Case b:17-cv-00374-LPS Document 746 Filed 10/O2/20 Page l of 8 PagelD #: 17642
`
`Al E20 Ray, ORION
`
`Mail Stop &
`Director of the U.S, Patent and Trademark Office
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`PICKET NO. |
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`PLAINTIFF
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`DEFENDANT
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`District of Dalaware
`
`BristolMyers Squibb Campany and Pfizer inc.
`
`Aurobindo Pharma USA Inc.
`
`TRADEMARK NO
`
`HOLDER OF PATENT OR TRADEMARS.
`
`Yn the above-~onttthec
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`Copy 2-—Upon Hing document adding patent(s), mail this capy to Direetar Capy 4—Case fie copy
`
`
`
`Al E20 Ray, ORION
`
`Mail Stop &
`Director of the U.S, Patent and Trademark Office
`33, Box 1456
`Alexandria, VA 22323-1456
`
`REPORTON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OB
`TRADEMARR
`
`in Compliance with
`Med in the US. Distriat Cour
`
`
`
`§ you are hereby advised that @ court action hay been
`
`
`
`on the Rllowing
`
`f) Trademarks or
`
`PICKET NO. |
`
`PLAINTIFF
`
`‘
`
`i201F
`
`US. OP
`
`URE
`
`DEFENDANT
`
`District of Dalaware
`
`BristolMyers Squibb Campany and Pfizer inc.
`
`Aurobindo Pharma USA Inc.
`
`TRADEMARK NO
`
`HOLDER OF PATENT OR TRADEMARS.
`
`Yn the above-~onttthec
`
`
`IICLUDED BY
`
` se,
`
`the fallowMEP
`fe Axngsaciresnt 7 Answer
`
`Sristol- Myers Squibb Company
`
`en rendered oy sRigenient is9 edd:
`
`HOLDEROF PATENT OR TRADEMARK
`
`tu the aboveentidlad case, Une follasvi
`
`wagn
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`ss
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`sybene wo aeA, Skewes | Pe Z~ ASrs RennAOAREOOOOOETA
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`Copy i—Upen initiation af action, mail this cepy to Direstor Copy 3—Upar termination of action, mad this capy to Director
`Copy 2-—Upon Hing document adding patent(s), mail this capy to Direetar Capy 4—Case fie copy
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`
`
`Case b:17-cv-00374-LPS Document 746 Filed 10/O2/20 Page 2 of PagelD #: 17643
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BRISTOL-MYERS SQUIBB COMPANYand
`PFIZER INC,
`
`Plaintiffs and Counterclaim-Defendants,
`
`Y.
`
`C.A. No. 17-cv-374-LPS
`(CONSOLIDATED)
`
`
`
`AUROBINDO PHARMAUSA UNC, and
`AUROBINDO PHARMA LTD.,
`
`DefendantsandCounterclaim-Plaintiffs. |
`
`=
`
`
`
`
`PROPOSED] ORDER AND FINAL JUDGMENT
`
`This action, having beentried before the Court from October 23, 2019, to November 13,
`
`2019, the Honorable Leonard P. Stark, Chief District Judge, presiding, the evidence and
`
`testimony ofwitnesses ofeach side having been heard and a dseisiogRaving been rendered:
`IT IS HEREBY ORDERED AND ADIUBGED this APSday ofAugust, 2020, for the
`
`> eS
`
`reasons set forth in the Opinion dated August 5, 2020 (D1. 735), that:
`
`i,
`
`Judgment is entered in favor of Plaintiffs Bristol-Myers Squibb Co. and Pfizer
`
`Inc. (together, “Plaintiffs”) and against Defendant Sigmapharm Laboratories, LLC
`
`(“Sigmapharm’) on Plaintiffs’ claims that Sigmapharm’s submission of a certification under 35
`
`USC. § 355WAVING) with respect to U.S. Patent No. 6,967,208 (the “208 Patent’) in
`
`Sigmapharm’s Abbreviated New Drug Application (ANDA”) No, 210053 infringes claims 13
`
`and 104 of the °208 Patent.
