ANDA Litigation Settlements

Spring 2019

Case Name	Drug	Patent No(s).	Publicly Available Terms
Allergan, Inc. v. Saptalis Pharms., LLC, 18-1231 (D. Del.)	Restasis® (cyclosporine ophthalmic emulsion)	8,633,162 8,642,556	N/A
Allergan, Inc. v. Amneal Pharms. LLC, 18-1457 (D. Del.)	Restasis® (cyclosporine ophthalmic emulsion)	8,633,162 8,642,556	N/A
AstraZeneca LP v. Prinston Pharm. Inc., 17-1639 (D. Del.)	Brilinta® (ticagrelor tablets)	6,251,910 RE 46,276 7,250,419 7,265,124	Prinston is enjoined from infringing the ’276, ’419, and ’124 patents. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Amgen Inc. v. Watson Labs., Inc., 18-2414 (Fed. Cir.)	Sensipar® (cinacalcet hydrochloride tablets)	9,375,405	After launching at-risk, Watson will withdraw its product from the market. Watson will pay Amgen an undisclosed amount. Waston will wait until 2021 to re-launch its generic product.
Senju Pharm. Co., Ltd. v. Amneal Pharms. LLC, 18-16991 (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 asserted patents against Amneal are not held invalid or unenforceable, Amneal’s admits that its ANDA product infringes those patents. Amneal is enjoined from selling its ANDA product except as permitted by the settlement agreement. Each party to bear its own costs.
Chiesi U.S.A., Inc. v. Teva Pharms. USA, Inc., 17-1772 (D. Del.)	Bethkis® (tobramycin injection solution)	6,987,094 7,696,178 7,939,502	Teva is enjoined from selling its ANDA product until the expiration of the patents-in-suit. Each party waives its appeal rights. Each party to bear its own costs. All claims are dismissed without prejudice.
Delcor Asset Corp. v. Glenmark Pharms. Ltd., 18-0460 (D. Del.)	Olux-E® (clobetasol propionate aerosol foam)	6,730,288	Glenmark submitted a patent amendment to revise its certification from Paragraph IV to Paragraph III. All claims and counterclaims are dismissed without prejudice. Parties to bear their own costs and fees.
Gilead Sciences, Inc. v. Strides Pharma, Inc., 18-11134 (D.N.J.)	Truvada® (emtricitabine / tenofovir disoproxil fumarate tablets)	6,642,245 6,703,396 8,592,397 8,716,264 9,457,036 9,744,181	All claims and counterclaims dismissed with prejudice. Parties to bear their own costs and fees.
Sumitomo Dainippon Pharma Co., Ltd. v. Macleods Pharms. Ltd., 18-13833 (D.N.J.)	Latuda® (lurasidone HCl tablets)	9,815,827 9,907,794	Macleods admits that the ’827 patent is enforceable and valid. Macleods is enjoined from infringing the ’827 patent. All claims and demands for relief prayed for by Plaintiffs against Macleods and Macleods against Plaintiffs in this action are deemed to be satisfied.
Mayne Pharma Int’l Pty Ltd. v. Lupin Ltd., 17-1637 (D. Del.)	Doryx® MPC (doxycycline hyclate delayed-release tablets)	9,295,652 9,446,057 9,511,031	Each asserted claim would be infringed by any unlicensed manufacture, sale, offer for sale, use, or importation in the US of the Lupin ANDA Product. Each asserted claim of each of the Licensed Patents is valid and enforceable. Lupin is is enjoined from making, having made, using, selling, offering to sell or distributing the Lupin ANDA Product in, or importing into, the US. Lupin shall be entitled to contest the infringement, validity, and/or enforceability of the Licensed Patents in any future litigation of the Licensed Patents, pertaining to any product that is not the Lupin ANDA Product. Each Party acknowledges and agrees that the 30-month stay with respect to the Lupin ANDA is terminated. All claims, counterclaims, and affirmative defenses are dismissed with prejudice, without costs and fees.
AstraZeneca AB v. Apotex Corp., 16-0583 (D. Del.)	Onglyza® (saxagliptin hydrochloride tablets)	RE44,186	The ’186 patent is enforceable and valid. Apotex ANDA product infringes the ’186 patent. Apotex is enjoined from making, having made, using, selling, offering to sell, importing or distributing its ANDA product until the expiration of the ’186 patent. Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of the approval of Apotex’s ANDA shall be no earlier than the expiration date of the the ’186 patent. All remaining claims and counterclaims are dismissed with prejudice. The parties waive any right to appeal.
Forest Labs., LLC v. Prinston Pharm. Inc., 17-7191 (D.N.J.)	Byvalson® (nebivolol / valsartan tablets)	7,803,838 7,838,552	The patents-in-suit are enforceable and valid. Prinston’s filing of its ANDA infringes the patents-in-suit. Prinston is enjoined from making, having made, using, selling, offering to sell, importing or distributing its ANDA product until the expiration of the patents-in-suit. All remaining claims and counterclaims are dismissed with prejudice. The parties waive any right to appeal.
