Updates & Events

June 20, 2017

Kyle Bass Ends with a Bang: Success in Final PTAB Decision

Authors: Tucker Terhufen and Tasha Francis

Introduction

On June 7, 2017, Kyle Bass received his last final written decision in a long list of PTAB decisions rendered over the past two years as Kyle Bass sought to invalidate pharma patents.  U.S. Patent No. 8,476,010 (the “’010 patent”) is owned by Fresenius Kabi USA, and is the only Orange Book patent covering Fresenius’ anesthetic drug Diprivan®.  The Board found all challenged claims unpatentable as obvious.

Background and Decision

Diprivan® is a commonly used intravenous anesthesia agent.  The key ingredient, propofol, is an insoluble oil that must be incorporated with solubilizing agents, solvents, or an oil in water emulsion.  If the mixture is not stored in inert containers, propofol degrades.  Claims of the ’010 patent cover sterile propofol-oil in water emulsion mixtures stored in an inert container.  The specification lists advantages of the invention including excellent exhibition of antimicrobial activity.

On November 25, 2015, Kyle Bass and Erich Spangenberg filed an inter partes review (“IPR”) of claims 1, 13-15, 17, 18, 20, and 24-28 of the ’010 patent—all on obviousness grounds—and on June 8, 2016 the Board instituted review.  The claims were challenged in view of two prior art combinations, each containing three prior art references.  (IPR2016-00254, Paper No. 47 at 5.)  The primary reference in each combination was a Diprivan® Physician’s Desk Reference that provided product information dating back to 1997.  (Id. at 5.)  The main secondary reference was also shared among the combinations, and was an article discussing the storage of Diprivan®.  Each combination also had a third reference, the first combination included a patent that discusses siliconizing containers and rubber stoppers, and the second combination included a patent application that discusses the same.  (Id. at 10, 28.)  The Board found all of the challenged claims to be obvious in light of the cited prior art and held them all unpatentable.  (Id. at 30.)  Fresenius presented no objective evidence of nonobviousness.

Summary of Bass’s IPR Activity

This final written decision marks the end of Bass’s challenges to pharma patents.  Over the past two years, Bass filed 37 IPR petitions, challenging 30 patents, covering 17 different drugs.  The Board instituted 21 of those petitions.  In two instances (Bravecto® and Suprenza®), opposing parties declined to file a response or abandoned the contest, resulting in cancelled claims.  As shown in the table below, Bass was successful in 10 of the 19 IPRs where the PTAB issued a final written decision.  That means Bass had a trial win rate of 53%.  While Bass committed to seeing the IPR challenges through final written decision, it appears as though Bass is not participating in appeals of PTAB decisions in which he successfully invalided patent claims.   Bass has not filed an IPR since March of 2016, so this is likely the last we will hear from Bass’s pharma patent challenges.

IPR Case No. Filing Date Patent Owner Drug US Pat No. Claims Invalidated
IPR2015-00988 4/1/15 Shire Inc./Cosmo Technologies Ltd. Lialda® 6,773,720 None
IPR2015-00990 4/1/15 NPS Pharmaceuticals, Inc. Gattex® 7,056,886 46-52 and 61-75
IPR2015-01092 4/23/15 Celgene Corporation Pomalyst® and Revlimid® 6,045,501 1-10 (all)
IPR2015-01093 4/23/15 NPS Pharmaceuticals, Inc. Gattex® 7,056,886 1-27, 31-40, and 44-45
IPR2015-01096 4/23/15 Celgene Corporation Pomalyst® and Revlimid® 6,315,720 1-32 (all)
IPR2015-01102 4/23/15 Celgene Corporation Pomalyst® and Revlimid® 6,315,720 1-32 (all)
IPR2015-01103 4/23/15 Celgene Corporation Pomalyst® and Revlimid® 6,315,720 1-32 (all)
IPR2015-01718 8/12/15 Horizon Pharma USA Vimovo® 8,945,621 None
IPR2015-01776 8/20/15 Anacor Pharmaceuticals, Inc. Kerydin® 7,582,621 1-12 (all)
IPR2015-01780 8/20/15 Anacor Pharmaceuticals, Inc. Kerydin® 7,767,657 1-24 (all)
IPR2015-01785 8/20/15 Anacor Pharmaceuticals, Inc. Kerydin® 7,767,657 1-24 (all)
IPR2015-01835 8/28/15 The Trustees of the University of Pennsylvania Juxtapid® 8,618,135 None
IPR2015-01836 8/28/15 The Trustees of the University of Pennsylvania Juxtapid® 7,932,268 None
IPR2015-01850 9/2/15 Acorda Therapeutics, Inc. Ampyra® 8,440,703 None
IPR2015-01853 9/2/15 Acorda Therapeutics, Inc. Ampyra® 8,007,826 None
IPR2015-01857 9/2/15 Acorda Therapeutics, Inc. Ampyra® 8,663,685 None
IPR2015-01858 9/2/15 Acorda Therapeutics, Inc. Ampyra® 8,354,437 None
IPR2015-01993 9/28/15 Biogen MA, Inc. Tecfidera® 8,399,514 None
IPR2016-00245 11/24/15 Alpex Pharma Suprenza® 8,440,170 1-3, 5-6, and 8-9
IPR2016-00694 3/1/16 Nissan Chemical Industries, Ltd. Bravecto™

 

8,796,464 1
IPR2016-00254 11/25/2015 Fresenius Kabi USA, LLC Diprivan® 8,476,010 1, 13-15, 17, 18, 20, and 24-28

 

No Comments

Sorry, the comment form is closed at this time.

Fill out the form below to receive our monthly newsletter and updates on your selected areas of interest. You can unsubscribe at any time by clicking the unsubscribe link at the bottom of the email.

  • This field is for validation purposes and should be left unchanged.