Case 1:15-cv-01159-GMS-SRF Document 155 Filed 03/01/18 Page 1 of 48 PageID #: 3153
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 15-1159-GMS
`CONSOLIDATED
`
`ALCON RESEARCH, LTD.,
`
`Plaintiff,
`
`v.
`
`WATSON LABS., INC.,
`
`Defendant.
`
`ALCON RESEARCH, LTD.,
`
`Plaintiff,
`
`v.
`
`LUPIN LTD., & .
`LUPIN PHARMA., INC.,
`
`Defendants.
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`I.
`
`INTRODUCTION
`
`MEMORANDUM
`
`In this patent infringement action, Alcon Research, Ltd. alleges that Watson Labs., Inc.,
`
`Lupin Ltd., and Lupin Pharma. Inc., (collectively, "the Defendants") infringes the asserted claims
`
`of the patents-in-suit. The court held a four-day bench trial in this matter beginning on October
`
`2, 2017. Presently before the court are the parties' post-trial proposed findings of fact and
`
`conclusions oflaw concerning the validity of the patents-in-suit, specifically whether the asserted
`
`claims are invalid as obvious under 35 U.S.C. § 103. (D.I. 149; D.I. 150.)
`
`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 asserted claims of the patents-in-suit
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`Case 1:15-cv-01159-GMS-SRF Document 155 Filed 03/01/18 Page 2 of 48 PageID #: 3154
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`are not invalid due to obviousness. These findings of fact and conclusions of law are set forth in
`
`further detail below.
`
`IT.
`
`FINDINGS OF FACT1
`
`A. The Parties
`
`Plaintiff Alcon Research, Ltd. ("Alcon") is a corporation organized and existing under the
`1.
`laws ofthe State of Delaware, having its principal place of business at 6201 South Freeway, Fort
`Worth, Texas 76134.
`
`Defendant Watson Laboratories, Inc. ("Watson") is a corporation organized and existing
`2.
`under the laws of the State of Nevada, having its principal place ofbusiness at 311 Bonnie Circle,
`Corona, California 92880, and a place of business at Morris Corporate Center III, 400 Interpace
`Parkway, Parsippany, New Jersey 07054.
`
`Defendant Lupin Ltd. ("Lupin") is a corporation organized and existing under the laws of
`3.
`India, with a principal place of business at B/4 Laxmi Towers, Bandra-Kurla Complex, Bandra €,
`Mumbai 400 051, India.
`
`Lupin Pharmaceuticals, Inc. ("Lupin Pharms") is a corporation organized and existing
`4.
`under the laws of Delaware having a principal place of business at Harborplace Tower, 111 South
`Calbert Street, Baltimore, Maryland 21202.
`
`Lupin Pharms is an indirectly wholly-owned subsidiary of Lupin Ltd. (collectively,
`5.
`"Lupin").
`
`6.
`
`The court has subject matter jurisdiction and personal jurisdiction over all parties.
`
`B. Background
`
`On January 30, 2015, Novartis Pharmaceuticals Corp., an affiliate of Alcon, received
`7.
`approval from the FDA to market olopatadine hydrochloride ophthalmic solution (0. 7%) under the
`trade name Pazeo® for the treatment of ocular allergic conjunctivitis.
`
`8.
`
`Alcon has asserted claims 4-6, 8-10, 12-14, and 20-27 of the' 154 Patent.
`
`1 Prior to trial, the parties submitted an exhibit of uncontested facts in conjunction with their Pretrial Order.
`(D.I. 131, Ex. 1.) The court takes most of its findings of fact from the parties' uncontested facts. The court has also
`reordered and renumbered some paragraphs and made minor edits for the purpose of concision and clarity that it does
`not believe alters the meaning of the paragraphs from the Pretrial Order. Otherwise, any differences between this
`section and the parties' statement of uncontested facts are unintentional.
`The court's findings of fact with respect to matters that were the subject of dispute between the parties are
`included in Part III this opinion ("Discussion and Conclusions of Law"), preceded by the phrase "the court finds" or
`"the court concludes."
`
`2
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`The Prescribing Information. for Patanol® (Olopatadine Hydrochloride Opthalmic
`9.
