ANDA Litigation Settlements

Reported settlements in federal district court cases

Fall 2020

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act.

Case Name Drug Patent No(s). Publicly Available Terms
Purdue Pharma L.P. v. Intellipharmaceutics Corp., Nos. 17-392, 18-404, 20-515 (D. Del.) OxyContin® (oxycodone HCl extended-release tablets) 9,060,976
9,073,933
9,522,919
9,492,389
9,492,391
9,775,808
9,763,886
9,763,933
8,309,060
9,675,610
10,407,434
10,369,109
N/A
Pfizer Inc. v. Qilu Pharma, Inc., 19-0754 (D. Del.) Ibrance®
(palbociclib capsules)
6,936,612
7,208,489
7,456,168
N/A
Sucampo AG v. Sun Pharm. Indus., Ltd., 18-15482 (D.N.J.) Amitiza®
(lubiprostone capsules)
7,795,312
8,097,653
8,389,542
8,026,393
8,338,639
8,779,187
8,748,481
Sun admits that the submission of its ANDA was a technical act of infringement of the patents-in-suit. Each of the defenses and counterclaims set forth in Sun’s answer should be dismissed, without prejudice. Sun is enjoined from infringing the patents-in-suit until January 1, 2023 or at such earlier date as may be permitted by the resolution to which the parties have agreed. Sun is entitled to maintain its paragraph IV certification to the patents-in-suit. The parties waive any right to appeal. The consent judgment and order of permancne injunction is without prejudice to, and shall have no preclusive effect as to, any claim, defense or counterclaim in any future action between Sun and Plaintiffs regarding the patents-in-suit and/or a generic lubiprostone product other than Sun’s ANDA product.
Exela Pharma Sciences, LLC v. Avadel Legacy Pharms., LLC, 20-0024 (D. Del.) Elcys® (cysteine HCl for injection) Nouress™ (cysteine HCl for injection) 10,478,453 All claims, counterclaims, and defenses as between the parties are dismissed with prejudice. The parties expressly waive any right to appeal. Each party shall bear its own costs, expenses, and taxes in conection with the action.
Vanda Pharms. Inc. v. Lupin Ltd., 15-1073 (D. Del.) Fanapt®
(iloperidone tablets)
8,586,610
9,138,432
Lupin acknowledges that the patents-in-suit are valid and enforceable with respect to Lupin’s ANDA products. Lupin acknowledges it has technically infringed the patents-in-suit by filing its ANDA. Lupin is permanently enjoined from infringing the patents-in-suit. All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Boehringer Ingelheim Pharms., Inc. v. Fresenius Kabi USA, LLC, 18-3244 (D.N.J.) Gilotrif® (afatinib dimaleate tablets) RE43,431
8,426,586
The patents-in-suit are valid and enforceable. Fresenius is enjoined from infringing the patents-in-suit. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorney fees to any aprty.
Actelion Pharms. Ltd. v. Zydus Pharms. (USA), Inc., 19-22193 (D.N.J.) Tracleer®
(bosentan tablets)
8,309,126 The submission of the Zydus ANDA to the FDA before the expiration of the ’126 patent constitutes infringement . The ’126 patent is valid and enforceable solely with respect to the Zydus ANDA. Zydus is enjoined from infringing the ’126 patent. until the expiration of the ’126 patent, including any patent term extensions and/or patent term adjustments. All affirmative defenses, claims and counterclaims are dismissed without prejudice. Each party shall bear its own fees and costs. The parties waive all right to appeal.
Actelion Pharms. Ltd. v. Aurobindo Pharma USA Inc., 19-15437 (D.N.J.) Opsumit® (macitentan tablets) 7,094,781 Aurobindo admits that the claims of the ’781 patent are valid and enforceable, and that they would be infringed by the Aurobindo ANDA product. Unless otherwise specifically authorized by Actelion, Aurobindo is enjoined from infringing the ’781 patent  All claims, counterclaims, affirmative defenses, and demands in this action are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. Nothing shall prohibit or restrict Aurobindo from maintaining or filing Paragraph IV certifications in Aurobindo’s ANDA and nothing herein shall prohibit or restrict the FDA from reviewing or approving Aurobindo’s ANDA The 30-month stay with respect to the approval of Aurobindo’s ANDA is terminated.
