Source: https://www.patentdocs.org/new_biotech_cases/
Timestamp: 2019-04-19 10:51:04+00:00

Document:
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation.
Horizon Therapeutics, LLC v. Par Pharmaceutical, Inc.
• 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.
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.
AstraZeneca LP v. Hisun Pharmaceutical (Hangzhou) Co., Ltd.
• Defendants: Hisun Pharmaceutical (Hangzhou) Co., Ltd. and Hisun Pharmaceuticals USA, Inc.
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.
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.
• Defendants: Lupin Atlantis Holdings SA and Lupin Ltd.
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®.
AbbVie Inc. v. Sandoz Inc.
• Plaintiffs: AbbVie Inc., and Abbvie Biotechnology Ltd.
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.
Athenex Pharma Solutions, LLC v. Par Pharmaceutical, Inc.
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.
Valeant Pharmaceuticals v. Actavis Laboratories FL., Inc.
• 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.
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®.
Insys Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.
• Plaintiffs: Insys Therapeutics, Inc. and Insys Development Co., Inc.
• Defendants: Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.
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.
Celgene Corp. v. Synthon Pharmaceuticals, Inc.
Synoposis: Celgene claims Infringement of the '262, '939, '428, and '427 patents. Celgene holds approved NDA No. 204026 for pomalidomide capsules, which it sells under the trade name POMALYST®. POMALYST® is an FDA-approved medication used for the treatment of multiple myeloma. The claims of the patents-in-suit cover, inter alia, methods of use and administration of pomalidomide, or pharmaceutical compositions containing pomalidomide. Synthon Pharmaceuticals, Inc. submitted ANDA No. 210232 to engage in the commercial manufacture, use, offer for sale, sale, or importation into the United States of Synthon's Proposed Products, prior to the expiration of the '262 patent.
• Plaintiffs: Huvepharma EOOD and Huvepharma, Inc.
• Defendants: E.I. du Pont de Nemours and Company; DuPont Industrial Biosciences USA, LLC; Danisco USA, Inc.; and Danisco US Inc.
Synopsis: Huvepharma claims infringement of the '150, '063, and '232 patents. Plaintiff claims that beginning in the 2003 time frame, Defendants contracted with Fermic S.A. de C.V. in Mexico to manufacture Phyzyme phytase products in Mexico, followed by manufacturing Phyzyme phytase products at a second location in Europe which was also imported by Defendants and/or their predecessors-in-interest into the United States.
Synoposis: Genentech has multiple patents on Herceptin®, its manufacture, and its use for the treatment of HER2-positive breast cancer. Plaintiffs claim that Amgen is seeking FDA approval of a biosimilar version of Herceptin® called ABP 980 with the same label indications and usage as Herceptin®. Plaintiffs allege infringement based upon Amgen's submission of its aBLA for ABP 980. Plaintiffs also seek a declaratory judgment. Genentech claimed patent infringement and Defendant expressed concern that complaint contained confidential information. Complaint was sealed on June 25, 2018, a redacted version of the Complaint was filed on July 2, 2018.
Astellas Pharma Inc. v. Aurobindo Pharma Ltd.
• Plaintiffs: Astellas Pharma Inc.; Astellas Pharma U.S., Inc.; Astellas Ireland Co., Ltd.; and Astellas Pharma Europe Ltd.
• Defendant: Aurobindo Pharma Ltd.
Synopsis: Astellas Pharma Inc. claims infringement the ′927 patent. Astellas Pharma U.S., Inc. holds approved NDA No. 21518 for VESIcare® tablets in 5 mg and 10 mg strength tablet dosage forms, which contain the active ingredient solifenacin succinate. Aurobindo India submitted ANDA No. 206817 seeking FDA approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of generic solifenacin succinate 5 mg and 10 mg tablets, for the treatment of overactive bladder prior to the expiration of the ′927 patent. Aurobindo India's ANDA submission included a certification that, in Aurobindo India's opinion, the claims of the ′927 patent are invalid.
Celgene Corp. v. Sandoz Inc.
