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

InnoPharma Licensing, LLC v AstraZeneca AB

PTAB Petition:  IPR2017-00900; filed February 17, 2017.

Patent at Issue:  U.S. Patent No. 8,329,680 ("Formulation," issued December 11, 2012) claims a method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation comprising: about 50 mgml^-1 of fulvestrant; about 10% w/v of ethanol; about 10% w/v of benzyl alcohol; about 15% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml^-1 for at least four weeks.

Petitioners InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. are challenging the '680 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '680 patent is involved in litigations captioned AstraZeneca Pharms. LP. v. Agila Specialties, Inc., No. 1:15-cv-06039 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma, Inc., No. 1:16-cv-894 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma Licensing LLC, No. 1:16-cv-1962 (D.N.J.); AstraZeneca Pharms. LP v. Sandoz Inc., No. 1:14-cv-03547 (D.N.J.); AstraZeneca Pharms. LP v. Sagent Pharms., Inc., No. 1:14-cv-05539 (D.N.J.) and 1:14-cv-7358-EEC (N.D. Ill.); AstraZeneca Pharms. LP v. Glenmark Pharms. Inc., USA, No. 1:15-cv-615 
(D.N.J.); AstraZeneca Pharms. LP v. Teva Pharms. USA, Inc., No. 1:15-cv-7889 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Pharms. Inc., No. 1:15-cv-7009 (D.N.J.); AstraZeneca Pharms. LP v. Dr. Reddy's Laboratories, Inc., No. 1:17-cv-926 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Institutional LLC, No. 1:16-cv-4612 (D.N.J.).  Also, the '680 patent was the subject of IPR2016-01325 (Mylan Pharmaceuticals; filed 06/29/2016; institution denied 12/14/2016).

InnoPharma Licensing, LLC v AstraZeneca AB

PTAB Petition:  IPR2017-00904; filed February 17, 2017.

Patent at Issue:  U.S. Patent No. 6,774,122 ("Formulation," issued August 10, 2004) claims a method of treating a hormonal dependent benign or malignant disease of the breast or reproductive tract by administration to a human in need of such treatment an intra-muscular injection of a pharmaceutical formulation comprising fulvestrant, a mixture of 10% weight of ethanol per volume of formulation, 10% weight of benzyl alcohol per volume of formulation and 15% weight of benzyl benzoate per volume of formulation and a sufficient amount of a castor oil vehicle, whereby a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml^-1 is attained for at least 2 weeks after injection.

Petitioners InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. are challenging the '122 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '122 patent is involved in litigations captioned AstraZeneca Pharms. LP. v. Agila Specialties, Inc., No. 1:15-cv-06039 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma, Inc., No. 1:16-cv-894 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma Licensing LLC, No. 1:16-cv-1962 (D.N.J.); AstraZeneca Pharms. LP v. Sandoz Inc., No. 1:14-cv-03547 (D.N.J.); AstraZeneca Pharms. LP v. Sagent Pharms., Inc., No. 1:14-cv-05539 (D.N.J.) and 1:14-cv-7358-EEC (N.D. Ill.); AstraZeneca Pharms. LP v. Glenmark Pharms. Inc., USA, No. 1:15-cv-615 
(D.N.J.); AstraZeneca Pharms. LP v. Teva Pharms. USA, Inc., No. 1:15-cv-7889 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Pharms. Inc., No. 1:15-cv-7009 (D.N.J.); AstraZeneca Pharms. LP v. Dr. Reddy's Laboratories, Inc., No. 1:17-cv-926 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Institutional LLC, No. 1:16-cv-4612 (D.N.J.).  Also, the '122 patent was the subject of IPR2016-01316 (Petitioner Mylan Pharmaceuticals Inc.; filed 06/29/2016; terminated through settlement 01/10/2017); and US Pat. No. 8,329,680, a continuation of the '122 patent, was the subject of IPR2016-01325 (Mylan Pharmaceuticals; filed 06/29/2016; institution denied 12/14/2016).

InnoPharma Licensing, LLC v AstraZeneca AB

PTAB Petition:  IPR2017-00905; filed February 17, 2017.

