Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 1 of 24 PageID: 144
`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 1 of 24 PageID: 144
`
`IN THE UNITED SFAIWSS DISTRlCT COURT
`
`FOR TH E- INSTRIC’I‘ O F NEW JERSEY
`
`M F; If) AC PM A RM A ,, 1N{3 . and M Ii DA C
`
`(Bi-VS.” $1,, gSCHAI‘T FUR KLINISCEUE
`S P1321! A LPRAPAR/YH *1 M B} l 5
`
`Ir’laintifik,
`
`V" .
`
`ANTARES PliARi‘v'igh INC, LEO PHARMA AIS?
`and [,le PHARMA INC”
`
`Defendants.
`
`V‘V'VVVVV‘W"~_A"‘VV‘U\V‘
`
`No. 1:14—cv-01498~JBS~KMW
`
`Motion Date: August 4’ 2014
`
`MEMORANDUM 1N SUPPORT OF DEFENDAN'I‘S’
`
`MOTION TO STAY PENDING INTER PARTES REVIEW
`
`

`

`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 2 of 24 PageID: 145
`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 2 of 24 PageID: 145
`
`y‘i‘ABLE OF CONTEN’I‘S
`
`L
`
`ll .
`
`lM’R(i)l”)ti(f’i”l(")hl ............................................................................................................... 1
`
`11% ACK (3 Rtflj N1) ................................................................................................................. l
`
`A.
`
`B.
`
`C.
`
`if).
`
`:‘Xntarcg’ Accused Product and Modaoig Asgcrted Patent ........................................ l
`
`’llho Present Litigation .............................................................................................. 2
`
`infer Furies Review Procudmgs?
`
`Antama‘ lPR Petition Will likely Succeed In Cancelling the ’23l
`Patent Claims ........................................................................................................... 5
`
`I ll .
`
`AR GU MEN“? ....................................................................................................................... 6
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`All li‘aetors li‘avor 3 Stay .......................................................................................... 6
`
`The Early Stage of This Litigation Favors a Stay .................................................... 8
`
`A Stay Will Simplify the Issues and May Eliminate the Need for Trial ................. 9
`
`A Stay Will Not Unduly Prejudice Mcdac ............................................................ 13
`
`The Case Should Be Stayed While the PTAB Considers lnstituting
`Antares“ IPR Petition ............................................................................................. 15
`
`IV.
`
`CONCLUSION .................................................................................................................. 18
`
`

`

`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 3 of 24 PageID: 146
`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 3 of 24 PageID: 146
`
`"I'ABL E OF Al.§T1-.I(')RITI 19:51
`
`I’age(s)
`
`Federal Cases
`
`[Rm-31.4117 S‘km’ehfl/ lnnomzinm. 12.11.11 12. 2331;2an [In/dings, Inca,
`NC). 12~CV»1109(HMS)! 2014 W1. 1369721 (13. 1.361. Apr. 7, 2014) ............................... 13, 14
`
`Bram .S’mith. [123' ’13. RP] Inch/1.. Inca,
`Nu. 09416344 ("1111113115311 2010 WL 4444717 (13.19.11. Nov. 1,, 2010') .......................... 7,, 8, 9, 13
`
`Brit/mm $00111er Ltd. v. Juniper Networks; Inc: ,
`No. 13~C§\I’—0061 64111153, 2014 W1. 1677991 (ND. Cal. Apr. 28, 2014) ........................ 8., 10, 11
`
`(Edwin L: On Demand BOO/m; LLL‘,
`
`7N0. 12»~821~(3MS, 2013 11.8.0131. LEXIS 121449 (D. Del. Aug. 21, 2013) .......................... 14
`
`Derma 5676312665. Inc. v. 11»Iarizxktzrned 1,151.,
`No. 123388 (.1AP),2013 W116096459(1).N.J. July 18, 2013) .............................................. 16
`
`[Javiinalion Maternity Carp. v. Targef Corp,
`N0.C1V.A. 126680, 2014 WL 1202941 (13.13. Pa. Mar. 24, 2014) .................................. 14, 17
`
`341/211172, Inc. v. A C'Ti Carp,
`No. SA~12—CA~695, 2013 WL 6334372 (WI). 'l‘cx. Aug. 9, 2013) ................................. 12, 16
`
`El Du I’On! De anaurs (12 (30. v. MacDermid Printing Solmians LLC’,
`No. C1V.A. 10-3409 MLC, 2012 WL 2995182 (13.14.11.
`.1u1y 23, 2012) ............................ 14., 15
`
`Elhicon, Inc. v. Quigga
`849 F20 1422 (Fed. Cir. 1988) .................................................................................................. 7
`
`Evolutionary Intelligence. IJLC 1!. Apple. Inc,
`No. C 13~04201 WHA, 2014 WI, 93954 (N.D.Ca1.1an. 9,2014) .................................... 11, 13
`
`Evolutionmy Intelligence, LLC v. Facebook, Inc,
`
`Nos. C 13-4202, —4204 SI, 2014 WL 261837 (ND. Cal. Jan. 23, 2014) ................................. 17
`
`Hill-Rom SC?}"1’S.. Inc. v. Stalker Corp,
`N0. 1:11—CV—1120-1MS—DKL, 2012 WL 5878087 (SD. Ind. Nov. 20, 2012) ...................... 15
`
`[CI Uniqema, Inc. v. Kobo Prods” Inc.,
`No. 062943 (JAP), 2009 WL 4034829 (DNJ. NOV. 20, 2009) ...................................... 6. 7, 8
`
`Ignite USA LLC v. Pac. Marke/ Int 7, LLC,
`No. 14—0856, 2014 WL 2505166, 21109.1). 111. May 29, 2014) ............................................. 10
`
`ii
`
`

