ANDA Litigation Settlements

Winter 2020

Case Name	Drug	Patent No(s).	Publicly Available Terms
Wyeth LLC v. Alembic Pharms., Ltd., 16-1305 (D. Del.)	Bosulif® (bosutinib tablets)	7,417,148	All claims and counterclaims are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees and expenses. The parties have entered into a settlement and license agreement with respect to their respective claims. Alembic will not make, use, or sell the accused product in the US except as provided for in the agreement. The stipulation and order shall not act as an adjudication on the merits.
Fresenius Kabi USA, LLC v. Custopharm, Inc., 18-0665 (W.D. Tex.)	Naropin® (ropivacaine HCl for injection)	8,118,802 8,162,915	N/A
CyDex Pharms., Inc. v. Teva Pharms. USA, Inc., 17-1832 (D. Del.)	Evomela® (melphalan HCl for Injection)	8,410,077 9,200,088 9,493,582	N/A
Adverio Pharma GMBH v. Alembic Pharms. Ltd., 18-0073 (D. Del.)	Adempas® (riociguat tablets)	6,743,798	All claims between plaintiffs and Alembic are dismissed in their entirety with prejudice.
Genzyme Corp. v. Cipla Ltd., 18-1838 (D. Del.)	Cerdelga® (eliglustat capsules)	6,916,802 7,196,205 7,253,185 7,615,573	All claims between plaintiffs and Cipla are dismissed in their entirety with prejudice.
Teijin Ltd. v. Alkem Labs. Ltd., 19-0768 (D. Del.)	Uloric® (febuxostat tablets)	7,361,676 8,372,872 9,107,912	All claims between plaintiffs and Alkem are dismissed in their entirety without prejudice.
Shire Development LLC v. Impax Labs., Inc., 18-0549 (D. Del.)	Mydayis® (dextroamphetamine saccharate / amphetamine aspartate monohydrate / dextroamphetamine sulfate / amphetamine sulfate extended-release capsules)	6,913,768 8,846,100 9,173,857	The patents-in-suit are valid and enforceable solely with respect to the Impax ANDA product, and any other product asserted to be bioequivalent to Mydayis marketed by, with the assistance of, or on behalf of, Impax. All affirmative defenses, claims, and counterclaims with respect to the validity or enforceability of the patents-in-suit are dismissed with prejudice. Defendant admits that in the absence of a license, it would infringe each of the asserted claims by making and selling the Impax ANDA product. The Impax ANDA product infringes the asserted claims. Defendant is enjoined during the term of the patents-in-suit from challenging the validity or enforceability of the patents-in-suit, and from making and selling the Impax ANDA product until the expiration of the patents-in-suit, except as otherwise authorized or licensed by Plaintiffs. The parties waive all right to appeal. Each party is to bear its own costs, expenses, and attorneys’ fees.
Duke University v. Akorn, Inc., 18-14035 (D.N.J.)	Latisse® (bimatoprost ophthalmic solution)	9,579,270	The filing of Akorn’s ANDA was an act of technical infringement, and its ANDA product, if approved, would infringe the patent-in-suit. All other claims, defenses, and counterclaims are dismissed without prejudice. Absent a license, Akorn is enjoined from making and selling its ANDA product during the life of the patent-in-suit. The parties waive any right to appeal. Nothing prohibits Akorn from maintaining a Paragraph IV certification with respect to the patents-in-suit.
Biogen Int’l GmbH v. Hetero USA Inc., 17-0825, 19-0211 (D. Del.)	Tecfidera® (dimethyl fumarate delayed-release capsules)	7,619,001 6,509,376 7,320,999 8,399,514	Hetero stipulates not to launch its ANDA product prior to the expiration of the ’001 patent (June 20, 2020). All claims, defenses, and counterclaims regarding the ’001 patent are dismissed without prejudice. This dismissal will have no effect on the statutory stay of FDA approval of Hetero’s ANDA currently in effect. Any judgment entered in the consolidated action concerning willful infringement, enhanced damages, exceptional case, or costs shall not be entered in the 19-211 action. The parties have agreed to waive any claim for attorneys’ fees and/or costs.
