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  • PTAB Life Sciences Report — Part IV

    By John Cravero and Richard Martin —

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

    Merial, Inc. v. Fidopharm, Inc.

    PTAB Petition:  IPR2016-01182; filed June 10, 2016.

    PTAB Trial Instituted Document filed November 7, 2016.

    Patent at Issue:  U.S. Patent No. 8,829,038 ("Parasiticidal formulation," issued September 9, 2014) claims a parasiticidal formulation comprising: Fipronil, or a veterinarily acceptable derivative thereof; at least one C1-C6 alcohol co-solvent, wherein the total amount of C1-C6 alcohol is up to 8% by weight of the formulation; at least one organic solvent which is not the C1-C6 alcohol co-solvent; and at least one crystallization inhibitor, wherein the total amount of crystallization inhibitor is from 2 to 20% by weight of the formulation.

    Petitioner Merial, Inc. is challenging the '038 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1, 3, and 6) or obviousness under 35 U.S.C. § 103(a) (grounds 2, 4, and 5).  View the petition here.  Administrative Patent Judges Michael P. Tierney, Lora M. Green, and Robert A. Pollock (author) issued a decision instituting inter partes review of claims 1-3 and 7-21 of the '038 patent under 35 U.S.C. § 103(a) as being obvious over Etchegaray (Ground 4a) and as being obvious over Frontline Top Spot references (Ground 4b); claims 4-6 of the '038 patent under 35 U.S.C. § 103(a) as being obvious over Etchegaray in view of Maddison, Jeannin, or Young (Ground 5); and claims 1-3, 9, and 18-19 of the '038 patent under 35 U.S.C. § 102(b) as being anticipated by Pan (Ground 6).  Grounds 1-3 were all denied institution.

    Related Matters:  According to the petition, the '038 patent is not involved in any related matters.


    Mylan Pharmaceuticals, Inc. v. Shire Laboratories, Inc.

    PTAB Petition:  IPR2016-01033; filed May 12, 2016.

    PTAB Trial Instituted Document filed November 17, 2016.

    Patent at Issue:  U.S. Patent No. RE42,096 ("Oral Pulsed Dose Drug Delivery System," issued February 1, 2011) claims a pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising: (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating; and (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release, wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes.

    Petitioner Mylan Pharmaceuticals, Inc. is challenging the '096 patent on one ground as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Toni R. Scheiner (author), Lora M. Green, and Sheridan K. Snedden issued a decision instituting inter partes review of claims 18–25 of the '096 patent under 35 U.S.C. § 103 as being obvious in view of Mehta, PDR 1997, Brown, and Amidon.

    Related Matters:  According to the petition, the '096 patent is currently (or was) the subject, as the parent patent or current reissue form, of the following litigations:  Shire LLC v. Amerigen Pharms. Ltd., 14-cv-6095 (D.N.J); Shire LLC v. Corepharma, LLC, 14-05694 (D.N.J); Shire LLC v. Par Pharm., Inc., 15-cv-01454 (D.N.J); Shire Labs., Inc. v. Impax Labs, Inc., 03-cv-1164 (D. Del.); Shire LLC v. Sandoz, Inc., 07-cv- 197 (D. Colo.); Shire Labs., Inc. v. Barr Labs., Inc., 03-cv-1219,-6632 (SDNY); Shire LLC v. Watson Pharms., Inc., 11-cv-2340 (SDNY); Shire LLC v. Neos Therapeutics, Inc., 13-cv-1452 (N.D. Tx.); Shire LLC v. Colony, Pharms. Inc., 1:07-cv-00718 (D. Md.); Shire Labs., Inc. v. Andrx Pharms. LLC, 07-cv-22201 (S.D. Fla.); and Shire Llc v. Abhai LLC, 15-cv-13909 (D. Mass.).  Also, the '096 patent is currently the subject of Inter Partes Review IPR2015-02009 (Amerigen Pharms. Ltd. v. Shire LLC; Petitioner Amerigen Pharmaceuticals; filed 10/01/2015; instituted 04/18/2016).


    Alkermes Pharma Ireland Ltd. and Alkermes, Inc. v. Otsuka Pharmaceutical Co., Ltd.

    PTAB Petition:  IPR2017-00287; filed November 17, 2016.

    Patent at Issue:  U.S. Patent No. 9,125,939 ("Carbostyril derivatives and mood stabilizers for treating mood disorders," issued August 2, 2006) claims a method of treating bipolar disorder in a patient partially nonresponsive to lithium or valproic acid, divalproex sodium or a salt thereof monotherapy comprising: administering an amount of a composition comprising aripiprazole, and lithium or a salt thereof in a pharmaceutically acceptable carrier, wherein the amount of lithium is about 0.01 to 500 parts by weight and the amount of aripiprazole is about 1 part by weight, wherein the bipolar disorder is chosen from bipolar disorder I, bipolar disorder II, bipolar disorder with or without psychotic features, mania, acute mania, bipolar depression, and mixed episodes.

    Petitioners Alkermes Pharma Ireland Ltd. and Alkermes, Inc. are challenging the '939 patent on six grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '939 patent is not the subject of any pending litigations or post-grant reviews.  However, the '939 patent was the subject of a litigation in the District of New Jersey captioned Otsuka Pharmaceutical Co., LTD. v. Stason Industrial Corp., et al., No. 1:16-cv-00557-JBS-KMW.


    Wockhardt Bio AG v. Eli Lilly & Company

    PTAB Petition:  IPR2016-01337; filed June 30, 2016.

    PTAB Petition:  IPR2016-01335; filed June 30, 2016.

    PTAB Petition:  IPR2016-01393; filed July 8, 2016.

    PTAB Trial Instituted Document filed November 18, 2016 (IPR2016-01337 and IPR2016-01335).

    PTAB Trial Instituted Document filed November 21, 2016 (IPR2016-01393).