`

`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 4 of 24 PageID: 147
`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 4 of 24 PagelD: 147
`
`[12:11:51 71:71:12. 1165601142 hm v, 11$?Elergfzrcmics Inc,
`No. (3191511. 12949 1‘3; 2013, WI, 51130108 (_‘1_).N.J. Sept. 12. 2013) ......................................... 7
`
`1?. eliaggsz Zmz,
`1111607281 Patent? {70:313.
`N1), (3 12413385 813/1, 2013 WL 4609533 (ND. Cal. Aug. 28, 2013) .............................. 13. 16
`
`flipped: 1*. Fun! 11111111121” (.70.,
`6:07 1"".3d 1261 (Fed. (113?. 2012) ................................................................................................ 12
`
`(32:, v. 711111.?ameriwFin. 1.1/1? lm‘. Ca,
`Linmln Nat ‘/ 1115/11; In»:
`Ne. 1:08aC\f«135, 2009 “WI, 1108822 (ND. 1nd. Apr. 24, 2009) ............................................. 9
`
`Nesta ()1! (211/ v, [Ap’mum’i' Fuels, [1117,
`3‘10. CV 12-1744~(3MS,2013 WL 3353984 {1). Del. giuly 2, 2013) .................................... 8, 10
`
`(21111221. [1d, v. 1-“21165/2fin-2., incl,
`Nu. 104875 (PCS), 2012 W1, 1067901')(D.N.1. Mar. 29, 2012) ........................................ 9, 14
`
`./’../. (him/wrg (70.,
`'I‘eCI’2rm/agim, LLC' v.
`Pave/Ike? 21/1511)
`No. (3V 1245256111., 2014 WI; 1652633 (If). De]. Apr. 24. 2014) ......................................... 7
`
`POW?!“ Survey. LLC“ v. I’m/flier Utility Serviws, LLC,
`No. 2:13-«cv’05670 (1)141. June 4, 2014) ................................................................................ 16
`
`.S”i[1~*er}"eak 15:125., Inc,
`Riverbed Tech, [mz v.
`No. C 13*02980 11SW.2014 WL 1647399(N.D.Ca1. Mar. 14, 2014) .................. 10, 12, 13, 17
`
`Semicxmducz0r Energy Lab. Ca. Ltd. v. Chimei [I’IHOIZLXT Corp,
`No. SACV 12-21-.1S"1"J1:’RX, 2012 WL 7170593 (C1). Cal. Dec. 19,2012) ..................... 9, 17
`
`‘
`SMTSalm‘imzs, Inc. v. ExpaEven/ Supply LLC,
`No. 11~~-6225 (EZS)(C1,\V),2012 WL 3526830 (DNJ. Aug. 15, 2012) ................................... l3
`
`Sofhmre Rights Archive, LLC v. Facebook, Inc,
`
`Nos. 012—3970, -3971, ~3972 RMW, 2013 W115225522 (ND. Ca1. Sept. 17,
`2013) ........................................................................................................................................ 11
`
`Star Envirotech, Inc. v. Recfline Detectian, LLC,
`N0. SACV 1201861 JGB, 2013 WL 1716068 (CD. Ca1.Apr. 3,2013) ........................... 9,11
`
`Tierrmfisinn, Inc. v. Goagle. Inc,
`No. 11cv2170 DMS(BGS), 2012 WL 559993 (SD. Cal. Feb. 21,2012) ................................. 9
`
`Federal Statutes
`
`35 USC. §§ 301—19,etseq. ............................................................................................................ 3
`
`3511.8.C. § 307 ................................................................................................................................ 4
`
`iii
`
`

