UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`Mylan Pharmaceuticals Inc.,
`Petitioner,
`
`v.
`
`Nissan Chemical Industries, Ltd.,
`Patent Owner
`________________
`
`
`
`U.S. Patent No. 5,856,336
`
`Issue Date: January 5, 1999
`
`Title: Quinoline Type Mevalonolactones
`
`________________
`
`Inter Partes Review No. IPR2015-01069
`
`
`
`NISSAN CHEMICAL INDUSTRIES, LTD.’S
`PRELIMINARY RESPONSE
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`

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`TABLE OF CONTENTS
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` PAGE
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`INTRODUCTION ...................................................................................................1
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`MYLAN FAILED TO IDENTIFY A REAL PARTY-IN-INTEREST ....................5
`
`A.
`
`B.
`
`C.
`
`Facts .............................................................................................................5
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`Applicable Legal Principles .........................................................................7
`
`Argument .....................................................................................................9
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`1. Mylan N.V. is a real party-in-interest ...............................................9
`
`2.
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`Correction of the real party-in-interest would be futile ................. 11
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`
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`I.
`
`II.
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`III.
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`THE PETITION FAILS ON THE MERITS ..........................................................12
`
`A.
`
`B.
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`C.
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`D.
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`E.
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`F.
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`G.
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`Relevant Aspects of the Prosecution History and Interference
`Proceedings ................................................................................................12
`
`Summary of the ‘336 Patent ......................................................................14
`
`Claim Construction ....................................................................................15
`
`Person of Ordinary Skill in the Art ............................................................16
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`Legal Standard for Institution of Inter Partes Review ..............................17
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`Vertical Redundancy ..................................................................................18
`
`Legal Principles Regarding Chemical Obviousness ..................................19
`
`H. Mylan Has Failed to Demonstrate a Reasonable Likelihood That
`the Challenged Claims are Invalid .............................................................21
`
`1.
`
`Ground 1: Obviousness ..................................................................21
`
`Ground 11, Claim 1 (Mylan’s 10-Reference
`Obviousness Argument) .....................................................21
`
`i.
`
`
`
`The Petition Both Misrepresents and
`Oversimplifies the State of the Art in Statin
`Research as of August 20, 1987 .............................22
`
`a.
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`i
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`

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`b.
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`c.
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`d.
`
`
`ii.
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`Mylan’s 6-Step Theory Is Based on
`Impermissible Hindsight ........................................25
`
`Ground 12, Claims 1 and 2 (Mylan’s 14-Reference
`Obviousness Argument) .....................................................47
`
`Ground 11+2, Claim 2 .........................................................51
`
`The Gortler Declaration Is Not Sufficiently Described
`in the Petition to Be Considered ........................................52
`
`e.
`
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`Secondary Considerations Already of Record and
`Known by Mylan Demonstrate Non-Obviousness ............53
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`2.
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`CONCLUSION ......................................................................................................57
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`Ground 2: Anticipation .................................................................55
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`IV.
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`
`
`ii
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`

`
`TABLE OF AUTHORITIES
`
`
`
`Cases
`
`
`
`PAGE
`
`Actavis Inc. v. Research Corp. Techs., Inc.,
`IPR2014-01126, Paper No. 22 (PTAB Jan. 9, 2015) ............................................... 57
`
`Akzo N.V. v. U.S. Int’l Trade Comm’n.,
`808 F.2d 1471 (Fed. Cir. 1986) ................................................................................ 29
`
`Allergan, Inc. v. Sandoz Inc.,
`818 F. Supp. 2d 974 (E.D. Tex. 2011) ...................................................................... 22
`
`Amazon.com, Inc. v. Appistry, Inc.,
`IPR2015-00480, Paper No. 18 (PTAB Jul. 13, 2015) ................................................ 7
`
`Apotex Inc. v. Merck Sharp & Dohme Corp.,
`IPR2015-00419, Paper No. 14 (PTAB Jun. 25, 2015) ....................................... 18, 20
`
`Apotex Inc. v. Wyeth LLC,
`IPR2014-00115, Paper No. 94 (PTAB Apr. 20, 2015) ............................................ 27
`
`Ariosa Diagnostics v. Verinata Health, Inc.,
`IPR 2013-00276, Paper No. 43 (PTAB Oct. 23, 2014) ........................................... 52
`
`Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,
`776 F.2d 281 (Fed. Cir. 1985) .................................................................................. 27
`
`Atlanta Gas Light Co. v. Bennett Regulator Guards Inc.,
`IPR2013-00453, Paper No. 88 (PTAB Jan. 6, 2015) ........................................... 8, 12
`
`Atofina v. Great Lakes Chem. Corp.,
`441 F.3d 991 (Fed. Cir. 2006) .................................................................................. 56
`
`Bayer AG v. Carlsbad Tech. Inc.,
`No. 01CV0867-B, 2002 U.S. Dist. LEXIS 27830 (S.D. Cal. Aug. 7, 2002) ..... 35, 44
`
`BioDelivery Sciences Int’l v. RB Pharm. Ltd.,
`IPR2014-00325, Paper No. 43 (PTAB June 30, 2015) ............................................ 38
`
`i
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`