Patent at Issue:  U.S. Patent No. 8,466,139 ("Formulation," issued June 18, 2013) claims a method for treating a hormonal dependent benign or malignant disease of the breast or reproductive tract comprising administering intramuscularly to a human in need of such treatment a formulation comprising: about 50 mgml^-1 of fulvestrant; a mixture of from 17-23% w/v of ethanol and benzyl alcohol; 12-18% w/v of benzyl benzoate; and a sufficient amount of castor oil vehicle; wherein the method achieves a blood plasma fulvestrant concentration of at least 2.5 ngml^-1 for at least two weeks.

Petitioners InnoPharma Licensing, LLC, InnoPharma, Inc., and Pfizer Inc. are challenging the '139 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 '139 patent is involved in litigations captioned AstraZeneca Pharms. LP. v. Agila Specialties, Inc., No. 1:15-cv-06039 (D.N.J.); AstraZeneca Pharms. LP v. InnoPharma, Inc., No. 1:16-cv-894 (D.N.J.) ("the First InnoPharma Action"); AstraZeneca Pharms. LP v. InnoPharma Licensing LLC, No. 1:16-cv-1962 (D.N.J.) (part of the Consolidated Fulvestrant Action); AstraZeneca Pharms. LP v. Sandoz Inc., No. 1:14-cv-03547 (D.N.J.); AstraZeneca Pharms. LP v. Sagent Pharms., Inc., No. 1:14-cv-05539 (D.N.J.) and 1:14-cv-7358-EEC (N.D. Ill.); AstraZeneca Pharms. LP v. Glenmark Pharms. Inc., USA, No. 1:15-cv-615 
(D.N.J.); AstraZeneca Pharms. LP v. Teva Pharms. USA, Inc., No. 1:15-cv-7889 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Pharms. Inc., No. 1:15-cv-7009 (D.N.J.); AstraZeneca Pharms. LP v. Dr. Reddy's Laboratories, Inc., No. 1:17-cv-926 (D.N.J.); AstraZeneca Pharms. LP v. Mylan Institutional LLC, No. 1:16-cv-4612 (D.N.J.).  Also, the '139 patent was the subject of IPR2016-01326 (Petitioner Mylan Pharmaceuticals Inc.; filed 06/29/2016; terminated through settlement 01/10/2017); and US Pat. No. 8,329,680, a parent of the '139 patent, was the subject of IPR2016-01325 (Mylan Pharmaceuticals; filed 06/29/2016; institution denied 12/14/2016).

Celltrion, Inc. v Genentech, Inc.

PTAB Petition:  IPR2017-00959; filed February 21, 2017.

Patent at Issue:  U.S. Patent No. 8,591,897 ("Anti-ERBB2 antibody adjuvant therapy," issued November 26, 2013) claims a method of adjuvant therapy comprising administering to a human subject with nonmetastatic HER2 positive breast cancer, following definitive surgery, anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and trastuzumab or an antibody that blocks binding of trastuzumab to HER2.

Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '897 patent on three grounds as anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) or as obvious under 35 U.S.C. § 103(a) (ground 3).  View the petition here.

Related Matters:  According to the petition, the '897 patent is not involved in any other matters.

Celltrion, Inc. v Biogen, Inc.

PTAB Petition:  IPR2016-01614; filed August 15, 2016.

PTAB Trial Instituted, entered February 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 Celltrion, Inc. is challenging the '161 patent on three grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Francisco C. Prats, Erica A. Franklin (author), and Sheridan K. Snedden issued a decision instituting inter partes review of whether claims 1–3, 5–7, and 9–11 are unpatentable under 35 U.S.C. § 103(a) as obvious over Edwards, the Rituxan® Label, O'Dell, and Kalden.

Related Matters:  According to the petition, the '161 patent was the subject of 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).

Smith & Nephew, Inc. v. ConforMIS, Inc.

PTAB Petition:  IPR2017-00983; filed February 28, 2017.