`Solution) 0.1 % (Revised August 2002) ("Patanol® Label") was publicly available before October
`19, 2010, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not
`concede that it is relevant prior art.
`
`Highlights of Prescribing Information for Pataday® (Olopatadine Hycdrochloride
`10.
`Opthalmic Solution) 0.2% (Revised August 2010) ("Pataday® Label") was publicly available
`before October 19, 2010, and meets the requirements of35 U.S.C. § 102(b) as prior art, but Alcon
`does not concede that it is relevant prior art.
`
`Alcon Highlights of Prescribing Information and Labeling for Patanase® (Olopatadine
`11.
`Hydrochloride) Nasal Spray (Revised March 2008) ("Patanase® Label") was publicly available
`before October 19, 2010, and meets the requirements of35 U.S.C. § 102(b) as prior art, but Alcon
`does not concede that it is relevant prior art.
`
`Each of Alcon's Patanol®, Pataday®, and Patanase® olopatadine products were
`12.
`commercially available in the United States prior to October 19, 2010, and meets the requirements
`of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is relevant prior art.
`
`C. The Patents-in-Suit
`
`13.
`
`The '154 Patent may be referred to as the "Patent-in-suit."
`
`United States Patent No. 8,791,154 ("the '154 Patent") issued on July 29, 2014 and is
`14.
`entitled "High Concentration Olopatadine Ophthalmic Composition." The '154 Patent names
`Daniel A. Gamache, Laman Alani, Malay Ghosh, Francisxo Javier Galan, Nuria Carreras
`Perdiguer, and Onkar N. Singh as inventors.
`
`The application that matured into the '154 Patent was filed on May 18, 2012 and claims
`15.
`priority to a provisional patent application (No. 61/487,789) that was filed on October 19, 2011.
`
`]6.
`
`The priority date for the asserted claims is October 19, 2011.
`
`The '154 Patent is listed in the Approved Drug Products with Therapeutic Equivalence
`17.
`Evaluations ("Orange Book") at the U.S. Food and Drug Administration ("FDA") in connection
`with Pazeo®.
`
`18.
`
`Alcon is the assignee of and owns the '154 Patent.
`
`It is stipulated that the products that are the subject of Defendants' Abbreviated New Drug
`19.
`Applications infringe asserted claims 8-9 and 21-24 of the '154 Patent. (D.I. 73); (D.I. 93); (D.I.
`131-1, ir 96.)
`
`3
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`1. The Asserted Claims
`
`Alcon has asserted infringement of claims 8, 9, and 21-24 of the '154 Patent against
`20.
`Watson.
`
`Alcon has asserted infringement of claims 8, 9, and 21-24 of the the '154 Patent against
`
`21.
`Lupin.
`
`22.
`
`Claim 8 of the '154 Patent claims:
`
`i. '154 Patent, Claim 8
`
`"[ a]n aqueous ophthalmic solution for treatment of allergic conjunctivitis, the solution comprising:
`at least 0.67 w/v% but no greater than 1.0 w/v% olopatadine dissolved in the solution;
`2.0 w/v% to 6.0 w/v% PEG having a molecular weight of 300 to 500;
`2.0 w/v% to 6.0 w/v% polyvinylpyrrolidone;
`at least 0.5% w/v% but no greater than 2.0 w/v% hydroxypropyl-y-cyclodextrin; and
`water."
`
`ii. '154 Patent, Claim 9
`
`Claim 9 of the '154 Patent claims: [a] solution as in claim 8 further comprising borate at a
`23.
`concentration of at least 0.18 w/v% but less than 0.5 w/v%."
`
`iii. '154 Patent, Claim 21
`
`Claim 21 of the '154 Patent claims: "[a]n aqueous ophthalmic solution for treatment of
`24.
`ocular allergic conjunctivitis, the solution comprising:
`At least 0.67 w/v% but no greater that 1.0 w/v% olopatadine dissolved in the silution;
`2.0 w/v% to 6.0 w/v% PEG having a molecular weight of 300 to 500;
`2.0 w/v% to 6.0 w/v% polyvinylpyrrolidone;
`at least 0.5 w/v% but no greater than 2.0 w/v% hydroxypropyl-y-cyclodextrin;
`greater than 0.003 w/v% but less than 0.03 w/v% benzalkonium chloride; and
`water.;
`wherein the pH of the solution is 6.0 to 7.8 and the osmolality of the solution is 200 to 400
`mOsm/kg."
