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Boston Scientific Corp. v. Edwards Lifesciences Corp.

United States District Court, D. Delaware

January 10, 2018

BOSTON SCIENTIFIC CORPORATION and BOSTON SCIENTIFIC SCMED, INC., Plaintiffs,
v.
EDWARDS LIFESCIENCES CORPORATION, Defendant. EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES PVT, INC., and EDWARDS LIFESCIENCES LLC, Counterclaim and Third-Party Plaintiffs,
v.
BOSTON SCIENTIFIC CORPORATION, BOSTON SCIENTIFIC SCIMED, INC., and SADRA MEDICAL, INC., Counterclaim and Third-Party Defendants.

         UNDER SEAL

          MEMORANDUM OPINION

          Sherry R. Fallon Judge

         I. INTRODUCTION

         Presently before the court in this patent infringement action is Edwards Lifesciences Corporation, Edwards Lifesciences PVT, Inc., and Edwards Lifesciences LLC (collectively, "Edwards") motion for leave to amend its answer and counterclaims pursuant to Federal Rules of Civil Procedure 15(a)(2) and 16(b)(4). (D.I. 166) Plaintiffs and counterclaim defendants Boston Scientific Corporation and Boston Scientific Scimed, Inc., and third-party defendant Sadra Medical Inc. ("Sadra") (collectively, "Boston Scientific"), oppose the motion. (D.I. 176) For the following reasons, the court will grant Edwards' motion for leave to amend its answer and counterclaims.

         II. BACKGROUND

         A. Procedural History

         On April 19, 2016, Boston Scientific filed this suit against Edwards Lifesciences Corporation, alleging infringement of U.S. Patent No. 8, 992, 608 ("the '608 patent"). (D.I. 1) On June 9, 2016, Edwards filed its answer and counterclaims for noninfringement, invalidity, and infringement of U.S. Patent Nos. 9, 168, 133, 9, 339, 383, and 7, 510, 575. (D.I. 10) Pursuant to the court's scheduling order, the deadline to file a motion to amend pleadings was November 30, 2016. (D.I. 34 at ¶ 2) On November 30, 2016, Edwards filed its first motion for leave to amend its answer, which was subsequently granted by the court. (D.I. 65; D.I. 103)

         On February 17, 2017, Edwards served subpoenas on Dr. Jennifer K. White ("Dr. White"), [1] seeking her deposition and the production of documents pertaining to her work on heart valves. (D.I. 94) The court's scheduling order prohibited deposing individuals before February 24, 2017. (D.I. 34, ¶ 1 (f)(1)) Dr. White produced responsive documents on April 3, 2017 and April 12, 2017. (D.I. 167 at 8) Edwards deposed Dr. White on April 18, 2017. (D.I. 167, Ex. 1) On May 3, 2017, Edwards filed the present motion for leave to amend its answer to include new defenses and counterclaims involving improper inventorship of the '608 patent based on information obtained during the deposition of Dr. White. (Id.) According to the most recent revised scheduling order, fact discovery closed on June 30, 2017. (D.I. 153)

         B. Facts Underlying Inventorship Claim

         During her deposition, Dr. White testified that she met with Amr Salahieh ("Mr. Salahieh"), one of the named inventors of the '608 patent and co-founder of Sadra, in August 2003 and September 2003 to discuss designing new transcatheter heart valves ("THVs") for Sadra. (D.I. 167, Ex. 1 at 142:23-154:3) In October 2003, Dr. White met with Mr. Salahieh and others specifically to brainstorm ideas for a THV replacement device for Sadra that would address the problem of sealing paravalvular leaks. (Id. at 154:5-161:10) Dr. White described to Sadra how to use "pockets" in an external seal to improve THVs' effectiveness. (Id. at 160:16-180:22) Shortly after these meetings, Dr. White created prototype THVs on her own, as well as with Robert Geshlider, a named inventor of the '608 patent. (Id. at 182:16-183:8; 189:19-191:7; 196:3-196:23; 201:7-201:16) The collaboration between Dr. White and Sadra concluded in December 2003. (Id. at 204:20-205:10)

         On June 26, 2009, Sadra filed the application leading to the '608 patent, bearing number 12/492, 512 ("the '512 Application"), with the United States Patent and Trademark Office. (D.I. 1, Ex. A) The '512 Application claimed a THV system that avoided paravalvular leaks. (Id.) The '512 Application listed Ulrich R. Huag, Hans F. Valencia, Robert A. Geshlider, Tom Saul, Amr Salahieh, Dwight P. Morejohn, and Kenneth J. Michlitsch as inventors. (D.I. 167, Exs. 2, 3) When the '512 Application issued as the '608 patent, the same individuals were listed as inventors. (D.I. 1, Ex. A) Dr. White was not included as one of the inventors in either the '512 Application or the '608 patent. (Id.)

         On April 21, 2016, Edwards entered into an Asset Purchase Agreement with Dr. White and Jenesis.[2] (D.I. 167, Ex. 1 at 20:7-22) Thereafter, Dr. White informed Edwards' CEO that she had collaborated with members employed by Sadra before the '608 patent was filed. (Id. at 21:3-23:3) Dr. White met with Edwards an additional three times prior to her deposition on April 18, 2017. (Id. at 258:21-24) At these meetings with Edwards, Dr. White discussed her work on seal technology for heart valves. (Id. at 263:4-264:8)

         On November 9, 2016, Edwards submitted its invalidity contentions to Boston Scientific alleging invalidity of the '608 patent pursuant under 35 U.S.C. §§ 102(f) or 116.[3] (D.I. 167, Ex. 4 at 15) In the invalidity contentions, Edwards stated that it had reason to believe that Dr. White contributed to the conception of the '608 patent by explaining how to create THV seals by using pockets during an October 2003 meeting with Sadra employees. (Id.) On February 14, 2017, the General Hospital Corporation ("GHC"), an entity of MGH, purportedly assigned the rights and interests of Dr. White's inventions to Edwards.[4] (D.I. 167, Exs. 6, 7) On May 3, 2017, Edwards filed the present motion for leave to amend its answer to include new defenses, including Edwards' alleged ownership interest in the '608 patent, and a correction of inventorship counter claim pursuant to 35 U.S.C § 256. (D.I. 166) On June 6, 2017, Dr. White filed a lawsuit against Boston Scientific in the United States District Court for the District of Massachusetts, seeking to be added as an inventor to the '608 patent and U.S. Patent Application No. 14/873, 462. (D.I. 223) However, Edwards is not a party to the Massachusetts action, no party has moved to transfer the case to this court, and the case does not concern the validity of the '608 patent. (Id.)

         III. ...


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