ANDA Litigation Settlements

Summer 2019

Case Name	Drug	Patent No(s).	Publicly Available Terms
Leo Pharma A/S v. Perrigo UK Finco Ltd. Partnership, 18-1874 (D. Del.)	Finacea® (azelaic acid foam)	10,117,812	The Court retains jurisdiction to enforce or supervise performance under the Dismissal Order and the Settlement Agreement. All claims, counterclaims, affirmative defenses and demands in this action between Plaintiffs and Perrigo are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Duke University v. Alembic Pharms., Ltd., 17-7453 (D.N.J.)	Latisse® (bimatoprost ophthalmic solution)	9,579,270	The ANDA filing was a technical act of infringement under 271(e)(2)(A). No decision has been obtained regarding the validity or infringement of the patent-in-suit. All other claims, defenses, and counterclaims are dismissed without prejudice. Alembic is enjoined from selling and making its ANDA product during the life of the patent-in-suit unless it is found invalid or unenforceable. Parties waive any right to appeal. Court retains jurisdiction over the Stipulation and Order dismissing the case.
Valeant Pharms. North America LLC v. Macleods Pharms. Ltd., 19-7296 (D.N.J.)	Jublia® (efinaconazole topical solution)	10,105,444	Absent a license, the ‘444 patent would be infringed by any unlicensed manufacture, sale, offer for sale, use, or importation in the US of the generic products that are the subject of Macleods’ ANDA. Macleods is enjoined until expiration of the ‘444 patent from making, using, or selling its ANDA product in the US. Macleods shall be shall be entitled to contest the infringement, validity and/or enforceability of the ‘444 patent in any future litigation over the ‘444 Patent pertaining to any product that is not the Macleods ANDA. Each party to bear its own costs.
Arena Pharms., Inc. v. Lupin Ltd., 16-0887 (D. Del.)	Belviq® (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	Lupin has infringed the patents-in-suit pursuant to 35 U.S.C. §27l(e)(2) by filing its ANDAs. Lupin is enjoined from making, using, or selling its ANDA products until the grant of license to the patents-in-suit becomes effective under the Settlement Agreement. All claims and counterclaims, affirmative defenses and demands of the parties are dismissed without prejudice and without costs, disbursements or attorneys’ fees. The parties waive any right to appeal. The court retains jurisdiction over the Parties for purposes of enforcing this Consent Judgment as well as any dispute regarding the Settlement Agreement.
Valeant Pharms. North America LLC v. Acrux DDS Pty Ltd., 18-14194 (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 9877955	All claims and counterclaims are dismissed without prejudice. In the event that the claims of the patents-in-suit are not held invalid or unenforceable, absent a license or other authorization from Plaintiffs, the patents-in-suit would be infringed by the ANDA product. Defendant 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 attorneys’ fees and costs. The court will retain jurisdiction to enforce this stipulated dismissal and injunction. Plaintiffs acknowledge that Defendant is entitled to maintain its Paragraph IV certification to the patents-in-suit. The 30-month stay with respect to ANDA product is terminated.
Cosmo Technologies Ltd. v. Lupin Ltd., 15-0669 (D. Del.)	Uceris® (budesonide tablets)	7,410,651 RE43,799	N/A
Valeant Pharms. North America LLC v. Solaris Pharma Corp., 18-13695 (D.N.J.)	Jublia® (efinaconazole topical solution)	7,214,506 8,039,494 8,486,978 9,302,009 9,56,6272 9,662,394 9,861,698 9,877,955	The case is dismissed without prejudice, with each party to bear its own attorneys’ fees and costs. Solaris is entitled to maintain its PIV certification to the patents-in-suit pursuant to 21 C.F.R. § 314.94(a)(12)(v). The 30-month stay with respect to the approval of the Solaris ANDA under 21 U.S.C. § 355(j)(5)(B)(iii) is hereby terminated.
Teva Pharms. USA, Inc. v. Biocon Ltd., 16-0278 (D. Del.)	Copaxone® (glatiramer acetate injection)	8,232,250 8,399,413 8,969,302 9,155,776	All claims, counterclaims and affirmative defenses are dismissed with prejudice. Each party to bear its own costs and fees.
