ANDA Litigation Settlements

Spring 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
Adamas Pharma, LLC v. Sandoz Inc., 18-9032 (D.N.J.) Gocovri® (amantadine HCl extended-release capsules) 8,389,578
8,796,337
8,889,740
8,895,614
8,895,615
8,895,616
8,895,617
8,895,618
8,741,343
9,867,791
9,867,792
9,867,793
9,877,933
All claims, counterclaims, defenses, motions, and petitions are dismissed without prejudice. Any discovery Confidentiality Order shall remain in full force and effect. Each party to bear its own costs, expenses, and attorneys’ fees.
Senju Pharm. Co., Ltd. v. Aurobindo Pharma USA Inc., 19-13348 (D.N.J.) Prolensa® (bromfenac ophthalmic solution) 8,129,431
8,669,290
8,754,131
8,871,813
8,927,606
9,144,609
9,517,220
9,561,277
10,085,958
In the event that the claims of the patents-in-suit are not held invalid or unenforceable, absent a license from plaintiffs, the patents-in-suit would be infringed by Aurobindo’s ANDA product. Aurobindo is enjoined from infringing the patents-in-suit until the expiration of the patents-in-suit, except as permitted by the parties’ settlement agreement. Aurobindo shall be entitled to contest the infringement, validity, and/or enforceability of the patents-in-suit pertaining to any product that is not the ANDA product. Each party will bear its own fees and costs.
Forest Labs. Holdings, Ltd. v. Sandoz Inc., 18-0171 (D. Del.) Linzess® (linaclotide capsules) 7,304,036
7,371,727
7,704,947
8,080,526
8,748,573
8,802,628
All claims, defenses, and counterclaims are dismissed without prejudice. Sandoz is enjoined from infringing the patents-in-suit until their expiration, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the patents-in-suit are found invalid or unenforceable. The FDA may grant final approval to Sandoz’s ANDA product. The parties waive any right to appeal. This stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between Sandoz and any of the Plaintiffs regarding the patents-in-suit and a product other than the ANDA product.
Novartis Pharms. Corp. v. Mylan Pharms. Inc., 19-1042 (D. Del.), 19-0120 (N.D.W.V.) Afinitor® (everolimus tablets) 5,665,772
8,778,962
8,436,010
The parties dismiss all claims, counterclaims, and defenses asserted without prejudice.
Forest Labs. Holdings, Ltd. v. Teva Pharms. USA, Inc., 18-0198 (D. Del.) Linzess® (linaclotide capsules) 7,304,036
7,371,727
7,704,947
8,080,526
8,748,573
8,802,628
All claims, defenses, and counterclaims are dismissed without prejudice. Teva is enjoined from infringing the patents-in-suit until their expiration, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the patents-in-suit are found invalid or unenforceable. The FDA may grant final approval to Teva’s ANDA product. The parties waive any right to appeal.
Bayer Intellectual Property Gmbh v. Macleods Pharms. Ltd., 19-0880 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218 All claims, counterclaims, and defenses asserted by the parties are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
iCeutica Pty Ltd. v. Novitium Pharma LLC, 18-0599 (D. Del.) Vivlodex® (meloxicam capsules) 9,526,734
9,649,318
9,808,468
All claims, counterclaims, defenses, motions, and petitions are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each waive any right to appeal or otherwise move for relief.
Valeant Pharms. North America LLC v. Slayback Pharma, LLC, 19-8218 (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
10,105,444
The action is voluntarily dismissed without prejudice with each party to bear its own attorneys’ fees and costs. Slayback is entitled to maintain its Paragraph IV certifications to the patents-in-suit. The parties agree that the 30-month stay with respect to the approval of the Slayback ANDA is terminated.