`

`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 5 of 24 PageID: 148
`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 5 of 24 PageID: 148
`
`WU‘sCfiLSHm) ........................................................................................................................... 3
`
`34115;,(34314 ................................................................................................................................ 3
`
`35mm §314(a) ........................................................................................................................... 4
`
`”S‘x‘ISSC §315121(-) ................................................................................................................. 411
`
`3311511 §31©{a)(11) ..................................................................................................................... 4
`
`35 11.53.13. § 318(211) ........................................................................................................................... 4
`
`Leahyfimith America 1nvents Act, Pub. L. No. 1 12-299 125 Stat. 284 (2011) ............................... 3
`
`Regulations
`
`37 CPR. § 42.107(b‘) ...................................................................................................................... 3
`
`77 Fed. Reg. 48.680 (Aug. 14, 2012) ........................................................................... 1, 3, 8, 11, 16
`
`Other Authorities
`
`(Taming Gilber! Inc. v. PFC Braadband, Inca?
`
`€~ Watch, Ina,
`Aaiobotix,‘ Carp. v.
`1PR2013~OO499, Paper 17 (P.'1‘.A.B. Apr. 9, 2014) ................................................................... 4
`
`iv
`
`

`

`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 6 of 24 PageID: 149
`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 6 of 24 PageID: 149
`
`I.
`
`iN’l“lifll3iiCTR???
`
`Dctbudauts Antsrss Pitai‘t‘i’tét, ins. (“Animus”), Loo Pitarma M53 (“loco Pharma"), and Leo
`
`Pharms inc. (“lists lino”) {alt solioctivsty “Auturcs‘i‘l rtqutst a stay oftbis litigation pcndiug
`
`rcsoiution tifa potition for tater purists rcvicw (“WE”) tiicd by Antares in the US, Patcrtt and
`
`’l‘rsdsmark {Bliss (“l’TCD”) on July ll 2.814? sacking cancellation, ofall claims ofasscrtod US!
`
`listsut No, 356642231 (“tho- 231 patcutfit
`
`lPtts arc a rolativcly now procedure created by
`
`Congrcss in 2013 as a *‘costct‘i‘cctivc alternative- to titigation.” 77 Fed. Reg. 4&680. A stay is
`
`appropritttc because: (l) this action is in the curly stages; {2) the IPR will simplify the issues to
`
`bc litigated in this action and may eliminate the need for atrial; ('3) any issucs litigated in this
`
`action bctbrc this ll’R is resolved may mood to ho rolitiga’tcd aftcr the il’R; and (4) Plaintiffs
`
`Medac Pharma, Ittc‘ and Mcdac Gcscllsohafi For Klittischc Spczialprétparatc MBH (all
`
`collectively “‘Mcdac”) will not suffer undue prejudice from a stay. Accordingly, this action
`
`should be stayed pending resolution of the lPR before any further litigation burden is placed on
`
`the Court or the parties.
`
`11.
`
`BACKGROUND
`
`A.
`
`Antares” Accused Product and Medac’s Assertcd Patent
`
`Antares is a small publically traded, Now Jersey based developer of automatic~injcctior1
`
`devices used to self—administer pharmaceuticals Over the past several years, Antares has made
`
`considerable cffotts to transition itself from a drug-delivery device manufacturer into a fully
`
`integrated pharmaceutical company These efforts led to Antares’ first FDA—approved product,
`
`Otrcxup I M (methotrexatc) injection for subcutaneous use. Otrcxup is the first product approved
`
`by the FDA for the subcutaneous administration ofmethotrcxatc to treat rheumatoid arthritis
`
`(RA), polyarticular juvenile idiopathic arthritis (leA), and psoriasis.
`
`(EX. 1, OtrcxupTM label.)
`
`Otrexup was approved by the FDA in October 2014, and Antares began selling it in February
`
`