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`
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`PAGE
`
`Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
`752 F.3d 967 (Fed. Cir. 2014) ................................................................ 32, 34, 35, 38
`
`Conopco, Inc. v. The Proctor & Gamble Company,
`IPR2013-00510, Paper No. 9 (PTAB Feb. 12, 2014) .............................................. 52
`
`Daiichi Sankyo Co. v. Matrix Labs, Ltd.,
`619 F.3d 1346 (Fed. Cir. 2010) ................................................................................ 20
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .......................................................................... 20, 51
`
`DeSilva v. DiLeonardi,
`181 F.3d 865 (Fed. Cir. 1999) .................................................................................. 53
`
`Eisai Co. Ltd. v. Dr. Reddy’s Labs. Ltd.,
`533 F.3d 1353 (Fed. Cir. 2008) ................................................................................ 42
`
`Eli Lilly & Co. v. Teva Pharm. USA, Inc.,
`No. 02-0512, 2004 U.S. Dist. LEXIS 14724 (S.D. Ind. Jul. 29, 2004) ................... 21
`
`Eli Lilly & Co. v. Zenith Goldline Pharm., Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) .......................................................................... 20, 57
`
`Endo Pharm. Inc. v. Mylan Pharm. Inc.,
`No. 11-cv-00717, 2014 U.S. Dist. LEXIS 10037 (D. Del. Jan. 28, 2014) .............. 57
`
`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996) ............................................................................ 14, 43
`
`Grain Processing Corp. v. Am. Maize-Prods. Co.,
`840 F.2d 902 (Fed. Cir. 1988) .................................................................................. 19
`
`Impax Labs., Inc. v. Aventis Pharm. Inc.,
`468 F.3d 1366 (Fed. Cir. 2006) .......................................................................... 18, 57
`
`In re Hedges,
`783 F.2d 1038 (Fed. Cir. 1986) ................................................................................ 19
`
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) ................................................................................ 21
`
`ii
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`

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`PAGE
`
`In re Petering,
`49 C.C.P.A. 993 (1962) ............................................................................................ 56
`
`In re Rosuvastatin Calcium Patent Litig. v. Aurobindo Pharma Ltd.,
`703 F.3d 511 (Fed. Cir. 2012) ................................................................ 38, 39, 45, 47
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) ............................................... 36
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00003, Paper No. 7 (PTAB Oct. 25, 2012) ............................................ 18
`
`Merck Sharp & Dohme Pharm. v. Teva Pharm. USA, Inc.,
`No. 07-1596, 2009 U.S. Dist. LEXIS 131869 (D.N.J. Aug. 19, 2009) ................... 29
`
`Mylan Pharm. Inc. v. Gilead Sciences, Inc.,
`IPR2014-00885, Paper No. 15 (PTAB Dec. 9, 2014) ........................................ 18, 19
`
`Mylan Pharm. Inc. v. Gilead Sciences, Inc.,
`IPR2014-00887, Paper No. 16 (PTAB Dec. 9, 2014) .............................................. 39
`
`Omron Oilfield & Marine, Inc. v. MD/Totco, a Division of Varco, L.P.,
`IPR2013-00265, Paper No. 11 (PTAB Oct. 31, 2013) ............................................. 53
`
`Orthopedic Equip. Co. v. United States,
`702 F.2d 1005 (Fed. Cir. 1983) ................................................................................ 19
`
`Otsuka Pharm. Co. v. Sandoz, Inc.,
`No. 3:07-cv-01000, 2010 U.S. Dist. LEXIS 121349 (D.N.J. Nov. 15, 2010) ......... 16
`
`Otsuka Pharm. Co., Ltd. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) .............................................................. 19, 20, 27, 35
`
`Pfizer Inc. v. Teva Pharm. USA Inc.,
`555 F. App’x 961 (Fed. Cir. 2014) ..................................................................... 33, 37
`
`Reflectix, Inc. v. Promethean Insulation Tech. LLC,
`IPR2015-00044, Paper No. 18 (PTAB Apr. 24, 2015) .............................. 8, 9, 11, 12
`
`RPX Corp. v. VirnetX Inc.,
`IPR2014-00171, Paper No. 57 (PTAB June 5, 2014) ................................................ 8
`
`iii
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`

