About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.
Celgene Corp. v. Synthon Pharmaceuticals, Inc.
2:18-cv-10775; filed June 19, 2018 in the District of New Jersey (Newark)
• Plaintiffs: Celgene Corp.
• Defendants: Alvogen Pine Brook, LLC; Synthon BV; Synthon Pharmaceuticals, Inc.; and Synthon S.R.O
Claim: Infringement of U.S. Patent Nos.:
• 8,198,262: ″Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione″
• 8,673,939: ″Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione″
• 8,735,428: ″Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione″
• 8,828,427: ″Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione″
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.
View the complaint here.
Huvepharma EOOD f/k/a Huvepharma ADl v. E.I. du Pont de Nemours and Company
1-18-cv-00914; filed June 20, 2018 in the District of Delaware (Wilmington)
• 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.
Claim: Infringement of U.S. Patent Nos.:
• 7,026,150: ″Overexpression of phytase genes in yeast systems″
• 7,312,063: ″Overexpression of phytase genes in yeast systems″
• 8,455,232: ″Overexpression of phytase genes in yeast systems″
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.
View the complaint here.
Genentech, Inc. v. Amgen Inc.
1-18-cv-00924; filed June 21, 2018 in the District of Delaware (Wilmington)
• Plaintiffs: Genentech, Inc. and City of Hope
• Defendant: Amgen Inc.
Claim: Infringement of Patent Nos.:
• 6,121,428: ″Protein recovery″
• 6,242,177: ″Methods and compositions for secretion of heterologous polypeptides″
• 6,331,415: ″Methods of producing immunoglobulins, vectors and transformed host cells for use therein″
• 6,407,213: ″Method for making humanized antibodies″
• 6,417,335: ″Protein purification″
• 6,489,447: ″Protein purification″
• 6,586,206: ″Methods for making recombinant proteins using apoptosis inhibitors″
• 6,620,918: ″Separation of polypeptide monomers″
• 6,627,196: ″Dosages for treatment with anti-ErbB2 antibodies″
• 6,870,034: ″Protein purification″
• 7,371,379: ″Dosages for treatment with anti-ErbB2 antibodies″
• 7,449,184: ″Fixed dosing of HER antibodies″
• 7,501,122: ″Treatment with anti-ErbB2 antibody combinations″
• 7,846,441: ″Treatment with anti-ErbB2 antibodies″
• 7,892,549: ″Treatment with anti-ErbB2 antibodies″
• 7,923,221: ″Methods of making antibody heavy and light chains having specificity for a desired antigen″
• 7,993,834: ″Detection of ErbB2 gene amplification to increase the likelihood of the effectiveness of ErbB2 antibody breast cancer therapy″
• 8,044,017: ″Protein purification″
• 8,076,066: ″Gene detection assay for improving the likelihood of an effective response to a HER2 antibody cancer therapy″
• 8,314,225: ″Heavy chain mutant leading to improved immunoglobulin production″
• 8,357,301: ″Chromatography equipment characterization″
• 8,425,908: ″Treatment with anti-ErbB2 antibodies″
• 8,440,402: ″Gene detection assay for improving the likelihood of an effective response to a HER2 antibody cancer therapy″
• 8,460,895: ″Method for producing recombinant proteins with a constant content of pCO2 in the medium″
• 8,512,983: “Production of proteins in glutamine-free cell culture media″
• 8,574,869: ″Prevention of disulfide bond reduction during recombinant production of polypeptides″
• 8,691,232: ″Extending time to disease progression or survival in cancer patients″
• 8,710,196: ″Protein purification″
• 8,771,988: ″Protein expression from multiple nucleic acids″
• 9,047,438: ″Chromatography equipment characterization″
• 9,080,183: ″Promoter″
• 9,249,218: “Protein purification″
• 9,428,766: “Protein expression from multiple nucleic acids″
• 9,487,809: ″Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase″
• 9,493,744: ″Methods for viral inactivation and other adventitious agents″
• 9,714,293: ″Production of proteins in glutamine-free cell culture media″
• 9,868,760: ″Protein purification″
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.
View redacted complaint here.
Astellas Pharma Inc. v. Aurobindo Pharma Ltd.
1-18-cv-00932; filed on June 25, 2018 in The District of Delaware (Wilmington)
• Plaintiffs: Astellas Pharma Inc.; Astellas Pharma U.S., Inc.; Astellas Ireland Co., Ltd.; and Astellas Pharma Europe Ltd.
• Defendant: Aurobindo Pharma Ltd.
