Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 1 of 49 PageID #: 9332
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE COPAXONE CONSOLIDATED
`CASES
`
`)
`)
`)
`)
`)
`)
`)
`
`Civil Action No. 14-1171-GMS
`(CONSOLIDATED)
`
`I.
`
`INTRODUCTION
`
`MEMORANDUM
`
`In
`
`this consolidated Hatch-Waxman patent
`
`infringement action, Plaintiffs Teva
`
`Pharmaceuticals USA Inc. ("Teva"), Teva Pharmaceutical Industries Ltd. ("Teva Ltd."), Teva
`
`Neuroscience Inc., and Yeda Research and Development Co. Ltd. ("Yeda") (collectively "T.eva")
`
`allege patent infringement by Defendants Sandoz Inc., Momenta Pharmaceuticals Inc., Dr. Reddy' s
`
`Laboratories Inc. ("DRL"), Dr. Reddy's Laboratories Ltd. ("DRL Ltd."), Mylan Pharmaceuticals
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`Inc., Synthon Pharmaceuticals Inc. ("Synthon"), Synthon B.V., Synthon s.r.o. Blansko ("Synthon
`
`s.r.o"), Amneal Pharmaceuticals LLC ("Amneal"), Amneal Pharmaceuticals Company GinbH
`
`("Amneal GmbH"), and Pfizer Inc. Plaintiffs allege that, by filing Abbreviated New Drug
`
`Applications ("AND As") seeking approval to market generic versions of COP AXONE® 40mg,
`
`Defendants infringed U.S. Patent Nos. 8,399,413 ("the '413 patent"), 8,232,250 ("the '250
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`patent"), 8,969,302 (''the '302 patent"), and 9,155,776 ("the '776 patent"). The court held a seven-
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`day bench trial in this matter beginning on September 26, 2016. Presently before the court are the
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`parties' post-trial proposed findings of fact and conclusions of law concerning the validity of the
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`patents-in-suit and whether Defendants' generic pharmaceutical compositions infringe the patents-
`
`in-suit. (D.I. 272); (D.I. 273).
`
`

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`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 2 of 49 PageID #: 9333
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`Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire
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`record in this case and the applicable law, the court concludes that all asserted claims of the patents-
`
`in-suit are invalid as obvious. The findings of fact and conclusions of law relevant to the court's
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`decision are set forth in further detail below.
`
`II.
`
`FINDINGS OF FACT 1
`
`A.
`
`The Parties
`
`1.
`
`Plaintiff Teva is a Delaware Corporation with its principal place ofbusiness at 1090
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`Horsham Road, North Wales, PA 19454.
`
`2.
`
`Plaintiff Teva Ltd. is an Israeli company with its principal place of business at 5 Basel
`
`Street, P.O. Box 3190, Petah Tikva, 49131, Israel.
`
`3.
`
`Plaintiff Teva Neuroscience is a Delaware corporation with its principal place of business
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`at 901E.104th Street, Suite 900, Kansas City, Missouri 64131.
`
`4.
`
`Plaintiff Y eda is an Israeli company with its principal place of business at P .0. Box 95,
`
`Rehovot, 76100, Israel.
`
`5.
`
`Defendant Amneal is a limited liability company organized and existing under the laws of
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`Delaware with a principal place of business at 400 Crossing Blvd., Third Floor, Bridgewater, NJ
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`08807-2863.
`
`1 Prior to trial, the parties submitted an exhibit of uncontested facts in conjunction with their Pretrial Order.
`(D.I. 254, Ex. A.) The court takes most of its findings of fact from the parties' uncontested facts. The court has also
`reordered and renumbered some paragraphs, corrected some formatting errors, and made minor edits for the purpose
`of concision and clarity that it does not believe alters the meaning of the paragraphs from the Pretrial Order. Otherwise,
`any differences between this section and the parties' statement of uncontested facts are unintentional.
`The court's findings of fact with respect to matters that were the subject of dispute between the parties are
`included in Part III of this opinion ("Discussion and Conclusions of Law"), preceded by the phrase "the court finds" or
`"the court concludes."
`
`2
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`

