About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents.
Pfizer, Inc. v. Biogen, Inc.
PTAB Petition: IPR2017-01115; filed March 24, 2017.
Patent at Issue: U.S. Patent No. 7,820,161 ("Treatment of autoimmune diseases," issued October 21, 2010) claims a method of treating rheumatoid arthritis in a human comprising: (a) administering to the human more than one intravenous dose of a therapeutically effective amount of rituximab; and (b) administering to the human methotrexate.
Petitioner Pfizer, Inc. is challenging the '161 patent on three grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '161 patent is presently the subject of inter partes review IPR2016-01614 (Celltrion, Inc.; filed 08/15/2016; instituted 02/24/2017; pending). Also, the '161 patent was the subject of inter partes reviews IPR2015-00415 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 12/15/2014; instituted 07/17/2015; terminated 10/01/2015 pursuant to a Request for Adverse Judgment by petitioner); and IPR2015-01744 (Celltrion, Inc.; filed 08/17/2015; terminated 10/06/2015 pursuant to a Motion to Dismiss filed by petitioner).
Celltrion, Inc. v Genentech, Inc.
PTAB Petition: IPR2017-01139; filed March 24, 2017.
Patent at Issue: U.S. Patent No. 6,627,196 ("Dosages for treatment with anti-ErbB2 antibodies," issued September 30, 2003) claims a method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks.
Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '379 patent on one ground as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '379 patent is the subject of inter partes review IPR2017-00804 (Hospira, Inc; filed 01/30/2017; pending). Also, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent No. 7,371,379 (IPR2017-01140; filed 03/24/2017; pending), which is also the subject of inter partes review IPR 2017-00805 (Hospira, Inc.; filed 01/30/2017; pending).
Celltrion, Inc. v Genentech, Inc.
PTAB Petition: IPR2017-01140; filed March 24, 2017.
Patent at Issue: U.S. Patent No. 7,371,379 ("Dosages for treatment with anti-ErbB2 antibodies," issued May 13, 2008) claims a method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks; and further comprising administering an effective amount of a chemotherapeutic agent to the patient.
Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '379 patent on one ground as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '379 patent is the subject of inter partes review IPR 2017-00805 (Hospira, Inc.; filed 01/30/2017; pending). Also, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent No. 6,627,196 (IPR2017-01139; filed 03/24/2017; pending), which is also the subject of inter partes review IPR2017-00804 (Hospira, Inc; filed 01/30/2017; pending).
Lupin Ltd. v Horizon Therapeutics, LLC.
PTAB Petition: IPR2017-01159; filed March 27, 2017.
Patent at Issue: U.S. Patent No. 9,254,278 ("Methods of therapeutic monitoring of nitrogen scavenging drugs," issued February 9, 2016) claims a method of treating a subject with a urea cycle disorder, the method comprising: administering to the subject in need thereof glyceryl tri-[4-phenylbutyrate] in an amount sufficient to produce a fasting plasma ammonia level that is less than half the upper limit of normal for plasma ammonia level.
Petitioners Lupin Ltd. and Lupin Pharmaceuticals Inc. are challenging are challenging the '278 patent on three grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petition, the '278 patent is the subject of the following litigations: Horizon Therapeutics, LLC. v. Lupin Ltd. et al., 1:16-cv-04438 (D.N.J.), and Horizon Therapeutics, Inc. v. Par Pharmaceutical, Inc., 1-16-cv-03910 (D.N.J.). Also, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent No. 9,326,966 (IPR2017-01160; filed 03/27/2017; pending).
Lupin Ltd. v Horizon Therapeutics, LLC.
PTAB Petition: IPR2017-01160; filed March 27, 2017.
Patent at Issue: U.S. Patent No. 9,326,966 ("Methods of therapeutic monitoring of nitrogen scavenging drugs," issued February 9, 2016) claims a method of treating a subject with a urea cycle disorder, the method comprising: administering to the subject in need thereof glyceryl tri-[4-phenylbutyrate] in an amount sufficient to produce a fasting plasma ammonia level that is less than half the upper limit of normal for plasma ammonia level.
Petitioners Lupin Ltd. and Lupin Pharmaceuticals Inc. are challenging are challenging the '966 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) and as being obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here.
