Ferring Pharmaceuticals Inc. et al v. Serenity Pharmaceuticals, LLC et al
Filing
669
DECISION ON MOTIONS IN LIMINE denying as moot 642 Motion in Limine; granting 646 Motion in Limine; denying 649 Motion in Limine; denying 651 Motion in Limine. This constitutes the decision and order of the court. It is a written opinion. The Clerk is directed to remove the following motions from the court's list of open motions: Docket ## 642, 646, 649, and 651. (Signed by Judge Colleen McMahon on 3/11/2020) (mml)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
______________________________________________x
FERRING B.V., FERRING
INTERNATIONAL CENTER S.A., and
FERRING PHARMACEUTICALS INC.,
Plaintiffs and
Counter-Defendants,
-against-
No. 17 Civ. 9922 (CM)
SERENITY PHARMACEUTICALS, LLC,
REPRISE BIOPHARMACEUTICS, LLC,
AVADEL SPECIALTY PHARMACEUTICALS, LLC,
Defendants and
Counterclaimants.
______________________________________________x
DECISION ON MOTIONS IN LIMINE
McMahon, C.J.:
The court, for its decision on Counterclaimants' and Ferring's motions in limine:
Counterclaimants' In Limine Challenges
Counterclaimants have filed three in limine motions that seek to (i) preclude Ferring's
indefiniteness theory (Dkt. No. 646); (ii) exclude testimony and argument related to Ferring's
failed claim construction positions (Dkt. No. 649); and (iii) to preclude Ferring from offering
evidence or argument related to Dr. Fein's response to the Notice of Opposition in the European
Patent Office ("EPO") proceeding. (Dkt. No. 651.)
Each will be considered in turn.
A.
Motion to Preclude Ferring's Indefiniteness Theory
1.
Background
Ferring's pretrial submission (Dkt. No. 637, Ex. 2) indicates that it intends to present
argument or evidence at trial in support of the theory that certain asserted claims of the patentsin-suit are invalid based on indefiniteness. (35 U.S.C. § 112 ¶ 2.) Specifically, Ferring intends to
present a defense at trial that the "about" limitations of several asserted claims are indefinite
(e.g., '321 patent, cl. 6 ("wherein the method produces a plasma/serum desmopressin
concentration in the patent of a maximum of no more than about 10 pg/ml")).
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Counterclaimants allege that the indefiniteness theory was "undisclosed" because while
Ferring asserted an indefiniteness claim in its original Complaint for Declaratory Judgment (1)
neither that pleading, nor Ferring's Amended Complaint for Declaratory Judgement, contain
allegations related to the "about" claim limitations, (2) Ferring's Answer to Counterclaimants'
infringement counterclaim did not plead that the "about" claim limitations are indefinite (Dkt.
No. 18 ¶¶ 132-137; Dkt. No. 22 ¶¶ 132-137), (3) neither Ferring's initial nor final invalidity
contentions disclosed an invalidity theory based on indefiniteness.
After the close of fact and expert discovery, Ferring asked to depose Counterclaimants'
expert, Dr. Mayersohn, on his rebuttal report related to Ferring's enablement defense. According
to Counterclaimants, it was then that Ferring asked Dr. Mayersohn questions relating to the
"about" claim limitations. The basis of Ferring's indefiniteness theory arise out of Dr.
Mayersohn's response to Ferring's questions related to indefiniteness. (Dkt. No. 637, Ex. 2 at 64,
DFF249-250). Ferring is not relying on its own expert testimony to establish the indefiniteness
theory, but rather, on the testimony of Counterclaimants' expert.
Counterclaimants allege that they reasonably relied on the fact that Ferring had
abandoned its original indefiniteness defense (which were not directed at the "about" claim
limitations), because Ferring did not include any indefiniteness theories in its initial or final
invalidity contentions. Therefore, Counterclaimants sought no discovery on indefiniteness and
did not develop or disclose expert testimony on the issue.
2.
Counterclaimants motion to preclude Ferring's indefiniteness theory
is GRANTED
Ferring's failure to disclose its indefiniteness theory in both the initial and final invalidity
contentions precludes it from asserting its "about" limitation indefiniteness theory because it
would unduly prejudice Counterclaimants.