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`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 3 of 49 PageID #: 9334
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`6.
`
`Defendant Amneal GmbH is a limited liability company organized and existing under the
`
`laws of Switzerland with a principal place of business at Turnstrasse 30, 6312 Steinhausen,
`
`Switzerland.
`
`7.
`
`Defendant DRL Ltd. is a corporation organized and existing under the laws of India with
`
`its principal place of business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana 500
`
`034, India.
`
`8.
`
`Defendant DRL is a corporation organized and exiting under the laws of New Jersey with
`
`its principal place of business at 107 College Road East, Princeton, NJ 08540, and is a wholly(cid:173)
`
`owned subsidiary ofDRL Ltd.
`
`9.
`
`Defendant Mylan is a corporation organized and existing under the laws of West Virginia
`
`with its principal place of business at 781 Chestnut Ridge Rd., Morgantown, WV 26505. Mylan
`
`is a wholly-owned subsidiary of Mylan Inc., which is a corporation organized and existing under
`
`the laws of Pennsylvania with its principal place of business at 1000 Mylan Blvd., Canonsburg,
`
`PA15317.
`
`10.
`
`Defendant Sandoz is a corporation organized and existing under the laws of Colorado with
`
`its principal place of business at 100 College Road West, Princeton, NJ 08540.
`
`11.
`
`Defendant Momenta is a corporation organized and existing under the laws of Delaware
`
`with its principal place of business at 675 West Kendall Street, Cambridge, MA 02142.
`
`12.
`
`Defendant Synthon is a corporation organized and existing under the laws of North
`
`Carolina with its principal place of business at 1007 Slater Road, Suite 150, Durham, NC 27703.
`
`13.
`
`Defendant Synthon B.V. is a corporation organized and existing under the laws of the
`
`Netherlands with its principal place. of business at Microweg 22, P.O. Box 7071, 6503 CM
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`Nijmegen, The Netherlands.
`
`3
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`

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`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 4 of 49 PageID #: 9335
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`14.
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`Synthon s.r.o is a Czech entity having a principal place of business at Bmenska 32/cp.597,
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`678 17 Blansko, Czech Republic. Synthon and Synthon s.r.o are sister companies with Synthon
`
`B.V. as their ultimate parent company.
`
`15.
`
`Defendant Pfizer is a corporation organized and existing under the laws of Delaware with
`
`its principal place of business at 23 5 East 4 2nd Street, New York, NY 1001 7.
`
`16.
`
`The court has subject matter jurisdiction as well as personal jurisdiction over all parties.
`
`B.
`
`Background
`
`17.
`
`These consolidated actions arise out of Defendants' respective submissions of ANDAs
`
`under§ 505G) of the Federal Food, Drug and Cosmetic Act to the United States Food and Drug
`
`Administration ("FDA") with certifications pursuant to 21 U.S.C. § 355G)(2)(A)(vii)(IV), seeking
`
`approval to market and sell glatiramer acetate ("GA") for injection, in 40 mg/mL prefilled
`
`synnges.
`
`18.
`
`The three-times-weekly 40 mg/mL dose of GA was approved by the FDA in January
`
`2014.
`
`19.
`
`Teva is the holder of New Drug Application ("NDA") number 20-622, which was
`
`supplemented by Teva in 2013 to receive approval by the FDA of the use of GA 40 mg/mL three
`
`times per week, marketed as COP AX ONE® 40 mg/mL, for the treatment of patients with
`
`relapsing forms of multiple sclerosis such as relapse-remitting multiple sclerosis.
`
`20.
`
`Teva, Teva Ltd. and Teva Neuroscience's (collectively, "Teva") COPAXONE® 40
`
`mg/mL product is supplied as single-dose prefilled synringes that contain 40 mg/mL GA for
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`injection, manufactured by Teva Ltd., and marketed and sold in the United States by Teva
`
`Neuroscience.
`
`4
`
`

