Case 1:17-cv-00420-RGA Document 8 Filed 05/16/17 Page 1 of 6 PageID #: 76
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
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`NOV ARTIS PHARMACEUTICALS
`CORPORATION and NOV ARTIS AG,
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`Plaintiffs,
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`v.
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`BRECKENRIDGE PHARMACEUTICAL, INC.,
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`Defendant.
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`Plaintiffs,
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`v.
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`BRECKENRIDGE PHARMACEUTICAL, INC.,
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`Defendant.
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`Plaintiffs,
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`v.
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`BRECKENRIDGE PHARMACEUTICAL, INC.,
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`Defendant.
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`C.A. No. 14-1043-RGA
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`C.A. No. 16-0431-RGA
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`C.A. No. 17-00420-RGA
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`FINAL JUDGMENT
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`WHEREAS this matter came before the Court for trial on the merits of Civil Action No.
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`14-1043-RGA to resolve the questions of: (i) whether claims 1-3, 7 and 10 of U.S. Patent No.
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`5,665,772 ("'772 patent") are invalid by reason of obviousness or obviousness-type double
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`patenting; (ii) whether claim 7 of U.S. Patent No. 6,239,124 ('"124 patent") and claim 7 of U.S.
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`Case 1:17-cv-00420-RGA Document 8 Filed 05/16/17 Page 2 of 6 PageID #: 77
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`Patent No. 6,455,518 ("' 518 patent") are invalid by reason of obviousness or obviousness-type
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`double patenting; and (iii) whether Defendant Breckenridge Pharmaceutical, Inc.
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`("Breckenridge") would induce infringement of claim 7 of the '124 patent on account of its
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`kidney transplant indication for its 0.25 mg, 0.5 mg, and 0.75 mg dosage strength everolimus
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`tablets ("ANDA products"), and claim 7 of the '518 patent on account of its kidney transplant
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`and liver transplant indications for its ANDA products (the "Breckenridge Zortress Litigation");
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`and
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`WHEREAS, pursuant to 35 U.S.C. § 271(e)(2)(A), the filing of Breckenridge's
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`Abbreviated New Drug Application ("ANDA") No. 205432 with certifications according to 21
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`U.S.C. § 355G)(2)(A)(vii)(IV) with respect to the '772, '518and'124 patents constituted an
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`artificial act of infringement of the '772, '518, and '124 patents; and
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`WHEREAS the Court has heard the witness testimony of the Plaintiffs Novartis
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`Pharmaceuticals Corporation and Novartis AG ("Plaintiffs"), Defendant West-Ward
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`Pharmaceuticals International Limited, Defendant Par Pharmaceutical, Inc., and Defendant
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`Breckenridge, (collectively "the parties"), and has considered the evidence submitted by the
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`parties, and the Court has reviewed the post-trial submissions of the parties; and
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`WHEREAS the parties stipulated and the Court ordered in advance of trial (C.A. No. 14-
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`1043-RGA, D.I. 152) that Breckenridge's generic versions of Zortress® and Afinitor® everolimus
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`products, if approved by the FDA, would infringe claims 1-3, 7 and 10 of the '772 patent, and
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`that the Court's decision regarding the validity of the '772 patent in Civil Action No. 14-1043-
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`RGA shall apply in Civil Action No. 16-0431-RGA, (C.A. No. 14-1043-RGA, D.I. 152); and
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`Case 1:17-cv-00420-RGA Document 8 Filed 05/16/17 Page 3 of 6 PageID #: 78
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`WHEREAS the parties hereby stipulate that the Court's decision regarding the validity
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`of the '772 patent in Civil Action No. 14-1043-RGA shall apply in District of Delaware Civil
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`Action No. 17-00420-RGA; and
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`WHEREAS the parties hereby stipulate that the Court's order regarding the infringement
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`of claims 1-3, 7 and 10 ofthe '772 patent in Civil Action Nos. 14-1043-RGA and 16-0431-RGA
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`shall apply in District of Delaware Civil Action No. 17-00420-RGA; and
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`WHEREAS Plaintiffs at the Breckenridge Zortress Litigation trial informed the Court
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`that they were no longer asserting infringement of claims 1-3 of the '772 patent against
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`Breckenridge; and
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`WHEREAS, as of May 2, 2017, the Approved Drug Products with Therapeutic
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`Equivalence Evaluations ("Orange Book") entry for Zortress indicates that the term of the '124
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`patent expires on August 11, 2017, and that the pediatric exclusivity associated with the '124
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`patent expires on February 11, 2018; and
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`WHEREAS, on July 19, 2016, Plaintiffs filed a terminal disclaimer of the '124 patent in
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`view of the '518 patent ("the Terminal Disclaimer"), such that, notwithstanding any contrary
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`information in the Orange Book, the term of the '124 patent expires on July 29, 2017, the same
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`expiration date as the '518 patent, and the pediatric exclusivity associated with the '124 patent
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`and the '518 patent expires on January 29, 2018;
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`IT IS ORDERED AND ADJUDGED, for the reasons set forth in the Court's Amended
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`Trial Opinion dated April 3, 2017, that Final Judgment is hereby entered in District of Delaware
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`Civil Action No. 14-1043-RGA in favor of Breckenridge and against Plaintiffs, that claims 1-3, 7
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`and 10 of the '772 patent are invalid for obviousness-type double patenting; and it is further
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`Case 1:17-cv-00420-RGA Document 8 Filed 05/16/17 Page 4 of 6 PageID #: 79
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`ORDERED AND ADJUDGED, for the reasons set forth in the Court's April 3, 2017
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`Amended Trial Opinion, that pursuant to Rule 54(b) of the Federal Rules of Civil Procedure, this
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`Court now makes (a) "an express determination that there is no just reason for delay;" and (b)
