About 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).