`
`2.
`
`Judgment is entered in favor of Plaintiffs and against Sigmapharm on Plaintiffs’
`
`claim that Sigmapharm would directly infringe claims 13 and [04 of the ’208 Patent by making,
`
`using, offering to sell, or selling the products that are the subject of Sigmapharm’s ANDA No.
`
`
`
`Case b17-cv-00374-LPS Document 746 Filed 10/O2/20 Page 3 of 8 PagelD #: 17644
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`210053, inchiding any amendments or supplements thereto, in the United States, or by importing
`
`the products that are the subject of Sigmapharm’s ANDA No. 210053, including any
`
`amendments or supplements thereto, into the United States.
`
`3,
`
`Judgment is entered in favor of Plaintiffs and against Sigmapharm on Plaintiffs’
`
`claimfor a declaratory judgment that Sigmapharm’'s use of crystalline apixaban in the United
`
`States to manufacture the products that are the subject of Sigmapharm’s ANDA No. 210053,
`
`inchiding any amendments or supplements thereto, would infringe claim 164 of the °208 Patent.
`
`4.
`
`Judgment is entered in favor of Plaintiffs and against Defendant Unichem
`
`Laboratories Ltd. “Unichem”) on Plaintiffs’ claim that Unichem’s submission of a certification
`
`under 35 US.C. § 3535QQKAMVIDUV) with respect to the “208 Patent in Unichem’s ANDA No,
`
`210108 infringes claims 13 and 104 of the °208 Patent.
`
`5.
`
`Judgment is entered in favor of Plaintiffs and against Unichem on Plaintiffs’
`
`claim that Unichem would directly infringe claims 13 and 104 of the °208 Patent by making,
`
`using, offering to sell, or selling the products that are the subject of Unichem’s ANDA No.
`
`210108, including any amendments or supplements thereto, in the United States, or by importing
`
`the products that are the subject of Unichem’s ANDA No. 210108, including any amendments or
`
`supplements thereto, into the United States.
`
`6.
`
`Judgment is entered in favor of Plaintiffs and against Siemapharm on Plaintiffs’
`
`claims that Sigmapharm’s submission ofa certification under 35 U.S.C. § SSS)2WAMVITY)
`
`with respect to US, Patent No. 9,326,945 (the “°945 Patent’) in Sigmapharm’s ANDA No.
`
`210083 infringes claims 21 and 22 of the 945 Patent.
`
`7,
`
`Judgment is entered in favor of Plaintiffs and against Sigmapharm on Plaintiffs’
`
`claim that Sigmapharm would directly infringe claims 21 and 22 of the °945 Patent by making,
`
`
`
`Case b:17-cv-00374-LPS Document 746 Filed 10/O2/20 Page 4 of 8 PagelD #: 17645
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`using, offering to sell, or selling the products that are the subject of Sigmapharm’s ANDANe.
`
`210053, including any amendments or supplements thereto, in the United States, or by importing
`
`the products that are the subject of Sigmapharm’s ANDA No. 2106053, including any
`
`amendments or supplements thereto, into the United States.
`
`g.
`
`Judgment is entered in favor of Plaintiffs and against Unichem on Plaintiffs’
`
`claim that Unichern’s submission of a certification under 35 ULS.C. § 355Q@)@2WAVIDOY) with
`
`respect to the “945 Patent in Unichem’s ANDA No. 210108 infringe claums 21 and 22 ofthe
`
`G45 Patent.
`
`9.
`
`Judgrnent is entered in favor of Plaintiffs and against Unichem on Plaintiffs’
`
`claim that Unichem would directly infringe claims 2] and 22 of the °945 Patent by making,
`
`using, offering to sell, or selling the products that are the subject of Unichem’s ANDA No.
`
`210108, including any amendments or supplements thereta, in the United States, or by importing
`
`the products that are the subject of Unichem’s ANDA Noa. 210108, including any amendments or
`
`supplements thereto, into the United States.
`
`10.