    Patent at Issue:  U.S. Patent No. 7,772,209 ("Antifolate combination therapies," issued August 10, 2010) claims a method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

    Petitioner Wockhardt Bio AG is challenging the '209 patent on one ground as being obvious under 35 U.S.C. § 103(a).  View the petition for IPR2016-01335 here, the petition for IPR2016-01337 here, and the petition for IPR2016-01393 here.  Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued decisions (IPR2016-01337, IPR2016-01335, and IPR2016-01393) instituting inter partes review of  claims 1–22 of the '209 patent under 35 U.S.C. § 103 as being obvious in view of Rusthoven, EP 0,595,005 A1, and the knowledge of one of ordinary skill in the art.  The Panel also granted Petitioner's Motion for Joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22–42.122(b), joining the instant proceeding with IPR2016-00240, and terminating the instant proceeding under 37 C.F.R. § 42.72.

    Related Matters:  According to the petition, the '209 Patent has been the subject of the following lawsuits in the Southern District of Indiana:  Eli Lilly and Company v. Biocon Ltd., 1:16-cv-00469; Eli Lilly and Company v. Dr. Reddy's Laboratories, Ltd. et al., 1:16-cv-00308; Eli Lilly and Company v. Fresenius Kabi USA, LLC, 1:15-cv-00096; Eli Lilly and Company v. Sandoz Inc., 1:14-cv-02008; Eli Lilly and Company et al. v. Nang Kuang Pharm. Co., Ltd. et al., 1:14-cv- 01647; Eli Lilly and Company v. Glenmark Pharm. Ltd. et al., 1:14-cv-00104; Eli Lilly and Company v. Sun Pharm. Global FZE et al., 1:13-cv-01469; Eli Lilly and Company v. Accord Healthcare, Inc., USA, 1:13-cv- 00335; Eli Lilly and Company v. Apotex, Inc. et al., 1:12-cv-00499; Eli Lilly and Company v. Accord Healthcare, Inc., USA, 1:12-cv-00086; Eli Lilly and Company v. App Pharm., LLC, 1:11-cv-00942; and Eli Lilly and Company v. Teva Parental Medicines, Inc., et al., 1:10-cv-01376.  Also, the '209 patent is involved in IPR2013-00356 (Petitioner, Accord Healthcare, Inc.; filed 06/14/2013; denied institution 10/01/2013); IPR2016-00318 (Petitioner, Sandoz Inc.; filed Dec. 14, 2015; instituted 06/16/2016); IPR2016-00237 (Petitioner Neptune Generics, LLC; filed Nov. 24, 2015; instituted 06/03/2016); and IPR2016-00240 (Petitioner Neptune Generics, LLC; filed Nov. 24, 2015; instituted 06/03/2016).


    OmniActive Health Technologies, Inc. v. Kemin Industries, Inc.

    PTAB Petition:  IPR2017-00305; filed November 21, 2016.

    Patent at Issue:  U.S. Patent No. 8,815,955 ("Method of treating ocular disorders," issued August 26, 2014) claims a method of treating the increased age-related macular degeneration present in a subject having age-related macular degeneration and either hyperopia or astigmatism, relative to the age-related macular degeneration present in a subject having age-related macular degeneration but neither hyperopia nor astigmatism, comprising administering to the subject having the macular degeneration and either the hyperopia or astigmatism a composition comprising a therapeutically effective amount of one or more ocular antioxidants.

    Petitioner OmniActive Health Technologies, Inc. is challenging the '995 patent on three grounds as being obviousness under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '955 patent is the subject of a complaint under 19 U.S.C. § 1337 against Petitioner in the International Trade Commission (ITC), captioned Certain Food Supplements and Vitamins, Including Ocular Antioxidants and Components Thereof and Products Containing the Same, Inv. No. 337-TA-3177.  Also, the '955 patent is the subject of a litigation in the District of New Jersey captioned OmniActive Health Technologies, Inc. v. Kemin Industries, Inc., No. 1:16-cv-4988.


    Mylan Pharmaceuticals Inc. v. ICOS Corp.

    PTAB Petition:  IPR2017-00323; filed November 22, 2016.

    Patent at Issue:  U.S. Patent No. 6,943,166 ("Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction," issued September 13, 2005) claims method of treating sexual dysfunction in a patient in need thereof comprising orally administering one or more unit dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day, of a compound.

    Petitioner Mylan Pharmaceuticals Inc. is challenging the '166 patent on one ground as being obviousness under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '166 patent is the subject of several litigations in the Eastern District of Virginia: Eli Lilly and Company et al v. Mylan Pharmaceuticals Inc., No. 1:16-cv-01122; Eli Lilly & Co. et al. v. Alembic Pharmaceuticals Ltd. et al., No. 16-cv-01120; Eli Lilly & Co. et al. v. Zydus Pharmaceuticals, No. 16-cv-01170; Eli Lilly & Co. et al. v. Teva Pharmaceuticals USA Inc., No. 16-cv-01169; Eli Lilly & Co. et al. v. Aurobindo Pharma Ltd. et al., No. 16-cv-01121; Eli Lilly & Co. et al. v. Sun Pharmaceutical Indus., Ltd. et al., No. 16-cv-01168; Eli Lilly & Co. et al. v. Actavis Labs. UT, Inc., No. 16-cv-01119; Eli Lilly & Co. et al. v. Cipla USA, Inc., No. 16-cv-01208; Eli Lilly & Co. et al. v. Accord Healthcare, Inc., No. 16-cv-01352.  Also, the '166 patent was involved in IPR2016-00678 (IntelGenX Corp.; filed 02/26/2016; denied 09/01/2016).


  • PTAB Life Sciences Report — Part III

    By John Cravero and Richard Martin —

    USPTO SealAbout 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.

    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 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 IPR2016-0110 here, the petition for IPR2016-01242 here, 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.

  • News from Abroad: Antibodies in the European Patent Office

    The following article was reprinted with permission from J A Kemp.

    The European Patent Office (EPO) continues to grant many patents relating to antibodies, and in doing so applies the same patentability criteria as to other inventions.  However, some commentators have suggested that antibodies are regarded as a special case by the EPO when evaluating inventive step / obviousness.  It is implied that the EPO sets a higher patentability threshold for inventions in this field as compared to, for example, small molecule therapeutics.

