UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________
`
`LUPIN LIMITED
`Petitioner,
`v.
`JANSSEN SCIENCES IRELAND UC
`Patent Owner.
`
`________________________________
`
`Case IPR2015-01030
`Patent 8,518,987 B2
`________________________________
`
`
`
`DECLARATION OF DR. GIRIJ PAL SINGH
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`Lupin Ex. 1093 (Page 1 of 6)
`
`
`________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________
`
`LUPIN LIMITED
`Petitioner,
`v.
`JANSSEN SCIENCES IRELAND UC
`Patent Owner.
`
`________________________________
`
`Case IPR2015-01030
`Patent 8,518,987 B2
`________________________________
`
`
`
`DECLARATION OF DR. GIRIJ PAL SINGH
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`Lupin Ex. 1093 (Page 1 of 6)
`
`
`
`
`
`I, Dr. Girij Pal Singh, declare as follows:
`
`1.
`
`I am the Senior Vice President of Research & Development – Generic
`
`Research for Lupin Limited (“Lupin Ltd.”).
`
`2.
`
`Lupin Ltd. is a corporation organized and existing under the laws of
`
`India, engaged in the business of, e.g., selling, distributing, and manufacturing
`
`drugs, including generic drugs.
`
`3.
`
`Lupin Ltd. is the parent company of many subsidiary companies,
`
`including Lupin Pharma, Lupin Inc., and Lupin Atlantis. As part of its business,
`
`Lupin Ltd. prepares and files Abbreviated New Drug Applications (“ANDAs”)
`
`with the U.S. Food and Drug Administration (“FDA”) directed to generic drug
`
`products.
`
`4.
`
`Lupin Ltd. solely prepared ANDA No. 202-073 (“Lupin Ltd.’s
`
`ANDA”), which is directed to Darunavir Tablets, 75 mg, 150 mg, 300 mg, 400 mg,
`
`600 mg, and 800 mg (“Lupin Ltd.’s ANDA Products”). Lupin Ltd. is the owner of
`
`all rights and title to Lupin Ltd.’s ANDA No. 202-073, originally filed with FDA
`
`in 2010. Lupin Ltd. paid all fees associated with filing ANDA No. 202-073. The
`
`individuals who prepared ANDA No. 202-073 are employed on behalf of Lupin
`
`Ltd. Counsel for Lupin Ltd. signed the Paragraph IV notice letter to Janssen
`
`Products, L.P. and Janssen R&D Ireland (collectively, “Janssen”) stating that
`
`Lupin Ltd. had filed an ANDA that included a Paragraph IV certification to U.S.
`
`
`
`1
`
`Lupin Ex. 1093 (Page 2 of 6)
`
`
`
`
`
`Patent No. 8,518,987 B2 (“the ‘987 patent”) and that Lupin Ltd.’s ANDA Products
`
`will not infringe the ‘987 patent and/or that the ‘987 patent is invalid. Lupin Ltd.
`
`maintains all decision making power with regards to Lupin Ltd.’s ANDA No. 202-
`
`073.
`
`5.
`
`Lupin Pharma is the U.S. agent for Lupin Ltd. in connection with
`
`FDA’s requirements that a U.S. agent be designated for any non-U.S. company’s
`
`ANDA filing. At the direction of Lupin Ltd., Lupin Pharma thus was the entity
`
`that filed ANDA No. 202-073 with FDA on behalf of Lupin Ltd. Lupin Pharma
`
`does not control or direct any decisions or communications regarding ANDA No.
`
`202-073, steps needed to secure FDA approval, or patent challenges based thereon.
`
`6.
`
`Janssen sued Lupin Ltd. and Lupin Pharma for infringement of, inter
`
`alia, the ‘987 patent as a result of Lupin Ltd.’s filing of ANDA No. 202-073.
`
`Lupin Ltd. is the sole party directing, controlling, and funding that litigation.