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`PAGE
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) ................................................................................ 56
`
`Takeda Chem. Indus. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) .............................................................. 20, 30, 34, 39
`
`Takeda Chem. Indus. v. Mylan Labs., Inc.,
`417 F. Supp. 2d 341 (S.D.N.Y. 2006) ...................................................................... 26
`
`Torrent Pharm. Ltd. v. Merck Frosst Canada & Co.,
`IPR2014-00559, Paper No. 8 (PTAB Oct. 1, 2014) .................................... 17, 39, 57
`
`Yamanouchi Pharm. Co., Ltd. v. Danbury Pharmacal, Inc.,
`231 F.3d 1339 (Fed. Cir. 2000) ................................................................................ 26
`
`Zerto, Inc. v. EMC Corp.,
`IPR2014-01254, Paper No. 32 (PTAB Feb. 12, 2015) .............................................. 8
`
`ZOLL Lifecore Corp. v. Philips Elecs. N.A. Corp.,
`IPR2013-00606, Paper No. 13 (PTAB Mar. 20, 2014) ........................................ 9, 12
`
`Rules
`
`Fed. R. Civ. P. 7.1 ..................................................................................................... 11
`
`37 C.F.R. § 42.22 ..................................................................................................... 52
`
`37 C.F.R. § 42.106 ..................................................................................................... 9
`
`Statutes
`
`35 U.S.C. § 103 .................................................................................................. 16, 21
`
`35 U.S.C. § 312 ...................................................................................................... 1, 7
`
`35 U.S.C. § 314 ........................................................................................................ 17
`
`35 U.S.C. § 315 .................................................................................................... 9, 12
`
`iv
`
`

`
`
`
`Publications
`
`
`
`PAGE
`
`Rules of Practice for Trials Before the Patent Trial and Appeal Board and Judicial
`Review of Patent Trial and Appeal Board Decisions,
`77 Fed. Reg. 48,612 (Aug. 14, 2012)......................................................................... 9
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756 (Aug. 14, 2012) ................ 8
`
`Other Authorities
`
`2 Chisum on Patents § 5.04… ................................................................................. 22
`
`
`
`v
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`

`
`
`
`Exhibit No.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`Livalo 10-16-2013 package insert.
`
`Description
`
`Mylan Completes Acquisition of Abbott’s Non-U.S. Developed
`Markets Specialty and Branded Generics Business (Feb 27, 2015),
`available at http://www.mylan.com/news/press-
`releases/item?id=123282.
`Mylan to Acquire Abbott’s Non-U.S. Developed Markets Specialty
`and Branded Generics Business in An All-Stock Transaction (July
`14, 2014), available at
`http://newsroom.mylan.com/index.php?s=2429&ite=123238.
`Mylan Inc. Form 10-K (Annual Report), filed 03/02/15 for the
`Period Ending 12/31/14.
`Mylan N.V. Form 8-K (Current report filing), filed 06/19/15 for the
`Period Ending 06/19/15.
`Defendants’ Answer to Amended Complaint and Counterclaims,
`filed June 4, 2015 in Noven v. Mylan, C.A. No. 15-cv-69. USDC
`NDWVA.
`February 12, 2015 Mylan letter to Securities and Exchange
`Commission regarding inversion transaction.
`Mylan Corporate Governance, available at
`http://www.mylan.com/en/company/corporate-governance.
`
`Updated Mandatory Notices and Petitions filed by Mylan
`identifying Mylan N.V. as a real party-in-interest (various dates).
`
`Mylan N.V. and Mylan Inc. Joint Press Releases: Mylan Launches
`Generic Subutex® Sublingual Tablets (Mar 11, 2015), available at
`http://www.mylan.com/en/news/press-releases/item?id=123289;
`Mylan Launches Generic Antabuse® Tablets (Mar 11, 2015),
`available at
`http://news/com.mylan.com/index.php?s=22429&item=123288
`Mylan Launches First and Only Available Intermediate Dosage
`Strengths of Fentanyl Transdermal System 37.5, 62.5 and 87.5
`mcg/hr (Mar 11, 2015), available at
`http://news.com.mylan.com/index.php?s=2429&item=123287
`Mylan Press Releases: Mylan Confirms First-to-File Patent
`Challenge Relating to Nexavar® (Feb 09, 2015), available at
`
`i
`
`