Synoposis: Celgene Corp. claims infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 Patents. Celgene makes and sells OTEZLA® (apremilast) 10 mg, 20 mg, and 30 mg tablets for treatment of adult patients with active psoriatic arthritis as well as patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. OTEZLA® is the first approved pharmaceutical product to contain apremilast and was granted five years of regulatory exclusivity for a new chemical entity, which expires on March 21, 2019. Plaintiff alleges Sandoz submitted ANDA No. 211658 to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or importation into the United States of generic apremilast tablets prior to the expiration of the patents-in-suit. Celgene claims infringement and Sandoz counters that the patents-in-suit are invalid, unenforceable, or would not be infringed.
• Celgene Corp. v. Macleods Pharmaceuticals Ltd.
• Celgene Corp. v. MSN Laboratories Private Ltd.
• Celgene Corp. v. Prinston Pharmaceutical Inc.
• Celgene v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc.
• Celgene Corp. v. Emcure Pharmaceuticals Ltd. and Heritage Pharmaceuticals Inc.
• Celgene Corp. v. Annora Pharma Private Ltd. and Hetero USA Inc.
• Celgene Corp. v. Torrent Pharmaceuticals Ltd.
• Celgene Corp. v. Shilpa Medicare Ltd.
• Celgene Corp. v. Glenmark Pharmaceuticals Ltd.
• Celgene Corp. v. Dr. Reddy's Laboratories, Inc.
• Celgene Corp. v. Unichem Laboratories, Ltd.
• Celgene Corp. v. Zydus Pharmaceuticals USA, Inc.
• Celgene Corp. v. Alkem Laboratories Ltd.
• Celgene Corp. v. Cipla Ltd.
• Celgene Corp. v. Aurobindo Pharma Ltd.
Synopsis: Xlear is the assignee of all rights, title, and interest in the ′143, ′372, and ′883 patents. Plaintiff has recently become aware that Defendant has sold, is selling, or offering to sell nasal sprays containing xylitol through its stores and its website. Plaintiff alleges that the Defendants' nasal sprays (1) instruct and actively induce users to nasally administer an effective amount of xylitol/xylose in solution; (2) contain xylitol in amounts that infringe; and (3) products, packaging and/or websites provide instruction on the method that users of its products should follow to nasally administer an effective amount of xylitol/xylose to the nasopharynx of a human. Plaintiffs thus claim that Defendant infringes either literally, equivalently or contributorily one or more claims in the patents at issue.
Gilead Sciences, Inc. v. Strides Pharma Inc.
• Defendants: Strides Pharma, Inc. and Strides Pharma Global PTE Ltd.
• 8,716,264: ″Compositions and methods for combination antiviral therapy"
Synopsis: Gilead is the holder of NDA No. 21-752 which relates to tablets containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate. The tablets are prescribed and sold under the trademark Truvada® for the treatment of HIV-1 infection in adults. The ′397, ′264, ′036, and ′181 patents are assigned to Gilead and the ′245 and ′396 Patents to Emory, Gilead is a licensee with enforcement rights. Defendant submitted ANDA No. 091055 seeking approval to engage in the commercial manufacture, use, sale and/or importation of tablets containing 200 mg of emtricitabine and 300 mg tenofovir disoproxil fumarate for the purpose of treating HIV infection. Plaintiffs claimed infringement of the patents noted, Defendants countered that the issued patents were either not valid or not infringed.
Synopsis: Fresnius claims infringement of the ′082 and ′229 patents. Fresenius owns all rights, title, and interest in the '082 and '229 patents. Fresenius is the holder of NDA No. 019034 for Dilaudid® Injection. Eurohealth submitted amendments to ANDA No. 202159 to engage in the commercial manufacture, use, importation, offer for sale, or sale of generic Deluadid® Injection.
• Plaintiffs: CIPLA Ltd. and CIPLA USA, Inc.
• Defendants: Eli Lilly and Company and ICOS Corp.
Synopsis: Cipla seeks a declaratory judgment that the ′975 and ′958 patents are invalid. ICOS is the assignee of the ′975 and ′958 patents. Lilly is the exclusive licensee of both patents. The patents are associated with submitted NDA No. 022332. Cipla was not the first generic drug manufacturer to file an ANDA directed to tadalafil tablets in the 20 mg dosage strength. Cipla sent Lilly and ICOS notice of Cipla's Paragraph IV certification with ANDA No. 210255. Cipla's Notice Letter initiated a 45-day statutory period during which Defendants did not file an action against Cipla for infringement of the '975 or '958 patents. Cipla believes the patents are an impediment to entry into the market. As a subsequent ANDA filer, Cipla's ANDA for 20 mg tadalafil tablets cannot be approved by the FDA until the first ANDA filer's 180-day exclusivity period is either forfeited or runs out. As of the date of this Complaint, the '975 and '958 patents are the only two remaining unexpired patents listed on the Orange Book for NDA No. 022332. As such, there are no patents barring the first ANDA filer from entering the market. Additionally, no first ANDA filer has entered the market. Cipla seeks a declaratory judgment to allow entry into the market.