`
`Janssen has never sued Lupin Atlantis or Lupin Inc. with respect to Lupin Ltd.’s
`
`ANDA. Additionally, in a related litigation regarding the same Lupin Ltd. ANDA
`
`and a related patent, Janssen directed a notice of Rule 30(b)(6) deposition to Lupin
`
`Ltd. and Lupin Pharma, but not to Lupin Atlantis or Lupin Inc.
`
`7.
`
`Lupin Ltd. was also the sole party responsible for directing,
`
`controlling, and funding the preparation and filing of the petition for inter partes
`
`review of the ‘987 patent (the “instant Petition”). Lupin Ltd. was the only Lupin
`
`
`
`2
`
`Lupin Ex. 1093 (Page 3 of 6)
`
`
`
`
`
`entity that paid any filing or legal fees associated with the preparation of the instant
`
`Petition. None of the Lupin subsidiaries participated in the decision to file the
`
`instant Petition, nor did any co-author the instant Petition, nor exercise any control
`
`over the filing or content of the instant Petition, nor provide funding or other
`
`compensation for the preparation and filing of the instant Petition. At no point was
`
`the filing, content, or funding of the instant Petition discussed at any meeting of the
`
`Board for any of the Lupin subsidiaries. The individuals primarily responsible for
`
`the decision to file and the content of the instant Petition, Rachita Naidu and
`
`Shirish Vishnupurikar, are employed on behalf of Lupin Ltd. Rachita Naidu and
`
`Shirish Vishnupurikar are not employed by any of the Lupin subsidiaries.
`
`8.
`
`On behalf of Lupin Ltd., I signed the power of attorney associated
`
`with Lupin Ltd.’s instant Petition seeking inter partes review of the ‘987 patent.
`
`(See Paper 2).
`
`9.
`
`Lupin Ltd. has filed at least the following inter partes review petitions
`
`that are currently pending or instituted:
`
` IPR2015-00405
` IPR2015-01097
` IPR2015-01099
` IPR2015-01100
` IPR2015-01105
` IPR2015-01773
` IPR2015-01774
` IPR2015-01775
`
`
`
`
`
`3
`
`Lupin Ex. 1093 (Page 4 of 6)
`
`
`
`
`
`Lupin Atlantis and Lupin Inc. have not been named as real parties-in-interest in
`
`any of these petitions. Only Lupin Ltd. and Lupin Pharma have been named as
`
`real parties-in-interest in these petitions. The Board instituted review of IPR2015-
`
`00405 on July 9, 2015. See Lupin Ltd. v. Vertex Pharm. Inc., IPR2015-00405,
`
`Paper 13 (P.T.A.B. July 9, 2015).
`
`10. Neither Lupin Inc. nor Lupin Atlantis has any reason for or interest in
`
`seeking review of the ‘987 patent. Lupin Inc. and Lupin Atlantis are holding
`
`companies; they conduct no independent operations involving Lupin Ltd.’s ANDA
`
`Products accused by Janssen. Neither Lupin Inc. nor Lupin Atlantis has ever been
`
`accused of infringing the ‘987 patent, nor has either Lupin Inc. or Lupin Atlantis
`
`moved to intervene in the ongoing litigation, or sought a declaratory judgment of
`
`invalidity of any of the ‘987 patent in Federal district court.
`
`11.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and further that these statements were made with the
`
`knowledge that willful false statements and the like so made are punishable by fine
`
`or imprisonment, or both, under Section 1001 of Title 18 of the United States
`
`4
`
`
`
`Code.
`
`
`
`Lupin Ex. 1093 (Page 5 of 6)
`
`
`
`Dated: August 28, 2015
`
`Respectful
`
`sub itted,
`
` I
`» IV?)/V)/‘
`
`G.P. Singh
`
`.___s__:____)
`
`Senior Vice President, Research &
`Development — Generic Research
`LUPIN LIMITED
`
`Lupin Ex. 1093 (Page 6 of 6)
`
`Lupin Ex. 1093 (Page 6 of 6)
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