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`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 5 of 49 PageID #: 9336
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`C.
`
`The Patents-in-Suit
`
`i.
`
`The '250 Patent
`
`21.
`
`The '250 patent, entitled "Low Frequency Glatiramer Acetate Therapy" was issued on
`
`July 31, 2012.
`
`22.
`
`23.
`
`Ety Klinger is the named inventor of that patent.
`
`The '250 patent was submitted by Teva to the FDA to be listed in the FDA publication
`
`"Approved Drug Products with Therapeutic Equivalence Evaluations," commonly referred to as
`
`"the Orange Book" with respect to the COP AXONE® 40 mg/mL product.
`
`ii.
`
`The '413 Patent
`
`24.
`
`The '413 patent, entitled "Low Frequency Glatiramer Acetate Therapy" was issued on
`
`March 19, 2013.
`
`25.
`
`26.
`
`Ety Klinger is the named inventor of that patent.
`
`The '413 patent was submitted by Teva to the FDA to be listed in the Orange Book with
`
`respect to the COP AX ONE® 40mg/mL product.
`
`iii.
`
`The '302 Patent
`
`27.
`
`The '302 patent, entitled "Low Frequency Glatiramer Acetate Therapy" was issued on
`
`March 3, 2015.
`
`28.
`
`Ety Klinger is the named inventor of the '302 patent.
`
`29.
`
`The '302 patent was submitted by Teva to the FDA to be listed in the Orange Book with
`
`respect to the COP AX ONE® 40 mg/mL product.
`
`iv.
`
`The '776 Patent
`
`30.
`
`The '776 patent, entitled "Low Frequency Glatiramer Acetate Therapy" was issued on
`
`October 13, 2015.
`
`5
`
`

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`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 6 of 49 PageID #: 9337
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`31.
`
`Ety Klinger is the named inventor of the '776 patent.
`
`32.
`
`The'776 patent was submitted by Teva to the FDA to be listed in the Orange Book with
`
`respect to the COP AX.ONE® 40 mg/mL product.
`
`D. The Asserted Claims
`
`i.
`
`'250 patent, Claims 1, 5, 13-17
`
`Claims 1, 5, 13-17 read:
`
`A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human
`1.
`patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a
`first clinical episode and is determined to be at high risk of developing clinically definite multiple
`sclerosis comprising administering to the human patient a therapeutically effedive regimen of
`three subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days
`with at least one day between every subcutaneous injection, the regimen being sufficient to
`alleviate the symptom of the patient.
`
`The method of claim 1, wherein alleviating a symptom comprises reducing brain atrophy
`5.
`in the patient.
`
`The method of claim 1, wherein the patient has not received glatiramer acetate therapy
`13.
`prior to initiation of the regimen.
`
`The method of claim 1, wherein the frequency of an immediate post injection reaction or
`14.
`the frequency of an injection site reaction is reduced relative to daily subcutaneous administration
`of 20 mg glatiramer acetate.
`
`A method of increasing the tolerability of GA treatment in a human patient suffering from
`15.
`relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and
`is determined t9 be at high risk of developing clinically definite multiple sclerosis which
`comprises reducing frequency of subcutaneous injections from daily subcutaneous injections of a
`pharmaceutical composition comprising a 20 mg dose of glatiramer acetate to a regimen of three
`subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days with at
`least one day between every injection, wherein the regimen is therapeutically effective, so as to
`thereby increase the tolerability of GA treatment in the patient.
`
`The method of claim 15, wherein increasing the tolerability of glatiramer acetate treatment
`16.
`in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the
`frequency of an immediate post injection reaction.
`
`The method of claim 15, wherein increasing the tblerability of glatiramer acetate treatment
`17.
`in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the
`frequency of an injection site reaction.
`
`6
`
`