Astellas Parma Inc. v. Cipla Ltd.
Synopsis: Astellas claims infringement of the ′927 patent. Astellas Pharma U.S., Inc. holds approved NDA No. 21518 for VESIcare® tablets in 5 mg and 10 mg strength tablet dosage forms, which contain the active ingredient solifenacin succinate. VESIcare® is indicated for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Cipla submitted ANDA No. 209839 for generic solifenacin succinate 5 mg and 10 mg tablets, as a pharmaceutical composition in an oral dosage form for the treatment of overactive bladder prior to the expiration of the '927 patent. In response, Plaintiffs filed for patent infringement.
Biozone Laboratories, Inc. v. Next Step Laboratories Corp.
• Plaintiff: Biozone Laboratories, Inc.
Synopsis: BioZone claims infringement of patents ′322, ′160, ′596, ′421, ′883, and ′190. The Patents-in-Suit cover BioZone’s proprietary QuSome® and Inflacin® proprietary technologies. Plaintiffs claim Defendants directly and indirectly infringe, by offering to sell QuSomes Products according to the claims of the patents-in-suit.
H. Lundbeck A/S v. MSN Laboratories Private Ltd.
• Plaintiffs: H. Lundbeck A/S, Takeda Pharmaceutical Co. Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International AG, and Takeda Pharmaceuticals America, Inc.
• Defendants: MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc., and MSN Pharmachem Private Ltd.
Synopsis: Plaintiffs claim infringement of the ′630 patent. Plaintiff H. Lundbeck is the assignee and owner of the ′630 patent. Lundbeck granted Takeda Japan an exclusive license to the ′630 patent. Takeda Japan issued sublicenses to its subsidiary Plaintiffs. Takeda USA is the holder of New Drug Application ("NDA") No. 204447 for TRINTELLIX® tablets (5 mg, 10 mg, 15 mg, and 20 mg dosage strengths) containing the active ingredient vortioxetine hydrobromide for the treatment of Major Depressive Disorder. Defendants have submitted ANDA No. 211101 to FDA, or caused ANDA No. 211101 to be submitted to FDA, under 21 U.S.C. § 355(j), in order to obtain approval to engage in the commercial manufacture, use, or sale of vortioxetine hydrobromide tablets as purported generic versions of TRINTELLIX® tablets prior to the expiration of the ’630 Patent.
Purdue Pharma LP v. Ascent Pharmaceuticals, Inc.
• Defendant: Ascent Pharmaceuticals, Inc.
Synopsis: Plaintiffs claim infringement of the ′060, ′976, ′933, ′533, ′919, ′610, and ′582 patents. Plaintiffs have approved NDA No. 022272 in the 10 mg, 15 mg, 20 mg, 30 mg, 60 mg and 80 mg dosage strengths. Defendant filed ANDA No. 211178 seeking approval to engage in the commercial manufacture, use, or sale of Defendant's ANDA Products, a generic product based on the Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272. Plaintiffs sued for patent infringement.
Teijin Ltd. v. MSN Laboratories Private Ltd.
• Plaintiffs: Teijin Ltd., Teijin Pharma Ltd., and Takeda Pharmaceuticals U.S.A., Inc.
• Defendants: MSN Laboratories Private Ltd. and MSN Pharmaceuticals, Inc.
Synopsis: Plaintiffs claim infringement of the ′676, ′872, and ′912 patents. Plaintiffs own the patents noted. In addition, Takeda holds NDA No. 21-856 for oral tablets containing 40 mg or 80 mg of the active ingredient febuxostat. Takeda markets and sells these tablets in the United States under the brand name Uloric®. MSN certified in ANDA No. 210461 that the claims of 7 the patents-in-suit are invalid, unenforceable, or would not be infringed by the commercial manufacture, use, offer for sale, or sale of MSN’s Generic Products. Plaintiff claims the Defendant infringes the claims of the ′676, ′872, and ′912 patents.
Horizon Therapeutics, Inc. v. Lupin Ltd. et al.