    This perception likely reflects no more than the crowded nature of the antibody field, which has matured rapidly in recent years.  As a result, EPO Examiners are able to make a large (and increasing) number of assumptions regarding the background knowledge of the skilled person.  For example, in the absence of evidence to the contrary, the EPO considers it to be routine to raise an antibody to a known target.  The EPO also considers it to be routine to optimise certain characteristics of an antibody, such as affinity or immunogenicity.

    Although it is not unique to the field, the approach of the EPO can present significant challenges to applicants seeking to pursue claims to antibodies, particularly antibodies to known targets.  We have set out below our suggestions for how grant of antibody claims at the EPO might nonetheless be achieved in different factual scenarios.  We have also set out the types of supporting evidence that may be required in each case.  Figure 1 provided at the end of this briefing summarises the suggestions in the form of a decision tree, which may help to guide you to the most appropriate strategy at different stages in an antibody development project.

    Scenarios likely to Result in Broad claims

    Broad antibody claims typically arise from two basic scenarios.  In the first scenario, the target is a newly-identified molecule, or is a molecule to which it has previously proven difficult to raise an antibody.  In such cases, the antibody may be defined solely in terms of the target bound.  For example:

    "An antibody which specifically binds to <target>"

    In the second scenario, the target is found to have a previously unappreciated role in a disease.  That is, the target is found to be associated with a new medical use.  In such cases, the antibody may be defined by reference to the target bound and the new medical use.  For example:

    "An antibody which specifically binds to <target> for use in a method of treating <new disease or condition>".

    These two basic scenarios are discussed in more detail below.

    Newly-Identified or Difficult Target

    The extensive mapping of genomes and proteomes means that truly "new" targets are increasingly rare.  However, an applicant who identifies, for example, a new polypeptide (potentially including new mutant forms of a known polypeptide) can expect to obtain broad claims to any antibody that specifically binds to the new polypeptide.  It is not typically necessary to provide evidence that an antibody has actually been produced if the target is susceptible to routine methods of antibody production.

    An applicant who develops a method allowing an antibody to be raised for a known target which was not susceptible to routine methods can also expect to obtain broad claims.  The EPO effectively views such a target as a special category of new target — it is "newly available" for antibody production.  Inventions of this type are though increasingly rare.  Methods of antibody production have developed such that few targets are not now susceptible to them, and overcoming technical difficulties is frequently seen as routine.  If the EPO can be persuaded otherwise for a particular case, the patent application will need to include clear evidence that an antibody to the target has indeed been raised, as well as sufficient information to allow this to be repeated.

    For antibodies to such newly-identified targets or difficult targets, medical use claims may be allowable even without direct evidence of a clinically-relevant functional effect.

    New Medical Use

    Where a known target molecule is found to have a previously unappreciated role in a disease, it may be possible to obtain claims directed to any antibody that specifically binds to the target for use in a particular method of treatment.  In a typical scenario of this type, the target has a known association with one disease, but is subsequently found to have a role in a different (new) disease that was not previously appreciated.  Under such circumstances the claims will be limited to an antibody for use in a method of treating the new disease, but will cover any anti-target antibody for the said use.

    It will be necessary to establish that the new medical use is not obvious from any previous disclosure regarding the target or existing antibodies that bind to it.  It will also be necessary to establish that it is at least plausible that an antibody binding to the target will have a therapeutic effect.  At present this is a relatively low threshold at the EPO and in vitro functional data will likely be sufficient, particularly if it derives from a disease model or other assay relevant to the indication.  In vivo data from animal models is helpful but not required.  It is not normally expected that a patent application will include in vivo data from human clinical trials.

    Similar considerations may apply if it was previously thought that the only antibodies that could be produced to a target were pharmaceutically irrelevant (for example due to low affinity), but it is subsequently found that they have a therapeutic effect1.  In such cases a claim to a pharmaceutical composition comprising any antibody specific for the target may be possible.

    Scenarios which may Result in Narrower Claims

    It is unlikely that broad antibody claims will be available if both the target and associated medical uses are known.  However, grant of narrower claims may still be possible.  Such claims will likely need to incorporate limitations from either or both of the following categories.

    New or Improved Characteristic of an Antibody

    Limitations to specific functional characteristics of the antibody, such as a required level of affinity or a down-stream functional effect, likely also with at least some structural (sequence) characteristics.

    New Development of a Known Medical Use

    Limitations to specific aspects of the medical use, such as a particular patient group or a dosing/administration regime.

    Both categories are discussed in more detail in the following section.  The categories are not mutually exclusive, and claims including both should be pursued wherever possible as part of a comprehensive filing strategy (see additional comments on filing strategy in the separate section below).  However, in our experience, at any given stage in development a particular antibody project is likely to favour limitations from one category over the other.

    New or Improved Characteristic of an Antibody

    Examples of the types of functional characteristic that applicants may seek to rely upon are described in more detail below.  These examples should not be viewed as exhaustive or mutually exclusive.  In practice a combination of these and other characteristics may well provide the best route to allowable claims.

    Irrespective of the characteristic(s) relied upon, pursuit of this approach will likely require that applicants have provided a significant amount of structural information (primary amino acid sequences) in the patent application.  Whether a particular antibody is claimed directly or is recited as a reference antibody, the EPO often insists that structural detail be provided at a level at least sufficient to define the target binding region of an antibody.  It may alternatively be possible to meet these requirements by reference to a biological deposit of, for example, a hybridoma, provided the deposit is made in accordance with the Budapest Treaty.

    Historically, the EPO has accepted structural definitions of antibodies which refer only to one or two CDR sequences.  However, EPO Examiners are likely now to insist upon all six CDRs as a minimum requirement, unless data is available to show that any characteristic relied upon is achieved with fewer CDRs.  There is though an increasing appreciation of the relevance of framework regions to target binding, and so there is a trend towards requiring that the heavy and light chain variable region sequences be recited in full.  In some cases it may even be necessary to specify the isotype of the constant region if this is relevant to the characteristic(s) relied upon.

