Paper No. __
`Filed: November 20, 2014
`
`
`Filed on behalf of: Senju Pharmaceutical Co., Ltd.
`By: M. Andrew Holtman, Ph.D.
`
`Jonathan R.K. Stroud
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Telephone: 202-408-4000
`Facsimile: 202-408-4400
`E-mail: andy.holtman@finnegan.com
`
` jonathan.stroud@finnegan.com
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`METRICS, INC., MAYNE PHARMA, and
`JOHNSON MATTHEY, INC.
`Petitioners
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`
`
`Case IPR2014-01041
`Patent 8,129,431
`
`
`Patent Owner’s Preliminary Response
`to the Petition for Inter Partes Review
`of U.S. Patent No. 8,129,431
`
`
`
`
`
`
`
`

`
`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`Table of Contents
`
`I.
`
`II.
`
`Introduction .................................................................................................................... 1
`
`The Board should deny institution as creating an unjust, inefficient, and
`dilatory conflict between the AIA and the Hatch-Waxman Act where a
`second ANDA filer files an identical IPR to subvert its forum of choice. .......... 4
`
`1.
`
`2.
`
`3.
`
`4.
`
`The Board’s authority ............................................................................................. 4
`
`The Hatch-Waxman Act’s objectives ...................................................................... 5
`
`Relevant concurrent proceedings ............................................................................... 7
`
`Denial of institution would avoid statutory, regulatory, and administrative
`conflict .................................................................................................................... 9
`
`III. The petition’s filing date should be vacated because Metrics did not
`identify all real parties-in-interest as required by 35 U.S.C. § 312(a)(2). ............. 14
`
`1.
`
`2.
`
`3.
`
`Coastal shared this petition’s contents—the references and arguments. ........ 15
`
`Coastal could have controlled Metrics’ involvement in this petition. ............. 18
`
`Prior decisions of the PTO support vacating the filing date in this
`proceeding. ................................................................................................. 19
`
`IV. Claim Construction ..................................................................................................... 20
`
`A. Overview of the ’431 patent. .......................................................................... 20
`
`B.
`
`C.
`
`Standard and procedure. ................................................................................. 22
`
`Claim terms addressed in the petition. ......................................................... 22
`
`1.
`
`2.
`
`3.
`
`“consisting essentially of” ........................................................................... 22
`
`“about” .................................................................................................... 23
`
`“ophthalmic” ............................................................................................ 24
`
`
`
`i
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`

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`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
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`
`The Board may decline institution on procedural grounds because the
`PTO already considered substantially the same references, grounds, and
`arguments. ..................................................................................................................... 25
`
`V.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Ogawa ...................................................................................................... 26
`
`Fu ............................................................................................................ 29
`
`Sallmann .................................................................................................. 32
`
`Other exhibits—EX1002 (Metrics’ “Hara”). ......................................... 34
`
`Other exhibits—Desai and Yasueda ........................................................ 36
`
`VI. The petition is not reasonably likely to prevail against the challenged
`claims. ............................................................................................................................ 37
`
`A. Metrics alleges two grounds for unpatentability and does not raise
`others with particularity under 35 U.S.C. § 312(a)(3). ................................ 38
`
`i.
`
`ii.
`
`iii.
`
`Metrics improperly relies on references not identified in the stated
`grounds of unpatentability pursuant to § 312(a)(3) and the Board’s
`rules, and then argues for a new ground of unpatentability not pleaded
`in accordance with the same statute and rules. ............................................ 38
`
`Sallmann in view of Ogawa is not presented with particularity, failing
`§312(a)(3). .............................................................................................. 41
`
`The petition fails to show with particularity a reasonable likelihood of
`prevailing on any claim of the ’431 patent.................................................. 42
`
`B.
`
`The petition contains multiple failures of proof for the dependent
`claims of the ’431 patent. ................................................................................ 43
`
`i.
`
`ii.