• Plaintiff: Horizon Therapeutics, Inc.
Infringement of U.S. Patent Nos. 9,254,278 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued February 9, 2016) and 9,326,966 (same title, issued May 3, 2016) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone). View the complaint here.
Allergan, Inc. v. TWi Pharmaceuticals, Inc. et al.
• Defendants: TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.
The complaints in these cases are substantially identical. Infringement of U.S Patent Nos. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014), 8,633,162 (same title, issued January 21, 2014), 8,642,556 (same title, issued February 4, 2014), 8,648,048 (same title, issued February 11, 2014), 8,685,930 (same title, issued April 1, 2014), and 9,248,191 (same title, issued February 2, 2016) following a Paragraph IV certification as part of TWi's filing of an ANDA to manufacture a generic version of Allergan's Restasis® (cyclosporine ophthalmic emulsion, 0.05%, used to treat dry eye). View the Delaware complaint here.
AstraZeneca AB et al. v. Aurobindo Pharma Ltd. et al.
• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.
Valeant Pharmaceuticals Luxembourg S.A.R.L. et al. v. Actavis Laboratories UT. Inc. et al.
Infringement of U.S. Patent No. 6,670,335 ("Fluorouracil-Containing Formulation," issued December 30, 2003) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Valeant's Carac® (fluorouracil 0.5% cream, used to treat multiple actinic or solar keratoses of the face and anterior scalp). View the complaint here.
Shionogi Inc. et al. v. Actavis Laboratories UT, Inc.
• Plaintiffs: Shionogi Inc.; Concordia Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 6,793,931 ("Ectoparasite Asphyxiator Compositions and Methods for their Applications," issued September 21, 2004) and 7,294,342 (same title, issued November 13, 2007) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Shionogi's Ulesfia® (benzyl alcohol lotion, 5%, for the topical treatment of head lice infestation in patients 6 months of age and older). View the complaint here.
Actavis Elizabeth LLC v. Novartis Corp. et al.
Declaratory judgment of noninfringement of U.S. Patent No. 9,283,209 ("Oral Formulations of Deferasirox," issued March 15, 2016) based on Activis' Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novartis' Jadenu® (deferasirox, used for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions). View the complaint here.
Helsinn Healthcare S.A. v. Zydus Pharmaceuticals (USA) Inc. et al.
• Plaintiff: Helsinn Healthcare S.A.
• Defendants: Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.
Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting). View the complaint here.
DSM IP Assets, B.V. et al. v. Lallemand Specialties, Inc. et al.
• Plaintiffs: DSM IP Assets, B.V.; DSM Bio-Based Products & Services B.V.
Infringement of U.S. Patent No. 8,795,998 ("Fermentative Glycerol-Free Ethanol Production," issued August 5, 2014) based on defendants' manufacture and sale of certain transgenic yeast cells, including their TransFerm Yield+ product. View the complaint here.
Tris Pharma Inc. v. Actavis Elizabeth LLC et al.
• Plaintiff: Tris Pharma Inc.
• Defendants: Actavis Elizabeth LLC; Actavis Inc.
Infringement of U.S. Patent Nos. 8,202,537 ("Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes," issued June 19, 2012), 8,287,903 ("Orally Effective Methylphenidate Extended Release Powder and Aqueous Suspension Product," issued October 16, 2012), 8,999,386 ("Methylphenidate Extended Release Chewable Tablet," issued April 7, 2015), and 9,295,642 (same title, issued March 29, 2016) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Tris' QuilliChew ER® (methylphenidate hydrochloride extended-release chewable tablets, used to treat ADHD in children 6 years and above). View the complaint here.
Imprimis Pharmaceuticals, Inc. v. Alcon Pharmaceuticals Ltd. et al.
• Plaintiff: Imprimis Pharmaceuticals, Inc.
• Defendants: Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.
Declaratory judgment of noninfringment of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) based on Imprimis' manufacture and sale of certain ophthalmic products. View the complaint here.
Gilead Sciences, Inc. et al. v. Aurobindo Pharma Ltd. et al.
Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003), 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004), 8,592,397 ("Compositions and Methods for Combination Antiviral Therapy," issued November 26, 2013), and 8,716,264 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate, used for the treatment of HIV-1 infection in adults). View the complaint here.
Merck Sharp & Dohme Corp. v. Genentech, Inc. et al.