`

`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 7 of 49 PageID #: 9338
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`ii.
`
`'413 patent, claims 1, 7, 15, and 20
`
`A method of reducing the frequency of relapses in a human patient suffering from
`1.
`relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and
`has MRI featur_es consistent with multiple sclerosis comprising administering to the human
`patient a therapeutically effective dosage regimen of three subcutaneous injections of 1 ml of a
`pharmaceutical composition comprising 40 mg of glatiramer acetate over a period of seven days
`with at least one day between every subcutaneous injection, the regimen being sufficient to reduce
`the frequency of relapses in the patient.
`
`The method of Claim 1, wherein the frequency of an immediate post injection reaction or
`7.
`the frequency of an injection site reaction is reduced relative to daily subcutaneous administration
`of 20 mg glatiramer acetate.
`
`The method of claim 14, wherein, the lesion is a demyelinating white matter lesion visible
`15.
`on brain MRI and wherein the white matter lesion is at least 3 mm in diameter.
`
`A method of reducing the frequency of relapses in a human patient who has experienced a
`20.
`first clinical episode and has MRI features consistent with multiple sclerosis comprising
`administering to the human patient a therapeutically effective dosage rvgimen of three
`subcutaneous injections of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer
`acetate over a period of seven days with at least one day between every subcutaneous injection,
`wherein the pharmaceutical composition is in a prefilled syringe for self administration by the
`patient, wherein the pharmaceutical composition further comprises mannitol, and wherein the
`pharmaceutical composition has a pH in the range of 5.5 to 7.0, the regimen being sufficient to
`reduce the frequency of relapses in the patient.
`
`ii.
`
`'302 patent, claims 1, 10, and 11
`
`A method of treatment of a human patient suffering from a relapsing form of multiple
`1.
`sclerosis comprising administration to the human patient of three subcutaneous injections of a 40
`mg/ml dose of glatiramer acetate per week so as to treat the human patient.
`
`A method of treatment of a human patient suffering from a relapsing form of multiple
`10.
`sclerosis comprising subcutaneous injection by the human patient of a 40 mg/ml dose of
`glatiramer acetate three times per week with at least one day between every subcutaneous
`injection, wherein the glatiramer acetate is present in 1 ml of a pharmaceutical composition in a
`prefilled syringe for self injection by the human patient, and wherein the pharmaceutical
`composition further comprises mannitol and has a pH in the range of 5.5 to 7.0.
`
`The method of claim 10, wherein each subcutaneous injection is on day 1, day 3 and day
`11.
`5; day 1, day 3 and day 6; day 1, day 4 and day 6; day 2, day 4 and day 6; day 2, day 4 and day 7;
`2, day 5 and day 7; or day 3, day 5 and day 7 every week.
`
`7
`
`

`

`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 8 of 49 PageID #: 9339
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`iii.
`
`'776 patent, claims 1, 2, 5, 6, 9, 12, 16, and 17
`
`A method of treating a human patient suffering from a relapsing form of multiple
`1.
`sclerosis, while inducing reduced severity of injection site reactions in the human patient relative
`to administration of20 mg of glatiramer acetate s.c. daily, the method consisting of one
`subcutaneous injection of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer
`acetate on only each of three days during each week of treatment with at least one day without a
`subcutaneous injection of the pharmaceutical composition between each day on which there is a
`subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe, and
`wherein the pharmaceutical composition further comprises mannitol and has a pH in the range 5.5
`to 7 .O,so as to thereby treat the human patient with reduced severity of injection site reactions
`relative to administration of 20 mg of glatiramer acetate s.c. daily.
`
`The method of claim 1, which induces reduced frequency and severity of immediate post
`2.
`injection reactions and injection site reactions in the human patient relative to administration of
`20 mg of glatiramer acetate s.c. daily.
`
`A method for reducing the frequency of relapses by 3 0% or more as compared to placebo
`5.
`in a human population, for reducing brain atrophy, for reducing the cumulative number of
`enhancing lesions on Tl-weighted images, or for reducing the level of disability as measured by
`EDSS Score of a human patient suffering fyom a relapsing form of multiple sclerosis, while
`inducing reduced severity of injection site reactions in the human patient relative to
`administration of 20 mg of glatiramer acetate s.c. daily, which method consists of one
`subcutaneous injection of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer
`acetate on only each of three days during each week of treatment with at least one day without a
`subcutaneous injection of the pharmaceutical composition between each day on which there is a
`subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe, and
`wherein the pharmaceutical composition further comprises mannitol and has a pH in the range 5.5
`to 7 .O,so as to thereby reduce the frequency· of relapses by 30% or more as compared to placebo in
`a human population, reduce brain atrophy, reduce the cumulative number of enhancing lesions on
`Tl- weighted images, or reduce the level of disability as measured by EDSS Score of the human
`patient with reduced severity of injection site reactions relative to administration of20 mg of
`glatiramer acetate s.c. daily.
`
`The method of claim 5, which reduces brain atrophy and for reducing the frequency of
`6.
`relapses by 30% or more as compared to placebo in a human population.
`
`The method of claim 5, which induces reduced frequency and severity of immediate post
`9.
`injection reactions and injection site reactions in the human patient relative to administration of
`20 mg of glatiramer acetate s.c. daily.
`
`A method for improving the tolerability of glatiramer acetate treatment of a human patient
`12.
`suffering from a relapsing form of multiple sclerosis which is as effective as administration of 20
`mg of glatiramer acetate s.c. daily, which method consists of one subcutaneous injection of 1 ml
`of a pharmaceutical composition comprising 40 mg of glatiramer acetate on only each of three
`days during each week of treatment with at least one day without a subcutaneous injection of the
`
`8
`
`