Leo Pharma A/S v. Teva Pharms. USA, Inc., 19-1282 (D. Del.)	Finacea® (azelaic acid foam)	10,322,085	All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees.
Amgen Inc. v. Accord Healthcare, Inc., 18-0956 (D. Del.)	Sensipar® (cinacalcet HCl tablets)	9,375,405	The ’405 patent is enforceable and valid. Making and selling Accord’s ANDA product would infringe the ’405 patent. Accord is enjoined until the expiration of the ’405 patent from infringing activities. Accord agrees that jurisidciton and venue in this court for an action for injunctive relief is proper. All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorneys’ fees.
Genentech, Inc. v. Micro Labs Ltd., 19-0111 (D. Del.)	Esbriet® (pirfenidone capsules 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	The complaint is dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Braintree Labs., Inc. v. Hetero Labs Ltd., 19-15676 (D.N.J.)	Suprep® (sodium sulfate / potassium sulfate / magnesium sulfate oral lavage solution)	6,946,149	Braintree dismisses without prejudice its complaint. Each party to bear its own costs and fees.
Allergan Sales, LLC v. Micro Labs Ltd., 19-9759 (D.N.J.)	Fetzima® (levomilnacipran HCl extended-release capsules)	8,481,598 8,865,937 RE43,879	Micro Labs admits that submission of its ANDA was a technical act of infringement of the patents-in-suit. Micro Labs stipulates to the enforceability and validity of the patents-in-suit. The parties agree that all other claims, defenses, and counterclaims set forth in the pleadings should be dismissed without prejudice.
Anacor Pharms., Inc. v. Mylan Pharms. Inc., 18-1699, 19-0632 (D. Del.), 18-0202 (N.D.W.V.)	Kerydin® (tavaborole topical solution)	9,459,938 9,566,289 9,566,290 9,572,823	Parties stipulate and agree that all claims between Anacor and the Mylan Defendants in the are dismissed without prejudice, and each party shall bear its own costs, attorneys’ fees, and expenses.
Bristol-Myers Squibb Co. v. Zydus Pharms. (USA) Inc., 17-0412 (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.
Wyeth LLC v. Sun Pharm. Indus. Ltd., 17-1362 (D. Del.)	Bosulif® (bosutinib tablets)	7,417,148 7,919,625	All claims adn counterclaims between plaintiff and Sun are dismissed without prejudice. Each party shall bear itos own costs, attorneys’ fees, and expenses. Sun will not make or sell the accused product in the US except as provided in the parties’ Settlement Agreement.
Bayer Intellectual Property GMBH v. Mylan Pharms. Inc., 17-0462, 17-0584 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218	The claims of the ’218 patent are valid and enforceable and Mylan’s commercial manufacture, use, and/or sale of its ANDA Products in the US would constitute infringement absent authorization by Plaintiffs. Mylan is enjoined from commercial manufacturing, using, and/or selling in the US its ANDA products during the term of the ’218 patent other than as permitted by the Settlement Agreement. Neither this Judgment and Order nor the entry of this Judgment and Order may be asserted by Plaintiffs against Mylan, and shall have no preclusive effect in any proceeding with respect to any product other than the Mylan ANDA products. All affirmative defenses, claims, and counterclaims are dismissed with prejudice. Parties shall shall bear their own fees and costs fees. Parties waive all right to appeal.
AstraZeneca LP v. Apotex Inc., 17-0714 (D. Del.)	Brilinta® (ticagrelor tablets)	RE46,276 7250419 7265124	Unless authorized by the Settlement Agreement, Apotex is enjoined from infringing the patents-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.