`
`iv. '154 Patent, Claim 22
`
`Claim 22 of the '154 Patent claims: "[a] solution as in claim 21 further comprising at least
`25.
`0.15 w/v% but no greater than 1.0 w/v% hydroxypropylinethyl cellulose."
`
`v. '154 Patent, Claim 23
`
`26.
`
`Claim 23 of the '154 Patent claims: "[a] solution as in claim 22 wherein:
`i) the concentration of PEG is at least 3.0 w/v% but no greater than 5.0 w/v%;
`
`4
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`ii) the concentration of polyvinylprrolidone is at least 3.0 w/v% but no greater than 5.0
`w/v%; and
`iii) the concentration of hydroxypropyl methylcellulose is at least 0.3 w/v% but no
`greater than 0.5 w//v%."
`
`vi. '154 Patent, Claim 24
`
`Claim 24 of the' 154 Patent claims: "[a] solution as in claim 23 further comprising: at least
`27.
`0.18 w/v% but less than 0.4 w/v% boric acid and at least 0.05 w/v% but no greater than 0.5 w/v%
`mannitol.
`
`2. The Accused Products
`
`i.
`
`ANDA No. 20-8637 Submitted by Watson
`
`28. Watson submitted an Abbreviated New Drug Application ("ANDA") No. 208637 to the
`Food and Drug Administration ("FDA") under Section 505(j) of the Federal Food, Drug, and
`Cosmetic Act ("FFDCA"), 21 U.S.C. § 355(j) seeking approval to engage in the commercial
`manufacture, use, and sale of a generic olopatadine ophthalmic solution ("Watson's ANDA
`Product") prior to the expiration of the '154 Patent. .
`
`29. Watson sent Alcon a letter dated November 3, 2015("Watson'154 Notice Letter"), stating
`that Watson had submitted an ANDA No. 208637 to the FDA seeking approval of the Watson's
`ANDA product.
`
`30. Watson's '154 Notice Letter stated that the claims of the '154 patent are invalid,
`unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the
`product described in ANDA No. 208637.
`·
`
`Alcon brought suit against Watson alleging infringement of the '154 patent under 35
`31.
`U.S.C. § 100 et seq., including§ 271(e)(2)(A), on December 16, 2015, within 45 days of receipt
`of Watson's' 154 Notice Letter.
`
`32. Watson had submitted an Abbreviated New Drug Application ("ANDA") No. 208637 to
`the Food and Drug Administration ("FDA") under Section 505G) of the Federal Food, Drug, and
`Cosmetic Act ("FFDCA"), 21 U.S.C. § 355(j) seeking approval to engage in the commercial
`manufacture, use, and sale of a generic olopatadine ophthalmic solution ("Watson's ANDA
`Product") prior to the expiration of the '154 Patent.
`
`33. Watson's '154 Notice Letter stated that the claims of the '154 patent are invalid,
`unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the
`product described in ANDA No. 208637.
`
`5
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`Alcon brought suit against Watson alleging infringement of the '154 patent under 35
`34.
`U.S.C. § 100 et seq., including§ 271(e)(2)(A), on December 16, 2015, within 45 days of receipt
`of Watson's '154 Notice Letter.
`
`For purposes of this action only and only with respect to ANDA No. 208637, Watson's
`35.
`submission of ANDA No. 208637 constitutes an act of infringement of claims 4-6, 8-10, 12-14,
`16-18, and 20-27 of the' 154 Patent pursuant to 35 U.S.C. § 271(e)(2)(A), provided those claims
`are not found invalid or unenforceable. The commercial manufacture, use, sale, offer to sell, and/or
`importation into the United States of Watson's ANDA Product prior to the expiration of the '154
`Patent would directly infringe, contribute to infringement of, and/or induce infringement of claims
`4-6, 8-10, 12-14, and 20-27 of the '154 Patent pursuant to 35 U.S.C. § 271, to the extent those
`claims are not found invalid or unenforceable. ·
`
`ii.
