ANDA Litigation Settlements

Reported settlements in federal district court cases

Summer 2020

Robins Kaplan 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
AstraZeneca LP v. Dr. Reddy’s Labs., Ltd.,
19-15739 (D.N.J.)
Brilinta® (ticagrelor tablets) RE46,276 Unless authorized by the settlement agreement, Dr. Reddy’s is enjoined from infringing the patent-in-suit.
All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Bayer Intellectual Property GmbH v. Teva Pharms. USA, Inc., 18-1926 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218 Plaintiffs’ action against Teva and Teva’s action against Plaintiffs, including all claims and defenses are dismissed with prejudice.
All parties shall bear their own costs, disbursements and attorneys’ fees.
Bayer Intellectual Property GMBH v. Aurobindo Pharma Ltd., 17-0483 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218 Plaintiffs’ action against Aurobindo and Aurobindo’s action against Plaintiffs, including all claims and defenses are dismissed with prejudice.
All parties shall bear their own costs, disbursements and attorneys’ fees.
AstraZeneca Pharms. LP v. Aurobindo Pharma Ltd., 19-12567 (D.N.J.) Daliresp® (roflumilast tablets) 8,536,206
8,604,064
8,618,142
Unless authorized by the settlement agreement, Aurobindo 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.
Mitsubishi Tanabe Pharma Corp. v. Macleods Pharms., Ltd., 17-13130 (D.N.J.) Invokana® (canagliflozin tablets) 7,943,582
8,513,202
All claims, defenses, and counterclaims are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
Boehringer Ingelheim Pharms. Inc. v. Macleods Pharms. Ltd., 19-1772 (D. Del.) Tradjenta® (linagliptin tablets) 8,673,927
8,853,156
9,173,859
The patents-in-suit are valid and enforceable. Macleods is enjoined from infringing the patents-in-suit until their expiration.
Nothing prohibits Macleods from maintaining its PIV certification with respect to the patents-in-suit.
The complaint and all remaining claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
H. Lundbeck A/S v. Cipla Ltd., 18,0147, 18-0753 (D. Del.) Trintellix® (vortioxetine hydrobromide tablets) 8,598,348
8,722,684
8,969,355
9,101,626
9,125,908
9,125,909
9,125,910
9,227,946
9,278,096
9,861,630
Unless otherwise authorized by the Settlement Agreement, Cipla 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.
Astellas Pharma Inc. v. Lupin Ltd., 16-0908, 16-0924 (D. Del.) Myrbetriq® (mirabegron extended-release tablets) 7,342,117
7,982,049
8,835,474
RE44,872
All claims and counterclaims are dismissed without prejudice. The parties will submit their settlement and license agreement to the FTC and the DOJ as soon as practicable. Each Party will bear its own costs and attorneys’ fees.
Bausch Health US, LLC v. Strides Pharma Inc., 20-2746 (D.N.J.) Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
In view of, and subject to the provisions of the Settlement Agreement, this action is
dismissed without prejudice. Defendants shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation pertaining to any product that is not the Strides ANDA product and is not the subject of the Strides ANDA. Each party will bear its own attorneys’ fees and costs. Plaintiffs acknowledge that Defendants are entitled to maintain their PIV certification to the patents-in-suit. Each party acknowledges and agrees that the 30-month stay with respect to the approval of the Strides ANDA is terminated. Plaintiffs acknowledge that Defendant is entitled to pursue and obtain FDA approval for Defendant’s ANDA and Strides’ ANDA product prior to expiration of the patents-in-suit.
Bausch Health US, LLC v. Alkem Labs. Ltd., 20-2737 (D.N.J.) Jublia® (efinaconazole topical solution) 10,512,640
10,342,875
10,478,601
In view of the parties’ settlement agreement, this action is dismissed without prejudice. Alkem shall be entitled to contest the infringement, validity, and enforceability of the patents-in-suit in any future litigation over the patents-in-suit pertaining to any product that is not the Alkem ANDA product. Each party will bear its own attorneys’ fees and costs. Plaintiffs acknowledge that Alkem is entitled to maintain its PIV certifications to the patents-in-suit. Each Party acknowledges and agrees that the 30-month stay with respect to the approval of the Alkem ANDA is terminated. Plaintiffs acknowledge that Alkem is entitled to pursue and obtain FDA approval for its ANDA prior to the expiration of the patents-in-suit.
Mallinckrodt Hospital Products IP Ltd. v. Baxter Healthcare Corp., 20-0434 (D. Del.) Ofirmev® (acetaminophen for injection) 9,399,012
9,610,265
9,987,238
10,383,834
6,992,218
The submission of Baxter’s ANDA before the expiration of the ’218 patent was a technical act of infringement. Unless otherwise permitted under the settlement agreement, Baxter is enjoined from infringing the patents-in-suit. All claims and demands for relief prayed for by the parties are satisfied. Each party shall bear its own costs, disbursements and attorneys’ fees. The parties waive any right to appeal or move for relief from the consent judgment and order.
AstraZeneca Pharms. LP v. Xiromed, LLC, 19-19081 (D.N.J.) Faslodex® (fulvestrant for injection) 6,774,122
7,456,160
8,329,680
8,466,139
Except as authorized pursuant to the Settlement Agreement, Xiromed is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.
