In re Omeprazole Patent Litigation

Decision Date31 May 2007
Docket NumberNo. 00 Civ. 6749(BSJ).,No. 03 Civ. 8719(BSJ).,No. 01 Civ. 2998(BSJ).,No. 03 Civ. 6057(BSJ).,MDL Docket No. 1291.,No. M-21-81 (BSJ),,No. 00 Civ. 7597(BSJ).,No. 00 Civ. 4541(BSJ).,No. 01 Civ. 9351(BSJ).,M-21-81 (BSJ),,00 Civ. 6749(BSJ).,03 Civ. 6057(BSJ).,00 Civ. 4541(BSJ).,03 Civ. 8719(BSJ).,01 Civ. 9351(BSJ).,00 Civ. 7597(BSJ).,01 Civ. 2998(BSJ).
Citation490 F.Supp.2d 381
PartiesIn re OMEPRAZOLE PATENT LITIGATION. Astrazeneca AB, et al., Plaintiffs, v. Mylan Laboratories Inc., et al., Defendants. Astrazeneca AB, et al., Plaintiffs, v. Laboratorios Dr. Esteve, S.A., et al., Defendants. Astrazeneca AB, et al., Plaintiffs, v. Lek Pharmaceutical and Chemical Co., D.D., et al., Defendants. Astrazeneca AB, et al., Plaintiffs, v. Apotex Corp., et al., Defendants. Astrazeneca AB, et al., Plaintiffs, v. Impax Laboratories, Inc., Defendant.
CourtU.S. District Court — Southern District of New York
Opinion & Order

BARBARA S. JONES, United States District Judge.

TABLE OF CONTENTS

                INTRODUCTION ............................................................................390
                   I.  The Parties ......................................................................390
                  II.  The Patents-In-Suit ..............................................................392
                       A.  Patent Ownership .............................................................394
                 III.  The Pleadings ....................................................................395
                       A.  Complaint Against Mylan/Esteve ...............................................396
                       B.  Complaints Against Lek .......................................................397
                       C.  Complaint Against Apotex .....................................................398
                       D.  Complaints Against Impax .....................................................398
                DISCUSSION ..............................................................................399
                   I.  Daubert Motions ..................................................................399
                       A.  Choice of Law ................................................................399
                       B.  Legal Requirements Under Daubert and Rule 702 ................................400
                       C.  Expert Qualifications ........................................................402
                           1.  Plaintiffs' Expert Witnesses .............................................402
                       D.  Daubert Analysis Applies to Weight and Credibility ...........................412
                  II.  Infringement .....................................................................413
                       A.  General Principles ...........................................................413
                       B.  Infringement Analysis ........................................................414
                           1.  Claim Construction .......................................................415
                               a.  Statement of the Law .................................................415
                               b.  Construed Claims of the '505 and '230 Patents ........................418
                           2.  Applying The Claims To The Allegedly Infringing Product ..................422
                               a.  Literal Infringement .................................................422
                               b.  Infringement Under The Doctrine Of Equivalents .......................423
                       C.  Mylan/Esteve's Product .......................................................424
                           1.  Mylan/Esteve's Formulation and Manufacturing Process .....................425
                               a.  Bulk Omeprazole From Esteve ..........................................427
                           2.  Claim 1(a): An Effective Amount of an Alkaline Reacting
                                 Compound (ARC) .........................................................427
                               a.  Presence of an ARC ...................................................427
                                     i.  Talc ...........................................................428
                                    ii.  HPMC ...........................................................431
                                   iii.  TEA ............................................................433
                                    iv.  Combination of Carbonates/Bicarbonates in Talc and
                                           HPMC and TEA in Omeprazole ...................................435
                               b.  Effective Amount of an ARC in Mylan/Esteve's Final Product ...........435
                                     i.  Carbonates in Talc and HPMC ....................................436
                                    ii.  TEA in Omeprazole ..............................................439
                               c.  Micro-pH of the Omeprazole in Mylan/Esteve's Product .................440
                
                               d.  Doctrine of Equivalents ..............................................442
                               e.  Alkaline Omeprazole Salt Equivalent ..................................443
                           3.  Claim 1(b): An Inert Subcoating That is Soluble or Rapidly
                                 Disintegrating in Water ................................................443
                               a.  Presence of A Subcoating .............................................443
                               b.  Inert ................................................................444
                               c.  Water Soluble or Rapidly Disintegrating in Water .....................444
                           4.  Claim 1(c): Enteric Coating and Enhanced Stability .......................447
                           5.  Conclusion ...............................................................447
                       D.  Lek's Product ................................................................448
                           1.  Lek's Formulation and Manufacturing Process ..............................448
                               a.  Bulk Omeprazole Used in Lek's Product ................................449
                               b.  Lek's Product Manufacturing Process ..................................449
                           2.  Claim 1(a) of the '505 Patent: An Effective Amount of an Alkaline
                                 Reacting Compound (ARC) ................................................450
                               a.  Micro-pH of the Omeprazole in Lek's Product ..........................450
                                    i.  Microenvironment of Lek's Omeprazole ............................451
                                   ii.  pH of the Omeprazole Used in Lek's Formulation ..................453
                               b.  Presence of an. ARC ..................................................455
                                    i.  Presence of MA in Lek's Bulk Omeprazole .........................456
                                   ii.  Presence of TEA and MA in Lek's Final Formulation ...............457
                                        (a) Mass Spectrometry Testing of Lek's Final Product ............457
                               c.  Effective Amount of TEA and MA .......................................462
                               d.  Doctrine of Equivalents ..............................................464
                               e.  Alkaline Omeprazole Salt Equivalent ..................................464
                           3.  Claim 1(b): An Inert Subcoating That is Soluble or Rapidly
                                 Disintegrating in Water ................................................465
                           4.  Claim 1(c): Enteric Coating and Enhanced Stability .......................470
                           5.  Conclusion ...............................................................471
                       F.  Apotex's Product .............................................................471
                           1.  Apotex's Formulation and Manufacturing Process ...........................471
                           2.  Claim 1(a): An Effective Amount of an Alkaline Reacting Compound
                                 (ARC) ..................................................................472
                           3.  Claim 1(b): An Inert Subcoating That is Soluble or Rapidly Disintegrating
                                 in Water ...............................................................473
                               a.  Presence Enteric Subcoating ..........................................474
                               b.  Inert ................................................................483
                               c.  Water Soluble or Rapidly Disintegrating in Water .....................483
                           4.  Claim 1(c): Enteric Coating and Enhanced Stability .......................484
                           5.  Claim 5 of the '505 Patent and Claim 6 of the '230 Patent ................484
                           6.  Claim 6 of the '505 Patent and Claim 7 of the '230 Patent ................485
                           7.  Claim 10 of the '505 Patent and Claim 13 of the '230 Patent ..............485
                           8.  Conclusion ...............................................................486
                       F.  Impax's Product ..............................................................486
                           1.  Impax's Objections to Plaintiffs' Exhibits ...............................487
                           2.  Impax's Formulation and Manufacturing Process ............................487
                           3.  Claim 1 of the '505 and '230 Patents .....................................488
                               a.  Claim 1(a): An Effective Amount of an Alkaline Reacting
                                     Compound (ARC)......................................................488
                               b.  Claim 1(b): An Inert Subcoating That is Soluble or Rapidly
                                     Disintegrating in Water ............................................489
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