LITIGATION MISCONDUCT AND THE INEQUITABLE CONDUCT DEFENSE: AN ARGUMENT FOR LIMITING REGENERON PHARMACEUTICALS, INC. V. MERUS N.V - Intellectual ...
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LITIGATION MISCONDUCT AND THE
INEQUITABLE CONDUCT DEFENSE: AN
ARGUMENT FOR LIMITING REGENERON
PHARMACEUTICALS, INC. V. MERUS N.V.
CONNOR ROMM*
Abstract: Inequitable conduct is a defense to a claim of patent infringement
that can invalidate the underlying patent. At its inception, the defense was
meant to encourage honest representations in the patent prosecution
process. It later morphed into a source of troubling litigation tactics. In May
2011, in Therasense, Inc. v. Becton, Dickinson & Co., the United States
Court of Appeals for the Federal Circuit, sitting en banc, sought to address
disturbing trends in the doctrine and raised the standard required to prevail
on the defense. In July 2017, in Regeneron Pharmaceuticals, Inc. v. Merus
N.V., the same court appeared to take a step back from the strict standard
for finding intent in its prior decision. Because the plaintiff in Regeneron
engaged in both pre- and post-prosecution misconduct, the court adversely
inferred specific intent to deceive the United States Patent and Trademark
Office. This essay argues that the Regeneron decision should be interpreted
as a strictly-defined exception to the heightened standard that the Federal
Circuit adopted in Therasense.
INTRODUCTION
In patent litigation, the doctrine of inequitable conduct is often criticized as
a source of troubling litigation tactics that clutter up the patent system.1 Indeed, it
has been called a plague for its overuse and burdensome effects.2 A successful
claim of inequitable conduct protects an alleged patent infringer by invalidating the
underlying patent.3 At its inception, the doctrine was meant to discourage
fraudulent behavior in the patent prosecution process and to ensure honest
representations to the United States Patent and Trademark Office.4 Over time, it
__________________________________________________________________
Copyright © Boston College Intellectual Property & Technology Forum, Connor Romm
*
J.D. Candidate, Boston College Law School (expected 2021).
1
Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1288–89 (Fed. Cir. 2011) (en banc).
2
Id.
3
Regeneron Pharm., Inc. v. Merus N.V., 864 F.3d 1343, 1350 (Fed. Cir. 2017), cert. denied, 139
U.S. 122 (2018).
4
See Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 818 (1945)
(explaining that public policy requires patent applicants to provide the PTO with relevant facts).
12 Boston College Intellectual Property & Technology Forum [BC IPTF
morphed into a potent weapon used to attack the moral turpitude of the other side
on the slightest justifications.5
In 2011, in Therasense, Inc. v. Becton, Dickinson & Co., the United States
Court of Appeals for the Federal Circuit agreed to conduct an en banc review of the
case in order to address problems created by use of the inequitable conduct
doctrine.6 The court’s holding stiffened the requirements for finding inequitable
conduct.7 This decision lead to a significant decrease in the use of the inequitable
conduct doctrine as a defense to patent litigation.8
In 2017, in Regeneron Pharmaceuticals, Inc. v. Merus N.V., the United
States Court of Appeals for the Federal Circuit created a new way for accused
infringers to prove the elements of the inequitable conduct defense.9 The decision
introduced litigation misconduct as a new factor in proving inequitable conduct.10
This essay discusses the standards for finding inequitable conduct adopted
by the Federal Circuit in Therasense.11 Next, this essay analyzes cases and
secondary sources relevant to the inequitable conduct defense following the
Therasense decision.12 Finally, this essay makes a case for a narrow interpretation
of the Regeneron decision, which incorporates the holding as a strictly-defined
exception to the intent requirement adopted by the Federal Circuit in Therasense.13
I. INEQUITABLE CONDUCT AND THERASENSE
A. The Inequitable Conduct Defense
Inequitable conduct is an affirmative defense to patent infringement in
which an accused infringer claims that a patent is unenforceable because it was
acquired through inappropriate conduct.14 Inequitable conduct is a judge-made
doctrine that developed out of the doctrine of unclean hands.15 In a patent
infringement case, the accused infringer may decide to mount the defense against
the patentee on the grounds that the patent was obtained through misrepresentations
made to the PTO.16 This defense does not focus on the merits of validity and
infringement issues lodged against the accused infringer; rather, it attacks the
underlying validity of the patent itself, arguing that the patent holder should not be
entitled to enforcement of the patent.17
__________________________________________________________________
5
Therasense, 649 F.3d at 1288.