`
`ANDA No. 20-8896 Submitted by Lupin
`
`Lupin sent Alcon a letter dated March 11, 2016("Lupin's'154 Notice Letter"), stating that
`36.
`Lupin Ltd. had submitted an ANDA No. 208896 to the FDA under § 505G) of the FFDCA §
`355G) seeking approval to engage in the commercial manufacture, use, and sale of a generic
`olopatiadine ophthalmic solution ("Lupin's ANDA Product") prior to the expiration of the '154
`patent. Lupin's Ltd. 's '.154 Notice Letter stated that the claims of the '154 patent are invalid,
`unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the
`product described in ANDA No. 208886.
`
`Alcon brought suit against Lupin alleging infringement of the' 154 patent under 35 U.S.C.
`37.
`§ 100 et seq., including§ 271(e)(2)(A), on March 28, 2016, within 45 days of receipt of Lupin
`Ltd.'s '154 Notice Letter.
`
`For purposes of this action only and only with respect to ANDA No. 208896, Watson's
`38.
`submission of ANDA No. 208896 constitutes an act of infringement of claims 4-6, 8-10, 12-14,
`16-18, and 20-27 of the '154 Patent pursuant to 35 U.S.C. § 271(e)(2)(A), provided those claims
`are not found invalid or unenforceable. The commercial manufacture, use, sale, offer to sell, and/or
`importation into the United States of Lupin's ANDA Product prior to the expiration of the '154
`Patent would directly infringe, contribute to infringement of, and/or induce infringement of claims
`4-6, 8-10, 12-14, and 20-27 of the '154 Patent pursuant to 35 U.S.C. § 271, to the extent those
`claims are not found invalid or unenforceable.
`
`Lupin sent Alcon a letter dated March 11, 2016("Lupin's'154 Notice Letter"), stating that
`39.
`Lupin Ltd. had submitted an ANDA No. 208896 to the FDA under § 505G) of the FFDCA §
`355G) seeking approval to engage in the commercial manufacture, use, and sale of a generic
`olopatiadine ophthalmic solution ("Lupin's ANDA Product") prior to the expiration of the '154
`patent. Lupin' s Ltd.' s '154 Notice Letter stated that the claims of the '154 patent are invalid,
`unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the
`product described in ANDA No. 208886.
`
`6
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`Alcon brought suit against Watson alleging infringement of the '154 patent under 35
`34.
`U.S.C. § 100 et seq., including§ 271(e)(2)(A), on December 16, 2015, within 45 days of receipt
`of Watson's '154 Notice Letter.
`
`For purposes of this action only and only with respect to ANDA No. 208637, Watson's
`35.
`submission of ANDA No. 208637 constitutes an act of infringement of claims 4-6, 8-10, 12-14,
`16-18, and 20-27 of the '154 Patent pursuant to 35 U.S.C. § 271(e)(2)(A), provided those claims
`are not found invalid or unenforceable. The commercial manufacture, use, sale, offer to sell, and/or
`importation into the United States of Watson's ANDA Product prior to the expiration of the ·' 154
`Patent would directly infringe, contribute to infringement of, and/or induce infringement of claims
`4-6, 8-10, 12-14, and 20-27 of the '154 Patent pursuant to 35 U.S.C. § 271, to the extent those
`claims are not found invalid or unenforceable.
`
`ii.
`
`ANDA No. 20-8896 Submitted by Lupin
`
`Lupin sent Alcon a letter dated March 11, 2016("Lupin's'154 Notice Letter"), stating that
`36.
`Lupin Ltd. had submitted an ANDA No. 208896 to the FDA under § 5050) of the FFDCA §
`3550) seeking approval to engage in the commercial manufacture, use, and sale of a generic
`olopatadine ophthalmic solution ("Lupin's ANDA Product") prior to the expiration of the '154
`patent.. Lupin's Ltd.'s '154 Notice Letter stated that the claims of the '154 patent are invalid,
`unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the
`product described in ANDA No. 208886.
`
`Alcon brought suit against Lupin alleging infringement of the '154 patent under 35 U.S.C.
`37.
