MARICAL INC et al v. COOKE AQUACULTURE INC et al
DECISION AND ORDER granting 214 Motion to Amend. REMINDER: After entry of this Order, if Amending a COMPLAINT, counsel are REQUIRED to separately file the AMENDED COMPLAINT Document. By MAGISTRATE JUDGE JOHN C. NIVISON. (CWP)
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
MARICAL INC., et al.,
COOKE AQUACULTURE INC., et al., )
DECISION AND ORDER ON DEFENDANTS’
MOTION TO AMEND ANSWER
In this action, Plaintiffs and Counter-claim Defendants Marical Inc., Europharma
AS, and Europharma Inc. Canada (“Plaintiffs”), allege that Defendants and Counter-claim
Plaintiffs Cooke Aquaculture Inc., Cooke Aquaculture USA Inc., True North Salmon Co.
Ltd., True North Salmon US Inc., True North Sales US Inc., and Salmones Cupquelan SA
(“Defendants”), produce and import salmon raised by methods that infringe Plaintiffs’
United States patents, which patents teach methods for raising pre-adult anadromous fish.
(Complaint, ECF No. 1.) In their counterclaim for declaratory judgment, Defendants seek
a judgment of invalidity and non-infringement. (Answer and Counterclaims, ECF No. 16.)
The matter is before the Court on Defendants’ Motion for Leave to Amend Their
Answer. (ECF No. 214.)1 Through the motion, Defendants seek to add an affirmative
defense and five counterclaims in which they allege that the patents-in-suit are
unenforceable under the doctrine of inequitable conduct and “infectious unenforceability.”
The public version of the motion (ECF No. 214) is redacted.
(Answer ¶¶ 13 – 66, 159 – 243.) Defendants assert they would “limit the inequitable
conduct claims to those ‘representative’ claims in the litigation, and claim 46 of the ‘792
Following a review of the record, and after consideration of the parties’ written
arguments, the Court grants the motion.
“Inequitable conduct is an equitable defense to patent infringement that, if proved,
bars enforcement of a patent. This judge-made doctrine evolved from a trio of Supreme
Court cases that applied the doctrine of unclean hands to dismiss patent cases involving
egregious misconduct ….” Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276,
1285 (Fed. Cir. 2011). Through a claim of inequitable conduct, a patent infringement
defendant asserts that the patentee obtained the patent-in-suit by making material
misrepresentations to the PTO or by taking measures to suppress evidence that, if disclosed,
would have prevented issuance of a patent. Id. at 1285 – 87. “Inequitable conduct occurs
when a patentee breaches his or her duty to the PTO of candor, good faith, and honesty.”
U.S. Water Servs., Inc. v. Novozymes A/S, 843 F.3d 1345, 1352 (Fed. Cir. 2016) (quoting
Ferring B.V. v. Barr Labs., Inc., 437 F.3d 1181, 1186 (Fed. Cir. 2006), and citing 37 C.F.R.
§ 1.56(a) (2015) (explaining that a party appearing before the PTO has “a duty to disclose
... all information known to that individual to be material to patentability”)).3
June 30, 2017, Letter of Michael McGraw, counsel for Defendants.
Claims of inequitable conduct involve “particularly egregious misconduct, including perjury, the
manufacture of false evidence, and the suppression of evidence.” Therasense, 649 F.3d at 1287. As
explained in Therasense, inequitable conduct claims have a significant impact on patent litigation:
Defendants argue that information obtained on the final day of fact-related
discovery supports their request to assert the inequitable conduct defense and
counterclaims. On February 28, 2017, Defendants deposed Dr. William Harris, the lead
inventor of the patents-in-suit. Dr. Harris testified, in part, as Plaintiffs’ Rule 30(b)(6)
designee. According to Defendants, Dr. Harris testified that he knew of material prior art
that he did not disclose to the United States Patent and Trademark Office (“PTO”) during
the patent prosecution process. (Motion at 1.) Based on the testimony, Defendants argue
they can state an actionable claim of inequitable conduct and that the timing of the
revelation justifies an amendment despite the expiration of the scheduling order deadline
for amendment of the pleadings. Plaintiffs argue Defendants lack good cause for the late
motion to amend and have not stated an actionable claim.
A charge of inequitable conduct conveniently expands discovery into corporate practices
before patent filing and disqualifies the prosecuting attorney from the patentee’s litigation
team. Moreover, inequitable conduct charges cast a dark cloud over the patent’s validity
and paint the patentee as a bad actor. Because the doctrine focuses on the moral turpitude
of the patentee with ruinous consequences for the reputation of his patent attorney, it
discourages settlement and deflects attention from the merits of validity and infringement
issues. Inequitable conduct disputes also increase the complexity, duration and cost of
patent infringement litigation that is already notorious for its complexity and high cost.