Sun Pharma Global FZE v. Lupin Ltd., 18-2213 (D.N.J.) BromSite® (bromfenac ophthalmic solution) 8,778,999 N/A
Fresenius Kabi USA, LLC v. Wockhardt USA LLC, 19-20383 (D.N.J.) Naropin® (ropivacaine HCl for injection) 8,118,802 N/A
Actelion Pharms. Ltd. v. Zydus Pharms. (USA) Inc., 18-1397 (D.N.J.) Opsumit® (macitentan tablets) 7,094,781 Amneal admits that the ’781 patent is valid and enforceable, and that it would be infringed by the commercial manufacture, use, and sale of Amneal’s ANDA product. Amneal is enjoined from infringing the ’781 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall prohibit Amneal from maintaining or filing PIV certifications in its ANDA and nothing shall prohibit FDA from reviewing and approving Amneal’s ANDA. The 30-month stay is terminated.
Novartis Pharms. Corp. v. Apotex Inc., 20-0133 (D. Del.) Gilenya® (fingolimod capsules) 10,543,179 All claims, counterclaims, defenses, motions, and petitions are dismissed without prejudice. The Protective Order 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.
Mitsubishi Tanabe Pharma Corp. v. Sandoz Inc., 17-5319, 6375, 12082, 18-6112 (D.N.J.) Invokana® (canagliflozin tablets) 7,943,788 All claims and counterclaims are dismissed without prejudice. Parties shall bear their own attorneys’ fees and costs.
Pharmacyclics LLC v. Fresenius Kabi USA, LLC, 18-0192 (D. Del.) Imbruvica® (ibrutinib tablets) 8,008,309
7,514,444
8,697,711
8,735,403
8,957,079
9,181,257
8,754,091
8,497,277
8,952,015
8,476,284
8,754,090
9,296,753
9,725,455
9,540,382
9,713,617
No party admits liability. Each party shall bear its own costs, attorney fees, and expenses. Plaintiffs’ claims against Fresenius are dismissed without prejudice. Fresenius’s claims against Plaintiffs are dismissed without prejudice.
Abraxis Bioscience, LLC v. HBT Labs, Inc., 18-2019 (D. Del.) Abraxane® (paclitaxel protein-bound particles for injection) 7,758,891
7,820,788
7,923,536
8,034,375
8,138,229
8,268,348
8,314,156
8,853,260
9,101,543
9,393,318
9,511,046
9,597,409
HBT is enjoined from infringing the patents-in-suit until their expiration, unless otherwise specifically authorized by Abraxis. All claims, counterclaims, affirmative defenses and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing prohibits HBT from maintaining a PIV certification against the patents-in-suit. Nothing restricts the FDA from approving the HBT NDA.
Merz Pharms., LLC v. Annora Pharma Private Ltd., 19-2165 (D. Del.) Cuvposa® (glycopyrrolate oral solution) 7,638,552
7,816,396
Pursuant to a settlement and license agreement, the parties request that all claims and counterclaims be dismissed without prejudice.  Each party to bear its own costs and attorneys’ fees. The court will retain jurisdiction subject to the FTC and DOJ’s approval of the settlement agreement.
Merck Sharp & Dohme Corp. v. Torrent Pharms. Ltd., 19-0320 (D. Del.) Januvia® (sitagliptin phosphate) 7,326,708 Unless otherwise authorized pursuant to the settlement agreement, Torrent 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.
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 between the parties are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
Patheon Softgels Inc. v. PuraCap Pharm. LLC, 18-14693 (D.N.J.) Naproxen Sodium (EQ 200 mg Base) OTC capsules 9,693,978
9,693,979
10,022,344
10,028,925
All claims, counterclaims, and affirmative defenses are dismissed with prejudice. Each party will 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, counterclaims, defenses, motions, and petitions asserted by Hetero or against Hetero are dismissed without prejudice. Any Protective Order entered by the Court 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, counterclaims, defenses, motions, and petitions asserted by Zydus or against Zydus are dismissed without prejudice. Any Protective Order entered by the Court 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.