`

`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 9 of 49 PageID #: 9340
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`pharmaceutical composition between each day on which there is a subcutaneous injection,
`wherein the pharmaceutical composition is in a prefilled syringe, and wherein the pharmaceutical
`composition further comprises mannitol and has a pH in the range 5.5 to 7.0, so as to thereby treat
`the human patient as effectively as by administration of 20 mg of glatiramer acetate s.c. daily, and
`with reduced severity of injection site reactions relative to administration of 20 mg of glatiramer
`acetate s.c. daily.
`
`A met]}od for improving the tolerability of glatiramer acetate therapy reducing the
`16.
`frequency of relapses, reducing brain atrophy, reducing the cumulative number of enhancing
`lesions on Tl- weighted images, or reducing the level of disability as measured by EDSS Score,
`of a human patient suffering from a relapsing form of multiple sclerosis as effectively as
`administration of20 mg of glatiramer acetate s.c. daily, which method consists of one
`subcutaneous injection of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer
`acetate on only each of three days during each week of treatment with at least one day without a
`subcutaneous injection of the pharmaceutical composition between each day on which there is a
`subcutaneous injection, wherein the pharmaceutical composition I in a prefilled syringe, and
`wherein the pharmaceutical composition further comprises mannitol and has a pH in the range 5.5
`to 7 .0, so as to thereby reduce the frequency of relapses, reduce brain atrophy, reduce the
`cumulative number of enhancing lesions on Tl weighted images, or reduce the level of disability
`as measured by EDSS Score, of the human patient as effectively as by administration of20 mg of
`glatiramer ac~tate s.c. daily, and with reduced severity of injection site reactions relative to
`administration of20 mg of glatiramer acetate s.c. daily.
`
`The method of claim 16, which reduces the frequency of relapses as effectively as
`17.
`administration of 20 mg of glatiramer acetate s.c. daily.
`
`E. Defendants' ANDAs
`
`"i.
`
`Amneal ANDA
`
`33.
`
`Amneal GmbH, through its U.S. agent Amneal LLC, filed an ANDA under 21 U.S.C. §
`
`355(i) seeking FDA approval for GA injection, 40 mg/mL, which was assigned ANDA number
`
`207553 ("Amneal's GA Product"), prior to the expiration of the '250 and '413 patents.
`
`34.
`
`Amneal GmbH also filed with the FDA a certification pursuant to 21 U.S.C. §
`
`355G)(2)(A)(vii)(IV) alleging that the claims of the
`
`'250 and
`
`'413 patents are invalid,
`
`unenforceable, and/or would not be infringed by Amneal's GA Product.
`
`9
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`

`

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`35.
`
`By letter dated January 23, 2015, Amneal LLC sent notice to Teva that Amneal LLC had
`
`filed ANDA No. 207553 seeking approval to market Amneal's GA Product prior to the expiration
`
`of the '250 and '413 patents ("First Notice Letter").
`
`36.
`
`Amneal also filed with the FDA a certification pursuant to 21 U.S.C.
`
`§ 355G)(2)(A)(vii)(IV) alleging that the claims of the '302 patent are invalid, unenforceable,
`
`and/or would not be infringed by Amneal's GA Product.
`
`37.
`
`By letter dated March 18, 2015, Amneal LLC notified Teva that it had filed an amendment
`
`to ANDA No. 207553 with a Paragraph IV certification related thereto seeking approval to market
`
`Amneal's GA Product prior to the expiration of the '302 patent.
`
`38.
`
`Amneal also filed with the FDA a certification pursuant to 21 U.S.C. § 355G)(2)(A)(vii)(IV)
`
`alleging that the claims of the '776 patent are invalid, unenforceable, and/or would not be infringed
`
`by Amneal' s GA Product.
`
`39.
`
`By letter dated October 29, 2015, Amneal LLC notified Teva that it had filed an amendment
`
`to ANDA No. 207553 with a Paragraph IV certification related thereto seeking approval to market
`
`Amneal's GA Product prior to the expiration of the '776 patent.
`
`ii.
`
`Amneal Procedural History
`
`40.
`
`On February 3, 2015, Plaintiffs sued Amneal LLC in this court for patent infringement of
`
`the '250 and '413 patents, related to ANDA No. 207553. See Teva Pharms. USA, Inc., et al. v.
`
`Amneal Pharms. LLC, C.A. No. 15-124-GMS (D. Del.). Pursuant to 21 U.S.C. § 355G)(5)(B)(iii),
`
`Plaintiffs sued Amneal within 45 days ofreceipt of Amneal's First Notice Letter.
`
`41.
`
`On March 9, 2015, this court consolidated the multiple pending actions regarding GA 40
`
`mg/mL products into Civil Action No. 1: 14-cv-01171-GMS.
`
`10
`
`