Novartis AG v. Mylan Pharms. Inc., 16-0289 (D. Del.)	Gilenya® (fingolimod capsules)	5,604,229	The ’229 patent is valid and enforceable. Mylan’s ANDA product infringes the ’229 patent. Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any final approval of Mylan’s ANDA product shall be a date not earlier than Aug. 18, 2019, the date of expiration of the ’229 patent together with a period of pediatric exclusivity awarded to Novartis under 21 U.S.C. § 355a. Pursuant to 35 U.S.C. § 271(e)(4)(B), Mylan is enjoined from engaging in the commercial manufacture, use, offer for sale, sale, in the US and/or importation into the US of its ANDA product until Feb. 18, 2019. All issues in this case, including costs and fees, have been resolved.
Astellas Pharma Inc. v. Xellia Pharms. APS, 18-1818 (D. Del.)	Mycamine® (micafungin sodium for injection)	6,774,104	The complaint and counterclaim are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Nothing shall prohibit Xellia from filing or maintaining any Paragraph IV certifications under 21 U.S.C. § 355G)(2)(A)(vii)(IV), and nothing herein shall prohibit or restrict the FDA from reviewing and approving ANDA No. 211713.
Janssen Products, L.P. v. Amneal Pharms. LLC, 18-17585 (D.N.J.)	Prezista® (darunavir tablets)	8,518,987 7,126,015 7,595,408	Amneal admits that at least one claim in each of the patents-in-suit are are valid and enforceable solely with respect to the Amneal ANDA product. All affirmative defenses, claims and counterclaims with respect to the Amneal Product and the patents-in-suit are dismissed with prejudice. Amneal admits that its ANDA product infringes the patents-in-suit. Amneal is enjoined during the life of the patents-in-suit from manufacturing, using, offering for sale, selling in the US, or importing into the US the Amneal ANDA product until the occurrence of the start date under the License Agreement. The parties waive all right to appeal. The court shall retain jurisdiction of this action and over the parties for purposes of enforcement of the provisions of this Judgment and Order. Each party is to bear its own costs and attorneys’ fees.
Onyx Therapeutics, Inc. v. Aurobindo Pharma USA, Inc., 17-1699 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, Aurobindo is enjoined from infringing the patents-in-suit by making or selling its ANDA product. All claims, counterclaims, affirmative defenses and demands in this action by either Onyx or Aurobindo are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Onyx Therapeutics, Inc. v. InnoPharma, Inc., 16-1036, 17-1155 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, Aurobindo is enjoined from infringing the patents-in-suit by making or selling its ANDA product. InnoPharma withdraws all factual allegations in its pleadings, including those concerning unclean hands, litigation misconduct, and inequitable conduct, and its foregoing affirmative defenses and counterclaims as well as all other claims, counterclaims, affirmative defenses and demands in this action by either Onyx or InnoPharma are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Onyx Therapeutics, Inc. v. Sagent Pharms., Inc., 16-1000 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, Sagent is enjoined from infringing the patents-in-suit by making or selling its ANDA product. All claims, counterclaims, affirmative defenses and demands in this action by either Onyx or Sagent are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Onyx Therapeutics, Inc. v. Apotex Inc., 16-1039, 17-1202, 18-0132 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, Apotex is enjoined from infringing the patents-in-suit by making or selling its ANDA product. All claims, counterclaims, affirmative defenses and demands in this action by either Onyx or Apotex are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Onyx Therapeutics, Inc. v. Fresenius Kabi USA, Inc., 16-1012 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, Fresenius is enjoined from infringing the patents-in-suit by making or selling its ANDA product. Fresenius withdraws all factual allegations in its pleadings, including those concerning unclean hands, litigation misconduct, and inequitable conduct, and its foregoing affirmative defenses and counterclaims as well as all other claims, counterclaims, affirmative defenses and demands in this action by either Onyx or Fresenius are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Bristol-Myers Squibb Co. v. Sandoz Inc., 17-0407 (D. Del.)	Eliquis® (apixaban tablets)	6,967,208 9,326,945	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 with respect to the matters dismissed. The parties each expressly waive any right to appeal or otherwise move for relief from this stipulation and order.
Horizon Pharma, Inc. v. Lupin Ltd., 16-4920 (D.N.J.)	Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets)	8,945,621 9,220,698 9,345,695	All claims, counterclaims and affirmative defenses asserted by the parties are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party. The court retains jurisdiction over the parties for the purpose of adjudicating any issues arising from the settlement of this action.