`§ 100 et seq., including § 271(e)(2)(A), on March 28, 2016, within 45 days of receipt of Lupin
`Ltd.'s '154 Notice Letter.
`
`For purposes of this action only and only with respect to ANDA No. 208896, Watson's
`38.
`submission of ANDA No. 208896 constitutes an act of infringement of claims 4-6, 8-10, 12~14,
`16-18, and 20-27 of the '154 Patent pursuant to 35 U.S.C. § 271(e)(2)(A), provided those claims
`are not found invalid or unenforceable. The commercial manufacture, use, sale, offer to sell, and/or
`importation into the United States of Lupin's ANDA Product prior to the expiration of the '154
`Patent would directly infringe, contribute to infringement of, and/or induce infringement of claims
`4-6, 8-10, 12-14, and 20-27 of the '154 Patent pursuant to 35 U.S.C. § 271, to the extent those
`claims are not found invalid or unenforceable.
`
`Lupin sent Alcon a letter dated March 11, 2016 ("Lupin's '154 Notice Letter"), stating that
`39.
`Lupin Ltd. had submitted an ANDA No. 208896 to the FDA under § 5050) of the FFDCA §
`355(j) seeking approval to engage in the commercial manufacture, use, and sale of a generic
`olopatadine ophthalmic solution ("Lupin' s ANDA Product") prior to the expiration of the '154
`patent. Lupin's Ltd.'s '154 Notice Letter stated that the claims of the '154 patent are invalid,
`unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the
`product described in ANDA No. 208886.
`
`6
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`Alcon brought suit against Lupin alleging infringement of the '154 patent under 35 U.S.C.
`40.
`§ 100 et seq., including§ 271(e)(2)(A), on March 28, 2016, within 45 days of receipt of Lupin
`Ltd.'s '154 Nonce Letter.
`
`3. State of the Art
`
`U.S. Patent No. 5,641,805 ("Hayakawa"), entitled "Topical Ophthalmic Formulations for
`41.
`Treating Allergic Eye Diseases," issued on June 24, 1997 to Hayakawa et al., and meets the
`requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is relevant prior
`art.
`
`Vogelson et al., "Preclinical and clinical antiallergic effect of olopatadine 0.2% solution
`42.
`24 hours after topical ocular administration." Allergy Asthma Proc. 2004 Jan.-Feb., 25(1):69-75
`("Vogelson") was published in 2004, and meets the requirements of 35 U.S.C. § 102(b) as prior
`art, but Alcon does not concede that it is relevant prior art.
`
`Yanni et al., "The In Vitro and In Vivo Ocular Pharmacology of Olopatadine (AL- 4943A),
`43.
`an Effective Anti-Allergic/Antihistamine Agent," Journal of Ocular Pharmacology and
`Therapeutics, 12(4):389-400 (1996) ("Yanni 1996") was published in 1996, and meets the
`requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is relevant prior
`art.
`
`U.S. Patent No. 6,375,973 ("Yanni 2002") issued on April 23, 2002 to John Yanni, and
`44.
`meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is
`relevant prior art.
`
`45.
`U.S. Patent Application Publication No. 2008/0139531 ("Yanni 2008") was published on
`June 12, 2008 to Yanni et al., and meets the requirements of 35 U.S.C. § 102(b) as prior art, but
`Alcon does not concede that it is relevant prior art.
`
`U.S. Patent Publication No. 2011/0082145 ("Schneider") was published on April 7, 2011
`46.
`to Schneider et al., and meets the requirements of 35 U.S.C. § 102(e) as prior art, but Alcon does
`not concede that it is relevant prior art.
`
`47.
`U.S. Patent Application Publication No. 2010/0227917 ("Nakakura") was published on
`September 9, 2010 to Nakakura et al., and meets the requirements of 35 U.S.C. § 102(b) as prior
`art, but Alcon does not concede that it is relevant prior art.
`
`Sharif et al., "Characterization of the Ocular Antiallergic and Antihistaminic Effects of
`48.
`Olopatadine (AL-4943A), a Novel Drug for Treating Ocular Allergic Diseases," The Journal of
`Pharmacology and Experimental Therapeutics, 278(3):1252-61 (1996) ("Sharif') was published
`in 1996, and meets the requirements of35 U.S.C. § 102(b) as prior art, but Alcon does not concede
`that it is relevant prior art.
