PTAB Life Sciences Report - August 2017

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

Celltrion, Inc. v. Biogen Inc. et al.

PTAB Petition:  IPR2017-01230; filed March 30, 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 in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging the '612 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (ground 3) and as obvious under 35 U.S.C. § 103(a) (grounds 1, 2, 4, and 5).  View the petition here.

Related Matters:  According to the petition, Petitioners concurrently filed a second petition for inter partes review of the '612 patent (IPR2017-01227; filed 03/30/2017; pending) as well as a petition for inter partes review of related U.S. Patent No. 8,206,711 (IPR2017-01229; filed 03/31/2017; pending).

Celltrion, Inc. v. Biogen Inc. et al.

PTAB Petition:  IPR2017-01227; filed March 31, 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 in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are 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 petition, Petitioners concurrently filed a second petition for inter partes review of the '612 patent (IPR2017-01230; filed 03/30/2017; pending) as well as a petition for inter partes review of related U.S. Patent No. 8,206,711 (IPR2017-01229; filed 03/31/2017; pending).

Celltrion, Inc. v. Biogen Inc. et al.

PTAB Petition:  IPR2017-01229; filed March 31, 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.

Petitioners Celltrion, Inc., Celltrion Healthcare Co. Ltd., and Teva Pharmaceuticals International GmbH are challenging  the '711 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 2) and as obvious under 35 U.S.C. § 103(a) (grounds 3-6).  View the petition here.

Related Matters:  According to the petition, Petitioners concurrently filed petitions for inter partes review of related U.S. Patent No. 7,682,612 (IPR2017-01230; filed 03/30/2017; pending) and (IPR2017-01227; filed 03/31/2017; pending).

Teva Pharmaceuticals USA, Inc. v. Allergan, Inc.; Akorn Inc. v. Allergan, Inc.

PTAB Petition:  IPR2017-00578; filed January 6, 2017.

PTAB Petition:  IPR2017-00596; filed January 6, 2017.

PTAB Trial Instituted; entered March 31, 2017.

Patent at Issue:  U.S. Patent No. 8,629,111 ("Methods of providing therapeutic effects using cyclosporin components," issued January 14, 2014) claims a topical ophthalmic emulsion for treating an eye of a human comprising cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight; wherein cyclosporin A is the only peptide present in the topical ophthalmic emulsion.

Petitioners Teva Pharmaceuticals USA, Inc. (IPR2017-00578) and Akorn Inc. (IPR2017-00596) are challenging the '111 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petitions here (IPR2017-00578) and here (IPR2017-00596).  Both Petitioners also seek joinder with IPR2016-01128 through Motions for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  Administrative Patent Judges Sheridan K. Snedden, Tina E. Hulse, and Christopher G. Paulraj (author) issued decisions instituting inter partes review of whether claims 1−27 are anticipated under 35 U.S.C. § 102(b) by Ding '979; claims 1−27 are obvious under 35 U.S.C. § 103(a) over the combination of Ding '979 and Sall; and claims 11 and 16 are obvious under 35 U.S.C. § 103(a) over the combination of Ding '979, Sall, and Acheampong.  View the decisions here (IPR2017-00578) and here (IPR2017-00596).

Related Matters:  According to the petition, the '111 patent is involved in the following litigations: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. et al., No. 2:15cv1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '111 patent was the subject of IPR2015-01282 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Inter partes review petitions for related patents include IPR2016-01127 (U.S. Patent No. 8,685,930 B2); IPR2016-01129 (U.S. Patent No. 8,642,556 B2); IPR2016-01130 (U.S. Patent No. 8,633,162 B2); IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and IPR2016-01132 (U.S. Patent No. 9,248,191 B2).  U.S. Application No. 15/011,159, filed January 29, 2016, claims the benefit of U.S. Application No. 14/222,478 (the '191 patent), which is a continuation, via U.S. Application Nos. 13/961,828 and 11/897,177, of the '857 application.

Teva Pharmaceuticals USA, Inc. v. Allergan, Inc.; Akorn Inc. v. Allergan, Inc.

PTAB Petition:  IPR2017-00576; filed January 6, 2017.

PTAB Petition:  IPR2017-00594; filed January 6, 2017.

PTAB Trial Instituted; entered March 31, 2017.

Patent at Issue:  U.S. Patent No. 8,685,930 ("Methods of providing therapeutic effects using cyclosporin components," issued April 1, 2014) claims a topical ophthalmic emulsion comprising cyclosporin A for treating an eye with keratoconjuctivitis sicca.

