In re Omeprazole Patent Litigation, No. M-21-81 (BSJ),

CourtUnited States Courts of Appeals. United States Court of Appeals (5th Circuit)
Writing for the CourtBarbara S. Jones
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.
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).
Decision Date31 May 2007

Page 381

490 F.Supp.2d 381
In 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.
No. M-21-81 (BSJ),
MDL Docket No. 1291.
No. 00 Civ. 6749(BSJ).
No. 03 Civ. 6057(BSJ).
No. 00 Civ. 4541(BSJ).
No. 03 Civ. 8719(BSJ).
No. 01 Civ. 9351(BSJ).
No. 00 Civ. 7597(BSJ).
No. 01 Civ. 2998(BSJ).
United States District Court, S.D. New York.
May 31, 2007.

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Errol B. Taylor, Fred Zullow, Jack Griem, Milbank, Tweed, Hadley & McCloy for Astrazaneca.

Robert S. Silver, Allan H. Fried, William C. Youngblood, Marc Bassler, Alan H. Bernstein, Lynne Terrebonne, Ceasar, Rivise, Bernstein, Cohen & Pokotilow, Karen J. Bernstein, Pryor, Cahsman, Sherman & Flynn, LLP, for Apotex.

Jeffrey J. Toney, John North, Sutherland, Asbill & Brennan, LLP, Steven J. Lee, Thomas J. Meloro, Anthony Giaccio, Kenyon & Kenyon, for Impax.

Douglass C. Hochstetler, Beth D. Jacob, Joanne Kokoski, Schiff, Hardin & Waite, Michael Muczynski, Marshall Gerstein & Borum, Joseph Angland, Heller Ehrmann LLP, for Lek.

Mark A. Pacella, James H. Wallace, Jr., Wiley, Rein & Fielding, for Mylan & Esteve.

Opinion & Order

BARBARA S. JONES, United States District Judge.


TABLE OF CONTENTS

Page 387

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
                

Page 388

 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
                 i. Presence of A Continuous Subcoating ............................490
                 ii. Inert ..........................................................493
                 iii. Water Soluble or Rapidly Disintegrating in Water ...............493
                 iv. Representativeness .............................................494
                 c. Claim 1(c): Enteric Coating and Enhanced Stability ...................497
                

Page 389

 d. Claim 5 of the '505 Patent and Claim 6 of the '230 Patent ............498
                 e. Claim 6 of the '505 Patent and Claim 7 of the '230 Patent ............498
                 f. Claim 8 of the '505 Patent and Claim 10 of the '230 Patent ...........498
                 g. Claim 10 of the '505 Patent and Claim 13 of the '230 Patent ..........499
                 h. Conclusion ...........................................................499
                 III. Invalidity .......................................................................499
                 A. Presumption of Validity ......................................................499
                 B. 35 U.S.C. § 112 .........................................................500
                 1. The Written Description and Enablement
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33 practice notes
  • Ca Inc. v. Simple.Com Inc., No. 02 Civ. 2748 (DRH)(MLO).
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • 5 March 2009
    ...as proof of publication for books, articles, or trade publications.”) (citing [780 F.Supp.2d 308] In re Omeprazole Patent Litig., 490 F.Supp.2d 381, 517–522 (S.D.N.Y.2007) as “accepting prior art references as printed publications without additional evidence of their publication date”). Ind......
  • Alcon Research, LTD. v. Apotex Inc., 1:06-cv-1642-RLY-TAB
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Southern District of Indiana)
    • 23 May 2011
    ...Elizabeth LLC, 676 F.Supp.2d 352,Page 114377-78 (D.N.J. 2009); AstraZeneca, 623 F.Supp.2d at 598-99; In re Omeprazole Patent Litig., 490 F.Supp.2d 381, 499 (S.D.N.Y. 2007); Depomed, Inc. v. Ivax Corp., 532 F.Supp.2d 1170, 1181-82 (N.D. Cal. 2007); Purdue Pharma L.P. v. Boehringer Ingelheim ......
  • Research v. Apotex Inc., No. 1:06–cv–1642–RLY–TAB.
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Southern District of Indiana)
    • 23 May 2011
    ...v. Actavis Elizabeth LLC, 676 F.Supp.2d 352, 377–78 (D.N.J.2009); AstraZeneca, 623 F.Supp.2d at 598–99; In re Omeprazole Patent Litig., 490 F.Supp.2d 381, 499 (S.D.N.Y.2007); Depomed, Inc. v. Ivax Corp., 532 F.Supp.2d 1170, 1181–82 (N.D.Cal.2007); Purdue Pharma L.P. v. Boehringer Ingelheim ......
  • Levenger Co. v. Feldman, No. 06-81054.
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • 21 September 2007
    ...prior to the date of the application for patent in the United States." 35 U.S.C. "§ 102(b); see In re Omeprazole Patent Litigation, 490 F.Supp.2d 381, 510 (S.D.N.Y.2007). In order to show that a claim is invalid due to anticipation by prior art, a party must prove "that all of the elements ......
  • Request a trial to view additional results
33 cases
  • Ca Inc. v. Simple.Com Inc., No. 02 Civ. 2748 (DRH)(MLO).
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • 5 March 2009
    ...as proof of publication for books, articles, or trade publications.”) (citing [780 F.Supp.2d 308] In re Omeprazole Patent Litig., 490 F.Supp.2d 381, 517–522 (S.D.N.Y.2007) as “accepting prior art references as printed publications without additional evidence of their publication date”). Ind......
  • Alcon Research, LTD. v. Apotex Inc., 1:06-cv-1642-RLY-TAB
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Southern District of Indiana)
    • 23 May 2011
    ...Elizabeth LLC, 676 F.Supp.2d 352,Page 114377-78 (D.N.J. 2009); AstraZeneca, 623 F.Supp.2d at 598-99; In re Omeprazole Patent Litig., 490 F.Supp.2d 381, 499 (S.D.N.Y. 2007); Depomed, Inc. v. Ivax Corp., 532 F.Supp.2d 1170, 1181-82 (N.D. Cal. 2007); Purdue Pharma L.P. v. Boehringer Ingelheim ......
  • Research v. Apotex Inc., No. 1:06–cv–1642–RLY–TAB.
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Southern District of Indiana)
    • 23 May 2011
    ...v. Actavis Elizabeth LLC, 676 F.Supp.2d 352, 377–78 (D.N.J.2009); AstraZeneca, 623 F.Supp.2d at 598–99; In re Omeprazole Patent Litig., 490 F.Supp.2d 381, 499 (S.D.N.Y.2007); Depomed, Inc. v. Ivax Corp., 532 F.Supp.2d 1170, 1181–82 (N.D.Cal.2007); Purdue Pharma L.P. v. Boehringer Ingelheim ......
  • Levenger Co. v. Feldman, No. 06-81054.
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • 21 September 2007
    ...prior to the date of the application for patent in the United States." 35 U.S.C. "§ 102(b); see In re Omeprazole Patent Litigation, 490 F.Supp.2d 381, 510 (S.D.N.Y.2007). In order to show that a claim is invalid due to anticipation by prior art, a party must prove "that all of the elements ......
  • Request a trial to view additional results

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