PTAB Institutes Series of IPRs Brought by Pfizer Against Sanofi Patents

By IPWatchdog
August 26, 2019

During the week of August 12 – 16, the Patent Trial and Appeal Board (PTAB), issued 26 institution-phase decisions in inter partes review (IPR) proceedings. Nine IPR petitions were denied institution while 17 were instituted; nine of the instituted IPRs were joined to other proceedings that are already ongoing at the agency. Pfizer saw a lot of success last week in having seven IPRs instituted against Sanofi-Aventis, challenging four injectable insulin treatment patents that are at the center of district court infringement litigation between the two parties. The PTAB also instituted IPRs on a series of three LifeNet patents covering tissue graft technologies, which have been asserted against RTI Surgical, including one patent which helped LifeNet earn a multimillion-dollar award for patent infringement in district court.

Pfizer Inc. v. Sanofi-Aventis Deutschland GmbH

On August 15, the PTAB instituted a series of seven IPR petitions that were filed by drugmaker Pfizer against rival pharmaceutical firm Sanofi-Aventis. The IPRs challenge the validity of a series of three patents covering Sanofi’s Lantus and Lantus SoloSTAR injectable diabetes treatments. In all but one case, the Pfizer IPRs instituted by the PTAB have also been joined with other IPRs that were petitioned by Mylan.

The Lantus patents challenged by Pfizer have been asserted by Sanofi in the District of New Jersey against Mylan and in two District of Delaware cases filed against Eli Lilly and Merck, Sharp and Dohme. The patents challenged in the recently instituted Pfizer IPRs include U.S. Patent No. 8992486, Pen-Type Injector; U.S. Patent No. 8603044, same title as the ‘486 patent; U.S. Patent No. 8679069, same title as the ‘486 patent; and U.S. Patent No. 9604008, Drive Mechanisms Suitable for Use in Drug Delivery Devices.

Sanofi began its enforcement of these and other patents covering injectable treatments for diabetes in response to abbreviated new drug applications (ANDAs) filed by the defendants with the U.S. Food and Drug Administration (FDA) to market generic versions of Lantus and Lantus SoloSTAR. Sanofi filed its lawsuit against Eli Lilly in May 2014, where it noted that the ‘044 and ‘069 patents were listed in the FDA’s Orange Book as part of the portfolio covering the Lantus treatments. At the time that Sanofi filed suit against Eli Lilly, Lantus was the most widely prescribed insulin treatment in the world, totalling $7.78 billion worth of sales during 2013. In Sanofi’s case against Merck, U.S. District Judge Richard Andrews dismissed Merck’s motion for summary judgment of noninfringement of six patents, including the ‘486, ‘069 and ‘044 patents, over Merck’s arguments that Sanofi exhausted its patent rights in injectable pen components sold to Merck by Ypsomed, which had entered into a license agreement with Sanofi regarding the injectable pen patents. Sanofi’s lawsuit against Mylan, where it asserted all four patents challenged in the recently instituted Pfizer IPRs, was filed in October 2017.

Sanofi’s ‘486 patent was challenged on Section 103 obviousness grounds by three of Pfizer’s IPR petitions recently instituted and joined with Mylan’s petitions. In IPR2019-00980, 26 claims of the ‘486 patent are challenged over prior art reference U.S. Patent No. 6235004, Injection Syringe (“Steenfeldt-Jensen”) alone or Steenfeldt-Jensen in combination with U.S. Patent Application No. 20020052578, Injection Device (“Moller”). Claims 51 through 57 of the ‘486 patent challenged in IPR2019-00981 are alleged to be unpatentable over various combinations of Steenfeldt-Jenson, Moller and U.S. Patent No. 6221046, Recyclable Medication Dispensing Device (“Burroughs”). Then in IPR2019-00982 , Pfizer challenges the same claims targeted in the ‘980 IPR based on Burroughs as the sole prior art reference.

Two of the Pfizer IPRs challenge the ‘044 patent based on the same prior art. IPR2019-00977 challenges claims 11, 14, 15, 18 and 19 as obvious over Burroughs, and IPR2019-00978  challenges the same claims of the ‘044 patent based on Steenfeldt-Jensen either alone or in combination with Moller. The final Pfizer IPR joined to a Mylan petition is IPR2019-00987, which challenges claims 1, 3, 7, 8, 11 and 17 of the ‘008 patent based on the combination of Steenfeldt-Jensen and Moller.

IPR2019-00979, the sole Pfizer IPR challenging the ‘069 patent, was instituted by the PTAB but the Board denied Pfizer’s motion for joinder with the ongoing Mylan proceedings. Claims 1 through 3 of the ‘069 patent are challenged based on the same three pieces of prior art asserted in the other Pfizer IPRs. In denying Pfizer’s motion for joinder, the PTAB found that joining the IPRs wouldn’t create judicial efficiency because claims 2 and 3 aren’t challenged in the Mylan IPR and withdrawing Pfizer’s expert testimony as per the joinder agreement would eliminate testimony required to evaluate the patentability of claims 2 and 3.

Mylan has seen some success already in challenging Sanofi’s Lantus patents at the PTAB. Last December, the PTAB issued final written decisions in two Mylan IPRs which reportedly invalidated all claims of two Lantus patents as obvious over the asserted prior art. Although Sanofi presented evidence of Lantus’ commercial success to overcome the obviousness allegations, the PTAB found that Sanofi failed to account for blocking patents covering the insulin glargine compound preventing competitors from commercializing their own insulin products.