Therasense, 649 F.3d at 1288. According to the Federal Circuit, “the remedy for inequitable conduct is the
‘atomic bomb’ of patent law.” Id. (quoting Aventis Pharma S.A. v. Amphastar Pharm., Inc., 525 F.3d 1334,
1349 (Fed. Cir. 2008) (Rader, J., dissenting)). “Unlike validity defenses, which are claim specific, see 35
U.S.C. § 288, inequitable conduct regarding any single claim renders the entire patent unenforceable.” Id.
In addition to the impact such claims have on patent litigation, inequitable conduct claims have had a
significant negative impact on the patent prosecution process. Id. at 1289. “With inequitable conduct
casting the shadow of a hangman’s noose, it is unsurprising that patent prosecutors regularly bury PTO
examiners with a deluge of prior art references, most of which have marginal value.” Id. at 1289. The
resulting deluge contributes to administrative backlog. Id. at 1290. See also Agfa Corp. v. Creo Products
Inc., 451 F.3d 1366, 1379 (Fed. Cir.2006) (explaining that infectious unenforceability occurs when
inequitable conduct renders unenforceable claims in a related application).
U.S. Patent Application No. 09/687,476 (the ‘476 Application), which issued as the
’792 Patent, was filed on October 12, 2000, by Antoinette G. Giugliano of the law firm
Hamilton, Brook, Smith & Reynolds, P.C. (“Hamilton Brook firm”). (Proposed Am.
Compl. ¶ 14.) David E. Brook of the Hamilton Brook firm is counsel of record for the
prosecution of the application. (Id. ¶ 15.)
On March 24, 2002, a patent examiner with the PTO issued an office action rejecting
all pending claims under the judicially created doctrine of nonstatutory double patenting,
citing prior patent number 6,337,391 (the ‘391 Patent), and explaining that “the claims if
allowed, would improperly extend the ‘right to exclude’ already granted in the [‘391]
patent.” (Id. ¶ 16; see also ECF No. 213-2.) The patent examiner further wrote: “The
subject matter claimed in the instant [‘476] application is fully disclosed in the [‘391]
patent and is covered by the patent since the patent and application are claiming common
subject matter, as follows: the patent discloses a method of improving the raising of fish
comprising adding magnesium and calcium to increase expression and/or sensitivity of at
least one PVCR.” (Proposed Am. Compl. ¶ 17.)
In response to the March 24, 2002, Office Action, applicants submitted a reply dated
April 23, 2002. (Id. ¶ 18; see also ECF No. 214-4.) In their reply, applicants stated:
The claimed methods involve adding magnesium and calcium to the
freshwater in which the pre-adult anadromous fish are maintained prior to
transfer to seawater, and adding a specially made feed for fish consumption
to the freshwater. The feed contains NaCl and at least one PolyValent Cation
Sensing Receptor (PVCR) modulator (e.g., an amino acid). The PVCR
modulator present in the feed is sufficient to contribute to a significantly
increased level of calcium and/or magnesium in serum of these fish, and the
magnesium and calcium added to the freshwater increase expression and/or
sensitivity of at least one PVCR in the fish.
Assuming that the Examiner meant to issue a 102(e) or 102(e)/103 rejection,
the disclosure of the ’391 patent also does not describe the claimed invention.
The ’391 patent does not even disclose or mention the specially made feed
used in the claimed methods e.g., feed having NaCl and at least one PVCR
modulator. The methods that are included in the ’391 patent describe slowly
adapting fish to different salinities. According to the ’391 patent, once the
flounder, a non-anadromous fish, were maintained in either a hypersalinity
or hyposalinity environment, their body composition changed. See Example
10 of the ’391 patent. The claimed invention is used for an entirely different
purpose, namely, for transferring anadromous fish to seawater, and it
involves steps that are not mentioned or suggested in the ’391 patent. There
is no mention of preparing anadromous fish for transfer to seawater by
adding calcium and magnesium to the freshwater in which the anadromous
fish are maintained in sufficient amounts to increase expression and/or
sensitivity of at least one PVCR. Also, there is no mention of adding feed to
the freshwater, wherein the feed contains a PVCR modulator to significantly
increase calcium and magnesium levels in the serum of fish. These two steps
work together. The specially made feed causes the fish to ingest increased
amounts of freshwater having the additional calcium and magnesium, and as
a result, the levels of calcium and magnesium cause increased sensitivity
and/or expression of at least one PVCR which, in turn, prepares the fish for
transfer to seawater. The invention, as a whole, is not described nor
suggested in the ’391 patent.
For example, there is no support for accomplishing the transfer of
anadromous fish to seawater by adding both the magnesium and calcium to
increase expression of at least one PVCR, and there is certainly no support
for the NaCl/PVCR modulator feed.
(Id. ¶¶ 19 – 21.)
