PTAB Life Sciences Report -- December 2016 #2

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

Dec 20, 2016

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

Apotex Inc. and Apotex Corp. v. Alcon Research, Ltd.

PTAB Petition: IPR2016-01640; filed August 18, 2016.

PTAB Trial Instituted Document filed October 5, 2016.

Patent at Issue: U.S. Patent No. 8,791,154 ("High concentration olopatadine ophthalmic composition," issued July 29, 2014) claims an ophthalmic aqueous solution containing relatively high concentrations of olopatadine solubilized within the solution where the composition is preferably capable of providing enhanced relief from symptoms of ocular allergic conjunctivitis, particularly late phase symptoms of ocular allergic conjunctivitis.

Petitioners Apotex Inc. and Apotex Corp. are challenging the '154 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Jennifer Meyer Chagnon, Christopher M. Kaiser (author), and Christopher G. Paulraj issued a decision instituting review of claims 1–4, 8, 12, 13, 21, and 22 as obvious under 35 U.S.C. § 103(a) over Bhowmick, Yanni, and Castillo; and claims 1–4, 8, 12, 13, 21, and 22 as obvious under 35 U.S.C. § 103(a) over Schneider, Hayakawa, Bhowmick, and Castillo. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00544 (Argentum Pharmaceuticals v. Alcon Research, Ltd, Argentum Pharmaceuticals; filed 02/02/2016; Instituted 07/18/2016), adding Apotex Inc. and Apotex Corp. as petitioners to IPR2016-00544 and terminating IPR2016-01640 under 37 C.F.R. § 42.72.

Related Matters: According to the petition, the '154 patent is the subject of two litigations in the District of Delaware captioned Alcon Research, Ltd. v. Watson Laboratories, Inc., Case No. 1-15-cv-01159-SLR, and Alcon Research, Ltd. v. Lupin Ltd., Case No. 1-16-cv-00195.

ABS Global, Inc. v. Inguran, LLC

PTAB Petition: IPR2016-000927; filed April 21, 2016.

PTAB Trial Instituted Document filed October 5, 2016.

Patent at Issue: U.S. Patent No. 8,198,092 ("Digital sampling apparatus and methods for sorting particles," issued June 12, 2012) claims a system and method for sorting a mixture of stained particles including a digital signal processor for analyzing and classifying the digital information generated from the particles and providing a sorting signal to a sorting system as a function of the analyzed and classified digital information.

Petitioner ABS Global, Inc. is challenging the '092 patent on three grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Grace Karaffa Obermann, Kristina M. Kalan (author), and Christopher M. Kaiser issued a decision instituting review of claims 1–3, 5–9, 11–13, 16, 18–19, 21, 28, 32, 40–41, and 43–46 as obvious under 35 U.S.C. § 103 over Godavarti and Leary; claims 4, 26–27, 42, and 49 as obvious under 35 U.S.C. § 103 over Godavarti, Leary, and Johnson; and claim 10 as obvious under 35 U.S.C. § 103 over Godavarti, Leary, and Piper.

Related Matters: According to the petition, the '092 patent is involved in litigation in the Western District of Wisconsin captioned ABS Global, Inc. v. Inguran, LLC, Case No. 3:14-cv-00503-wmc.

Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC. v. Eli Lilly & Company

PTAB Petition: IPR2016-01341; filed July 1, 2016.

PTAB Trial Instituted Document filed October 6, 2016.

Patent at Issue: U.S. Patent No. 7,772,209 ("Antifolate combination therapies," issued August 10, 2010) claims a method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent.

Petitioners Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC are challenging the '209 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1–22 as obvious under 35 U.S.C. § 103(a) over Niyikiza in view of U.S. Patent No. 5,217,974, and in further view of European Patent Application No. 0,595,005 A1. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00237 (Neptune Generics, LLC. v. Eli Lilly & Compnay, Petitioners GKC General Partner II, LLC; GKC Partners II, LLC; Gerchen Keller Capital, LLC; and Neptune Generics, LLC; filed 11/24/2015; Instituted 06/03/2016), adding Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC as petitioners to IPR2016-00237, and terminating IPR2016-01341 under 37 C.F.R. § 42.72.

