Case 2:15-cv-01455-WCB Document 430 Filed 08/22/17 Page 1 of 25 PageID #: 20895
`(cid:53)(cid:40)(cid:39)(cid:36)(cid:38)(cid:55)(cid:40)(cid:39)
`
`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`ALLERGAN, INC.,
`
`Plaintiff,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`et al.
`
`Defendants.
`
`Civil Action No. 2:15-cv-01455-WCB
`LEAD CASE
`FILED UNDER SEAL
`
`(cid:51)LAINTIFF ALLER(cid:42)AN(cid:15) INC.(cid:182)S RES(cid:51)ONSE TO DEFENDANTS(cid:182)
`MOTION FOR SUMMARY JUDGEMENT OF NON-INFRINGEMENT
`
`CONFIDENTIAL UNDER PROTECTIVE ORDER
`
`MYLAN - EXHIBIT 1154
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`0001
`
`

`

`Case 2:15-cv-01455-WCB Document 430 Filed 08/22/17 Page 2 of 25 PageID #: 20896
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`TABLE OF CONTENTS
`Introduction ............................................................................................................................. 1
`Legal Standard ........................................................................................................................ 2
`Response to statement of issues to be decided by the court ................................................... 4
`Response to defendants(cid:182) statement of Material Facts ............................................................. 4
`A. Dry Eye and KCS Are Both Disorders of the Tear Film ................................................ 5
`B. Increasing Tear Production Treats KCS and Dry Eye, as Stated on the Product Labels 6
`C. Data Submitted to the FDA Shows that Restasis® Treats Dry Eye and KCS by
`Increasing Tear Production ............................................................................................ 8
`D. Marketing Materials Allowed by FDAs State that Restasis® Treats KCS and Dry Eye
`and Restores Tear Production ......................................................................................... 9
`Argument .............................................................................................................................. 10
`A. A Showing of Infringement Does Not Require that the Label and the Claims Use the
`Same Language ............................................................................................................ 10
`B. There Is at Least a Factual Dispute as to Whether the Indication on the Label Meets
`All the Claims ............................................................................................................... 12
`C. Defendants(cid:182) Cases All Deal with Entirely Different Uses on the Label and Claims and
`Are Inapplicable Here .................................................................................................. 14
`D. Defendants(cid:182) Labels Induce Infringement of Claims to KCS, Dry Eye, and Restoring
`Tearing, and there Are No Substantial Non-Infringing Uses ....................................... 17
`Conclusion ............................................................................................................................ 19
`
`ii
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`0002
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`

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`Case 2:15-cv-01455-WCB Document 430 Filed 08/22/17 Page 3 of 25 PageID #: 20897
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`TABLE OF AUTHORITIES
`
`Cases
`Allergan v. Apotex, Nos. 1(cid:29)10(cid:177)c(cid:89)(cid:177)681, 1(cid:29)11(cid:177)c(cid:89)(cid:177)298, 1(cid:29)11(cid:177)c(cid:89)(cid:177)650, 201(cid:22) WL 286251 (cid:11)M.D.
`N.C. Jan. 24, 2013) ................................................................................................................... 11
`Allergan, Inc. v. Alcon Laboratories, Inc., 324 F.3d 1322 (Fed. Cir. 2003) ................................ 15
`Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) ................................................................... 2
`Astrazeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010) ................................. 2, 11, 13, 18
`Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012) ......................... 14, 15
`Braintree Laboratories, Inc. v. Breckenridge Pharmaceuticals, Inc., -- F.3d --, 2017 WL
`1829140 (Fed. Cir. May 5, 2017) ................................................................................. 11, 13, 18
`Eli Lilly and Co. v. Actavis Elizabeth LLC, 435 F. App(cid:182)(cid:91) 917 (Fed. Cir. 2011) .......................... 19
`Glaxo Grp. Ltd. v. TorPharm, Inc., 153 F.3d 1366 (Fed. Cir. 1998) ............................................. 3
`Golden Blount, Inc. v. Robert H. Peterson Co., 365 F.3d 1054 (Fed. Cir. 2004) ........................... 3
`Hoffmann-La Roche, Inc. v. Apotex, Inc., No. 2:07-cv-4417, 2010 WL 3522786 (D.N.J. Sept. 2,
`2010) ......................................................................................................................................... 10
`In re Depomed Patent Litigation, No. 2:13-cv-4507, 2016 WL 7163647 (D.N.J. Sept. 30, 2016)
`................................................................................................................................................... 19
`L.A. Biomedical Research Institute at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., No. 2:13(cid:177)cv-
`08567, 2014 WL 11241786 (C.D. Cal. May 12, 2014) ...................................................... 12, 18
`(cid:50)mega Eng(cid:182)g, Inc., v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003) ........................................... 3
`Optical Disc Corp. v. Del Mar Avionics, 208 F.3d 1324 (Fed. Cir. 2000) .................................... 3
`Raytheon Co. v. Indigo Sys. Corp., 688 F.3d 1311 (Fed. Cir. 2012) ............................................. 3
`SRAM Corp. v. AD-II Eng(cid:182)g, Inc., 465 F.3d 1351 (Fed. Cir. 2006) ............................................... 2
`Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271 (Fed. Cir. 2013) ....................... 3
`Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) ................................. 15, 16
`Rules
`Fed. R. Civ. P. 56(c) ....................................................................................................................... 2
`
`iii
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`0003
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`

