PTAB Life Sciences Report -- Part I December 2016

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

Dec 8, 2016

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

Mylan Pharmaceuticals Inc. v. Shire Laboratories, Inc.

PTAB Petition: IPR2017-00011; filed October 4, 2016.

Patent at Issue: U.S. Patent No. RE41,148 ("Oral pulsed dose drug delivery system," issued February 23, 2010) claims a multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component.

Petitioner Mylan Pharmaceuticals Inc. is challenging the '148 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.

Related Matters: According to the petition, the '148 patent is involved several litigation proceedings: Shire LLC v. Amerigen Pharmaceuticals Ltd., No. 1:14-cv-06095-RMB-JS (D.N.J.); Shire LLC et al v. Abhai LLC, No. 1:15-cv-13909- WGY (D. Mass.); Shire LLC v. Par Pharmaceutical, Inc. et al, No. 1-15-cv-01454 (D.N.J.); Shire LLC v. CorePharma, LLC, No. 1-14-cv-05694 (D.N.J.); Shire LLC v. Neos Therapeutics, Inc., 3-13-cv-01452 (N.D. Tex.); Shire LLC v. Watson Pharms., Inc., et al, No. 1-11-cv-02340 (S.D.N.Y.). The petition also indicates that RE 42,096, a family member of the ’148 patent, is involved in IPR2016-01033 (Petitioner Mylan Pharmaceuticals Inc.; filed on 05/12/2016; pending) and IPR2015-02009 (Petitioner Amerigen Pharmaceuticals Ltd.; filed on 10/01/2015; instituted in part, denied in part).

Fluidigm Corp. v. The Board of Trustees of the Leland Standford Junior Univ.

PTAB Petition: IPR2017-00013; filed October 4, 2016

Patent at Issue: U.S. Patent No. 7,563,584 ("Methods and compositions for detecting the activation state of multiple proteins in single cells," issued April 21, 2009) claims methods for simultaneously detecting the activation state of a plurality of proteins in single cells using flow cytometry.

Petitioner Fluidigm Corp. is challenging the '584 patent on four grounds as being obvious under 35 U.S.C. § 103(a) (grounds 1 through 4). View the petition here.

Related Matters: According to the petition, the '584 patent is not involved in any litigation or administrative proceeding.

Fluidigm Corp. v. The Board of Trustees of the Leland Standford Junior Univ.

PTAB Petition: IPR2017-00014; filed October 4, 2016

Patent at Issue: U.S. Patent No. 7,695,926 ("Methods and compositions for detecting receptor-ligand interactions in single cells," issued April 13, 2010) claims a kit for simultaneously detecting the activation state of a plurality of proteins in single cells using flow cytometry.

Petitioner Fluidigm Corp. is challenging the '926 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.

Related Matters: According to the petition, the '926 patent is not involved in any litigation or administrative proceeding.

Apotex Inc. and Apotex Corp. v. Eli Lilly & Company

PTAB Petition: IPR2016-01191; filed July 1, 2016.

PTAB Trial Instituted Document filed October 4, 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 Apotex Inc. and Apotex Corp. 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 of the '209 patent on the grounds 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 & Company, 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 Apotex Inc. and Apotex Corp as petitioners to IPR2016-00240 and terminating IPR2016-01191 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 in IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-01337 (Wockhardt) and IPR2016-01343 (Teva and Fresenius) seek to join IPR2016-00240. Also, IPR2016-01190 (Apotex), IPR2016-01335 (Wockhardt) and IPR2016-01341 (Teva and Fresenius) seek to join IPR2016-00237. Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt), and IPR2016-01340 (Teva and Fresenius) seek to join IPR2016-00318.

Apotex Inc. and Apotex Corp. v. Eli Lilly & Company

PTAB Petition: IPR2016-01429; filed July 14, 2016.

PTAB Trial Instituted Document filed October 4, 2016.

Petitioners Apotex Inc., Apotex Corp., Emcure Pharmaceuticals LTD., Heritage Pharma Labs Inc., Heritage Pharmaceuticals Inc., Glenmark Pharmaceuticals Inc., USA, Glenmark Holding SA, Glenmark Pharmaceuticals Ltd., and Mylan Laboratories Limited 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 1-20 of the '438 patent on the grounds 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 & Company, Sandoz; filed 12/14/2015; Instituted 06/16/2016), adding Apotex Inc., Apotex Corp., Emcure Pharmaceuticals LTD., Heritage Pharma Labs Inc., Heritage Pharmaceuticals Inc., Glenmark Pharmaceuticals Inc., USA, Glenmark Holding SA, Glenmark Pharmaceuticals Ltd., and Mylan Laboratories Limited as petitioners to IPR2016-00318 and terminating IPR2016-01429 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 in IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-01393 (Wockhardt) and IPR2016-01340 (Teva and Fresenius) seek to join IPR2016-00318. Also, IPR2016-01190 (Apotex Inc. and Apotex Corp.), IPR2016-01335 (Wockhardt), and IPR2016-01341 (Teva and Fresenius) seek to join IPR2016-00237. Additionally, IPR2016-01191 (Apotex Inc. and Apotex Corp.), IPR2016-01337 (Wockhardt) and IPR2016-01343 (Teva and Fresenius) seek to join IPR2016-00240.