Related Matters: According to the petition, the '209 patent is the subject of litigation in the Southern District of Indiana, including Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Case No. 1:10-cv-1376.

The '209 patent also has been challenged in the following instituted inter partes reviews: IPR2016-00237 and IPR2016-00240 by Neptune and IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-01190 (Apotex) and IPR2016-01335 (Wockhardt) seek to join IPR2016-00237. Also, IPR2016-01191 (Apotex), IPR2016-01337 (Wockhardt), and IPR2016-01343 (Teva) seek to join IPR2016-00240. Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt), and IPR2016-01340 (Teva) seek to join IPR2016-00318.

Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC. v. Eli Lilly & Company

PTAB Petition: IPR2016-01343; filed July 1, 2016.

PTAB Trial Instituted Document filed October 6, 2016.

Petitioners Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC are challenging the '209 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1–22 as obvious under 35 U.S.C. § 103(a) over Niyikiza in view of U.S. Patent No. 5,217,974, and in further view of European Patent Application No. 0,595,005 A1. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00240 (Neptune Generics, LLC. v. Eli Lilly & Compnay, Petitioners GKC General Partner II, LLC; GKC Partners II, LLC; Gerchen Keller Capital, LLC; and Neptune Generics, LLC; filed 11/24/2015; Instituted 06/03/2016), adding Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC as petitioners to IPR2016-00240, and terminating IPR2016-01343 under 37 C.F.R. § 42.72.

The '209 patent also has been challenged in the following instituted inter partes reviews: IPR2016-00237 and IPR2016-00240 by Neptune and IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-001191 (Apotex) and IPR2016-01337 (Wockhardt) seek to join IPR2016-00240. Also, IPR2016-01190 (Apotex), IPR2016-01335 (Wockhardt), and IPR2016-01341 (Teva) seek to join IPR2016-00237. Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt), and IPR2016-01340 (Teva) seek to join IPR2016-00318.

Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC. v. Eli Lilly & Company

PTAB Petition: IPR2016-01340; filed July 1, 2016.

PTAB Trial Instituted Document filed October 6, 2016.

Petitioners Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC are challenging the '209 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1–22 as obvious under 35 U.S.C. § 103(a) over Niyikiza in view of U.S. Patent No. 5,217,974, and in further view of European Patent Application No. 0,595,005 A1. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00318 (Sandoz Inc. v. Eli Lilly & Compnay, Sandoz; filed 12/14/2015; Instituted 06/16/2016), adding Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC as petitioners to IPR2016-00318 and terminating IPR2016-01340 under 37 C.F.R. § 42.72.

The '209 patent also has been challenged in the following instituted inter partes reviews: IPR2016-00237 and IPR2016-00240 by Neptune Generics, LLC and IPR2016-00318 by Sandoz. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-01393 (Wockhardt) and IPR2016-01429 (Apotex et al.) seek to join IPR2016-00318. Also, IPR2016-01190 (Apotex), IPR2016-01335 (Wockhardt), and IPR2016-01341 (Teva) seek to join IPR2016-00237. Additionally, IPR2016-01191 (Apotex), IPR2016-01337 (Wockhardt), and IPR2016-01343 (Teva) seek to join IPR2016-00240.

Minerva Surgical, Inc. v. Hologic, Inc.

PTAB Petition: IPR2016-00868; filed April 11, 2016.

PTAB Trial Instituted Document filed October 6, 2016.

Patent at Issue: U.S. Patent No. 6,872,183 ("System and method for detecting perforations in a body cavity," issued March 29, 2005) claims a method and system for detecting perforations in a body cavity, where a fluid (liquid or gas) is delivered into a body cavity to slightly pressurize the cavity. A pressure sensing system monitors the pressure within the cavity for a predetermined test period. If cavity pressure is not substantially sustained during the test period, the physician is alerted to further assess the cavity for perforations before initiating treatment within the cavity.

