In re Omeprazole Patent Litigation, No. M-21-81 (BSJ),
| Court | United States Courts of Appeals. United States Court of Appeals (5th Circuit) |
| Writing for the Court | Barbara S. Jones |
| Citation | 490 F.Supp.2d 381 |
| Parties | 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. |
| Docket Number | No. 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 Date | 31 May 2007 |
Page 381
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.
Page 382
COPYRIGHT MATERIAL OMITTED
Page 383
COPYRIGHT MATERIAL OMITTED
Page 384
COPYRIGHT MATERIAL OMITTED
Page 385
COPYRIGHT MATERIAL OMITTED
Page 386
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.
BARBARA S. JONES, United States District Judge.
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...To continue reading
Request your trial
33 practice notes
-
Ca Inc. v. Simple.Com Inc., No. 02 Civ. 2748 (DRH)(MLO).
...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
...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.
...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.
...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).
...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
...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.
...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.
...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