`
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`International Publication No. WO 2008/015695 ("Bhowmick") was published on February
`49.
`7, 2008 to Bhowmick et al., and meets the requirements of 35 U.S.C. § 102(b) as prior art, but
`Alcon does not concede that it is relevant prior art.
`
`Loftsson & Petersen, "Cyclodextrin solubilization ofETH-615, a zwitterionic drug," Drug
`50.
`Devel. Ind. Pharm., 24(4):365-70 (1998) ("Loftsson 1998") was published in 1998, and meets
`the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is relevant
`prior art.
`
`51.
`U.S. Patent No. 6,995,186 ("Castillo") issued on February 7, 2006 to Castillo et al., and
`meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is
`relevant prior art.
`·
`
`U.S. Patent Application Publication No. 2007/0142458 ("Singh") was published on June
`52.
`21, 2007 to Singh et al., and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon
`does not concede that it is relevant prior art.
`
`PCT International Application Publication No. WO 97/010805 ("Kis") was published on
`53.
`March 27, 1997 to Kis et al., and meets the requirements of35 U.S.C. § 102(b) as prior art, but
`Alcon does not concede that it is relevant prior art.
`
`Loftsson et al., "Cyclodextrins in eye drop formulations: enhanced topical delivery of
`54.
`corticosteroids to the eye," Acta Ophthalmologica Scandinavica 144-150 (2002) ("Loftsson
`2002") was published in 2002, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but
`Alcon does not concede that it is relevant prior art.
`
`Nandi et al., "Cyclodextrins in eye drop formulations: enhanced topical delivery of
`55.
`corticosteroids to the eye," Acta Ophthalmologica Scandinavica 144-150 (2002) ("Loftsson
`2002") was published in 2002, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but
`Alcon does not concede that it is relevant prior art.
`
`Handbook of Pharmaceutical Excipients (5th Ed. 2006) ("Handbook") was published in
`56.
`in 2006, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede
`that it is relevant prior art.
`
`Thorsteinn Loftsson & Dominique Duchene, "Cyclodextrins and Their Pharmaceutical
`57.
`Applications," International Journal of Pharmaceutics 329:1-11 (2007) ("Loftsson 2007") was
`published in 2007, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does
`not concede that it is relevant prior art.
`
`Brewster & Thorsteinn Loftsson, "Cyclodextrins as Pharmaceutical
`58. Marcus E.
`Solubilizers," Advanced Drug Delivery Reviews 59:645-66 (2007) ("Brewster") was published in
`2007, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede
`that it is relevant prior art.
`
`8
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`Jansook .et al., "CDs as solubilizers: Effects of excipients and competing drugs,"
`59.
`International Journal of Pharmaceutics, 379:32-40 (2009) ("Jansook") was published in 2009, and
`meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is
`relevant prior art.
`
`Ophthalmic Drug Facts, 20th ed. (Jimmy D. Bartlett, ed., 2009) ("Bartlett") was published
`60.
`in 2009, and meets the requirements of35 U.S.C. § 102(b) as prior art, but Alcon does not concede
`that it is relevant prior art.
`
`(Jimmy D.
`"Ophthalmic Drug Formulations," Clinical Ocular Pharmacology, 5th ed.
`61.
`Bartlett, ed., 2008) ("Bartlett II") was published in 2008, and meets the requirements of 35 U.S.C.
`§ 102(b) as prior art, but Alcon does not concede that it is relevant prior art.
`
`2006)
`Joseph P. Remington, The Science and Practice of Pharmacy (21st Ed.
`62.
`("Remington's") was published in in 2006, and meets the requirements of 35 U.S.C. § 102(b) as
`prior art, but Alcon does not concede that it is relevant prior art.
`
`U.S. Patent No. 6,407,079 Bl ("Janssen Patent") issued on June 18, 2002 to Muller et al.,
`63.
`and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it
`is relevant prior art.
`
`The Prescribing Information for Patanol® (Olopatadine Hydrochloride Opthalmic
`64.
