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Mitsubishi Chem. Corp.. v. Barr Laboratories Inc. .

Document Cited authorities 113 Cited in 22 Precedent Map Related
Vincent
Decision Date16 June 2010
Docket NumberNo. 07 Civ. 11614(JGK).,07 Civ. 11614(JGK).
Citation718 F.Supp.2d 382
PartiesMITSUBISHI CHEMICAL CORP., et al., Plaintiffs, v. BARR LABORATORIES, INC., et al., Defendants.
CourtU.S. District Court — Southern District of New York

718 F.Supp.2d 382

MITSUBISHI CHEMICAL CORP., et al., Plaintiffs,

v.BARR LABORATORIES, INC., et al., Defendants.

No. 07 Civ. 11614(JGK).

United States District Court,S.D. New York.

June 16, 2010.

OPINION TEXT STARTS HERE

COPYRIGHT MATERIAL OMITTED.

COPYRIGHT MATERIAL OMITTED.

COPYRIGHT MATERIAL OMITTED.

Andre K. Cizmarik, Anthony Joseph Viola, Edwards Angell Palmer & Dodge, LLP, Daniel Eric Shaw, Jonathan Lee Hochman, Schindler Cohen & Hochman, Robert J. Gunther, Jr., Sadaf R. Abdullah, Wilmer, Cutler, Hale & Dorr, L.L.P., New York, NY, Barbara L. Moore, Christopher P. Silva, David G. Conlin, Kathleen B. Carr, Thomas Hoelder Wintner, Windy Rosebush Catino, Adam Philllip Samansky, David Cotta, Edwards Angell Palmer & Dodge LLP, Christopher R. Noyes, Gregory P. Teran, Lisa J. Pirozzolo, William F. Lee, Wilmer, Cutler, Pickering, Hale and Dorr, LLP, Boston, MA, Jeffrey M. Drake, Martin L. Katz, Wood Phillips, Chicago, IL, Ken Sakurabayashi, Wilmer Cutler Pickering Hale & Dorr L.L.P., Washington, DC, for Plaintiffs.

Steven Howard Reisberg, Thomas John Meloro, Jr., Diane Christine Ragosa, Genevieve Elaine Blake, Heather Marie Schneider, Willkie Farr & Gallagher LLP, New York, NY, for Defendants.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

JOHN G. KOELTL, District Judge:

                +-----------------------------------------+
                ¦INTRODUCTION                         ¦388¦
                +-------------------------------------+---¦
                +-------------------------------------+---¦
                ¦LEGAL BACKGROUND AND FINDINGS OF FACT¦390¦
                +-------------------------------------+---¦
                +-----------------------------------------+
                 
                +---------------------------------------------------------------+
                ¦¦I.  ¦Jurisdiction                                         ¦390¦
                ++----+-----------------------------------------------------+---¦
                ++----+-----------------------------------------------------+---¦
                ¦¦II. ¦Relevant Statutory and Regulatory Provisions         ¦390¦
                ++----+-----------------------------------------------------+---¦
                ++----+-----------------------------------------------------+---¦
                ¦¦III.¦The Presumption of Validity and the Standard of Proof¦391¦
                ++----+-----------------------------------------------------+---¦
                ++----+-----------------------------------------------------+---¦
                ¦¦IV. ¦The Parties                                          ¦391¦
                ++----+-----------------------------------------------------+---¦
                ++----+-----------------------------------------------------+---¦
                ¦¦V.  ¦Background of the '052 Patent                        ¦392¦
                +---------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦A.¦The '052 Patent Technology Permits Injection of Argatroban With Less¦395¦
                ¦¦¦  ¦Fluid Volume                                                        ¦   ¦
                +++--+--------------------------------------------------------------------+---¦
                ¦¦¦B.¦The Ability to Supply Argatroban in 2.5 ml 100 mg/mL Vials Provides ¦396¦
                ¦¦¦  ¦Substantial Advantages                                              ¦   ¦
                +++--+--------------------------------------------------------------------+---¦
                ¦¦¦C.¦Clinical Background Relevant to the '052 Patent                     ¦397¦
                +-----------------------------------------------------------------------------+
                 
                +---------------------------+
                ¦¦¦¦1.¦HIT              ¦397¦
                ++++--+-----------------+---¦
                ¦¦¦¦2.¦Treatment of HIT ¦399¦
                +---------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦D.¦Background on Pharmaceutical Development and Formulation in the     ¦401¦
                ¦¦¦  ¦Prior Art Period                                                    ¦   ¦
                +++--+--------------------------------------------------------------------+---¦
                ¦¦¦E.¦Development of Argatroban Injection                                 ¦401¦
                +-----------------------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦¦1.¦The Surprising Nature of the Discoveries Claimed in the '052 Patent¦401¦
                ++++--+-------------------------------------------------------------------+---¦
                ¦¦¦¦2.¦Concurrent and Subsequent Failures of Others                       ¦402¦
                +-----------------------------------------------------------------------------+
                 
                +--------------------------------+
                ¦¦¦F.¦The '052 Patent Claims ¦403¦
                +--------------------------------+
                 
                +-----------------------+
                ++---+--------------+---¦
                ¦¦VI.¦The Prior Art ¦403¦
                +-----------------------+
                 
