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Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution, Inc.

United States District Court, D. Delaware

September 5, 2017

MALLINCKRODT HOSPITAL PRODUCTS IP LTD., INO THERAPEUTICS LLC and IKARIA, INC., Plaintiffs,
v.
PRAXAIR DISTRIBUTION, INC. and PRAXAIR, INC., Defendants

          MEMORANDUM

         I. INTRODUCTION

         In this patent infringement action, Mallinckrodt Hospital Products IP Ltd., INO Therapeutics LLC, and Ikaria, Inc. (collectively, "Plaintiffs" or "Ikaria") allege that Praxair Distribution, Inc. and Praxair, Inc. (collectively, "Defendants" or "Praxair") infringe the asserted claims of the patents-in-suit. (D.I. 1). The court held a seven-day bench trial in this matter, beginning on March 13, 2017. Presently before the court are the parties' post-trial proposed findings of fact and conclusions of law concerning the validity and infringement of the patents-in-suit. (D.I. 80; D.I. 81.) Specifically, Defendants allege that U.S. Patent Nos. 8, 282, 966, 8, 293, 284, 8, 795, 741, 8, 431, 163, and 8, 846112 (collectively, the "HF patents") are invalid under 35 U.S.C. § 101; Defendants argue that they do no infringe U.S. Patent Nos. 8, 573, 209, 8, 776, 794, 8, 776, 795, 9, 265, 911, and 9, 295, 802 (collectively, the "DSIR patents"); and they contend that they do not infringe U.S. Patent No. 9.279, 794 (the "Sensor Drift Patent").

         Pursuant to Federal Rule of Civil Procedure 52(a), having considered the entire record in this case and the applicable law, the court concludes that the HF patents are invalid under § 101, and that Defendants do not infringe the DSIR or the Sensor Drift patents. These findings of fact and conclusions of law are set forth in further detail below.

         II. FINDINGS OF FACT[1]

         A. The Parties

         1. Plaintiff Mallinckrodt Hospital Products IP Ltd. ("Mallinckrodt") is a private unlimited company having a share capital and formed under the laws of Ireland with company number 5683516 and having its registered office at Damastown Industrial Estate, Mulhuddart, Dublin 15. In September 2015, Mallinckrodt IP acquired rights in certain regulatory and intellectual property rights related to INOmax.

         2. Plaintiff INO Therapeutics, LLC ("INOT") is a wholly-owned subsidiary of Mallinckrodt Hospital Products Inc. and is a limited liability company organized and existing under the laws of the State of Delaware, having its principal place of business at Perryville III Corporate Park, P.O. Box 9001, 53 Frontage Road, Third Floor, Hampton, New Jersey 08827-9001.

         3. Plaintiff Ikaria, Inc. ("Ikaria") is a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at Perryville III Corporate Park, P.O. Box 9001, 53 Frontage Road, Third Floor, Hampton, New Jersey 08827-9001. Ikaria no longer exists as a formal legal entity, and has merged into Mallinckrodt Hospital Products, Inc.

         4. Defendant Praxair, Inc. is a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 10 Riverview Drive, Danbury, Connecticut 06810.

         5. Defendant Praxair Distribution, Inc. is a wholly-owned subsidiary of Praxair, Inc., and it is a corporation organized and existing under the laws of the State of Delaware, with its head office at 28 McCandless Ave., Pittsburgh, Pennsylvania 15201.

         6. U.S. Patent No. 8, 282, 966 ("the '966 patent"), entitled "Methods of Reducing the Risk of Occurrence of Pulmonary Edema in Children in Need of Treatment with Inhaled Nitric Oxide, " issued on October 9, 2012, and names James S. Baldassarre and Ralf Rosskamp as the inventors.

         7. The '966 patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for INOmax® (NDA No. N020845).

         8. Form 3542 for the '966 patent lists "A method of reducing the risk of pulmonary edema in patients in need of treatment with inhaled nitric oxide" as the use code for claims 1-29.

