United States District Court, S.D. New York
FERRING B.V., FERRING INTERNATIONAL CENTER S.A., and FERRING PHARMACEUTICALS INC., Plaintiffs and Counter-Defendants,
SERENITY PHARMACEUTICALS, LLC, REPRISE BIOPHARMACEUT1CS, LLC, AVADEL SPECIALTY PHARMACEUTICALS, LLC, Defendants and Counterclaimants.
MEMORANDUM DECISION AND ORDER DENYING DEFENDANTS'
MOTIONS FOR RELIEF UNDER FEDERAL RULE OF CIVIL PROCEDURE
defendants Ferring Pharmaceuticals Inc., Ferring B.V., and
Ferring International Center S. A. ("Ferring") move
to vacate this Court's Collateral Estoppel order, (Dkt.
No. 517), under Federal Rule of Civil Procedure 60(b).
Ferring alleges that certain findings of fact made by my
colleague The Hon. P. Kevin Castel in the action in which my
late colleague Judge Sweet originally entered an equitable
estoppel order - later relied on by this court to preclude
Ferring from asserting certain affirmative claims - renders
Judge Sweet's original order erroneous and should cause
this Court to vacate the Collateral Estoppel order.
motion is DENIED.
facts and prior proceedings underlying this action were
previously set forth in Ferring B.V. v. Serenity
Pharmaceuticals, LLC, 391 F.Supp.3d 265 (S.D.N.Y. 2019).
Familiarity with the general background of this case is
separate lawsuits, involving four patents directed to
pharmaceutical formulations of the drug desmopressin, are
relevant to this motion.
the patents - U.S. Patent Nos. 7, 405, 203, (the
'"203 patent") and 7, 579, 321, (the
"'321 patent") - are held by Dr. Seymour Fein
as the named inventor (collectively, the "Fein
other two - U.S. Patent Nos. 7, 560, 429 (the '"429
patent") and 7, 947, 654 (the '"654
patent") - are held by Ferring (collectively, the
first action (the 2012 Action) was brought by Ferring on
April 5, 2012. That suit sought to have Ferring replace Fein
as the inventor on the Fein Patents. Serenity and Reprise
counterclaimed for a declaration that Dr. Fein was in fact
the inventor of the Ferring Patents. The case was originally
pending before The Hon. Robert W. Sweet; it was transferred
to The Hon. P. Kevin Castel on April 8, 2019, following Judge
order and one judgement from the 2012 Action are relevant to
this motion: (1) Judge Sweet's September 22, 2015 opinion
in which he held that Ferring was equitably estopped to
assert its claim to have it replace Fein as the named
inventor on the Fein Patents, Ferring B. V. v. Allergan,
Inc., 253 F.Supp.3d 708 (S.D.N.Y. 2015), 12-cv-2650,
Dkt. No. 190 (the "Equitable Estoppel Opinion"))
and (2) Judge Castel's September 27, 2019 Findings of
Fact and Conclusions of Law, entered after the completion of
the trial on the Serenity/Repose counterclaims. (12-cv-2650,
Dkt. No. 453 ("Findings of Fact")).
second lawsuit (The 2017 Action, which is this case) was
filed in the District of Delaware on April 28, 2017, again by
Fencing. This time Ferring sought a declaration that the Fein
Patents (which were no longer being litigated in Action #1)
were invalid and unenforceable on various grounds. The case
was transferred to this District on December 20, 2017,
assigned to Judge Sweet on January 11, 2018, and reassigned
to me on April 8, 2019, again after Judge Sweet's death.
order from this action is relevant to this motion: this
Court's June 12, 2019 opinion holding that, under the
doctrine of collateral estoppel, Judge Sweet's Equitable
Estoppel opinion barred Ferring from asserting an affirmative
claim that it, rather than Fein, was the actual inventor on
the Fein Patents. (Dkt. No. 5l7.) ("Collateral Estoppel
The 2012 Action
2012, Ferring brought an action for correction of patent
inventorship under 35 U.S, C. § 256 against Serenity and
Reprise, (12-cv-2650, Dkt. No. 1 ("the 2012
sought a declaration that it - and not Dr. Fein - was the
inventor of Fein's '203 and '321 patents related
to the low dosage application of desmopressin. Ferring
therefore sought to have the PTO correct the patent by
listing Ferring and two Ferring employees, rather than Fein,
as the inventor on the Fein Patents.
and Reprise asserted counterclaims against Ferring, alleging
that Dr. Fein was the actual inventor, or at least a
co-inventor, of the inventions in Ferring's '429 and
'654 patents, I. The Equitable Estoppel
April 17, 2015, Serenity and Reprise - the defendants in the
2012 Action - moved for summary judgment dismissing
Ferring's inventorship claims. (12 civ. 2650 Dkt. No.
132.) They move on the ground that Ferring was equitably
estopped from claiming that it was the true inventor of the
'203 and '321 patents, because Ferring had unduly
"delayed advancing [its] claims in [the] litigation in
order to impose the risks and costs of drug development on
[Dr. Fein and his codefendants] and then to obtain patent
correction in [its] favor." Ferring B. V. v.