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RTI Surgical, Inc. v. LifeNet Health

On August 12, a panel of PTAB administrative patent judges (APJs) instituted a trio of IPR proceedings filed by medical implant firm RTI Surgical challenging three patents asserted against it in U.S. district court by rival bio-implant firm LifeNet. The challenged LifeNet patents include one covering a tissue graft preparation technology, which helped LifeNet earn a nearly $35 million award for patent infringement.

The LifeNet patents targeted in these IPR proceedings include U.S. Patent No. 6569200, Plasticized Soft Tissue Grafts, and Methods of Making and Using Same; U.S. Patent No. 9579420, Plasticized Bone and Soft Tissue Grafts and Methods of Making and Using Same; and U.S. Patent No. 9585986, same title as the ‘420 patent. All three of these patents are involved in pending litigation against RTI Surgical which is ongoing in Northern District of Florida. The ‘200 patent was involved in LifeNet’s case against LifeCell which resulted in a $34.7 million in patent infringement damages being awarded in the Eastern District of Virginia. That award and the ‘200 patent’s validity were both upheld in a September 2016 decision by the U.S. Court of Appeals for the Federal Circuit.

RTI Surgical challenges the validity of claims 1 through 10, 12, 13 and 15 of the ‘200 patent on grounds of either Section 102(b) anticipation or Section 103(a) obviousness in IPR2019-00571. RTI Surgical alleges that the majority of the challenged claims are either anticipated or obvious in light of either of two asserted prior art references: WO Patent Application No. 1998007452, Method of Sterilising Material for Implantation (“Walker”); or U.S. Patent No. 5336616, Method for Processing and Preserving Collagen-Based Tissues for Implantation (“Livesey”). Claim 4 of the ‘200 patent is challenged based on either Walker or Livesey in view of U.S. Patent No. 4357274, Process for the Manufacture of Sclero Protein Transplants With Increased Biological Stability (“Werner”). In instituting the IPR, the PTAB determined that RTI Surgical demonstrated a reasonable likelihood on prevailing on both its obviousness and anticipation allegations related to Walker, which covers a method for sterilizing implantable material by storing it in an ethanol solution and treating it with ethylene oxide, and Livesey, which covers a method for preserving tissue matrices for transplantation by treating them with a cryoprotectant solution such as glycerol. LifeNet argued that this IPR should be denied through the PTAB’s discretionary authority under 35 U.S.C. § 314(a) in part because the Livesey and Werner prior art references were already asserted in the LifeCell litigation. The PTAB refused to exercise this discretionary authority primarily because the ‘200 patent hadn’t been challenged in light of the Walker reference.

Challenges to the ‘420 patent in IPR2019-00572 and the ‘986 patent in IPR2019-00573 essentially rely on the same prior art challenges of Walker alone, Livesey alone or the combination of Walker, Livesey and Werner. The PTAB also determined that RTI Surgical demonstrated a reasonable likelihood of prevailing on its invalidity arguments leading to the institution of both of these IPRs. LifeNet also tried to have the PTAB exercise its discretion to deny institution of these IPRs, on 35 U.S.C. § 325(d) in both cases, but again such discretion was ultimately not exercised because of the Walker reference which hadn’t been analyzed in prior validity proceedings.

IPRs Instituted Week Ending Friday, August 16 

IPR2019-00451: Aquestive Therapeutics, Inc. v. Neurelis, Inc.U.S. Patent No. 9763876, Administration of Benzodiazepine Compositions

IPR2019-00583: KEMET Electronics Corp. v. MEC Resources, LLCU.S. Patent No. 6137390, Inductors With Minimized EMT Effect and the Method of Manufacturing the Same

IPR2019-00625: Curt Manufacturing, LLC v. Horizon Global Americas Inc.U.S. Patent No. 6068352, Microprocessor-Based Control for Trailer Brakes

IPR2019-00683: ClearOne, Inc. v. Shure Acquisition Holdings, Inc.U.S. Patent No. 9565493, Array Microphone System and Method of Assembling the Same

IPR2019-00702: Apple Inc. v. Uniloc 2017 LLCU.S. Patent No. 7969925, Peer-to-Peer Mobile Data Transfer Method and Device

IPR2019-00748: Google LLC v. Realtime Adaptive Streaming, LLCU.S. Patent No. 8934535, Systems and Methods for Video and Audio Data Storage and Distribution

IPR2019-00760: Comcast Cable Communications, LLC v. Realtime Adaptive Streaming, LLC – the ‘535 patent also challenged by Google

IPRs Denied Institution Week Ending Friday, August 16

IPR2019-00630: Nelson Products, Inc. v. Bal Seal Engineering, Inc.U.S. Patent No. 8561274, Method for Controlling Connect and Disconnect Forces of a Connector

IPR2019-00654: Kingston Technology Company, Inc. v. Memory Technologies, LLCU.S. Patent No. 7565469, Multimedia Card Interface Method, Computer Program Product and Apparatus

IPR2019-00658: Hewlett Packard Enterprise Company v. Chrimar Systems, Inc.U.S. Patent No. 9812825, Ethernet Device

IPR2019-00668 and IPR2019-00669: Niantic, Inc. v. Barbaro Technologies, LLCU.S. Patent No. 7373377, Interactive Virtual Thematic Environment

IPR2019-00671: Lyft Inc. v. RideApp, Inc.U.S. Patent No. 6697730, Communications and Computing Based Urban Transit System

IPR2019-00754: Supercell Oy v. GREE, Inc. U.S. Patent No. 9604137, Server, Control Method Therefor, Computer-Readable Recording Medium, and Game System

IPR2019-00756: Supercell Oy v. GREE, Inc.U.S. Patent No. 9956481, same title as the ‘137 patent

IPR2019-00804: Nitro Fluids, LLC v. Cameron International Corp. U.S. Patent No. 9903190, Modular Fracturing System

 

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