`
`
`
`Exhibit No.
`
`Description
`
`http://www.mylan.com/news/press-releases/item?id=123278; Mylan
`Launches Generic Seasonale® Tablets (May 5, 2015), available at
`http://newsroom.mylan.com/index.php?s=2429&item=123309
`Mylan N.V. Form 10-Q (Quarterly Report), filed 5/08/15 for the
`Period Ending 03/31/15.
`Mylan Inc. Form 10-K (Annual Report), filed 02/28/13 for the
`Period Ending 12/31/12.
`Supplemental Rule 7.1 Disclosure Statements of Mylan Inc. and
`Mylan Pharmaceuticals Inc., filed 5/15/15 in Kowa v. Mylan, C.A.
`No. 14-cv-02647, USDC SDNY.
`Interference No. 102,648 Excerpt: USPTO Declaration of
`Interference.
`Interference No. 102,648 Excerpt: Picard Request for Entry of
`Adverse Judgment, dated April 6, 1992.
`U.S. Application Serial Number 233,752 File History Excerpt:
`December 19, 1990 Amendment.
`Interference No. 102,648 Excerpt: Fujikawa Motion to Add Counts,
`June 11, 1992.
`Interference No. 102,648 Excerpt: Kitahara Declaration – Patentably
`Distinct Subject Matter, June 1, 1992.
`Fujikawa v. Wattanasin, BPAI Final Decision, Interference 102,648,
`Paper No. 119 (1995).
`5,856,336 Patent File History Excerpt: September 24, 1998
`Interview Summary.
`Endo, A., and Hasumi, K., “HMG-CoA Reductase Inhibitors,”
`Natural Product Reports 10, 6 (1993): 541-550.
`Roth, B.D., “The Discovery and Development of Atorvastatin, A
`Potent Novel Hypolipidemic Agent,” Progress in Medicinal
`Chemistry 40 (2002): 1-22.
`Endo, A., “Compactin (ML-236B) and Related Compounds as
`Potential Cholesterol-Lowering Agents That Inhibit HMG-CoA
`Reductase,” Journal of Medicinal Chemistry 28, 4 (1985): 401-405.
`
`Hoffman, W. F., et al., “3-hydroxy-3-methylglutaryl-coenzyme A
`Reductase Inhibitors. 4. Side Chain Ester Derivatives of Mevinolin,”
`Journal of Medicinal Chemistry 29, 5 (1986): 849-852.
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`ii
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`

`
`
`
`Exhibit No.
`
`Description
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations (Simvastatin and Pravastatin), Food and
`Drug Administration Website, available at
`http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
`Kathawala, F. G., “HMG-CoA Reductase Inhibitors: An Exciting
`Development in the Treatment of Hyperlipoproteinemia,” Medicinal
`Research Reviews 11, 2 (1991): 121-146.
`Istvan, E.S., and Deisenhofer, J., “Structural Mechanism for Statin
`Inhibition of HMG-CoA Reductase,” Science 292, 5519 (2001):
`1160-1164.
`Kathawala, F. G., “Exciting Developments in the Area of HMG-
`CoA Reductase Inhibitors,” Trends in Medicinal Chemistry ’88 12
`(1989): 709-728.
`Roth, B.D., et al., “Inhibitors of Cholesterol Biosynthesis. 1. trans-
`6-(2-pyrrol-1-ylethyl)-4-hydroxypyran-2-ones, a Novel Series of
`HMG-CoA Reductase Inhibitors. 1. Effects of Structural
`Modifications at the 2- and 5-positions of the Pyrrole Nucleus,”
`Journal of Medicinal Chemistry 33, 1 (1990): 21-31.
`
`iii
`
`