Merck Sharp & Dohme Corp. v. Alvogen Pine Brook LLC, 19-0310 (D. Del.) Janumet® XR (sitagliptin phosphate / metformin HCl extended-release tablets) 7,326,708 Unless otherwise specifically authorized pursuant to the settlement agreement, Alvogen is enjoined from infringing the ’708 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Galderma Labs., L.P. v. Sun Pharm. Indus. Ltd., 18-1588 (D. Del.) Oracea®
(doxycycline capsules)
10,058,564 The parties stipulate that all claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Mitsubishi Tanabe Pharma Corp. v. Aurobindo Pharma USA Inc., 17-12082 (D.N.J.) Invokana®
(canagliflozin tablets)
7,943,788
8,222,219
The submission of the Aurobindo ANDA to the FDA prior to the expiration of the patents-in-suit was a technical act of patent infringement under 35 U.S.C. § 271(e)(2)(A). The claims of the patents-in-suit are valid and enforceable solely with respect to the Aurobindo ANDA. Aurobindo is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit, other than as authorized by Plaintiffs. Neither this Judgment and Order nor the entry of this Judgment and Order may be asserted by Plaintiffs against Aurobindo, and shall have no preclusive effect in any cause of action, litigation or proceeding with respect to any product other than the Aurobindo ANDA product. All affirmative defenses, claims, and counterclaims, which have been or could have been raised are dismissed with prejudice. The parties shall bear their own fees and costs. The parties waive all right to appeal.
Cubist Pharms. LLC v. Amneal Pharms. LLC, 19-15439 (D.N.J.) Cubicin RF® (daptomycin for injection) 9,138,456 All claims, counterclaims, and defenses between the parties are dismissed without prejudice pursuant to Fed. R. Civ. P. 41(a)(1)(A)(ii) and (c). Each party shall bear its own costs and attorney’s fees with respect to any claim, counterclaim, or defense relating to the ’456 or ’382 patents.
H. Lundbeck A/S v. Apotex Inc., 18-0088, -0089 (D. Del.) Trintellix® (vortioxetine hydrobromide tablets) 8,722,684
8,969,355
9,227,946
Apotex is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Pfizer Inc. v. Apotex Inc., 19-0747 (D. Del.) Ibrance® (palbociclib capsules) 6,936,612
7,208,489
RE47,739
7,456,168
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorney fees, and expenses.
Pfizer Inc. v. Aizant Drug Research Solutions Pvt. Ltd., 19-0743 (D. Del.) Ibrance®
(palbociclib capsules)
6,936,612
7,456,168
All claims, counterclaims, and affirmative defenses between Plaintiffs and Cipla are dismissed without prejudice. Each party shall bear its own costs, attorney fees, and expenses.
Bial – Portela & Ca., S.A. v Hetero Labs Ltd., 18-0342 (D. Del.) Aptiom® (eslicarbazepine acetate tablets) 8,372,431
9,206,135
9,566,244
9,643,929
9,750,747
9,763,954
10,675,287
10,695,354
10,702,536
The patents-in-suit are patentable, valid, and enforceable in connection with the Aptiom NDA. Hetero admits that the maufacture and sale of its ANDA product would infringe the patents-in-suit. Hetero is enjoined from infringing the patents-in-suit, except as provided in the settlement agreement. All claims, counterclaims, and affirmative defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees.
Sanofi-Aventis U.S. LLC v. Actavis LLC, 20-0804 (D. Del.) Jevtana® Kit (cabazitaxel injection) 10,583,110 Plaintiffs’ claims against Hetero are dismissed with prejudice. Plaintiffs and Hetero are each to bear their own costs.
