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

Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc.

PTAB Petition:  IPR2017-00853; filed February 8, 2017.

Patent at Issue:  U.S. Patent No. 8,822,438 ("Methods and compositions for treating cancer," issued February 11, 2014) claims methods for treating cancer comprising administering a 17α-hydroxylase/C₁₇,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid.

Petitioners Actavis Laboratories FL, Inc., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC, Dr. Reddy's Laboratories, Inc., Dr. Reddy's Laboratories, Ltd., Sun Pharmaceuticals Industries, Ltd., Sun Pharmaceuticals Industries, Inc., Teva Pharmaceuticals USA, Inc., West-Ward Pharmaceutical Corp., and Hikma Pharmaceuticals, LLC are challenging the '438 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '438 patent is involved in the following litigations:  BTG Int'l Ltd. v. Amerigen Pharms., Inc., No. 16-cv-02449-KM-JBC (D.N.J.); BTG Int'l Ltd. v. Glenmark Pharms. Inc., USA, No. 16-cv-03743-KM-JBC (D.N.J.); and Janssen Biotech, Inc. v. Mylan Pharms. Inc., No. 15-cv-00130-IMK (N.D.W. Va.).  Also, the '438 patent is the subject of IPR2016-00286 (Petitioner Amerigen Pharms. Ltd.; filed 12/04/2016; instituted 05/31/2016; pending); IPR2016-01317 (Petitioner Argentum; filed 06/29/2016; instituted and joined to IPR2016-00286 09/19/2016; pending); IPR2016-01332 (Petitioner Mylan Pharmaceuticals Inc., filed 06/30/2016; instituted 01/10/2017; pending); and IPR2016-01582 (Petitioner Wockhardt Bio AG, filed 08/10/2016; instituted 01/19/2017; pending).

Koios Pharmaceuticals LLC v Medac Geselleschaft Fuer Klinische Spezial Praparate MBH

PTAB Petition:  IPR2016-01370; filed July 20, 2016.

PTAB Trial Instituted; entered February 8, 2017.

Patent at Issue:  U.S. Patent No. 8,664,231 ("Concentrated methotrexate solutions," issued March 4, 2014) claims a method for the treatment of inflammatory autoimmune diseases comprising subcutaneously administering a methotrexate in a  pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml.

Petitioner Koios Pharmaceuticals LLC is challenging the '231 patent on six grounds as anticipated under 35 U.S.C. § 102(b) (grounds 1 and 4) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 5, and 6).  View the petition here.  Administrative Patent Judges Jacqueline Wright Bonilla (author), Toni R. Scheiner, and Erica A. Franklin issued a decision instituting inter partes review of claims 1, 2, 4–6, 11–13, 17, and 22 under 35 U.S.C. § 102(b) as being anticipated by Grint; claims 7–10, 14–16, and 19–21 under 35 U.S.C. § 103(a) as being obvious over Grint, Arthur, Moitra, and Insulin Admin.; claim 18 under 35 U.S.C. § 103(a) as being obvious over Grint and Alsufyani; claims 1–6, 11–13, 17, 18, and 22 under 35 U.S.C. § 102(b) as being anticipated over Wyeth; and claims 1–6, 11–13, 17, 18, and 22 under 35 U.S.C. § 103(a) as being obvious over Wyeth, Brooks, Arthur, and Moitra.

Related Matters:  According to the petition, the '231 patent is the subject of IPR2014-01091 (Petitioners Antares Pharm, Inc., Leo Pharma A/S, and Leo Pharma Inc.; filed 07/01/2014; instituted 01/06/2015; terminated 04/30/2015 through settlement) and IPR2016-00649 (Petitioner Frontier Therapeutics, LLC; filed 02/22/2016; terminated 12/08/2016 through settlement).

Amneal Pharmaceuticals LLC v Hospira, Inc.

PTAB Petition:  IPR2016-01578; filed August 10, 2016.

PTAB Trial Instituted; entered February 9, 2017.

Patent at Issue:  U.S. Patent No. 8,338,470 ("Dexmedetomidine premix formulation," issued December 25, 2012) claims a ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL disposed within a sealed glass container.