Courts have granted motions in limine to preclude untimely disclosed theories. For
example, in Abbot Labs. v. Sandoz, Inc., 743 F. Supp. 2d 762, 777 (N.D. Ill. 2010), the defendant
did not disclose its enablement and written description defense theories in any expert report, nor
in defendant's initial or final invalidity contentions. Id. at 774-75. The court found that the
important inquiry in resolving plaintiff's in limine motion was whether plaintiff had sufficient
notice of its intended defense during discovery such that it would not be prejudiced by
introduction at trial. Id. at 776. The defendant argued that plaintiff's expert's construction of
certain claim terms, along with defendant's expert's analysis of those constructions, implied the
foundation for the new defense theories. Id. The court rejected the argument because this
supposed notice by the defendant was "too subtle to compensate for its failure to disclose these
defenses during discovery" and granted plaintiff's motion in limine to preclude argument or
evidence at trial of defendant's new and untimely disclosed theories of invalidity. Id. at 777.
Here, Ferring argues that its disclosure of its indefiniteness defense is timely because it
notified Counterclaimants of its indefiniteness defense by serving Supplemental and Amended
Invalidity Contentions on December 6, 2019 ("Supplemental Contentions"), within a month of
Dr. Mayersohn's final deposition and a few months before trial. According to Ferring, at Dr.
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Mayersohn's November 2019 deposition, he sought to "roll back the opinions in his Second
Rebuttal Report … and, in doing so, indicated that he could not determine the scope of the
claims—creating an indefiniteness argument." (Dkt. No. 661 at 3.) Ferring says that it raised this
indefiniteness defense "shortly after it became clear that a person of ordinary skill (i.e., Dr.
Mayersohn) could not determine the actual scope of the asserted claims." (Id.)
Ferring's argument is unavailing. Counterclaimants' expert rebuttal report could not
"create" an indefiniteness argument, as Ferring claims. Indefiniteness, like the reasonable person
standard, is an objective standard.1 See Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598
F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (noting that "the test requires an objective inquiry
into the four corners of the specification from the perspective of a person of ordinary skill in the
art"). The subjective ability of Counterclaimants' expert to determine the scope of the asserted
claims does not give rise to an indefiniteness claim.
If the asserted claims with the "about" limitations were indefinite during
Counterclaimants' expert testimony, they were indefinite when Ferring filed its initial and final
invalidity contentions. Ferring has known about the patents-in-suit – including the asserted
claims with the "about" limitations – since at least 2012 when it filed the 2012 Action. It might
have occurred to Ferring that it could raise such an argument during the deposition, but this is a
far cry from stating that the expert's opinion "created" the defense.
Permitting such argument or testimony at trial would frustrate the disclosure
requirements of the Federal Rules and unduly prejudice Counterclaimants, who had no notice of
this theory during fact or expert discovery and had no opportunity to conduct discovery into or
elicit expert witness opinions in response.
B.
Motion to Exclude Testimony and Argument Related to Ferring's Failed Claim
Construction Positions
1.
Background
On January 22, 2019, Judge Sweet handed down the claim construction order for this
case. (Dkt. No. 421.) The Court issued, inter alia, the following constructions:
•
•
•
"Transmucosal" ('203 patent, cls. 6, 10, 13; '321 patent, cls. 1, 12): "delivering
desmopressin by way of mucosal tissue, such as the sublingual mucosa"
"Transmucosal delivery/transmucosal … delivery" ('203 patent, cls. 6, 10, 13):
"delivering desmopressin by way of mucosal tissue, such as the sublingual mucosa"
"Delivering to the bloodstream … by [via] transmucosal… administration" ('321
patent, cl. 1): administering desmopressin by way of a mucosal tissue, such as the
sublingual mucosa
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"A patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the
prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the
invention." Nautilus v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014). Further, "terms of degree such as
'substantially,' 'about,' or 'closely approximate' do not necessarily render the claim indefinite, so long as the term
'provide[s] enough certainty to one of skill in the art when read in the context of the invention." Interval Licensing
LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014).
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•
"Transmucosal administration/administering … by transmucosal administration"
('203 patent, cl. 12)" administering desmopressin by way of a mucosal tissue, such as the
sublingual mucosa
(Dkt. No. 421.) Essentially, Judge Sweet held that transmucosal administration/delivery of
desmopressin does not require transmucosal absorption of desmopressin. In so doing, he rejected
Ferring's proposal that transmucosal administration, which is required by certain asserted claims,
necessitates transmucosal absorption.
In Ferring's Proposed Findings of Fact and Conclusions of Law and direct witness
statements, Ferring has disclosed that it plans to solicit testimony from Dr. Fein along the
following lines: "Dr. Fein has admitted his invention requires sublingual absorption, but the
patents in suit do not claim sublingual absorption. [Anticipated testimony of Dr. Fein]" (Dkt. No.
637, Ex. 2 at DFF259.)
2.