`

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`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 7 of 24 PagelD: 150
`
`2t’il4i
`
`I‘Dct‘ct‘idant Leo l’l‘iarma inc is the 101.8. subsidiary of Defendant lieu Pharma A/S, a
`
`leading; global pluu‘macc:uticai company specializing in dermatology and headquartered in
`
`iknmarlc in November 2011 Antares entered into an exclusive LLS. promotion and marketing
`
`agreement for ()trcxup for the treatment of psoriasis. (Ex. 29 Nov. i4, 2013, Antares Press
`
`Release.)
`
`l’iaintit’t‘Medan l’harma, inn. is a newly formed US. subsidiary ofthc German
`
`pharmaceutical company mcdac Gmbli. Medan has applied for FDA approval to sell a
`
`subcutaneously injected methotrcxatc product in the United States, but does not yet have a
`
`competing product on thc market. (Ex. ’3, clan. 27. 2014, Medac Press Release.) Medac’s ”231
`
`patent, titled “(.f‘oncentratcd h/tcthotrcxatc Solutions“ issued on March 4, 2014, and Medac
`
`brought this suit three days later.
`
`Mcdac‘s “231 patent describes a method oftrcating inflammatory autoimmune diseases,
`
`including RA and psoriasis. by subcutaneously administering a “concentrated" solution of
`
`methotrexate (“lVlTX‘”). "l‘he prior art described methods of treating RA and psoriasis by
`
`subcutaneously administering solutions of M'I‘Xt as the 5231 patent acknowledges. (Ex. 4, ’231
`
`Patent at 23486; 2:41-42) The alleged improvement in the ’231 patent is the use of more
`
`concentrated MTX solutions, and the ‘231 patent claims all concentrations greater than 30
`
`mg/ml.
`
`Id. at 1 21-10. As outlined in Antarcs’ lPR petition, however, this alleged “improvement”
`
`is trivial, and the claims in the ‘231 patent are unpatentable because the subject matter claimed is
`
`disclosed in, or obvious in view of, the prior art.
`
`(Ex. 5, July 1, 2014, Petition for IPR of ’23]
`
`Patent (IPR2014—01091) at 12-14.)
`
`B.
`
`The Present Litigation
`
`Mcdac filed its complaint on March 7, 2014. Defendants Antares and Leo Pharma lnc.
`
`answered on May 7 and Defendant Leo Pharma A/S answered on May 14, 2014. (Dis 19 and
`
`

`

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`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 8 of 24 PagelD: 151
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`21.) Magistrate Judgc ‘is’r'iliiams hold a scheduling conicrcncc on Juno l2, QOI 4i schoduling dates
`
`up to Now-inbcr 23; EDI 5? tor the liling ofdispositiva motions.
`
`in particular, over the next six
`
`months thc panics will begin tact discovery, exchange infringement: and invalidity contcntionsa
`
`proposed, claim constructions and supporting cvidcncc. filo opcning Mar/(man briefs, and
`
`complctc cxpcrt claim construction discovery.
`
`(13.1. 27 at 13:.) ’lhc Court did not set atrial data
`
`'l‘hus far, thc only discovery to have: taken place is tho .lunc 26 tiling ol’thc partics’ Initial
`
`I'Disclosurcs and Mcdac’s intringcmcnt Contentions;
`
`(I.
`
`InterParres Review Proceedings
`
`[mar Furies Rcricw is an administrative procccding conducted by the PTO to evaluate
`
`the validity and scope of an existing patent. See 35 U .S.C. §§ 30149, at seq.
`
`It was created by
`
`the Icahy—Smith America lnvcnts Act (“AIA”), Pub. L. No. I 12-29, 125 Stat. 284 (2011), as a
`
`less costly alternative to invalidity challenges in district courts. See Changes to Implement Inter
`
`Porter Review Proceedings, Post—Grant Review Proceedings, and Transitional Program for
`
`Covered Business Method Patents, Final Rule (“‘USPTO Inter Porter Review Implementation”),
`
`77 ch. Reg. 48,680 (Aug. l4, 2012) (AIA allows the PTO to “cngagefl in a transparent process
`
`to create a timely, costvci‘t‘cctivc alternative to litigation”) (emphasis added); see also id. at
`
`48,72l (“[l]t is anticipated that the [IPR] rules will minimize duplication of efforts”).
`
`The IPR process is straightforward, and its timelinc is statutorily mandated. IPR
`
`petitioners may request that the PTO canccl one or more claims of a patent based on prior art in
`
`the form of patents or printed publications. 35 U.S.C § 3 l l(b). The patent owner may file an
`
`optional prcliminary response within three months ol’thc petition: and the PTAB must then
`
`decide whether to institute trial within the following three months, creating a short, six-month
`
`time period from the filing date of the IPR petition to the PTAB’S decision on institution. 35
`
`U.S.C. §§ 313-14; 37 CPR. § 42.107(b). For an IPR to be instituted, the petition needs to show
`
`