`
`The arguments for claims 3–6, 11–17, and 20–22 do not show with
`particularity a reasonable likelihood of prevailing. ...................................... 46
`
`Elements in claims 20–22 are not addressed and do not depend from
`any claim where those elements are addressed. ............................................. 49
`
`
`
`ii
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`

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`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
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`Elements in claims 16 and 17 are not addressed by Metrics in its
`alleged grounds. ......................................................................................... 50
`
`iii.
`
`iv. Metrics’ attempted reliance on Iron Grip Barbell in connection with
`claims 12–14’s specific tyloxapol concentrations does not show with
`particularity a reasonable likelihood it will prevail. .................................... 50
`
`v.
`
`vi.
`
`The petition does not show with particularity a reasonable likelihood
`that claims 2–6, 11–17, and 19–22 reciting a bromfenac sodium
`salt are obvious over Ogawa in view of Sallmann. ...................................... 51
`
`For dependent claims 3–6, 11–17, and 20–22’s concentrations of
`bromfenac or a bromfenac sodium salt, the petition does not show with
`particularity a reasonable likelihood that Metrics will prevail. .................... 53
`
`vii.
`
`The petition’s discussion of the pH values recited in claims 9 and 10
`does not show with particularity a reasonable likelihood it will prevail. ....... 56
`
`viii. The petition does not show the obviousness of adding claims 7–10,
`13, 14, and 16–18’s additional elements with particularity and
`shows no reasonable likelihood that Metrics will prevail. ............................ 57
`
`VII. Conclusion .................................................................................................................... 58
`
`
`
`iii
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`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`FEDERAL CASES
`
`AK Steel Corp. v. Sollac,
`344 F.3d 1234 (Fed. Cir. 2003) ........................................................................................ 21
`
`Andrx Pharm., Inc. v. Biovail Corp.,
`276 F.3d 1368 (Fed. Cir. 2002) .......................................................................................... 5
`
`Asahi Glass Co. v. Toledo Eng’g Co.,
`505 F. Supp. 2d 423 (N.D. Ohio 2007) .......................................................................... 15
`
`Chapman v. Casner,
`315 F. App’x 294 (Fed Cir. 2009) ................................................................................... 55
`
`Davol, Inc. v. Atrium Med. Corp.,
`2013 WL 3013343 (D. Del. June 17, 2013) ................................................................... 10
`
`DeSilva v. DiLeonardi,
`181 F.3d 865 (Fed. Cir. 1999) .......................................................................................... 37
`
`E.E.O.C. v. Univ. of Pa.,
`850 F.2d 969 (3d Cir. 1988), aff’d, 493 U.S. 182 (1990) ............................................... 12
`
`Eisai Co. v. Dr. Reddy’s Labs., Ltd.,
`533 F.3d 1353 (Fed. Cir. 2008) ........................................................................................ 40
`
`Eli Lilly & Co. v. Actavis Elizabeth LLC,
`435 F. App’x 917 (Fed. Cir. 2011) ........................................................................... 41, 54
`
`Fresenius USA, Inc. v. Baxter Int’l, Inc.,
`721 F.3d 1330 (Fed. Cir. 2013), cert. denied, 134 S. Ct. 2295 (2014) ............................ 11
`
`Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc.,
`655 F.3d 1291 (Fed. Cir. 2011) ........................................................................................ 46
`
`In re Herz,
`537 F.2d 549 (C.C.P.A. 1976) .......................................................................................... 21
`
`
`
`iv
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`Patent 8,129,431
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`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ........................................................................................ 50
`
`In re May,
`574 F.2d 1082 (C.C.P.A. 1978) ........................................................................................ 55
`
`Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings,
`370 F.3d 1354 (Fed. Cir. 2004), cert. granted, 546 U.S. 945 (2005),
`cert. dismissed, 548 U.S. 124 (2006) .............................................................................. passim
`
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) ........................................................................................ 40
`
`Pall Corp. v. Micron Separations, Inc.,
`66 F.3d 1211 (Fed. Cir. 1995) .......................................................................................... 22
`
`In re Patel,
`566 F. App’x 1005 (Fed. Cir. 2014) ................................................................................ 45
