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In re Copaxone consolidated cases

United States District Court, D. Delaware

January 30, 2017

IN RE COPAXONE CONSOLIDATED CASES

          MEMORANDUM

         I. INTRODUCTION

         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 "Teva") 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 Inc., Synthon Pharmaceuticals Inc. ("Synthon"), Synthon B.V., Synthon s.r.o. Blansko ("Synthon s.r.o"), Amneal Pharmaceuticals LLC ("Amneal"), Amneal Pharmaceuticals Company GmbH ("Amneal GmbH"), and Pfizer Inc. Plaintiffs allege that, by filing Abbreviated New Drug Applications ("ANDAs") seeking approval to market generic versions of COPAXONE® 40mg, Defendants infringed U.S. Patent Nos. 8, 399, 413 ("the '413 patent"), 8, 232, 250 ("the '250 patent"), 8, 969, 302 ("the '302 patent"), and 9, 155, 776 ("the '776 patent"). The court held a seven-day bench trial in this matter beginning on September 26, 2016. Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning the validity of the patents-in-suit and whether Defendants' generic pharmaceutical compositions infringe the patents-in-suit. (D.I. 272); (D.I. 273).

         Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire 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 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 of business at 1090 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 at 901 E. 104th Street, Suite 900, Kansas City, Missouri 64131.

         4. Plaintiff Yeda is an Israeli company with its principal place of business at P.O. Box 95, Rehovot, 76100, Israel.

         5. Defendant Amneal is a limited liability company organized and existing under the laws of Delaware with a principal place of business at 400 Crossing Blvd., Third Floor, Bridgewater, N.J. 08807-2863.

         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, N.J. 08540, and is a wholly-owned subsidiary of DRL 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, PA 15317.

         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, N.J. 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 Nijmegen, The Netherlands.

         14. Synthon s.r.o is a Czech entity having a principal place of business at Brnenska 32/cp.597, 67817 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 235 East 42nd Street, New York, NY 10017.

         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 AND As under § 505(j) 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. § 355(j)(2)(A)(vii)(TV), seeking approval to market and sell glatiramer acetate ("GA") for injection, in 40 mg/mL prefilled syringes.

         18. The three-times-weeldy 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 COPAXONE® 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 injection, manufactured by Teva Ltd., and marketed and sold in the United States by Teva Neuroscience.

         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. Ety Klinger is the named inventor of that patent.

         23. 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 COPAXONE® 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. Ety Klinger is the named inventor of that patent.

         26. The '413 patent was submitted by Teva to the FDA to be listed in the Orange Book with respect to the COPAXONE® 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 COPAXONE® 40 mg/mL product.

         iv. The '776 Patent

         30. The '776 patent, entitled "Low Frequency Glatiramer Acetate Therapy" was issued on October 13, 2015.

         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 COPAXONE® 40 mg/mL product.

         D. The Asserted Claims

         i. '250 patent, Claims 1, 5, 13-17

         Claims 1, 5, 13-17 read:

         1. A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human 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 effective 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.

         5. The method of claim 1, wherein alleviating a symptom comprises reducing brain atrophy in the patient.

         13. The method of claim 1, wherein the patient has not received glatiramer acetate therapy prior to initiation of the regimen.

         14. The method of claim 1, wherein the frequency of an immediate post injection reaction or the frequency of an injection site reaction is reduced relative to daily subcutaneous administration of 20 mg glatiramer acetate.

         15. A method of increasing the tolerability of GA treatment in a human 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 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.

         16. The method of claim 15, wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an immediate post injection reaction.

         17. The method of claim 15, wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an injection site reaction.

         ii.'413 patent, claims 1, 7, 15, and 20

         1. A method of reducing the frequency of relapses in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and has MRI features 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.

         7. The method of claim 1, wherein the frequency of an immediate post injection reaction or the frequency of an injection site reaction is reduced relative to daily subcutaneous administration of 20 mg glatiramer acetate.

         15. The method of claim 14, wherein, the lesion is a demyelinating white matter lesion visible on brain MRI and wherein the white matter lesion is at least 3 mm in diameter.

         20. A method of reducing the frequency of relapses in a human patient who has experienced a first clinical episode and has MRI features 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, 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

         1. A method of treatment of a human patient suffering from a relapsing form of multiple 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.

         10. A method of treatment of a human patient suffering from a relapsing form of multiple 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.

         11. The method of claim 10, wherein each subcutaneous injection is on day 1, day 3 and day 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.

         iii. '776 patent, claims 1, 2, 5, 6, 9, 12, 16, and 17

         1. A method of treating a human patient suffering from 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, 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 7.0, 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.

         2. The method of claim 1, which induces reduced frequency and severity of immediate post injection reactions and injection site reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily.

         5. A method for reducing the frequency of relapses by 30% or more as compared to placebo 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 from 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 7.0, 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 of 20 mg of glatiramer acetate s.c. daily.

         6. The method of claim 5, which reduces brain atrophy and for reducing the frequency of relapses by 30%) or more as compared to placebo in a human population.

         9. The method of claim 5, which induces reduced frequency and severity of immediate post injection reactions and injection site reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily.

         12. A method for improving the tolerability of glatiramer acetate treatment of a human patient 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 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.

         16. A method for improving the tolerability of glatiramer acetate therapy reducing the 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 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 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 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.

         17. The method of claim 16, which reduces the frequency of relapses as effectively as administration of 20 mg of glatiramer acetate s.c. daily.

         E. ...


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