    By contrast to its approach for small molecule therapeutics, the EPO does not in general consider that a unique structure can confer inventive step on an antibody to a known target.  Thus, whilst an antibody comprising a unique primary sequence will be considered to be novel, structural non-obviousness arguments are unlikely to be accepted even when both variable region sequences are recited in full.

    This means that applicants will generally be unable to rely upon, for example, the determination of unique CDR and framework sequences to provide an inventive step.

    Instead, the EPO has developed a requirement that a new antibody to a known target must demonstrate "an unexpected effect" relative to pre-existing antibodies to the same target2 in order for inventive step to be acknowledged.  It will therefore generally be necessary to demonstrate that the antibody as claimed possesses a functional characteristic (or combination of characteristics) which could not reasonably have been predicted from the prior art.

    Ideally, at least some direct experimental evidence of the characteristic(s) relied upon will be provided in the patent application, for at least one exemplary antibody.

    Under some circumstances it may be possible to rely upon supplementary data filed later, but there must be a connection to the characteristic(s) shown in the application.  The characteristic(s) relied upon must be at least plausible at the filing date3.

    This test has been applied very strictly by the EPO on at least one occasion.  In a specific case4 the Board of Appeal held that a particular effect relied upon by an applicant to support inventive step could not be derived from the patent application itself, even though an arguably related effect was explicitly demonstrated in the Examples.  Accordingly the effect relied upon was considered to have been demonstrated only after the filing date of the application, and was not taken into account when assessing inventive step.

    If the EPO is persuaded that "an unexpected effect" is present and plausible, the breadth of claim that is allowed will depend upon the circumstances of each case — in particular the state of the prior art and the data available.

    At the narrowest end of the spectrum, it may be necessary to limit the claims to the specific sequences of an antibody which has been shown to possess the unexpected effect.  For example:

    "An antibody which binds specifically to <target> and which comprises a VH region comprising SEQ ID NO: x and a VL region comprising SEQ ID NO: y."

    At the opposite end of the spectrum, and more rarely, it may be possible to claim a general class of antibodies which achieves the said effect, defined solely in functional terms. For example:

    "An antibody which binds specifically to <target> and which has <unexpected functional characteristic(s)>."

    It will be necessary for the application to include sufficient information such that the skilled person can generate further examples of an antibody which meets the functional definition.  The identification in the patent application of a specific, structurally-defined antibody which can be used as a reference / control in a screening method is usually acceptable.  However, it is not unusual for an Examiner to require that the claim also include some structural information about the claimed antibody or the reference antibody.  As such, allowable claims may be a hybrid of the two types shown above.  For example:

    "An antibody which binds specifically to <target> and which has <unexpected functional characteristic(s)>, wherein the antibody competes for binding to <target> with an antibody which comprises a VH region comprising SEQ ID NO: x and a VL region comprising SEQ ID NO: y."

    Examples of Possible New Characteristics

    As mentioned above, the following examples should not be viewed as exhaustive or mutually exclusive.  In practice a combination of these and other characteristics may well provide the best route to allowable claims.  The goal is to establish that there is a technical effect or characteristic (or multiple such effects or characteristics) which can be shown to have been unexpected based on the relevant prior art.

    Affinity

    The EPO considers the generation of an antibody with nanomolar affinity to be achievable by routine methods for the vast majority of targets.  Whilst there may be exceptions for particularly difficult targets, high affinity alone is now unlikely to be sufficient to establish an inventive step.  However, high affinity in combination with another advantageous characteristic is nonetheless likely to be helpful.

    Specificity

    The EPO tends to view high specificity for target to be an inherent characteristic of all antibodies and so an increase in specificity alone is unlikely to be sufficient to establish an inventive step.  However, an increase in specificity which gives rise to an unexpected technical advantage, or which was previously thought to be difficult to achieve, may be enough.  For example if a new antibody is able to distinguish between closely-related targets to a greater extent than was previously possible.

    Epitope

    An antibody which can bind to an epitope in a target that was previously unrecognised and/or previously considered to be inaccessible is likely to be viewed as inventive.  Under certain circumstances this may even be seen as a sub-category of the "Newly-identified or difficult target" scenario described above.  If binding to the particular epitope also provides a functional advantage (e.g. enhanced specificity) this is likely to be helpful.

    Manufacturability

    Routine optimisation for improved solubility etc is unlikely to be viewed as inventive.  However, there may be exceptions if the nature or position of any substitutions, and the subsequent effect, can be shown to have been unexpected.  For example, if a surprising increase in affinity or specificity occurs.

    Immunogenicity

    Humanisation of antibodies to reduce anti-isotypic or idiotypic responses is now largely viewed as routine, as is the production of fully human antibodies.  However, as with manufacturability there may be exceptions if the nature or position of any substitutions, and the subsequent effect, can be shown to have been unexpected.

    The Board of Appeal has held in one case5 that particular point mutations to introduce human sequences in the framework regions of a specific mouse antibody were sufficient to acknowledge inventive step for that antibody.  The evidence in that case persuaded the Board that the skilled person could not reasonably have expected that those specific mutations would reduce immunogenicity without significantly reducing affinity.

    Down-Stream Functional Effects

    Any improvement in down-stream function is likely to be helpful when seeking to establish an inventive step.  However, adaptations of an antibody to enhance down-stream functions such as ADCC are unlikely to be viewed as inventive where they rely upon known phenomena such as altered glycosylation of Fc regions.

    New Development of a Known Medical Use

    It seems it is becoming ever more challenging to persuade the EPO that a new or improved characteristic of an antibody is enough alone to establish inventive step.  However, in our experience antibody inventions are treated no differently to other therapeutics when assessing further developments of a known medical use, in which a new and unexpected technical effect can be demonstrated.

    The scope of claim that may be available via this route will depend upon the data produced, since it will be necessary to show that the effect relied upon is achieved across substantially the whole scope claimed.  This may require limitation to an antibody defined by a complete structural definition (including constant regions), if the EPO do not accept that the effect relied upon applies more generally, for example to all antibodies possessing the same six CDRs.

    Ideally the data showing the effect should be present in the patent application.  However, data generated post-filing may be used to supplement arguments later in prosecution, provided the effect relied upon is plausible at the filing date6.