`
`Pension Fund of Eighth Dist. Elec. Pension Fund v. Wasatch Front Elec. & Const.,
`LLC, No. 2:09-CV-00632 (D. Utah June 8, 2012) ....................................................... 15
`
`Powell v. Gorham,
`No. 2:13-cv-00055 (N.D. Ala. June 14, 2013) ............................................................... 15
`
`In re Ruschig,
`343 F.2d 965 (C.C.P.A. 1965) .......................................................................................... 53
`
`Sanofi–Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) ........................................................................................ 56
`
`Taylor v. Sturgell,
`553 U.S. 880 (2008) ........................................................................................................... 14
`
`U.S. Fire Ins. Co. v. Goodyear Tire & Rubber Co.,
`920 F.2d 487 (8th 1990) .................................................................................................... 12
`
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011), cert. denied, 132 S. Ct. 1755 (2012) ...................... passim
`
`
`
`v
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`

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`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`
`ViiV Healthcare Co. v. Mylan Inc.,
`Civ. No. 1:12-cv-01065, Docket 59 (D. Del. filed Aug. 22, 2012) ............................ 10
`
`In re Wesslau,
`353 F.2d 238 (C.C.P.A. 1965) .......................................................................................... 41
`
`FEDERAL STATUTES
`
`U.S.C. § 247(c)(2)(A) ............................................................................................................... 11
`
`21 U.S.C. § 355(j)(2)(A) ............................................................................................................ 5
`
`21 U.S.C. § 355(j)(2)(A)(vii) ..................................................................................................... 6
`
`21 U.S.C. § 355(j)(5)(B)(iii) ....................................................................................................... 6
`
`21 U.S.C. § 355(j)(5)(B)(iv) ................................................................................................... 6, 7
`
`21 U.S.C. § 355(j)(5)(D) .......................................................................................................... 14
`
`35 U.S.C. § 103 ............................................................................................................ 23, 41, 52
`
`35 U.S.C. § 112 ......................................................................................................................... 10
`
`35 U.S.C. § 271(e)(1) ................................................................................................................. 5
`
`35 U.S.C. § 271(e)(2) ............................................................................................................. 6, 8
`
`35 U.S.C. § 312 .................................................................................................................. 40, 42
`
`35 U.S.C. § 312(a)(2) .......................................................................................................... 2, 13
`
`35 U.S.C. § 312(a)(3) ......................................................................................................... passim
`
`35 U.S.C. § 313 ........................................................................................................................... 1
`
`35 U.S.C. § 314(a) ................................................................................................... 4, 36, 37, 48
`
`35 U.S.C. § 315(a)(1) .......................................................................................................... 9, 11
`
`35 U.S.C. § 315(a)(2) ................................................................................................................. 9
`
`35 U.S.C. § 315(e) .................................................................................................................... 18
`
`
`
`vi
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`35 U.S.C. § 325(a) ...................................................................................................................... 9
`
`35 U.S.C. § 325(d) .............................................................................................................. passim
`
`FEDERAL STATUTES
`
`Leahy–Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284
`(2011). ............................................................................................................................ passim
`
`Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman
`Act”), Pub. L. No. 98-417, 98 Stat. 1585 (1984) ..................................................... passim
`
`REGULATIONS
`
`37 C.F.R. § 42.6(a)(3) .............................................................................................................. 48
`
