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

Complex Innovations, LLC.  v. AstraZeneca AB

PTAB Petition:  IPR2017-00631; filed January 9, 2017.

Patent at Issue:  U.S. Patent No. 7,759,328 ("Composition for inhalation," issued July 20, 2010) claims pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, 1,1,1,2,3,3,3-heptafluoropropane (HFA227), PVP K25 (polyvinyl pyrrolidone with a nominal K-value of 25), and PEG-1000 (polyethylene glycol with an average molecular weight of 1,000) as well as a method of treating symptoms of a respiratory disorder.

Petitioner Complex Innovations, LLC is challenging the '328 patent on four grounds as being 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 '328 patent is not involved in any related matters.

Apotex Corp. v. OSI Pharmaceuticals, Inc.

PTAB Petition:  IPR2016-01284; filed June 28, 2016.

PTAB Trial Instituted; entered January 9, 2017.

Patent at Issue:  U.S. Patent No. 6,900,221 ("Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof," issued May 31, 2005) claims a homogeneous crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-Quinazolinamine designated the B polymorph.

Petitioners Apotex Inc., Apotex Corp., Apotex Pharmaceuticals Holdings Inc., and Apotex Holdings, Inc. are challenging the '221 patent on three grounds as being 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. Administrative Patent Judges Lora M. Green (author), Rama G. Elluru, and Zhenyu Yang issued a decision instituting inter partes review of claims 44‒46 and 53 as obvious in view of Schnur and OSI's 10-K or Gibbs; and claim 47 as obvious in view of Schnur, Gibbs, and Moscatello.

Related Matters:  According to the petition, the '221 patent is involved in the following litigations:  OSI Pharmaceuticals, LLC and Genentech, Inc. v. Apotex Inc. and Apotex Corp., No. 1:15-cv-00772-SLR (D. Del); and 
Pfizer Inc., OSI Pharmaceuticals, LLC and Genentech, Inc. v. Breckenridge Pharmaceutical, Inc. and Natco Pharma Ltd., No. 1:15-cv-01063-SLR (D. Del.).

Mylan Pharmaceuticals Inc. v. Janssen Oncology, Inc.

PTAB Petition:  IPR2016-01332; filed June 30, 2016.

PTAB Trial Instituted; entered January 10, 2017.

Patent at Issue:  U.S. Patent No. 8,822,438 ("Methods and compositions for treating cancer," issued September 2, 2014) claims a method for the treatment of a prostate cancer in a human comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of prednisone.

Petitioners Mylan Pharmaceuticals Inc., Mylan Inc., Mylan N.V., and Mylan LLC are challenging the '438 patent on two grounds as obvious under 35 U.S.C. § 103(a).  Petitioners concurrently filed a Motion for Joinder seeking to join this case, under 35 U.S.C. § 315(c), with the inter partes review in IPR2016-00286 (Amerigen Pharmaceuticals, Ltd. v. Janssen Oncology, Inc.; filed 12/04/2015; instituted 05/31/2016).  View the petition here and the Motion for Joinder here.  Administrative Patent Judges Lora M. Green, Rama G. Elluru, and Kristina M. Kalan (author) issued a decision instituting inter partes review of claims 1–20 as obvious in view of O'Donnell and Gerber; and claims 1–4 and 6–11 as obvious in view of Barrie and Gerber.  In their decision, the Board denied Petitioners' Motion for Joinder.

Related Matters:  According to the petition, the '438 patent is involved in the following litigations:  BTG Int'l Ltd. v. Actavis Labs. FL, Inc., No. 15-cv-5909-KM-JBC (D.N.J.); BTG Int'l Ltd. v. Amerigen Pharms., Inc., No. 16-cv-02449-KM-JBC (D.N.J.); Janssen Biotech, Inc. v. Mylan Pharms. Inc., No. 15-cv-00130-IMK (N.D.W. Va.); and BTG Int'l Ltd. v. Glenmark Pharms. Inc., USA, No. 16-cv-03743-KM-JBC (D.N.J.).  The '438 patent is also the subject of IPR2016-00286 (Petitioner Amerigen Pharmaceuticals Inc.; filed on 12/04/2015; instituted 05/31/2016; pending) and IPR2016-01317 (Petitioner Argentum Pharmaceuticals LLC; filed 06/29/2016; instituted 09/19/2016; joined with IPR2016-00286 09/19/2016; pending).

Amerigen Pharmaceuticals Limited v. Shire, LLC.