Genzyme Corp. v. Teva Pharms. USA, Inc., 18-1796 (D. Del.) Cerdelga® (eliglustat capsules) 6,916,802
7,196,205
7,253,185
7,615,573
The parties’ claims and counterclaims are dismissed with prejudice. The parties shall bear their own costs. Nothing shall prevent FDA from granting final approval to Teva’s ANDA.
Currax Pharms. LLC v. Zydus Pharms. (USA) Inc., 19-1569 (D. Del.) Silenor® (doxepin HCl tablets) 8,513,299
9,107,898
9,486,437
9,532,971
9,861,607
9,907,780
10,238,620
The parties’ claims and defenses with respect to the asserted patents are dismissed without prejudice. Zydus is enjoined from infringing the patents-in-suit, absenta license or other authorization from Plaintiff, except to the extent permitted by the settlement agreement. The parties waive any right to appeal. Each party shall bear its own fees and costs, including attorney fees.
Pfizer Inc. v. Cipla USA Inc., 19-0749 (D. Del.) Ibrance® (palbociclib capsules) 6,936,612
7,208,489
7,456,168
N/A
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Annora Pharma Private Ltd., 18-1996 (D. Del.) Velphoro® (sucroferric oxyhydroxide chewable tablets) 9,561,251 All claims, counterclaims, and affirmative defenses are dismissed without prejudice and, except as specifically provided by agreement, without costs, disbursements, or attorneys’ fees to any party.
Sanofi-Aventis U.S. LLC v. Accord Healthcare Inc., 20-0803 (D. Del.) Jevtana® Kit
(cabazitaxel injection)
10,583,110 The claims and counterclaims are dismissed with prejudice. The parties shall bear their own costs.
Par Pharm., Inc. v. Fresenius Kabi USA, LLC, 19-1985 (D. Del.) Vasostrict® (vasopressin for injection) 9,744,239 The claims of the ’239 patent have not been, and would not be infringed by Fresenius’s ANDA product. Judgment is entered that the claims of the ’239 patent are not infringed by Fresenius’s ANDA product. Fresenius’s counterclaims seeking declaratory judgments of invalidity and unenforceability of the ’239 patent are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees with respect to the ’239 patent.
Celgene Corp. v. Mankind Pharma Ltd., 18-11081 (D.N.J.) Otezla® (apremilast tablets) 6,962,940
7,659,302
8,455,536
9,018,243
9,724,330
7,427,638
7,893,101
10,092,541
Mankind admits that the patents-in-suit are valid and enforceable. Mankind admits that the patents-in-suit would be infringed by Mankind’s ANDA product. Until expiration of the patents-in-suit, including all extensions and pediatric exclusivities, Mankind is enjoined from infringing the patents-in-suit except as authorized by Amgen in writing. All claims, affirmative defenses, counterclaims, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Boehringer Ingelheim Pharms., Inc. v. Apotex Inc., 18-11350 (D.N.J.) Gilotrif® (afatinib tablets) 8,426,586 Except as authorized by Boehringer, Apotex is enjoined from infringing the patent-in-suit until its expiration. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Boehringer Ingelheim Pharms., Inc. v. Aurobindo Pharma USA Inc., 17-7887 (D.N.J.) Gilotrif® (afatinib dimaleate tablets) 8,426,586 Except as authorized by Boehringer, Aurobindo is enjoined from infringing the patent-in-suit until its expiration. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Exela Pharma Sciences, LLC v. Sandoz, Inc., 20-0645 (D. Del.) Elcys®
(cysteine HCl injection)
10,478,453
10,583,155
Plaintiff’s claims are dismissed without prejudice. Each party shall bear its own costs, expenses, and taxes in connection with this action. The U.S. District Court for the District of Delaware retains jurisdiction to resolve any disputes arising under this stipulation of dismissal.
Sanofi-Aventis U.S. LLC v. MSN Pharms., Inc., 20-0646 (D. Del.) Jevtana® Kit (cabazitaxel injection) 10,583,110 Each of Plaintiffs’ claims against MSN is dismissed with prejudice. Plaintiffs and MSN are each to bear their own costs.