6
Id. at 1285.
7
Id. at 1290.
8
Matthew Avery, Matthew Kempf & Amy Liang, The Return of the Plague: Inequitable Conduct
After Regeneron V. Merus, 34 SANTA CLARA HIGH TECH. L.J. 328, 330 (2018).
9
Regeneron, 864 F.3d at 1356; Avery, Kempf & Liang, supra note 8, at 330.
10
Regeneron, 864 F.3d at 1356; Avery, Kempf & Liang, supra note 8, at 361.
11
See infra notes 14–55 and accompanying text.
12
See infra notes 56–88 and accompanying text.
13
See infra notes 89–100 and accompanying text.
14
Avery, Kempf & Liang, supra note 8, at 330.
15
Therasense, 649 F.3d at 1285.
16
Id. at 1287.
17
Id. at 1287–88.2019] Inequitable Conduct Defense: An Argument for Limiting Regeneron v. Merus 3
The inequitable conduct doctrine evolved from three Supreme Court cases
that, applying the doctrine of unclean hands, refused to enforce patents involving
egregious misconduct.18 All three cases featured deceitful misrepresentations made
to the PTO during the patent prosecution process and to the courts in later attempts
to enforce the patents.19 Prior to Therasense, an accused infringer could prevail on
the defense of inequitable conduct if there was clear and convincing evidence that
(1) the applicant misrepresented or omitted material information with the (2)
specific intent to deceive the PTO.20 Unlike the standard adopted in Therasense,
materiality was based on a reasonable examiner standard.21 Under this standard, the
materiality requirement was satisfied if a reasonable examiner would likely find it
relevant in determining whether to issue a patent.22 The intent requirement could
be satisfied by proving gross negligence or even negligence on the part of the
applicant.23 If an accused infringer could prove that a patentee knew or should have
known that a reasonable examiner would likely find information relevant to the
PTO’s determination, then the failure to provide it would satisfy the requirement of
intent to deceive the PTO.24
Over time, the doctrine became a common litigation strategy and a burden
on the patent system.25 A study estimated that inequitable conduct was alleged in
eighty percent of patent infringement cases.26 Patent prosecutors, attempting to
avoid future inequitable conduct claims, flooded the PTO with excessive prior art
references.27 This practice undermined the patent examination process and led to
an increased PTO backlog and impaired patent quality.28 Patent adjudication grew
increasingly expensive and complex.29
B. En Banc Review in Therasense, Inc. v. Becton, Dickinson & Co.
The troubling issues surrounding the inequitable conduct defense led to a
total restructuring of the doctrine by the en banc decision in Therasense.30 In
Therasense, the Federal Circuit held that, to prevail on a defense of inequitable
conduct, the accused infringer must prove by clear and convincing evidence (1) that
__________________________________________________________________
18
Therasense, 649 F.3d at 1285; see Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324
U.S. 806, 819 (1945); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 250–51 (1944);
Keystone Driller Co. v. General Excavator Co., 290 U.S. 240, 247 (1933).
19
Therasense, 649 F.3d at 1287.
20
Id.
21
Id. at 1288.
22
Id.
23
Id. at 1287–88.
24
Id. (quoting Driscoll v. Cebalo, 731 F.2d 878, 885 (Fed. Cir. 1984)).
25
Avery, Kempf & Liang, supra note 8, at 330.