Bayer Intellectual Property GMBH v. Breckenridge Pharm., Inc., 17-0462, 17-1129 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218	The submission of the Breckenridge ANDA prior to the expiration of the ’218 patent was a technical act of patent infringement with respect to the claims of the ’218 patent under 35 U.S.C. §271(e)(2)(A). The asserted claims of the ’218 patent are valid and enforceable. Breckenridge’s manufacture, use, and sale of its ANDA products in the United States would constitute infringement of the asserted claims of the ’218 patent absent authorization by Plaintiffs. Breckenridge is enjoined from making, using, and selling its ANDA products during the term of the ’218 patent, other than as authorized by Plaintiffs. All affirmative defenses, claims, and counterclaims with respect to the Breckenridge ANDA products 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.
Delcor Asset Corp. v. Taro Pharm. Indus., Ltd., 17-5405 (S.D.N.Y.)	Evoclin® (clindamycin phosphate aerosol foam)	7,141,237 7,374,747	All claims, defenses, and counterclaims are hereby dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses.
Boehringer Ingelheim Pharms., Inc. v. Lupin Atlantis Holdings SA, 18-16708 (D.N.J.)	Spiriva® HandiHaler® (tiotropium bromide inhalation powder)	6,777,423 6,908,928 7,309,707 7,642,268	All claims, counterclaims, and affirmative defenses between BI and Lupin should be dismissed without prejudice. Each party will bear its own costs, disbursements, and attorney fees.
Shire Development LLC v. Teva Pharms. USA, Inc., 17-1696 (D. Del.)	Mydayis® (amphetamine aspartate / amphetamine sulfate / dextroamphetamine saccharate / dextroamphetamine sulfate extended-release capsules)	6,913,768 8,846,100 9,173,857	The patents-in-suit are valid and enforceable. All affirmative defenses, claims, and counterclaims are dismissed with prejudice. Teva admits that in the absence of a license, it would infringe each of the asserted claims by making, using, or selling its ANDA product. Judgment on the basis of infringement is entered in favor of Plaintiffs. Teva is permanently enjoined from making, selling, or using its ANDA product until the expiration of the patents-in-suit. Any Protective Order shall remain in full force and effect. The parties waive all right to appeal. Teva may maintain its PIV certifications and nothing shall prohibit the FDA from approving Teva’s ANDA product. The 30-month stay with respect to Teva’s ANDA product is terminated.
AstraZeneca Pharms. LP v. Alkem Labs. Ltd., 18-16399 (D.N.J.)	Daliresp® (roflumilast tablets)	8,536,206 8,604,064 8,618,142	Unless otherwise specifically authorized by AstraZeneca in writing, Alkem is enjoined from infringing the patents-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.
Amgen Inc. v. The ACME Labs. Ltd., 19-1702 (D. Del.)	Sensipar® (cinacalcet HCl tablets)	9,375,405	Acme admits that the ’405 patent is enforceable and valid. Acme admits that its ANDA product infringes the ’405 patent. Except as the parties have provided in the settlement agreement, this action is deemed satisfied. Acme is enjoined from infringing the ’405 patent unless specifically authorized pursuant to the settlement agreement. The action, including all claims, counterclaims, and affirmative defenses, is dismissed without prejudice and without costs, disbursements or attorneys’ fees to any party.
Biogen Int’l GMBH v. Glenmark Pharms. Ltd., 17-0852 (D. Del.)	Tecfidera® (dimethyl fumarate delayed-release capsules)	6,509,376 7,320,999 8,399,514	Glenmark stipulates that, until expiration of the patents-in-Suit, Glenmark is enjoined from infringing the patents-in-Suit by making and selling its ANDA product, unless specifically authorized by plaintiffs in writing. All claims and defenses of Plaintiffs are dismissed without prejudice. All counterclaims and defenses of Glenmark are dismissed with prejudice. The parties have waived any right to appeal. Each party will bear its own attorneys’ fees and costs.