Braintree Labs., Inc. v. Alkem Labs. Ltd., 20-2904 (D.N.J.), 20-0362 (D. Del.) Suprep® Bowel Prep Kit (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution) 6,946,149 Braintree dismisses without prejudice its complaint for patent infringement, with each party to bear its own costs and fees.
Merck Sharp & Dohme Corp. v. Macleods Pharms. Ltd., 19-0316 (D. Del.) Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) 7,326,708 Unless authorized by the settlement agreement, Macleods is enjoined from infringing the patent-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Gilenya® (fingolimod capsules) 10,543,179 All claims and counterclaims, defenses, motions, and petitions asserted by Bionpharma or against Bionpharma are dismissed without prejudice. Any protective order entered by the court in this action shall remain in full force and effect. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees.
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Gilenya® (fingolimod capsules) 10,543,179 All claims and counterclaims, defenses, motions, and petitions asserted by Ezra or against Ezra are dismissed without prejudice. Any protective order entered by the court in this action shall remain in full force and effect. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees.
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Gilenya® (fingolimod capsules) 10,543,179 All claims and counterclaims, defenses, motions, and petitions asserted by Prinston or against Prinston are dismissed without prejudice. Any protective order entered by the court in this action shall remain in full force and effect. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees.
Keryx Biopharms., Inc. v. Watson Labs., Inc., 19-0885 (D. Del.) Auryxia® (ferric citrate tablets) 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
9,328,133
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 or otherwise move for relief.
Salix Pharms., Ltd. v. Sandoz Inc., 19-18566 (D.N.J.) Xifaxan® (rifaximin tablets) 7,045,620
7,612,199
7,902,206
7,906,542
7,915,275
8,158,644
8,158,781
8,193,196
8,309,569
8,518,949
8,741,904
8,835,452
8,853,231
9,271,968
The asserted claims are not invalid, are not unenforceable, and would be infringed by any unlicensed manufacture, sale, offer for sale, use or importation in the US of Sandoz’s ANDA product. Unless permitted by license, Sandoz is enjoined from infringing the asserted claims. Sandoz shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation pertaining to any product other than the Sandoz ANDA product. Each party will bear its own attorneys’ fees and costs. Plaintiffs acknowledge that Sandoz is entitled to maintain its PIV certificaiton to the patents-in-suit and each party acknowledges and agrees that the 30-month stay with respect to the approval of the Sandoz ANDA is terminated.
Sun Pharma Global FZE v. Teva Pharm. Indus. Ltd., 18-1552 (D. Del.) Yonsa® (abiraterone acetate tablets) 9,889,144 Teva agrees that the claims of the ’144 and ’990 patents are valid and enforceable. The complaint and all remaining claims, counterclaims, 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.
Astellas Pharma Inc. v. Windlas Healthcare, Pvt. Ltd., 16-0930 (D. Del.) Myrbetriq® (mirabegron extended-release tablets) 7,342,117
7,982,049
8,835,474
RE44,872
Pursuant to a settlement and license agreement, all claims and counterclaims are dismissed without prejudice. The parties will submit their settlement and license agreement to the FTC and DOJ as soon as practicable. Each party will bear its own costs and attorneys’ fees.
Astellas Pharma Inc. v. Actavis Elizabeth LLC, 16-0905 (D. Del.) Myrbetriq® (mirabegron extended-release tablets) 7,342,117
7,982,049
8,835,474
RE44,872
Pursuant to a settlement and license agreement, all claims and counterclaims are dismissed without prejudice. The parties will submit their settlement and license agreement to the FTC and DOJ as soon as practicable. Each party will bear its own costs and attorneys’ fees.
Assertio Therapeutics Inc. v. Alkem Labs. Ltd., 19-17170 (D.N.J.) Nucynta® ER (tapentadol HCl extended-release tablets) 8,309,060 The claim of infringement of the ’060 patent is dismissed without prejudice. This stipulation shall not preclude either party from filing claims or counterclaims relating to infringement of the ’060 patent or the validity of the ’060 patent. Each party shall bear its own costs and attorneys’ fees.
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Gilenya® (fingolimod capsules) 10,543,179 All claims and counterclaims, defenses, motions, and petitions asserted by Glenmark or against Glenmark are dismissed without prejudice. Any protective order entered by the court in this action shall remain in full force and effect. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees.
Duchesnay Inc. v. Actavis Labs. FL, Inc., 18-1895 (D. Del.) Bonjesta® (doxylamine succinate / pyridoxine HCl extended-release tablets) 9,089,489
9,375,404
9,526,703
9,937,132
All claims and counterclaims are dismissed wihout prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses incurred in connection with the claims and counterclaims dismissed.
Par Pharm., Inc. v. American Regent, Inc., 19-1490 (D. Del.) Vasostrict® (vasopressin for injection) 9,375,478
9,687,526
9,744,209
9,750,785
The patents-in-suit are valid and enforceable. Defendant committed a technical act of infringement by filing its NDA with the FDA. Except as permitted by the settlement agreement, defendant is enjoined from infringing the patents-in-suit until permitted to do so under the settlement agreement. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees. The applicable stay of FDA approval of defendant’s NDA product is terminated. The parties waive any right to appeal.
