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

Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc.

PTAB Petition:  IPR2016-01317; filed June 29, 2016.

PTAB Trial Instituted September 19, 2016.

Patent at Issue:  U.S. Patent No. 8,822,438 ("Methods and compositions for treating cancer," issued September 2, 2014) claims methods for treating cancer comprise administering a 17α-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid.

Petitioner Argentum Pharmaceuticals Inc. is challenging the '438 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Lora M. Green, Rama G. Elluru, and Kristina M.Kalan (author) issued a decision instituting review of claims 1-20 of the '438 patent under 35 U.S.C. § 103 as being obvious over O'Donnell and Gerber, and claims 1–4 and 6–11 under 35 U.S.C. § 103 as being obvious over Barrie and Gerber.  View the decision here.  The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00286 (Amerigen Pharmaceuticals, Ltd. v. Janssen Oncology, Inc., Petitioner Amerigen Pharmaceuticals; filed 12/06/2015; Instituted 05/31/2016), adding Argentum as a petitioner to IPR2016-00286 and terminating IPR2016-01317 under 37 C.F.R. § 42.72.

Related Matters:  According to the petition, the '438 patent is involved in several litigation proceedings: BTG International Ltd. et al. v. Glenmark Pharmaceuticals Inc., USA et al., 2-16-cv-03743 (District of New Jersey), filed June 24, 2016; BTG International Ltd. et al. v. Amerigen Pharmaceuticals, Inc. et al., 2-16-cv-02449 (District of New Jersey), filed May 2, 2016; Janssen Biotech, Inc. et al. v. Mylan Pharmaceuticals Inc. et al., 1-15-cv-00130 (Northern District of West Virginia), filed August 4, 2015; Janssen Biotech, Inc. et al. v. Amneal Pharmaceuticals LLC et al., 1-15-cv-00679 (District of Delaware), filed August 3, 2015; BTG International Ltd. et al. v. Actavis Laboratories FL, Inc. et al., 9-15-cv-81076-DMM (Southern District of Florida), filed August 3, 2015; and BTG International Ltd. et al. v. Actavis Laboratories FL, Inc., et al., 2-15-cv-05909-KM-JBC (District of New Jersey), filed July 31, 2015.

Praxair Distribution, Inc. et al. v. Mallinckrodt Hospital Products IP LTD. et al.

PTAB Petitions: 

IPR2016-00777, filed March 23, 2016

IPR2016-00778, filed March 23, 2016

IPR2016-00779, filed March 23, 2016

IPR2016-00780, filed March 23, 2016

PTAB Trial Instituted September 22, 2016.

Patents at Issue: 

IPR2016-00777 U.S. Patent No. 8,282,966 ("Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide," issued October 9, 2012).  View the petition here.

IPR2016-00778 U.S. Patent No. 8,431,163 ("Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas," issued April 30, 2013).  View the petition here.

IPR2016-00779 U.S. Patent No. 8,293,284 ("Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide, issued October 23, 2012).  View the petition here.

IPR2016-00780 U.S. Patent No. 8,795,741 ("Methods for treating patients who are candidates for inhaled nitric oxide treatment," issued August 5, 2014).  View the petition here.

The involved patents are all related and share substantially the same specification, which discloses methods of reducing the risk of an adverse event, such as pulmonary edema, associated with treating a patient with inhaled nitric oxide gas.

Administrative Patent Judges Lora M. Green, Tina E. Hulse (author), and Robert A. Pollock issued one decision for all four petitions stating that the decision addresses issues common to each of the cases.  The decision denies institution of Inter Partes Review of (1) claims 1–29 of the '966 patent (IPR2016-00777); (2) claims 1–25 of the '163 patent (IPR2016-00778); (3) claims 1–30 of the '284 patent (IPR2016-00779); and (4) claims 1–44 of the '741 patent (IPR2016-00780).  View the decision here.