Petitioner Minerva Surgical, Inc. is challenging the '183 patent on seven grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Meredith C. Petravick (author), Mitchell G. Weatherly, and Timothy J. Goodson issued a decision instituting review of claims 1, 4, 6, 7, 9, 11–13, and 15 as obvious under 35 U.S.C. § 103 over Masterson and Bolduc; claim 14 as obvious under 35 U.S.C. § 103 over Masterson, Bolduc, and Isaacson; claim 5 as obvious under 35 U.S.C. § 103 over Masterson, Bolduc, and Himmelstein; claims 8 and 10 as obvious under 35 U.S.C. § 103 over Masterson, Bolduc, and Benaron; claims 1–4, 6, 7, 9, and 11–15 as obvious under 35 U.S.C. § 103 over Isaacson and Goldrath; claim 5 as obvious under 35 U.S.C. § 103 over Isaacson, Goldrath, and Himmelstein; and claims 8 and 10 as obvious under 35 U.S.C. § 103 over Isaacson, Goldrath, and Benaron.

Related Matters: According to the petition, the '183 patent is the subject of litigation in the District of Delaware captioned Hologic, Inc. v. Minerva Surgical, Inc., Case No. 1:15-cv-01031-SLR.

Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GmbH

PTAB Petition: IPR2017-00041; filed October 7, 2016

Patent at Issue: U.S. Patent No. 7,157,456 ("Substituted oxazolidinones and their use in the field of blood coagulation," issued January 27, 2007) claims oxazolidinone derivatives, the processes for their preparation and the use of such oxazolidinone derivatives as active compounds in medicaments.

Petitioner Mylan Pharmaceuticals, Inc. is challenging the '456 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 '456 patent is involved in litigation in the District of Delaware, captioned Bayer Intellectual Property GmbH et al v. Aurobindo Pharma Limited et al, 1:15-cv-00902-SLR; Bayer GmbH v. Breckenridge Pharmaceutical, Inc., 1:16-cv-00628, District of Delaware; and Bayer GmbH v. InvaGen Pharmaceutical Inc., 1:16-cv-00064, in the District of Delaware. 

Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GmbH

PTAB Petition: IPR2017-00042; filed October 7, 2016

Patent at Issue: U.S. Patent No. 7,585,860 ("Substituted oxazolidinones and their use in the field of blood coagulation," issued September 8, 2009) claims oxazolidinone derivatives, the processes for their preparation and the use of such oxazolidinone derivatives as active compounds in medicaments.

Petitioner Mylan Pharmaceuticals, Inc. is challenging the '860 patent on one ground as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '860 patent is involved in litigation in the District of Delaware, captioned Bayer Intellectual Property GmbH et al v. Aurobindo Pharma Limited et al, 1:15-cv-00902-SLR; Bayer GmbH v. Breckenridge Pharmaceutical, Inc., 1:16-cv-00628, District of Delaware; and Bayer GmbH v. InvaGen Pharmaceutical Inc., 1:16-cv-00064, District of Delaware. 

Sienna Biopharmaceuticals, Inc. v. Rice University

PTAB Petition: IPR2017-00045; filed October 7, 2016

Patent at Issue: U.S. Patent No. 6,530,944 ("Optically-active nanoparticles for use in therapeutic and diagnostic methods," issued March 11, 2003) claims a method for inducing localized hyperthermia in a cell or tissue comprising the steps of delivering nanoparticles to said cell or tissue and exposing said nanoparticles to infrared radiation under conditions wherein said nanoparticles emit heat upon exposure to said infrared radiation.

Petitioner Sienna Biopharmaceuticals, Inc. is challenging the '944 patent on seven grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 2, 3, and 4) or obviousness under 35 U.S.C. § 103(a) (grounds 5, 6, and 7). View the petition here.

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