Related Matters: According to the petition, the '966 patent is the subject of the following litigation: Horizon Therapeutics, LLC. v. Lupin Ltd. et al., 1:16-cv-04438 (D.N.J.). Also, Petitioners concurrently filed a petition for inter partes review of related U.S. Patent No. 9,254,278 (IPR2017-01159; filed 03/27/2017; pending).
Smith & Nephew Inc. v. ConforMIS, Inc.
PTAB Petition: IPR2016-01874; filed September 21, 2016.
PTAB Trial Instituted; entered March 27, 2017.
Patent at Issue: U.S. Patent No. 9,055,953 ("Methods and compositions for articular repair," issued June 16, 2015) claims a surgical instrument for the repair of a diseased articular joint surface of a joint, comprising: an inner surface having a curvature or shape based on information from image data of the diseased articular joint surface; and a slit defining a cutting path through at least a portion of the joint when the inner surface is applied to the diseased articular joint surface.
Petitioner Smith & Nephew Inc. is challenging the '953 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Beverly M. Bunting, James A. Worth (author), and Amanda F. Wieker issued a decision instituting inter partes review of whether claims 1–3 and 21–23 are obvious over Radermacher; claims 4–6, 10, 12–16, 19, 24–26, 30, 32–36, 40, 50–53, and 55–61 are obvious over Radermacher and Alexander; claims 7–9, 11, 17, 18, 20, 27–29, 31, 37–39, 41–49, and 54 are obvious over Radermacher, Alexander, and Carignan; claims 4–6, 10, 12–16, 19, 24–26, 30, 32–36, 40, 50–53, and 55–61 are obvious over Radermacher and Fell; and claims 7–9, 11, 17, 18, 20, 27–29, 31, 37–39, 41–49, and 54 are obvious over Radermacher, Fell, and Carignan.
Related Matters: According to the petition, the '532 patent is the subject of the following litigation: ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).
Merck Sharp & Dohme Corp. v Wyeth LLC.
PTAB Petition: IPR2017-01194; filed March 29, 2017.
Patent at Issue: U.S. Patent No. 8,895,024 ("Multivalent pneumococcal polysaccharide-protein conjugate composition," issued November 25, 2014) claims a multivalent immunogenic composition comprising 13 distinct polysaccharide-protein conjugates and a physiologically acceptable vehicle, wherein each of the conjugates comprises a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to a carrier protein, wherein the serotypes consist essentially of 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, and wherein the carrier protein is CRM197.
Petitioner Merck Sharp & Dohme Corp. is challenging the '024 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) and as being obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.
Related Matters: According to the petition, Petitioner has filed two Petitions for post grant review of related U.S. Patent No. 9,399,060 (PGR2017-00016; filed 03/22/2017; pending), and (PGR2017-00017; filed 03/24/2017; pending). Petitioner also filed petitions for inter partes review of related U.S. Patent Nos. 8,562,999 (IPR2017-00378; filed 12/01/2016; pending, IPR2017-00380; filed 12/01/2016; pending, and IPR2017-00390; filed 12/02/2016; pending).
Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.
PTAB Petition: IPR2017-00060; filed October 12, 2016.
PTAB Trial Instituted; entered March 29, 2017.
Patent at Issue: U.S. Patent No. 8,992,608 ("Everting heart valve," issued March 31, 2015) claims a system for replacing a heart valve.
Petitioners Edwards Lifesciences Corp., Edwards Lifesciences LLC., and Edwards Lifesciences AG are challenging the '608 patent on eleven grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 11), and as being obvious under 35 U.S.C. § 103(a) (grounds 2-10). View the petition here. Administrative Patent Judges Neil T. Powell, James A. Tartal (author), and Robert L. Kinder issued a decision instituting inter partes review of whether claims 1–4 are obvious over Spenser and Elliot under 35 U.S.C. § 103(a); whether claims 1–4 are obvious over Spenser and Thornton under 35 U.S.C. § 103(a); and whether claims 1–4 are obvious over Spenser and Cook, under 35 U.S.C. § 103(a).
Related Matters: According to the petition, the '608 patent is the subject of the following litigation: Boston Scientific Corp. et al. v. Edwards Lifesciences Corp., Case No. 1:16-cv-00275 (D. Del.).
