PTAB Life Sciences Report - January 2018

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

Micro Labs Ltd. v. Santen Pharmaceutical Co.

PTAB Petition:  IPR2017-01434; filed May 12, 2017.

Institution of Inter Partes Review; entered November 29, 2017.

Patent at Issue:  U.S. Patent No. 5,886,035 ("Difluoroprostaglandin derivatives and their use," issued March 23, 1999) claims a fluorine-containing prostaglandin derivative of formula (1) or a salt thereof.

Petitioners Micro Labs Ltd. and Micro Labs USA Inc. are challenging the '035 patent on two grounds as obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Lora M. Green, Jo-Anne M. Kokoski (author), and Christopher G. Paulraj issued a decision instituting inter partes review of whether claims 1-14 are unpatentable under 35 U.S.C. § 103(a) over Klimko, Kishi, and Ueno; and whether claims 1-14 are unpatentable under 35 U.S.C. § 103(a) over Klimko, Kishi, Bezuglov 1982 and/or Bezuglov 1986, and Ueno.

Related Matters:  According to the petition, the '035 patent is the subject of the following litigations:  Santen Pharmaceutical Co., Ltd. v. Micro Labs Ltd., Case No. 16-cv-00353 (D. Del. 2016), and Santen Pharmaceutical Co., Ltd. v. Sandoz Inc., Case No. 16-cv-00354 (D. Del. 2016).

Samsung Bioepis Co., Ltd. v. Genentech, Inc.

PTAB Petition:  IPR2018-00192; filed November 30, 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 in said human patient, without increase in overall severe adverse events.

Petitioner Samsung Bioepis Co. is challenging the '441 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

Related Matters:  According to the petition, the European counterpart of '441 patent, EP 1,037,926, was invalidated and revoked as lacking inventive step in two proceedings:  (1) Hospira UK, Ltd. v. Genentech, Inc., No. HP-2014-000034, [2015] EWHC (HC) 1796 (Pat), (Jun. 24, 2015) (Ex. 1003), aff’d Hospira UK, Ltd. v. Genentech, Inc., No. A3 2015 3238, [2016] EWCA Civ 1185 (Nov. 30, 2016) (Ex. 1021); and (2) Decision to Revoke European Patent EP 1,037,926, Application No. 98,963,840.8 (Jun. 13, 2016) (Ex. 1020).

Petitioner has identified several other inter partes review petitions on the '441 patent, including:  IPR2017-0073 (Hospira Inc.; U.S. Patent No. 7,846,441; filed 01/20/2017; denied 07/27/2017; instituted following request for rehearing 10/26/2017; pending); IPR2017-01121 (Celltrion, Inc.; U.S. Patent No. 7,846,441; filed 03/21/2017; Instituted 10/04/2017; pending); IPR2018-00016 (Pfizer Inc.; U.S. Patent No. 7,846,441; filed 10/03/2017; pending).  The Peition also identifies inter partes review petitions IPR2017-00737 (Hospira Inc.; U.S. Patent No. 7,892,549; filed 01/20/2017; instituted 07/27/2017; pending); IPR2017-00739 (Hospira Inc.; U.S. Patent No. 7,892,549; filed 01/20/2017; denied 07/27/2017); IPR2017-01122 (Celltrion Inc.; U.S. Patent No. 7,892,549; filed 03/21/2017; instituted 10/04/2017; pending); and IPR2017-01960 (Samsung Bioepis; U.S. Patent No. 7,892,549; filed 08/25/2017; pending).

Trans Ova Genetics, LC. v. XY, LLC

PTAB Petition:  IPR2018-00247; filed November 30, 2017.

Patent at Issue:  U.S. Patent No. 7,723,116 ("Apparatus, methods and processes for sorting particles and for providing sex-sorted animal sperm," issued May 25, 2010) claims a method of flow cytometry sperm processing.

Petitioner Trans Ova Genetics, LCC is challenging the '116 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 '116 patent is the subject of the following litigation:  XY, LLC et al. v. Trans Ova Genetics, LC, No. 1:17-cv-00944 (D. Colo.).  Petitioner has filed a separate inter partes review petition on claims 42-59, 65-67, and 69 of the '116 patent (IPR2018-00248; filed 11/30/2017; pending).

Trans Ova Genetics, LC. v. XY, LLC

PTAB Petition:  IPR2018-00248; filed November 30, 2017.

Patent at Issue:  U.S. Patent No. 7,723,116 ("Apparatus, methods and processes for sorting particles and for providing sex-sorted animal sperm," issued May 25, 2010) claims a method of flow cytometry sperm processing.

Petitioner Trans Ova Genetics, LCC is challenging the '116 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 '116 patent is the subject of the following litigation:  XY, LLC et al. v. Trans Ova Genetics, LCC, No. 1:17-cv-00944 (D. Colo.).  Petitioner has filed a separate inter partes review petition on claims 1-26, 33, 34, and 39-41 of the '116 patent (IPR2018-00247; filed 11/30/2017; pending).

Roquette Frères, S.A. v. Tate & Lyle Ingredients Americas LLC

PTAB Petition:  IPR2017-01506; filed May 30, 2017.

Institution of Inter Partes Review; entered November 30, 2017.

Patent at Issue:  U.S. Patent No. 7,608,436 ("Process for producing saccharide oligomers," issued October 27, 2009) claims a process for preparing saccharide oligomers, comprising: heating an aqueous feed composition that comprises at least one monosaccharide or linear saccharide oligomer, and that has a solids concentration of at least about 70% by weight, to a temperature of at least about 40oC.; and contacting the feed composition with at least one catalyst that accelerates the rate of cleavage or formation of glucosyl bonds for a time sufficient to cause formation of non-linear saccharide oligomers, wherein a product composition is produced that contains a higher concentration of non-linear saccharide oligomers than linear saccharide oligomers; wherein the product composition comprises non-linear saccharide oligomers having a degree of polymerization of at least three in a concentration of at least about 20% by weight on a dry solids basis.

Petitioners Roquette Frères, S.A. are challenging the '436 patent on eight grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 3, and 5) or obvious under 35 U.S.C. § 103(a) (grounds 2, 4, and 6-8).  View the petition here.  Administrative Patent Judges Lora M. Green, Grace Karaffa Obermann (author), and Jacqueline T. Harlow issued a decision instituting inter partes review of whether claims 1-4, 15-18, 23-29, 31, and 32 are anticipated under 35 U.S.C. § 102(b) by Shah; whether claims 1-4, 15-18, 23-29, 31, and 32 are unpatentable under 35 U.S.C. § 103(a) over Shah and Craig; and whether claims 1-4, 15-18, 23-29, 31, and 32 are unpatentable under 35 U.S.C. § 103(a) over Shah, Craig, and Cleland.

Related Matters:  According to the petition, the Petitioner concurrently filed a petition for inter partes review of related patent U.S. Patent No. 8,057,840 (IPR2017-01507; filed 05/30/2017; institution denied 11/30/2017).

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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