Counterclaimants' motion to exclude testimony and argument related
to Ferring's failed claim construction positions is DENIED
Counterclaimants aver that "Because the claims have already been construed by the Court
and Dr. Fein's understanding of his own invention is irrelevant to the determination of proper
inventorship or patent validity, Ferring's related evidence and arguments have no probative
value" (Dkt. No. 650 at 3) and that its probative value is therefore substantially outweighed by
confusion of issues, unfair prejudice to Counterclaimants, and waste of time.
Counterclaimants motion is deficient primarily because Counterclaimants
mischaracterize Ferring's intentions regarding claim construction. Ferring does not seek to
"reargue" claim construction. Counterclaimants have affirmatively put Dr. Fein's invention story
and his understanding of his invention at issue by submitting a direct witness affidavit from Dr.
Fein that includes a section testifying about his purported "Desmopressin Inventions." (Dkt. No.
623 at ¶¶ 31-35.) In the affidavit, Dr. Fein explains that his invention is predicated on sublingual
absorption:
So, I said this new dosage form, the orodispersible tablet, provides an opportunity
to avoid the oral route of administration if it were adapted to be placed under the
tongue. That's called sublingual route of administration, and what it means is that
the drug is dissolving and being directly absorbed into the bloodstream through
the capillary bed under the tongue. That's a type of transmucosal route of
administration or transmucosal absorption.
(Dkt. No. 623 at ¶¶ 34-35.) Ferring intends to make the point that with respect to the patents in
suit, Dr. Fein did not claim sublingual absorption and therefore his purported contributions are
limited to low dose and sublingual administration. The fact that the construed claims do not
require Dr. Fein's purported contribution of sublingual absorption is relevant to the determination
of whether Dr. Fein invented what is claimed.
With respect to 102(f), an inventorship analysis "begins as a first step with a construction
of each asserted claim to determine the subject matter encompassed thereby. The second step is
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then to compare the alleged contributions of each asserted co-inventor with the subject matter of
the properly construed claim to then determine whether the correct inventors were named."
Trovan, Ltd. v. Sokymat SA, Irori, 299 F.3d 1292, 1302 (Fed. Cir. 2002).
The first step of the analysis was completed by the Court in its claim construction
analysis. As to the second step, courts look to both the alleged inventor's purported contributions
to the construed claims (i.e. Ferring's contributions) as well as the purported contributions of the
named inventor to those claims (i.e., Fein's contributions). See Advanced Magnetic Closures, Inc.
v. Rome Fastener Corp., No. 98-cv-7766, 2007 WL 1552395, at *5-6 (S.D.N.Y. May 29, 2007)
(comparing evidence of named inventor's versus the alleged inventor's contributions to the
claims in § 102(f) analysis); Finkelstein v. Mardkha, 495 F. Supp. 2d 329, 340 (S.D.N.Y. 2007)
(same). The fact that the construed claims do not require Dr. Fein's purported contribution of
sublingual absorption is relevant to the determination of whether Dr. Fein invented what is
claimed. It is also relevant to Ferring's § 112 arguments, including the written description
requirement which ensures that the "inventor actually invented the invention claimed." Ariad,
598 F.3d at 1351.
At its core, what Counterclaimants ultimately seek is an order precluding Ferring from
cross-examining Dr. Fein on his direct witness affidavit and how his "invention story" detailed
therein relates to the invention claimed in the patents in suit. However, this cross-examination is
relevant to claims and defenses Ferring has raised including invalidity under 35 U.S.C. §§ 102(f)
and 112. Counterclaimants have no reasonable basis for precluding such testimony.
C.
Motion to Preclude Ferring from Offering Evidence or Testimony related to Dr.
Fein's Response to the Notice of Opposition in the EPO.
1.
Background
Ferring initiated an opposition proceeding before the EPO after Dr. Fein was awarded a
European patent for some of his other "work"2—work directed to a specific "metered dose spray
device" used for delivery of an intranasal dosage form. In opposing the issuance of that patent,
Ferring argued to the EPO that the claims of Dr. Fein's European "metered dose spray" patent
were invalid in light of prior art references, including the '203 patent at issue here. According to
Counterclaimants, Ferring argued that the prior art, including Dr. Fein's '203 patent "enabled," or
was obvious, and so negated the novelty or inventive step of Dr. Fein's intranasal dosage form
European patent claim that Ferring was opposing.
Counterclaimants assert that "enabled" under European patent law, has a different
meaning than "enabled" under United States patent laws. According to Counterclaimants, under
European law, whether something is "enabled" by prior art reference asks whether the prior art
was obvious or negated the inventive step.