`

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`Case 1:14-cv-01498-JBS-KMW Document 28-1 Filed 07/11/14 Page 9 of 24 PagelD: 152
`
`a ”reasonable likelil’inod that the petitioner lwill) prevail with respect, to at least i otithe claims
`
`challenged in the petition.” 313 USC. § 314(a).
`
`tflénce an lPl‘i is instituted the PTO is statutorily required to issue its final written decision
`
`as to the pater’ttability ol’the challenged claims within one year, absent a showing at good cause.
`
`35 t‘»( §§ Blots/X1 1), 3 1 Sta). Where good cause is shown the proceeding can be extended
`
`but only by a l’TlttKilI‘tttl‘tl titan additional six months. See 35 1.38.0 § 316(at)(l I). To date,
`
`however. the ITIAB does not appear to have granted any such extensions. See, tag, Coming
`
`Gilbert [as V, PFC Broadband, Inca, ‘lP'lQOlB’OOE-élf’i. Paper 16 (P.'l‘.A.B. Dec. 23, 2013) (“the
`
`“up to six months" extension .
`
`.
`
`. has a high, bar, and likely would not apply if the situation can be
`
`resolved reasonably in another way”) (Ex. 6); Mobolix (for-p. v. all/arch, Inca, lPRZOl3-OO499,
`
`Paper l7 (P.'l"‘./\.B. Apr. 9., 2014) (denying extension) (Ex. 7). Thus, absent unusual
`
`circumstances, the ll’R process will be completed within eighteen months of the petition tiling
`
`date.
`
`When the lPR process is complete: the PTAB will issue an order that either affirms the
`
`validity ol‘ the patent, cancels the patent, or modifies the patent. 35 U.S.C. § 307. Once the PTO
`
`issues a final written decision, the petitioner will be estopped from asserting in litigation any
`
`invalidity ground that was raised or reasonably could have been raised in the IPR. See 35 U.S.C.
`
`§ 315(c)(2). Thus, if the patent survives the IPR process, the petitioner will be estopped in the
`
`district court litigation From asserting invalidity based on any patents or written publications.
`
`Eighty percent of IPR petitions have been granted.
`
`(Ex. 8: PTAB AlA Progress Statistics
`
`at AlA Trials instituted/Disposals, dated July 2, 2014, also available at http:./’/'wvvw.uspto.gov/
`
`ip/boards/bpai/stats/aiaflstatistics~07¢02w20l4.pdf (last accessed July 9, 2014).) As of July 2,
`
`2014, the PTAB had issued decisions on 74l petitions seeking lPR review and had granted 590
`
`

`

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`
`of” those petitions.
`
`1:1, And since the IPR process was institutem the Pit) has cancelled over
`
`633%} ol‘thc claims reviewed in final written decisitans,I
`
`I).
`
`Antares3 II’R Petition Will Likely Succeed l n Cancelling the ’231
`Patent Claims
`
`Antares tiled its 113R with the PTO seeking cancellation of all claims of the “231 patent on
`
`July l, 2014, less than four months alter Medac tiled its complaint.
`
`(13x. :3.) Accordingly, the
`
`NAB must issue its decision instituting Antares” lCPR request no later than January 2, 2015.
`
`Antares" petition asserts eight grounds for cancellation of the claims based on eight highly»
`
`relevant. prionart references. Notably, among the eight references relied uporn five were not
`
`considered by the PTO in the original prosecution of the ’231 patent.
`
`As described in Antares‘ lPR petition, one prior art reference, Grint (US. Pat. No.
`
`5,644,504), anticipates claims 0 l‘ the ’231 patent because it discloses the use of subcutaneous
`
`M'l‘X, at concentrations of" more than 30 rug/ml as claimed in the ”231 patent, to treat
`
`inflammatory autoimmune diseases.
`
`(EX. 5 at l5~18.) Other references, such as the PDRfor
`
`Attention; disclose injectable MTX solutions in concentrations greater than 30 mg/ml
`
`(concentrations ranging from 2 mg/ml all the way to 125 mg/ml) for the treatment of psoriasis,
`
`an inflammatory autoimmune disease. 1d. at 28—30.
`
`'1he PDRfor il/Iexaret‘jls discloses
`
`intramuscular injections, not subcutaneous injections, but other prior art, such as Brooks, taught
`
`that the intramuscular and subcutaneous injection ol‘MTX are “interchangeable” and that
`
`subcutaneous administration “may be a more convenient and less painful way” to inject MTX.
`
`Id. at 31-32. Thus, a skilled artisan would have been motivated to administer the highly
`
`concentrated MTX solutions disclosed in the PDber iliexate® subcutaneously to increase
`
`convenience and decrease pain. Id. at 33-34. Additionally, prior art references such as Hoekstm
`
`
`1 Based on internal analysis of all published PTAB decisions as of July 2, 2014.
`
`U1
`
`