`Solution) 0.1 % (Revised August 2002) ("Patanol® Label") was publicly available before October
`19, 2010, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon does not
`concede that it is relevant prior art.
`
`Highlights of Prescribing Information for Pataday® (Olopatadine Hycdrochloride
`65.
`Opthalmic Solution) 0.2% (Revised August 2010) ("Pataday® Label") was publicly availavle
`before October 19, 2010, and meets the requirements of35 U.S.C. § 102(b) as prior art, out Alcon
`does not concede that it is relevant prior art.
`
`Alcon Highlights of Prescribing Information and Labeling for Patanase® (Olopatadine
`66.
`Hydrochloride) Nasal Spray (Revised March 2008) ("Patanase® Label") was publicly available
`before October 19, 2010, and meets the requirements of 35 U.S.C. § 102(b) as prior art, but Alcon
`does not concede that it is relevant prior art.
`
`Each of Alcon's Patanol®, Pataday®, and Patanase® olopatadine products were
`67.
`commercially available in the United States prior to October 19, 2010, and meets the requirements
`of 35 U.S.C. § 102(b) as prior art, but Alcon does not concede that it is relevant prior art.
`
`D. Procedural History
`
`On December 16, 2015, Plaintiff filed patent infringement claims against Watson asserting
`68.
`infringement of the patents-in-suit, within 45 days ofreceipts of Watson's' 154 Notice Letter under
`Civil Action No. 15-1159. (D.I. 1.)
`
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`Case 1:15-cv-01159-GMS-SRF Document 155 Filed 03/01/18 Page 11 of 48 PageID #: 3163
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`On June 2, 2016, Plaintiff added Lupin Ltd., and Lupin Pharms., Inc. to Civil Action No.
`69.
`15-1159 for infringement of the patents-in-suit. (D.I. 31.)
`
`On December 9, 2016, it was stipulated that Watson's ANDA infringes claims 8-9 and 21-
`70.
`24 of the '154 Patent. (D.I. 71.)
`
`71.
`On February 2, 2017, it was stipulated that Lupin's ANDA infringe claims 8-9 and 21-24
`of the '154 Patent. (D.I. 90.)
`
`On March 24, 2017, Alcon brought suit against Lupin alleging infringement of the '053
`72.
`Patent within 45 days of receipt of Lupin's '053 Notice Letter.
`
`On October 4, 2017, Plaintiff and Watson stipulated that Alcon's claims against Watson
`73.
`for infringement of the '053 Patent are dismissed with prejudice as applied to ANDA No. 208637
`and that Defendants' counterclaims against Alcon regarding the '053 Patent are dismissed with
`prejudice. (D.I. 140.)
`
`On October 4, 2017, Plaintiff and Lupin stipulated that Alcon's claims against Lupin for
`74.
`infringement of the '053 Patent are dismissed with prejudice as applied to ANDA No. 208896 and
`that Lupin's counterclaims against Alcon regarding the '053 Patent are dismissed with prejudice.
`(D.I. 140.)
`
`In the Proposed Joint Pretrial Order, Defendants asserted obviousness, enablement, and
`75.
`written description defenses. (D.I. 131.)
`
`The court held a bench trial on October 2, 2017 through October 5, 2017. After opening
`76.
`statements, Defendants dropped all written description arguments and all but one enablement
`argument. Tr. 56:4-25, 58:1-5. At trial, the court granted judgment rejecting Defendants'
`remaining enablement argument at the close of Defendants'· case. Tr. 391 :25-393:11. Thus, only
`Defendants' assertion of obviousness remains for decision.
`
`77.
`On November 16, 2017, Defendants and Plaintiff submitted their Post-Trial Proposed
`Findings of Fact and Conclusions of Law. (D.I. 149); (D.I. 150).
`
`On February 22, 2018, Plaintiff Alcon Research, Ltd. and Defendant Watson Laboratories,
`78.
`Inc. Stipulated to dismissal of all claims and defenses asserted by Alcon against Watson and all
`claims and defenses asserted by Watson against Alcon. Parties agreed to bear their own costs,
`disbursements and attorneys' fees. (D.I. 153.)
`
`The only remaining issue for the court to decide is whether claims 8-9 and 21-24 of the
`79.
