Teva Pharms. USA, Inc. v. Mylan Pharms. Inc.
| Court | United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York |
| Citation | 876 F.Supp.2d 295 |
| Docket Number | Nos. 08 Civ. 7611 (BSJ) (AJP), 09 Civ. 8824 (BSJ) (AJP).,s. 08 Civ. 7611 (BSJ) (AJP), 09 Civ. 8824 (BSJ) (AJP). |
| Parties | TEVA PHARMACEUTICALS USA, INC., et al., Plaintiffs, v. SANDOZ, INC., et al., Defendants. Teva Pharmaceuticals USA, Inc., et al., Plaintiffs, v. Mylan Pharmaceuticals Inc., et al., Defendants. |
| Decision Date | 29 June 2012 |
876 F.Supp.2d 295
TEVA PHARMACEUTICALS USA, INC., et al., Plaintiffs,
v.
SANDOZ, INC., et al., Defendants.
Teva Pharmaceuticals USA, Inc., et al., Plaintiffs,
v.
Mylan Pharmaceuticals Inc., et al., Defendants.
Nos. 08 Civ. 7611 (BSJ) (AJP), 09 Civ. 8824 (BSJ) (AJP).
United States District Court,
S.D. New York.
June 29, 2012.
[876 F.Supp.2d 300]
David M. Hashmall, Goodwin Procter, LLP, Elizabeth J. Holland, Miriam London Martinez, Steven Jeffrey Lee, Carolyn Anne Blessing, Patrice Polyxene Jean, Kenyon & Kenyon, Jeffrey A. Simes, Jonathan Aaron Auerbach, Joseph B. Crystal, Goodwin Procter, LLP, Brian Jeffrey Eutermoser, Weil, Gotshal & Manges LLP, New York, NY, Daryl L. Wiesen, John T. Bennett, Nicholas K. Mitrokostas, Goodwin Procter, LLP, Boston, MA, William G. James, II, Kenyon & Kenyon LLP, Washington, DC, for Plaintiffs.
Anders T. Aannestad, Brian Matthew Kramer, David C. Doyle, Morrison & Foerster LLP, San Diego, CA, Karen Louise Hagberg, Richard B. Mills-Robertson, Morrison & Foerster LLP, Andrew Levine, Friedman, Kaplan, Seiler & Adelman LLP, Beth D. Jacob, Schiff Hardin LLP, New York, NY, David L. Anstaett, Sarah C. Walkenhorst, Perkins Coie LLP, Madison, WI, Ricardo Solano, Jr., Friedman, Kaplan, Seiler & Adelman LLP, Newark, NJ, for Defendants.
BARBARA S. JONES, District Judge.
+-----------------+
¦TABLE OF CONTENTS¦
+-----------------¦
¦ ¦
+-----------------+
+----------------------------------+
¦INTRODUCTION ¦303¦
+------------------------------+---¦
¦ ¦ ¦
+----------------------------------+
+-----------------------------------+
¦I.¦The Parties ¦304¦
+-----------------------------------+
+-------------------------------------------------------------------+
¦ ¦A.¦Teva ¦304 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦B.¦Sandoz ¦304 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦C.¦Mylan ¦304 ¦
+-------------------------------------------------------------------+
+---------------------------------------------------+
¦ ¦ ¦ ¦
+---+------------------------------------------+----¦
¦II.¦The Patents–in–Suit ¦304 ¦
+---------------------------------------------------+
+-------------------------------------------------------------------+
¦ ¦A.¦Overview ¦304 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦B.¦Copaxone®—Teva NDA ¦306 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦C.¦Sandoz's and Momenta's ANDA ¦307 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦D.¦Mylan and Natco ANDA ¦307 ¦
+-------------------------------------------------------------------+
+--------------------------------------------------------------------+
¦ ¦ ¦ ¦
+----+--------------------------------------------------------+------¦
¦III.¦Procedural History and ClaimConstruction ¦308 ¦
+--------------------------------------------------------------------+
+-------------------------------------------------------------------+
¦ ¦A.¦July 2011 Inequitable Conduct Trial ¦309 ¦
+-------------------------------------------------------------------+
+--------------------------------------------------------------+
¦ ¦ ¦i. ¦Teva's Witnesses ¦309 ¦
+----+--+---+-------------------------------------------+------¦
¦ ¦ ¦ii.¦Defendants' Witnesses ¦310 ¦
+--------------------------------------------------------------+
+-------------------------------------------------------------------+
¦ ¦B.¦September 2011 Infringement and Invalidity Trial ¦310 ¦
+-------------------------------------------------------------------+
+----------------------------------------------------------------------------+
¦ ¦ ¦i. ¦Teva's Witnesses ¦310 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦ii. ¦Mylan's Witnesses ¦311 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦iii.¦Sandoz's Witnesses ¦312 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦iv. ¦Witnesses Testifying by Deposition ¦312 ¦
+----------------------------------------------------------------------------+
+-------------------------------------------------------------+
¦ ¦ ¦ ¦
+----+--------------------------------------------------+-----¦
¦IV. ¦The Patents–in–Suit and the Patent Claims at Issue¦313 ¦
+-------------------------------------------------------------+
+-------------------------------------------------------------------+
¦ ¦A.¦Molecular Weight Claim Limitations ¦313 ¦
+-------------------------------------------------------------------+
+----------------------------------------------------------------------------+