                +----------------------------------------------------------+
                ¦¦¦A.¦Ordinary Skill in the Art                        ¦403¦
                +++--+-------------------------------------------------+---¦
                ¦¦¦B.¦Relevance of the Chemical Structure of Argatroban¦404¦
                +----------------------------------------------------------+
                 
                +-----------------------------+
                ++----+-------------------+---¦
                ¦¦VII.¦Claim Construction ¦407¦
                +-----------------------------+
                 
                +---------------------------------------------+
                ¦¦¦A.¦The Law Governing Claim Construction¦407¦
                +---------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦¦1.¦Claims Are To Be Given Their Ordinary Meaning                      ¦408¦
                ++++--+-------------------------------------------------------------------+---¦
                ¦¦¦¦2.¦Limitations From the Specification Should Not Be Read Into the     ¦408¦
                ¦¦¦¦  ¦Claims                                                             ¦   ¦
                ++++--+-------------------------------------------------------------------+---¦
                ¦¦¦¦3.¦The Role of Prosecution History and Extrinsic Evidence             ¦409¦
                +-----------------------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦B.¦The Construction of Claim Terms                                     ¦410¦
                +++--+--------------------------------------------------------------------+---¦
                ¦¦¦C.¦The Proper Construction of “Pharmaceutical Composition For          ¦411¦
                ¦¦¦  ¦Injection”                                                          ¦   ¦
                +-----------------------------------------------------------------------------+
                 
                +------------------------+
                ++-----+-------------+---¦
                ¦¦VIII.¦Anticipation ¦413¦
                +------------------------+
                 
                +---------------------------------+
                ¦¦¦A.¦The Law of Anticipation ¦413¦
                +++--+------------------------+---¦
                ¦¦¦B.¦Yamamoto                ¦416¦
                +---------------------------------+
                 
                +-----------------------------------+
                ¦¦¦¦1.¦The Yamamoto Translations¦416¦
                +-----------------------------------+
                 
                +-------------------------------------+
                ¦¦¦¦¦i.  ¦The Hartmann Translation¦417¦
                +++++----+------------------------+---¦
                ¦¦¦¦¦ii. ¦The Aschmann Translation¦418¦
                +++++----+------------------------+---¦
                ¦¦¦¦¦iii.¦The FDA Translation     ¦418¦
                +-------------------------------------+
                 
                +-----------------------------------+
                ¦¦¦¦¦iv.¦The Cross Translation  ¦419¦
                +++++---+-----------------------+---¦
                ¦¦¦¦¦v. ¦The Yamamoto Reference ¦419¦
                +-----------------------------------+
                 
                +-----------------------------------------------------------------------+
                ¦¦¦¦2.¦Yamamoto Did Not Anticipate Claims 1 and 2 of the '052 Patent¦420¦
                +-----------------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦¦¦i. ¦Yamamoto Did Not Disclose the Patented Method for Dissolving     ¦420¦
                ¦¦¦¦¦   ¦Argatroban in Ethanol, Water, and a Saccharide                   ¦   ¦
                +++++---+-----------------------------------------------------------------+---¦
                ¦¦¦¦¦ii.¦Yamamoto Was Not Enabling                                        ¦422¦
                +-----------------------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------+
                ¦¦¦¦3.¦Yamamoto Did Not Anticipate Claims 3 and 4 of the '052 Patent¦423¦
                +-----------------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦¦¦   ¦Yamamoto Did Not Disclose a Pharmaceutical                       ¦   ¦
                ¦¦¦¦¦i. ¦                                                                 ¦423¦
                ¦¦¦¦¦   ¦Composition for Injection Comprising Argatroban, Water, Ethanol, ¦   ¦
                ¦¦¦¦¦   ¦and a Saccharide                                                 ¦   ¦
                +++++---+-----------------------------------------------------------------+---¦
                ¦¦¦¦¦ii.¦Yamamoto Did Not Enable Claims 3 and 4 of the '052 Patent        ¦424¦
                +-----------------------------------------------------------------------------+
                 
                +---------------------+
                ++---+------------+---¦
                ¦¦IX.¦Obviousness ¦425¦
                +---------------------+
                 
                +--------------------------------+
                ¦¦¦A.¦The Law of Obviousness ¦425¦
                +--------------------------------+
                 
                +-----------------------------------------+
                ¦¦¦¦1.¦The Defendants' Burden of Proof¦427¦
                +-----------------------------------------+
                 
                +-----------------------------------------+
                ¦¦¦B.¦The Defendants' Prima Facie Case¦428¦
                +-----------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦¦1.¦The Prior Art Provided No Basis for One Skilled in the Art to      ¦428¦
                ¦¦¦¦  ¦Create the Invention                                               ¦   ¦
                +-----------------------------------------------------------------------------+
                 
                +-----------------------------------------------------------------------------+
                ¦¦¦¦¦i.  ¦Prior Art References Involving Argatroban                       ¦428¦
                +++++----+----------------------------------------------------------------+---¦
                ¦¦¦¦¦    ¦One Skilled in the Art Would Not Have Been                      ¦   ¦
                ¦¦¦¦¦ii. ¦                                                                ¦429¦
                ¦¦¦¦¦    ¦Motivated to Pursue the '052 Invention in View of the Prior Art ¦   ¦
                ¦¦¦¦¦
...

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