26
Therasense, 649 F.3d at 1289 (citing Committee Position Paper, The Doctrine of Inequitable
Conduct and the Duty of Candor in Patent Prosecution: Its Current Adverse Impact on the
Operation of the United States Patent System, 16 AIPLA Q. J. 74, 75 (1988)).
27
Id. at 1289.
28
Id. at 1290.
29
Id. at 1290.
30
Avery, Kempf & Liang, supra note 8, at 331.4 Boston College Intellectual Property & Technology Forum [BC IPTF
a patent applicant acted with the specific intent to deceive the PTO, and (2) that the
deception had a material effect on the PTO’s decision to award a patent.31 The court
held that claimants must prove intent and materiality separately.32 A sliding scale
where a weak showing of one requirement may be offset by a strong showing of
the other should not be employed.33 Specific intent to deceive may be inferred from
indirect and circumstantial evidence only if it is the sole most reasonable inference
that one could draw from the evidence.34 The court in Therasense held that, to
satisfy the materiality requirement, claimants must show but-for materiality.35 But-
for materiality refers to deception that, had the PTO been aware of, it would not
have allowed the claim.36
C. Post-Therasense Decision
Following Therasense, inequitable conduct is rarely raised as a defense.37 It
is challenging for most defendants to meet the high standard of proving that a
plaintiff acted with specific intent to deceive the PTO.38 Further, the new but-for
materiality standard ensures that the defense is only applicable in instances where
a patent holder received a patent through misrepresentations made to the PTO.39
Some commentators were optimistic about the changes to the defense, reasoning
that it would help reduce meritless inequitable conduct claims.40 Indeed, the
heightened standard substantially decreased the use of the doctrine.41 Other
commentators felt that the pendulum had swung too far.42 They felt that the decision
over compensated for past abuse and that the standard was too rigid.43 Nevertheless,
courts closely followed the standard set out in Therasense.44
For instance, in 2013, in General Electric Co. v. Mitsubishi Heavy
Industries, Ltd., the United States District Court for the Northern District of Texas
__________________________________________________________________
31
Therasense, 649 F.3d at 1290–91.
32
Id. at 1290.
33
Id.
34
Id.
35
Id. at 1291.
36
Id.
37
Ryan Davis, Inequitable Conduct A Dying Defense 2 Years Post-Therasense, LAW360 (May 23,
2013, 9:13 PM), https://www.law360.com/articles/444480/inequitable-conduct-a-dying-defense-2-
years-post-therasense.
38
Avery, Kempf & Liang, supra note 8, at 335.
39
Therasense, 649 F.3d at 1291; Avery, Kempf & Liang, supra note 8, at 336.
40
Avery, Kempf & Liang, supra note 8, at 336.
41
Davis, supra note 37.
42
Ryan Davis, High Court Pass Won’t Be Last Word on Inequitable Conduct, LAW360 (October
15, 2013, 7:54 PM), https://www.law360.com/articles/480299/high-court-pass-won-t-be-last-word-
on-inequitable-conduct.
43
See id. (reasoning that the new standard makes it too difficult raise the defense).