`

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`
`disclose the use oi‘high doses of M’IK (up to 40 mg) administered subcutaneously lor the
`
`treatment of RA.
`
`id. at 43. Administering up to 40 mg of MTK subcutaneously would have
`
`required injecting; a patient with a volume of solution greater than 1 ml.
`
`[(1, at 45. The prior art”
`
`such (:15t/{Wgttfli'tjft recognized however, that the pain associated with subcutaneous injectirms
`
`was directly reiated to the volume ofsoiution injected into a patient.
`
`Id. at 44. Thus: .fnrgmsgn
`
`taught that subcutaneous injections should be administered in volumes of less than 1.0 ml.
`
`Id.
`
`Accordingly, a skilled artisan would be motivated to “concentrate” the MTX solution disclosed
`
`in Hockrtrrrz such that l ml or less of solution could be subcutaneously administered to a patient
`
`in order to reduce pain.
`
`Id. at 45—46.
`
`In fact, Medac‘s own clinical studies with highly
`
`concentrated MIX solutions confirmed the teaching; of .lmgensen in that patients pret‘eircd the
`
`highly concentrated solution because ot"‘a smaller volume of administered drug, which improves
`
`the comfort ot’injection and may represent a psy'clioltiigical benefit to the patient.” Id. at 58.
`
`Given the trivial nature ofthc ‘23] patenti the hi ghly material prior art cited in Antares”
`
`[PR petition, and the statistics showing, that 80% til"ll’R petitions have been instituted and over
`
`65% ol‘ the claims reviewed in lPRs have been cancelled, it is very likely that Antares” IPR will
`
`be instituted and mosh if not all, of the claims of the ”231 patent will be cancelled or modified.
`
`indeed, in the European Patent Office, Medac conceded that its broader claims in the ’231 patent
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`are not patent-able and has narrowed its patent to a single M'l‘X concentration 50 mg/ml. (Ex. 9,
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`EP Pat. No. 2046332 at claim I.) Notably, Antares is also challenging the validity of the
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`narrower EPO patent.
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`Ill.
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`ARGUMENT
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`A.
`
`All Factors Favor 21 Stay
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`A district court has the discretion to stay judicial proceedings pending PTO review ol‘a
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`patent. See 1C1 Uniqema, Inc. v. K0170 Prods, Inc, No. 06—2943 (JAP), 2009 WL 4034829, at
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`

`

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`*1 (rims. Nov. 2th 2009). "the 1’cdcral Circuit has also rccognizcd the inherent: power oithc
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`trial court “to managc litsl docked ] and stay proceedings, including the authority to order a stay
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`{bonding conclusion oft: 1’11) rccxamination.” Ethicon, Inc.
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`1}. Quinn, 849 19.2d 1422, 1426-47
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`(Pod (Tit: 1988) (citation omitted).
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`Prior to tho A11)“ patents could be rcvicwcd by the P10 in a rccxamination proceeding.
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`in analyzing stays in that contcxt, the District of New Jersey has a history of favoring stays.
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`“it‘tlthough cvcry casc is fact specificl almost cvcry rcportcd New lcrscy District Court opinion
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`that has considered the issuc has granted a stay where a reexamination rcqucst was pending."
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`Brass Smith, LLC v. RP] Intros, Inc, No. 09416344 (NIH/.153), 2010 WI; 4444717, at *6 (D.N.J.
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`Nov. 3, 2010) (staying casc although PTO had not yet instituted one reexamination request); see
`
`also Indus. Tech. Research Inst. 1?. LG Electronics Inc, No. CIVA. 12-949 ES, 2013 WL
`
`51 801021 at *3 (DNJ. Sept. 12, 2013) (“Courts in this District have observed that granting a
`
`reexamination stay is favored and commonplace”); [CI Uniqema, 2009 WL 4034829, at *1
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`(“[Ciourts havc noted that granting a stay pending reexamination is favored”). Such a rationale
`
`is reasonable and entirely consistent with the notion ol‘conscrving the Court’s and parties
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`resources by avoiding duplicativc, and perhaps inconsistent work.
`
`thn considering a stay pending lPR, courts have applied the same basic legal test
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`previously applied when considering motions to stay pending the PTO’S reexamination
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`procedure. See Perch/tie Map Technologies, LLC v. JJ. Gumberg Co, No. CV 12-1525—SLR,
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`2014 W1, 1652633,, at >"2 (D. Del. Apr. 24, 2014). This three-part test considers: “(1) whether a
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`stay would unduly prejudice or present a clear tactical disadvantage to the non—moving party; (2)
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`whether a stay will simplify the issues in question and trial of the case; and (3) whether
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`discovery is complete and whether atrial date has been set.” [C] Uniqema, 2009 WL 4034829,
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`