Bayer Intellectual Property GMBH v. Lupin Ltd., 17-1047 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218 Plaintiffs’ action against Lupin and Lupin’s action against Plaintiffs, including all claims and defenses asserted by Plaintiffs against Lupin and all claims and defenses asserted by Lupin against Plaintiffs, are hereby dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Bayer Intellectual Property GMBH v. Alembic Pharms. Ltd., 17-0462 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218 Plaintiffs’ action against Alembic and Alembic’s action against Plaintiffs, including all claims and defenses asserted by Plaintiffs against Alembic and all claims and defenses asserted by Alembic against Plaintiffs, are hereby dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Adapt Pharma Operations Ltd. v. Perrigo UK Finco Ltd. Partnership, 18-15287, -16987 (D.N.J.) Narcan® (naloxone HCl nasal spray) 9,211,253
9,468,747
9,561,177
9,629,965
9,775,838
10,085,937
Perrigo 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.
Forest Labs., LLC v. Westward Pharms. Int’l Ltd., 17-10321 (D.N.J.) Fetzima® (levomilnacipran HCl extended-release capsules) 8,481,598
8,865,937
RE43,879
Hikma admits that the submission of its ANDA before the expiration of the patents-in-suit was a technical act of infringement. Absent a license, Hikma is enjoined from infringing the patents-in-suit until their expiration and until all of the claims are found invalid or unenforceable by a court decision from which no appeal has been taken. Parties waive any right to appeal. Parties stipulate to the enforceability and validity of the patents-in-suit. All other claims, defenses, and counterclaims are dimissed without prejudice.
Eisai Co., Ltd. v. Lupin Ltd., 19-1336 (D. Del.) Banzel® (rufinamide oral suspension) 6,740,669 The ’669 patent is enforceable and valid. Lupin has technically infringed the ’669 patent by filing its ANDA with a PIV certification to the patent. Except as permitted by the settlement agreement, Lupin is enjoined from infringing the ’669 patent until the license to the ’669 patent provided in the settlement agreement becomes effective. All claims and counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or, except to the extent set forth in the settlement agreement, attorneys’ fees. The parties waive any right to appeal or otherwise move for relief from this consent judgment.
Horizon Medicines LLC v. Ajanta Pharma Ltd., 19-18555 (D.N.J.) Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets) 9,345,695
8,852,636
8,858,996
9,161,920
9,198,888
9,707,181
The parties’ claims and counterclaims are dismissed without prejudice. Each party shall bear its own attorneys’ fees and costs.
Teva Pharms. Int’l Gmbh v. Lupin, Ltd., 19-1251 (D. Del.) Bendeka® (bendamustine HCl for injection) 8,609,707
9,265,831
9,572,796
9,572,797
9,034,908
9,144,568
9,572,887
9,597,397
9,597,398
9,597,399
9,000,021
9,579,384
10,010,533
10,052,385
N/A
Sun Pharm. Indus., Inc. v. Perrigo Co., 18-0703 (D. Del.) Ultravate® (halobetasol propionate lotion) 8,962,028 Parties acknoweldge that Perrigo is entitled to maintina its PIV certification to the ’028 patent. The complaint, all remaining claims, and 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.
Galderma Labs. L.P. v. Teva Pharms. USA, Inc., 19-0351 (D. Del.) Soolantra® (ivermectin cream) 10,206,939 The parties stipulate to the dismissal of this action with prejudice, with each party bearing its own fees and costs.
Arena Pharms., Inc. v. Aurobindo Pharma Ltd., 19-0811 (D. Del.) Belviq® (lorcaserin HCl tablets) 6,953,787
7,514,422
7,977,329
8,207,158
8,273,734
9,770,455
All claims, counterclaims, affirmative defenses, and demands of the parties are dismissed without prejudice. Each party shall bear its own costs, expenses, and attorneys’ fees.
Hospira, Inc. v. Gland Pharma Ltd., 18-0190 (D. Del.) Precedex® (dexmedetomidine HCl for injection) 8,455,527
8,648,106
9,320,712
9,616,049
The administrative stay in this action is lifted. Gland’s proposed ANDA products do not infringe any valid claim of the patents-in-suit. The action is dismissed with prejudice. The judgment constitutes a final, non-appealable judgment.