    Bearing this in mind, we consider that inventions of this type are generally in one of two categories:

    Combinations

    (Bispecific Molecules/Combination or Co-Administration with other Therapeutics/Conjugates)

    Any form of therapy which combines an antibody with another functionality may give rise to allowable claims.  Examples include a combination with another binding functionality in the same molecule (a bispecific molecule), a combination with another effector functionality in the same molecule (a drug/toxin conjugate), or the co-administration of the antibody with another therapeutic (combination or co-administration), or any combination of these types.  In each case, as with any combination of known therapeutics, it will be necessary to establish that the combination results in a technical effect (typically an advantage) which was not obvious from the prior art (e.g. synergistic increase in efficacy).  It will likely be necessary to include experimental evidence of the technical effect in the patent application.

    Treatment Methodologies

    (Patient Group/Dose or Formulation/Administration Route or Regime)

    The Enlarged Board of Appeal of the EPO has established7 that claims to second/further medical uses of a substance may be based not only on the treatment of a different disease, but also on the treatment of the same disease by a method which differs for example in the dosage, formulation, administration regime, group of subjects or route of administration.  In each case, as with any known therapeutic, it will be necessary to establish that the difference gives rise to a technical effect (typically an advantage) which was not obvious from the prior art (e.g. surprisingly enhanced efficacy for topical versus parenteral administration).  It will likely be necessary to include experimental evidence of the technical effect in the patent application.

    New Types of Antibody

    An invention which relates to a new type of antibody may give rise to broad claims which are not limited to a specific antibody or target.  Examples of possible inventions in this category could include a novel and inventive arrangement of the binding domains (a new antibody "format"), a novel and inventive effector region (such as a modified Fc domain), or an entirely different class of antibody molecule isolated from a newly-discovered species.

    For inventions of this type, the assumptions that the EPO would otherwise make regarding production and optimisation of known antibody types should largely be negated.  The EPO should treat such inventions in the same way as any other technology, since normal considerations of novelty, inventive step and sufficiency of disclosure should apply.  As such the assessment of each case will depend upon its merits.

    Comprehensive Filing Strategy

    A typical antibody development project will pass through different stages, and at each stage it may correspond more closely to one or the other of the scenarios outlined above.  This briefing is intended to provide some suggestions as to how patentable claims may be achieved in each scenario.  These suggestions are also summarised in Figure 1.

    However, the scenarios that are described are not mutually exclusive.  As with any therapeutic invention, a comprehensive filing strategy should seek to explore all of the available options for patent protection throughout the lifespan of the project and beyond.  For example, an initial broad filing to a new medical indication should be followed with multiple narrower filings to antibodies with improved characteristics and/or developments of the treatment methodology.

    Figure 1

    Figure 1
    1     Board of Appeal decision T601/05: claims to a pharmaceutical composition comprising human anti-TNFα antibodies were found to be inventive. At the time only low affinity human antibodies to the target could be generated, and it was thought that these were not suitable for pharmaceutical use.
    2 Board of Appeal decision T735/00
    3 Board of Appeal decision T1329/04
    4 Board of Appeal decision T2637/11
    5 Board of Appeal decision T0067/11
    6 Board of Appeal decision T1329/04
    7 Enlarged Board of Appeal decision G2/08

    This article was reprinted with permission from J A Kemp.

  • Guest Post — The Patient Side of the CRISPR Patent Battle

    By Nicholas Vincent* and Anthony D. Sabatelli** —

    A contentious patent battle has continued to rage between the Broad Institute at Harvard/MIT and the University of California ("UC").  UC is challenging thirteen patents related to CRISPR gene editing technology that are currently held by the Broad Institute.  The basis of the challenge lies in explaining the potential influence that the work of Jennifer Doudna (UC Berkeley) and Emanuelle Charpentier (then at Umeå University) had on Feng Zhang's (Broad Institute) later work, and whether his work was an obvious development beyond that of Doudna/Charpentier, or whether it has the earliest priority claim.  Although the patent battle remains active with an uncertain outcome, Doudna, Charpentier, and Zhang remain key players with regards to both the patents and research advances/startup companies related to the technology.

    As the patent battle for CRISPR gene editing technology wages on, it has been easy to overlook other clinical and therapeutic advances that these companies are researching and pioneering at a rapid pace.  Although early investigations have focused primarily on oncology/cancer treatments, many expect the field of CRISPR-based therapeutics to progress into treating rare and orphan diseases, many of which have well-understood pathologies and disease mechanisms, but that currently lack effective treatments.  With regard to these diseases, there is huge promise for a lifelong cure after just a single treatment.  Understandably, this is extremely attractive to patients.  The development of novel treatments and therapeutic approaches promises to reveal clear opportunities for patent-eligible therapeutics and other related findings, even in light of the current CRISPR patent landscape.

    CRISPR (clustered regularly interspaced short palindromic repeats) was originally discovered and described as a bacterial immune system, serving to fend off viral infections by bacteriophages.  The real value of the technology, however, was soon recognized as a gene editing technology with clear promise not only for basic science applications, but also for its therapeutic potential.  CRISPR-related research and applications efforts have exploded in recent years, resulting in several companies seeking to develop technologies that focus on CRISPR-based therapeutics.  Included are Editas, CRISPR Therapeutics, Caribou Biosciences, and Intellia Therapeutics.

    Editas, a publically traded company as of early 2016, is not only focusing on engineering various aspects of the CRISPR system to achieve more precise directed genome targeting, but also modalities and methods of delivery including viral vectors, nanoparticles, and engineered cells.  Intellia Therapeutics, another company that went public in 2016, is also focused on better engineering CRISPR technology for more effective and targeted disease treatment.  Intellia is targeting both in vivo and ex vivo therapies.  Although Editas and Intellia have experienced dips in their stock prices since their IPOs, it is possible that these price drops are indicative of the movement of the larger market, and in particular, biotechnology trading patterns this year.  It will be interesting to track the stock performance of CRISPR Therapeutics, which has just recently gone public in late October, as they continue to develop novel therapies for beta-thalassemia, sickle cell disease, severe combined immunodeficiency, hemophilia, and cystic fibrosis, among others.

