About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation.
Horizon Therapeutics, LLC v. Par Pharmaceutical, Inc.
1-18-cv-01224; filed August 10, 2018 in the District Court of Delaware
• Plaintiff: Horizon Therapeutics, LLC
• Defendants: Par Pharmaceuticals, Inc., Par Pharmaceutical Companies, Inc.
Claim: Infringement of U.S. Patent No.
• 8,642,012: "Methods of treatment using ammonia-scavenging drugs"
Synopsis: Horizon Therapeutics, LLC claims infringement of the ′012 patent for RAVICTI® (glycerol phenylbutyrate oral liquid 1.1gm/ml). Horizion Therapeutics holds NDA No. 20324 for RAVICTI®, which is used as a nitrogen-binding agent for chronic management of adult and pediatric patients with urea cycle disorders. Defendants, under ANDA No. 205742, seek approval to engage in the commercial manufacture, use, or sale of a generic version of RAVICTI® prior to the expiration of the '012 patent.
View the complaint here.
Allergan, Inc. v. Saptalis Pharmaceuticals, LLC
1-18-cv-01231; filed August 10, 2018 in the District Court of Delaware (Wilmington)
• Plaintiffs: Allergan, Inc. and Saint Regis Mohawk Tribe
• Defendant: Saptalis Pharmaceuticals, LLC
Claim: Infringement of U.S. Patent Nos.
• 8,633,162: ″Methods of providing therapeutic effects using cyclosporin components"
• 8,642,556: "Methods of providing therapeutic effects using cyclosporin components"
Synopsis: Allergan and Saint Regis Mohawk Tribe allege infringement of the ′162 and ′556 patents. The Saint Regis Mohawk Tribe, as assignee, owns the entire right, title, and interest in the ′162 and ′556 patents. Allergan is the holder of approved NDA No. 50-790 for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark. Allergan holds an exclusive field-of-use license to the ʼ162 and ′556 patents with respect to commercializing RESTASIS®. On information and belief, Saptalis submitted ANDA No. 211943 seeking FDA approval to engage in the commercial manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion, 0.05%, a generic version of Allergan's RESTASIS® product. Plaintiffs seek declaratory judgment of Infringement of the ′012 and '556 patents.
View the complaint here.
AstraZeneca LP v. Hisun Pharmaceutical (Hangzhou) Co., Ltd.
1-18-cv-01232; filed August 10, 2018 in the District Court of Delaware (Wilmington)
• Plaintiffs: AstraZeneca LP, AstraZeneca AB, AstraZeneca UK Ltd., and AstraZeneca Pharmaceuticals LP
• Defendants: Hisun Pharmaceutical (Hangzhou) Co., Ltd. and Hisun Pharmaceuticals USA, Inc.
Claim: Infringement of U.S. Patent Nos.
• 7,250,419: ″Trisubstituted triazolopyrimidines for use in platelet aggregation inhibition″
• 7,265,124: ″Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compound″
• RE46276: ″Triazolo(4,5-D)pyrimidine compounds″
Synopsis: AstraZeneca claims infringement of the ′419, ′124, and ′276 patents. AstraZeneca is the holder of NDA No. 022433 for the marketing and sale of BRILINTA® (ticagrelor) tablets in 90 mg and 60 mg dosage strengths. BRILINTA® is intended to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction. Hisun filed ANDA No. 208575 for commercial manufacture, use, and sale of generic ticagrelor tablets.
View the complaint here.
Related Cases: 15-cv-1042-RGA: AstraZeneca previously filed suit against Hisun regarding its ticagrelor ANDA and its proposed 90 mg dosage strength generic ticagrelor tablet. The parties later jointly dismissed the case without prejudice.
Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Atlantis Holdings SA
3-18-cv-12663; filed August 10, 2018 in the District Court of New Jersey (Trenton)
• Plaintiffs: Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, and Boehringer Ingelheim Pharma GmbH & Co. KG
• Defendants: Lupin Atlantis Holdings SA and Lupin Ltd.
Claim: Infringement of U.S. Patent Nos.
• 7,070,800: ″Inhalable Powder Containing Tiotropium″
• 7,694,676: ″Dry Powder Inhaler″
Synopsis: Boehringer claims infringement of the ′800 and ′676 patents. Boehringer is the holder of NDA No. 021395 for SPIRIVA® HandiHaler®, an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations. Lupin submitted ANDA No. 211287 to engage in the commercial manufacture, use, or sale of tiotropium bromide inhalation powder, 18 mcg/capsule, as a purported generic version of SPIRIVA® HandiHaler®.
View the complaint here.
AbbVie Inc. v. Sandoz Inc.