Patent at Issue:  U.S. Patent No. 8,657,827 ("Surgical tools for arthroplasty," issued February 25, 2014) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

Petitioner Smith & Nephew, Inc. is challenging the '827 patent on six grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '827 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Petitioner is concurrently filing a petition for inter partes review of claims 50-64 of the '827 patent (IPR2017-00984).  Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents: U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending); and 8,062,302 (IPR2017-00779; filed 01/26/2017; pending).

Smith & Nephew, Inc. v. ConforMIS, Inc.

PTAB Petition:  IPR2017-00984; filed February 28, 2017.

Patent at Issue:  U.S. Patent No. 8,657,827 ("Surgical tools for arthroplasty," issued February 25, 2014) claims patient-specific surgical tool for use in surgically repairing a joint of a patient.

Petitioner Smith & Nephew, Inc. is challenging the '827 patent on four grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '827 patent is the subject of a litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT (D. Mass.).  Petitioner is concurrently filing a petition for Inter Partes Review of claims 50-64 of the '827 patent (IPR2017-00983).  Also, Petitioner filed petitions requesting inter partes review of related ConforMIS patents: U.S. Patent Nos. 9,055,953 (IPR2016-01874; filed 09/21/2016; pending); 9,216,025 (IPR2017-00115; filed 10/20/2016; pending) and (IPR2017-00307; filed 11/21/2016; pending); 8,377,129 (IPR2017-00372; filed 11/30/2016; pending); 8,551,169 (IPR2017-00373; filed 11/30/2016; pending); 9,295,482 (IPR2017-00487; filed 12/14/2016; pending) and (IPR2017-00488; filed 12/14/2016; pending); 7,981,158 (IPR2017-00510; filed 12/20/2016; pending) and (IPR2017-00511; filed 12/20/2016; pending); 7,534,263 (IPR2017-00544; filed 12/27/2016; pending) and (IPR2017-00545; filed 12/27/2016; pending); and 8,062,302 (IPR2017-00779; filed 01/26/2017; pending).

Arthrex, Inc. v KFx Medical, LLC

PTAB Petition:  IPR2016-01697; filed August 31, 2016.

PTAB Trial Instituted, entered February 28, 2017.

Patent at Issue:  U.S. Patent No. 9,044,226 ("System and method for attaching soft tissue to bone," issued June 02, 2015) claims a bone implant, comprising a substantially hollow cylinder; and a method of fixating a bone implant within bone.

Petitioner Arthrex, Inc. is challenging the '226 patent on seven grounds as anticipated under 35 U.S.C. § 102(b) (ground 1) and obvious under 35 U.S.C. § 103(a) (grounds 2-7).  View the petition here.  Administrative Patent Judges Lora M. Green, Josiah C. Cocks (author), and Richard H. Marschall issued a decision instituting inter partes review of whether claims 1-20 are unpatentable under 35 U.S.C. § 103(a) as obvious over Meridew, Pietrzak or Goble, Fucci or Schmieding, and Anspach.

Related Matters:  According to the petition, the '226 patent is the subject of a litigation captioned Arthrex, Inc. v. Joseph Tauro et al., No: 3:15-cv-06580 (D.N.J.).

Arthrex, Inc. v KFx Medical, LLC

PTAB Petition:  IPR2016-01698; filed August 31, 2016.

PTAB Trial Instituted, entered February 28, 2017.

Patent at Issue:  U.S. Patent No. 8,926,663 ("System and method for attaching soft tissue to bone," issued January 6, 2015) claims a bone implant, comprising a substantially hollow cylinder; and a method of fixating a bone implant within bone.

Petitioner Arthrex, Inc. is challenging the '663 patent on seven grounds as anticipated under 35 U.S.C. § 102(b) (ground 1) and obvious under 35 U.S.C. § 103(a) (grounds 2-7).  View the petition here.  Administrative Patent Judges Lora M. Green, Josiah C. Cocks, and Richard H. Marschall (author)issued a decision instituting inter partes review of whether claims 1-18 are unpatentable under 35 U.S.C. § 103(a) as obvious over Meridew, Pietrzak or Goble, Fucci or Schmieding, and Anspach.

Related Matters:  According to the petition, the '663 patent is the subject of a litigation captioned Arthrex, Inc. v. Joseph Tauro et al., No: 3:15-cv-06580 (D.N.J.).