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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`PATENT TRIAL AND APPEAL BOARD
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`ADAMIS PHARMACEUTICALS CORPORATION
`Petitioner
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`v.
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`BELCHER PHARMACEUTICALS, LLC
`Patent Owner
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`_____________________
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`CASE: IPR2019-01021
`U.S. PATENT NO. 9,283,197
`_____________________
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`PETITIONER’S UPDATED MANDATORY NOTICE TO NOTIFY BOARD
`OF DISTRICT COURT’S SUPPLEMENTAL CLAIM CONSTRUCTION
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
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`Exhibits Filed by Petitioner
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`Ex. 1001: U.S. Patent No. 9,283,197 (“‘197 Patent”), filed August 15, 2014,
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`issued March 15, 2016
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`Ex. 1002: Declaration of James Kipp, Ph.D.
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`Ex. 1003: Curriculum vitae of James Kipp, Ph.D.
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`Ex. 1004: Prosecution History of U.S. Patent No. 9,283,197
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`Ex. 1005: Stepensky, D., Long-Term Stability Study of L-Adrenaline Injections:
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`Kinetics of Sulfonation and Racemization Pathways of Drug
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`Degradation, Journal of Pharmaceutical Sciences, Vol. 93 No. 4
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`(“Stepensky”), published in April 2004
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`Ex. 1006: U.S. Patent Application Publication No. 2008/0269347 to Bruss et al.
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`(“Bruss”)
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`Ex. 1007: Fyllingen, G., Racemisation and oxidation in adrenaline injections,
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`Acta Pharm. Nord. 2(5) (“Fyllingen”), published in 1990
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`Ex. 1008: Vidal-Ollivier, E., Assay for epinephrine and its impurities using
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`reversed-phase high-performance liquid chromatography, Journal of
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`Chromatography (“Vidal”), published in 1987
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`Ex. 1009: Kerddonfak, S., The Stability and Sterility of Epinephrine Prefilled
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`Syringe, Asian Pacific Journal of Allergy and Immunology,
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`(“Kerddonfak”), published in 2010
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`
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`i
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`Ex. 1010: U.S. Patent No. 5,002,973 to Zeleznick et al. (“Zeleznick”)
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`Ex. 1011:
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`International Patent Publication No. WO 2014/127015 to Gupta et al.
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`(“Gupta”).
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`Ex. 1012: Connors, K.A., Chemical Stability of Pharmaceuticals: A Handbook
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`for Pharmacists, 2nd Edition (“Connors”), published in 1986
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`Ex. 1013:
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`2004 United States Pharmacopeia Monograph for Epinephrine (“2004
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`USP”)
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`Ex. 1014:
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`2014 United States Pharmacopeia Monograph for Epinephrine (“2009
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`USP” or “USP”)
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`Ex. 1015: 2014 United States Pharmacopeia Monograph for Epinephrine (“2014
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`USP”)
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`Ex. 1016: Szulczewski, D. et al., Analytical Profiles of Drug Substances, 7,
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`Epinephrine (“Szulczewski”), published in 1978
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`
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`Ex. 1017: Moed H.D. et al., Synthesis of beta-phenyl-ethylamine derivatives III
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`Bronchodilators. Rec. Trav. Chim. 74 (“Moed”), published in 1955
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`Ex. 1018:
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`IMS Product Information
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`Ex. 1019: Claim Construction Order
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`in Case No. 17-775-LPS, Belcher
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`Pharmaceuticals, LLC v. Hospira, Inc.
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`ii
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`Ex. 1020: Belcher Initial Infringement Contentions in Case No. 8:18-cv-02379-
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`WFJ-AAS,
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`Adamis
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`Pharmaceuticals
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`Corp.
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`v.
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`Belcher
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`Pharmaceuticals, LLC
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`Ex. 1021: U.S. Patent Application Publication No. 12/846,656 to MacKay
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`(“MacKay”)
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`Ex. 1022: Goodman, L.S., The Pharmacological Basis of Therapeutics, 5th
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`Edition, (“Goodman”) published in 1975
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`Ex. 1023: Belcher Expert Report
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`in Case No. 17-775-LPS, Belcher
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`Pharmaceuticals, LLC v. Hospira, Inc.
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`Ex. 1024: Order regarding supplemental claim construction in Case No. 17-775-
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`LPS, Belcher Pharmaceuticals, LLC v. Hospira, Inc.
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`Ex. 1025: Memorandum Opinion regarding supplemental claim construction in
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`Case No. 17-775-LPS, Belcher Pharmaceuticals, LLC v. Hospira, Inc.
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`iii
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`Pursuant to 37 C.F.R. §§ 42.8(a)(3) and 42.8(b)(2), Petitioner Adamis
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`Pharmaceuticals Corporation hereby updates its mandatory notice concerning
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`Related Matters.
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`On May 30, 2019, the district court in related case No. 17-775-LPS, issued a
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`supplemental claim construction Order construing the following terms from U.S.
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`Patent No. 9,283,197:
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`Claim Term
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`Court’s Construction
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`Refers to pH of final product
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`said liquid formulation having a pH
`between 2.8 and 3.3
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`[claim 6 of the ’197 Patent]
`compounded in an aqueous solution
`as 1.0 to 1.06 mg/mL l-epinephrine
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`[claim 6 of the ’197 Patent]
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`(Ex. 1024; see also Ex. 1025 at 2 and 4). On June 11, 2019, the District Court
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`Product-by-process limitation
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`unsealed the Memorandum Opinion regarding supplemental claim construction,
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`which is submitted as Exhibit 1025.
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`1
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`Respectfully submitted by
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`K&L Gates LLP,
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`/Jason A. Engel/
`Jason A. Engel
`Reg. No. 51,654
`Customer No. 24573
`Date: June 19, 2019
`K&L GATES LLP
`Jason.Engel.PTAB@klgates.com
`T: (312) 807-4236
`F: (312) 827-8145
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
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`
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`By:
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`2
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`Certification of Service Under 37 C.F.R. §42.6(e)(4)
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`A copy of this Updated Notice and supporting materials has been served on
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`the following correspondence address of record for the subject patent via Federal
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`Express Priority Overnight® on:
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`MICHAEL J. COLITZ, JR.
`640 Douglas Avenue
`Dunedin, FL 34698
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`By:
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`/Jason A. Engel/
`Jason A. Engel
`Reg. No. 51,654
`Customer No. 24573
`Date: June 19, 2019
`K&L GATES LLP
`Jason.Engel.PTAB@klgates.com
`T: (312) 807-4236
`F: (312) 827-8145
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
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