Related Matters:  According to the petition, the '966 patent is involved in litigation in the District of Delaware, captioned INO Therapeutics LLC v. Praxair Distribution, Inc., No. 1:15-cv-00170 (GMS).  Petitioner previously filed petitions requesting inter partes review of the claims of each of the involved patents:  Case IPR2015-00522, filed 01/05/2015; denied 07/29/2015 (the '966 patent); Case IPR2015-00524, filed 01/05/2015, denied 07/29/2015 (the '284 patent); Case IPR2015-00525, filed 01/05/2015, denied 07/29/2015 (the '163 patent); Case IPR2015-00526, filed 01/05/2015, denied 07/29/2015 (the '741 patent).

Mylan Laboratories Ltd. v. Aventis Pharma S.A.

PTAB Petition:  IPR2016-00712; filed March 15, 2016.

PTAB Trial Instituted September 22, 2016.

Patent at Issue:  U.S. Patent No. 8,927,592 ("Antitumoral use of cabazitaxel," issued January 6, 2015) claims a method for treating a patient with prostate cancer that has progressed during or after treatment with docetaxel, comprising administering to said patient a dose of 20 to 25 mg/m2 of cabazitaxel, or a hydrate or solvate thereof, in combination with a corticoid.

Petitioner Mylan Laboratories Ltd. is challenging the '592 patent on ten grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Brian P. Muryphy (author), Tina E. Hulse, and Christopher M. Kaiser issued a decision instituting review of claims 1, 2, 5, 12, 13, 17–20, 22–25, and 27–29 as being obvious over Winquist and the TROPIC Listing in view of Attard and Beardsley; and claims 3 and 4 as being obvious over Winquist, the TROPIC Listing, and Didier; claims 7–9 as being obvious over Winquist, the TROPIC Listing, and Mita; claims 10, 11, 14, and 16 as being obvious over Winquist, the TROPIC Listing, and Tannock; claims 21, 26, and 30 as being obvious over Winquist, the TROPIC Listing, and Pivot; and claim 15 as being obvious over Winquist, the TROPIC Listing, Pivot, and Tannock.  The decision denies instituting a portion of Ground 1, but the claims denied under Petitioner's Ground 1 are instituted under other Grounds so that claims 1-5 and 7-30 of the '592 patent are instituted.  View the decision here.

Related Matters:  According to the petition, the '592 patent is involved in several litigation proceedings:  Sanofi-Aventis U.S. LLC et al. v. Mylan Laboratories Ltd., C. A. No. 15-03392 (MAS)(LHG), filed in the District of New Jersey; Sanofi-Aventis U.S. LLC et al. v. Apotex Corp. et al., C. A. No. 15-01835; Sanofi-Aventis U.S. LLC et al. v. Breckenridge Pharmaceutical, Inc., C. A. No. 15-01836; Sanofi-Aventis U.S. LLC et al. v. Accord Healthcare, Inc., C. A. No. 15-02520; Sanofi-Aventis U.S. LLC et al. v. BPI Labs, LLC et al., C. A. No. 15-02521; Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy Laboratories, Inc. et al., C. A. No. 15-02522; Sanofi-Aventis U.S. LLC et al. v. Glenmark Generics Inc. et al., C. A. No. 15- 02523; Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC, C. A. No. 15- 02631; and Sanofi-Aventis U.S. LLC et al. v. Actavis LLC et al., C. A. No. 15-03107.

Teva Pharmaceuticals USA, INC. v. AstraZeneca AB.

PTAB Petition:  IPR2016-01122; filed June 1, 2016.

PTAB Trial Instituted September 23, 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 Dipeptidyl peptidase IV (DP 4) inhibiting compounds, pharmaceutical compositions, and methods of treating diabetes, insulin resistance, hyperglycemia, hyperinsulinemia, impaired glucose homeostasis, or impaired glucose tolerance in a mammal comprising administering to the mammal a pharmaceutical composition.

Petitioner Teva Pharmaceuticals 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 granting Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2015-01340 (Mylan Pharms., Inc. v. AstraZeneca AB, LLC , Petitioner Mylan Pharmaceuticals; filed 06/04/2015; Instituted 05/02/2016), adding Teva as a petitioner to IPR2015-01340 and terminating IPR2016-01122 under 37 C.F.R. § 42.72.  View the decision here.