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`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 11 of 49 PageID #: 9342
`
`42.
`
`On April 10, 2015, Plaintiffs also sued Amneal LLC in this court for patent infringement of
`
`the '302 patent, related to ANDA No. 206767. See Teva Pharms. USA, Inc., et al. v. Dr. Reddy's
`
`Labs., Ltd., et al., C.A. No. 1:15-0306-GMS (D. Del.). That action was consolidated with the current
`
`action.
`
`43.
`
`On April 30, 2015, Plaintiffs filed a First Amended Complaint in In re Copaxone 40 mg
`
`Consolidated Cases, C.A. No. 1:14-cv-01171-GMS (D. Del.). The First Amended Complaint
`
`named both Amneal LLC and Amneal GmbH as defendants.
`
`44.
`
`On November 10, 2015, Plaintiffs filed a Second Amended Complaint in In re Copaxone
`
`40 mg Consolidated Cases, C.A. No. 1 :14-cv-01171-GMS (D. Del.). The Second Amended
`
`Complaint alleged infringement of the '776 patent.
`
`iii.
`
`Amneal Stipulations
`
`45.
`
`Amneal has stipulated that, for purposes of this action, its ANDA product contains "GA" as
`
`recited in the claims of the patents-in-suit. (D.I. 195).
`
`iv.
`
`DRLANDA
`
`46.
`
`DRL filed an ANDA under 21 U.S.C. § 355G) seeking FDA approval for GA injection, 40
`
`mg/mL, which was assigned ANDA number 206767 ("DRL's GA Product"), prior to the expiration
`
`of the '250 patent and the '413 patent.
`
`47.
`
`DRL also filed with the FDA a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`alleging that the claims of the '250 and '413 patents are invalid, unenforceable, and/or would not
`
`be infringed by DRL's GA Product.
`
`48.
`
`By letter dated August 1, 2014, DRL sent notice to Teva that DRL had filed ANDA No.
`
`206767 seeking approval to market DRL's GA Product prior to the expiration of the '250 and '413
`
`patents ("First Notice Letter").
`
`11
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`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 12 of 49 PageID #: 9343
`
`49.
`
`. Teva received DRL's First Notice Letter on or about August 6, 2014.
`
`50.
`
`DRL also filed with the FDA a certification pursuant to 21 U.S.C. § 355(i)(2)(A)(vii)(IV)
`
`alleging that the claims of the '302 patent are invalid, unenforceable, and/or would not be infringed
`
`by DRL's GA Product.
`
`51.
`
`By letter dated May 19, 2015, DRL sent notice to Teva that DRL had filed ANDA No.
`
`206767 seeking approval to market DRL's GA Product prior to the expiration of the '302 patent.
`
`52.
`
`DRL also filed with the FDA a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`alleging thatthe claims of the '776 patent are invalid, unenforceable, and/or would.not be infringed
`
`by DRL's GA Product.
`
`53.
`
`By letter dated January 14, 2016, DRL sent notice to Teva that DRL had filed ANDA No.
`
`206767 seeking approval to market DRL's GA Product prior to the expiratio~ of the '776 patent.
`
`v.
`
`DRL Procedural History
`
`53.
`
`On September 10, 2014, Plaintiffs sued DRL in this court for patent infringement of the
`
`'250 and '413 patents, related to ANDA No. 206767. See Teva Pharms. USA, Inc., et al. v. Dr.
`
`Reddy's Labs., Ltd., et al., C.A. No. 14-1172-GMS (D. Del.). Pursuant to 21 U.S.C. §
`
`355(i)(5)(B)(iii), Plaintiffs sued DRL within 45 days of receipt ofDRL's First Notice Letter.
`
`54.
`
`On March 9, 2015, this Court consolidated the multiple pending actions regarding GA 40
`
`mg/mL products into Civil Action No. 1:14-cv-01171-GMS.
`
`55.
`
`On April 10, 2015, Plaintiffs also sued DRL in this court for patent infringement of the '302
`
`patent, related to ANDA No. 206767. See Teva Pharms. USA, Inc., et al. v. Dr. Reddy's Labs.,
`
`Ltd., et al., C.A. No. 1:15-0306-GMS (D. Del.). That action was consolidated with the current
`
`action.
`
`12
`
`