Bausch Health US, LLC v. Taro Pharms. U.S.A., Inc., 18-15060, 20-2747 (D.N.J.) Jublia® (efinaconazole topical solution) 7,214,506
8,039,494
8,486,978
9,302,009
9,566,272
9,662,394
9,861,698
9,877,955
10,512,640
10,342,875
10,478,601
All claims, affirmative defenses, and counterclaims asserted in this action are dismissed without prejudice, except that in the event of termination of the settlement agreement between the parties concerning this case, either party may seek to re-open the litigation. Defendants are permanently enjoined from infringing the patents-in-suit except as permissible under the parties’ settlement agreement. Each party shall bear its own costs, expenses and taxes in connection with this litigation.
Bayer Healthcare LLC v. Apotex Inc., 16-1222, 18-1465 (D. Del.) Stivarga®
(regorafenib tablets)
9,957,232
8,637,553
All claims and defenses are dismissed with prejudice.
Celgene Corp. v. Macleods Pharms. Ltd., 18-11212 (D.N.J.) Otezla®
(apremilast tablets)
7,427,638
10,092,541
Macleods admits that the patents-in-suit are valid and enforceable. Macleods admits that the patents-in-suit would be infringed by its ANDA product. Until expiration of the patents-in-suit, Macleods is enjoined from infringing with its ANDA product the patents-in-suit, except as authorized by Amgen in writing. All claims, affirmative defenses, counterclaims, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Sun Pharm. Indus. Ltd. v. Pfizer, Inc., 19-9330 (D.N.J.) Lyrica® CR (pregabalin extended-release tablets) 9,393,205 All claims and counterclaims between the parties are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses incurred inconnection with the claims and counterclaims dismissed by the Stipulation and Order of Dismissal. The parties have entered into a settlement and license agreement with respect to their respective claims. This Stipulation and Order of Dismissal shall not act as adjudication on the merits.
Galderma Labs., L.P. v. Amneal Pharms. LLC, 19-0440 (D. Del.) Oracea® (doxycycline capsules) 10,058,564 All claims, counterclaims, and affirmative defenses  are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Millennium Pharms., Inc. v. Baxter Healthcare Corp., 20-0682 (D. Del.) Velcade® (bortezomib for injection) 6,713,446 The filing of defendant’s ANDA is an articial act of infringement. The asserted claims are not invalid. The effective date of any FDA approval of defendant’s ANDA shall be May 1, 2022, and Millennium has agreed to provide a regulatory exclusivity waiver to confirm that effective date. Millennium is enjoined from infringing the patents-in-suit until Jan. 25, 2022, and is enjoined form engaging in the commercial sale of the ANDA product prior to May 1, 2022. Parties shall bera their own costs, expenses, and attorneys’ fees.
Par Pharm., Inc. v. Amphastar Pharms., Inc., 18-2032 (D. Del.) Vasostrict® (vasopressin for injection) 9,375,478
9,687,526
9,744,209
9,744,239
9,750,785
9,937,223
Par’s action against Amphastar and Amphastar’s action against Par, including all claims and defenses asserted by Par against Amphastar and all claims and defenses asserted by Amphastar against Par, are hereby dismissed without prejudice.
Eisai R&D Management Co., Ltd. v. Sandoz Inc., 20-3895 (D.N.J.) Halaven® (eribulin mesylate for injection) RE46,965 Plaintiffs dismiss matter without prejudice and without costs.
Merck Sharp & Dohme Corp. v. Sandoz Inc., 20-0783 (D.N.J.) Noxafil® (posaconazole oral suspension) 8,263,600 N/A
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 20-3229 (D.N.J.) Sprycel® (dasatinib tablets) 7,491,725 All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Boehringer Ingelheim Pharms. Inc. v. Macleods Pharms. Ltd., 18-1764, 19-1864 (D. Del.) Jardiance®
(empagliflozin tablets)
Glyxambi® (empagliflozin / linagliptin tablets) Synjardy®
(empagliflozin / metformin tablets)
7,713,938
8,551,957
9,949,998
10,258,637
The patents-in-suit are valid, enforceable, and infringed by Macleods ANDA products. Macleods is enjoined from infringing the patents-in-suit until their expiration. The Complaints and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Astellas US LLC v. Gland Pharma Ltd., 20-0347 (D. Del.) Lexiscan®
(regadenoson for injection)
8,106,183
RE47,301
8,524,883
All claims and counterclaims, defenses, motions, and petitions asserted in this action are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties waive any right to appeal or otherwise move for relief.