Related Matters:  According to the petition, the '186 patent is involved in several litigation proceedings:  AstraZeneca AB v. Mylan Pharmaceuticals Inc., 14- cv-00696 (D. Del. 2014); AstraZeneca AB v. Mylan Pharmaceuticals 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 Laboratories FL, Inc., 14-cv-01356 (D. Del. 2014); AstraZeneca AB v. Sun Pharma Global FZE et al., 14-cv-00694 (D. Del. 2014); AstraZeneca AB v. Amneal Pharmaceuticals LLC., 14-cv-00697 (D. Del. 2014); and AstraZeneca AB v. Wockhardt Bio AG et al., 14-cv-00696 (D. Del. 2014).

Elekta Inc. v. Varian Medical Systems, Inc. et al.

PTAB Petition:  IPR2016-00843; filed April 5, 2016.

PTAB Trial Instituted September 28, 2016.

Patent at Issue:  U.S. Patent No. 8,696,538 ("Methods and apparatus for the planning and delivery of radiation treatments," issued April 15, 2014) claims a method for planning delivery of radiation dose to a target region within a subject, and a program product comprising a non-transitory computer-readable medium comprising computer readable instructions which, when executed by a processor, cause the processor to execute a method for planning delivery of radiation dose to a target region within a subject.

Petitioner Elekta Inc. is challenging the '538 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 4, 5, and 6).  View the petition here.  Administrative Patent Judges Brian J. McNamara, Patrick M Boucher, and Garth D. Baer (author) issued a decision instituting review of claims 23, 25, and 26 as being obvious under 35 U.S.C. § 103(a) over Earl '261 and Otto; claims 39–41 as being obvious under 35 U.S.C. § 103(a) over Earl '261, Otto, Yu, and Podgorsak; claims 23, 25, and 26 as being obvious under 35 U.S.C. § 103(a) over Duthoy and Otto; and claims 39–41 as being obvious under 35 U.S.C. § 103(a) over Duthoy, Otto, Yu, and Podgorsak.  View the decision here.

Related Matters:  According to the petition, the '538 patent is involved in litigation captioned Varian Medical Systems, Inc. et al. v. Elekta AB et al., No. 3:15-cv-04428 (N.D. Cal., Sept. 25, 2015), and proceedings pending before the International Trade Commission in Investigation No. 337-TA-968.

Merial, Inc. v. Sergeant's Pet Care Products, Inc

PTAB Petition:  IPR2016-00798; filed March 25, 2016.

PTAB Trial Instituted September 29, 2016.

Patent at Issue:  U.S. Patent No. 8,614,244 ("Spot-on pesticide composition," issued December 24, 2013) claims an A spot-on pesticide composition for animals, specifically mammals, including dogs and cats, which composition comprises a combination of active components, including fipronil and a pyrethroid.

Petitioner Merial Inc. challenged the '244 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Toni R. Scheiner, Sheridan K. Snedden, and Susan L. C. Mitcell (author) issued a decision denying instituting of Inter Partes review of claims 1-22 as being obvious under 35 U.S.C. § 103(a).  View the decision here.

Related Matters:  According to the petition, the '244 patent is not involved in any co-pending litigation or administrative matter.

Smith & Nephew, Inc. et al. v. Arthrex, Inc.

PTAB Petition:  IPR2016-00817; filed March 30, 2016.

PTAB Trial Instituted September 29, 2016.

Patent at Issue:  U.S. Patent No. 6,875,216 ("Tapered bioabsorbable interference screw for endosteal fixation of ligaments," issued April 5, 2005) claims a bioabsorbable interference screw having a tapered profile which extends along substantially the entire length of the screw where the tapered profile makes the screw easy to insert while providing superior fixation resulting from a progressively increasing diameter.