• Plaintiff: Merck Sharp & Dohme Corp.
Declaratory judgment of invalidity and noninfringement of U.S. Patent No. 7,923,221 ("Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen," issued April 12, 2011) based on Merck's manufacture and sale of its Keytruda® product (pembrolizumab, used to treat patients with unresectable or metastatic melanoma, and for the treatment of patients with metastatic or PD-L1 positive, non-small cell lung cancer, as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy) and/or Merck's anticipated manufacture and sale of its bezlotoxumab products (to be used for the prevention of Clostridium difficile infection recurrence). View the complaint here.
AstraZeneca AB v. Apotex Corp. et al.
• Defendants: Apotex Corp.; Apotex Inc.
Infringement of U.S. Patent No. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus). View the complaint here.
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,900,638 ("Solid Preparation Comprising Alogliptin and Metformin Hydrochloride," issued December 2, 2014). View the complaint here.
Alcon Pharmaceuticals Ltd. et al. v. Imprimis Pharmaceuticals, Inc.
• Plaintiffs: Alcon Pharmaceuticals Ltd.; Alcon Research, Ltd.
• Defendants: Imprimis Pharmaceuticals, Inc.
Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) based on Imprimis' manufacture and sale of moxifloxacin ophthalmic products, similar to Alcon's Vigamox® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis). View the complaint here.
Horizon Therapeutics, Inc. v. Par Pharmaceutical, Inc.
Infringement of U.S. Patent Nos. 9,095,559 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued August 4, 2015), 9,254,278 (same title, issued February 9, 2016), and 9,326,966 (same title, issued May 3, 2016) following Par's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone). View the complaint here.
Genzyme Corp. et al. v. Zydus Pharmaceuticals (USA) Inc.
• Defendant: Zydus Pharmaceuticals (USA) Inc.
Infringement of U.S. Patent No. 5,661,136 ("2-Halo-2'-Fluoro ARA Adenosines as Antinoplastic Agents," issued August 26, 1997) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Genzyme's Clolar® (clofarabine injection, used to treat acute lymphoblastic leukemia). View the complaint here.
Defendant: Zydus Pharmaceuticals (USA) Inc.
Infringement of U.S. Patent Nos. 7,897,590 ("Methods to mobilize progenitor/stem cells" issued March 1, 2011) and 6,987,102 ("Methods to mobilize progenitor/stem cells" issued January 17, 2006) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Genzyme's Mozobil® (plerixafor solution for injection, used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma). View the complaint here.
Infringement of U.S. Patent No. 6,407,079 ("Pharmaceutical Compositions Containing Drugs Which Are Instable or Sparingly Soluble in Water and Methods for Their Preparation," issued June 18, 2002) following a Paragraph IV certification as part of Xellia’s filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic injectable voriconazole product, which relies upon the NDA filed for Janssen's Sporanox® (itraconazole, used for the treatment of certain fungal infections). View the complaint here.
BTG International Ltd. et al. v. Glenmark Pharmaceuticals Inc., USA et al.
Defendants: Glenmark Pharmaceuticals Inc., USA; Glenmark Pharmaceuticals SA; Glenmark Pharmaceuticals Ltd.
Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of Glenmark’s filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer). View the complaint here.
Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Infringement of U.S. Patent Nos. 6,642,245 ("Antiviral Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-l,3-oxathiolane," issued November 4, 2003) and 6,703,396 ("Method of Resolution and Antiviral Activity of 1,3-Oxathiolane Nucleoside Enantiomers," issued March 9, 2004) following a Paragraph IV certification as part of Aurobindo’s filing of an ANDA to manufacture a generic version of Gilead's Emtriva® (emtricitabine, used for the treatment of HIV-1 infection in adults). View the complaint here.
Abbvie Inc. et al. v. Medimmune Ltd.
Declaratory judgment of invalidity of U.S. Patent No. 6,248,516 ("Single Domain Ligands, Receptors Comprising Said Ligands Methods for Their Production, and Use of Said Ligands and Receptors," issued June 19, 2001) relating to AbbVie's marketing and sale of its Humira® product (adalimumab, used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis). View the complaint here.
Eli Lilly and Company et al. v. Apotex Inc. et al.
