PTAB Life Sciences Report -- Part III

By John Cravero, Richard Martin
McDonnell Boehnen Hulbert & Berghoff LLP

Dec 23, 2016

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

Sienna Biopharmaceuticals, Inc. v. Rice University

PTAB Petition: IPR2017-00046; filed October 7, 2016.

Patent at Issue: U.S. Patent No. 6,685,730 ("Optically-absorbing nanoparticles for enhanced tissue repair," issued February 3, 2004) claims methods involving localized induction of hyperthermia in tissue or materials by delivering nanoparticles to the tissue or materials and exposing the nanoparticles to an excitation source under conditions wherein they emit heat and the use thereof for the repair of tissue.

Petitioner Sienna Biopharmaceuticals, Inc. is challenging the '730 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 2, and 3) or obviousness under 35 U.S.C. § 103(a) (grounds 4, 5, and 6). View the petition here.

Related Matters: According to the petition, the '730 patent is not involved in any litigation or administrative proceeding.

Merck Sharp & Dohme Corp. v. Genentech, Inc. and City of Hope

PTAB Petition: IPR2017-00047; filed October 11, 2016.

Patent at Issue: U.S. Patent No. 6,331,415 ("Methods of producing immunoglobulins, vectors and transformed host cells for use therein," issued December 18, 2001) claims a process for producing an immunoglobulin or an immunologically functional immunoglobulin fragment containing at least the variable domains of the immunoglobulin heavy and light chains. The processes can use one or more vectors which produce both the heavy and light chains or fragments thereof in a single cell.

Petitioner Merck Sharp & Dohme Corp. is challenging the '415 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 '415 patent is involved IPR2015-01624 (Sanofi-Aventis US LLC v. Genentech, Inc. and City of Hope; Petitioners Sanofi-Aventis US LLC; filed on 07/27/2015; instituted on 02/05/2016; and terminated 09/02/2016 through settlement). The petition also indicates that the '415 patent is involved in IPR2016-00383 (Petitioner Genzyme Corporation; filed on 12/30/2015; Institution denied 06/23/2016); IPR2016-00460 (Petitioner Genzyme Corp.; filed on 01/15/2016; Instituted 06/08/2016; terminated 09/02/2016); IPR2016-00710 (Petitioner Mylan Pharmaceuticals Inc.; filed on 03/03/2016; Instituted 09/08/2016; pending); and IPR2016-01373 (Petitioner Merck Sharp & Dohme Corp.; filed on 07/07/2016; pending).

Thermo Fisher Scientific Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2017-00054; filed October 14, 2016.

Patent at Issue: U.S. Patent No. 8,236,504 ("Systems and methods for fluorescence detection with a movable detection module," issued August 7, 2012) claims a fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler and methods of use are provided. In one embodiment, the apparatus includes a support structure attachable to the thermal cycler and a detection module movably mountable on the support structure.

Petitioner Thermo Fisher Scientific Inc. is challenging the '504 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 3, 4, and 5). View the petition here.

Related Matters: According to the petition, the '504 patent is involved in litigation in the District of Delaware, captioned Bio-Rad Labs, Inc. v. Thermo Fisher Scientific Inc., C.A. No. 16-358.

Thermo Fisher Scientific Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2017-00055; filed October 14, 2016.

Petitioner Thermo Fisher Scientific Inc. is challenging the '504 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 '504 patent is involved in litigation in the District of Delaware, captioned Bio-Rad Labs, Inc. v. Thermo Fisher Scientific Inc., C.A. No. 16-358.

OSI Pharmaceuticals, LLC. and Genentech, Inc. v. Arch Development Corp. and Dana-Farber Cancer Institute, Inc.

PTAB Petition: IPR2016-01034; filed May 13, 2016.

PTAB Trial Instituted Document filed October 18, 2016.

Patent at Issue: U.S. Patent No. 7,838,512 ("DNA damaging agents in combination with tyrosine kinase inhibitors," issued November 23, 2010) claims a method of improving chemotherapeutic intervention in a patient comprising: (a) administering a DNA damaging agent to the patient; (b) administering a therapeutically effective amount of a low molecular weight tyrosine kinase inhibitor to the patient, wherein the low molecular weight inhibitor binds intracellularly to inhibit the activity of more than one tyrosine kinase protein, and wherein the agent and the inhibitor act in combination by effecting a series of intracellular events to enhance cell death, thereby improving chemotherapeutic intervention.