`

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`at t i (citation ottiittedi
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`iiiecause all three tractors here weigh in favor oi’n stay, Antares" motion
`
`to stay pending resolution ot‘thc IPR should be granted.
`
`13,
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`The Early Stage of'l‘his Litigation Favors :1 Stay
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`As discussed shove, one thetor the Court must consider in determining whether to grant a
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`stay is “whether discovery is complete and whether a trial date has been set.” See, e 5; [Cl
`
`tfnz’qerrzrn 200‘} W 1;. 4034829, at1, (citation omitted); News 07’] OK] 1:. Dmarnic Fuels, LLQ No.
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`(TV 12~1744-GMS, 2013 WI; 3353984.? at *5 (ll Del. July 2, 201.3) (“This factor weighs strongly
`
`in Favor of” granting a stay, as the present case is in its infancy”) Here, the Court has entered a
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`schedule only through November 201i and no trial date has been set. See D1. 27 at 5. 1n
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`contrast Antares’ ll’R will be completed no later than January 2016, likely before the trial date
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`in this litigation. Granting a stay at this early stage is entirely consistent with the intent behind
`
`establishing the [PR procedure in the first place. See USPTO Inter Parles Review
`
`ltnplcrncntatiiim, 77 Fed. Reg. at 48,721 (“By requiring the tiling ol'an inter par/es review
`
`petition earlier than a request for inter porter reexamination, .
`
`.
`
`. it is anticipated that the current
`
`high level of duplication between litigation and reexamination will be reduced”).
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`Further, discovery is still at its earliest phase. The parties just recently served Initial
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`Disclosures, and Mcdac served its Infringement Contentions on June 26. While Medac served its
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`initial document requests and interrogatories on July 9, no other discovery has been conducted.
`
`See Brixham Solutions Ltd. v. Juniper Nelworks; Inc, No. 13-CV-00616—J CS, 2014 WL
`
`1677991, at *2 (ND. Cal. Apr. 285 2014) (granting stay, noting that “although some written and
`
`document discovery has been conducted, the case is at a relatively early stage”); Brass Smith,
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`2010 WL 4444717: at *6.
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`Similarly, the claim construction process has not started.
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`(If. Brixham Solutions Ltd. ,
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`2014 WL 1677991, at *2 (granting stay where parties had filed claim construction briefs, but
`
`

