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 and Genentech, Inc.
PTAB Petition: IPR2017-02126; filed October 6, 2017.
Patent at Issue: U.S. Patent No. 7,682,612 ("Treatment of hematologic malignancies associated with circulating tumor cells using chimeric anti-CD20 antibody," issued March 23, 2010) claims a method of treating chronic lymphocytic leukemia (CLL) in a human patient, comprising administering rituximab to the patient in an amount effective to treat the CLL, wherein the rituximab is administered to the patient at a dosage of 500 mg/m2.
Petitioner Pfizer Inc. is challenging the '612 patent on three grounds as obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petiton, the '612 patent is involved in inter partes review IPR2017-01227 (Celltrion, Inc.; filed 03/31/2017; institution denied 10/12/2017) and IPR2017-01230 (Celltrion, Inc.; filed 03/31/2017; institution denied 10/12/2017).
Pfizer Inc. v. Biogen, Inc and Genentech, Inc.
PTAB Petition: IPR2017-02127; filed October 6, 2017.
Patent at Issue: U.S. Patent No. 8,206,711 ("Treatment of chronic lymphocytic leukemia using anti-CD20 antibodies," issued June 26, 2012) claims a method of treating chronic lymphocytic leukemia (CLL) in a human patient, comprising administering rituximab to the patient in an amount effective to treat the CLL, wherein the rituximab is administered to the patient at a dosage of 500 mg/m2.
Petitioner Pfizer Inc. is challenging the '711 patent on three grounds as obvious under 35 U.S.C. § 103(a). View the petition here.
Related Matters: According to the petiton, the '711 patent is involved in inter partes review IPR2017-01229 (Celltrion, Inc.; filed 03/31/2017; institution denied 10/23/2017).
Actavis LLC v. Abraxis Bioscience, LLC
PTAB Petition: IPR2017-01101; filed April 4, 2017.
Institution of Inter Partes Review; entered October 10, 2017.
Patent at Issue: U.S. Patent No. 7,820,788 ("Compositions and methods of delivery of pharmacological agents," issued October 26, 2010) claims a pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises albumin, wherein the albumin and the paclitaxel in the composition are formulated as particles, wherein the particles have a particle size of less than about 200 nm, and wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1.
Petitioner Actavis LLC is challenging the '788 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here. Administrative Patent Judges Jeffrey N. Fredman, Rama G. Elluru, and Susan L. Mitchell (author) issued a decision instituting inter partes review of whether claims 1-9, 11, and 12 of the '788 patent are anticipated by Desai; claims 1-12 of the '788 patent are obvious over Desai; and claims 1-12 of the '788 patent are obvious over the combination of Desai, Kadima, and Liversidge.
Related Matters: According to the petition, the '788 patent was asserted in Abraxis BioScience, LLC v. Actavis LLC, Case No. 2:16-cv-09074-JMV-MF (D.N.J. April 6, 2016), and in Abraxis BioScience, LLC v. Cipla Ltd., Case No. 2:16-cv-09074 (D.N.J. Dec. 7, 2016). Also, Petitioners filed petitions for inter partes review of related U.S. Patent Nos. 8,853,260 (IPR2017-01100; filed 04/04/2017; institution denied 10/11/2017); 7,923,536 (IPR2017-00804; filed 01/30/2017; instituted 07/27/2017; pending); and 8,138,229 (IPR2017-01104; filed 04/04/2017; instituted 10/10/2017; pending).
Actavis LLC v. Abraxis Bioscience, LLC
PTAB Petition: IPR2017-01104; filed April 4, 2017.
Institution of Inter Partes Review; entered October 10, 2017.
Patent at Issue: U.S. Patent No. 8,138,229 ("Compositions and methods of delivery of pharmacological agents," issued October 26, 2010) claims a liquid pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises albumin, wherein the albumin and the paclitaxel in the composition are formulated as particles, wherein the particles have a particle size of less than about 200 nm, wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1, wherein the liquid pharmaceutical composition comprises about 0.5% to about 5% by weight of albumin, and wherein the liquid pharmaceutical composition further comprises saline.
Petitioner Actavis LLC is challenging the '229 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here. Administrative Patent Judges Jeffrey N. Fredman (author), Rama G. Elluru, and Susan L. Mitchell issued a decision instituting inter partes review of whether claims 1-19 and 21-48 of the '229 patent are anticipated by Desai; claims 1-19 and 21-48 of the '229 patent are obvious over Desai; claims 1-19 and 21-48 of the '229 patent are obvious over the combination of Desai, Kadima, and Liversidge; claim 20 of the '229 patent are obvious over the combination of Desai and Taxol label; and claim 20 of the '229 patent is obvious over the combination of Desai, Taxol label, Kadima, and Liversidge.
Related Matters: According to the petition, the '229 patent was asserted in Abraxis BioScience, LLC v. Actavis LLC, Case No. 2:16-cv-09074-JMV-MF (D.N.J. April 6, 2016), and in Abraxis BioScience, LLC v. Cipla Ltd., Case No. 2:16-cv-09074 (D.N.J. Dec. 7, 2016). Also, Petitioners filed petitions for inter partes review of related U.S. Patent Nos. 8,853,260 (IPR2017-01100; filed 04/04/2017; institution denied 10/11/2017); 7,923,536 (IPR2017-00804; filed 01/30/2017; instituted 07/27/2017; pending); and 7,820,788 (IPR2017-01101; filed 04/04/2017; instituted 10/10/2017; pending).
Samsung Bioepis Co., Ltd. v Genentech, Inc.
PTAB Petition: IPR2017-01960; filed August 25, 2017
Institution of Inter Partes Review; entered October 13, 2017.
Patent at Issue: U.S. Patent No. 7,892,549 ("Treatment with anti-ErbB2 antibodies," issued February 22, 2011) claims a method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient in an amount effective to extend the time to disease progression in the human patient, wherein the antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.
Petitioner Samsung Bioepis Co., Ltd is challenging the '549 patent on six grounds as obvious under 35 U.S.C. § 103(a). Petitioners also seek joinder with IPR2017-00737 through Motions for Joinder under 35 U.S.C. § 315(c), and 37 C.F.R. §§ 42.22 and 42.122(b). View the petition here. Administrative Patent Judges Zhenyu Yang, Christopher G. Paulraj, and Robert A. Pollock (author) issued a decision instituting inter partes review of whether 1–11 and 14–17 are obvious over the combination of Baselga '97 and Gelmon; claim 12 is obvious over the combination of Baselga '97, Gelmon, and Drebin; claim 13 is obvious over the combination of Baselga '97, Gelmon, and Presta; claims 1–11 and 14–17 are obvious over the combination of Baselga '96, Baselga '94, and Gelmon; claim 12 is obvious over the combination of Baselga '96, Baselga '94, Gelmon, and Drebin; and claim 13 is obvious over the combination of Baselga '96, Baselga '94, Gelmon, and Presta. The Judges also ordered that IPR2017-01960 and IPR2017-00737 be joined and administratively terminated IPR2017-01960 under 37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be made in IPR2017-00737 (Petitioners, Hospira, Inc.; filed 01/20/2017; instituted 07/27/2017; pending).
Related Matters: According to the petition, the '549 patent is involved in inter partes reviews IPR2017-00737 (Hospira, Inc.; filed 01/20/2017; instituted 07/27/2017; pending); IPR2017-00739 (Hospira, Inc.; filed 01/20/2017; institution denied 07/27/2017); and IPR2017-01122 (Celltrion, Inc.; filed 03/21/2017; instituted 10/04/2017; pending).