`'154 Patent are obvious.
`
`III. DISCUSSION AND CONCLUSIONS OF LAW
`
`These consolidated cases arise under the patent laws of the United States. The court has
`
`subject matter jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331, 1338(a). Venue is
`
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`Case 1:15-cv-01159-GMS-SRF Document 155 Filed 03/01/18 Page 12 of 48 PageID #: 3164
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`proper in this court under 28 U.S.C. §§ 1391, and 1400(b). After having considered the entire
`
`record in this case, the substantial evidence in the record, the parties' post-trial submissions, and
`
`the applicable law, the court concludes that the Defendants have failed to establish by clear and
`
`convincing evidence that the asserted claims of the '154 Patent would have been obvious to a
`
`person having ordinary skill in the art as of the October 19, 2011 priority date. The asserted claims
`
`of the '154 Patent are, therefore, valid under 35 U.S.C. § 103. The court's reasoning follows.
`
`A. Obviousness
`
`1. The Legal Standard
`
`35 U.S.C. § 103(a) provides that a patent may not be obtained "ifthe differences between
`
`the subject matter sought to be patented and the prior art are such that the subject matter as a whole
`
`would have been obvious to a person having ordinary skill in the art." Obviousness is a question
`
`oflaw that is predicated on several factual inquires. See Richardson-Vicks v. Upjohn Co., 122 F.3d
`
`1476, 1479 (Fed. Cir. 1997). The trier of fact is directed to assess four considerations: (1) the
`
`scope and content of the prior·art; (2) the level of ordinary skill in the art; (3) the differences
`
`between the claimed subject matter and the prior art; and (4) secondary considerations of non-
`
`obviousness, such as commercial success, long felt but unsolved need, failure of others,
`
`acquiescence of others in the iil~ustry that the patent is valid, and unexpected results. See Graham
`
`v. John Deere Co., 383 U.S. 1, 17-18 (1966).
`
`"A patent shall be presumed valid." 35 U.S.C. § 282. A party seeking to challenge the
`
`validity of a patent based on obviousness must demonstrate by clear and convincing evidence2 that
`
`the invention described in the patent would have been obvious to a person of ordinary skill in the
`
`2 "Clear and convincing evidence is evidence that places in the fact finder an abiding conviction that the truth
`of [the] factual contentions are highly probable." Alza Corp v. Andrx Phanns., LLC, 607 F. Supp. 2d 614, 631 (D.
`Del. 2009) (internal quotations omitted) (quoting Colorado v. New Mexico, 467 U.S. 310, 316 (1984)).
`
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`Case 1:15-cv-01159-GMS-SRF Document 155 Filed 03/01/18 Page 13 of 48 PageID #: 3165
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`art at the time the invention was made. Importantly, in determining what would have been obvious
`
`to one of ordinary skill in the art, the use of hindsight is not permitted. See KSR Int 'l Co. v. Teleflex,
`
`Inc., 550 U.S. 398, 421 (2007) (cautioning the trier of fact against "the distortion caused by
`
`hindsight bias" and "arguments reliant upon ex post reasoning" in determining obviousness). In
`
`KSR, the Supreme Court rejected the rigid application of the principle that there should be an
`
`explicit teaching, suggestion, or motivation in the prior art, the "TSM test," in order to find
`
`obviousness. See id. at 415. The KSR Court acknowledged, however, the importance of identifying
`
`"a reason that would have prompted a person of ordinary skill in the relevant field to combine the
`
`elements in the way the claimed new invention does." Id. at 418.
`
`"Obviousness does not require absolute predictability of success," but rather, requires "a
`
`reasonable expectation of success." See Medichem, S.A. v. Rolado, S.L., 437 F.3d 1157, 1165
`
`(Fed. Cir. 2006) (quoting In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)). To this end,
`
`obviousness "cannot be avoided simply by a showing of some degree of unpredictability in the art
`
`·so long as there was a reasonable probability of success." Pfizer, Inc. v. Apotex, Inc., 480 F.3d
`
`1348, 1364 (Fed. Cir. 2007). Moreover, while the Federal Circuit has noted that pharmaceuticals
`
`can be an "unpredictable art" to the extent that results may b