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`Case 2:15-cv-01455-WCB Document 430 Filed 08/22/17 Page 4 of 25 PageID #: 20898
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`INTRODUCTION
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`Defendants(cid:182) motion for summary (cid:77)udgment should be denied, as it is based on a
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`fundamental misunderstanding of both the facts and the law. Restasis® was the first-ever
`
`product that treats the problem underlying dry eye and KCS by increasing the production of a
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`patient(cid:182)s tears. The label for Restasis® and proposed labels for all Defendants(cid:182) copycat products
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`state that the products are indicated for (cid:179)increas[ing] tear production in patients whose tear
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`production is presumed to be suppressed due to ocular inflammation associated with
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`keratocon(cid:77)unctivitis sicca.(cid:180) (Dkt. 342, Ex. 4, Restasis® Label AGN_RES0069704-709 at
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`AGN_RES0069705.) There is no dispute that increasing tear production does, in fact, treat KCS
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`and dry eye. A deficiency in tears is the way that physicians diagnose KCS, a form of dry eye,
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`and an increase in tear production is the way to treat those conditions. In fact, there is no other
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`reason to increase tear production other than to treat KCS or dry eye, thereby restoring tears in
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`patients suffering from those conditions.
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`Yet, according to Defendants, there is not even a factual dispute as to whether claims to
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`(cid:179)treating KCS,(cid:180) (cid:179)treating dry eye,(cid:180) and (cid:179)restoring tear production(cid:180) are infringed.1 This
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`argument is specious(cid:178)Defendants(cid:182) labels directly instruct physicians and patients to use the
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`products to increase tear production in patients with KCS, which is a subset of dry eye disease,
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`thereby treating those patients(cid:182) KCS and dry eye. And it takes no more than the application of
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`1 Pursuant to the Court(cid:182)s (cid:50)rder dated January 26, 2017 (Dkt. 265) Allergan further limited its
`asserted claims on Friday, June 9, reducing the number to 13. The only still-asserted claims at
`issue in Defendants(cid:182) motion are claims 13, 16, 22, 26, and 27 of the (cid:182)191 patent and claim 26 of
`the (cid:182)111 patent. Allergan believes that Defendants(cid:182) motion as to the claims no longer at issue
`(claims 13, 14, and 24 of the (cid:182)162 patent, claims 11 and 18 of the (cid:182)556 patent, and claims 17 and
`25 of the (cid:182)111 patent) is wrong, but Allergan will not address those claims because they are no
`longer at issue and are now moot.
`
`1
`
`0004
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`

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`Case 2:15-cv-01455-WCB Document 430 Filed 08/22/17 Page 20 of 25 PageID #: 20914
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`keratocon(cid:77)unctivitis sicca,(cid:180) that does not mean that the FDA ultimately made a finding that
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`Restasis® does not treat KCS or dry eye. Defendants ignore that, after the FDA initially rejected
`
`the proposed indication, Allergan continued to perform further analysis on the data to
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`demonstrate efficacy, leading the FDA to approve the product with a labeled indication that more
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`precisely describes how the product works and expressly contemplates use in treating KCS (a
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`subset of dry eye). (See Ex. 4, Corr. to FDA of Oct. 28, 2002, AGN_RES0066832 at
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`AGN_RES0066836 ((cid:179)Schirmer wetting is a clinically relevant and appropriate end point for
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`studying dry eye disease.(cid:180))(cid:30) Dkt. 342 at 12 (Defendants state (cid:179)KCS [] is a subset of dry eye.(cid:180))
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`(emphasis added); Claim Construction Order, Dkt. 214 at 13 (defining KCS as (cid:179)a type of dry eye
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`disease involving an absolute or partial deficiency in aqueous tear production(cid:180)) (emphasis
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`added); see also Dkt. 342, Ex. 4, Restasis® Label AGN_RES0069704-709 at
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`AGN_RES0069705.)
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`Moreover, as discussed above, the FDA has also allowed Allergan to market Restasis®
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`for treatment of KCS and dry eye, and to refer to its ability to restore tears. (Ex. 6,
`
`Advertisement AGN_RES0585435-441 at AGN_RES0585435, AGN_RES0585437,
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`AGN_RES0585441; Ex. 7, FAQ AGN_RES1103931-32 at AGN_RES1103931.) There is
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`nothing about the history of the approval process for Restasis® to suggest that use of the product
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`to treat dry eye or KCS, or to restore tearing, are distinct, off-label uses.
`
`D.
`
`Defendants(cid:182) La(cid:69)els Induce Inf(cid:85)in(cid:74)e(cid:80)ent of Claims to KCS, Dry Eye, and
`Restoring Tearing, and there Are No Substantial Non-Infringing Uses
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`Finally, Defendants(cid:182) arguments concerning lack of intent to induce and substantial non-
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`infringing uses are all built on the faulty premise that uses of the product for treatment of KCS
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`and dry eye and for restoring tear production are (cid:179)off-label(cid:180) and non-infringing. But, as
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`discussed in detail above, there is at least a factual dispute on those arguments.
`
`17
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`0005
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`