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`claim construction had not been decided). Over the next six rru‘mtihas the parties will have to
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`prepare and exol'iange terms tor construction, construction ot‘those terms, extrinsic evidence in
`
`Slipptirl ol’those constructions, complete claim construction discovery, and submit opening
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`trim/imam briefs.
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`17111 27 at 2—3é
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`'l‘he nascent phase oftho claim construction process thus also
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`lax-tors a stay.
`
`(:ff ficrrcwision, [rat is. (“itmglta 1mg; No.
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`1 lCVBl 70 DMSQGS‘), 2012 WL
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`359993 at *2 (8.1.). Cal. Feb. 21, 2012) (granting stay when: rl/icm’tmmz hricl's were soon due and
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`parties had exchanged proposed claim constructions and extrinsic evidence).
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`“[Clonsidering the general time line of patent litigatiom there is more work ahead ofthc
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`parties and the Court than behind the parties and the Court,” favoring a stay. Semiconductor
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`Energy Lola. (30., Ltd it (Wintei [nrzolux (70177., No. SACV lZ-Zl—JST JPRX, 2012 WI, 7170591
`
`at *2 (Cl). Cal. Dec. 19, 2012) (Citations and quotations omitted). Indeed, as discussed in more
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`detail below, “failing to grant a stay at this time may in fact prolong, rather than expedite,
`
`resolution of” this litigation,” by forcing the parties to re—litiga’te issues that may be modified in
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`light oi‘thc PTAB‘S IPR decision on the ’231 patent‘ 0y Ajal, Ltd. v. Valech Am, Inc, No. 10—
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`4375 (Post), 2012 WL 1067900, at *27 (D.N.J. Mar. 29, 2012).
`
`C.
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`A Stay Will Simplify the Issues and May Eliminate the Need for Trial
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`“[l]t is Virtually undeniable that a stay followed by a PTO [review] will simplify the
`
`issues in the case and streamline the proceedings.” Lincoln Nat '1 Life Ins. Co. v. Transamerica
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`Fin. we Ins. Ca, No. l:08~CV-135, 2009 WL 1 108822, at *4 (ND. 1nd. Apr. 24, 2009); Brass
`
`Smith, 2010 W 11 4444717, at *5 (PTO review “ha[s] the potential to eliminate trial on the issue
`
`altogether or at least reduce the costs associated with litigating it”) (citation omitted); Star
`
`Envirorech, Inc, v. Redline Detection, LLC, No. SACV 12—01861 1GB, 2013 WL 1716068, at *2
`
`(CD. Cal. Apr. 3, 2013) (“find[ing] that staying the case pending review would significantly
`
`9
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`

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`simplity the issues”), Ammo; the specii‘ic benefits assrgieiated with V170 review of an issued
`
`patent are:
`
`9
`
`it
`
`at
`
`¢
`
`o
`
`“if patent is declared invalid, the suit will likeiy be dismissed,"
`
`“the outcome ol‘thc [13’1”‘(3 review] may encourage a settlement
`without thither involvement of the court,"
`
`"the record oi’the [P'l‘O review] would probably be entered at trial,
`reducing the complexity and length, ot‘the litigation,”
`
`“issues, defenses, and evidence will he more easily limited in
`pretrial conferences,” and
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`“the cost will likely he reduced both for the parties and the court.”
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`New; ()1! (1)11], 2013 WL 3353984, at *4. These benefits apply equally to the present case.
`
`Antares has petitioned for FTC) review of all 22 claims of the “231 patent, favoring a stay
`
`oflitigation. Riverbed ’l‘ech, Inc. v. Silver Peak 81th Inc, No. C 13-02980 JSW, 2014 WL
`
`1647399, at *3 (NJ). Cal. Mar. 14, 2014) (because “the parties have sought IPR for almost all of
`
`the claims on the patents in suit .
`
`.
`
`. the PTAB’s review of the petitions, it‘grantcd. could
`
`potentially streamline invalidity, claim construction, and infringement issues in this action”).
`
`Further, as noted above, the PTO institutes the vast majority oflPR petitions, and in
`
`nearly all final written decisions, the PTO has cancelled some or all of the challenged claims,
`
`necessarily narrowing the issues in dispute. Brixham Solutions, 2014 WL 1677991, at *1 (“it is
`
`likely that a stay will simplify the issues .
`
`.
`
`. because the vast majority of requests for inter partes
`
`review are accepted and in virtually all of the cases in which final written decisions have been
`
`issued, the PTO has cancelled some or all of the challenged claims”). Based on these statistics,
`
`courts have noted that, “[i]n virtually every scenario, U SPTO review of the IPR petition will
`
`simplify the case." Ignite USA LLC v. Pac. Market lm’l, LLC, No. l4-C-856, 2014 WL
`
`2505166, at *3 (ND. 111. May 29, 2014). For instance, if the PTO finds all claims invalid,
`
`Medac’s infringement claims would be disposed ofin their entirety. If only some claims are
`
`10
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`

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`eeznicelied, the. case would be simplified by reducing the claims in dispute. [it at *4. And “lclvcn
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`ilthell claims are not all cancelled, the IPR could encourage settlement or lead to amendments to
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`the claims which could create intervening rights and limit potential damages." Sofiwnre Rights
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`Arc/(tire. 1.].(3‘ v. f'tzceltook, [mat Nos. (LIZ—397th $971, {7972 RMWC 2013 WL 5225522,, at *4
`
`(N13. Cal. Sent. 17, 20i3).
`
`t
`The AlA‘s estoppel provision, 3S [ESQCA § 315(e)(Ix) )a have significant implications on
`
`Antares” ability to raise invalidity positions during litigation and reinforces the notion that a stay
`
`would simplify the litigat