`
`Judgment is entered in favor of Plaintiffs and against Defendants Sunshine Lake
`
`Pharma Co., Lid. and HEC Pharm USAInc. (together, “Sunshine Lake”) on Plaintiffs’ claim that
`
`Sunshine Lake’s submission of a certification under 35 U.S.C. § 35S@)2KAMWIDTY) with
`
`respect to the “945 Patent in Sunshine Lake’sANDA No. 209944 infringe claims 2] and 22 of
`
`the °945 Patent.
`
`li.
`
`Judgment is entered in favor of Plaintiffs and against Sunshine Lake on Plaintiffs’
`
`claun that Sunshine Lake would directly infringe claims 21 and 22 ofthe °945 Patent by making,
`
`using, offering to sell, or selling the products that are the subject of Sunshine Lake’sANDANo.
`
`200944, including any amendments or supplements thereto, in the United States, or by importing
`
`Lad
`
`
`
`Case b:17-cv-00374-LPS Document 746 Filed 10/O2/20 Page 5 ofS PagelD #: 17646
`
`the products that are the subject of Sunshine Lake’s ANDA No, 200044, including any
`
`amendments or supplements thereto, into the United States.
`
`12.
`
`Judgment is entered in favor of Plaintiffs and against Sigmapharm and Unichem
`
`on Plaintiffs’ claim for a declaratory judgment that claims 13 and 104 of the °208 Patent are not
`
`invalid.
`
`13.
`
`Judgment is entered in favor of Plaintitts and against Sigmaphanm, Unichern, and
`
`Sunshine Lake on Plaintiffs’ claim for a declaratory judgment that claims ZI and 22 ofthe °945
`
`Patent are not invalid.
`
`14.
`
`Judgmentis entered in favor of Plaintiffs and against Sigmapharm and Unichem
`
`on Sigmapharm’s and Unichem’s counterclaims for declaratory judgments of invalidity of claims
`
`13 and 104 of the °208 Patent.
`
`1S.
`
`Judgment is entered in favor of Plaintiffs and against Sigmapharm on
`
`Sigmapharm’s counterclaims for a declaratory judgment of non-infringement of claims 13 and
`
`104 of the °208 Patent.
`
`16.
`
`Judgment is entered in favor of Plaintiffs and against Sigmapharm, Unichem, and
`
`Sunshine Lake on Sigmapharm’s, Unichern’s, and Sunshine Lake’s counterclaims for declaratory
`
`judgments of invalidity of claims 21 and 22 ofthe “045 Patent.
`
`17.
`
`Judgment is entered in favor of Plaintiffs and agamst Sigmapharm, Unichem, and
`
`Sunshine Lake on Sigmapharm’s, Unichem’s, and Sunshine Lake’s counterclaims for declaratory
`
`judgments of non-infringement of claims 21 and 22 of the °945 Patent.
`
`1g.
`
`Pursuant to 35 ULS.C. § 271 (ex4)(A}, His hereby ordered that the effective date
`
`of amy final approval by the Food and Drug Admmistration (“FDA”) of Sigmapharm’s ANDA
`
`No, 210053, including any amendments or supplements thereto, is to be a date not earlier than
`
`
`
`Case b17-cv-00374-LPS Document 746 Filed 10/O2/20 Page 6 of 8 PagelD #: 17647
`
`the date of expiration of the last to expire of the "208 Patent, inclusive of the patent tenn
`
`extension granted under 35 U.S.C, § 156, and the °945 Patent (currently February 24, 2034),
`
`plus any regulatory exclusivity Gacliding pediatric exclusivity) to which Plaintiffs are or became
`
`entitled. Sigmapharm shall notify the FDA of this judgrnent within two (2} business daysofits
`
`entry.
`
`1g.
`
`Pursuant to 35 U.S.C, § 27 1(e}(4)(8) and 35 U.S.C. § 283, Siamapharm and its
`
`officers, agents, servants, employees, and attorneys, and those persons in active concert or
`
`participation with them, are hereby enjoined from manufacturing, using, offering to sell, or
`
`selling within the United States, or unporting into the United States, the product that is the
`
`subject of Sigmapharm’s ANDA No. 210053, including any amendments or supplementsthereto,
`
`during the term of the ’208 Patent, inclusive of the patent term extension granted under 35
`
`USC. § £56, and the °945 Patent (currently February 24, 2034).
