About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents.
Mylan Pharmaceuticals, Inc. v. Cosmo Technologies Ltd.
PTAB Petition: IPR2017-01034; filed March 9, 2017.
Patent at Issue: U.S. Patent No. 8,784,888 ("Controlled Release and Taste Masking Oral Pharmaceutical Compositions," issued June 22, 2014) claims a controlled release oral pharmaceutical composition consisting essentially of: (1) a tablet core consisting essentially of: a) budesonide in an amount effective to treat intestinal inflammatory disease; and b) a macroscopically homogeneous composition comprising at least one lipophilic excipient, at least one amphiphilic excipient, and at least one hydrogel-forming hydrophilic excipient other than a gum, wherein said budesonide is dispersed in said macroscopically homogeneous composition; and (2) a coating on said tablet core, said coating consisting essentially of a gastro-resistant film.
Petitioners Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., Mylan Inc., and Mylan N.V. are challenging the '888 patent on three grounds as anticipated under 35 U.S.C. § 102(b) (ground 3) or as obvious under 35 U.S.C. § 103(a) (grounds 1 and 2). View the petition here.
Related Matters: According to the petition, the '888 patent is the subject of the following litigations: Cosmo Technologies Ltd. et al. v. Mylan Pharmaceuticals Inc., 16-cv-00152 (D. Del.); Cosmo Technologies Ltd. et al. v. Mylan Pharmaceuticals Inc., 16-cv-00040 (N.D.W.Va.); Cosmo Technologies Ltd. et al. v. Lupin Ltd. et al, 15-cv-00669 (D. Del.); Cosmo Technologies Ltd. et al. v. Alvogen Pine Brook, Inc., 15-cv-00193 (D. Del.); Cosmo Technologies Ltd. et al. v Actavis Laboratories FL, Inc., 15-cv- 01312 (D.N.J.); Cosmo Technologies Ltd. et al. v Actavis Laboratories FL, Inc., 15- cv-00164 (D. Del.); Cosmo Technologies Ltd. et al. v. Par Pharmaceutical, Inc., 15-cv-00116 (D. Del.). Petitioner concurrently filed a petition for inter partes review of U.S. Patent No. 9,320,716 (IPR2017-01035; filed 03/09/2017; pending).
West-Ward Pharmaceuticals International Ltd. v. Novartis AG
PTAB Petition: IPR2017-01078; filed March 13, 2017.
Patent at Issue: U.S. Patent No. 9,006,224 ("Neuroendocrine tumor treatment," issued April 14, 2015) claims a method for treating pancreatic neuroendocrine tumors, comprising administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.
Petitioners West-Ward Pharmaceuticals International Ltd., Hikma Pharmaceuticals PLC, Roxane Laboratories, Inc., and West-Ward Pharmaceuticals Corp. are challenging the '224 patent on four grounds as obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '224 patent is the subject of the following litigations: Novartis Pharm. Corp. v. Breckenridge Pharm., Inc., 14-1043-RGA (D. Del.); Novartis Pharm. Corp. v. Roxane Labs., Inc., 14-1196-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 14-1289-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 14-1494-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 15-78-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 15-475-RGA (D. Del.); Novartis Pharm. Corp. v. Par Pharm., Inc., 15-1050-RGA (D. Del.); Novartis Pharm. Corp. v. Roxane Labs., Inc., 14-1508-RGA (D. Del.); Novartis Pharm. Corp. v. Roxane Labs., Inc., 15-128-RGA (D. Del.); and Novartis Pharm. Corp. v. Breckenridge Pharm., Inc., 16-431-RGA (D. Del.). The '224 patent is also the subject of inter partes reviews IPR2016-01461 (Roxane Labs., Inc.; filed 07/19/2016; Institution denied 02/13/2017); IPR2017-01063 (Argentum Pharm. LLC; filed 03/10/2017; pending); and IPR2016-01479 (Par Pharm., Inc.; filed 07/22/2016; Instituted 02/15/2017; pending).
Celltrion, Inc. v. Biogen Inc.
PTAB Petition: IPR2017-01093; filed March 15, 2017.
Patent at Issue: U.S. Patent No. 8,329,172 ("Combination therapies for B-cell lymphomas comprising administration of anti-CD20 antibody," issued December 11, 2012) claims a method of treating low grade B-cell non-Hodgkin's lymphoma in a human patient comprising administering to the patient chemotherapy consisting of CVP therapy to which the patient responds, followed by rituximab maintenance therapy, wherein the maintenance therapy comprises four weekly administrations of rituximab at a dose of 375 mg/m2 every 6 months, and wherein the maintenance therapy is provided for 2 years.
Petitioners Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; and Teva Pharmaceuticals International GmbH are challenging the '172 patent on four grounds as anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or as obvious under 35 U.S.C. § 103(a) (grounds 3 and 4). View the petition here.
Related Matters: According to the petition, Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 8,557,244 (IPR2017-01094; filed 03/15/2017; pending) and 9,296,821 (IPR2017-01095; filed 03/15/2017; pending).