44
Avery, Kempf & Liang, supra note 8, at 336; see, e.g., Barry v. Medtronic, Inc., 245 F. Supp. 3d
793, 805 (E.D. Tex. 2017) (following Therasense and holding that plaintiffs’ errors in their
application to the PTO did not show specific intent to deceive the PTO); Hospira, Inc. v. Sandoz,
Inc., No. 09-4591 (MCL), 2012 WL 1587688 (D.N.J. 2012) (following Therasense and holding that
gross negligence in submitting data to the PTO does not show specific intent to deceive the PTO).2019] Inequitable Conduct Defense: An Argument for Limiting Regeneron v. Merus 5
held that Mitsubishi failed to prove that General Electric (GE) purposely mislead
the PTO.45 GE’s patent covered methods for obtaining zero voltage ride through in
the controls of a wind turbine.46 GE submitted just one instance of prior art and
failed to disclose all of the relevant wind turbines dominating the market at the
time.47 The facts showed that GE attorneys had considered the materiality of prior
art to their patent and then withheld it.48 The court found that the alleged prior art
was but-for material, but the court reluctantly held that there was not enough
evidence to determine that GE purposely mislead the PTO.49 The court described
its holding as being strained and that its hands were tied by the Therasense
precedent.50
Similarly, in 2012, in 1st Media, LLC v. Electronic Arts, Inc., the United
States Court of Appeals for the Federal Circuit also followed Therasense and found
that there was insufficient proof that an inventor and his attorney, who failed to
provide three material references to the PTO, had engaged in inequitable conduct.51
The inventor claimed it must have been an oversight, and the prosecuting attorney
could not remember why he did not share the material with the PTO.52 The United
States District Court for the District of Nevada found that the inventor and attorney
knew that the references were material, and the court inferred intent to deceive the
PTO from their inability to offer a believable justification for the nondisclosure.53
The Federal Circuit reversed, holding that awareness of a particular reference and
its materiality does not satisfy the intent standard detailed in Therasense. 54 Rather,
there must be proof of a deliberate decision to withhold the references.55
II. IMPLICATIONS OF REGENERON ON THE INEQUITABLE CONDUCT DEFENSE
A. Regeneron Pharmaceuticals, Inc. v. Merus N.V.
In 2017, in Regeneron Pharmaceuticals, Inc. v. Merus N.V., the United
States Court of Appeals for the Federal Circuit, sitting en banc, chose to detour
from the strict standard for finding intent laid out by Therasense, Inc. v. Becton,
Dickinson & Co.56 The plaintiff, Regeneron, filed suit against the defendant, Merus,
__________________________________________________________________
45
Gen. Elec. Co. v. Mitsubishi Heavy Indus., Ltd., 946 F. Supp. 2d 582, 591 (N.D. Tex. 2013).
46
Id. at 594.
47
Id. at 591.
48
Id.
49
Id. at 590.
50
Id.
51
1st Media, LLC v. Elec. Arts, Inc., 694 F.3d 1367, 1369 (Fed. Cir. 2012).
52
Id. at 1371.
53
Id. at 1372.
54
Id. at 1374; Therasense, 649 F.3d at 1290.
55
1st Media, 694 F.3d at 1376–77 (quoting Therasense, 649 F.3d at 1290).
56
See Regeneron Pharm., Inc. v. Merus N.V., 864 F.3d 1343, 1364 (Fed Cir. 2017) cert. denied,
139 U.S. 122 (2018) (holding that an adverse inference of specific intent to deceive the PTO was
appropriate); Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011)
(en banc) (holding that specific intent to deceive the PTO must be proved by clear and convincing
evidence).6 Boston College Intellectual Property & Technology Forum [BC IPTF
for patent infringement.57 Merus raised the defense of inequitable conduct alleging
that Regeneron withheld four material references.58 The United States District
Court for the Southern District of New York scheduled two separate bench trials
on Regeneron’s potential inequitable conduct.59 The first trial would rule on the
materiality of the withheld references, and the second would deal with whether
Regeneron had acted with specific intent to deceive the PTO.60 Following the first
trial, the district court found that the four withheld references were but-for
material.61 The court, however, never held the second trial regarding specific intent
to deceive the PTO.62 Instead, following the first trial, the district court drew an
adverse inference of specific intent to deceive the PTO based on Regeneron’s
litigation misconduct.63 The finding of but-for materiality coupled with the adverse
inference of specific intent allowed the district court to conclude that Regeneron
had engaged in inequitable conduct, without having to hold the second trial.64
In its determination of an adverse inference, the district court cited various
instances of Regeneron engaging in troubling behavior.65 The court described a
pattern of misconduct including failure to produce non-privileged documents and
failure to produce previously privileged documents to which Regeneron had
affirmatively waived the privilege.66 Further, the court reasoned that Regeneron
repeatedly chose to engage in devious litigation practices throughout the patent
litigation.67 Regeneron engaged in sword/shield tactics by withholding documents
on the basis of attorney-client privilege and then later making trial declarations
implicating that same information.68 Among these documents were the prosecuting
attorney’s mental impressions of the withheld references during the prosecution of
the patent.69 The district court reasoned that these documents were important to
ascertaining whether Regeneron sought to mislead the PTO.70
On appeal, the Federal Circuit affirmed the district court’s judgement.71 The
court distinguished this case from its 2001 decision in Aptix Corp. v. Quickturn
Design Systems, which held that courts may not punish a party’s post-prosecution
misconduct by declaring the underlying patent unenforceable.72 The noted
difference, in Regeneron, is that the patentee engaged in both post-prosecution
__________________________________________________________________
57
Regeneron, 864 F.3d at 1346.