    Although promising, many questions do remain with regard to CRISPR-based therapies.  For example, it is as of yet unclear whether patients receiving a course of therapy could develop an immune response against the introduced CRISPR therapeutic, rendering it ineffective and causing potential harm to the patient.  Off target editing effects are also a concern with CRISPR-based therapeutics.  It will be essential for those developing technologies and therapies to show that off target editing effects are virtually absent, and that there are no detectable modifications that could result in heritable changes from generation to generation.  Although CRISPR-based technologies have shown a decrease in off target effects when compared to earlier gene editing technologies, many still report the present of off target effects, which likely will be unacceptable in treatments.  There are also many regulatory and safety concerns that must be considered as these technologies and therapies are being developed, including the potential for non-therapeutic use, which could theoretically result in parents selecting both physical and non-physical traits for their unborn children.

    In assessing the current landscape of patents in this area, it is readily apparent that the space is largely dominated by the initial patents that were filed for CRISPR technologies by Jennifer Doudna, Emmanuelle Charpentier, and Feng Zhang, and that research being done by the previously mentioned companies and others has been governed by the granting of both exclusive and non-exclusive licenses.  As the patent battle for CRISPR technologies continues, we eagerly anticipate inventors being required to approach the subject of patent-eligibility with regards to CRISPR in a new light — one that not only allows for the patenting of novel therapeutics, methodologies, and advances, but also remains flexible in light of the pending ruling on the current Broad Institute/UC Berkeley case.

    * Nicholas Vincent is a Technology Specialist at Dilworth IP
    ** Dr. Sabatelli is a Partner with Dilworth IP

  • PTAB Life Sciences Report — Part II

    By John Cravero and Richard Martin —

    USPTO SealAbout 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.

    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 IPR2016-00240 (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.

    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, IPR2016-001191 (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.

    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 IPR2016-00318 (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.

    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 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.

  • Conference & CLE Calendar

    CalendarDecember 20, 2016 – "Demonstrating Patent Eligibility Post-Alice: Impact of McRo and Other Recent Cases — Navigating the Nuances and Leveraging Guidance From Federal Circuit and PTAB Opinion" (Strafford) – 1:00 to 2:30 pm (EST)

    January 4, 2017 – "Parallel Patent Proceedings After Murata, Skyhawke and Shaw: Navigating Claim Construction, Estoppel, RPI, Stays and More" (Strafford) – 1:00 to 2:30 pm (EST)

    January 12, 2017 – "Navigating Administrative Law in Patent Appeals Involving Review Proceedings — Identifying and Preserving Administrative Errors in IPR Proceedings; Impact of Recent Court Decisions" (Strafford) – 1:00 to 2:30 pm (EST)

    January 18, 2017 – "Top Patent Law Stories of 2016" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    ***Patent Docs is a media partner of this conference or CLE

  • Webinar on Impact of Administrative Law in Patent Appeals

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Navigating Administrative Law in Patent Appeals Involving Review Proceedings — Identifying and Preserving Administrative Errors in IPR Proceedings; Impact of Recent Court Decisions" on January 12, 2017 from 1:00 to 2:30 pm (EST).  Arti K. Rai, Elvin R. Latty Professor of Law and co-Director at Duke Law Center for Innovation Policy, Duke Law School; Kevin B. Laurence of Renaissance IP Law Group; and Jonathan R.K. Stroud, Chief Patent Counsel, Unified Patents will provide guidance to patent counsel on the impact of administrative law in patent appeals, and examine the effect of recent Federal Circuit and Supreme Court decisions on the role of administrative law in post-grant proceedings and what it means for patent counsel going forward.  The webinar will review the following issues:

    • What role does administrative law have in IPR proceedings?
    • What are the implications of recent Federal Circuit and Supreme Court decisions for post-grant proceedings?
    • What steps can patent counsel take to be prepared to preserve administrative errors in post-grant proceedings?

    The registration fee for the webinar is $297. Those interested in registering for the webinar, can do so here.

  • Webinar on Parallel Patent Proceedings

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Parallel Patent Proceedings After Murata, Skyhawke and Shaw: Navigating Claim Construction, Estoppel, RPI, Stays and More" on January 4, 2017 from 1:00 to 2:30 pm (EST).  Kenneth R. Adamo of Kirkland & Ellis, Honorable Faith Hochberg, and Scott E. Kamholz of Foley Hoag will provide guidance to patent counsel involved in challenging or defending patent validity on the impact of concurrent proceedings at the USPTO and in the courts on claim construction, estoppel, real-parties-in-interest (RPI) and stays, and offer best practices for dealing with concurrent litigation and USPTO proceedings.  The webinar will review the following issues:

    • What litigation tactics can counsel employ to challenge or defend patent validity?
    • What are the implications for claim construction and estoppel when patents are challenged in concurrent proceedings?
    • What difficulties do counsel face when challenging or defending patent validity in concurrent proceedings?

    The registration fee for the webinar is $297. Those interested in registering for the webinar, can do so here.

  • iVenture Card Traveler Ltd v. Smart Destinations, Inc. (PTAB 2016)

    Patent Directed to Programmable Ticketing System Determined to be Eligible for Covered Business Method Patent Review

    By Joseph Herndon —

    USPTO SealPetitioner, iVenture Card Traveler Ltd, filed a Petition seeking to institute a covered business method patent review of all claims of U.S. Patent No. 7,765,128, owned by Smart Destinations, Inc.  The Board, applying the standard that requires demonstration that more likely than not Petitioner would prevail with respect to at least one challenged claim, the Board granted Petitioner's request to institute the CBM review.

    The '128 Patent

    The '128 patent is titled "Programmable Ticketing System."  The '128 patent describes a system and business model for allowing tourists access to a variety of attractions using a passcard.  The system may include reward terminals that are located at attractions and are configured to read smart cards presented to them and, assuming the card is valid for that location, allow the card holder to access the attraction.  Each smart card may be programmed with a product code that defines the attractions at which the card may be used.  Product codes may be stored in a central database along with a list of the attractions associated with each product code.  The list of attractions may be updated as desired, thereby updating and changing the attractions at which any given card may be used.