         9. The '966 patent is owned by Mallinckrodt IP.

         10. The '966 patent was filed on June 22, 2010.

         11. The '966 patent claims priority to U.S. Patent Application No. 12/494, 598, filed on June 30, 2009.

         12. U.S. Patent No. 8, 293, 284 ("the '284 patent"), entitled "Methods of Reducing the Risk of Occurrence of Pulmonary Edema in Term or Near-Term Neonates in Need of Treatment with Inhaled Nitric Oxide, " issued on October 23, 2012, and names James S. Baldassarre and Ralf Rosskamp as the inventors.

         13. The '284 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         14. Form 3542 for the '284 patent lists "A method of reducing the risk of pulmonary edema in patients in need of treatment with inhaled nitric oxide" as the use code for claims 1-30.

         15. The '284 patent is owned by Mallinckrodt IP.

         16. The '284 patent was filed on June 22, 2010.

         17. The '284 patent claims priority to U.S. Patent Application No. 12/494, 598, filed on June 30, 2009.

         18. U.S. Patent No. 8, 431, 163 ("the ' 163 patent"), entitled "Methods of Reducing the Risk of Occurrence of Pulmonary Edema Associated with the Inhalation of Nitric Oxide Gas, " issued on April 30, 2013, and names James S. Baldassarre and Ralf Rosskamp as the inventors.

         19. The ' 163 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         20. Form 3542 for the ' 163 patent lists "A method of reducing the risk of pulmonary edema in patients in need of treatment with inhaled nitric oxide" as the use code for claims 1-25.

         21. The ' 163 patent is owned by Mallinckrodt IP.

         22. The '163 patent was filed on October 15, 2012.

         23. The '163 patent claims priority to U.S. Patent Application No. 12/821, 041, filed on June 22, 2010, which claims priority to U.S. Patent Application No. 12/494, 598, filed on June 30, 2009.

         24. U.S. Patent No. 8, 795, 741 ("the '741 patent"), entitled "Methods For Treating Patients Who Are Candidates For Inhaled Nitric Oxide Treatment, " issued on August 5, 2014, and names James S. Baldassarre as the inventor.

         25. The '741 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         26. Form 3542 for the '741 patent lists "A method of reducing the risk of pulmonary edema in patients in need of treatment with inhaled nitric oxide" as the use code for claims 1-44.

         27. The '741 patent is owned by Mallinckrodt IP.

         28. The '741 patent was filed on November 21, 2012.

         29. The '741 patent claims priority to U.S. Patent Application No. 13/651, 660, filed on October 15, 2012, which claims priority to U.S. Patent Application No. 12/820, 866, filed on June 22, 2010, which claims priority to U.S. Patent Application No. 12/821, 041, filed on June 22, 2010, which claims priority to U.S. Patent Application No. 12/494, 598, filed on June 30, 2009.

         30. U.S. Patent No. 8, 846, 112 ("the ' 112 patent"), entitled "Methods of Distributing A Pharmaceutical Product Comprising Nitric Oxide Gas For Inhalation" issued on September 30, 2014, and names James S. Baldassarre as the inventor.

         31. The ' 112 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         32. Form 3542 for the ' 112 patent lists "A method of reducing the risk of pulmonary edema in patients in need of treatment with inhaled nitric oxide" as the use code for claims 1-19.

         33. The '112 patent is owned by Mallinckrodt IP.

         34. The ' 112 patent was filed on November 21, 2012.

         35. The '112 patent claims priority to U.S. Patent Application No. 13/651, 660, filed on October 15, 2012, which claims priority to U.S. Patent Application No. 12/820, 866, filed on June 22, 2010, which claims priority to U.S. Patent Application No. 12/821, 041, filed on June 22, 2010, which claims priority to U.S. Patent Application No. 12/494, 598, filed on June 30, 2009.

         36. U.S. Patent No. 8, 291, 904 ("the '904 patent"), entitled "Gas Delivery Device and System" issued on October 23, 2012, and names Duncan P. Bathe, John Klaus, and David Christensen as the inventors.

         37. The '904 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         38. Form 3542 for the '904 patent lists "A method of providing a predetermined concentration of nitric oxide to a patient" as the use code for claims 11-15.