Petitioners OSI Pharmaceuticals, LLC. and Genentech, Inc are challenging the '512 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney, Lora M. Green, and Robert A. Pollock (author), issued a decision instituting review of claims 1–3, 5, and 6 of the '512 patent under 35 U.S.C. § 103(b) as being obvious over the combination of Honma, the knowledge of a person of ordinary skill in the art, Honma 1992, and McGahon; and claims 1–3, 5, and 6 of the '512 patent under 35 U.S.C. § 103(b) as being obvious over the combination of Akinaga, the knowledge of a person of ordinary skill in the art, Seynaeve, Tam, and Friedman.

Related Matters: According to the petition, the '512 patent is the subject of litigation in the Northern District of Illinois captioned Arch Development Corp. et al. v. Genentech, Inc. et al., No. 1:15-cv-6597.

General Electric Co. v. University of Virginia Patent Foundation

PTAB Petition: IPR2017-00109; filed October 19, 2016.

Patent at Issue: U.S. Patent No. RE45,725 ("Method and apparatus for spin-echo-train MR imaging using prescribed signal evolutions," issued October 6, 2015) claims a magnetic resonance imaging "MRI" method and apparatus for lengthening the usable echo-train duration and reducing the power deposition for imaging.

Petitioner General Electric Co. is challenging the '725 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 3, and 4). View the petition here.

Related Matters: According to the petition, the '725 patent is involved in litigation in the Western District of Virginia, captioned UVAPF v. General Electric Co., No. 3:14-cv-00051-nkm. The petition also indicates that the '725 patent is a continuation of U.S. Patent No. RE44,644 which is involved in IPR2016-00357 (Petitioner General Electric Co.; filed on 12/16/2015; instituted 06/22/2016); IPR2016-00358 (Petitioner General Electric Co.; filed on 12/16/2015; instituted 06/23/2016); and IPR2016-00359 (Petitioner General Electric Co.; filed on 12/16/2015; instituted 06/24/2016).

Smith & Nephew, Inc. v. Conformis, Inc.

PTAB Petition: IPR2017-00115; filed October 20, 2016.

Patent at Issue: U.S. Patent No. 9,216,025 ("Joint arthroplasty devices and surgical tools," issued December 22, 2015) claims a surgical system including an articular repair system and a patient-specific surgical tool for use in surgically repairing a joint of a patient.

Petitioner Smith & Nephew, Inc. is challenging the '025 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 '025 patent is involved in litigation in the District of Massachusetts, captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No. 1:16-cv-10420-IT.

Aurobindo Pharma USA, Inc. v. AstraZeneca AB

PTAB Petition: IPR2016-01117; filed June 2, 2016.

PTAB Trial Instituted Document filed October 21, 2016.

Patent at Issue: U.S. Patent No. RE44,186 ("Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method," issued April 30, 2013) claims compounds said to inhibit the enzyme dipeptidyl peptidase IV.

Petitioner Aurobindo Pharma USA, Inc. is challenging the '186 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney, Rama G. Elluru (author), and Christopher G. Paulraj issued a decision instituting review of claims 1, 2, 4, 6–11, 25–28, 32–35, and 40 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag and Hanessian; claims 12-16, 29, 30, 36, 37, 41 and 42 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag, Hanessian, Bachovchin and the GLUCOPHAGE Label; claims 12, 17, 18 and 22 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag, Hanessian, Bachovchin and the XENICAL Label; and claims 12 and 19-21 of the '186 patent as being obvious under 35 U.S.C. § 103(a) over Ashworth, Villhauer, Raag, Hanessian, Bachovchin and the MEVACOR Label. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2015-01340 (Mylan Pharms., Inc. v. AstraZeneca AB, LLC , Mylan Pharms., Inc.; filed 06/04/2015; instituted 05/02/2016), adding Aurobindo as a petitioner to IPR2015-01340 and terminating IPR2016-01117 under 37 C.F.R. § 42.72.