Petitioners Teva Pharmaceuticals USA, Inc. (IPR2017-00576) and Akorn Inc. (IPR2017-00594) are challenging the '930 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petitions here (IPR2017-00576) and here (IPR2017-00594).  Both Petitioners also seek joinder with IPR2016-01127 through Motions for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  Administrative Patent Judges Sheridan K. Snedden (author), Tina E. Hulse, and Christopher G. Paulraj issued decisions instituting inter partes review of whether claims 1−36 are anticipated under 35 U.S.C. § 102 by Ding '979; claims 1−36 are obvious under 35 U.S.C. § 103(a) over the combination of Ding '979 and Sall; and claims 11, 23, and 35 are obvious under 35 U.S.C. § 103(a) over the combination of Ding '979, Sall, and Acheampong.  The Judges also ordered the cases joined and administratively terminated under 37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be made in IPR2016-01127.  View the decisions here (IPR2017-00576) and here (IPR2017-00594).

Related Matters:  According to the petition, the '930 patent is involved in the following litigations: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. et al., No. 2:15cv1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '930 patent was the subject of IPR2015-01283 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents in IPR2016-01128 (U.S. Patent No. 8,629,111 B2); IPR2016-01129 (U.S. Patent No. 8,642,556 B2); IPR2016-01130 (U.S. Patent No. 8,633,162 B2); IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and IPR2016-01132 (U.S. Patent No. 9,248,191 B2).

Teva Pharmaceuticals USA, Inc. v. Allergan, Inc.; Akorn Inc. v. Allergan, Inc.

PTAB Petition:  IPR2017-00579; filed January 6, 2017.

PTAB Petition:  IPR2017-00598; filed January 6, 2017.

PTAB Trial Instituted; entered March 31, 2017.

Patent at Issue:  U.S. Patent No. 8,642,556 ("Methods of providing therapeutic effects using cyclosporin components," issued February 4, 2014) claims a topical ophthalmic emulsion for treating a human eye comprising cyclosporin A.

Petitioners Teva Pharmaceuticals USA, Inc. (IPR2017-00579) and Akorn Inc. (IPR2017-00598) are challenging the '556 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 through 5).  View the petitions here (IPR2017-00579) and here (IPR2017-00598).  Both Petitioners also seek joinder with IPR2016-01129 through Motions for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  Administrative Patent Judges Sheridan K. Snedden, Tina E. Hulse, and Christopher G. Paulraj (author) issued decisions instituting inter partes review of whether claims 1–20 are anticipated under 35 U.S.C. § 102(b) by Ding '979; claims 1–20 are obvious under 35 U.S.C. § 103(a) over Ding '979 and Sall; claims 14 and 19 are obvious under 35 U.S.C. § 103(a) over Ding '979, Sall, and Glonek; claims 11, 18, and 20 are obvious under 35 U.S.C. § 103(a) over Ding '979, Sall, and Acheampong; and claim 19 is obvious under 35 U.S.C. § 103(a) over Ding '979, Sall, Glonek, and Acheampong.  The Judges also ordered the cases joined and administratively terminated under 37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be made in IPR2016-01129.  View the decisions here (IPR2017-00579) and here (IPR2017-00598).

Related Matters:  According to the petition, the '556 patent is involved in the following litigations: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. et al., No. 2:15cv1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '556 patent was the subject of IPR2015-01286 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents IPR2016-01127 (U.S. Patent No. 8,685,930 B2); IPR2016-01128 (U.S. Patent No. 8,629,111 B2); IPR2016-01130 (U.S. Patent No. 8,633,162 B2); IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and IPR2016-01132 (U.S. Patent No. 9,248,191 B2).

Teva Pharmaceuticals USA, Inc. v. Allergan, Inc.; Akorn Inc. v. Allergan, Inc.

PTAB Petition:  IPR2017-00583; filed January 6, 2017.

PTAB Petition:  IPR2017-00599; filed January 6, 2017.

PTAB Trial Instituted; entered March 31, 2017.

Patent at Issue:  U.S. Patent No. 8,633,162 ("Methods of providing therapeutic effects using cyclosporin components," issued February 4, 2014) claims a method of treating dry eye disease comprising topically administering an emulsion comprising cyclosporin A.

Petitioners Teva Pharmaceuticals USA, Inc. (IPR2017-00583) and Akorn Inc. (IPR2017-00599) are challenging the '162 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petitions here (IPR2017-00583) and here (IPR2017-00599).  Both Petitioners also seek joinder with IPR2016-01130 through Motions for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  Administrative Patent Judges Sheridan K. Snedden, Tina E. Hulse (author), and Christopher G. Paulraj issued decisions instituting inter partes review of whether claims 1–10, 12–14, 16–20, and 22–24 are obvious over Ding '979 and Sall; claims 11 and 21 are obvious over Ding '979, Sall, and Acheampong; and claim 15 is obvious over Ding '979, Sall, and Glonek.  The Judges also ordered the cases joined and administratively terminated under 37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be made in IPR2016-01130.  View the decisions here (IPR2017-00583) and here (IPR2017-00599).