         39. The '904 patent is owned by Mallinckrodt IP.

         40. The '904 patent was filed on June 11, 2012.

         41. The '904 patent claims priority to U.S. Patent Application No. 13/509, 873, filed on June 11, 2012, which is the National Stage Entry of PCT/US11/20319, filed January 6, 2011.

         42. U.S. Patent No. 8, 573, 210 ("the '210 patent"), entitled "Nitric Oxide Delivery Device" issued on November 5, 2013 and lists Duncan P. Bathe, John Klaus, and David Christensen as the inventors.

         43. The '210 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         44. Form 3542 for the '210 patent lists "A method of treating hypoxic respiratory failure by verifying gas information of nitric oxide prior to delivery to patient" as the use code for claims 12-16.

         45. The '210 patent is owned by Mallinckrodt IP.

         46. The '210 patent was filed on November 15, 2012.

         47. The '210 patent claims priority from U.S. Patent Application No. 13/509, 873, filed June 11, 2012, which is the National Stage Entry of PCT/US11/20319, filed January 6, 2011.

         48. U.S. Patent No. 8, 573, 209 ("the '209 patent"), entitled "Gas Delivery Device And System" issued on November 5, 2013, and names Duncan P. Bathe, John Klaus, and David Christensen as the inventors.

         49. The '209 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         50. Form 3542 for the '209 patent does not provide a use code.

         51. The '209 patent is owned by Mallinckrodt IP.

         52. The '209 patent was filed on June 11, 2012.

         53. The '209 patent is the National Stage Entry of PCT/US 11/20319, which was filed on January 6, 2011.

         54. U.S. Patent No. 8, 776, 794 ("the '794 patent"), entitled "Nitric Oxide Delivery Device" issued on July 15, 2014, and names Duncan P. Bathe, John Klaus, and David Christensen as the inventors.

         55. The '794 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         56. Form 3542 for the '794 patent lists "A method of providing a predetermined concentration of nitric oxide to a patient" as the use code for claims 15-20.

         57. The '794 patent is owned by Mallinckrodt IP.

         58. The '794 patent was filed on October 29, 2013.

         59. The '794 patent claims priority to U.S. Patent Application No. 13/677, 483, filed on November 15, 2012, which claims priority to U.S. Patent Application No. 13/509, 873, filed June 11, 2012, which is the National Stage Entry of PCT/US2011/020319, filed January 6, 2011.

         60. U.S. Patent No. 8, 776, 795 ("the '795 patent"), entitled "Gas Delivery Device and System" issued on July 15, 2014, and names Duncan P. Bathe, John Klaus, and David Christensen as the inventors.

         61. The '795 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         62. Form 3542 for the '795 patent lists "A method of providing a predetermined concentration of nitric oxide to a patient" as the use code for claims 15-20.

         63. The '795 patent is owned by Mallinckrodt IP.

         64. The '795 patent was filed on October 29, 2013.

         65. The '795 patent claims priority to U.S. Patent Application No. 13/509, 873, filed on June 11, 2012, which is the National Stage Entry of PCT/US11/20319, filed January 6, 2011.

         66. U.S. Patent No. 9, 295, 802 ("the '802 patent"), entitled "Gas Delivery Device and System" issued on March 29, 2016, and names Duncan P. Bathe, John Klaus, and David Christensen as the inventors.

         67. The '802 patent is listed in the Orange Book for INOmax® (NDA No. N020845).

         68. Form 3542 for the '802 patent lists "A method of providing a predetermined concentration of nitric oxide to a patient" as the use code for claims 10-20.

         69. The '802 patent is owned by Mallinckrodt IP.

         70. The ' 802 patent was filed on February 24, 2015.

         71. The '802 patent claims priority to U.S. Patent Application No. 14/065, 962, filed on October 29, 2013, which claims priority to U.S. Patent Application No. 13/509, 873, which is the National Stage Entry of PCT/US 11/20319, filed January 6, 2011.

         72. U.S. Patent No. 9, 265, 911 ("the '911 patent"), entitled "Gas Delivery Device and System" issued on February 23, 2016, and names Duncan P. Bathe, John Klaus, ...


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