`

`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 13 of 49 PageID #: 9344
`
`56.
`
`On November 10, 2015, Plaintiffs filed a Second Amended Complaint in In re Copaxone
`
`40 mg Consolidated Cases, C.A. No. 1 :14-cv-01171-GMS (D. Del.). The Second Amended
`
`Complaint alleged infringement ofthe'776 patent.
`
`vi.
`
`DRL Stipulations
`
`57.
`
`DRL has stipulated that, for purposes of this action, its ANDA product contains "GA" as
`
`recited in the claims of the patents-in-suit. (D.I. 195).
`
`vii. Mylan ANDA
`
`58. Mylan filed an ANDA under 21 U.S.C. § 355G) seeking FDA approval for GA injection,
`
`40 mg/mL, which was assigned ANDA number 206936 ("Mylan's GA Product") prior to the
`
`expiration of the '250 and '413 patents.
`
`59. Mylan also filed with the FDA a certifica~ion pursuant to 21 U.S.C. § 355G)(2)(A)(vii)(IV)
`
`alleging that the claims of the '250 and '413 patents are invalid, unenforceable, and/or would not
`
`be infringed by Mylan's GA Product.
`
`60.
`
`By letter dated August 28, 2014, Mylan sent notice to Teva that Mylan had filed ANDA No.
`
`206936 seeking approval to market Mylan' s GA Product prior to the expiration of the '250 and
`
`'413 patents ("First Notice Letter").
`
`61. Mylan also filed with the FDA a certification pursuant to 21 U.S.C. § 355G)(2)(A)(vii)(IV)
`
`alleging that the claims of the '302 patent are invalid, unenforceable, and/or would not be infringed
`
`by Mylan's GA Product.
`
`62.
`
`By letter dated March 9, 2015, Mylan sent notice to Teva that Mylan had filed ANDA No.
`
`206936 seeking approval to market Mylan's GA Product prior to the expiration of the '302 patent.
`
`13
`
`

`

`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 14 of 49 PageID #: 9345
`
`63. Mylan also filed with the FDA a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`alleging that the claims of the '776 patent are invalid, unenforceable, and/or would not be infringed
`
`by Mylan's GA Product.
`
`64. Mylan also notified Teva that it had filed an amendment to ANDA No. 206936 with a
`
`Paragraph IV certification related thereto seeking approval to market Mylan's GA Product prior to
`
`the expiration of the '776 patent.
`
`viii. Mylan Procedural History
`
`65.
`
`On October 6, 2014, Plaintiffs sued Mylan in this court for patent infringement of the '250
`
`and '413 patents, related to ANDA No. 206936. See Teva Pharms. USA, Inc., et al. v. Mylan
`
`Pharms Inc., et al., C.A. No. 14-1278-GMS (D. Del.). Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii),
`
`Plaintiffs sued Mylai;i within 45 days of receipt ofMylan's First Notice Letter.
`
`66.
`
`On March 9, 2015, this court consolidated the multiple pending actions regarding GA 40
`
`mg/mL products into Civil Action No. 1 :14-cv-01171-GMS.
`
`67.
`
`On April 10, 2015, Plaintiffs sued Mylan in this court for patent infringement of the '302
`
`patent, related to ANDA No. 206936. See Teva Pharms. USA, Inc., et al. v. Dr. Reddy's Labs.,
`
`Ltd., et al., C.A. No. 1:15-0306-GMS (D. Del.). That action was consolidated with the current
`
`·action.
`
`68.
`
`On November 10, 2015, Plaintiffs filed a Second Amended Complaint in In re Copaxone
`
`40 mg Consolidated Cases, C.A. No. 1:14-cv-01171-GMS (D. Del.). The Second Amended
`
`Complaint alleged infringement ofthe'776 patent.
`
`ix. Mylan Stipulations
`
`69. Mylan has stipulated that, for purposes of this action, its ANDA product contains "GA" as
`
`recited in the claims of the patents-in-suit. (D.I. 195).
`
`14
`
`