Petitioners Smith & Nephew, Inc. and Arthrocare Corp. are challenging the '216 patent on five grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges William V. Saindon, Barry L. Grossman, and Timothy J. Goodson (author) issued a decision instituting review of claims 1–7 as being obvious in view of Endo-Fix; claims 1–7 as being obvious in view of Endo-Fix and Weiler; claims 1–7 as being obvious in view of Simon; and claims 1–7 as being obvious in view of Simon and Weiler.  View the decision here.

Related Matters:  According to the petition, the '216 patent is related to two other patents for which inter partes review has been requested.  The '216 patent is a division of U.S. Patent No. 6,629,977, which is the subject of IPR2016-00819 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 10/04/2016).  Also, U.S. Patent No. 7,322,986, which is the subject of IPR2016-00818 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 10/04/2016), is a continuation of the '216 patent.  The '977, '216, and '986 patents have been asserted by Patent Owner in the U.S. District Court for the Eastern District of Texas in Arthrex, Inc. v. Smith & Nephew, Inc., Civil Action No. 2:2015-cv-01047.

Apotex Inc. et al. v. Eli Lilly & Company

PTAB Petition:  IPR2016-01190; filed July 1, 2016.

PTAB Trial Instituted September 30, 2016.

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

Petitioners Apotex Inc. and Apotex Corp. are challenging the '209 patent on one ground as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1-20 of the '438 patent as being 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 Apotex Inc. and Apotex Corp as petitioners to IPR2016-00237 and terminating IPR2016-01190 under 37 C.F.R. § 42.72.  View the decision here.

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

The '209 patent also has been challenged in the following instituted inter partes reviews:  IPR2016-00237 and IPR2016-00240 by Neptune, and in IPR2016-00318 by Sandoz Inc.  Several parties, including Petitioner, seek to join the instituted reviews.  Specifically, in addition to the current case, IPR2016-01335 (Wockhardt) and IPR2016-01341 (Teva and Fresenius) seek to join IPR2016-00237.  Also, IPR2016-01191 (Apotex), IPR2016-01337 (Wockhardt), and IPR2016-01343 (Teva and Fresenius) seek to join IPR2016-00240.  Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt) and IPR2016-01340 (Teva and Fresenius) seek to join IPR2016-00318.

Lupin Ltd. et al. v. Horizon Therapeutics, Inc.

PTAB Petition:  IPR2016-00829; filed April 1, 2016.

PTAB Trial Instituted September 30, 2016.

Patent at Issue:  U.S. Patent No. 9,095,559 ("Methods of therapeutic monitoring of nitrogen scavenging drugs," issued August 4, 2015) claims methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.

Petitioners Lupin Ltd. and Lupin Pharmaceuticals Inc. are challenging the '559 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Toni R. Scheiner, Deborah Katz (author), and Grace Karaffa Obermann issued a decision instituting review of claims 1-15 of the '559 patent on the grounds that claims 1, 2, 4, 5, 7–10, 12, and 13 are obvious under 35 U.S.C. § 103 over Blau, Simell, and 2010/0008859 A1 (the '859 Publication); and claims 3, 6, 11, 14, and 15 are obvious under 35 U.S.C. § 103 over Blau, Simell, the '859 publication, and Saul W. Brusilow et al., Treatment of Episodic Hyperammonia in Children with Inborn Errors of Urea Synthesis, 310 NEW ENGLAND JOURNAL OF MEDICINE 1630–34 (1984).  View the decision here.

Related Matters:  According to the petition, the '559 patent is the subject of litigation in the District Court for the District of New Jersey captioned Horizon Therapeutics, Inc v. Lupin Ltd. et al, Case No. 1:15-cv-07624 as well as Horizon Therapeutics, Inc. v. Par Pharmaceutical, Inc., Case No. 1:16-cv-03910-RBK-JS, also in the District of New Jersey.  The petition also states that U.S. Patent No. 8,404,215, which issued from the parent application of the '559 patent, was the subject of IPR2015-01127, filed by Par Pharmaceutical, Inc., and IPR2016-00284, which was instituted and joined with the IPR2015-01127 proceeding.