About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents.

Sun Pharmaceuticals Industries, Ltd. v. Novartis AG

PTAB Petition:  IPR2017-01929; filed August 16, 2017.

Institution of Inter Partes Review:  entered October 2, 2017.

Patent at Issue:  U.S. Patent No. 9,187,405 ("S1P receptor modulators for treating relasping-remitting multiple sclerosis," issued November 17, 2015) claims a method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.

Petitioners Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., and Sun Pharma Global FZE are challenging the '405 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).  Petitioners also seek joinder with IPR2017-00854 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 and the Motion for Joinder here.  Administrative Patent Judges Lora M. Green, Christopher M. Kaiser, and Robert A. Pollock (author) issued a decision instituting inter partes review of whether claims 1-6 are unpatentable under 35 U.S.C. § 103 over the combination of Kovarik and Thomson; claims 1–6 are unpatentable under 35 U.S.C. § 103 over the combination of Chiba, Kappos 2005, and Budde; and claims 1–6 are anticipated under 35 U.S.C. § 102 by Kappos 2010.  The Judges also ordered IPR2017-01929 and IPR2017-00854 joined, administratively terminated IPR2017-01929 under 37 C.F.R. § 42.72, and ordered all further filings in the joined proceedings shall be made in Case IPR2017-00854 (Petitioners, Apotex Inc.; filed 02/03/2017; instituted 07/18/2017; pending).

Related Matters:  According to the petition, the '405 patent is involved in IPR2017-01550 (Argentum Pharmaceuticals LLC; filed 06/09/2017; instituted and joined to IPR2017-00854 08/09/2017; pending).

Pfizer Inc. v. Genentech, Inc.

PTAB Petition:  IPR2018-00016; filed October 3, 2017.

Patent at Issue:  U.S. Patent No. 7,846,441 ("Treatment with anti-ErbB2 antibodies," issued December 7, 2010) claims a method for the treatment of a human patient with a malignant progressing tumor or cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression in said human patient, without increase in overall severe adverse events.

Petitioner Pfizer Inc. is challenging the '441 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '441 patent is involved in inter partes review IPR2017-00731 (Hospira, Inc.(subsidiary of Pfizer); filed 01/20/2017; denied 07/27/2017; rehearing requested 08/25/2017; pending); Celltrion, Inc. (IPR2017-01121; filed 03/21/2017; pending).  Petitioner also identified that related European patent EP 1,037,926 B1 was invalidated as obvious in the following proceedings: (1) Hospira UK, Ltd. v. Genentech, Inc., No. HP-2014-000034, [2015] EWHC (HC) 1796 (Pat), (Jun. 24, 2015), aff’d Hospira UK, Ltd. v. Genentech, Inc., No.A3 2015 3238, [2016] EWCA Civ 1185 (Nov. 30, 2016); and (2) Decision to Revoke European Patent EP 1,037,926, Application No. 98,963,840.8 (Jun. 13, 2016).

Hologic, Inc. v. Enzo Life Sciences, Inc.

PTAB Petition:  IPR2018-00019; filed October 4, 2017.

Patent at Issue:  U.S. Patent No. 6,221,581 ("Processes for detecting polynucleotides, determining genetic mutations or defects in genetic material, separating or isolating nucleic acid of interest from samples, and useful compositions of matter and multihybrid complex compositions," issued April 24, 2001) claims a process for detecting a nucleic acid of interest.

Petitioners Hologic and Gen-Probe Inc. are challenging the '581 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, the '581 patent is presently the subject of the following patent infringement lawsuits:  Enzo Life Scienced, Inc. v. Hologic, Inc., 1:16-cv-00894 (D. Del.); and Enzo Life Scienced, Inc. v. Digene Corp., 1:02-cv-00212 (D. Del.).

Celltrion, Inc. v Genentech, Inc.

PTAB Petition:  IPR2017-01139; filed March 24, 2017.

Institution of Inter Partes Review:  entered October 4, 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 '196 patent on one ground as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Zhenyu Yang (author), Christopher G. Paulraj, and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1–3, 5, 7, 9–11, and 17–33 of the '196 patent are obvious over the combination of Slamon, Watanabe, Baselga, and Pegram.

Related Matters:  According to the petition, the '196 patent is the subject of inter partes reviews IPR2017-00804 (Hospira, Inc; filed 01/30/2017; instituted 07/27/2017; 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 IPR 2017-00805 (Hospira, Inc.; filed 01/30/2017; instituted 07/27/2017; pending).

Celltrion, Inc. v Genentech, Inc.

PTAB Petition:  IPR2017-01121; filed March 21, 2017.

Institution of Inter Partes Review:  entered October 4, 2017.

Patent at Issue:  U.S. Patent No. 7,846,441 ("Treatment with anti-ErbB2 antibodies," issued December 7, 2010) claims a method for the treatment of a human patient with a malignant progressing tumor or cancer characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression in said human patient, without increase in overall severe adverse events.

Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '441 patent on one ground as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Zhenyu Yang (author), Christopher G. Paulraj, and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1–14 of the '441 patent are obvious over the combination of Baselga 1996, Seidman 1996, and the 1995 TAXOL PDR entry, and the knowledge of a person of ordinary skill in the art.

Related Matters:  According to the petition, the '441 patent is involved in inter partes review IPR2017-00731 (Hospira, Inc.; filed 01/20/2017; institution denied; request for reconsideration filed 08/25/2017; pending).  Petitioner concurrently filed a petition for inter partes review of related U.S. Patent No. 7,892,549 (IPR2017-01122; filed 03/21/2017; instituted 10/04/2017) which is also the subject of IPR2017-00737 (Hospira, Inc.; filed 01/20/2017; instituted 07/27/2017; pending) and IPR2017-00739 (Hospira, Inc.; filed 01/20/2017; institution denied 07/27/2017).

Celltrion, Inc. v Genentech, Inc.

PTAB Petition:  IPR2017-01122; filed March 21, 2017.

Institution of Inter Partes Review:  entered October 4, 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.

Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '549 patent on one ground as being obvious under 35 U.S.C. § 103(a).  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 claims 1–11 and 14–17 of the ’549 Patent are obvious over the combination of Baselga 1996, Seidman 1996, Pegram, and the 1995 TAXOL PDR entry, and the knowledge of a person of ordinary skill in the art.

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) and IPR2017-00739 (Hospira, Inc.; filed 01/20/2017; institution denied 07/27/2017).  Petitioner concurrently filed a petition for inter partes review of related U.S. Patent No. 7,846,441 (IPR2017-01123; filed; pending) which is also the subject of IPR2017-00731 (Hospira, Inc.; filed 01/20/2017; pending).

Celltrion, Inc. v Genentech, Inc.

PTAB Petition:  IPR2017-01140; filed March 24, 2017.

Institution of Inter Partes Review:  entered October 4, 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 obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Zhenyu Yang, Christopher G. Paulraj (author), and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1–3, 5, 7, 9–11, 16–28, and 30–40 of the ’549 Patent are obvious over the combination of Slamon, Watanabe, Baselga ’96, and Pegram ’98.

Related Matters:  According to the petition, the '379 patent is the subject of inter partes reviews IPR 2017-00805 (Hospira, Inc.; filed 01/30/2017; instituted 07/27/2017; 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 IPR2017-00804 (Hospira, Inc; filed 01/30/2017; instituted 07/27/2017; pending).