Petitioner Amneal Pharmaceuticals LLC is challenging the '470 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Michael J. Fitzpatrick, Sheridan K. Snedden (author), and Zhenyu Yang issued a decision instituting inter partes review of claims 1-7 under 35 U.S.C. § 103(a) as being obvious over 2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and Lavoisier.

Related Matters:  According to the petition, the '470 patent is the subject of the following litigation:  Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697 (D.Del.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,242,158 (IPR2016-01577; filed 08/10/2016; instituted 02/09/2017); 8,455,527 (IPR2016-01579; filed 08/10/2016; instituted 02/09/2017; pending); and 8,648,106 (IPR2016-01580; filed 08/11/2016; institution denied 02/03/2017).

Amneal Pharmaceuticals LLC v Hospira, Inc.

PTAB Petition:  IPR2016-01579; filed August 10, 2016.

PTAB Trial Instituted; entered February 9, 2017.

Patent at Issue:  U.S. Patent No. 8,455,527 ("Methods of treatment using a dexmedetomidine premix formulation," issued June 4, 2013) claims a method of providing sedation to a patient in need thereof, the method comprising administering to the patient an effective amount of a composition, wherein the composition comprises dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL, wherein the composition is a ready to use liquid pharmaceutical composition for parenteral administration to the patient disposed within a sealed glass container.

Petitioner Amneal Pharmaceuticals LLC is challenging the '527 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  In a per curiam decision, Administrative Patent Judges Michael J. Fitzpatrick, Sheridan K. Snedden, and Zhenyu Yang issued a decision instituting inter partes review of claims 1-11 and 13 under 35 U.S.C. § 103(a) as being obvious over 2010 Precedex Label, De Giorgi, Eichhorn, Palmgrén, and Lavoisier.

Related Matters:  According to the petition, the '470 patent is the subject of the following litigation:  Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697 (D.Del.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,242,158 (IPR2016-01577; filed 08/10/2016; instituted 02/09/2017); 8,338,470 (IPR2016-01578; filed 08/10/2016; instituted 02/09/2017; pending); and 8,648,106 (IPR2016-01580; filed 08/11/2016; institution denied 02/03/2017).

Mylan Pharmaceuticals, Inc. v. Boehringer Ingelheim International GmbH

PTAB Petition:  IPR2016-01565; filed August 10, 2016.

PTAB Trial Instituted; entered February 9, 2017.

Patent at Issue:  U.S. Patent No. 8,853,156 ("Treatment for diabetes in patients inappropriate for metformin therapy," issued October 7, 2014) claims a method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising orally administering to the patient a DPP-IV inhibitor wherein the contraindication is selected from the group consisting of renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary galactose intolerance.

Petitioners Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., Mylan Inc., and Mylan N.V. are challenging the '156 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.  Administrative Patent Judges Toni R. Scheiner (author), Brian P. Murphy, and Zhenyu Yang issued a decision instituting inter partes review of claims 1, 2, 4, 5, and 23 under 35 U.S.C. § 102 as being anticipated by Mikhail; and claims 1, 2, 4, 5, and 23 under 35 U.S.C. § 103 as being obvious over Mikhail.

Related Matters:  According to the petition, the '156 patent is the subject the following litigation:  Boehringer Ingelheim Pharmaceuticals Inc., et al. v. HEC Pharm Group, et al., No. 3:15-cv-05982-PGS-TJB (D.N.J.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 9,173,859 (IPR2016-01566; filed 08/10/2016; institution denied 02/03/2017); 8,846,695 (IPR2016-01564; filed 08/10/2016; instituted 01/31/2017; pending); and 8,673,927 (IPR2016-01563; filed 08/10/2016; instituted 02/03/2017; pending).

Amneal Pharmaceuticals LLC v Hospira, Inc.

PTAB Petition:  IPR2016-01577; filed August 10, 2016.

PTAB Trial Instituted; entered February 9, 2017.

Patent at Issue:  U.S. Patent No. 8,242,158 ("Dexmedetomidine premix formulation," issued August 14, 2012) claims a ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 4 μg/mL disposed within a sealed glass container.