Celltrion, Inc. v. Biogen Inc.
PTAB Petition: IPR2017-01094; filed March 15, 2017.
Patent at Issue: U.S. Patent No. 8,557,244 ("Treatment of aggressive non-Hodgkins lymphoma with anti-CD20 antibody," issued October 15, 2013) claims a method of treating a patient with diffuse large cell lymphoma, comprising administering an unlabeled chimeric anti-CD20 antibody and CHOP (cyclophosphamide, hydroxydaunorubicin/doxorubicin, vincristine, and prednisone/prednisolone) chemotherapy to the patient, wherein the patient is >60 years old and has bulky disease (tumor >10 cm in diameter).
Petitioners Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; and Teva Pharmaceuticals International GmbH are challenging the '244 patent on four grounds as obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 8,329,172 (IPR2017-01093; filed 03/15/2017; pending) and 9,296,821 (IPR2017-01095; filed 03/15/2017; pending).
Fluidigm, Corp. v. Board of Trustees of the Leland Stanford Junior University
PTAB Petition: IPR2017-00013; filed October 4, 2016.
PTAB Trial Instituted; entered March 15, 2017.
Patent at Issue: U.S. Patent No. 7,563,584 ("Methods and compositions for detecting the activation state of multiple proteins in single cells," issued July 21, 2009) claims a method of detecting the activation state of at least a first and a second activatable protein in single cells, said method comprising the steps of: a) providing a population of cells comprising said first and said second activatable proteins, wherein said first and second activatable proteins are distinct proteins that each have at least an activated isoform, and a non-activated isoform; b) permeabilizing said population of cells; c) contacting said permeabilized population of cells with at least two distinguishably labeled activation state-specific antibodies, wherein a first of said at least two distinguishably labeled activation state-specific antibodies is specific for said activated isoform of said first activatable protein; and a second of said at least two distinguishably labeled activation state-specific antibodies is specific for said activated isoform of said second activatable protein; and d) using flow cytometry to detect binding of said first and said second distinguishably labeled activation state-specific antibodies to their corresponding activated isoform of said first and second activatable proteins in single cells of said population of cells, wherein said binding of said first distinguishably labeled activation state-specific antibody is indicative of the activation state of said first activatable protein, and said binding of said second distinguishably labeled activation state-specific antibody is indicative of the activation state of said second activatable protein.
Petitioner Fluidigm Corp. is challenging the '926 patent on four grounds as obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Erica A. Franklin (author), Georgianna W. Braden, and Zhenyu Yang issued a decision instituting inter partes review of whether claims 1, 2, 4–6, 10–21, and 23–27 are unpatentable under 35 U.S.C. § 103(a) as obvious over Fleisher; whether claims 3, 7–9, and 22 are unpatentable under 35 U.S.C. § 103(a) as obvious over Fleisher and Belloc; whether 1, 2, 4–6, 10–21, and 23–27 are unpatentable under 35 U.S.C. § 103(a) as obvious over Darzynkiewicz and Yen; and whether claims 3, 7–9, and 22 are unpatentable under 35 U.S.C. § 103(a) as obvious over Darzynkiewicz, Yen, and Belloc.
Related Matters: According to the petition, the '926 patent is not involved in any judicial proceedings.
Fluidigm, Corp. v. Board of Trustees of the Leland Stanford Junior University
PTAB Petition: IPR2017-00014; filed October 4, 2016.
PTAB Trial Instituted; entered March 15, 2017.
Patent at Issue: U.S. Patent No. 7,695,926 ("Methods and compositions for detecting receptor-ligand interactions in single cells," issued April 13, 2010) claims a kit comprising a first activation-state specific antibody and a second activation-state specific antibody and instructions for use of the antibodies, wherein at least one of the antibodies is specific for a phosphorylation site, wherein said first activation state-specific antibody binds to an activation form of a first protein within the MAPK (mitogen activated protein kinase), AKT (homolog of V-akt murine thymoma viral oncogene), NFkB (nuclear factor kappa B), PKC (protein kinase C), STAT (signal transducers and activators of transcription) or WNT (Win gless/Int) signaling pathways, and said second activation state-specific antibody binds to an activation form of a second protein within the MAPK, AKT, NFkB, PKC, STAT or WNT signaling pathways, and wherein said first and second proteins are different proteins.
Petitioner Fluidigm Corp. is challenging the '926 patent on three grounds as anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here. Administrative Patent Judges Erica A. Franklin (author), Georgianna W. Braden, and Zhenyu Yang issued a decision instituting inter partes review of whether claims 1–5 and 11–12 are unpatentable under 35 U.S.C. § 102 as anticipated by Shen; whether claims 1-9 are unpatentable under 35 U.S.C. § 103(a) as obvious over Fleisher; and whether claims 1-9 are unpatentable under 35 U.S.C. § 103(a) as obvious over Darzynkiewicz and Yen.
Related Matters: According to the petition, the '926 patent is not involved in any judicial proceedings.