Cephalon Inc. v. Innopharma Inc., Nos. 17-2377, 17-2378 (Fed. Cir.)	Treanda® (bendamustine hydrochloride injection)	8,436,190 8,609,863 8,791,270 8,895,756	N/A
Shire Development LLC v. SpecGx LLC, 18-0800 (D. Del.)	Mydayis® (dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate extended-release capsules)	6,913,768 8,846,100 9,173,857	SpecGx acknowledges that the ’768 patent is valid and enforceable. SpecGx acknowledges that its ANDA product infringes the ’768 patent. Shire acknowledges that the SpecGx ANDA product does not infringe the ’100 and ’857 patents. Shire and SpecGx agree to dismiss without prejudice all other claims, counterclaims and affirmative defenses. Both parties waive their right to appeal and to seek costs and fees.
Pfizer Inc. v. Prinston Pharm. Inc., 18-0380 (D. Del.)	Xeljanz® (tofacitinib tablets)	RE41,783	All claims and counterclaims between Plaintiffs and Prinston are dismissed without prejudice. Any protective orders entered by the Court shall remain in full force and effect notwithstanding the dismissal of this action. The parties waive any right of appeal. Each party shall bear its own costs and fees.
Almirall, LLC v. Taro Pharms. Indus. Ltd., 17-0663 (D. Del.)	Aczone® (dapsone gel)	9,517,219	N/A
Indivior Inc. v. Alvogen Pine Brook LLC, 18-5285 (D.N.J.)	Suboxone® (buprenorphine HCl / naloxone HCl sublingual film)	9,931,305	N/A
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 incurred in connection with the claims dismissed by this Order. Plaintiffs’ claims against Teva and Hetero are dismissed without prejudice. Tevaand Hetero’s claims against Plaintiffs are dismissed without prejudice.
Valeant Pharms. North America LLC v. Perrigo Pharma Int’l DAC, 18-17518 (D.N.J.)	Jublia® (efinaconazole topical solution)	10,105,444	Perrigo’s ANDA product infringes the ‘444 patent. Perrigo is enjoined from (i) making, using, offering to sell, selling, or importing until expiration of the ‘444 patent the Perrigo ANDA product in the United States, and (ii) participating in the profits from making, using, offering to sell, selling, or importing the Perrigo Product in the United States, and (iii) indemnifying others with respect to any making, using, offering to sell, selling, or importing the Perrigo Product in the United States. Each party will bear its own attorneys’ fees and costs. Perrigo is entitled to maintain its Paragraph IV certification to the ‘444 Patent pursuant to 21 C.F.R. § 314.94(a)(12)(v). The 30-month stay with respect to the approval of the Perrigo ANDA is terminated.
Osi Pharms., LLC v. Shilpa Medicare Ltd., 18-1096 (D. Del.)	Tarceva® (erlotinib HCl tablets)	6,900,221	The complaint is dismissed, without prejudice. Each party shall bear its own costs and attorneys’ fees.
Genzyme Corp. v. Fresenius Kabi USA, LLC, 18-1934 (D. Del.)	Mozobil® (plerixafor for injection)	7,897,590 6,987,102	Fresenius Kabi is enjoined from making, having made, using, selling, offering to sell and/or importing in or into the US any product under ANDA No. 212395. All claims are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees. The parties each expressly waive any right to appeal.
Arena Pharms., Inc. v. Teva Pharms. USA, Inc., 17-0231 (D. Del.)	Belviq XR® (lorcaserin HCl tablets)	6,953,787 7,514,422 7,977,329 8,207,158 8,273,734 8,546,379 8,575,149 8,999,970 9,169,213	Teva has infringed the patents-in-suit by filing ANDA No. 209918. Except as permitted by the Settlement Agreement, Teva is enjoined from making, having made, using, selling, offering to sell, importing or distributing any lorcaserin HCl product pursuant to ANDA No. 209918, until any grant of license to the patents-in-suit provided in the Settlement Agreement to Teva becomes effective. All claims and counterclaims, affirmative defenses and demands are dismissed without prejudice and without costs, disbursements or attorneys’ fees. The parties each expressly waive any right to appeal.
Apotex Inc. v. Symplmed Pharms., LLC, 17-0276 (D. Del.)	Prestalia® (perindopril arginine / amlodipine besylate oral tablets)	6,696,481 7,846,961	Defendants grant to Apotex a non-exclusive license to manufacture, import, offer for sale, and sell the Apotex ANDA Product in the U.S. as of the date, and upon the terms, set forth in the Confidential License Agreement. Apotex’s action is dismissed with prejudice.
Delcor Asset Corp. v. Glenmark Pharms. Ltd., 17-1653 (D. Del.)	Evoclin® (clindamycin phosphate aerosol, foam)	7,141,237 7,374,747	All claims, defenses, and counterclaims between the parties are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Biogen MA Inc. v. Sun Pharma Global FZE, 17-0848 (D. Del.)	Tecfidera® (dimethyl fumarate delayed-release capsules)	8,399,514	N/A
Pharmacyclics LLC v. Shilpa Medicare Ltd., 18-0237 (D. Del.)	Imbruvica® (ibrutinib tablets)	9,296,753 9,725,455 8,999,999 9,801,881 9,801,883	No party admits liability. Each party shall bear its own costs, attorney fees, and expenses. Plaintiffs’ claims against Defendant are dismissed without prejudice. Defendant’s claims against Plaintiffs are dismissed without prejudice.