    The subject matter of the '128 patent is illustrated by Figure 2 of the patent, which is reproduced below:

    FIG. 2The reward terminals are configured as smart card readers.  Reward terminals are located at each partner attraction and can read cards presented to it to indicate whether or not a card-visitor has access to the attraction.  A database is updated over a network with nightly downloads to the terminals of any changes to products that use the attractions (and the cards that, therefore, allow access) and uploads to the database of actual use data.  A user interface allows a system manager to access the system network and run programs on gateway or store or retrieve data from database.  A central controller is used to calculate compensation for each attraction based on level of use, e.g., the compensation for allowing the bearer of each card access to the attraction.

    Thus, owners of cards have access to multiple attractions without having to pay separately for each attraction.  Rather, a person may simply pay once for a card and use that card to access attractions that are partners of the system.  Attractions may be paid by the system manager, at the end of a day, week, month, or other time frame, access fees corresponding to all the cards that have been used at that attraction during the time period.

    Claim 1 is representative and is reproduced below:

    1.  A manager system that permits access to a plurality of attractions, the system comprising:
        a network interface configured to:
            receive data corresponding to actual use of reward terminals to access respective attractions of the plurality of attractions for a time period, the reward terminals being located in proximity to the plurality of attractions, being configured to access the respective attractions using at least one product code, the data identifying at least one attraction; and
            provide at least one product definition to the reward terminals, the at least one product definition including associations between the at least one product code and the respective attractions, whereby a change in the associations between the at least one product code and the respective attractions changes the access to the respective attractions via the reward terminals using the at least one product code;
        a database to store the at least one product definition;
        a database to store the data corresponding to the actual use of the reward terminals to access the attractions; and
        a controller to calculate an aggregated compensation for each attraction based on the actual use of the reward terminals to access the respective attraction by a plurality of users, wherein the controller does not compensate the attractions based on the actual use of the reward terminals at a time of the actual use of the reward terminals via a card.

    Standing-Financial Product or Service

    A covered business method patent is "a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service."  AIA § 18(d)(1).

    This prong was easily met since all independent claims cover methods or systems for calculating aggregated compensation.

    Standing-Technological Invention Exception

    The AIA excludes from covered business method patent review patents for a "technological invention."  AIA § 18(d)(1).  To determine whether a patent is for a "technological invention," the Board considers whether the claimed subject matter as a whole recites a technological feature that is novel and unobvious over the prior art; and solves a technical problem using a technical solution.

    Petitioner argued that all of the claim elements of the '128 patent were known in the prior art, and specifically that everything illustrated in Figure 2 of the '128 Patent, and described in the accompanying text, was conventional technology used in conventional ways before the asserted priority date.  The Petitioner further relied on testimony from its expert to demonstrate that each of the steps of each of the method claims and each of the elements of each of the system claims are present in the prior art.

    The Board agreed, and found that the '128 patent is directed to a business problem, in contrast to a solution to a technical problem.  Among other reasons, the '128 patent itself describes the invention as "a system and business model for allowing tourists access to a variety of attractions."  Further, the claims were found to be directed to solving the business problem of calculating aggregated compensation based on actual use, as recited in the claims.

    The Board thus agreed with Petitioner's analysis demonstrating that the claims address a business problem of calculating compensation and apply standard known computer components to achieve this business goal.

    Thus, the exclusion for "technological inventions" was not found to apply here.  Thus, the '128 patent was found to be a CBM eligible patent for review.

    Subject Matter Eligibility Under 35 U.S.C. § 101

    Now that the '128 patent was found to be eligible for CBM review, the Petitioner still has to establish that the claims are more likely than not invalid for the CBM trial to be instituted.

    The Petition challenged the '128 patent claims as directed to unpatentable subject matter under 35 U.S.C. § 101.

    The Board followed the two-step framework set forth by the Supreme Court for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.

    In the first step, the Board determines whether the claims at issue are directed to an abstract idea.

    The alleged abstract idea was that the claims are directed to calculating aggregated compensation for attractions based on actual usage (over some period of time, but not at the actual time of use).  The Petitioner asserted that using a card to access an attraction and calculating aggregated compensation based on actual use of the attraction have been disclosed in the prior art.  The Petitioner referred to prosecution of the application for the '128 patent, in which the applicant specifically distinguished the claims over prior art based on calculating "aggregate compensation  . . . wherein the controller does not compensate the attractions based on the actual use of the reward terminals at a time of the actual use of the reward terminals via a card."

    The Board was persuaded by this reasoning.  This is a little confusing given that claims were found to be directed to an abstract idea simply because aspects of the claims were disclosed in the prior art.  Whether the claims recite "known" material should be addressed under novelty and obviousness — not as a threshold for determining whether the claims recite subject matter eligible for patenting.

    In any event, the Board turned to the second step, in which the Board considered the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application.

    The Board found that the claim elements recite off-the-shelf general purpose computing tools such as terminals and card readers, smart card technology, servers, standard databases, and a controller.  Thus, the Board easily found that claims of the '128 Patent merely teaches using generic computers, and computer components, to perform generic functions that do not improve the functioning of the computing devices or network communications and are not used in an unconventional way.  As a result, the Board was persuaded that the claims do not recite an inventive concept.

    Thus, the Board determined that the Petitioner had made a sufficient showing that it is more likely than not to prevail on its challenge under 35 U.S.C. § 101 to at least one of the '128 patent claims.  As a result, the CBM trial was instituted.

    Not a surprising result from the Board here, but another example of mixing analysis of patentable subject matter with novelty/obviousness, which is seen quite often for software patents these days.

