`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ALEMBIC PHARMACEUTICALS LIMITED,
`Petitioner,
`
`
`
`v.
`
`
`
`UCB PHARMA GMBH,
`Patent Owner.
`
`
`
`Case IPR2016-01596
`Patent 6,858,650 B1
`
`
`
`PATENT OWNER MANDATORY NOTICE INFORMATION
`UNDER 37 C.F.R. § 42.8
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-01596
`Patent 6,858,650 B1
`A. Real Party in Interest
`UCB Pharma GmbH (“UCB”), formerly known as Schwarz Pharma AG and
`
`organized and existing under the laws of Germany, holds title to U.S. Patent No.
`
`6,858,650 (the “‘650 patent”) and is the real party-in-interest.
`
`B. Related Matters
`UCB and Pfizer Inc. (“Pfizer”), the exclusive licensee of the ‘650 patent,
`
`have sued Mylan Pharmaceuticals Inc. for infringement of the ‘650 patent in the
`
`following pending actions: Pfizer, Inc. and UCB Pharma GmbH v. Mylan
`
`Pharmaceuticals, Inc., No. 1:15-cv-00079-GMS (D. Del.) and Pfizer Inc. and UCB
`
`Pharma GmbH v. Mylan Pharmaceuticals Inc., Case No. 1:15-cv-00013-IMK
`
`(N.D.W.Va.).
`
`The following action also involved the ‘650 patent: Pfizer, Inc. and UCB
`
`Pharma GmbH v. Sandoz, Inc., et al., No. 1:13-cv-01110-GMS (D. Del.).
`
`Following trial before Judge Gregory Sleet in the District Court of Delaware in
`
`July 2015, judgment was entered that, inter alia, (1) the claims are not obvious
`
`under 35 U.S.C. § 103, (2) the claims are not anticipated under 35 U.S.C. § 102,
`
`and (3) the claims are not indefinite under 35 U.S.C. § 112. Defendants did not
`
`file a Notice of Appeal to the Federal Circuit. Defendants’ arguments at trial
`
`regarding obviousness included the assertion of, inter alia, Brynne (Petitioner’s
`
`Ex. 1007), Bundgaard (Petitioner’s Ex. 1012), Johansson (Petitioner’s Ex. 1005),
`
`
`
`
`2
`
`
`
`
`
`
`
`IPR2016-01596
`Patent 6,858,650 B1
`and the Detrol Label (Petitioner’s Ex. 1009). Defendants identified Postlind
`
`(Petitioner’s Ex. 1010) in the Pretrial Order as a prior art reference potentially
`
`relevant for obviousness.
`
`The Patent Trial and Appeal Board has instituted Inter Partes Review of
`
`Petitions filed by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited,
`
`which are listed in the table below, relating to either the ‘650 patent or four other
`
`patents related to the ‘650 patent (U.S. Patent Nos. 7,384,980; 7,855,230;
`
`7,985,772; and 8,338,478):
`
`Patent No. Petitioners
`
`Case No.
`
`IPR Filing Date Claims
`
`IPR2016-00510 January 28, 2016 1-5, 21-24
`
`IPR2016-00512 January 28, 2016 1-16
`
`IPR2016-00514 January 28, 2016 1-5
`
`6,858,650 Mylan
`Pharmaceuticals
`Inc. and Mylan
`Laboratories
`Limited
`7,384,980 Mylan
`Pharmaceuticals
`Inc. and Mylan
`Laboratories
`Limited
`
`7,855,230 Mylan
`Pharmaceuticals
`Inc. and Mylan
`Laboratories
`Limited
`
`
`
`
`
`3
`
`
`
`
`
`
`
`IPR2016-01596
`Patent 6,858,650 B1
`7,985,772 Mylan
`Pharmaceuticals
`Inc. and Mylan
`Laboratories
`Limited
`
`8,338,478 Mylan
`Pharmaceuticals
`Inc. and Mylan
`Laboratories
`Limited
`
`
`IPR2016-00517 January 28, 2016 1, 3, 4, 6-8
`
`IPR2016-00516 January 28, 2016 1-3, 5-8, 10-
`12
`
`Additionally, UCB understands that Torrent Pharmaceuticals Limited and
`
`Amerigen Pharmaceuticals Limited have each filed an Inter Partes Review
`
`Petition relating to the ‘650 patent, as well as Motions for Joinder of their petitions
`
`with IPR2016-00510:
`
`Patent No. Petitioner
`
`Case No.
`
`IPR Filing Date Claims
`
`6,858,650
`
`Torrent
`Pharmaceuticals
`Limited
`
`6,858,650 Amerigen
`Pharmaceuticals
`Limited
`
`
`
`IPR2016-01636 August 18, 2016 1-5, 21-24
`
`IPR2016-01665 August 22, 2016 1-5, 21-24
`
`C. Lead and Back-up Counsel
`Lead Counsel
`Jeffrey Oelke, Reg. No. 37,409
`White & Case LLP
`1155 Avenue of the Americas
`
`
`
`
`4
`
`
`
`
`
`
`
`IPR2016-01596
`Patent 6,858,650 B1
`New York, NY 10036
`(212) 819-8936
`joelke@whitecase.com
`
`
`
`Back-Up Counsel
`
`James Trainor, Reg. No. 52,297
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8580
`jtrainor@whitecase.com
`
`Robert Counihan, Reg. No. 61,382
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8255
`rcounihan@whitecase.com
`
`
`
`
`D. Service Information
`
`UCB may be served at its counsel, White & Case LLP, at the above-
`
`indicated email addresses.
`
`E. Patent Owner Preliminary Response
`
`Patent Owner reserves the right to file a preliminary response at a later date.
`
`
`
`
`5
`
`
`
`
`
`
`
`IPR2016-01596
`Patent 6,858,650 B1
`
`Date: September 9, 2016
`
`WHITE & CASE LLP
`
`/s/ Jeffrey J. Oelke (Electronically signed)
`Jeffrey J. Oelke, Reg. No. 37,409
`James S. Trainor, Jr., Reg. No. 52,297
`Robert Counihan, Reg. No. 61,382
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8200
`
`Attorneys for UCB Pharma GmbH
`
`
`
`
`
`
`
`
`6
`
`
`
`
`
`
`
`
`
`IPR2016-01596
`Patent 6,858,650 B1
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner
`
`Mandatory Notice Information Under 37 C.F.R. § 42.8 and the associated Power of
`
`Attorney document were served on September 9, 2016, by filing this document
`
`through the Patent Trial and Appeal Board End to End System as well as delivering
`
`a copy via electronic mail upon the following attorneys of record for the Petitioner:
`
`Manish K. Mehta
`Sheppard Mullin Richter & Hampton, LLP
`70 W. Madison St., 48th Floor
`Chicago, Illinois 60602
`(312) 499-6352
`mmehta@sheppardmullin.com
`
`Laura Burson
`Sheppard Mullin Richter & Hampton, LLP
`333 S. Hope St., 43rd Floor
`Los Angeles, California 90071
`(213) 617-5527
`lburson@sheppardmullin.com
`
`
`
`Respectfully submitted,
`
`/s/ Jeffrey J. Oelke (Electronically signed)
`Jeffrey J. Oelke
`Reg. No. 37,409
`Phone: (212) 819-8936
`
`
`
`Date: September 9, 2016
`
`
`
`
`
`7