Petitioner Amneal Pharmaceuticals LLC is challenging the '158 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Michael J. Fitzpatrick, Sheridan K. Snedden, and Zhenyu Yang (Author) issued a decision instituting inter partes review of claims 1-4 under 35 U.S.C. § 103(a) as being obvious over Precedex Label, in view of the knowledge of one of skill in the art at the time of filing, as evidenced by De Giorgi, Eichhorn, Palmgrén, and Lavoisier.

Related Matters:  According to the petition, the '158 patent is the subject of the following litigation:  Hospira Inc. v. Amneal Pharmaceuticals LLC, 1:15-cv-00697 (D.Del.).  Petitioner concurrently filed petitions for inter partes review of U.S. Patent Nos. 8,455,527 (IPR2016-01579; filed 08/10/2016; instituted 02/09/2017; pending); 8,338,470 (IPR2016-01578; filed 08/10/2016; instituted 02/09/2017; pending); and 8,648,106 (IPR2016-01580; filed 08/11/2016; institution denied 02/03/2017).

Amneal Pharmaceuticals LLC v Purdue Pharma L.P., P.F. Laboratories, Inc., and Purdue Pharmaceuticals L.P.

PTAB Petition:  IPR2016-01412; filed July 16, 2016.

PTAB Trial Instituted; entered February 14, 2017.

Patent at Issue:  U.S. Patent No. 9,034,376 ("Pharmaceutical formulation containing gelling agent," issued May 19, 2015) claims a controlled release oral solid dosage form comprising oxycodone and a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose.

Petitioner Amneal Pharmaceuticals LLC is challenging the '376 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Michael P. Tierney, Lora M. Green, and Christopher G. Paulraj (Author) issued a decision instituting inter partes review of claims 1-13 and 16-19 under 35 U.S.C. § 103(a) as being obvious over Palermo, Joshi, and the Handbook; and claims 1-13 and 16-19 under 35 U.S.C. § 103(a) as being obvious over Oshlack, Joshi, the Handbook, and Doyon.

Related Matters:  According to the petition, the '376 patent is the subject of the following litigations:  Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 1:15-cv-00831 (D.Del.); and Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 1:15-cv-1152 (D.Del.).  U.S. Patent No. 8,337,888, which claims priority to the same earlier-filed application as the '376 Patent, was the subject of a district court proceeding in the Southern District of New York in Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, No. 13-3372 (S.D.N.Y.).  The Federal Circuit upheld the invalidity of the claims of the '888 Patent on April 8, 2016.  Petitioner filed a separate petition for inter partes review challenging the same claims of the '376 Patent on other grounds (IPR2016-01413; filed 07/15/2016; instituted 01/18/2017; pending).  Also, Petitioner previously filed petitions seeking cancellation of claim 1 of U.S. Patent No. 9,060,976, which is another member of the same patent family (IPR2016-01027; filed 05/11/2016; instituted 11/09/2016; pending) and (IPR2016-01028; filed 05/11/2016; instituted 11/09/2016; pending).

Par Pharmaceuticals, Inc. v Novartis AG

PTAB Petition:  IPR2016-01479; filed July 22, 2016.

PTAB Trial Instituted; entered February 15, 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.

Petitioner Par Pharmaceuticals, Inc. is challenging the '224 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Lora M. Green, Christopher L. Crumbley (Author), and Robert A. Pollock issued a decision instituting inter partes review of claims 1–3 under 35 U.S.C. § 103(a) as being obvious over Oberg 2004, Boulay 2004, and O'Donnell; claim 2 under 35 U.S.C. § 103(a) as being obvious over Oberg 2004, Boulay 2004, O'Donnell, and Tabernero; claims 1–3 under 35 U.S.C. § 103(a) as being obvious over Boulay 2004, O'Donnell, and Duran; and claim 2 under 35 U.S.C. § 103(a) as being obvious over Boulay 2004, O'Donnell, Duran, and Tabernero.

Related Matters:  According to the petition, the '224 patent is the subject of the following litigations:  Novartis Pharm. Corp. et al. v. Roxane Labs., Inc., No. 15-474-RGA (D.Del.); and Novartis Pharm. Corp. et al. v. Par Pharm., Inc., No. 15-475-RGA (D. Del.).  Claims 1 and 2 of the '224 patent were challenged in IPR2016-01461 (Roxanne Laboratories, Inc.; filed 07/22/2016; institution denied 02/13/2017).