PTAB Petition: IPR2017-00665; filed January 13, 2017.

Patent at Issue:  U.S. Patent No. 8,846,100 ("Controlled dose drug delivery system," issued September 30, 2014) claims a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt.

Petitioner Amerigen Pharmaceuticals Ltd. is challenging the '100 patent on one ground as being anticipated under 35 U.S.C. § 102(b).  View the petition here.

Related Matters:  According to the petition, the '100 patent is not involved in any related matters.

Amneal Pharmaceuticals LLC. v. Purdue Pharma L.P. et al.

PTAB Petition:  IPR2016-01413; filed July 15, 2016.

PTAB Trial Instituted; entered January 18, 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: a controlled release matrix comprising a mixture of oxycodone or a pharmaceutically acceptable salt thereof and a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose.

Petitioner Amneal Pharmaceuticals LLC is challenging the '376 patent on one ground as 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 as obvious over the combination of Royce, McGinity, Hoffmeister, Joshi, and PDR.

Related Matters:  According to the petition, the '376 patent is involved in the following litigations:  Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, No. 1:15-cv-00831 (D.E.D.), and Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC, 1-15-cv-01152 (D.E.D.).  Petitioner concurrently filed a second inter partes review IPR2016-01412 seeking cancellation of these same claims on other grounds.  Petitioner previously filed IPR2016-01027 (filed 05/11/2016; instituted 11/09/2016; pending) and IPR2016-01028 (filed 05/11/2016; instituted 11/09/2016; pending) seeking cancellation of claim 1 of U.S. Patent No. 9,060,976, which is a member of this patent family.

Mylan Institutional Inc. v. Fresenius Kabi USA, LLC

PTAB Petition:  IPR2017-00645; filed January 19, 2017.

Patent at Issue:  U.S. Patent No. 9,006,289 ("Levothyroxine formulations," issued April 14, 2015) claims a lyophilized solid composition, comprising levothyroxine sodium; a phosphate buffer; and mannitol.

Petitioners Mylan Inc., Mylan Institutional Inc., and Mylan NV are challenging the '289 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '289 patent is currently the subject of the following litigations:  Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC, 17-01099 (Fed. Cir.); Fresenius Kabi USA, LLC v. Innopharma Licensing, LLC et al., 2:15-cv-03655-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC, 2:15-cv-03654-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Par Sterile Products, LLC et al., No. 2:15-cv-03852-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Dr. Reddy's Laboratories, Inc. et al., 1:16-cv-00169-GMS (D. Del.); Fresenius Kabi USA, LLC v. Dr. Reddy's Laboratories, Inc. et al., 2:16-cv-01542-KM-MAH (D.N.J.); Fresenius Kabi USA, LLC v. Maia Pharmaceuticals, Inc., 1:16-cv-00237-GMS (D. Del.); Fresenius Kabi USA, LLC v. Dr. Reddy's Laboratories, Inc. et al., 2:16-cv-03316-KM-MAH (D.N.J.); and Fresenius Kabi USA, LLC v. Maia Pharmaceuticals, Inc., 2:16-cv-03315-KM-MAH (D.N.J.).

Hospira, Inc. v. Genentech, Inc.

PTAB Petition:  IPR2017-00731; filed January 20, 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.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '441 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, Petitioner concurrently filed two inter partes petitions for claims of U.S. Patent No. 7,892,549.  According to the petition, the '441 patent is not involved in any other related judicial or administrative matters.

Hospira, Inc. v. Genentech, Inc.

PTAB Petition:  IPR2017-00737; filed January 20, 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.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '549 patent on six grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, Petitioner concurrently filed an inter partes petition for claims of U.S. Patent No. 7,846,441 and two inter partes petitions for claims of U.S. Patent No. 7,892,549.  According to the petition, the '549 patent is not involved in any other related judicial or administrative matters.

Hospira, Inc. v. Genentech, Inc.

PTAB Petition:  IPR2017-00739; filed January 20, 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.

Petitioners Hospira, Inc. and Pfizer Inc. are challenging the '549 patent on three grounds as anticipated under 35 U.S.C. § 102(a) (grounds 2 and 3) and § 102(b) (ground 1).  View the petition here.

Related Matters:  According to the petition, Petitioner concurrently filed an inter partes petition for claims of U.S. Patent No. 7,846,441 and two inter partes petitions for claims of U.S. Patent No. 7,892,549.  According to the petition, the '549 patent is not involved in any other related judicial or administrative matters.