3-18-cv-12668; filed August 10, 2018 in the District Court of New Jersey (Trenton)
• Plaintiffs: AbbVie Inc., and Abbvie Biotechnology Ltd.
• Defendants: Sandoz Inc., Sandoz GmbH, and Sandoz International GmbH
Claim: Infringement of U.S. Patent Nos.
• 9,187,559: ″Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease″
• 9,750,808: ″Formulation of human antibodies for treating TNF-Alpha associated disorders″
Synopsis: Abbvie Biotechnology Ltd. is the owner by assignment of the ′559 and ′808 patents. AbbVie Inc. is the holder of Biologic License Application No. 125057 for HUMIRA®, whose active pharmaceutical ingredient is the antibody adalimumab. Sandoz had submitted an abbreviated Biologics License Application ("aBLA") requesting that its biosimilar adalimumab product GP2017 be licensed for commercial sale by relying on AbbVie's demonstration that HUMIRA® is safe and effective. Abbvie alleges that the aBLA provides Sandoz an abbreviated regulatory pathway for its biosimilar version of HUMIRA®, however in doing so Sandoz has infringed AbbVie's patents.
View the complaint here.
Athenex Pharma Solutions, LLC v. Par Pharmaceutical, Inc.
1-18-cv-00896; filed August 13, 2018 in the District Court Western District of New York (Buffalo)
• Plaintiffs: Athenex Pharma Solutions, LLC and Athenex Pharmaceutical Division, LLC
• Defendants: Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Co., LLC
Claim: Infringement of U.S. Patent Nos.
• 9,375,478: ″Vasopressin formulations for use in treatment of hypotension″
• 9,687,526: ″Vasopressin formulations for use in treatment of hypotension″
• 9,744,209: ″Vasopressin formulations for use in treatment of hypotension″
• 9,744,239: ″Vasopressin formulations for use in treatment of hypotension″
• 9,750,785: ″Vasopressin formulations for use in treatment of hypotension″
• 9,937,223: ″Vasopressin formulations for use in treatment of hypotension″
Synopsis: Athenex seeks a declaration of non-infringement and invalidity of the ′478, ′526, ′209, ′239, ′785, and ′223 Patent. Par Sterile is the manufacturer of Vasostrict® and is the holder of NDA No. 204485. The active ingredient in Vasostrict® is vasopressin. Athenex's compounded vasopressin products will be administered to patients in a ready-to-use form, eliminating the need for mixing by a health care professional. As a result, Plaintiffs allege that their compounded vasopressin products do not, and would not, if marketed, infringe any claims of the patents in suit.
View the complaint here.
Valeant Pharmaceuticals v. Actavis Laboratories FL., Inc.
1-18-cv-01288; filed August 22, 2018 in the District Court of Delaware (Wilmington)
• Plaintiff: Valeant Pharmaceuticals International, Salix Pharmaceuticals Ltd., and Cosmo Technologies Ltd.
• Defendant: Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd.
Claim: Infringement of U.S. Patent No.
• 10,052,286: ″Controlled release and taste masking oral pharmaceutical composition″
Synopsis: Valent claims infringement of the ′286 patent. VPI holds NDA No. 203634 for oral tablets containing 9 mg of the active ingredient budesonide, which are sold in the United States under the brand name Uceris®. Uceris® is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Actavis Labs submitted ANDA No. 205457 and seeks to engage in making, using, offering to sell and selling in the United States and/or importing into the United States its generic version of Uceris®.
View the complaint here.
Insys Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.
1-18-cv-01308; filed August 23, 2018 in the District Court of Delaware (Wilmington)
• Plaintiffs: Insys Therapeutics, Inc. and Insys Development Co., Inc.
• Defendants: Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.
Claim: Infringement of U.S. Patent Nos.
• 8,486,972: ″Sublingual fentanyl spray″
• 8,486,973: ″Sublingual fentanyl spray″
• 8,835,459: ″Sublingual fentanyl spray″
• 8,835,460: ″Sublingual fentanyl spray and methods of treating pain″
• 9,241,935: ″Sublingual fentanyl spray″
• 9,289,387: ″Method of treating pain by administering sublingual fentanyl spray″
• 9,642,797: ″Sublingual fentanyl spray and methods of use to treat pain″
• 9,642,844: ″Sublingual fentanyl spray″
Synopsis: Insys claims infringement of the ′972, ′973, ′459, ′460, ′935, ′387, ′797, and ′844 patents. Insys holds NDA No. 202788 on SUBSYS®, a fentanyl sublingual spray, and is the exclusive distributor of SUBSYS® in the United States. Defendants, under ANDA No. 211209 have indicated they intend to engage in the commercial manufacture, use, or sale of a Fentanyl Sublingual Spray, 0.8 mg before the expiration of the patents-in-suit.
View the complaint here.