Amgen Inc. v. Amneal Pharms. LLC, 16-0925 (D. Del.) Sensipar®
(cinacalcet HCl tablets)
9,375,405 Amneal admits that the ’405 patent is enforceable and valid. Amneal shall not dispute the validity and enforceability of the ’405 patent in any other or future cause of action or litigation concerning a generic equivalent of Sensipar tablets. Except as provided in the settlement agreement, all claims and demands for relief prayed for by Amgen against Amneal are deemed satisfied. Except as provided in the settlement agreement, all claims and demands for relief prayed for by Amneal are deemed to be satisfied. The action, including any counterclaims and affirmative defenses, is dismissed without prejudice and without costs, disbursements or attorneys’ fees to any party.
Bayer Intellectual Property Gmbh v. Unichem Inc., 20-5439 (D.N.J.) Xarelto® (rivaroxaban tablets) 7,157,456
9,539,218
The claims and defenses of all parties are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Galephar Pharm. Research, Inc. v. Upsher-Smith Labs., LLC, 19-2546 (D.N.J.) Absorica® (isotretinoin capsules) 7,435,427
8,367,102
8,952,064
9,078,925
9,089,534
The complaint and all remaining claims or affirmative defenses are dismissed without prejudice and each party shall bear its own costs and attorneys’ fees. No appeal shall be taken by any party, the right to appeal having been expressly waived by all parties.
ViiV Healthcare Co. v. Mylan Pharms. Inc., 17-0197 (N.D.W.V.) Triumeq® (abacavir / dolutegravir / lamivudine tablets) 9,242,986 All claims, counterclaims, affirmative defenses, and demands in this action are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits Mylan from maintining any PIV certification with respect to the ’986 patent. The 30-month stay is no longer in effect.
Boehringer Ingelheim Pharms., Inc. v. Sun Pharm. Indus. Ltd., 17-8819 (D.N.J.) Gilotrif® (afatinib dimaleate tablets) 8,426,586 The patent-in-suit is valid and enforceable. Sun is enjoined from infringing the patent-in-suit. The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any aprty.
Chiesi USA, Inc. v. Hikma Pharms. USA Inc., 20-0484 (D. Del.) Ferriprox®
(deferiprone tablets)
7,049,328 All claims and counterclaims are dismissed without prejudice with all parties to bear their own costs and attorneys’ fees.
Mitsubishi Tanabe Pharma Corp. v. Laurus Labs Ltd., 17-5302 (D.N.J.) Invokana®
(canagliflozin tablets)
7,943,582
8,513,202
The submission of the Laurus ANDA prior to the expiration of the patents-in-suit was a technical act of patent infringement. The claims of each of the patents-in-suit are valid and enforceable. Laurus’s manufacture, sale, offer for sale, use or import of the Laurus ANDA Product in the US constitutes infringement of the patents-in-suit. Laurus is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit , other than as authorized by Plaintiffs. All affirmative defenses, claims, and counterclaims, which have been or could have been raised by the parties are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal.
H. Lundbeck A/S v. Prinston Pharm. Inc., 18-0148 (D. Del.) Trintellix® (vortioxetine hydrobromide tablets) 8,722,684
8,969,355
9,125,908
9,125,909
9,125,910
9,227,946
9,278,096
9,861,630
Prinston is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Celgene Corp. v. Dr. Reddy’s Labs., Ltd., 18-6378 (D.N.J.) Revlimid® (lenalidomide capsules) 6,315,720
6,561,977
6,755,784
8,315,886
8,626,531
Until expiration of the patents-in-suit, DRL is enjoined from infringing them, unless otherwise specifically authorized by Celgene. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits DRL from maintaining any “Paragraph IV Certification” with respect to the patents-in-suit. Nothing prohibits DRL from engaging in any activity permitted under 35 U.S.C. § 271(e)(1). Nothing restricts the FDA from approving DRL’s ANDA.