`
`
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc.’s (“Mylan,” “MPI,” or “Petitioner”) Petition
`
`(“Pet.”) seeking inter partes review of U.S. Patent No. 5,856,336 (the “’336
`
`Patent”) should be denied.
`
`As a preliminary matter, MPI’s petition should be dismissed for failing to
`
`identify Mylan N.V. (“MNV”) as a real party-in-interest. See 35 U.S.C. §
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`312(a)(2) (providing that an IPR petition “may be considered only if . . . the
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`petition identifies all real parties-in-interest”) (emphasis added). Mylan N.V., the
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`parent of MPI and additional real party-in-interest Mylan Inc. (“MI”), was created
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`through an inversion transaction completed on February 27, 2015. Since that time,
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`Mylan N.V. has been identified as a real party-in-interest in fifteen (15) other
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`Patent Trial and Appeals Board (“PTAB”) proceedings involving MPI and/or MI.
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`Each of these fifteen other proceedings, like the proceeding at issue here, sought to
`
`invalidate an Orange Book listed patent. Mylan N.V. shares the same corporate
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`executive leadership and directors with MI, and MI has acknowledged to the SEC
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`that the legal risks relating to its ANDA filings and generic pharmaceutical practice
`
`also apply to Mylan N.V. On May 15, 2015, in related litigation involving the
`
`same ‘336 Patent at issue in this IPR proceeding in the U.S. District Court for the
`
`Southern District of New York, MPI and MI acknowledged that each is an
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`indirectly wholly-owned subsidiary of Mylan N.V. Mylan N.V., however, has not
`
`1
`
`

`
`
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`been identified as a real party-in-interest in the instant proceeding. Accordingly,
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`MPI’s petition should be dismissed.
`
`The Petition also has no substantive merit. The claims of the ‘336 Patent are
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`directed to a novel compound, pitavastatin calcium, and to a method for reducing
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`hyperlipidemia, hyperlipoproteinemia, or atherosclerosis by administering that
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`compound. Pitavastatin calcium is sold under the trademark Livalo® and has
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`enjoyed substantial commercial success.
`
`Prior to the invention claimed in the ‘336 Patent, no one had disclosed a
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`compound with pitavastatin calcium’s unique structure. The two claims of the
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`‘336 Patent issued after a years-long interference proceeding in which both the
`
`Board of Patent Appeals and Interferences and the Federal Circuit expressly found
`
`the incorporation of a cyclopropyl substituent on the quinoline core of the
`
`molecule to be non-obvious. Pitavastatin calcium – the active ingredient in
`
`Livalo® – remains the only statin ever approved by the FDA with a quinoline core,
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`as well as the only statin ever approved by the FDA with a cyclopropyl substituent:
`
`[Ex. 2001 (Livalo® Package Insert, Oct. 2013).]
`
`
`
`2
`
`

`
`
`
`Mylan’s obviousness challenge is remarkable in that it relies on a minimum
`
`of ten references to support an invalidity theory requiring at least six discrete
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`chemical “steps.”1 Mylan’s theory requires it to prove that a person of ordinary
`
`skill in the art would have: (1) identified a specific “pharmacophore” for HMG-
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`CoA reductase inhibitors despite the fact that no such “pharmacophore” had ever
`
`been disclosed in the art; (2) selected as a “lead compound” XU 62-320 (SRI 62-
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`320), a compound that conveniently fits Mylan’s fabricated “pharmacophore”; (3)
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`altered the indole ring “core” of XU 62-320 to make it into a quinoline ring; (4)
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`moved the isopropyl, 3,5-dihydroxy heptenoic acid, and 4’-fluorophenyl groups of
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`XU 62-320 from the 1-, 2- and 3- positions in XU 62-320 to the 2-, 3-, and 4-
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`positions of the new quinoline ring, respectively; (5) changed the isopropyl group
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`on the quinoline ring to a cyclopropyl group; and (6) modified pitavastatin to its
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`calcium salt.
`
`Mylan must prove that each of these six steps, standing alone, would have
`
`been obvious, and further, that it would have been obvious to combine all six steps
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`to yield the claimed invention. Mylan fails to meet its burden of proving the
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`obviousness of any of the six steps. For this reason alone the Petition should be
`
`
`1 Mylan also attacks the ‘336 priority date, in an effort to expand its list of
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`references to fourteen for purposes of its arguments based on a later priority date.
`
`Pet. at 4.
`
`3
`
`