Biogen Int’l GMBH v. Aurobindo Pharma U.S.A., Inc., 17-0824 (D. Del.)	Tecfidera® (dimethyl fumarate delayed-release capsules)	7,320,999 8,399,514	Aurobindo stipulates to the validity and enforceability of the ’514 patent. Aurobindo stipulates that the ’514 patent would be infringed by Aurobindo’s ANDA product. All claims and defenses of Plaintiffs are dismissed without prejudice. All counterclaims and defenses of Aurobindo are dismissed with prejudice. The parties waive any right to appeal. Each party will bear its own attorneys’ fees and costs.
Alkermes Pharma Ireland Ltd. v. Luye Pharma Group Ltd., 19-1340 (D. Del.)	Risperdal Consta® (extended-release risperidone for injection)	6,667,061	All claims asserted are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Plaintiffs waive any right to receive payment or financial consideration arising out of or in connection with the Court’s October 11, 2019 Order Regarding Scheduling and Provisions Due To Expedited Nature of Case (D.I. 39) and November 5, 2019 Order to post a judicial bond. All obligations associated with the aforementioned bond order are deemed moot. The parties waive any right to appeal.
Taro Pharms. U.S.A., Inc. v. Glenmark Pharms. Ltd., 18-12569 (D.N.J.)	Topicort® (desoximetasone topical spray)	8,277,780 8,715,624	All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear their own costs and attorneys’ fees.
Actelion Pharms. Ltd. v. Natco Pharma Ltd., 19-12984 (D.N.J.)	Tracleer® (bosentan tablets)	8,309,126	Natco’s ANDA submission and the commercial manufacture and sale of its ANDA product would constitute infringement of the asserted claims. The asserted claims are valid and enforceable. Natco is enjoined from infringing the asserted claims until the expiration of the ’126 patent. All affirmative defenses, claim, and counterclaims are dismissed without prejudice. Each party shall bear its own fees and costs. The parties waive all right to appeal.
Piramal Healthcare UK Ltd. v. Sumitomo Dainippon Pharma Co., Ltd., 19-14307 (D.N.J.)	Latuda® (lurasidone HCl tablets)	8,729,085	The submission of Piramal’s ANDA, and the manufacture, use, and sale of its ANDA product, does not infringe the ’085 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice. The consent judgment is non-appealable.
Genzyme Corp. v. Zenara Pharma Private Ltd., 19-0264 (D. Del.)	Cerdelga® (eliglustat capsules)	6,916,802 7,196,205 7,253,185 7,615,573	All claims and counterclaims are dismissed with prejudice.
Bayer Intellectual Property GMBH v. Sigmapharm Labs., LLC, 17-0648 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218	All claims, counterclaims, and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Bayer Intellectual Property GMBH v. Micro Labs Ltd., 17-0560 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218	All claims, counterclaims, and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
AstraZeneca AB v. Teva Pharms. USA, Inc., 18-1685 (D. Del.)	Symbicort® (budesonide / formoterol fumarate dehydrate inhalation aerosol)	7,759,328 8,143,239 8,575,137 7,967,011	Unless authorized by the settlement agreement, Teva and Catalent are enjoined from infringing the patents-in-suit by making, selling, or importing into the US Teva’s ANDA product. Compliance with this Consent Judgment may be enforced by AstraZeneca as permitted by the terms of the Settlement Agreement. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Abraxis Bioscience, LLC v. Sun Pharma Advanced Research Co., Ltd., 19-16495 (D.N.J.)	Abraxane® (paclitaxel protein-bound particles for injectable suspension)	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	Abraxis BioScience dismisses its claims without prejudice and without costs.
Indivior Inc. v. Aveva Drug Delivery Systems, Inc., 19-60757 (S.D. Fla.)	Suboxone® (buprenorphine HCl / naloxone HCl sublingual film)	8,017,150 8,603,514 9,687,454 9,931,305	Unless otherwise authorized by the Settlement Agreement, Apotex is enjoined from infringing the patents-in-suit by making, selling, or importing into the US its ANDA product. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party.
