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

Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH

PTAB Petition:  IPR2017-01526; filed June 5, 2017.

Institution of Inter Partes Review; entered December 13, 2017.

Patent at Issue:  U.S. Patent No. 7,476,652 ("Acidic insulin preparations having improved stability," issued January 13, 2009) claims a pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from polysorbate 20 and polysorbate 80; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

Petitioners Mylan N.V., Biocon Research Ltd., and Biocon Ltd. are challenging the '652 patent on six grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Erica A. Franklin, Robert A. Pollock, and Michelle N. Ankenbrand (author) issued a decision instituting inter partes review of whether claims 1–25 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Lougheed; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and FASS; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Grau; claims 1–25 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Lougheed; claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and FASS; and claims 7 and 24 of the '652 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Grau.

Related Matters:  According to the petition, the '652 patent is not involved in any related proceedings.  However, the Patent Owner identified that the '652 patent is involved in the following civil litigations:  Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A. No. 1-16- cv-00812-RGA (D. Del.); Sanofi-Aventis v. Merck Sharp & Dohme Corp., C.A. No. 2-17-cv-05914 (D.N.J.).  Patent Owner also identified the following concluded litigations involving the '652 patent:  Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00113-RGA (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00884-RGA (D. Del.).  Patent Owner also identified a related inter partes review that Petitioner filed challenging U.S. Patent No. 7,713,930, which issued from a continuation application to the application that issued as the '652 patent (IPR201-01528; filed 06/05/2017; instituted 12/13/2017; pending).

Mylan Pharmaceuticals, Inc. v. Sanofi Aventis Deutschland GmbH

PTAB Petition:  IPR2017-01528; filed June 5, 2017.

Institution of Inter Partes Review; entered December 13, 2017.

Patent at Issue:  U.S. Patent No. 7,713,930 ("Acidic insulin preparations having improved stability," issued May 11, 2010) claims a pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from esters and ethers of polyhydric alcohols; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

Petitioners Mylan N.V., Biocon Research Ltd., and Biocon Ltd. are challenging the '930 patent on eight grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Erica A. Franklin, Robert A. Pollock, and Michelle N. Ankenbrand (author) issued a decision instituting inter partes review of whether claims 1–20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Lougheed; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and FASS; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label and Grau; claim 19 of the '930 patent is unpatentable under 35 U.S.C. § 103 over the combination of Lantus Label, FASS or Grau, and Lougheed; claims 1–20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Lougheed; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and FASS; claims 1–18 and 20 of the '930 patent are unpatentable under 35 U.S.C. § 103 over the combination of Owens and Grau; and claim 19 of the '930 patent is unpatentable under 35 U.S.C. § 103 over the combination of Owens, FASS or Grau, and Lougheed.

Related Matters:  According to the petition, the '930 patent is not involved in any related proceedings.  However, the Patent Owner identified that the '930 patent is involved in the following civil litigations:  Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., C.A. No. 1-16- cv-00812-RGA (D. Del.); Sanofi-Aventis v. Merck Sharp & Dohme Corp., C.A. No. 2-17-cv-05914 (D.N.J.).  Patent Owner also identified the following concluded litigations involving the '930 patent:  Sanofi-Avent0s U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00113-RGA (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., C.A. No. 1-14-cv-00884-RGA (D. Del.).  Patent Owner also identified related inter partes review that Petitioner filed challenging U.S. Patent No. 7,476,652, which issued from a parent application to the application that issued as the '930 patent (IPR201-01526; filed 06/05/2017; instituted 12/13/2017; pending).

Pfizer, Inc. v. Biogen, Inc.

PTAB Petition:  IPR2018-00285; filed December 14, 2017.

Patent at Issue:  U.S. Patent No. 8,329,172 ("Combination therapies for B-cell lymphomas comprising administration of anti-CD20 antibody," issued February 14, 2017) claims a method of treating low grade B-cell non-Hodgkin's lymphoma in a human patient comprising administering to the patient chemotherapy consisting of CVP therapy to which the patient responds, followed by rituximab maintenance therapy, wherein the maintenance therapy comprises four weekly administrations of rituximab at a dose of 375 mg/m.sup.2 every 6 months, and wherein the maintenance therapy is provided for 2 years.

Petitioner Pfizer, Inc. is challenging the '172 patent on 2 grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, Petitioners previously filed an inter partes review petition on the '172 patent (IPR2017-01166; filed 04/21/2017; institution denied 11/13/2017; request for rehearing submitted 12/12/2017).  Petitioners also identified the following additional inter partes review challenges to the '172 patent:  IPR2015-00418 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 12/15/2014; institution denied 07/13/2015) and IPR2017-01093 (Celltrion Inc.; filed 03/15/2017; institution denied 10/06/2017).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition:  IPR2018-00300; filed December 14, 2017.

Patent at Issue:  U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on five grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '392 patent is involved in the following civil litigation:  Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.).  Additionally, the '392 patent is involved in the following ITC proceeding:  Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC).  Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00301 and IPR2018-00302; filed 12/14/2017; pending).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition:  IPR2018-00301; filed December 14, 2017.