`

`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 15 of 49 PageID #: 9346
`
`x.
`
`Sandoz Inc. ANDA
`
`70.
`
`Sandoz Inc. filed an ANDA under 21 U.S.C. § 355(j) seeking FDA approval for GA
`
`injection, 40 mg/mL, purported to be generic to Teva's COPAXONE® 40 mg/mL product, which
`
`was assigned ANDA number 206921 ("Sandoz Inc.'s GA Product"), prior to the expiration of the
`
`'250 and '413 patents.
`
`71.
`
`Sandoz Inc. also filed with the FDA a certification pursuant to 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV) alleging that the claims of the
`
`'250 and
`
`'413 patents are invalid,
`
`unenforceable, and/or would not be infringed by Sandoz Inc.' s GA Product.
`
`72.
`
`By letter dated August 27, 2014, Sandoz Inc. sent notice to Teva that Sandoz Inc. had filed
`
`ANDA No. 206921 seeking approval to market Sandoz Inc.'s GA Product prior to the expiration
`
`ofthe '250 and '413 patents ("First Notice Letter").
`
`73.
`
`74.
`
`Teva received Sandoz Inc.'s First Notice Letter on or about August 28, 2014.
`
`Sandoz Inc. also filed with the FDA a certification pursuant to 21 U.S.C. §
`
`355G)(2)(A)(vii)(IV) alleging that the claims of the '302 patent are invalid, unenforceable, and/or
`
`would not be infringed by Sandoz Inc. 's GA Product.
`
`75.
`
`By letter dated March 6, 2015, Sandoz Inc. sent notice to Teva that Sandoz Inc. had filed
`
`ANDA No. 206921 seeking approval to market Sandoz Inc.'s GA Product prior to the expiration
`
`of the '302 patent.
`
`76.
`
`Sandoz Inc. also filed with the FDA a certification pursuant to 21 U.S.C. §
`
`355G)(2)(A)(vii)(IV) alleging that the claims of the '776 patent are invalid, unenforceable, and/or
`
`would not be infringed by Sandoz Inc.' s GA Product.
`
`15
`
`

`

`Case 1:14-cv-01171-GMS Document 294 Filed 01/30/17 Page 16 of 49 PageID #: 9347
`
`77.
`
`Sandoz Inc. also notified Teva that it had filed an amendment to ANDA No. 206921 with a
`
`Paragraph IV certification related thereto seeking approval to market Sandoz Inc.'s GA Product
`
`prior to the expiration of the '776 patent.
`
`xi.
`
`Sandoz Procedural History
`
`78.
`
`On September 10, 2014, Plaintiffs sued Sandoz Inc. and Momenta Pharmaceuticals, Inc. in
`
`this court for patent infringement of the '250 and '413 patents, related to ANDA No. 206921. See
`
`Teva Pharm. USA, Inc., et al. v. Sandoz, Inc., et al., C.A. No. 1 :14-cv-01171 GMS (D. Del.).
`
`Pursuant to 21 U.S.C. § 355G)(5)(B){iii), Plaintiffs sued Sandoz Inc .. and Momenta
`
`Pharmaceuticals, Inc. within 45 days of receipt of Sandoz Inc.' s First Notice Letter.
`
`79.
`
`On March 9, 2015, this Court consolidated the multiple pending actions regarding GA 40
`
`mg/mL produds into Civil Action No. 1 :14-cv-01171-GMS.
`
`80.
`
`On April 10, 2015, Plaintiffs sued Sandoz Inc. and Momenta Pharmaceuticals, Inc. in this
`
`court for patent infringement of the '302 patent, related to ANDA No. 206921. See Teva Pharm.
`
`USA, Inc., et al. v. Dr. Reddy's Labs., Ltd., et al., C.