United States District Court, E.D. Texas, Marshall Division
MEMORANDUM OPINION AND ORDER
WILLIAM C. BRYSON UNITED STATES CIRCUIT JUDGE
the Court is Defendants' Motion for Leave to Amend
Invalidity Contentions (“Motion to
Amend”), Dkt. No. 303. The Motion to
Amend is GRANTED, and the parties are directed to meet
and confer regarding appropriate fact discovery related to
the subject matter of the motion, as discussed below.
defendant pharmaceutical companies are seeking approval by
the Food and Drug Administration to sell a generic version of
Restasis, an ophthalmic product sold by plaintiff Allergan,
Inc. On August 24, 2015, Allergan filed a patent infringement
action under the Hatch-Waxman Act against defendants Teva
Pharmaceuticals USA, Inc.; Akorn, Inc.; Mylan
Pharmaceuticals, Inc.; and Mylan, Inc., alleging infringement
of several Allergan patents related to Restasis.
Allergan, Inc. v. Teva Pharmaceuticals USA, Inc.,
No. 2:15-cv-1455 (E.D. Tex.). Allergan later filed related
actions against defendants Innopharma, Inc., and Famy Care
Limited. Allergan, Inc. v. Innopharma, Inc., No.
2:15-cv-1504 (E.D. Tex., filed Sept. 8, 2015); Allergan,
Inc. v. Famy Care Ltd., No. 2:16-cv-401 (E.D. Tex.,
filed April 12, 2016). The latter two actions were
consolidated with case no. 2:15-cv-1455.
defendants asserted anticipation and obviousness defenses
based on two patents issued to Dr. Shulin Ding, who worked
for Allergan as a formulator from 1987 to 1998. See
Dkt. No. 303-2, at 9. During the discovery period, Allergan
turned over documents related to Dr. Ding's work on
cyclosporin treatments. In March 2016, Allergan produced Dr.
Ding's 1997 Technical Report entitled “Technology
Transfer Report for Phase III Manufacture of Cyclosporine
0.1% and 0.05% Ophthalmic Emulsions, ” as well as a
draft technical report entitled “Freeze to Thaw and Low
to High Cycling Studies Report for Cyclosporine Ophthalmic
Emulsion Formulations 8735X and 9054X.” See
Dkt. No. 315-1. In September 2016, Allergan produced the
laboratory notebook of Toan Ha, who worked under Dr. Ding.
See Dkt. No. 315-2.
January 2017, the defendants deposed several witnesses
regarding Dr. Ding's involvement in Allergan's
development of Restasis. See, e.g., Dkt. No. 314-2,
at 33, 51. On January 16, 2017, the defendants noticed Dr.
Ding's deposition and served a subpoena for the
production of documents related to her work on the
development of Restasis. See Dkt. No. 314, at 4.
discovery closed on February 10, 2017. See Dkt. No.
269, at 2. The defendants deposed Dr. Ding on February 24,
2017, as she had not been available before then, see
Dkt. No. 314, at 4. Additional materials were produced to the
defendants the day before her deposition, including a copy of
the previously produced draft technical report, but with Dr.
Ding's handwritten notes on it. Dkt. No. 303, at 6-7.
March 20, 2017, the defendants notified Allergan that they
intended to seek leave to add a new invalidity theory of
incorrect inventorship under 35 U.S.C. § 102(f).
Allergan opposed the amendment. See Dkt. No. 314, at
deadline for the parties to amend their pleadings was June 9,
2016. Dkt. No. 137, at 3. The defendants filed their Motion
to Amend on March 24, 2017.
scheduling order has been entered in a case and a deadline
has been set for filing amended pleadings, the decision
whether to permit a post-deadline amendment is governed by
Fed.R.Civ.P. 16(b). See Squyres v. Heico Companies,
L.L.C., 782 F.3d 224, 237 (5th Cir. 2015); EEOC v.
Serv. Temps Inc., 679 F.3d 323, 333-34 (5th Cir. 2012);
L.G. Motorsports, Inc. v. NGMCO, Inc., No.
4:11-cv-112, 2013 WL 2543398, at *6 (E.D. Tex. June 6, 2013).
Under Rule 16(b)(4), a motion to modify the scheduling order
by permitting the filing of an amended pleading after the
deadline in the scheduling order may be granted “only
for good cause and with the judge's consent.”
party seeking to modify a scheduling order has the burden to
show good cause. Squyres, 782 F.3d at 237; Self
v. Quinn's Rental Servs. (USA), LLC, Civil Action
No. H-15-1569, 2016 WL 6835093, at *1 (S.D. Tex. Nov. 21,
2016). Moreover, the Fifth Circuit has held that Rule 16
gives trial courts “broad discretion to preserve the
integrity and purpose of the pretrial order.”
Geiserman v. MacDonald, 893 F.2d 787, 790 (5th Cir.
1990) (quoting Hodges v. United States, 597 F.2d
1014, 1018 (5th Cir. 1979)). The Fifth Circuit has directed
that in deciding whether to permit amendments to the
pleadings after the deadline for such amendments, district
courts should consider “(1) the explanation for the
party's failure to [timely move for leave to amend]; (2)
the importance of the [amendment]; (3) potential prejudice in
allowing the [amendment]; and (4) the availability of a
continuance to cure such prejudice.” United States
ex rel. Bias v. Tangipahoa Parish Sch. Bd., 816 F.3d
315, 328 (5th Cir. 2016) (quoting S&WEnters., L.L.C. v. SouthTrust Bank of Ala., N.A.,
315 F.3d 533, 536 (5th Cir. 2003) ...