Patent at Issue:  U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on five grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the '392 patent is involved in the following civil litigation:  Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.).  Additionally, the '392 patent is involved in the following ITC proceeding:  Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC).  Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00300 and IPR2018-00302; filed 12/14/2017; pending).

10X Genomics, Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition:  IPR2018-00302; filed December 14, 2017.

Patent at Issue:  U.S. Patent No. 9,216,392 ("System for forming an array of emulsions," issued December 22, 2015) claims a ystem for forming an array of emulsions, comprising: a plate including an array of emulsion production units, each unit including at least one first input well to hold a continuous phase for an emulsion, a second input well to hold a dispersed phase for an emulsion, and an output well connected to the first and second input wells by a set of channels that form a channel junction, the set of channels including at least two input channels extending separately from the input wells to the channel junction and an output channel extending from the channel junction to the output well, each channel of the set of channels being circumferentially bounded; and a vacuum or pressure source configured to be connected operatively to wells of the plate to form a pressure drop between the input wells and the output well of each unit to drive the continuous phase and the dispersed phase from the first and second input wells of the unit to the channel junction, at which droplets of the dispersed phase are generated, and through the output channel for collection in the output well of the unit.

Petitioner 10X Genomics, Inc. is challenging the '392 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here. 

Related Matters:  According to the petition, the '392 patent is involved in the following civil litigation:  Bio-Rad Laboratories, Inc., et al. v. 10X Genomics, Inc., Case No. 3:17-CV-4339 (N.D. Cal.).  Additionally, the '392 patent is involved in the following ITC proceeding:  Re: Certain Microfluidic Devices, Investigation Number 337-TA-1068 (ITC).  Petitioners concurrently filed two additional inter partes review petitions challenging claims 1-21 of the '392 patent (IPR2018-00300 and IPR2018-00301; filed 12/14/2017; pending).

Becton, Dickinson and Company v. B. Braun Melsungen AG

PTAB Petition:  IPR2017-01586; filed June 16, 2017.

Institution of Inter Partes Review; entered December 15, 2017.

Patent at Issue:  U.S. Patent No. 8,328,762 ("Catheter insertion device," issued December 11, 2012) claims a embodiments of a catheter insertion device.

Petitioner Becton, Dickinson and Company is challenging the '762 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Scott A. Daniels (author), Michael L. Woods, and Robert L. Kinder issued a decision instituting inter partes review of whether claims 18 and 22 are unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten; whether claim 25 is unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten and Lynn; and whether claim 22 is unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten and Tauschinski.

Related Matters:  According to the petition, the '762 patent is the subject of the following civil litigation:  B. Braun Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D. Del.).  Petitioner also filed petitions for inter partes review in related U.S. Patent Nos. 9,149,626 (IPR2017-01587; filed 06/16/2017; instituted 12/15/2017; pending); 8,333,735 (IPR2017-01583; filed 06/16/2017; institution denied 11/29/2017); 8,337,463 (IPR2017-01585; filed 06/16/2017; institution denied 12/15/2017); 8,540,728 (IPR2017-01584; filed 06/16/2017; institution denied 11/29/2017); 8,597,249 (IPR2017-01589; filed 06/16/2017; instituted 01/12/2018; pending); 8,460,247 (IPR2017-01588; filed 06/16/2017; instituted 12/21/2017; pending); and 9,370,641 (IPR2017-01590; filed 06/16/2017; instituted 01/11/2018; pending).

Becton, Dickinson and Company v. B. Braun Melsungen AG

PTAB Petition:  IPR2017-01587; filed June 16, 2017.

Institution of Inter Partes Review; entered December 15, 2017.

Patent at Issue:  U.S. Patent No. 9,149,626 ("Catheter insertion device," issued October 6, 2015) claims a embodiments of a catheter insertion device.

Petitioner Becton, Dickinson and Company is challenging the '626 patent on four grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Scott A. Daniels, Michael L. Woods, and Robert L. Kinder (author) issued a decision instituting inter partes review of whether claims 11 and 20 are unpatentable under 35 U.S.C. § 102(b) as obvious over Van Heugten.

Related Matters:  According to the petition, the '626 patent is the subject of the following civil litigation:  B. Braun Melsungen AG et al. v. Becton, Dickinson & Co. et al., No. 1:16-cv-00411 (D. Del.).  Petitioner also filed petitions for inter partes review in related U.S. Patent Nos. 8,328,762 (IPR2017-01586; filed 06/16/2017; instituted 12/15/2017; pending); 8,333,735 (IPR2017-01583; filed 06/16/2017; institution denied 11/29/2017); 8,337,463 (IPR2017-01585; filed 06/16/2017; institution denied 12/15/2017); 8,540,728 (IPR2017-01584; filed 06/16/2017; institution denied 11/29/2017); 8,597,249 (IPR2017-01589; filed 06/16/2017; instituted 01/12/2018; pending); 8,460,247 (IPR2017-01588; filed 06/16/2017; instituted 12/21/2017; pending); and 9,370,641 (IPR2017-01590; filed 06/16/2017; instituted 01/11/2018; pending).