58
Id.
59
Id.
60
Id.
61
Id. at 1347.
62
Id.
63
Id. at 1356.
64
Id. at 1347.
65
Id. at 1357.
66
Id. at 1362.
67
Id. at 1357.
68
Id. at 1360–61.
69
Id. at 1362.
70
Id.
71
Id. at 1364.
72
Id. (citing Aptix Corp. v. Quickturn Design Sys., 269 F.3d 1369, 1378 (Fed. Cir. 2001)).2019] Inequitable Conduct Defense: An Argument for Limiting Regeneron v. Merus 7
misconduct and inequitable conduct during patent prosecution.73 Specifically, in
Regeneron, the court held that the plaintiff’s litigation misconduct cloaked its
earlier misrepresentations to the PTO when it failed to disclose documents
regarding the prosecuting attorneys’ mental impressions of the withheld
references.74 Because the plaintiff engaged in both pre- and post-prosecution
misconduct, the court affirmed the district court’s adverse inference of specific
intent.75
B. Policies Underlying Regeneron
The facts in Regeneron highlight a significant insufficiency in the
inequitable conduct defense following Therasense.76 Regeneron is an example of
the heightened intent requirements incentivizing litigation misconduct.77 The patent
litigators in Regeneron chose to engage in devious tactics rather than produce
documentation of their contemplation of the withheld references.78 They likely
recognized that, without clear and convincing evidence of a deliberate decision to
withhold the material from the PTO, they could not be found to have committed
inequitable conduct.79 The thinly veiled pattern of misconduct employed by the
litigators in Regeneron shows that they likely were not concerned about whether
the court found their assertions unconvincing and troublesome.80 The Northern
District of Texas’s decision in 2013, in General Electric Co. v. Mitsubishi Heavy
Industries, Ltd., makes it clear that, even if a court feels strained or that its hands
are tied by the Therasense decision, it must not find inequitable conduct without
evidence of specific intent to deceive the PTO.81 For these reasons, the Regeneron
decision was necessary in order to remove the incentive for patent litigators to use
troublesome tactics to obscure the patentee’s dealings with the PTO.82
__________________________________________________________________
73
Id.
74
Id.
75
Id.
76
See Regeneron, 864 F.3d at 1356–58 (outlining litigation misconduct of patent attorneys);
Therasense, 649 F.3d at 1290 (requiring clear and convincing evidence that the applicant made a
deliberate decision to withhold a known material reference).
77
See Regeneron, 864 F.3d at 1357 (outlining litigation misconduct of patent attorneys).
78
See id. at 1363 (adversely inferring specific intent to deceive the PTO based on Regeneron’s
pattern of misconduct).
79
See 1st Media, LLC v. Elec. Arts, Inc., 694 F.3d 1367, 1374 (Fed. Cir. 2012) (holding that
awareness of a particular reference and its materiality does not by itself prove intent to deceive).
80
See Regeneron, 864 F.3d at 1356–58 (outlining the attorneys’ litigation misconduct).
81
Gen. Elec. Co. v. Mitsubishi Heavy Indus., Ltd., 946 F. Supp. 2d 582, 590–91 (N.D. Tex. 2013).