`37 C.F.R. § 42.07 ....................................................................................................................... 1
`
`37 C.F.R. § 42.8 ........................................................................................................................ 18
`
`37 C.F.R. § 42.8(a)(1), (b)(1), (b)(2) ...................................................................................... 13
`
`37 C.F.R. § 42.22(a)(2) ............................................................................................................ 36
`
`37 C.F.R. § 42.63(b) ......................................................................................................... 32, 34
`
`37 C.F.R. § 42.100(b) ........................................................................................................ passim
`
`37 C.F.R. § 42.104 ............................................................................................................ 13, 18
`
`37 C.F.R. § 42.104(4) .............................................................................................................. 21
`
`37 C.F.R. § 42.104(b)(2) ............................................................................... 24, 32, 35, 37, 38
`
`37 C.F.R. § 42.104(b)(4) ......................................................................... 24, 32, 35, 42, 48, 49
`
`37 C.F.R. § 42.106 ................................................................................................................... 18
`
`37 C.F.R. § 42.106(a) ............................................................................................................... 13
`
`37 C.F.R. § 42.108(a) ................................................................................................................. 4
`
`
`
`vii
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`

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`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`
`Patent Office Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012) .......................................... 4, 14, 17, 18, 32, 33, 36
`
`PATENT AND TRADEMARK OFFICE CASES
`
`Athena Automation Ltd. v. Husky Injection Molding Sys. Ltd.,
`
`IPR2013-00290, Paper 45 (P.T.A.B. Oct. 23, 2014) .................................................... 52
`
`Conopco, Inc. d/b/a Unilever v. Procter & Gamble Co.,
`IPR2013-00509 (P.T.A.B. Aug. 14, 2013)...................................................................... 16
`
`In re Guan (“Trollbusters”), No. 95/001,045,
`Decision Vacating Filing Date (P.T.A.B. Aug. 25, 2008) ............................... 13, 14, 18
`
`Location Labs v. LocationNet Sys. Ltd.,
`IPR2014-00199, Paper 24 (P.T.A.B. June 11, 2014) .................................................... 16
`
`Monsanto Co. v. Pioneer Hi-Bred Int’l, Inc.,
`IPR2013-00022, Paper 43 (P.T.A.B. April 11, 2013) ................................................... 48
`
`Nat’l Envtl. Prods. Ltd. & N.E.P., Inc., d/b/a Neptronic v. Dri-Steem Corp.,
`IPR2014-01503 (P.T.A.B. Sept. 15, 2014) .............................................................. 16, 39
`
`Olympus Am. Inc. v. Perfect Surgical Techniques, Inc.,
` IPR2014-00241, Paper 24 (P.T.A.B. July 28, 2014) .................................................... 44
`
`Prism Pharma Co. v. Choongwae Pharma Corp.,
`IPR2014-00315, Paper 14 (P.T.A.B. Aug. 7, 2014) ...................................................... 23
`
`SAP Am., Inc. v. Versata Dev. Grp., Inc.,
`CBM2012-00001, Paper 70 (P.T.A.B. June 11, 2013) .................................................. 20
`
`Unilever, Inc. d/b/a Unilever v. Proctor & Gamble Co.,
`IPR2014-00506, Paper 17 (P.T.A.B. July 7, 2014) ................................................... 5, 23
`
`OTHER AUTHORITIES
`
`157 Cong. Rec. S5402 (daily ed. Sept. 8, 2011) ..................................................................... 6
`
`MPEP § 2111.03 (9th Rev. 2014) ......................................................................................... 21
`
`
`
`viii
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`Patent 8,129,431
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`
`
`TABLE OF FIGURES Pages(s)
`
`Figure 1: Chemical Structures, Compared ......................................................... 31
`
`Figure 2: Excerpt from EX1002, at 5 ................................................................. 35
`
`Figure 3: Two Grounds Presented, Graphically Represented .......................... 44
`
`
`
`
`
`ix
`
`

`
`I.
`
`Introduction
`
`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`Patent owner Senju Pharmaceutical Co., Ltd. (“Senju”),1 under 35 U.S.C. § 313
`
`and 37 C.F.R. § 42.07, responds to the petition for inter partes review (“IPR”) of
`
`U.S. Patent No. 8,129,431 (“the ’431 patent”) filed by Metrics, Inc., Mayne Pharma,
`
`and Johnson Matthey, Inc. (collectively “Metrics” or “Petitioner”). To avoid
`
`increased cost, inefficiency, and uncertainty, this petition should be denied for at least
`
`any of the following reasons.