H. Lundbeck A/S v. Hetero USA Inc., 18-0176 (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
Unless otherwise authorized by the Settlement Agreement, Hetero 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.
Impax Labs., Inc. v. Zydus Pharms. USA, Inc., 17-13476 (D.N.J.) Rytary® (levodopa / carbidopa capsules) 9,089,608 Action dismissed without prejudice with each party bearing its own costs and attorneys’ fees.
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Gilenya® (fingolimod capsules) 10,543,179 All claims and counterclaims, defenses, motions, and petitions asserted by Emcure and Heritage or against Emcure and Heritage are dismissed without prejudice. Any protective order entered by the court in this action shall remain in full force and effect. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees.
Pharmacyclics LLC v. Sun Pharma Global FZE, 20-0403 (D. Del.) Imbruvica® (ibrutinib tablets) 10,478,439 Plaintiffs dismiss their claims against Sun without prejudice.
Bial – Portela & Ca S.A. v. SPH Shanghai Zhongxi Pharm. Co., Ltd., 18-0775 (D. Del.) Aptiom® (eslicarbazepine acetate tablets) 5,753,646
8,372,431
9,206,135
9,566,244
9,643,929
9,750,747
9,763,954
All claims and counterclaims, defenses, motions, and petitions are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties waive any right to appeal.
Celgene Corp. v. Emcure Pharms. Ltd., 18-11218 (D.N.J.) Otezla® (apremilast tablets) 7,427,638
7,893,101
9,872,854
10,092,541
Emcure admits that the patents-in-suit are valid and enforceable. Emcure admits that the patents-in-suit would be infringed by Emcure’s ANDA product. Emcure is enjoined from infringing the patents-in-suit until they expire, excpet if 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. 
Pfizer Inc. v. Ajanta Pharma Ltd., 19-0517 (D. Del.) Xeljanz® (tofacitinib tablets) 6,965,027
RE41,783
All claims and counterclaims are dismissed without prejudice. Any protective orders shall remain in full force and effect. The parties waive any right of appeal. Each party shall bear its own costs and fees.
Pfizer Inc. v. Teva Pharms. USA, Inc., 19-0759 (D. Del.) Ibrance® (palbociclib capsules) 6,936,612
7,208,489
7,456,168
N/A
Merck Sharp & Dohme Corp. v. Wockhardt Bio AG, 19-0321 (D. Del.) Januvia® (sitagliptin phosphate) Janumet® (sitagliptin phosphate / metformin HCl) 7,326,708 Unless authorized by the settlement agreement, Wockhardt is enjoined from infringing the patent-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Bayer Intellectual Property GMBH v. Taro Pharm. Indus. Ltd., 17-0462 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218 Plaintiffs’ action against Taro and Taro’s action against Plaintifs are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
H. Lundbeck A/S v. Unichem Labs., Ltd., 18-0092 (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
Unless otherwise authorized by the Settlement Agreement, Unichem 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.
Janssen Products, L.P. v. Zydus Pharms. (USA) Inc., 20-0787 (D.N.J.) Prezista® (darunavir tablets) 7,700,645
8,518,987
7,126,015
7,595,408
The filing of Zydus’ ANDA constitutes an act of infringement of the patents-in-suit, absent authorization from Janssen. The asserted claims of patents-in-suit are valid and enforceable solely with respect to the manufacture, use, offer for sale, sale, and importation of the Zydus ANDA products in the US. Zydus is enjoined from infringing until the expiration of each of the patents-in-suit, including any patent term extensions and/or patent term adjustments and during the period of any associated exclusivity, other than pursuant to authorization from Janssen or as otherwise recognized by the Parties. All affirmative defenses, claims, and counterclaims in this action are dismissed without prejudice. Each party shall bear its own fees and costs in connection with this action, including attorneys’ fees. The parties waive all right to appeal.
Par Pharm., Inc. v. Sandoz Inc., 18-14895 (D.N.J.) Vasostrict® (vasopressin for injection) 9,375,478
9,687,526
9,744,209
9,744,239
9,750,785
9,937,223
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Gilenya® (fingolimod capsules) 10,543,179 All claims and counterclaims, defenses, motions, and petitions asserted by Strides or against Strides are dismissed without prejudice. Any protective order entered by the court in this action shall remain in full force and effect. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees.
Taro Pharm. Indus. Ltd. v. Novitium Pharma, LLC, 19-1028 (D.N.J.) Ovide® (malathion lotion) 7,560,445
7,977,324
Except as specifically authorized in the settlement and license agreement, Novitium is enjoined from infringing the patents-in-suit. Plaintiffs acknowledge that Novitium is entitled to maintain its Paragraph IV certification to the ’445 and ’324 patents. All claims and affirmative defenses are dismissed with prejudice, except that in the event of termination of the settlement and license agreement, either party may seek to re-open the litigation. Each party shall bear its own costs and attorneys’ fees. No appeal shall be taken by any party.
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