`
`
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`rejected. When all six steps are considered together, Mylan’s argument strains
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`credulity. Indeed, Mylan’s expert, Roger Newton, Ph.D. (“Dr. Newton”),
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`demonstrates that there is only one reason – hindsight – that one skilled in the art
`
`would embark down such a convoluted path. See Ex. 1008 (“Newton Decl.”) at ¶
`
`136 (“Having made all of the above modifications, a POSA would have reasonably
`
`arrived at a compound purportedly claimed in Claim 1 of the ‘336 patent.”
`
`(emphasis added)); see also Pet. at 46.
`
`After devoting the bulk of its petition to obviousness arguments, Mylan
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`offers a two-page, conclusory anticipation argument that is based on a selective
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`reading of a prior art reference (Picard) that discloses many thousands of
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`compounds. Mylan’s anticipation argument selects only the disclosures which
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`Mylan contends lead toward the invention claimed in the ‘336 Patent, while
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`ignoring the “blazemarks” leading away from it. In sum, Mylan’s IPR invalidity
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`challenges, whether based on obviousness or anticipation, lack merit.
`
`II. MYLAN FAILED TO IDENTIFY A REAL PARTY-IN-INTEREST
`
`A. FACTS
`
`
`
`The Petition in this proceeding was filed on April 18, 2015, three days
`
`before the expiration of the one-year period following the date on which MPI and
`
`4
`
`