Onyx Therapeutics, Inc. v. MSN Labs. Private, Ltd., 16-0999, 17-1833 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, MSN is enjoined from infringing the patents-in-suit by making or selling its ANDA product. All claims, counterclaims, affirmative defenses and demands in this action by either Onyx or MSN are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Gilead Sciences, Inc. v. Natco Pharma Ltd., 18-3592 (D.N.J.)	Sovaldi® (sofosbuvir tablets)	8,618,076 9,284,342 7,429,572 8,415,322 9,206,217 9,340,568	All affirmative defenses, claims and counterclaims, which have been or could have been raised by the parties are dismissed without prejudice. Except as otherwise provided by the parties’ agreement, Natco is enjoined from manufacturing, using, offering for sale, selling in the US, or importing into the US, the products of ANDA No. 211373 until permitted under the parties’ agreement. The parties waive all right to appeal. The court shall retain jurisdiction of this action and over the parties for purposes of enforcement of the provisions of this judgment and order. Each party is to bear its own costs and attorneys' fees.
Astellas Pharma Inc. v. Zydus Pharms. (USA) Inc., 16-1167 (D. Del.)	Xtandi® (enzalutamide capsules)	7,709,517 8,183,274 9,126,941	Parties’ claims and counterclaims are dismissed without prejudice. Parties shall bear their own costs. Court retains jurisdiction to enforce this order and the terms of the parties’ settlement agreement.
Celgene Corp. v. Synthon Pharms. Inc., 18-10775, 19-9737 (D.N.J.)	Pomalyst® (pomalidomide capsules)	8,198,262 8,673,939 8,735,428 8,828,427 10,093,647 10,093,648 10,093,649	Until the expiration of the patents-in-suit, Synthon is enjoined from making and selling its ANDA product. All claims, counterclaims, affirmative defenses and demands are dismised with prejudice and without costs, disbursements or attorneys’ fees. Nothing prohibits Synthon fomr maintaining a Paragraph IV Certification with respect to the patents-in-suit. Nothing restricts the FDA from approving Synthon’s ANDA.
Onyx Therapeutics, Inc. v. Dr. Reddy’s Labs., Inc., 16-1011, 17-1811 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, DRL is enjoined from infringing the patents-in-suit by making or selling its ANDA product. All claims, counterclaims, affirmative defenses and demands in this action by either Onyx or DRL are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Onyx Therapeutics, Inc. v. Breckenridge Pharm., Inc., 16-1001, 18-0262, 19-0071 (D. Del.)	Kyprolis® (carfilzomib for injection)	7,417,042 7,737,112 8,207,125	Except as specifically authorized pursuant to the Settlement Agreement, Breckenridge is enjoined from infringing the patents-in-suit by making or selling its ANDA product. Breckenridge withdraws all factual allegations in its pleadings, including those concerning unclean hands, litigation misconduct, and inequitable conduct, and its foregoing affirmative defenses and counterclaims as well as all other claims, counterclaims, affirmative defenses and demands in this action by either Onyx or Breckenridge are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Helsinn Healthcare S.A. v. Actavis LLC, 16-1683 (D.N.J.)	Aloxi® (palonosetron hydrochloride for injection)	7,947,724 9,066,980	All claims and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
Rhodes Pharms. L.P. v. Indivior Inc., 16-1308 (D. Del.)	Suboxone® (buprenorphine / naloxone sublingual film)	9,370,512	The Parties stipulate that all claims, counterclaims and affirmative defenses are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees. The district court shall retain jurisdiction to enforce and resolve any disputes arising under the parties’ settlement agreement.
BTG Int’l Ltd. v. Qilu Pharm. Co., Ltd., 18-16521 (D.N.J.)	Zytiga® (abiraterone acetate tablets)	8,822,438	Voluntary dismissal of all claims without prejudice.
BTG Int’l Ltd. v. MSN Pharms. Inc., 18-2372 (D.N.J.)	Zytiga® (abiraterone acetate tablets)	8,822,438	All claims and counterclaims dismissed without prejudice. Parties to bear own costs and fees.
Anacor Pharms., Inc. v. Ascent Pharms., Inc., 18-1673 (D. Del.)	Kerydin® (tavaborole topical solution)	9,459,938 9,566,289 9,566,290 9,572,823	Anacor and Aurobindo dismiss all claims and counterclaim without prejudice witheach party bearing their own costs.