Hologic, Inc v. Enzo Life Sciences, Inc.

PTAB Petition: IPR2016-00822; filed March 30, 2016.

PTAB Trial Instituted Document filed October 4, 2016.

Patent at Issue: U.S. Patent No. 7,064,197 ("System, array and non-porous solid support comprising fixed or immobilized nucleic acids," issued June 20, 2006) claims a non-porous solid support comprising one or more amine(s), hydroxyl(s) or epoxide(s) thereon, wherein at least one single-stranded nucleic acid is fixed or immobilized in hybridizable form to said non-porous solid support via said one or more amine(s), hydroxyl(s) or epoxide(s).

Petitioner Hologic Inc. is challenging the '197 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2–7). View the petition here. Administrative Patent Judges Michael J. Fitzpatrick (author), Zhenyu Yang, and Christopher G. Paulraj issued a decision instituting inter partes review of claims 17, 19, 25, 105, 106, 114, 116, 119, 128, 129, 150, 152, 178, 180, 186, and 187 as anticipated by Fish; claims 130, 131, 151, and 154 as obvious under 35 U.S.C. § 103(a) over Fish; claims 120 and 189 as obvious under 35 U.S.C. § 103(a) over Fish, Metzgar, and Sato; claims 113 and 185 as obvious under 35 U.S.C. § 103(a) over Fish and Gilham; claims 17, 19, 25, 105, 106, 114, 119, 120, 128, 129, 131, 150–152, 178, 180, 186, and 189 as obvious under 35 U.S.C. § 103(a) over VPK and Metzgar; and claims 113, 116, 130, 154, 185, and 187 as obvious under 35 U.S.C. § 103(a) over Noyes, VPK, Metzgar, and Ramachandran. The Decision denied institution under Ground 1 of anticipation for claim 131.

Related Matters: According to the petition, the '197 patent is the subject of several litigations: Enzo Life Sciences, Inc. v. Hologic, Inc., No. 1:15-cv-271 (D. Del.); Enzo Life Sciences, Inc. v. Siemens Healthcare Diagnostics, Inc., No. 1:12-cv-505 (D. Del.); Enzo Life Sciences, Inc. v. Affymetrix, Inc., No. 1:12-cv-433 (D. Del.); Enzo Life Sciences, Inc. v. Agilent Technologies Inc., No. 1:12-cv-434 (D. Del.); Enzo Life Sciences, Inc. v. Illumina Inc., No. 1:12-cv-435 (D. Del.); Enzo Life Sciences, Inc. v. Abbott Laboratories et al., No. 1:12-cv-274 (D. Del.); Enzo Life Sciences, Inc. v. Becton Dickinson and Company et al., No. 1:12-cv-275 (D. Del.); Enzo Life Sciences, Inc. v. Life Technologies Corp., No. 1:12-cv-105 (D. Del.); and Enzo Life Sciences, Inc. v. Roche Molecular Systems Inc. et al., No. 1:12-cv-106 (D. Del.). Petitioner has filed an additional petition to institute an inter partes review of the ’197 patent, in which it challenges other claims of the patent. See IPR2016-00820.

Hologic, Inc v. Enzo Life Sciences, Inc.

PTAB Petition: IPR2016-00820; filed March 30, 2016.

PTAB Trial Instituted Document filed October 4, 2016.

Petitioner Hologic Inc. is challenging the '197 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 4) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 3, and 5–7). View the petition here. Administrative Patent Judges Michael J. Fitzpatrick (author), Zhenyu Yang, and Christopher G. Paulraj issued a decision instituting inter partes review of claims 16, 32–34, 41, 61–63, 69, 70, 72–74, 79, 100, 191, 193, 194, 212, 213, 219, 222, 225–227, 230, 233, and 236 under 35 U.S.C. § 102(b) as anticipated by Fish; claims 31, 64, 68, 101, 192, and 195 as obvious under 35 U.S.C. § 103(a) over Fish; 38, 78, and 218 as obvious under 35 U.S.C. § 103(a) over Fish and Gilham; , 6, 8, 9, 12–15, 27, 31, 32, 34, 61–63, 68–70, 72, 74, 79, 100, 191–193, 194, 213, 219, 226, 227, and 236 as anticipated under 35 U.S.C. § 102(b) by VPK; claims 33, 41, 73, 212, 225, and 233 as obvious under 35 U.S.C. § 103(a) over VPK and Metzgar; and claims 16, 38, 64, 78, 101, 195, 218, 222, and 230 as obvious under 35 U.S.C. § 103(a) over Noyes, VPK, Metzgar, and Ramachandran.

Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.

PTAB Petition: IPR2016-00819; filed March 30, 2016.

PTAB Trial Instituted Document filed October 4, 2016.

Patent at Issue: U.S. Patent No. 6,629,977 ("Tapered bioabsorbable interference screw and method for endosteal fixation of ligaments," issued October 7, 2003) claims a bioabsorbable interference screw having a tapered profile which extends along substantially the entire length of the screw where the tapered profile makes the screw easy to insert while providing superior fixation resulting from a progressively increasing diameter.

Petitioners Smith & Nephew, Inc. and Arthrocare Corp. are challenging the '997 patent on four grounds as obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges William V. Saindon, Barry L. Grossman (author), and Timothy J. Goodson issued a decision instituting review of if claims 1, 2, and 4–6 would have been obvious under 35 U.S.C. § 103(a) in view of Endo-Fix; if claims 2 and 3 would have been obvious under 35 U.S.C. § 103(a) in view of Endo-Fix, Weiler, and Hannay; if claims 1, 2, and 4–6 would have been obvious under 35 U.S.C. § 103(a) in view of Simon; and if claims 2 and 3 would have been obvious under 35 U.S.C. § 103(a) in view of Simon, Weiler; and Hannay.

Related Matters: According to the petition, the '977 patent is the parent of U.S. Patent 6,875,216, which is the subject of IPR2016-00817 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 09/29/2016). The '216 patent is a division of the application that matured into the '977 patent. Also, U.S. Patent No. 7,322,986, which is the subject of IPR2016-00818 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 10/04/2016), is a continuation of the ’216 patent. The '977, '216, and '986 patents have been asserted by Patent Owner in the U.S. District Court for the Eastern District of Texas in Arthrex, Inc. v. Smith & Nephew, Inc., Civil Action No. 2:2015-cv-01047.

Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.

PTAB Petition: IPR2016-00819; filed March 30, 2016.

PTAB Trial Instituted Document filed October 4, 2016.

Patent at Issue: U.S. Patent No. 7,322,986 ("Bioabsorbable interference screw for endosteal fixation of ligaments," issued January 29, 2008) claims a bioabsorbable interference screw having a tapered profile which extends along substantially the entire length of the screw. The tapered profile makes the screw easy to insert while providing superior fixation resulting from a progressively increasing diameter. Upon insertion, the screw engages cortical bone at the back end of the bone tunnel and fills all but 5-10 mm. of the tunnel, thereby providing increased fixation strength while also promoting fast healing.

Petitioners Smith & Nephew, Inc. and Arthrocare Corp. are challenging the '986 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obviousness under 35 U.S.C. § 103(a) (grounds 2–7). View the petition here. Administrative Patent Judges William V. Saindon, Barry L. Grossman (author), and Timothy J. Goodson issued a decision instituting review of if claims 1–6 are anticipated under 35 U.S.C. § 102(b) by the '977 patent; if claims 1, 2, 5, and 6 would have been obvious under 35 U.S.C. § 103(a) in view of Ross; if claims 3 and 4 would have been obvious under 35 U.S.C. § 103(a) in view of Ross and Hannay; if claims 1–3, 5, and 6 would have been obvious under 35 U.S.C. § 103(a) in view of Endo-Fix; if claims 1, 2, 5, and 6 would have been obvious under 35 U.S.C. § 103(a) in view of Endo-Fix and Weiler; and if claims 3 and 4 would have been obvious under 35 U.S.C. § 103(a) in view of Endo-Fix, Weiler, and Hannay.

Related Matters: According to the petition, the '986 patent is a continuation of U.S. Patent 6,875,216, which is the subject of IPR2016-00817 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 09/29/2016). The '216 patent is a division of U.S. Patent 6,629,977, which is the subject of IPR2016-00819 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 10/04/2016). The '977, '216, and '986 patents have been asserted by Patent Owner in the U.S. District Court for the Eastern District of Texas in Arthrex, Inc. v. Smith & Nephew, Inc., Civil Action No. 2:2015-cv-01047.