Hospira, Inc. v. Jiangsu Hengrui Medicine Co., Ltd., 18-0191 (D. Del.) Precedex® (dexmedetomidine HCl for injection) 8,455,527
8,648,106
9,320,712
9,616,049
The administrative stay in this action is lifted. Hengrui’s proposed ANDA products do not infringe any valid claim of the patents-in-suit. The action is dismissed with prejudice. The judgment constitutes a final, non-appealable judgment.
Bausch Health Ireland Ltd. v. Teva Pharms. USA, Inc., 19-12404 (D.N.J.) Plenvu® (polyethylene glycol 3350 / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) 8,999,313
9,326,969
9,592,252
9,707,297
10,016,504
The complaint and all remaining claims, counterclaims, or affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees. Plaintiffs acknowledge that Defendants are entitled to maintain their Paragraph IV certification to the patents-in-suit. Each Party acknowledges and agrees that the 30-month stay is terminated.
Millennium Pharms., Inc. v. Fresenius Kabi USA, LLC, 19-2252 (D. Del.) Velcade® (bortezomib for injection) 6,713,446
6,958,319
The filing of the Fresenius ANDA infringes the asserted claims. The asserted claims are not invalid. The effective date of any FDA approval of the Fresenius ANDA shall not be earlier than May 2, 2022. Fresenius is enjoined from infringing the patents-in-suit. The parties shall bear their own costs, expenses, and attorneys’ fees.
Hospira, Inc. v. Par Sterile Products, LLC, 16-0879 (D. Del.) Precedex® (dexmedetomidine hydrochloride for injection) 8,242,158
8,338,470
8,455,527
8,648,106
The administrative stay in this action is lifted. Par’s proposed ANDA products do not infringe any valid claim of the patents-in-suit. The action is dismissed with prejudice. The judgment constitutes a final, non-appealable judgment.
Celgene Corp. v. Unichem Labs., Ltd., 18-11268 (D.N.J.) Otezla® (apremilast tablets) 6,962,940
7,427,638
7,659,302
7,893,101
8,455,536
9,018,243
Unichem admits that the patents-in-suit are valid and enforceable. Unichem admits that the patents-in-suit would be infringed by its ANDA product. Until expiration of the patents-in-suit, Unichem is enjoined from infringing the patents-in-suit, except to the extent specifically authorized by Amgen in writing. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
Merck Sharp & Dohme Corp. v. Accord Healthcare, Inc., 19-2192 (D. Del.) Januvia® (sitagliptin phosphate tablets) 7,326,708 Unless specifically authorized under the settlement agreement, Accord 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.
Mylan API US LLC v. American Regent, Inc., 19-5675 (E.D.N.Y.) Isosulfan Blue 1% injection 9,353,050 All claims, defenses, and counterclaims are dismissed without prejudice. Each party shall bear its own costs, disbursements, and attorneys’ fees.
Mitsubishi Tanabe Pharma Corp. v. MSN Labs. Private Ltd., 17-5302 (D.N.J.) Invokana® (canagliflozin tablets) 7,943,582
8,513,202
The submission of the Indoco ANDAs to the FDA prior to the expiration of the patents-in-suit was a technical act of patent infringement. The asserted claims of the patents-in-suit are valid and enforceable solely with respect to the Indoco ANDA products. Indoco is enjoined from infringing the patents-in-suit until their expiration, other than as authorized by Plaintiffs. Nothing shallh have preclusive effect with respect to any product other than the Indoco ANDA products in the United States. All affirmative defenses, claims, and counterclaims are dismissed with prejudice. The parties shall bear their own fees and costs. The parties waive all right to appeal or otherwise move for relief.
Leo Pharma A/S v. Taro Pharms. U.S.A., 19-0221 (D. Del.) Finacea® (azelaic acid foam) 7,700,076
8,435,498
8,722,021
8,900,554
9,211,259
9,265,725
10,117,812
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice, consistent with the trems of the parties’ settlement agreement, and without costs, disbursements, or attorneys’ fees to any party.
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