82
See Regeneron, 864 F.3d at 1356–58 (outlining litigation misconduct of patent attorneys); Gen.
Elec. Co. v. Mitsubishi Heavy Indus., Ltd., 946 F. Supp. 2d 582, 593 (N.D. Tex. 2013) (explaining
that disallowing courts from draw negative inferences from patentees’ extensive invocation of
attorney-client privilege when testifying at trial regarding potential inequitable conduct promotes
abuse of the privilege).8 Boston College Intellectual Property & Technology Forum [BC IPTF
C. Specific Intent in Regeneron
It is important that the adverse inference of specific intent exercised in
Regeneron does not provide an opportunity for abuse of the inequitable conduct
defense.83 In affirming the district court’s adverse inference of specific intent in
Regeneron, the Federal Circuit held that the inference was properly drawn because
Regeneron was accused not only of post-prosecution misconduct but also of
engaging in inequitable conduct during prosecution.84 The court reasoned that
Regeneron’s litigation misconduct obfuscated its prosecution misconduct.85
A broad interpretation of this holding could lead to widespread meritless
accusations of litigation misconduct in patent infringement suits.86 The Regeneron
decision could lower the intent requirement because accused infringers would need
only to link the alleged litigation misconduct to accusations of withheld references
or misrepresentations during patent prosecution.87 A patent holder’s post-
prosecution misconduct should not, by itself, dissolve the underlying property right
that is the subject of the litigation.88
III. A CASE FOR CORRALLING THE REGENERON HOLDING
Courts should interpret the Federal Circuit’s decision in Regeneron
Pharmaceuticals., Inc. v. Merus N.V. as a narrow exception to the specific intent
requirement in Therasense, Inc. v. Becton, Dickinson & Co.89 In patent enforcement
litigation, the inequitable conduct defense requires the court to act as an extension
of the PTO.90 The court must decide whether there is clear and convincing evidence
that a patentee acted with specific intent to deceive the PTO and that the deception
had a material effect on the PTO’s decision to award the patent.91 The Therasense
__________________________________________________________________
83
See Regeneron, 864 F.3d at 1364 (concluding that the district court was justified in drawing an
adverse inference of specific intent to deceive the PTO); Aron Fisher & Rachel Schwartz, A New
Strain of Inequitable Conduct Litigation, LAW360 (October 5, 2017, 12:06 PM),
https://www.law360.com/articles/971033/a-new-strain-of-inequitable-conduct-litigation
(explaining that the Regeneron decision gives defendants alternative means for proving inequitable
conduct).
84
Regeneron, 864 F.3d at 1364.
85
Id.
86
Brief of the Biotechnology Innovation Organization (BIO) as Amicus Curiae Supporting
Rehearing En Banc at 12, Regeneron, 864 F.3d 1343.
87
See Regeneron, 864 F.3d at 1364 (affirming the district court’s decision because the defendant
engaged not only in post-prosecution misconduct but also inequitable conduct during prosecution);
Fisher & Schwartz, supra note 83(explaining that the Regeneron decision gives defendants
alternative means for proving inequitable conduct).
88
Regeneron, 864 F.3d at 1364 (quoting Aptix, 269 F.3d at 1376).
89
See Regeneron Pharm., Inc. v. Merus N.V., 864 F.3d 1343, 1364 (Fed Cir. 2017), cert. denied,
139 U.S. 122 (2018) (concluding that the district court was justified in drawing an adverse inference
of specific intent to deceive the PTO).
90
See Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1306 (Fed. Cir. 2011) (en banc)
(Bryson, J., dissenting) (reasoning that inequitable conduct claims are essential to enforcing
disclosure to the PTO).