Pfizer Inc. v. Viwit Pharm. Co., Ltd., 20-0160 (D. Del.) Chantix® (varenicline tartrate tablets) 6,410,550
6,890,927
7,265,119
Case dismissed without prejudice.
Salix Pharms., Ltd. v. Sun Pharms. Indus., Ltd., 19-0734 (D. Del.) Xifaxan®
(rifaximin tablets)
7,045,620
7,612,199
7,902,206
7,906,542
8,158,644
8,158,781
8,835,452
8,853,231
7,915,275
8,193,196
8,518,949
8,741,904
9,271,968
7,928,115
All claims, affirmative defenses, and counterclaims are dismissed without prejudice. Each party will bear its own attorneys’ fees, expenses, and costs. The stipulation and order of dismissal shall not act as an adjudication on the merits. Sun is entitled to maintain its Paragraph IV certification to the patents-in-suit and any other patent listed in the Orange Book now or in the future for Xifaxan. The 30-month stay related to Sun’s ANDA is terminated.
Actelion Pharms. Ltd. v. Zydus Pharms. (USA) Inc., 18-1397 (D.N.J.) Opsumit® (macitentan tablets) 7,094,781 Zydus admits that the claims of the patent-in-suit are valid and enforceable and would be infringed by the the Zydus ANDA product. Unless authorized by Actelion, Zydus is enjoined from infringing the patent-in-suit. All claims, counterclaims, affirmative defenses, and demands in this action are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. Nothing shall prohibit Zydus from maintaining or filing Paragraph IV certifications in Zydus’s ANDA and nothing shall prohibit FDA from approving Zydus’s ANDA. Each party agrees that the 30-month stay with respect to the approval of Zydus’s ANDA is terminated.
Keryx Biopharms., Inc. v. Lupin Ltd., 19-0884 (D. Del.) Auryxia® (ferric citrate tablets) 5,753,706
7,767,851
8,093,423
8,299,298
8,338,642
8,609,896
8,754,257
8,754,258
8,846,976
8,901,349
9,050,316
9,387,191
9,757,416
All claims and counterclaims, defenses, motions and petitions are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each expressly waive any right to appeal.
Pfizer Inc. v. Apotex, Inc., 18-0795 (D. Del.) Inlyta®
(axitinib tablets)
8,791,140 Pfizer’s action against Apotex is dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Pfizer Inc. v. Hetero USA, Inc., 19-0751 (D. Del.) Ibrance®
(palbociclib capsules)
6,936,612
7,208,489
7,456,168
N/A
Collegium Pharm., Inc. v. Teva Pharms. USA Inc., 18-0300, 18-1900, 19-0876 (D. Del.) Xtampza® ER
(oxycodone extended-release capsules)
7,399,488
7,771,707
8,449,909
8,557,291
8,758,813
8,840,928
9,044,398
9,248,195
9,592,200
9,682,075
9,737,530
9,763,883
9,968,598
10,004,729
10,188,644
Teva would infringe each of the patents-in-suit. The patents-in-suit are valid and enforceable with respect to Teva’s ANDA product. All affirmative defenses, claims, and counterclaims which have been or could have been raised by Teva are dismissed with prejudice. Except as authorized and licensed by Collegium, Teva is enjoined from infringing the patents-in-suit until they expire. Teva shall not dispute that any of the patents-in-suit are infringed, or that the claims are valid and enforceable, in any other or future cause of action or litigation in the US. Nothing shall prohibit Teva from maintaining or filing a PIV certification against any other patents that may be listed in the Orange Book for Xtampza ER. Nothing shall prohibit FDA from granting final approval on Teva’s ANDA. The parties waive all right to appeal. Each party is to bear its own costs and attorneys’ fees.

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

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