Related Matters: According to the petition, the '186 patent is the subject of several litigations, including AstraZeneca AB v. Mylan Pharmaceuticals Inc., 14- cv-00696 (D. Del. 2014); AstraZeneca AB v. Mylan Pharms. Inc., 14-cv-00094 (D.W. Va. 2014); AstraZeneca AB v. Aurobindo Pharma Ltd. et al., 14-cv-014696 and 14-cv-00664 (D. Del. 2014); AstraZeneca AB v. Actavis Labs. FL, Inc., 14-cv-01356 (D. Del. 2014); AstraZeneca AB v. Watson Labs. Inc., 14-cv-01051 (D. Del. 2014); AstraZeneca AB v. Sun Pharma Global FZE et al., 14-cv-00694 (D. Del. 2014); AstraZeneca AB v. Amneal Pharms. LLC., 14-cv-00697 (D. Del. 2014); and AstraZeneca AB v. Wockhardt Bio AG et al., 14-cv-00696 (D. Del. 2014). The '186 patent also has been challenged in the following instituted inter partes reviews IPR2015-01340 (Mylan Pharms., Inc. v. AstraZeneca AB, LLC, Mylan Pharms., Inc.; filed 06/04/2015; Instituted 05/02/2016); IPR2016-01122 (Teva Pharmaceuticals USA, Inc. v. AstraZeneca AB, LLC, Teva Pharms., Inc. filed 06/01/2016; joined to IPR2016-01122 09/23/2016); and IPR2016-01209 (Wockhardt BIO AG v. AstraZeneca AB, LLC, Wockhardt BIO AG, filed 05/11/2016; joined to IPR2016-01122 08/23/2016).

Alembic Pharmaceuticals, Ltd. v. Research Corp. Technologies, Inc.

PTAB Petition: IPR2016-01101; filed May 25, 2016.

PTAB Petition: IPR2016-01242; filed June 21, 2016.

PTAB Petition: IPR2016-01245; filed June 22, 2016.

PTAB Trial Instituted Document filed October 24, 2016.

Patent at Issue: U.S. Patent No. RE38,551 ("Anticonvulsant enantiomeric amino acid derivatives," issued July 6, 2004) claims compounds in the R configuration about the asymmetric carbon and pharmaceutical compositions containing same and the use of such compounds in treating CNS disorders in animals.

Petitioners, Mylan Pharmaceuticals (IPR2016-01101), Breckenridge Pharmaceutical, Inc. (IPR2016-01242), and Alembic Pharmaceuticals, Ltd. (IPR2016-01245), are challenging the '551 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 3, and 4). View the petition for IPR2016-0110here, the petition for IPR2016-01242here, and the petition for IPR2016-01245 here. Administrative Patent Judges Francisco C. Prats, Jacqueline Wright Bonilla (author), and Christopher G. Paulraj issued a decision instituting review of claims 1-9 as being obvious under 35 U.S.C. § 103(a) over Kohn 1991 and Silverman; and claims 10-13 as obvious under 35 U.S.C. § 103(a) over Kohn 1991, Silverman, and the '729 patent. The panel also grants Petitioners' Motions under 37 C.F.R. § 42.122 for Joinder to IPR2016-00204 (Argentum Pharmaceuticals LLC. v. Research Corporation Technologies, Inc., Argentum Pharmaceuticals, LLC; filed 06/04/2015; instituted 05/02/2016), adding Mylan, Breckenridge, and Alembic as petitioners to IPR2015-01340 and terminating IPR2016-01101, IPR2016-01242, and IPR2016-01245 under 37 C.F.R. § 42.72.

Related Matters: According to the petitions, the '551 patent is the subject of several litigations, most of which have been consolidated with UCB, Inc. v. Accord Healthcare Inc., 1:13-cv-01206 (D. Del. Jul. 10, 2013). IPR2014-01126 (Petitioner Actavis, Inc.; filed 07/10/2014; denied 01/09/2015) is also identified as a related matter where a panel previously denied inter partes review challenging the same claims (1-13) of the '551 patent.