Shionogi Inc. v. Aurobindo Pharma Ltd., 17-0072 (D. Del.)	Fortamet® (metformin extended-release tablets)	6,790,459 6,866,866	All claims dismissed with prejudice. Each party to bear its own costs, expenses, and attorneys’ fees.
Novo Nordisk Inc. v. Teva Pharms. USA, Inc., 17-0227 (D. Del.)	Victoza® (liraglutide recombinant solution injection)	6,268,343 8,114,833 8,846,618 9,265,893 RE41,956	The patents-in-suit are infringed by any unlicensed manufacture, sale, offer for sale, use, or importation in the United States of the generic product that is subject of Teva’s ANDA. Teva will be enjoined until expiration of patents-in-suit from making, using, offering to sell, selling, or importing into the US the Teva ANDA Product. Teva shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation over the patents-in-suit pertaining to any product that is not the Teva Product. Each party will bear its own attorneys’ fees and costs.
Novartis Pharms. Corp. v. West-ward Pharms. Int’l Ltd., 14-1196, -1508, 15-0128 (D. Del.)	Afinitor® (everolimus tablets)	5,665,772 7,297,703 7,741,338 6,004,973 6,239,124 6,455,518	Parties stipulate and agree that all claims and counterclaims and affirmative defenses are dismissed without prejudice, and without costs, disbursements or attorneys’ fees to any party.
Adare Pharms., Inc. v. Teva Pharms. Int’l GMBH, 18-1079 (D. Del.)	Amrix® (cyclobenzaprine HCl extended-release capsules)	9,399,025 9,375,410	All claims asserted by Plaintiffs against Inventia are hereby dismissed with prejudice, and all counterclaims asserted by Inventia are hereby dismissed without prejudice. Each party to bear its own costs, attorneys’ fees, and expenses.
Astellas Pharma Inc. v. Aurobindo Pharma Ltd., 16-0942 (D. Del.)	Myrbetriq® (mirabegron extended-release tablets)	7,342,117 7,982,049 8,835,474 RE44,872	All claims and counterclaims dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Court shall retain jurisdiction over the settlement agreement in this case.
Sun Pharm. Indus. Ltd. v. Novartis Pharms. Corp., 19-0276 (D.N.J.)	Jadenu® (deferasirox tablets)	9,283,209	Sun voluntarily dismisses, without prejudice, its complaint. All parties shall pay their own costs, including attorneys’ fees.
Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., 18-1039 (D. Del.)	Gilenya® (fingolimod capsules)	9,187,405	N/A
Valeant Pharms. North America LLC v. Macleods Pharms. Ltd., 18-14204 (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	The patents-in-suit are infringed by Macleods’s ANDA product. Macleods will be enjoined until expiration of patents-in-suit from making, using, offering to sell, selling, or importing into the US its ANDA Product. Macleods shall be entitled to contest the infringement, validity and/or enforceability of the patents-in-suit in any future litigation over the patents-in-suit pertaining to any product that is not the Macleods Product. Each party will bear its own attorneys’ fees and costs.
Purdue Pharma L.P. v. Ascent Pharms., Inc., 18-0855 (D. Del.)	OxyContin® (oxycodone HCl extended-release tablets)	9,060,976 9,073,933 9,522,919 9,147,533 9,861,582 8,309,060 9,675,610	All claims and counterclaims are dismissed with prejudice. No right, written or oral license or sublicense, covenant not to sue, waiver or release or other written or oral authorization is or has been granted or implied by this Stipulated Dismissal. The Action is hereby dismissed without costs or attorney’s fees, save that the Court shall retain jurisdiction over the Action, including without limitation, over implementation of, or disputes arising out of, this Stipulated Dismissal or the settlement of the Action.
Celgene Corp. v. Lotus Pharm. Co., Ltd., 18-11518 (D.N.J.)	Revlimid® (lenalidomide capsules)	7,977,357 8,193,219 8,431,598	Lotus is enjoined from infringing the patents-in-suit until their expiration, unless authorized by Celgene. All claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. Nothing prohibits Lotus from maintaining any “Paragraph IV Ccrtiflcation” pursuant to 21 U.S.C. § 355G)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 31 4.94(a)( 12) with respect to the Patents-in-Suit. Nothing herein restricts or is intended to restrict the FDA from approving Lotus’s ANDA application.
In re: copaxone patent litigation, C.A. 16-1267 (D. Del.)	Copaxone® (glatiramer acetate injection)	9,155,775 9,763,993	Plaintiff Teva and Defendants Sandoz and Momenta dismiss with prejudice all calims and counterclaims against each other in this action. Each party to bear its own costs and fees. The Court shall retain jurisdiction to enforce the terms and conditions of this dismissal and the agreement and any disputes that may arise thereunder.