¦ ¦ ¦i. ¦Average Molecular Weight Limitations ¦313 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦ii. ¦Molar Fraction Limitations ¦313 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦iii.¦Predetermined Molecular Weight Profile Limitations ¦314 ¦
+----------------------------------------------------------------------------+
+-------------------------------------------------------------------+
¦ ¦B.¦Process Limitations ¦314 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦C.¦Treatment of Multiple Sclerosis ¦315 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦D.¦Pharmaceutical Composition ¦315 ¦
+-------------------------------------------------------------------+
+------------------------------------------+
¦ ¦ ¦ ¦
+--+----------------------------------+----¦
¦V.¦Copolymer–1 and Multiple Sclerosis¦315 ¦
+------------------------------------------+
+----------------------------------------------------------------------------+
¦ ¦A.¦Multiple Sclerosis: The Disease ¦315 ¦
+----+--+------------------------------------------------------------+-------¦
¦ ¦B.¦The Weismann Scientists' Discovery of Copolymer–1 ¦316 ¦
+----+--+------------------------------------------------------------+-------¦
¦ ¦C.¦Teva's Agreement with Weizmann ¦318 ¦
+----+--+------------------------------------------------------------+-------¦
¦ ¦D.¦Discovery of the Process for Achieving Low Molecular ¦321 ¦
¦ ¦ ¦WeightCopolymer–1 ¦ ¦
+----------------------------------------------------------------------------+
+-----------------------------------------------------------------------------+
¦ ¦ ¦ ¦
+----+----------------------------------------------------------------+-------¦
¦VI. ¦Background on Polypeptide Chemistry, Synthesis, Analytical ¦321 ¦
¦ ¦Testing ¦ ¦
+-----------------------------------------------------------------------------+
+-------------------------------------------------------------------+
¦ ¦A.¦Polypeptide Chemistry ¦321 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦B.¦Synthesis of Copolymer–1 ¦322 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦C.¦Size Exclusion Chromatography ¦323 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦D.¦Level of Ordinary Skill in the Art ¦328 ¦
+-------------------------------------------------------------------+
+----------------------------------+
¦ ¦ ¦
+------------------------------+---¦
¦DISCUSSION ¦329¦
+----------------------------------+
+-----------------------------------+
¦ ¦ ¦ ¦
+--+----------------------------+---¦
¦I.¦Infringement ¦329¦
+-----------------------------------+
+-------------------------------------------------------------------+
¦ ¦A.¦General Principles ¦329 ¦
+----+--+----------------------------------------------------+------¦
¦ ¦B.¦Findings of Fact as to Mylan ¦330 ¦
+-------------------------------------------------------------------+
+----------------------------------------------------------------------------+
¦ ¦ ¦i. ¦Mylan's ANDA Product ¦330 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦ii. ¦Amino Acid Composition ¦331 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦iii.¦Molecular Weight ¦331 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦iv. ¦Mylan's Manufacturing Process ¦333 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦v. ¦ANDA Process ¦334 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦vi. ¦Mylan's ANDA Product Label ¦335 ¦
+----------------------------------------------------------------------------+
+-------------------------------------------------------------------+
¦ ¦C.¦Conclusions of Law as to Mylan's ProductProduct ¦335 ¦
+-------------------------------------------------------------------+
+----------------------------------------------------------------------------+
¦ ¦ ¦i. ¦Mylan's Proposed Product Infringes Each o f the ¦335 ¦
¦ ¦ ¦ ¦Asserted Claims because Mylan's Product is Copolymer–1¦ ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦ii. ¦The Reason for Mylan's Molar Ratio is Irrelevant to ¦343 ¦
¦ ¦ ¦ ¦the Infringement Analysis ¦ ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦iii.¦The Doctrine of Equivalents ¦345 ¦
+----+---+----+------------------------------------------------------+-------¦
¦ ¦ ¦iv. ¦Mylan's Product Meets the Molecular Weight Limitations¦347 ¦
+----------------------------------------------------------------------------+
+---------------------------------------------------------------------+
¦ ¦ ¦ ¦1)¦Average Molecular Weight Limitations ¦347 ¦
+----+---+---+--+----------------------------------------------+------¦
¦ ¦ ¦ ¦2)¦Copolymer–1 Molar Fraction Limitations ¦348 ¦
+----+---+---+--+----------------------------------------------+------¦
¦ ¦ ¦ ¦3)¦TFA Copolymer–1 Molar Fraction Limitations ¦348 ¦
+---------------------------------------------------------------------+
+----------------------------------------------------------------------------+
¦ ¦ ¦v....To continue reading
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