represented by the
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`[Structure]
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`Chemical name: Pregna- l ,4-diene-3,20-dione,9-fluoro-l 1,17,2l—trihydroxy-16-methyl-,(l 1B, 1 600-.
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`Each mL contains: Active: dexamethasone 0.] %. Preservative: benzalkonium chloride 0.0] %.
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`Vehicle: hydroxypropyl methylcellulose 0.5%. Inactives: sodium chloride, dibasic sodium phosphate,
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`polysorbate 80, edetate disodium, citric acid andfor sodium hydroxide (to adjust pH), purified water.
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`CLINICAL PHARMACOLOGY: Dexamethasonc suppresses the inflammatory response to a variety
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`of agents and it probably delays or slows healing.
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`INDICATIONS AND USAGE: Steroid responsive inflammatory conditions of the palpebral and
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`bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne
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`rosacea, superficial punctate keratitis, herpes zoster keratitis,
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`conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution
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`in edema and inflammation; corneal injury from chemical, radiation, or thermal bums, or penetration
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`CONTRAINDICATIONS: Contraindicated in epithelial herpes simplex (dendritic keratitis), vaccinia,
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`varicella, and most other viral diseases of the cornea and conjunctiva; tuberculosis of the eye; fungal
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`disease of ocular structures; and in those persons who have shown hypersensitivity to any component
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`WARNINGS: Prolonged use may result in ocular hypertension andfor glaucoma, with damage to the
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`optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
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`Prolonged use may suppress the host response and thus increase the hazard of secondary ocular
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`infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to
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`occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids
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`may mask infection or enhance existing infection. If these products are used for 10 days or longer,
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`intraocular pressure should be routinely monitored even though it may be difficult in children and
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`uncooperative patients.
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`Employment of corticosteroid medication in the treatment of herpes simplex other than epithelial
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`herpes simplex keratitis,
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`microscopy is essential.
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`Page 4
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`PRECAUTIONS:
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`General. FOR TOPICAL OPHTHALMIC USE ONLY. The possibility of persistent fungal infections
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`of the cornea should be considered after prolonged corticosteroid dosing.
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`Information for Patients.
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`Do not touch dropper tip to any surface, as this may contaminate the contents. The preservative in
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`MAXIDEX® (dexamethasone ophthalmic suspension), benzalkonium chloride, may be absorbed by
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`soft contact lenses. MAXIDEX® (dexamethasone ophthalmic suspension) should not be administered
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`while wearing soft contact lenses.
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`Carcinogenesis, Mutagenesis, Impairment of Fertility.
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`Long-terrn animal studies have not been performed to evaluate the carcinogenic potential or the effect
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`on fertility of MAXIDEX® (dexamethasone ophthalmic suspension).
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`Pregnancy.
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`Pregnancy Category C. Dexamethasone has been shown to be teratogenic in mice and rabbits
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`following topical ophthalmic application in multiples of the therapeutic dose.
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`In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the
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`rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head,
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`ears, limbs, palate, etc.
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`There are no adequate or well-controlled studies in pregnant women. MAXIDEX® (dexamethasone
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`ophthalmic suspension) should be used during pregnancy only if the potential benefit to the mother
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`justifies the potential
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`substantial doses of corticosteroids during pregnancy should be observed carefully for signs of
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`Nursing Mothers.
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`Systemically administered corticosteroids appear in human milk and could suppress growth, interfere
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`with endogenous corticosteroid production, or cause other untoward effects. It is not known whether
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`topical administration of corticosteroids could result
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`detectable quantities in human milk. Because many drugs are excreted in human milk, caution should
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`be exercised when MAXIDEX® (dexamethasone ophthalmic suspension) is administered to a nursing
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`Pediatric Use. Safety and effectiveness in pediatric patients have not been established.
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`Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly
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`ADVERSE REACTIONS: Glaucoma with optic nerve damage, visual acuity and field defects;
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`cataract formation; secondary ocular infection following suppression of host response; and perforation
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`of the globe may occur.
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`NDA 13-422/SLR—035
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`Page 5
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`DOSAGE AND ADMINISTRATION:
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`SHAKE WELL BEFORE USING. One or two drops topically in the conjunctiva] sac(s). In severe
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`disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In
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`mild disease, drops may be used up to four to six times daily.
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`HOW SUPPLIED: MAXIDEX® (dexamethasone
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`DROP-TAINER® dispensers:
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`ophthalmic
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`suspension)
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`in
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`5 mL NDC 0998-0615-05
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`15 mL NDC 0998-0615-15
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`STORAGE: Store upright at 8°-27°C (46°-80°F).
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`Rx Only
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`©2002 Alcon Laboratories, Inc.
`MAXSGER-0802
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`Revised: August 2002
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`AIcon°
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`ALCON LABORATORIES, INC.
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`Fort Worth, Texas 76134 USA
`Printed in USA