Related Matters:  According to the petition, the '162 patent is involved in following litigations: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. et al., No. 2:15cv1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '162 patent was the subject of IPR2015-01278 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Petitioner concurrently filed inter partes review petitions to related patents IPR2016-01127 (U.S. Patent No. 8,685,930 B2); IPR2016-01128 (U.S. Patent No. 8,629,111 B2); IPR2016-01129 (U.S. Patent No. 8,642,556 B2); IPR2016-01131 (U.S. Patent No. 8,648,048 B2); and IPR2016-01132 (U.S. Patent No. 9,248,191 B2).

Teva Pharmaceuticals USA, Inc. v. Allergan, Inc.; Akorn Inc. v. Allergan, Inc.

PTAB Petition:  IPR2017-00585; filed January 6, 2017.

PTAB Petition:  IPR2017-00600; filed January 6, 2017.

PTAB Trial Instituted; entered March 31, 2017.

Patent at Issue:  U.S. Patent No. 8,648,048 ("Methods of providing therapeutic effects using cyclosporin components," issued February 11, 2014) claims method of increasing tear production in the eye of a human by topically administering an emulsion comprising cyclosporin A.

Petitioners Teva Pharmaceuticals USA, Inc. (IPR2017-00585) and Akorn Inc. (IPR2017-00600) are challenging the '048 patent on three grounds as being obvious under 35 U.S.C. § 103(a).  View the petitions here (IPR2017-00585) and here (IPR2017-00600).  Both Petitioners also seek joinder with IPR2016-01131 through Motions for Joinder under 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b).  Administrative Patent Judges Sheridan K. Snedden (author), Tina E. Hulse, and Christopher G. Paulraj issued decisions instituting inter partes review of whether claims 1–10, 12–14, 16–20, 22, and 23 are obvious over Ding '979 and Sall; claims 11 and 21 are obvious over Ding '979, Sall, and Acheampong; and claim 15 is obvious over Ding '979, Sall, Acheampong, and Glonek.  The Judges also ordered the cases joined and administratively terminated under 37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be made in IPR2016-01131.  View the decisions here (IPR2017-00585) and here (IPR2017-00600).

Related Matters:  According to the petition, the '048 patent is involved in the following litigations: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455 (E.D. Tex.); Allergan, Inc., v. Innopharma, Inc. et al., No. 2:15cv1504 (E.D. Tex.); and Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.).  Also, the '048 patent was the subject of IPR2015-01284 (Petitioners Apotex Corp. and Apotex Inc.; filed 06/04/2015; terminated through settlement 12/16/2015).  Inter partes review petitions to related patents include IPR2016-01127 (U.S. Patent No. 8,685,930 B2); IPR2016-01128 (U.S. Patent No. 8,629,111 B2); IPR2016-01129 (U.S. Patent No. 8,642,556 B2); IPR2016-01130 (U.S. Patent No. 8,633,162 B2); and IPR2016-01132 (U.S. Patent No. 9,248,191 B2).

Fisher & Paykel Healthcare Ltd. v. Resmed Ltd.

PTAB Petition:  IPR2017-00062; filed October 12, 2016.

PTAB Trial Instituted; entered March 31, 2017.

Patent at Issue:  U.S. Patent No. 9,119,931 ("Mask system," issued September 1, 2015) claims a mask system, comprising: (i) a shroud module; and (ii) a cushion module; wherein the shroud module includes a second opening positioned to align with a frame opening of the frame leading to the breathing chamber.

Petitioner Fisher & Paykel Healthcare Ltd. is challenging the '931 patent on five grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Richard E. Rice, Barry L. Grossman (author), and James J. Mayberry issued a decision instituting inter partes review of whether claims 57, 58, 61, 68, 69, 71, and 77–79 are obvious in view of D'Souza, Ultra Mirage, Barnett, and Matula-II; claim 60 is obvious in view of D'Souza Ultra Mirage, Barnett, Matula-II, and FlexiFit; claims 62–64 are obvious in view of D'Souza, Ultra Mirage, Barnett, Matula-II, FlexiFit, and Gunaratnam-II; and claims 43, 48–50, and 70 are obvious in view of D'Souza, Ultra Mirage, FlexiFit, Barnett, Jaffre, and Matula-II.

Related Matters:  According to the petition, the '931 patent is involved in U.S. International Trade Commission Investigation No. 337–TA–1022.  The '196 patent is also the subject of the following litigation: Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv- 02068 (S.D. Cal.).  Petitioner concurrently filed three additional petitions for inter partes review of the '931 Patent.  See IPR2017-00061 (filed 10/12/2016; instituted 03/23/2017), IPR2017-00064 (filed 10/12/2016; denied 04/11/2017), and IPR2017-00065 (filed 10/12/2016; denied 04/11/2017).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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