Eisai Co. v. Alkem Labs. Ltd., 19-1213 (D. Del.)	Banzel® (rufinamide oral suspension)	6,740,669	The ’669 patent is enforceable and valid. Except as permitted by the settlement agreement, Alkem is enjoined from infringing the ’669 patent until the license to the patent provided in the settlement agreement becomes effective. All claims and counterclaims, affirmative defenses, and demands of the parties are dismissed with prejudice and without costs, disbursements, or, except to the extent set forth in the settlement agreement, attorneys’ fees, to any party. The parties each expressly waive any right to appeal or otherwise move for relief from the entered consent judgment.
AstraZeneca LP v. HEC Pharm Co., Ltd., 19-14737 (D.N.J.)	Brilinta® (ticagrelor tablets)	RE46,276 7,265,124	Unless authorized by the settlement agreement, HEC 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.
Eli Lilly and Co. v. Eagle Pharms., Inc., 17-1293 (D. Del.)	Alimta® (pemetrexed for injection)	7,772,209	The parties stipulate and agree that all claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Valeant Pharms. North America LLC v. Cipla Ltd., 18-14225, 19-0988 (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	Absent a license or other authorization form Plaitniffs, the patents-in-suit would be infringed by Cipla’s ANDA product. Cipla is enjoined until their expiration from infringing the patents-in-suit. Cipla may contest the infringement, validity, and/or enforceability of the patents-in-suit pertaining to any other product. Each party will bear its own costs and attorneys’ fees. Cipla may maintain its Paragraph IV certifications as against the patents-in-suit and the 30-month stay related to the Cipla ANDA product is terminated.
Bayer Intellectual Property GMBH v. Torrent Pharms., Ltd., 17-1163 (D. Del.)	Xarelto® (rivaroxaban tablets)	9,539,218	Plaintiffs’ action against Torrent and Torrent’s action against Plaintiffs are dismissed with prejudice. All parties shall bear their own costs, disbursements and attorneys’ fees.
Genentech, Inc. v. Accord Healthcare, Inc., 19-0141, -0142 (D. Del.)	Esbriet® (pirfenidone capsules)	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 7,696,236 7,767,225 7,988,994 8,753,679	The complaints are dismissed without prejudice. Each party shall bear its own costs adn attorney’s fees.
Genentech, Inc. v. Aizant Drug Research Solutions Pvt. Ltd., 19-0223 (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	The complaint is dismissed without prejudice. Each party shall bear its own costs adn attorney’s fees.
Genentech, Inc. v. MSN Labs. Private Ltd., 19-0205 (D. Del.)	Esbriet® (pirfenidone tablets)	8,383,150 8,778,947	The complaint is dismissed without prejudice. Each party shall bear its own costs adn attorney’s fees.
Genentech, Inc. v. Alembic Pharms., Ltd., 19-0177 (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	The complaint is dismissed without prejudice.
Allergan Sales, LLC v. Ajanta Pharma Ltd., 19-1249 (D. Del.)	Bystolic® (nebivolol HCl tablets)	6,545,040	Ajanta’s ANDA was a technical act of nfringement of the ’040 patent. No court decision has been obtained by either party whether the ANDA product would infringe the ’040 patent. Ajanta is enjoined from infringing the ’040 patent until it expires, absent a license agreement or other authorization by Plaintiffs, unless all of the claims are found invalid or unenforceable. The parties waive any right to appeal. This stipulation and order are made without prejudice to any claim, defense, or counterclaim in any possible future action between the parties regarding the ’040 patent and a product that is not Ajanta’s ANDA product.
Genentech, Inc. v. Laurus Labs Ltd., 19-0078, -0104 (D. Del.)	Esbriet® (pirfenidone tablets and capsules)	7,566729 7,635707 7,767700 7,816383 7,910610 8,013002 8,084475 8,318780 8,383150 8,420674 8,592462 8,609701 8,648098 8,754109 8,778947 7,696236 7,767225 7,988994 8,753679	The complaint is dismissed without prejudice.