`
`First, Metrics creates a statutory conflict between the America Invents Act
`
`(“AIA”) and the Hatch-Waxman Act with their admitted attempt to extract
`
`commercial settlement from Senju through IPR. Metrics, as a second Abbreviated
`
`New Drug Application (“ANDA”) filer behind Lupin Ltd. (“Lupin”), seeks to
`
`sidestep its own first-choice forum for handling patent challenges by generic
`
`manufacturers. Metrics invoked the Hatch-Waxman Act by initiating district court
`
`litigation through its Paragraph IV certification challenging the ’431 patent, which
`
`Coastal Pharmaceuticals, Inc. (“Coastal”) filed on Metrics’ behalf. Metrics now
`
`simultaneously seeks to invoke the AIA, using copied invalidity arguments—under a
`
`
`1 Senju Pharmaceutical Co., Ltd. owns U.S. Patent No. 8,129,431, which it
`
`licenses to Bausch & Lomb Pharma Holdings Corp., a subsidiary of Bausch & Lomb,
`
`Inc.
`
`
`
`1
`
`

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`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
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`different party name. This petition has already increased the cost, delay, and injustice
`
`to Senju and violates the PTAB’s organizing tenets of “just, speedy, and inexpensive”
`
`resolution. Because there will be no stay of the related district court litigation,
`
`institution here will unnecessarily trigger a race to the Federal Circuit on identical
`
`validity grounds, risking inconsistent judgments and wasted efforts. Using the
`
`discretion provided to it by Congress, the Board can, and should, decline to entertain
`
`Metrics’ gamesmanship.
`
`Second, the petition lacks a lawful filing date because Metrics failed to identify
`
`Coastal as a real-party-in-interest (“RPI”). 35 U.S.C. § 312(a)(2). Metrics’ arguments
`
`in the petition are copies of those in Coastal’s Paragraph IV Notice Letter, issued the
`
`same day by the same counsel on Metrics’ behalf. Metrics conceded in district court
`
`that Metrics and Coastal are in privity and that any judgment reaching one would
`
`reach the other. By failing to name Coastal, Metrics failed to meet its burden of
`
`identifying the RPI. The Board accordingly should revoke the petition’s filing date for
`
`violating § 312(a)(2).
`
`Third, the petition rehashes references and arguments already considered and
`
`rejected during prosecution. Two applied references—and two of three background
`
`references discussed in the petition—were cited, thoroughly discussed and overcome
`
`during prosecution of the ’431 patent family. The other two references, EX1002 (the
`
`
`
`2
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`

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`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
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`uncertified “Hara” translation) and U.S. Patent No. 6,107,343 to Sallmann, add
`
`nothing of substance. EX1002 has serious credibility, translation and authentication
`
`issues, and Sallmann is cumulative over art already addressed. This panel should not
`
`give Metrics another bite at the apple, particularly given that Metrics’ petition lacks
`
`basic elements of proof, as discussed below.
`
`Fourth, Metrics has not established a reasonable likelihood of prevailing as to
`
`any challenged claim. Metrics identifies two alleged grounds in its petition—(1)
`
`Ogawa in view of Sallmann and (2) Ogawa in view of Sallmann, and further in view of
`
`Fu. As a matter of law, Metrics’ petition is limited to review on those alleged grounds.
`
`Metrics’ petition does not meet the statutory particularity requirements for any claim
`
`of the ’431 patent. See 35 U.S.C. § 312(a)(3). The petition attempts to address claim
`
`elements piecemeal using background references not asserted in the grounds for its
`
`petition.
`
`Additionally, the petition misstates or ignores the claim language “consisting
`
`essentially of” and fails to establish that the unlisted ingredients identified in the cited
`
`references would not materially affect the basic and novel properties of the ’431
`
`patent’s claimed preparations. Metrics also suggests exchanging diclofenac potassium
`
`for bromfenac sodium and tyloxapol for polysorbate 80, despite that the prosecution
`
`history and Metrics’ own cited references teach squarely away from doing so. In fact,
`
`
`
`3
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`Patent 8,129,431
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`during prosecution, the Examiner found unequivocally that “the present inventors
`
`have found that tyloxapol and polysorbate 80 are not equivalent compounds. Such
`
`unequivalency, and such remarkable effects, could not have been obvious to one
`
`skilled in the art from the cited references.” Metrics ignores these statements and
`
`does not explain why a person of ordinary skill in the art would have been taught
`
`otherwise.