2
Despite Counterclaimants assertion that Dr. Fein was granted the patent—Eur '821—for his "inventive work," the
EPO has revoked Eur '821. (See Cox Decl. Ex. C at 2, August 30, 2019 entry ("Despatch of communication that the
patent will be revoked").)
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Under United States law by contrast, enablement is the requirement that a patent set forth
the "manner and process of making and using [the invention] … as to enable any person skilled
in the art to which it pertains … to make and use the same." § 112, ¶ 1.
Counterclaimants allege that Ferring now takes "enabled" out of its European context in
alleging that that Dr. Fein has admitted that the '203 patent claims are not enabled under U.S.
patent laws. To Counterclaimants, this is simply a matter of the particular word, "enabled,"
having two different meanings under the U.S. and European patent laws.
2.
Counterclaimants' motion to preclude Ferring from offering evidence
or argument related to Dr. Fein's response to the Notice of Opposition in the
EPO Proceedings is DENIED
Counterclaimants have not cited a single citation to any European law or regulation
tending to show that "enabled" has "two entirely different meanings under the U.S. and European
patent laws." (Dkt. No. 652 at 1.)
By contrast, Ferring intends to show, through the testimony of its expert Dr. Polz, that
under EPO case law and EPO examination guidelines, a prior art reference must have an
enabling disclosure "such that the skilled person can reproduce the subject-matter using common
general knowledge." (Dkt. No. 632 at ¶¶ 7-13 (quoting DX-52-0001).) This "enablement"
requirement under European law for a prior art reference would be the same as under U.S. law,
both being directed to whether the disclosure is sufficient for the skilled person to practice the
technical teaching which is the subject of the prior art document. Dr. Polz so explained at his
deposition. (See Cox Decl. Ex. B. at, e.g., 23:9-19, 36:12-21, 37:11-38:16.)
This is relevant because in their argument before the EPO, Serenity stated that:
It is noteworthy that the teaching of [the '203 patent] with respect to the Table in
Col. 17 is not enabled, i.e. there is [sic] no examples demonstrating that any of the
suggested dose ranges are effective to establish a steady plasma/serum
desmopressin concentration in the range of from about .1 picograms of
desmopressin per mL plasma/serum to about 10.0 picogram desmopressin per mL
plasma/serum in a patient, let alone provide therapeutic efficacy for the conditions
indicated above (e.g., inducing an antidiuretic effect for less than about 6 hours,
and which lower the risk of hyponatremia).
(DX-38-0044 at ¶ 11.14 (emphasis in original).) Ferring intends to show that before the EPO,
Serenity argued that the disclosure of the '203 patent does not provide sufficient disclosure for
the claimed limitations in the '203 patent, namely that there are no examples of the suggested
dose ranges to achieve certain plasma concentrations much less provide therapeutic efficacy.
If so, Serenity's argument that the '203 patent is not enabled before the EPO, would be
relevant as an admission against interest. See, e.g., Funai Elec. Co. v. Orion Elec. Co., No. 01cv-3501 (AGS)(JCF), 2002 WL 1808419, at *2 (S.D.N.Y. Aug. 7, 2002) ("Actions and
statements against interest of the owner of a patent or inventor may be considered by a court
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when construing the scope of a patent and are relevant to the issues of infringement and validity"
(internal quotation admitted).).
Counterclaimants' motion in limine seems far better suited for a cross-examination of Dr.
Polz at the bench trial.
Ferring's In Limine Challenges
Ferring has submitted a motion in limine to preclude testimony of Teresa Stanek Rea, the
former Acting Under Secretary of Commerce for Intellectual Property and former Acting
Director of the PTO on the grounds that her proposed testimony "(1) parrots the rules of PTO
practice and procedure and the law, (2) opines on matters not relevant to any claim or defense to
be presented at trial, (3) opines on the intent or state of mind of Dr. Seymour Fein, and/or (4)
opines on issues admittedly beyond her expertise." (Dkt. No. 643 at 1.)
However, because the Court is granting Counterclaimants' motion for judgment on the
pleading dismissing Ferring's inequitable conduct affirmative defense, Ferring's motion is moot.
(See Dkt. No. 647 at 1 ("Ferring's motion will be moot if Counterclaimants' pending Rule 12(c)
Motion to preclude Ferring's inequitable conduct and 102(f) affirmative defenses is granted,
because Ms. Rea would no longer be called as a trial witness.").)
CONCLUSION
This constitutes the decision and order of the court. It is a written opinion. The Clerk is
directed to remove the following motions from the court’s list of open motions: Docket ## 642,
646, 649, and 651.
Dated: March 11, 2020
Chief Judge
BY ECF TO ALL COUNSEL
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