Helsinn Healthcare S.A. v. Actavis LLC, 16-1683 (D.N.J.)	Aloxi® (palonosetron hydrochloride for injection)	7,947,724 9,066,980	All claims and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
Rhodes Pharms. L.P. v. Indivior Inc., 16-1308 (D. Del.)	Suboxone® (buprenorphine / naloxone sublingual film)	9,370,512	The Parties stipulate that all claims, counterclaims and affirmative defenses are dismissed with prejudice. Each party shall bear its own costs and attorneys’ fees. The district court shall retain jurisdiction to enforce and resolve any disputes arising under the parties’ settlement agreement.
BTG Int’l Ltd. v. Qilu Pharm. Co., Ltd., 18-16521 (D.N.J.)	Zytiga® (abiraterone acetate tablets)	8,822,438	Voluntary dismissal of all claims without prejudice.
BTG Int’l Ltd. v. MSN Pharms. Inc., 18-2372 (D.N.J.)	Zytiga® (abiraterone acetate tablets)	8,822,438	All claims and counterclaims dismissed without prejudice. Parties to bear own costs and fees.
Anacor Pharms., Inc. v. Ascent Pharms., Inc., 18-1673 (D. Del.)	Kerydin® (tavaborole topical solution)	9,459,938 9,566,289 9,566,290 9,572,823	Anacor and Aurobindo dismiss all claims and counterclaim without prejudice witheach party bearing their own costs.
Kythera Biopharmaceuticals, Inc. v. Slayback Pharma LLC, 18-16012 (D.N.J.)	Kybella® (deoxycholic acid injection)	8,101,593 8,367,649 8,653,058	Filing of the ANDA was a technical act of infringement. No decision has been obtained by either party regarding the validity of the patents-in-suit and/or whether any commercial making, using, selling, or offering to sell within the United States, or importing into the United States, of the generic product described by the ANDA would infringe those patents. All other claims, defenses, and counterclaims are dismissed without prejudice. Slayback is enjoined enjoined from manufacturing, using, offering to sell, or selling within the US, or importing into the US, the generic deoxycholic acid injection product that is the subject of the ANDA during the life of the patents-in-suit. The parties waive any right to appeal.
Mitsubishi Tanabe Pharma Corp. v. Prinston Pharm. Inc., 18-6112 (D.N.J.)	Invokana® (canagliflozin tablets)	7,943,788 8,222,219	The submission of Prinston’s ANDA to the FDA for the purpose of obtaining regulatory approval to make and sell generic Invokana was a technical act of patent infringement. The asserted claims of each of the patents-in-suit are valid and enforceable. Prinston is enjoined from manufacturing, using, offering for sale, selling in the US, or into the US, the Prinston ANDA product until the expiration of the patents-in-suit. 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.
Boehringer Ingelheim Pharma GmbH & Co. KG v. Aurobindo Pharma Ltd., 19-8840 (D.N.J.)	Pradaxa® (dabigatran etexilate mesylate capsules)	6,087,380	N/A
Endo Pharms. Inc. v. Lupin Atlantis Holdings SA, 18-10952 (D.N.J.)	Nascobal® (cyanocobalamin nasal spray)	7,229,636 7,404,489 7,879,349 8,003,353 8,940,714 9,415,007	The patent are valid and enforceable. Lupin’s ANDA product infringes the patents, and is therefore enjoined from making or selling its ANDA product until it is allowed to do so. All claims, counterclaims, defenses, and demands are dismissed with prejudice and without costs and fees. The parties agree to waive their right to appeal.
Bristol-Myers Squibb Co. v. Dr. Reddy’s Labs., Ltd., 17-0401, 18-0115 (D. Del.)	Eliquis® (apixaban tablets)	6,967,208 9,326,945	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 from this Stipulation and Order.
Horizon Pharma, Inc. v. Mylan Pharms. Inc., 15-3327, 16-4921 (D.N.J.)	Vimovo® (naproxen / esomeprazole magnesium delayed-release tablets)	8,852,636 8,858,996 8,945,621 9,220,698 9,345,695	The parties stipulate and agree that all claims, counterclaims, and affirmative defenses asserted are dismissed with prejudice. Each party to bear its own costs and attorneys’ fees.
Genentech, Inc. v. Hetero Labs Ltd., 19-0178 (D. Del.)	Esbriet® (pirfenidone tablets)	7,566,729 7,635,707 7,767,700 7,816,383 7,910,610 8,013,002 8,084,475 8,318,780 8,383,150 8,420,674 8,592,462 8,609,701 8,648,098 8,754,109 8,778,947	Complaint is dismissed without prejudice. Each party to bear its own costs and fees.