`
`For any of these independent reasons, Senju respectfully requests the Board
`
`not institute the requested IPR.
`
`II. The Board should deny institution as creating an unjust, inefficient, and
`dilatory conflict between the AIA and the Hatch-Waxman Act where a
`second ANDA filer files an identical IPR to subvert its forum of choice.
`
`Simultaneous pursuit by Metrics of identical validity challenges as a second
`
`ANDA filer under the Hatch-Waxman Act and under the AIA improperly forces the
`
`statutes into conflict under the circumstances here. Doing so will create conflict
`
`among the courts, the U.S. Food and Drug Administration (“FDA”), and the Board,
`
`and encourages misuse and abuse of post-grant procedures.
`
`1. The Board’s authority
`
`Under 35 U.S.C. § 314(a), the Director, and the PTAB acting as her
`
`representative, has full discretion to deny institution of an IPR. The statute states the
`
`circumstances in which the PTAB cannot institute an IPR but identifies no
`
`
`
`4
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`

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`Patent 8,129,431
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`circumstance in which an IPR must be initiated. See 37 C.F.R. § 42.108(a) (“[T]he
`
`Board may authorize the review to proceed . . . on all or some of the grounds of
`
`unpatentability asserted . . . .”); Patent Office Trial Practice Guide (“TPG”), 77 Fed.
`
`Reg. 48,756, 48,765 (Aug. 14, 2012) (the Board can “exercise its discretion to decline
`
`to institute a petition”). Under several provisions, the PTO has “broad discretion” to
`
`decline to institute review. See Unilever, Inc. dba Unilever v. Proctor & Gamble Co.,
`
`IPR2014-00506, Paper 17, at 6 (P.T.A.B. July 7, 2014) (informative) (denying
`
`institution via the Board’s § 325(d) discretion).
`
`2. The Hatch-Waxman Act’s objectives
`
`Thirty years ago, Congress enacted the Drug Price Competition and Patent
`
`Term Restoration Act, commonly known as the Hatch-Waxman Act. Pub. L. No.
`
`98-417, 98 Stat. 1585 (1984). With it, Congress sought a sensitive balance between
`
`protecting pharmaceutical patents and encouraging streamlined generic market entry
`
`to reduce healthcare costs. See Andrx Pharm., Inc. v. Biovail Corp., 276 F.3d 1368,
`
`1370-71 (Fed. Cir. 2002). Congress envisioned a mutually beneficial compromise
`
`between innovator pharmaceutical companies and generic drug manufacturers.
`
`Congress established the ANDA process, whereby generic manufacturers can obtain
`
`FDA approval of generic versions of the patent owner’s approved products by
`
`demonstrating that their generic drugs are “bioequivalent” to the patent owner’s
`
`
`
`5
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`Patent 8,129,431
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`approved products and relying on the patent owner’s clinical trial results. 21 U.S.C.
`
`§ 355(j)(2)(A). Generic manufacturers can also use a drug claimed in a patent to
`
`prepare an ANDA for a generic copy of the patented drug without liability for
`
`infringement. 35 U.S.C. § 271(e)(1). But those benefits come with a countervailing
`
`obligation relating to how any resulting patent dispute is to be resolved.
`
`Specifically, when a company seeks abbreviated FDA approval to market a
`
`generic drug before the patents covering those drugs expire, the Hatch-Waxman Act
`
`requires it to file a certification, in this case a Paragraph IV Certification, asserting that
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`each patent “is invalid or will not be infringed by the manufacture, use, or sale” of
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`their generic product. 21 U.S.C. § 355(j)(2)(A)(vii). This certification process is in lieu
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`of the traditional filing of a declaratory judgment action seeking a declaration of
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`invalidity or noninfringement, which the statute forbids until after the patentee is
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`given the right to sue in a federal district court. A suit by the patent owner provoked
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`by a certification results in a statutory 30-month stay of FDA approval so that the
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`district court may adjudicate the dispute. See 35 U.S.C. § 271(e)(2); 21 U.S.C.
