Paper No. ___
`Date Filed: September 11, 2015
`
`JANSSEN’S EXHIBIT LIST AS OF SEPTEMBER 11, 2015
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`LUPIN LIMITED
`Petitioner
`
`v.
`
`JANSSEN SCIENCES IRELAND UC
`Patent Owner
`
`_______________________________
`
`CASE No. IPR2015-01030
`U.S. Patent No. 8,518,987 B2
`_______________________________
`
`
`
`
`
`
`
`
`Date Filed: September 11, 2015
`
`JANSSEN’S EXHIBIT LIST AS OF SEPTEMBER 11, 2015
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`LUPIN LIMITED
`Petitioner
`
`v.
`
`JANSSEN SCIENCES IRELAND UC
`Patent Owner
`
`_______________________________
`
`CASE No. IPR2015-01030
`U.S. Patent No. 8,518,987 B2
`_______________________________
`
`
`
`
`
`
`
`
`
`
`Janssen
`Exhibit No.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`Case IPR2015-01030
`Janssen’s Exhibit List as of September 1, 2015
`Pursuant to 37 C.F.R. § 42.63(e)
`
`
`Description
`
`Photographic image of outside of Lupin’s building in Baltimore,
`MD, accessed at http://articles.baltimoresun.com/2014-04-
`09/business/bal-lupin-name-marks-baltimore-expansion-
`20140408_1_lupin-pharmaceuticals-drug-company-drug-
`administration on July 17, 2015
`
`Lupin Annual Report 2015, accessed at
`http://lupinworld.com/pdf/15/Lupin_AR_2015-25-06-15.pdf
`
`2015 Annual Report – Lupin Pharmaceuticals, Inc., filed with the
`Commonwealth of Massachusetts on May 20, 2015
`
`“Application by Foreign Corporation for Authorization to
`Transact Business in Florida,” filed by Lupin Inc. with Florida
`Department of State, Division of Corporations on February 5,
`2014
`
`Florida Dept. of State Division of Corporations, “Detail by Entity
`Name” for Lupin Inc.
`
`LinkedIn Profile: Gary DePaolo, US Corporate Controller, Lupin
`Pharmaceuticals
`
`LinkedIn Profile: Bill Gileza, Finance Dept., Lupin
`Pharmaceuticals
`
`Lupin Pharmaceuticals, Inc., Pharmacy Times, July 14, 2014,
`accessed at http://www.pharmacytimes.com/publications/
`supplement/2014/Generic-Supplement-2014/Lupin-
`Pharmaceuticals-Inc on July 1, 2015
`
`Lupin Inc. to Expand Operations at Florida’s Coral Springs
`Corporate Park, Culrav.org, October 7, 2014, accessed at
`http://www.culrav.org/pr/lupin-inc-expand-operations-floridas-
`coral-springs-corporate-park.php on July 1, 2015
`
`
`
`
`
`
`Janssen
`Exhibit No.
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`Case IPR2015-01030
`Janssen’s Exhibit List as of September 1, 2015
`Pursuant to 37 C.F.R. § 42.63(e)
`
`
`Description
`
`Research-Oriented Pharmaceutical Firm Lupin Expands Coral
`Springs, Fl. Research Hub, Area Development, Oct. 6, 2014,
`accessed at http://www.areadevelopment.com/newsItems/10-6-
`2014/lupin-operations-expansion-coral-springs-
`florida782378.shtml on July 1, 2015
`
`Business Tax Details for Lupin Inc. in 2016, Broward County,
`Flordia, accessed at https://www.broward.county-
`taxes.com/public/business_tax/accounts/120853 on July 8, 2015
`
`Kenneth A. Connors, The Karl Fischer Titration of Water, DRUG
`DEV. AND INDUSTRIAL PHARM., 14(14), 1891-1903(1988)
`
`Dario Braga & Fabrizia Grepioni, Making crystals from crystals:
`a green route to crystal engineering and polymorphism, CHEM.
