Case Law Teva Pharms. USA, Inc. v. Mylan Pharms. Inc.

Teva Pharms. USA, Inc. v. Mylan Pharms. Inc.

Document Cited Authorities (77) Cited in (27) Related (1)

OPINION TEXT STARTS HERE

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.

Opinion and Order

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    ¦
...
5 cases
Document | U.S. District Court — District of New Jersey – 2014
Janssen Prods., L.P. v. Lupin Ltd.
"...is "an inextricable and essential part of what doctors are prescribing" when they prescribe Prezista. Teva Pharms. USA, Inc. v. Sandoz, Inc., 876 F.Supp.2d 295, 416–17 (S.D.N.Y.2012), aff'd, 723 F.3d 1363 (Fed.Cir.2013), cert. granted on other issues, ––– U.S. ––––, 134 S.Ct. 1761, 188 L.Ed..."
Document | U.S. District Court — District of New Jersey – 2015
AstraZeneca LP v. Breath Ltd.
"...and effective drug often supports the nonobviousness of a drug that finally achieves success.” Teva Pharma. USA, Inc. v. Sandoz, Inc., 876 F.Supp.2d 295, 417 (S.D.N.Y.2012). AstraZeneca introduced evidence of its own failures to create the claimed budesonide compositions using conventional ..."
Document | U.S. District Court — District of New Jersey – 2014
Depomed, Inc. v. Actavis Elizabeth LLC
"...the patents may be demonstrated by an ANDA filer's certification and Notice Letter to the patent holder. Teva Pham. U.S.A., Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295, 349 (S.D.N.Y 2012). In assessing whether an asserted noninfringing use is substantial, the factfinder considers not only the..."
Document | U.S. District Court — Southern District of New York – 2012
Chin–McKenzie v. Continuum Health Partners
"... ... Inc. (“Continuum”) and Long Island College ... See Amnesty Int'l USA v. Clapper, 638 F.3d 118, 129 n. 13 (2d ... "
Document | U.S. District Court — District of Delaware – 2013
Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.
"...Inc., 935 F.2d 1569, 1578 (Fed.Cir.1991) (internal quotation marks and citation omitted); see also Teva Pharm. USA, Inc. v. Sandoz, Inc., 876 F.Supp.2d 295, 417 (S.D.N.Y.2012) (“The repeated failure of others to solve a problem addressed by an invention is further confirmation of the invent..."

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2 books and journal articles
Document | ANDA litigation: strategies and tactics for pharmaceutical patent litigators – 2016
Use of Reissue Proceedings in Hatch-Waxman Litigation
"...found, again, that the ’808 patent was indefinite. On November 5, 2015, Teva then asked the Supreme 51. Teva Pharms. USA, Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295 (S.D.N.Y. 2012), aff’d in part, rev’d in part, 723 F.3d 1363 (Fed. Cir. 2013), judgment vacated, 135 S. Ct. 831. Of the nine pa..."
Document | ANDA litigation: strategies and tactics for pharmaceutical patent litigators. Second edition – 2016
Use of Reissue Proceedings in Hatch-Waxman Litigation
"...that the ’808 patent was indefinite. On November 5, 2015, Teva then asked the Supreme 51. Teva Pharms. USA, Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295 (S.D.N.Y. 2012), aff’d in part, rev’d in part, 723 F.3d 1363 (Fed. Cir. 2013), judgment vacated, 135 S. Ct. 831. Of the nine patents, seven w..."

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1 firm's commentaries
Document | Mondaq United States – 2014
Supreme Court To Consider Federal Circuit De Novo Review Of Claim Construction In Teva Pharmaceuticals USA Inc. V. Sandoz Inc.
"...that a person of ordinary skill in the art would know to use the peak average molecular weight. Teva Pharm. USA, Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295, 400 -01 (S.D.N.Y. 2012) aff'd in part, rev'd in part, 723 F.3d 1363 (Fed. Cir. 2013) cert. granted, 13-854, 2014 WL 199529 (U.S. Mar. 3..."

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2 books and journal articles
Document | ANDA litigation: strategies and tactics for pharmaceutical patent litigators – 2016
Use of Reissue Proceedings in Hatch-Waxman Litigation
"...found, again, that the ’808 patent was indefinite. On November 5, 2015, Teva then asked the Supreme 51. Teva Pharms. USA, Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295 (S.D.N.Y. 2012), aff’d in part, rev’d in part, 723 F.3d 1363 (Fed. Cir. 2013), judgment vacated, 135 S. Ct. 831. Of the nine pa..."
Document | ANDA litigation: strategies and tactics for pharmaceutical patent litigators. Second edition – 2016
Use of Reissue Proceedings in Hatch-Waxman Litigation
"...that the ’808 patent was indefinite. On November 5, 2015, Teva then asked the Supreme 51. Teva Pharms. USA, Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295 (S.D.N.Y. 2012), aff’d in part, rev’d in part, 723 F.3d 1363 (Fed. Cir. 2013), judgment vacated, 135 S. Ct. 831. Of the nine patents, seven w..."

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5 cases
Document | U.S. District Court — District of New Jersey – 2014
Janssen Prods., L.P. v. Lupin Ltd.
"...is "an inextricable and essential part of what doctors are prescribing" when they prescribe Prezista. Teva Pharms. USA, Inc. v. Sandoz, Inc., 876 F.Supp.2d 295, 416–17 (S.D.N.Y.2012), aff'd, 723 F.3d 1363 (Fed.Cir.2013), cert. granted on other issues, ––– U.S. ––––, 134 S.Ct. 1761, 188 L.Ed..."
Document | U.S. District Court — District of New Jersey – 2015
AstraZeneca LP v. Breath Ltd.
"...and effective drug often supports the nonobviousness of a drug that finally achieves success.” Teva Pharma. USA, Inc. v. Sandoz, Inc., 876 F.Supp.2d 295, 417 (S.D.N.Y.2012). AstraZeneca introduced evidence of its own failures to create the claimed budesonide compositions using conventional ..."
Document | U.S. District Court — District of New Jersey – 2014
Depomed, Inc. v. Actavis Elizabeth LLC
"...the patents may be demonstrated by an ANDA filer's certification and Notice Letter to the patent holder. Teva Pham. U.S.A., Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295, 349 (S.D.N.Y 2012). In assessing whether an asserted noninfringing use is substantial, the factfinder considers not only the..."
Document | U.S. District Court — Southern District of New York – 2012
Chin–McKenzie v. Continuum Health Partners
"... ... Inc. (“Continuum”) and Long Island College ... See Amnesty Int'l USA v. Clapper, 638 F.3d 118, 129 n. 13 (2d ... "
Document | U.S. District Court — District of Delaware – 2013
Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.
"...Inc., 935 F.2d 1569, 1578 (Fed.Cir.1991) (internal quotation marks and citation omitted); see also Teva Pharm. USA, Inc. v. Sandoz, Inc., 876 F.Supp.2d 295, 417 (S.D.N.Y.2012) (“The repeated failure of others to solve a problem addressed by an invention is further confirmation of the invent..."

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1 firm's commentaries
Document | Mondaq United States – 2014
Supreme Court To Consider Federal Circuit De Novo Review Of Claim Construction In Teva Pharmaceuticals USA Inc. V. Sandoz Inc.
"...that a person of ordinary skill in the art would know to use the peak average molecular weight. Teva Pharm. USA, Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295, 400 -01 (S.D.N.Y. 2012) aff'd in part, rev'd in part, 723 F.3d 1363 (Fed. Cir. 2013) cert. granted, 13-854, 2014 WL 199529 (U.S. Mar. 3..."

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