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`§ 355(j)(5)(B)(iii). During the stay, the FDA cannot approve a second or later-filed
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`ANDA.
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`To incentivize filing under these provisions, the statute grants the first ANDA
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`filer a 180-day market exclusivity period if it prevails in district court litigation.
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`
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`6
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`

`
`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`21 U.S.C. § 355(j)(5)(B)(iv). Second and subsequent filers are blocked from receiving
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`FDA approval of an ANDA for at least 180 days after the first filer’s FDA approval.
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`Id. The Hatch-Waxman Act carefully balances the rights of the patent holder with the
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`need to encourage and streamline generic approval to bring generic drugs to market,
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`specifically identifying the federal district courts as the forum for resolving any
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`resulting patent dispute.
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`Congress did not intend the AIA to up-end that sensitive balance. See 157
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`Cong. Rec. S5402, S5405 (daily ed. Sept. 8, 2011) (statement of Senator Charles
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`Grassley) (in debating AIA provisions, finding that “Congress certainly should not
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`expect nor allow mistakes by the bureaucracy to up-end the rights and provisions
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`included in the Hatch-Waxman Act . . . .”). But when a second ANDA filer seeks to
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`circumvent the provisions it has invoked by threatening and initiating parallel
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`administrative proceedings to extort settlement on different terms, it puts both the
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`innovator patent owners’ and other generic manufacturers’ positions at risk. That
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`happened here.
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`3. Relevant concurrent proceedings
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`
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`Metrics filed Paragraph IV Certifications challenging the ’431 and ’290 patents
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`and provoked a Hatch-Waxman patent lawsuit. EX2001. Coastal’s Paragraph IV
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`Notice Letter raised the same grounds as Metrics’ IPR using verbatim language, and
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`
`
`7
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`

`
`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`Metrics’ Paragraph IV Certifications provoked the patent-validity litigation under the
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`Hatch-Waxman Act. Compare id. with Second Corrected Petition, IPR2014-01041,
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`Paper 9, at 1–50 (Aug. 20, 2014). At the time of Metrics’ Paragraph IV Certification,
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`the patent owner was already engaged in Hatch-Waxman Act litigation with the first
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`ANDA filer for Prolensa®. EX1017. Lupin—not Metrics—was the first ANDA
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`filer at the FDA for Prolensa®. 21 U.S.C. § 355(j)(5)(B)(iv); EX2019 (’431); EX2018
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`(’290). The statute thus mandates that Metrics and other second filers wait for 180
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`days after the first filer enters the market.
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`
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`Not content with the rights to which it was potentially entitled under the
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`Hatch-Waxman Act, Metrics threatened Senju in a March 13, 2014, letter, stating that
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`it had filed an ANDA for Prolensa® with a Paragraph IV certification and had
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`prepared, but not yet filed, an IPR petition against the claims in the ’431 patent.
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`EX2002. Metrics’ letter sought to extract a commercially favorable settlement from
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`Senju in return for not filing this petition. Id. In later non-confidential discussions,
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`Metrics confirmed its intent to seek early market entry—to become more than a
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`second ANDA filer—either with its own ANDA product or with an authorized
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`generic, in spite of the first filer’s statutory 180-day exclusivity period. EX2016, at 3–
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`4.
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`
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`8
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`

`
`IPR2014-01041
`Patent Owner’s Preliminary Response
`Patent 8,129,431
`
`On June 20, 2014, Senju sued Metrics for infringement under 35 U.S.C.
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`§ 271(e)(2) based on Metrics’ admission it had engaged in the ANDA filing with a
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`Paragraph IV Certification. EX2017. Metrics subsequently made good on its threat,
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`filing IPR petitions against both the ’431 and ’290 patents challenging validity on
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`grounds identical to those to be litigated in federal district court. See Second
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`Corrected Petitions, IPRs2014-01041, -01043, Paper 9. Notably, Metrics has not