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`"an express direction for the entry of judgment" in favor of Breckenridge against Plaintiffs that
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`claims 1-3, 7 and 10 of the '772 patent are invalid for obviousness-type double patenting in Civil
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`Action Nos. 16-0431-RGA, and 17-00420-RGA. The Court is entering this Rule 54(b) judgment
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`for the purpose of rendering a final judgment appealable to the Federal Circuit, which the Court
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`believes will promote efficient judicial administration and will not result in any unfair prejudice
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`to the parties. This Rule 54(b) judgment does not include: Plaintiffs' allegations of infringement
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`of U.S. Patent No. 8,410,131 and U.S. Patent No. 8,778,962, which claims shall remain pending
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`and proceed on the schedule ordered by the Court following entry of this Rule 54(b) judgment;
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`and it is further
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`ORDERED AND ADJUDGED, for the reasons set forth in the Court's April 3, 2017
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`Amended Trial Opinion, that Final Judgment is hereby entered in Civil Action No. 14-1043-
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`RGA in favor of Plaintiffs and against Breckenridge that claim 7 of the' 124 patent and claim 7
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`of the '518 patent are not invalid by reason of obviousness or obviousness-type double patenting;
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`and it is further
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`ORDERED AND ADJUDGED, for the reasons set forth in the Court's April 3, 2017
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`Amended Trial Opinion, that Final Judgment is hereby entered in District of Delaware Civil
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`Action No. 14-1043-RGA in favor of Plaintiffs and against Breckenridge that Breckenridge
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`would induce infringement of claim 7 of the '124 patent by the sale in the United States of an
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`ANDA product approved by the FDA with proposed labeling containing the indication
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`"prophylaxis of organ rejection in adult patients: Kidney Transplant: at low-moderate
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`Case 1:17-cv-00420-RGA Document 8 Filed 05/16/17 Page 5 of 6 PageID #: 80
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`immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and
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`corticosteroids" ("the kidney transplant indication"); and it is further
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`ORDERED AND ADJUDGED, for the reasons set forth in the Court's April 3, 2017
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`Amended Trial Opinion, that Final Judgment is hereby entered in District of Delaware Civil
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`Action No. 14-1043-RGA in favor of Plaintiffs and against Breckenridge that Breckenridge
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`would induce infringement of claim 7 of the '518 patent by the sale in the United States of an
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`ANDA product approved by the FDA with proposed labeling containing the kidney transplant
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`indication and the indication "prophylaxis of organ rejection in adult patients: ... Liver
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`transplant: Administer no earlier than 30 days post-transplant. Use in combination with
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`tacrolimus (reduced doses) and corticosteroids" ("the liver transplant indication"); and it is
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`further
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`ORDERED, in view of the parties' aforementioned stipulation concerning infringement
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`of the asserted claims of the '772 patent, that Final Judgment is hereby entered in Civil Actions
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`Nos. 14-1043-RGA, 16-0431-RGA, and 17-00420-RGA in favor of Plaintiffs and against
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`Breckenridge that Breckenridge's generic versions of Zortress® and Afinitor® everolimus
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`products, if approved by the FDA, would infringe claims 7 and 10 of the '772 patent and that
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`claims 1-3 of the '772 patent are withdrawn from assertion by Plaintiffs; and it is further
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`ORDERED, pursuant to 35 U.S.C. § 271(e)(4)(A), that the effective date under§ 5050)
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`of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 3550)) of any final approval by the
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`United States Food and Drug Administration of Breckenridge's ANDA No. 205432, shall be a
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`date not earlier than the expiration of the pediatric exclusivity for the '124 and '518 patents,
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`which for both is January 29, 2018, except to the extent subsequently (a) agreed between
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`Case 1:17-cv-00420-RGA Document 8 Filed 05/16/17 Page 6 of 6 PageID #: 81
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`Plaintiffs and Breckenridge or (b) ordered or otherwise permitted by this Court or other tribunal;
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`and it is further
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`ORDERED, Plaintiffs are not entitled to any injunction under 35 U.S.C. § 271(e)(4)(B);
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`and it is further
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`ORDERED, in the event that a party appeals this Final Judgment, that any motion for
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`attorneys' fees and/or costs under Fed. R. Civ. P. 54(d) and/or Local Rules 54.1and/or54.3,
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`including any motion that this case is exceptional under 35 U.S.C. § 285, shall be considered
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`timely if filed and served within thirty (30) days after final disposition of any such appeal; and it
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`is further
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`ORDERED, in the event that no party appeals this Final Judgment, that any motion for
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`attorneys' fees and/or costs under Fed. R. Civ. P. 54(d) and/or Local Rules 54.1and/or54.3,
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`including any motion that this case is exceptional under 35 U.S.C. § 285, shall be considered
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`timely if filed and served within thirty (30) days after the expiration of the time for filing a notice
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`of appeal under Fed. R. App. P. 3 and 4; and it is further
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`ORDERED, in the event that Plaintiffs appeal the Final Judgment that claims 1-3, 7 and
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`10 of the '772 patent are invalid for obviousness-type double patenting, there shall not be three
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`separate appeals with respect to that issue, but one appeal, because the Court's April 3, 2017
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`Amended Trial Opinion concerning that issue is based on one set of stipulated facts.
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`Dated this jft_ day of Yn"'Jr,,.
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`'2017
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