`
`20.
`
`Pursuant to 35 US.C. § 283, Sigmapharm and its officers, agents, servants,
`
`employees, and attorneys, and those persons in active concert or participation with them, are
`
`hereby enjoined from using crystalline apixaban within the United States to manufacture the
`
`products that are the subject of Sigmapharm’s ANDA No. 210653, including any amendments or
`
`supplements thereto, during the term of the °208 Patent, inclusive of the patent term extension
`
`granted under 35 U.S.C. § 156 (currently Nevember 21, 2026).
`
`2i.
`
`Pursuant to 35 U.S.C. $ 271(e4A), it is hereby ordered that the effective date
`
`of any final approval by the FDA of Unichem’s ANDA No. 210108, including any amendments
`
`or supplements thereto, is to be a date not earlier than the date of expiration of the last to expire
`
`of the °208 Patent, inclusive of the patent term extension granted under 35 ULS.C. § 156, and the
`
`945 Patent (currently February 24, 2031), plus any regulatory exclusivity (including pediatric
`
`
`
`Case b:17-cv-00374-LPS Document 746 Filed 10/O2/20 Page 7 of 8 PagelD #: 17648
`
`exctusivity} to which Plaintiffs are or become entitled. Unichem shall notify the FDA of this
`
`judgment within two (2) business days ofiis entry.
`
`22.
`
`Pursuant to 35 ULS.C. 8 27 1(e4308) and 35 U.S.C. $ 283, Unichem and its
`
`officers, agents, servants, employees, and attorneys, and those persons in active concert or
`
`participation with them, are hereby enjoined from manufacturing, using, offering to sell, or
`
`selling within the United Siates, or importing into the United States, the product thatis the
`
`subject of Unichem’s ANDA No. 210108, inchiding any amendments or supplements thereto,
`
`during the tern of the °208 Patent, inclusive of the patent term extension granted under 35
`
`U.S.C. § 156, and the "945 Patent (currently February 24, 2031).
`
`23.
`
`Pursuant to 35 U.S.C. § 271 (eM4ICA}, it is hereby ordered that the effective date
`
`ofany final approval by the FDA of Sunshine Lake’s ANDA No. 209944, inchiding any
`
`amendments or supplements thereto, is to be a date not earlier than the date of expiration of the
`
`945 Patent (currently February 24, 2031), plus any regulatory exclusivity (including pediatric
`
`exclusivity) to which Plaintitts are or become entitled. Sunshine Lake shall notify the FDA of
`
`this judgment within two (2) business days of ifs entry.
`
`24,
`
`Pursuant to 35 U.S.C. § 271(¢)(4)(B) and 35 U.S.C. § 283, Sunshine Lake andits
`
`officers, agents, servants, employees, and attorneys, and those persons in active concert or
`
`participation with them, are hereby enjoined from manufacturing, using, offering to sell, or
`
`selling within the United States, or importing into the United States, the product that is the
`
`subject of Sunshine Lake’s ANDA No. 209944, including any amendments or supplements
`
`thereto, during the term of the "945 Patent (currently February 24, 2031}.
`
`25.
`
`Costs to be awarded to Plaintiffs and against Sigmapharm, Unichem, and
`
`Sunshine Lake in accordance with 28 LES.C. § 1920.
`
`
`
`Case b:17-cv-00374-LPS Document 746 Filed 10/O2/20 Page 6 of 8 PagelD #: 17649
`
`26.
`
`Any assessment of costs or motion for attorneys’ fees under Fed. R. Civ. P. 54{d}
`
`and D, Del. L.R. 54.1-54.3, including any motion that this case is exceptional under 35 U.S.C.
`
`§ 285, shall be deferred until all appeals relating to this case have been exhausted,
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