`
`
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`MI were served with a complaint alleging infringement of the ‘336 Patent.2 The
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`Petition identified two parties, MPI and MI, as real parties-in-interest, but made no
`
`mention of MNV.
`
`MNV is the ultimate parent of MPI and MI. MNV acquired MI, as well as
`
`certain assets of Abbott Laboratories (“Abbott”), as part of an inversion transaction
`
`completed on February 27, 2015. [Ex. 2002.] MI/MNV consummated the
`
`transaction to avoid the 35% corporate tax rate in the U.S. and lower its tax rate “to
`
`approximately 20-21% in the first full year, and to the high teens thereafter.” [Ex.
`
`2003 at 3.] As a result of the inversion transaction, MI and the assets acquired
`
`from Abbott “were reorganized under Mylan N.V.” [Ex. 2004 at 1 (Mylan, Inc.
`
`March 2, 2015 10K).] MI emerged from the transaction as a “wholly owned
`
`indirect subsidiary” of MNV. [Id. at 3.] MPI is likewise a wholly-owned
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`
`2 Mylan Inc. and Mylan Pharmaceuticals Inc. are defendants in related Hatch-
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`Waxman litigation involving Livalo®, in which Patent Owner Nissan Chemical
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`Industries, Ltd. (“NCI” or “Patent Owner”) is a named plaintiff and in which the
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`‘336 Patent is among the asserted patents. See Kowa Company, Ltd., et al. v.
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`Mylan Inc., et al., C.A. No. 14-cv-2647 (S.D.N.Y.) (the “Litigation”). The
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`Complaint in that action was served on both defendants on April 21, 2014.
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`Mylan’s one-year deadline specified by 35 U.S.C. § 315(b) thus ran at least as of
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`April 21, 2015.
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`5
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`subsidiary of MNV. [Id.] MNV is a Dutch company, registered in the Netherlands
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`with operational headquarters in Hatfield, Hertfordshire in the United Kingdom.
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`[Ex. 2005 at SEC numbered page 1.] MI is a Pennsylvania company having a
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`principal place of business in Canonsburg, Pennsylvania. [Ex. 2006 at 2.] MPI is
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`a West Virginia company headquartered in Morgantown, West Virginia. Id.
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`The lines between MNV, MI, and MPI with respect to the Mylan corporate
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`family’s shared pharmaceutical business are blurred. By way of example:
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`•
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`•
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`The executive officers and directors of MNV and MI are the
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`same [Ex. 2007 at 16], and MNV’s executive officers “carry out
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`the day-to-day conduct of Mylan N.V.’s worldwide business” at
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`the site of MI’s corporate headquarters in Canonsburg,
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`Pennsylvania. [Ex. 2008 at 1.]
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`Following the inversion transaction, MI represented in a 10-K
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`statement filed with the SEC that legal risks related to ANDA
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`filings and its generic pharmaceuticals practice – i.e., the part of
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`MI’s business involved in this proceeding – also apply to MNV.
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`[Ex. 2004 at SEC numbered pages 24, 32-33.]
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`MPI, MI and MNV have acknowledged their intertwined interests in at least
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`fifteen other IPR proceedings involving MPI and MI, where MNV was identified
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`as a real party-in-interest. See, e.g., IPR2014-00784, Paper No. 22 at 2; IPR2015-
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`6
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`
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`00131, Paper No. 14 at 2; IPR2015-00132, Paper No. 15 at 2; IPR2015-00140,
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`Paper No. 18 at 2; IPR2015-00141, Paper No. 16 at 2; IPR2015-00142, Paper No.
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`16 at 2; IPR2015-00143, Paper No. 16 at 2; IPR2015-00144, Paper No. 23 at 2;
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`IPR2015-00265, Paper No. 16 at 2; IPR2015-00268, Paper No. 16 at 2; IPR2015-
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`00503, Paper No. 8 at 2; IPR2015-00643, Paper No. 9 at 2, IPR2015-00644, Paper
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`No. 11 at 2; IPR2015-00830, Paper No. 1 at 2, and IPR2015-01340, Paper No. 3 at
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`16. [Consolidated for the convenience of the Board as Exhibit 2009.] The
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`identification of MNV as a real party-in-interest in all but one of these proceedings
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`occurred before the petition in this case was filed. [Id.] In addition, all of these
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`cases, like the case at hand, involved attempts to invalidate Orange Book listed
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`patents covering pharmaceutical drug products.
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`B. APPLICABLE LEGAL PRINCIPLES
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`An IPR petition “may be considered only if . . . the petition identifies all real
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`parties in interest.” 35 U.S.C. § 312(a)(2) (emphasis added); ZOLL Lifecore Corp.
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`v. Philips Elecs. N.A. Corp., IPR2013-00606, Paper No. 13 at 7, 11-12 (PTAB Mar.
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`20, 2014); see also Amazon.Com, Inc. v. Appistry, Inc., IPR2015-00480, Paper No.
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`18 at 6 (PTAB July 13, 2015) (dismissing petition as incomplete for failure to
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`name real party-in-interest); Reflectix, Inc. v. Promethean Insulation Techn. LLC,
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`IPR2015-00044, Paper No. 18 at 18 (PTAB Apr. 24, 2015); Atlanta Gas Light Co.
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`v. Bennett Regulator Guards Inc., IPR2013-00453, Paper No. 88 at 11 (PTAB Jan.
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`7
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`
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`6, 2015); RPX Corp. v. VirnetX Inc., IPR2014-00171, Paper No. 57 at 10 (PTAB
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`June 5, 2014). Determining whether a Petition identifies all real parties-in-interest
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`is a “threshold issue” on which Mylan bears the burden of persuasion. Reflectix,
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`IPR2015-00044, Paper No. 18 at 8. The determination of whether a non-party is a
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`real party-in-interest focuses on “the party’s relationship to the inter partes review
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`pending before the Board, and the degree of control the party can exert over the
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`proceeding.” Id. at 8-9. A non-party that does not actually control the proceeding
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`may nonetheless be a real party-in-interest if it is “capable of controlling” the