91
Id, at 1290–91.2019] Inequitable Conduct Defense: An Argument for Limiting Regeneron v. Merus 9
decision provided for an exception to the but-for materiality requirement.92 In cases
where the patentee has engaged in affirmative egregious misconduct, the
misconduct is material.93 The court reasoned that a patentee was unlikely to go to
great lengths to deceive the PTO with a falsehood unless it believes that the
falsehood will affect issuance of the patent.94
The Federal Circuit provided this exception in order to strike a necessary
balance between encouraging honesty before the PTO and preventing unfounded
accusations of inequitable conduct.95 Similar to the exception to the but-for
materiality requirement, Regeneron’s adverse inference of specific intent to deceive
the PTO should only occur in instances of affirmative egregious misconduct.96
Specifically, this essay argues for the following interpretation of the Regeneron
decision: in cases involving affirmative egregious misconduct in the enforcement
litigation of a patent, which obscures the alleged patent prosecution misconduct in
a significant way, a court may adversely infer specific intent to deceive the PTO.97
Limiting this exception to instances of affirmative egregious misconduct in the
enforcement of a patent will ensure that the exception does not allow accused patent
infringers an opportunity to circumvent the heightened intent requirement in
Therasense.98 Similar to the reasoning for the exception to the but-for materiality
requirement in Therasense, a patentee is unlikely to go to great lengths to deceive
the court in patent enforcement litigation unless she believes that the facts would
lead to a finding of specific intent to deceive the PTO.99 Interpreting Regeneron as
a narrow exception to the Therasense decision will encourage candor in patent
enforcement litigation while preventing meritless accusations of inequitable
conduct.100
CONCLUSION
In patent litigation, the doctrine of inequitable conduct is often criticized as
a source of troubling litigation tactics that clutter up the patent system. In May of
2011, in Therasense, Inc. v. Becton, Dickinson & Co., the en banc United States
Court of Appeals for the Federal Circuit tightened the standards for finding
inequitable conduct. This decision led to a significant decrease in the number of
__________________________________________________________________
92
Id. at 1292.
93
Id.
94
Id.
95
Id. at 1293.
96
See id. at 1292 (providing an exception to the materiality requirement in instances of affirmative
egregious misconduct).
97
See Regeneron, 864 F.3d at 1364 (holding that when a patentee engages in affirmative acts of
egregious misconduct, misconduct is material).
98
See Therasense, 649 F.3d at 1290 (tightening the standards for finding inequitable conduct);
Fisher & Schwartz, supra note 83 (arguing that the Regeneron decision may give courts broad
discretion to adversely infer specific intent to deceive the PTO based on litigation misconduct).
99
See Therasense, 649 F.3d at 1292 (reasoning that a patent holder is unlikely to deceive the PTO
unless it would affect the issuance of the patent).
100
See Regeneron, 864 F.3d at 1364 (concluding that the district court was justified in drawing an
adverse inference of specific intent to deceive the PTO); Therasense, 649 F.3d at 1292 (reasoning
that the affirmative egregious acts exception encourages honesty to the PTO and discourages
unfounded inequitable conduct claims).10 Boston College Intellectual Property & Technology Forum [BC IPTF inequitable conduct claims. In July of 2017, in Regeneron Pharmaceuticals, Inc. v. Merus N.V., the Federal Circuit chose to detour from the strict standard for finding intent laid out by Therasense. Because the plaintiff in Regeneron engaged in both pre- and post-prosecution misconduct, the court adversely inferred specific intent to deceive the PTO. It is important that the adverse inference of specific intent exercised in Regeneron does not provide an opportunity for abuse of the inequitable conduct defense. The Regeneron holding should be limited to cases involving affirmative egregious misconduct in the enforcement litigation of a patent, which obscures the alleged patent prosecution misconduct in a meaningful way. Recommended Citation: Connor Romm, Litigation Misconduct and the Inequitable Conduct Defense: An Argument for Limiting Regeneron Pharmaceuticals, Inc. v. Merus N.V., B.C. INTELL. PROP. & TECH. F. (Mar. 14, 2019), http://bciptf.org/2019/03/litigation-misconduct-and-the-inequitable- conduct-defense.
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