• Plaintiffs: Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,419,307 ("Spreading Implement," issued April 16, 2013), 8,177,449 (same title, issued May 15, 2012), 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013), 8,807,861 (same title, issued August 19, 2014), 8,993,520 (same title, issued March 31, 2015), 9,180,194 (same title, issued November 10, 2015), and 9,289,586 ("Spreading Implement," issued March 22, 2016) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Eli Lilly's Axiron® (testosterone metered transdermal solution, used to treat males for conditions associated with a deficiency or absence of endogenous testosterone). View the S.D. Indiana complaint here.
Noven Pharmaceuticals, Inc. v. Actavis Laboratories UT, Inc.
Infringement of U.S. Patent No. 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis). View the complaint here.
UCB, Inc. et al. v. Aurobindo Pharma Ltd. et al.
• Plaintiffs: UCB, Inc.; UCB Biopharma SPRL; Research Corporation Technologies, Inc.; Harris FRC Corp.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Aurobindo Pharma USA, Inc.; Aurobindo Pharma Ltd.
UCB, Inc. et al. v. Hetero USA Inc. et al.
• Defendants: Hetero USA Inc.; Hetero Labs Ltd.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. RE38,551 ("Anticonvulsant Enantiomeric Amino Acid Derivatives," issued July 6, 2004) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of UCB's Vimpat® (lacosamide, used as adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy aged 17 years and older). View the Aurobindo complaint here.
Shire Orphan Therapies LLC et al. v. InnoPharma Inc.
Infringement of U.S. Patent No. 5,648,333 ("Peptides Having Bradykinin Antagonist Action," issued July 15, 1997) following a Paragraph IV certification as part of InnoPharma's filing of an ANDA to manufacture a generic version of Shire's Firazyr® (icatibant, used to treat acute attacks of hereditary angioedema in adults 18 years of age and older). View the complaint here.
United Therapeutics Corp. et al. v. Actavis Laboratories FL, Inc.
• Plaintiffs: United Therapeutics Corp.; Supernus Pharmaceuticals, Inc.
• Defendant: Actavis Laboratories FL, Inc.
Infringement of U.S. Patent Nos. 7,417,070 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued August 26, 2008), 7,544,713 (same title, issued June 9, 2009), 8,252,839 (same title, issued August 28, 2012), 8,349,892 ("Solid Formulations of Prostacyclin Analogs issued January 8, 2013), 8,410,169 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued April 2, 2013), 8,497,393 ("Process to Prepare Treprostinil, the Active Ingredient in Remodulin®," issued July 30, 2013), 9,050,311 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued June 9, 2015), 8,747,897 ("Osmotic Drug Delivery System," issued June 10, 2014), and 9,278,901 ("Compounds and Methods for Delivery of Prostacyclin Analogs," issued March 8, 2016) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of UTC's Orenitram® (treprostinil, used to treat pulmonary arterial hypertension). View the complaint here.
Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al.
• Plaintiff: Janssen Biotech, Inc.
• Defendants: Celltrion Healthcare Co., Ltd.; Celltrion, Inc.; Hospira, Inc.
Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on defendants' alleged control of the development of cell culture media, used to manufacture of defendants' infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis). View the complaint here.
Infringement of U.S. Patent No. 7,598,083 ("Chemically Defined Media Compositions," issued October 6, 2009) based on HyClone's development of cell culture media, supplied to Celltrion and Hospira to manufacture an infliximab biosimilar, a biosimilar to Janssen's Remicade® (infliximab, used to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis). View the complaint here.
Novartis Pharmaceuticals Corp. et al. v. Breckenridge Pharmaceutical Inc.
• Defendant: Breckenridge Pharmaceutical Inc.
Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 8,410,131 ("Cancer Treatment," issued April 2, 2013), and 8,778,962 ("Treatment of Solid Tumors with Rapamycin Derivatives," issued July 15, 2014) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Novartis' Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected). View the complaint here.
LEO Pharma A/S et al. v. Perrigo UK FINCO Limited Partnership et al.
• Plaintiffs: LEO Pharma A/S; LEO Laboratories Ltd.; LEO Pharma, Inc.
• Defendants: Perrigo UK FINCO Limited Partnership; Perrigo Co.
