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Eli Lilly and Co. v. Zenith Goldline Pharm.

Document Cited authorities 143 Cited in 29 Precedent Map Related
Vincent
Decision Date14 April 2005
Docket NumberNo. 1:01 CV 443 RLY-VSS.,1:01 CV 443 RLY-VSS.
Citation364 F.Supp.2d 820
PartiesELI LILLY AND COMPANY and LILLY INDUSTRIES LTD., Plaintiffs, v. ZENITH GOLDLINE PHARMACEUTICALS, INC., Dr. Reddy's Laboratories, Ltd., and Teva Pharmaceuticals USA, Inc., Defendants.
CourtU.S. District Court — Southern District of Indiana

364 F.Supp.2d 820

ELI LILLY AND COMPANY and LILLY INDUSTRIES LTD., Plaintiffs, v. ZENITH GOLDLINE PHARMACEUTICALS, INC., Dr. Reddy's Laboratories, Ltd., and Teva Pharmaceuticals USA, Inc., Defendants.

No. 1:01 CV 443 RLY-VSS.

United States District Court, S.D. Indiana, Indianapolis Division.

April 14, 2005.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

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COPYRIGHT MATERIAL OMITTED

Andrew J. Miller, Budd, Larner, Gross, Rosenbaum, Short Hills, NJ.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

YOUNG, District Judge. 

                TABLE OF CONTENTS
                FINDINGS OF FACT
                  I.  The Parties .......................................................................830
                 II.  Background in the Relevant Field Prior to the Prosecution of the '382 Patent ......831
                      A.  Schizophrenia .................................................................831
                      B.  Early Drug Treatment — Typical Antipsychotic Drugs ............................831
                      C.  Clozapine: The First Atypical Antipsychotic ...................................832
                      D.  The Search for a Safe, Atypical Antipsychotic Drug ............................832
                      E.  Lilly's Attempts to Discover a Safe, Atypical Antipsychotic Drug ..............832
                      F.  The Discovery of Olanzapine ...................................................834
                III.  Prosecution History of the '382 Patent ............................................835
                      A.  The '143 Patent Application ...................................................835
                      B.  The '348 Continuation Application .............................................837
                 IV.  The Validity of the '382 Patent ...................................................841
                      A.  Anticipation ..................................................................841
                             1.  Anticipation by Chakrabarti 1980a ......................................841
                             2.  Anticipation by Schauzu ................................................843
                      B.  Obviousness ...................................................................844
                             1.  The Scope and Content of the Prior Art .................................844
                                 a.  Clozapine and Clozapine-Like Molecules .............................844
                                 b.  The '574 Patent ....................................................844
                                 c.  The Chakrabarti Articles ...........................................845
                                     (1) Chakrabarti 1980a ..............................................845
                                     (2) Chakrabarti 1982 ...............................................845
                                     (3) Chakrabarti 1989 ...............................................846
                                 d.  The Sullivan and Franklin Article ..................................846
                             2.  Ordinary Skill in the Art ..............................................846
                             3.  The Differences Between the Claimed Invention and the Prior Art ........847
                             4.  Motivation Provided by the Prior Art to Make Olanzapine ................847
                                 a.  Compound '222 as the Beginning Compound ............................847
                                     (1) Compound '222's Activity .......................................847
                                     (2) Hydrogen as a Preferred Substituent ............................848
                                         (a) Compound 6 .................................................848
                
                                         (b) Compound 36 ................................................848
                                         (c) Compound 34 ................................................849
                                 b.  Changing the 2-ethyl in Compound '222 to a 2-methyl ................849
                                 c.  Replacing the Fluorine Atom in Flumezapine with a
                                       Hydrogen Atom ....................................................850
                             5.  Reasonable Expectation of Success ......................................850
                             6.  Composition and Method Claims ..........................................851
                             7.  Secondary Considerations ...............................................852
                                 a.  Long-Felt Need .....................................................852
                                 b.  Failure of Others ..................................................852
                                 c.  Commercial Success .................................................853
                                 d.  Industry Acclaim ...................................................853
                                 e.  Unexpected Differences Between Compound '222 and
                                       Olanzapine — The Dog Studies .....................................853
                                     (1) Basic Principles of Toxicology .................................853
                                     (2) Lilly's and Defendants' Dog Toxicology Studies .................854
                                         (a) Lilly's D07290 Dog Study ...................................854
                                         (b) Zenith's Dog Study — The MPI Study .........................854
                                         (c) DRL's Dog Study — The Calvert Study ........................855
                                     (3) Criticisms of Lilly's Dog Study Evidence .......................856
                                         (a) The Dog as a Model .........................................856
                                         (b) Total Cholesterol as a Tested Parameter ....................856
                                         (c) Randomization ..............................................858
                                         (d) The Length of the Study ....................................859
                                         (e) The Number of Dogs and Analysis by Sex .....................859
                                         (f) The Dosage Used ............................................859
                                         (g) The Use of Equal Doses of Olanzapine and
                                               Compound '222 ............................................860
                                         (h) How the Study Was Conducted ................................860
                                               i)  Good Laboratory Practices Were Followed ..............860
                                              ii)  Double Rations .......................................860
                                         (i) The Results of Lilly's and Zenith's Studies ................861
                                               i)  Statistics Experts for All of the Parties Found a
                                                     Statistically Significant Cholesterol Increase
                                                     in the Compound '222-Treated Dogs ..................861
                                              ii)  The Repeated Measures Analysis Was
                                                     Appropriate ........................................863
                                             iii)  Dunnett's Test Does Not Show that the Effect
                                                     of Compound '222 Is Small ..........................864
                                              iv)  Dr. Gibbons' UPL Test Does Not Show that the
                                                     Effect of Compound '222 Is Small ...................864
                                         (j) The Cholesterol Results ....................................865
                                               i)  The Increase in Cholesterol Is Biologically
                                                     Significant ........................................865
                                              ii)  The Increase in Cholesterol Was Not Caused by
                                                     Other Factors ......................................866
                                                   a)  The Female Estrous Cycle .........................866
                                                   b)  Double Rations ...................................866
                                                   c)  The Alleged Hypothyroid Dog ......................866
                                             iii)  The Reference Range ..................................867
                                              iv)  Other Statistically Significant Changes ..............868
                                               v)  Dog Data Excluded from the Study Did Not
                                                     Effect the Study Findings ..........................869
                                 f.  Prolactin as a Previously Unconsidered Unexpected Result ...........869
                                     (1) The Results of the MPI Study ...................................869
                
                                     (2) The Results of the Calvert Study ...............................870
                                     (3) Olanzapine's Effect on Prolactin ...............................870
                                 g.  Unexpected Differences Between Olanzapine and
                                       Flumezapine ......................................................870
                                     (1) Liver and Muscle Enzyme Test Results from the Flumezapine
                                           Clinical Trials ..............................................871
                                     (2) Liver and Muscle Enzyme Test Results from Olanzapine
                                           Clinical Trials ..............................................871
                                     (3) Dr. Diamond's Opinion ..........................................872
                      C.  Double Patenting ..............................................................873
                      D.  Public Use ....................................................................873
                      E.  Inequitable Conduct ...........................................................875
                             1.  Lilly's Statements to the PTO Did Not Contradict Prior Statements
                                   It Made to the Swedish Board of Health ...............................875
                             2.  Lilly Did Not Believe that It Was Necessary to Compare Olanzapine
                                   and Compound '222 in a Second Species ................................877
                             3.  Dr. McGrath Believed the Effect of Compound '222 on Cholesterol
                                   Was Significant Before Dr. Symanowski Performed a Statistical
...

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