Claim: Infringement of U.S. Patent No.:
• 6,017,927: ″Quinuclidine derivatives and medicinal composition thereof″
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.
View the complaint here.
Celgene Corp. v. Sandoz Inc.
3-18-cv-11026; filed on June 26, 2018 in the District of New Jersey (Trenton)
• Plaintiff: Celgene Corp.
• Defendant: Sandoz Inc.
Claim: Infringement of U.S. Patent Nos.:
• 6,962,940: ″(+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso indoline-1,3-dione: methods of using and compositions thereof″
• 7,208,516: ″Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione″
• 7,427,638: ″(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof″
• 7,659,302: ″Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione″
• 7,893,101: ″Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof″
• 8,455,536: ″Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione″
• 8,802,717: ″Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline 1,3-dione″
• 9,018,243: ″Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof″
• 9,872,854: ″Methods for the treatment of psoriatic arthritis using apremilast″
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.
View the complaint here.
Related matters:
• Celgene Corp. v. Macleods Pharmaceuticals Ltd.
3-18-cv-11212; filed on June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 patent
• Celgene Corp. v. MSN Laboratories Private Ltd.
3-18-cv-11213; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 patent
• Celgene Corp. v. Prinston Pharmaceutical Inc.
3-18-cv-11216; filed on June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 patent
• Celgene v. Teva Pharmaceuticals USA, Inc and Actavis LLC
3-18-cv-11215; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents
• Celgene v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc.
3-18-cv-11219; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents
• Celgene Corp. v. Emcure Pharmaceuticals Ltd. and Heritage Pharmaceuticals Inc.
3-18-cv-11218; filed June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 and ′854 patents
• Celgene Corp. v. Annora Pharma Private Ltd. and Hetero USA Inc.
3:18-cv-11220; filed on June 28, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638 and ′854 patents
• Celgene Corp. v. Torrent Pharmaceuticals Ltd.
3-18-cv-11156; filed on June 27, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638, ′101, and ′854 patents
• Celgene Corp. v. Shilpa Medicare Ltd.
3-18-cv-11157 filed on June 27, 2018 in the District of New Jersey (Trenton)
Infringement of the ′638, ′101, and ′854 patents
• Celgene Corp. v. Glenmark Pharmaceuticals Ltd.
3:18-cv-11158; filed on June 27, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents
• Celgene Corp. v. Dr. Reddy's Laboratories, Inc.
3-18-cv-11269; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243, patents
• Celgene Corp. v. Unichem Laboratories, Ltd.
3-18-cv-11268; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243, patents
• Celgene Corp. v. Zydus Pharmaceuticals USA, Inc.
3-18-cv-11267; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243, patents
• Celgene Corp. v. Alkem Laboratories Ltd.
3-18-cv-11265; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243 patents
• Celgene Corp. v. Cipla Ltd.
3-18-cv-11262; filed on June 29, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents
• Celgene Corp. v. Amneal Pharmaceuticals LLC
3-18-cv-11358; filed on July 03, 2018 in the District of New Jersey (Trenton)
Infringement of the ′940, ′638, ′302, ′101, ′536, and ′243 patents
• Celgene Corp. v. Aurobindo Pharma Ltd.
1-99-cv-de807; filed on July 3, 2018 in the District of Delaware (Wilmington)
Infringement of the ′940, ′516, ′638, ′302, ′101, ′536, ′717, ′243, and ′854 patents
Xlear, Inc. v. Whole Foods Market
2-18-cv-00518 filed in the District Court of Utah (Central) on June 28, 2018
• Plaintiff: Xlear
• Defendant: Whole Foods Market
Claim: Infringement of Patent Nos.:
• 6,054,143: ″Xylitol delivery″
• 6,258,372: ″Xylitol nose spray″
• 6,599,883: ″Nasal delivery of xylitol″
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.
View the complaint here.
Gilead Sciences, Inc. v. Strides Pharma Inc.
3-18-cv-11134 filed in the District Court of New Jersey (Trenton) on June 27, 2018
• Plaintiffs: Gilead Sciences, Inc and Emory University
• Defendants: Strides Pharma, Inc. and Strides Pharma Global PTE Ltd.
Claim: Infringement of Patent Nos.:
• 6,642,245: ″Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3 oxathiolane″
• 6,703,396: ″Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers″
• 8,592,397: ″Compositions and methods for combination antiviral therapy″
• 8,716,264: ″Compositions and methods for combination antiviral therapy"
ª 9,457,036: ″Compositions and methods for combination antiviral therapy″
• 9,744,181: ″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.
View the complaint here.