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`proceeding. Id. at 9-10; see also Office Patent Trial Practice Guide, 77 Fed. Reg.
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`48756, 48,759 (Aug. 14, 2012) (quoting Wright & Miller § 4451). An opportunity
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`to exercise control over IPR proceedings can be shown where the lines between
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`two corporate affiliates are blurred. Reflectix, IPR2015-00044, Paper No. 18 at 11
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`(“When the intertwined nature of two corporations demonstrates that ‘it is difficult
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`for both insiders and outsiders to determine precisely where one ends and the other
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`begins, there exists an actual measure of control or opportunity to control.’”)
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`(quoting Zerto, Inc. v. EMC Corp., IPR2014-01254, Paper No. 32 at 10-14 (PTAB
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`Feb. 12, 2015)); ZOLL, IPR2013-0606, at 10.
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`When a petition fails to identify all real parties-in-interest, it loses its
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`original filing date. See 37 C.F.R. § 42.106(b) (“Where a party files an incomplete
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`petition, no filing date will be accorded. . . .”); ZOLL, IPR2013-00606, Paper No.
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`8
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`13 at 11-12. While 37 C.F.R. § 42.106(b) allows for a correction within one month
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`from the notice of an incomplete petition, the petitioner remains subject to the one-
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`year bar under 35 U.S.C. § 315(b).
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`C. ARGUMENT
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`1. Mylan N.V. is a real party-in-interest.
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`MNV is a real party-in-interest with respect to this proceeding. It sits atop
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`the Mylan corporate hierarchy as the ultimate parent, giving it at least the
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`opportunity to control MPI and MI. See 77 Fed. Reg. at 48,612, 48,617 (Aug. 14,
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`2012) (“Factors for determining actual control or the opportunity to control include
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`existence of a financially controlling interest in the petitioner.”). MNV also
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`identifies ANDA applications previously filed by MI as its own. [Ex. 2010 at 1;
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`Ex. 2011 at 1, 3.] This shows that MNV has the actual control and/or the
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`opportunity to control necessary to make it a real party-in-interest. Reflectix,
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`IPR2015-00044, Paper No. 18 at 11-12.
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`MNV’s control is further reflected by the degree to which its business is
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`intertwined with the businesses of MI and MPI. MNV and MI share the same
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`directors and executive officers. [Ex. 2007 at 16.] MNV has access to MPI’s
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`accounts receivable. [Ex. 2012 at SEC numbered page 7.] MI, which is also
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`owned by MNV, has represented that its U.S. sales are derived principally through
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`the activities of MPI. [Ex. 2013 (MI 2013 10-K) at SEC numbered page 4.]
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`9
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`Moreover, despite having been in existence for only six months, MNV
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`reported on May 5, 2015 that it had “273 ANDAs pending FDA approval
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`representing $106.9 billion in annual sales.” [Ex. 2010 at 1.] Prior press releases
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`(and common sense) show that the ANDAs that MNV now claims as its own must
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`include the ANDAs previously filed by MI and/or MPI. [Ex. 2011 at 1 (Feb. 9,
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`2015 MI press release immediately prior to inversion transaction reporting 283
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`ANDAs); Ex. 2010 at 1 (Mar. 11, 2015 MNV-MI joint press release reporting 281
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`ANDAs).]
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`Still further reflecting their intertwined relationship, MNV has issued
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`multiple joint press releases with MI announcing the launch of generic products.
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`[Ex. 2010.] MI also stated that “[i]mmediately following the [inversion]
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`Transaction, Mylan’s [MI] business will continue to comprise the substantial
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`portion of New Mylan’s [MNV’s] business,” [Ex. 2007 at 8], and MI represented
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`to the SEC that following the inversion transaction MNV’s business would be
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`identical to the business MI would have operated had MI simply purchased the
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`Abbott assets. [Id. at 7.] Finally MI represented to the SEC in a 10K statement
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`that the legal risks associated with its ANDA filings and generic pharmaceutical
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`practice also apply to MNV. [Ex. 2004 at 24, 32-33.] At a minimum, it is not clear
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`where MNV ends and where MI or MPI begins. Cf. Reflectix, Case IPR2015-
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`00044, Paper No. 18 at 11-12.
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`10
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`Finally, and most tellingly, MNV has been identified as a real party-in-
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`interest in fifteen other IPR proceedings before the Board in which Mylan and/or
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`MI sought to invalidate an Orange Book listed pharmaceutical patent. [Ex. 2009.]3
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`This is exactly what the Mylan entities are trying to do here. In litigation related to
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`this proceeding, on May 15, 2015, MI and MPI filed supplemental disclosures
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`under Fed. R. Civ. P. 7.1 identifying themselves as indirectly wholly-owned
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`subsidiaries of MNV. [Ex. 2014 (MI and MPI Supplemental Rule 7.1
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`Disclosures).] To date, however, Mylan has not disclosed to the Board that MNV
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`is a real party-in-interest in connection with this proceeding.
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`2. Correction of the real party-in-interest would be futile.
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`Mylan cannot correct its petition to name MNV as a real party-in-interest
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`because at this point, the earliest filing date that could be accorded to the new
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`petition would not fall within the one-year