`COMMUN., 3635-3645 (2005)
`
`Job Posting for Principal Scientist, Formulations at Lupin, RDD
`Online, accessed at http://www.rddonline.com/resources/jobs
`/job.php?id=267 on July 8, 2015
`
`License Information for Lupin Inc. in Coral Springs, Florida,
`accessed at https://govnow.coralsprings.org/wps/portal/!ut/p
`/c5/dY7LCoMwFES_pV9wL2o1XaYGacS on July 8, 2015
`
`Joel Bernstein, Polymorphism-A Perspective, CRYSTAL GROWTH
`& DESIGN PERSPECTIVE, Vol. 11, 632-650 (2011)
`
`Erik De Clercq, New Developments in Anti-HIV Chemotherapy,
`CURRENT MED. CHEM. Vol. 8, No. 13, 1543-1572 (2001)
`
`Erik De Clercq, Review New Developments in Anti-HIV
`Chemotherapy, BIOCHIMICA ET BIIOPHYSICA ACTA, Vol. 1587,
`258-275 (2002)
`
`2019
`
`U.S. Patent No. 7,470,506
`
`2
`
`
`
`
`Janssen
`Exhibit No.
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`Case IPR2015-01030
`Janssen’s Exhibit List as of September 1, 2015
`Pursuant to 37 C.F.R. § 42.63(e)
`
`
`Description
`
`Michael J. Jozwiakowski, Alteration of the Solid State of the
`Drug Substance: Polymorphs, Solvates, and Amorphous Forms,
`WATER-INSOLUBLE DRUG FORMULATION, 525-568, (2000)
`
`Sudha R. Vippagunta et al., Crystalline Solids, ADVANCE DRUG
`DELIVERY REVIEWS, Vol. 48, 3-26 (2001)
`
`Joel Bernstein, Crystal growth, polymorphism and structure-
`property relationships in organic crystals, J. PHYS. D: APPL.
`PHYS. Vol. 26, B66-B76 (1993)
`
`U.S. Patent No. 7,056,942
`
`U.S. Patent No. 6,861,426
`
`Matthew L. Peterson et al., Iterative High-Throughput
`Polymorphism studies on Acetaminophen and an Experimentally
`Derived Structure for Form III, J. AM. CHEM. SOC. Vol. 124,
`10958-10959 (2002)
`Sherry L. Morissette et al., High Throughput Crystallization:
`Polymorphs, Salts, Co-crystals and Solvates of Pharmaceutical
`Solids, ADVANCED DRUG DELIVERY REVIEWS, Vol. 56, 275-300
`(2004)
`Ning Shan and Michael J. Zaworotko, Polymorphic Crystal
`Foms and Cocrystals in Drug Delivery (Crystal Engineering),
`BURGER’S MED. CHEM., DRUG DISCOVERY, AND DEV. 7th ed.,
`187-218 (2010)
`Deposition of Michael J. Zaworotko, in Janssen Prods. v. Lupin
`Ltd., No. 10-5954 (D.N.J.), October 11, 2013 (excerpts)
`Trial Transcripts in Janssen Prods. v. Lupin Ltd., No. 10-5954
`(D.N.J.), for March 18, 2014-April 2, 2014 (excerpts)
`U.S. Patent No. 8,158,607
`Basics of Karl Fischer Titration, accessed at
`http://www.sigmaaldrich.com/analytical-chromatography/
`
`3
`
`
`
`
`Janssen
`Exhibit No.
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`Case IPR2015-01030
`Janssen’s Exhibit List as of September 1, 2015
`Pursuant to 37 C.F.R. § 42.63(e)
`
`
`Description
`
`titration/hydranal/learning-center/theory.html on July 16, 2015
`U.S. Patent No. 5,585,397
`“2013: Product Specification Sheet VX-478 (Amprenavir),”
`Cellagen Technology
`Otsuka Pharmaceutical v. Lupin et al., No. 14-cv-07105-JBS-
`KMW (D.N.J.), Lupin’s Answer to Amended Complaint for
`Patent Infringement, Mar. 9, 2015, ECF No. 37
`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations, accessed at http://www.accessdata.
`fda.gov/scripts/cder/ob/default.cfm on July 15, 2015
`Sanofi et al. v. Lupin et al., No. 15-cv-00415-RGA (D. Del.),
`Complaint for Patent Infringement, May 21, 2015, ECF No. 1
`Warner Chilcott v. Lupin Atlantis et al., 14-cv-01827-RWT, (D.
`Md.), Complaint for Patent Infringement, June 6, 2014, ECF. No.
