United States District Court, D. Delaware
BOSTON SCIENTIFIC CORPORATION and BOSTON SCIENTIFIC SCMED, INC., Plaintiffs,
EDWARDS LIFESCIENCES CORPORATION, Defendant. EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES PVT, INC., and EDWARDS LIFESCIENCES LLC, Counterclaim and Third-Party Plaintiffs,
BOSTON SCIENTIFIC CORPORATION, BOSTON SCIENTIFIC SCIMED, INC., and SADRA MEDICAL, INC., Counterclaim and Third-Party Defendants.
R. Fallon Judge
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.
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)
February 17, 2017, Edwards served subpoenas on Dr. Jennifer
K. White ("Dr. White"),  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.
Facts Underlying Inventorship Claim
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)
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.)
April 21, 2016, Edwards entered into an Asset Purchase
Agreement with Dr. White and Jenesis. (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
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. (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. (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.