    Before Administrative Patent Judges Thomas L. Giannetti, Rama G. Elluru, and Christopher M. Kaiser
    Decision by Administrative Patent Judge Thomas L. Giannetti

  • Patent Trolls Beware! — Supreme Court to Review Patent Venue Statute

    By Andrew Williams —

    Supreme Court Building #3In the past few years, the Supreme Court has been single-handedly tackling the so-called Patent Troll problem.  Sure, in that time, the President and Congress have made Patent Trolls a focus of their agendas, and have proposed many initiatives or legislative solutions to address the perceived problem.  And the mainstream media has certainly been reporting on the evils of the current patent systems, from the NPR "This American Life" and "Planet Money" podcasts (see "When NPR Podcasters Hit the Patent System"), to John Oliver's HBO commentary/comedy show "Last Week Tonight".  But only the Supreme Court has been effecting change that strikes at the heart of Patent Trolls — from Octane Fitness v. ICON Health & Fitness, which made it easier for district courts to award attorney fees, to Nautilus, Inc. v. Biosig Instruments, Inc., which made it easier for district courts to invalidate claims based on vague claim language, with many other decisions in between that expanded the meaning of patent ineligible subject matter.  To cap it off, earlier today, the Supreme Court granted a petition for writ of certiorari in a case that could have a significant impact on the ability of so-called patent trolls to take advantage of patent-friendly courts, such as the Eastern District of Texas — TC Heartland LLC v. Kraft Foods Group Brands LLC.

    This case involves the interpretation of the current venue statute.  At the time, we reported on the Federal Circuit's decision that denied a writ of mandamus to TC Heartland.  That case stemmed from a lawsuit brought by Kraft against TC Heartland and Heartland Packaging Corp. in the U.S. District Court for the District of Delaware.  TC Heartland is incorporated in Indiana, and has its headquarters in Carmel, Indiana.  Other than approximately 2% of its alleged infringing product ending up in Delaware, TC Heartland argued that it had no other contacts with that state.  As a result, it had moved the District Court to either dismiss the complaint for lack of personal jurisdiction, or to dismiss the action on venue grounds or transfer venue to the Southern District of Indiana.  Judge Stark denied that request.  TC Heartland followed that up with a petition to the Federal Circuit for a writ of mandamus to either dismiss or transfer the case.

    The issue essentially stemmed from a 1957 Supreme Court case, Fourco Glass Co. v. Transmirra Products Corp., 353 U.S. 222 (1957), in which the Court held that the general venue statute does not override the specific patent statute.  The result was that a corporation could only be sued in the state in which it was incorporated.  The specific venue statute for patent litigation was (and is) 28 U.S.C. § 1400(b):

    Any civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.

    28 U.S.C. § 1400(b).  The general venue statute, in turn, specified that:

    (c) A corporation may be sued in any judicial district in which it is incorporated or licensed to do business or is doing business, and such judicial district shall be regarded as the residence of such corporation for venue purposes.

    28 U.S.C. § 1391(c) (1952).  However, in 1988, Congress amended 28 U.S.C. § 1391 to be more definitional:

    (c) For purposes of venue under this chapter, a defendant that is a corporation shall be deemed to reside in any judicial district in which it is subject to personal jurisdiction at the time the action is commenced.

    28 U.S.C. § 1391(c) (1988).  Moreover, Congress again amended the statute by passing the Federal Courts Jurisdiction and Venue Clarification Act of 2011, making two changes, including expanding the applicability of the new definition to:  "all venue purposes."  By changing the § 1391(c) to a definition of "reside" for the purposes of venue, it was argued that Congress meant to expand the reach of patent venue statute.  The Federal Circuit agreed with this position in VE Holding Corp. v. Johnson Gas Appliance Co., 917 F.2d 1574 (Fed. Cir. 1990).  This ultimate result was that any forum was available for a patent infringement action, provided that the district court had personal jurisdiction over the defendant.

    Interestingly, even though the TC Heartland case could impact so-called patent trolls and litigation in the Eastern District of Texas, it involves neither.  Both parties in the case are practicing entities, and the case was filed in the District Court of Delaware.  Nevertheless, it is pretty clear that certiorari was granted because of concerns about trolls.  TC Heartland's brief highlighted all of the harm that has resulted from the Federal Circuit's interpretation of the statute.  For example, it included a pie chart of the impact of forum shopping in 2015, which showed that more than 43% of patent infringement cases were filed in the Texas court:

    ChartIn addition, it included citations to numerous law review articles that allegedly demonstrated the "pervasive dissatisfaction with the Federal Circuit's broad patent venue" rulings, which was to blame for the success of the so-called trolls.  Finally, TC Heartland's brief included a 2016 ABA Resolution that supported an interpretation of the patent venue statute that would limit the definition of "reside."  Moreover, six amicus briefs were filed, all in support of granting petition for certiorari.  Not only did these briefs complain about the patent troll problem that allegedly stemmed from the Federal Circuit's interpretation of the statute, but one was filed by known anti-patent troll advocacy group The Electronic Frontier Foundation.

    Kraft, for its part, did not deny the potential patent troll implications of the case.  Instead, it pointed out that even if the goal of combating trolls was lofty, this case was not the way to do it:

    Petitioner and the amici describe at length concerns with forum shopping in patent cases, primarily the disproportionate number of cases brought in the Eastern District of Texas, often by patent-assertion entities.  Respondent does not dispute the existence of patent venue shopping.  However, the task of patent venue reform lies squarely with Congress.  The judiciary's role is to enforce the straightforward statutory framework currently in place, and the Federal Circuit's decisions challenged here are scrupulously faithful to that framework.

    Brief in Opposition, page 1.  Moreover, Kraft argued that this was a poor vehicle to address the issue because it was set to go to trial in January 2017.  Even if the Supreme Court sides with TC Heartland, it probably won't make a difference.

    Without knowing what the parties will argue in their substantive briefs, one thing is clear:  the Supreme Court usually does not grant certiorari in cases it intends to affirm.  Therefore, it is possible that we will see a change in the environment that has given rise to the popularity of patent friendly jurisdictions.  If the Supreme Court does side with petitioner TC Heartland, so-called Patent Trolls will in most cases no longer be able to use the Eastern District of Texas as a tool for extorting settlements from accursed infringers.  Congress, for its part, has attempted to address the forum selection problem by, among other things, introducing the VENUE Act earlier this year.  It is possible that Congress will now postpone any further action until resolution of this Supreme Court case, a decision for which is expected by the of the term in June 2107.  We will continue to monitor the case as warranted.