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`Case 2:15-cv-01455-WCB Document 430 Filed 08/22/17 Page 21 of 25 PageID #: 20915
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`Though the labels for Restasis® and Defendants(cid:182) products state that they are indicated for
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`(cid:179)increas[ing] tear production in patients whose tear production is presumed to be suppressed due
`
`to ocular inflammation associated with keratoconjunctivitis sicca(cid:180) rather than simply saying they
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`are indicated for (cid:179)treating dry eye,(cid:180) (cid:179)treating KCS,(cid:180) or (cid:179)restoring tears,(cid:180) that does not make
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`those uses (cid:179)off-label.(cid:180) (Dkt. 342, Ex. 4, Restasis® Label AGN_RES0069704-709 at
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`AGN_RES0069705; Dkt. 342 at (cid:136) 38; Dkt. 342, Exs. 25-29 (Defendants(cid:182) ANDA labels,
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`mirroring that of Restasis®).) Like in L.A. Biomedical Research Institute, administration of
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`Restasis® (and Defendants(cid:182) products if approved) to increase tear production, as directed on the
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`label, (cid:179)results directly in treatment of the underlying(cid:180) KCS and dry eye conditions. 2014 WL
`
`11241786, at *5. Moreover, the indication expressly contemplates treatment of KCS patients,
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`which, under this Court(cid:182)s claim construction, are also dry eye patients. Use of the products as
`
`directed to increase tear production is (cid:179)not a distinct use(cid:180) of the product, but rather (cid:179)is the
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`means(cid:180) to treat the conditions identified in the claims. Braintree, 2017 WL 1829140, at *4
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`(emphasis original). Using Restasis® to treat KCS and dry eye or to restore tearing are simply
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`not off-label uses under the facts and the law. Because the claimed uses are (cid:179)on-label,(cid:180) the label
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`provides evidence of Defendants(cid:182) affirmative intent to induce infringement of the asserted claims
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`reciting these uses. Astrazeneca, 633 F.3d at 1058-61.
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`Moreover, with respect to substantial non-infringing uses, Defendants(cid:182) arguments again
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`improperly presume that using Restasis® to treat KCS and dry eye are (cid:179)off-label(cid:180) and therefore
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`qualify as non-infringing. As discussed in detail above, there is at least a factual dispute on that
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`issue. Moreover, even if Defendants were correct that treatment or dry eye or treatment of KCS
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`could be considered (cid:179)off-label,(cid:180) they would not be substantial non-infringing uses. (cid:179)In the
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`context of pharmaceutical products, a substantial non-infringing use must be one for which the
`
`18
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`0006
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`

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`Case 2:15-cv-01455-WCB Document 430 Filed 08/22/17 Page 22 of 25 PageID #: 20916
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`product is authori(cid:93)ed to be sold (cid:177) i.e., it must be on-label.(cid:180) In re Depomed Patent Litigation, No.
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`2:13-cv-4507, 2016 WL 7163647 at *68 (D.N.J. Sept. 30, 2016). As the Federal Circuit has
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`explained, even though a drug may be prescribed for off-label uses, (cid:179)[s]uch unauthori(cid:93)ed activity
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`does not avoid infringement by a product that is authorized to be sold solely for the infringing
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`use.(cid:180) Eli Lilly and Co. v. Actavis Elizabeth LLC, 435 F. App(cid:182)x 917, 927 (Fed. Cir. 2011) (non-
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`precedential). Thus, even if treatment of KCS or use for restoring tears could be considered an
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`off label use, which, as explained in detail above, they cannot, those uses still would not allow
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`Defendants to avoid contributory infringement under the law.
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`CONCLUSION
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`For the foregoing reasons, Defendants(cid:182) motion for summary judgement of non-
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`infringement of claims 13, 16, 22, 26, and 27 of the (cid:182)191 patent and claim 26 of the (cid:182)111 patent
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`should be denied. Moreover, because claims 13, 14, and 24 of the (cid:182)162 patent, claim 12 of the
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`(cid:182)191 patent, claims 11 and 18 of the (cid:182)556 patent, and claim 26 of the (cid:182)111 patent are no longer at
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`issue, Defendants(cid:182) motion as to those claims should be denied as moot.
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`Dated: June 13, 2017
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`Respectfully submitted,
`
`
`
`FISH & RICHARDSON P.C.
`
`/s/ Robert M. Oakes
`By:
`Jonathan E. Singer
`(CA Bar No. 187908, MN Bar No. 283459)
`LEAD ATTORNEY
`singer@fr.com
`Juanita R. Brooks (CA Bar No. 75934)
`brooks@fr.com
`12390 El Camino Real
`San Diego, CA 92130
`Telephone: 858-678-5070
`
`19
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`0007
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