Infringement of U.S. Patent Nos. 6,432,452 ("Anti-Cancer Compounds," issued August 13, 2002), 6,787,161 (same title, issued September 7, 2004), 6,844,013 ("Methods of Stimulating the Immune System," issued January 18, 2005), 7,410,656 ("Anti-Cancer Compounds," issued August 12, 2008), 8,278,292 ("Therapeutic Compositions," issued October 2, 2012), 8,372,827 (same title, issued February 12, 2013), 8,372,828 (same title, issued February 12, 2013), 8,377,919 (same title, issued February 19, 2013), 8,536,163 (same title, issued September 17, 2013), 8,716,271 (same title, issued May 6, 2014), and 8,735,375 (same title, issued May 27, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of LEO Pharma's Picato® ( ingenol mebutate gel, used for the topical treatment of actinic keratosis). View the complaint here.
Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc.
• Plaintiff: Purdue Pharma, L.P.
• Defendant: Collegium Pharmaceutical, Inc.; Collegium Pharmaceutical, Inc.
Infringement of U.S. Patent No. 9,155,717 ("Pharmaceutical Formulation Containing Irritant," issued October 13, 2015) based on Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain). View the complaint here.
Aurobindo Pharma USA Inc. et al. v. Apicore US LLC et al.
Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,662,992 ("Process for Preparation of Isosulfan Blue," issued February 16, 2010), 8,969,616 (same title, issued March 3, 2015), and 9,353,050 (same title, issued May 31, 2016) based on Aurobindo's filing of an ANDA to manufacture a 1% strength isosulfan blue for injection. View the complaint here.
Orexo AB et al. v. Actavis Elizabeth LLC et al.
• Plaintiffs: Orexo AB; Orexo US, Inc.
Infringement of U.S. Patent No. 9,259,421 ("Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependencen" issued February 16, 2016) following a Paragraph IV certification as part of Actavis' amendment of its ANDA to manufacture a generic version of Orexo's Zubsolv® (buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, used the maintenance treatment of opioid dependence and for the induction of buprenorphine maintenance therapy in patients suffering from opioid dependence). View the complaint here.
Alvogen Pine Brook LLC v. Noven Pharmaceuticals, Inc. et al.
• Defendants: Noven Pharmaceuticals, Inc.; Hisamitsu Pharmaceutical Co., Inc.
Declaratory judgment of noninfringement of U.S. Patent Nos. 6,841,716 ("Patch," issued January 11, 2005) and 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) based on Alvogen's filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis). View the complaint here.
AbbVie Inc. v. Amneal Pharmaceuticals, LLC et al.
Infringement of U.S. Patent Nos. 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006) and 7,364,752 ("Solid Dispersion Pharmaceutical Formulations," issued April 29, 2008) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection). View the complaint here.
Amgen Inc. et al. v. Sandoz Inc. et al.
• Plaintiffs: Amgen Inc.; Amgen Manufacturing, Ltd.
• Defendants: Sandoz Inc.; Sandoz International GmbH; Sandoz GmbH; Lek Pharmaceuticals, d.d.
Infringement of U.S. Patent Nos. 8,940,878 ("Capture Purification Processes for Proteins Expressed in a Non-Mammalian System" issued January 27, 2015) and 5,824,784 ("N-Terminally Chemically Modified Protein Compositions and Methods," issued October 20, 1998) based on Sandoz's filing of an aBLA to market a biosimilar version of Amgen's Neulasta® (pegfilgrastim, used to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs). View the complaint here.
Rhodes Pharmaceuticals L.P. v. Actavis, Inc. et al.
• Plaintiff: Rhodes Pharmaceuticals L.P.
Infringement of U.S. Patent Nos. 6,419,960 ("Controlled Release Formulations Having Rapid Onset and Rapid Decline of Effective Plasma Drug Concentrations," issued July 16, 2002), 7,083,808 ("Controlled/Modified Release Oral Methylphenidate Formulations," issued August 1, 2006), 7,247,318 ("Controlled Release Formulations Having Rapid Onset and Rapid Decline of Effective Plasma Drug Concentrations," issued July 24, 2007), 7,438,930 (same title, issued October 21, 2008), 8,580,310 (same title, issued November 12, 2013), and 9,066,869 (same title, issued June 30, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Rhodes' Aptensio XR® (methylphenidate hydrochloride extended-release capsules, used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)). View the complaint here.
Infringement of U.S. Patent Nos. 7,662,992 ("Process for Preparation of Isosulfan Blue," issued February 16, 2010) and 8,969,616 (same title, issued March 3, 2015) based on defendants' filing and approval of an ANDA to manufacture isosulfan blue products. View the complaint here.