Alkrgcm, Inc., 253 F.Supp.3d 708, 710. They argued that
it would be unfair for Ferring to claim that it was the true
inventor on the Fein patents after it sat on the sidelines
for seven years while Dr. Fein, relying on Ferring's
acquiescence, invested millions in developing his
September 22, 2015, Judge Sweet granted the motion by
Serenity and Reprise and dismissed Ferring's claim for
correction of patent inventorship on the '203 Patent and
the 321 patents - not on the merits, but on the ground of
equitable estoppel. (Ferring B. V. v. Allergan,
Inc., 253 F.Supp.3d 708 (S.D.N, Y. 2015), 12-cv-2650,
Dkt. No. 190 (the "Equitable Estoppel Opinion")).
Sweet found that Ferring was equitably estopped from bringing
a claim to obtain patent correction in its favor because
despite extensive correspondence spanning several years
between Ferring and Dr. Fein concerning Dr. Fein's
inventorship "Ferring made no response and took no
further action for over seven years, while Defendants
expended significant resources prosecuting, developing, and
commercializing Dr. Fein's patents." Id. at
717. Crucially, Ferring's litigation position that its
employees should be the named inventors of the Fein Patents
contradicted its representation to Fein that the low-dosage
formulation that was the subject of the patents "was not
patentable at all." Id. at 719. Judge Sweet
dismissed Ferring's inventorship claims because of
Defendants' reliance on Ferring's representations and
its delay in taking any action against Fein, despite knowing
that he had obtained patents on these supposedly
"unpatentable" inventions, and then - having
obtained the patents - developing products utilizing the
appeal from Judge Sweet's Equitable Estoppel Opinion is
presently pending in the Federal Circuit. (CAFC Appeal No.
the entry of summary judgment and the dismissal of
Ferring's claims, Judge Sweet began a trial on Serenity
and Reprise's counterclaims. However, on September 14,
2018, the trial was interrupted, and further proceedings were
stayed, pending the outcome of an interlocutory appeal filed
by Ferring with the Federal Circuit, Felling's petition
was finally denied by the Federal Circuit on March 8, 2019
(2012 Action, Dkt. No. 359). But before the trial could
resume, Judge Sweet unexpectedly died.
2012 Case was then transferred to my colleague, The Hon. P.
Kevin Castel, On May 10, 2019, Ferring filed a motion for
relief under Rule 60(b), seeking to vacate Judge Sweet's
Equitable Estoppel Opinion. Ferring argued that certain claim
construction rulings made by Judge Sweet in the 2017 Case
(17-cv-9922, Dkt. No. 421) "negated" the foundation
of that decision. (2012 Action, Dkt. No. 374 at 1.)
18, 2019, Judge Castel denied Ferring's 60(b) motion,
holding that "no exceptional circumstances"
warranted the vacatur of the Equitable Estoppel opinion.
Ferring B. V. el al v. Allergan, Inc. et
al, 2019 WL 3239007, *3 (S.D.N.Y. July 1 8, 2019).
Judge Castel's Findings of Fad and Conclusions of Law in
the 2012 Action
Castel then resumed the bench trial in the 2012 Action that
had been interrupted by Ferring's interlocutory appeal.
What remained to be tried were Serenity's and
Reprise's counterclaim for correction of inventorship of
Ferring's patents - the '429 and '654
September 27, 2019, following a five-day bench trial, Judge
Castel issued his Findings of Fact and Conclusions of Law in
the 2012 Action. (2012 Action, Dkt No. 453, the
"Findings of Fact.") Judge Castel concluded that
Serenity and Reprise had failed to prove, by clear and
convincing evidence, that Dr. Fein was the actual inventor of
the inventions claimed in the '429 and '654 patents.
Specifically, Judge Castel concluded that Serenity and
Reprise did not prove by clear and convincing evidence that
Dr. Fein "conceived of the general use of lower doses of
desmopressin" or "that Fein contributed 'to the
conception of the subject matter' of claims of the
patents-in-suit in any manner that was not insignificant in
quality." (Id. at 35) (citation omitted).
appeal was filed from Judge Castel's decision but was
later withdrawn. It is my understanding that the only issue
presently on appeal in the Federal Circuit in connection with
the 2012 Action is the Equitable Estoppel Opinion.
The Present Litigation
2017, Ferring filed a declaratory judgment lawsuit against
Serenity and Reprise in the District of Delaware, seeking a
declaration that the two Fein patents - the '203 and
'321 patents -were unenforceable because of Dr.
Fein's allegedly inequitable conduct before the Patent
Office. The complaint also sought a declaration that the Fein
patents were invalid for four separate reasons: (1)
invalidity under 35 U, SC § 102(f) on the grounds that
Dr. Fein did not actually invent the subject matter claimed
in the Patents in suit (because Ferring did); (2) invalidity
under 35 U, SC § 112 for lack of enablement; (3)