`1
`Lupin Atlantis Holdings SA Audited Accounts, 2014, accessed at
`http://www.lupinworld.com/pdf/14/subsidiaries/Lupin%20Atlant
`is%20(Standalone).pdf on July 16, 2015
`“The Lupin Story,” accessed at http://www.lupin.com/the-lupin-
`story.php on July 1, 2015
`WEBSTER’S THIRD NEW INTERNATIONAL DICTIONARY OF THE
`ENGLISH LANGUAGE UNABRIDGED (2002)
`AK Scientific, Inc., Fine & Specialty Chemicals in Catalog &
`Bulk, accessed at https://aksci.com/item_detail.php?cat=Z4214
`on July 15, 2015
`Hsien-Hsin Tung et al., Crystallization of Organic Compounds
`An Industrial Perspective (2009) (excerpts)
`Brian Moulton and Michael Zaworotko, From Molecules to
`Crystal Engineering: Supramolecular Isomerism and
`Polymorphism in Network Solids, CHEM. REVIEWS, Vol. 101, No.
`6, 1629-1658 (2001)
`Omathanu P. Perumal & Satheesh K. Podaralla, Role of
`Preformulation in Development of Solid Dosage Forms,
`PHARMACEUTICAL MANUFACTURING HANDBOOK: PRODUCTION
`
`4
`
`
`
`Case IPR2015-01030
`Janssen’s Exhibit List as of September 1, 2015
`Pursuant to 37 C.F.R. § 42.63(e)
`
`
`Description
`
`AND PROCESSES 933-975 (Shayne Cox Gad ed., 2008), John
`Wiley & Sons, Inc.
`Deposition of Garland Marshall in Janssen Prods. v. Lupin Ltd.,
`No. 10-5954 (D.N.J.), October 22, 2013 (excerpts)
`Robert J. Ouellette and J. David Rawn, Organic Chemistry:
`Structure, Mechanism, and Synthesis (2014) (excerpts)
`Waiver of the Service of Summons, Janssen Prods., L.P. et al. v.
`Lupin Ltd. et al., C.A. No. 14-1370 (D.N.J.), Docs. 6-7.
`September 1, 2015 Lupin Certificate on behalf of Ms. Rachita
`Naidu
`September 1, 2015 Lupin Certificate on behalf of Mr. Shirish
`Vishnupurikar
`Petitioner’s Power of Attorney dated December 10, 2014
`September 4, 2015 Deposition Transcript of Girij Pal Singh,
`Ph.D.
`Proposed Protective Order
`
`FDA website printout for ANDA 202073
`
`FDA website printout of Tentative Approvals for December 2014
`Lupin Pharmaceuticals, Inc., et al. v. Craig Richards, C. A. No.
`RDB-15-1281 (D. Md., July 2, 2015) – Memorandum Opinion
`
`
`Janssen
`Exhibit No.
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`
`
`
`
`Respectfully submitted,
`
`
`
`By: /Dianne B. Elderkin /
`Dianne B. Elderkin (Reg. No. 28,598)
`Barbara L. Mullin (Reg. No. 38,250)
`Ruben H. Munoz (Reg. No. 66,998)
`Irena Royzman (Reg. No. 73,354)
`Counsel for Patent Owner
`
`5
`
`Dated: September 11, 2015
`
`
`
`Case IPR2015-01030
`Janssen’s Exhibit List as of September 1, 2015
`Pursuant to 37 C.F.R. § 42.63(e)
`
`
`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that a copy of the foregoing
`
`
`
`JANSSEN’S EXHIBIT LIST AS OF SEPTEMBER 11, 2015 PURSUANT TO
`
`37 C.F.R. § 42.63(e) (along with Exhibits 2048 through 2055) were served upon
`
`counsel of record on September 11th, 2015 by filing this document through the
`
`Patent Review Processing System, as well as delivering a copy via email to
`
`counsel of record for the Petitioner as follows:
`
`
`Deanne M. Mazzochi
`dmazzochi@rmmslegal.com
`Tara M. Raghavan
`traghavan@rmmslegal.com
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`
`
`
`Dated: September 11, 2015
`
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`/s/ Dianne B. Elderkin
`Dianne B. Elderkin
`Registration No. 25,598
`Counsel for Patent Owner
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