Ajinomoto Co., Inc. et al. v. CJ Cheiljedang Corp. et al.
• Plaintiffs: Ajinomoto Co., Inc.; Ajinomoto Heartland Inc.
Infringement of U.S. Patent Nos. 7,666,655 ("Escherichia Bacteria Transformed with the yddG Gene to Enhance L-Amino Acid Producing Activity," issued February 23, 2010) and 6,180,373 ("Microorganisms for the Production of Tryptophan and Process for the Preparation Thereof," issued January 30, 2001) based on defendants' manufacture and sale of its BestAminoTM feed-grade L-tryptophan product. View the complaint here.
AstraZeneca LP et al. v. Watson Laboratories Inc.
• Defendant: Watson Laboratories Inc.
Infringement of U.S. Patent Nos. 6,525,060 ("Triazolo(4,5-d)pyrimidine Compounds," issued February 25, 2003), 7,250,419 ("Trisubstituted Triazolopyrimidines for Use in Platelet Aggregation Inhibition," issued July 31, 2007), and 7,265,124 ("Cristalline and Amorphous Form of a Triazolo (4,5-D) Pyridimine Compound," issued September 4, 2007) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of AstraZeneca's Brilinta® (ticagrelor, used to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction). View the complaint here.
Endo Pharmaceuticals Inc. v. Impax Laboratories, Inc.
Infringement of U.S. Patent Nos. 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), 8,329,216 (same title, issued December 11, 2012), and 8,808,737 ("Method of Treating Pain Utilizing Controlled Release Oxymorphone Pharmaceutical Compositions and Instruction on Dosing for Renal Impairment," issued August 19, 2014) in conjunction with Impax's manufacture and sale of a generic version of Endo's Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time). View the complaint here.
Imprimis Pharmaceuticals, Inc. v. Regents of the University of California et al.
• Defendants: Regents of the University of California; Urigen Pharmaceuticals, Inc.
Declaratory judgment of invalidity of U.S. Patent No. 7,414,039 ("Interstitial Therapy for Immediate Symptom Relief and Chronic Therapy in Interstitial Cystitis," issued August 19, 2008) relating to certain of Imprimis' commercialization of its Hep-Lido-A product (used to treat interstitial cystitis). View the complaint here.
Aurobindo Pharmaceuticals Ltd. et al. v. Daiici Sankyo, Inc. et al.
• Plaintiffs: Aurobindo Pharmaceuticals Ltd.; Aurobindo Pharma, Inc.
• Defendants: Daiici Sankyo, Inc.; Daiichi Sankyo Co., Ltd.; Mylan Pharmaceuticals Inc.
Declaratory judgment of non-infringement of U.S. Patent No. 6,878,703 ("Pharmaceutical Composition," issued April 12, 2005) in conjunction with Aurobindo's filing of ANDAs to manufacture a generic version of Daiichi's Benicar® (olmesartan medoxomil, used to treat hypertension) and Benicar® HCT (olmesartan medoxomil/ hydrochlorothiazide, used to treat hypertension). View the complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Zhejiang Huahai Pharmaceutical Co., Ltd. et al.
• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
Infringement of U.S. Patent No. 9,089,567 ("Method of Treating Cognitive Impairments and Schizophrenias," issued July 28, 2015) following Zhejiang's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.
Infringement of U.S. Patent No. 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of Zhejiang's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.
BTG International Ltd. et al. v. Amerigen Pharmaceuticals, Inc. et al.
• Defendants: Amerigen Pharmaceuticals, Inc.; Amerigen Pharmaceuticals Ltd.
Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of Amerigen's filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer). View the complaint here.
AstraZeneca AB et al. v. Hetero USA Inc. et al.
• Defendants: Hetero USA Inc.; Hetero Labs Ltd. Unit-III; Hetero Labs Ltd.
Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.
Boehringer Ingelheim Pharmaceuticals Inc. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
• Defendants: Dr. Reddy's Laboratories, Ltd.; Reddy's Laboratories, Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC; Huahai US Inc.; Zhejiang Huahai Pharmaceutical Co., Ltd.; Invagen Pharmaceuticals Inc.
Infringement of U.S. Patent No. 9,173,859 ("Uses of DPP-IV Inhibitors," issued November 3, 2015) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Boehringer's Tradjenta® (linagliptin, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus) and Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products. View the complaint here.

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