At his deposition, Dr. Harris testified that he would have reviewed the April 23,
2002, reply to the PTO before it was sent. (Id. ¶ 26.) Dr. Harris also stated that the
“specially made feed” referenced in the April 23, 2002, reply could be feed with either
sodium chloride and a PVCR modulator added, or feed with only sodium chloride added,
because sodium chloride is a PVCR modulator. (Id. ¶ 27.)
Dr. Harris knew that all prior art feeds contained sodium chloride. (Id. ¶ 30.) He
also acknowledged that it would have been important to disclose to the Patent Office if he
knew that all prior art feed contained sodium chloride. (Id. ¶ 31.) 6+6 Freshwater Feed
was a feed sold by Moore-Clark from at least 1992-1999 to enhance the smoltification
process that contains special salts and Finnstim (betaine and other amino acids). (Id. ¶ 32.)
6+6 Freshwater Feed is prior art to the patents-in-suit. (Id. ¶ 33.) 6+6 Freshwater Feed
was used and offered for sale in the United States before the priority date of the patents-insuit. (Id. ¶¶ 36 – 37.) 6+6 Freshwater Feed contained more than 1% added sodium
chloride.4 (Id. ¶ 38.)
Dr. Harris knew at the time the patents were filed that all prior art feeds contained
tryptophan, but he did not disclose the information to the Patent Office. (Id. ¶ 41.) 6+6
Freshwater Feed contained amino acids. (Id. ¶ 42.) Dr. Harris testified that he was familiar
with nutritional guidelines for feeds at the time the patent applications were filed. The
nutritional guidelines, such as the Nutrient Requirements of Fish, published through the
National Research Council in 1993 (“NRC 1993”), existed as written documents at the
time the patents-in-suit were filed and were readily available, and as such were prior art.
(Id. ¶¶ 43 – 44.) NRC 1993 discloses a tryptophan requirement of 0.2% of dry weight for
juvenile Chinook salmon.5 (Id. ¶ 45.) Dr. Harris explained that he did not disclose to the
The Court accepted MariCal’s proposed construction of “an amount of NaCl sufficient” and construed the
term to mean “between about 1% and about 10% NaCl content by weight or a NaCl/feed ratio of between
about 10,000 mg/kg and 100,000 mg/kg.” (Proposed Am. Compl. ¶ 39.)
As to the construction of the term “amount of NaCl and at least one PVCR modulator sufficient to
contribute to,” the Court stated that “[i]nsofar as PVCR modulator content in feed is described in Term
Patent Office that all feed contained tryptophan because it was common knowledge. He
further explained that protein is a nutritional requirement of fish feed, and all protein
contains tryptophan. (Id. ¶ 46.) Dr. Harris confirmed that MariCal’s feed is “special” only
because it contained sodium chloride and tryptophan. (Id. ¶ 47.)
The fact that feed manufacturers had been adding NaCl to smolt feeds for many
years as of 2002 or that amino acids were added to smolt feeds for nutritional reasons was
evidently not disclosed to the Patent Office. (Id. ¶ 57.) Dr. Harris testified at his deposition
that he did not recall whether he disclosed the nutritional guidelines to the Patent Office,
even though he discussed them with his lawyers. (Id. ¶ 60.) According to Dr. Harris, the
other inventors, who also knew all prior art feeds contained tryptophan, similarly failed to
disclose the information to the Patent Office. (Id. ¶ 61.) Defendants alleged that Dr. Harris
misled the PTO by referring to MariCal’s feed as “specially made” instead of disclosing
that he believed that all prior art feeds contained sodium chloride and tryptophan. (Id. ¶
Claim 46 of the ‘792 patent is directed to an aquatic food composition that contains
NaCl in a concentration of about 10,000 mg/kg to about 100,000 mg/kg (i.e., 1% to 10%)
and tryptophan in a concentration of about 1 gm/kg to about 10 gm/kg (i.e., 0.1% to 1.0%).
Dr. Harris did not disclose to the PTO that he believed that all prior art feeds contained
sodium and tryptophan. According to Defendants, the PTO would have rejected at least
18D, Patent ‘792 ‘specifies tryptophan in an amount between about 1 gm/kg and about 10 gm/kg’ or another
amino acid in the same concentration.” (Proposed Am. Compl. ¶ 48.)
claim 46 under 35 U.S.C. §§ 102 and/or 103 if it had been aware of the information that
Dr. Harris failed to disclose. (Id. ¶ 149.)
Citing Dr. Harris’s deposition testimony, in their proposed amended answer,
Defendants assert the affirmative defense of inequitable conduct, and counterclaims of
“unenforceability” against each of the four patents-in-suit.
(Id. ¶¶ 159 – 229,
Counterclaims 9 – 12.) Defendants allege the information allegedly withheld from the
PTO was material to issuance of each of the patents-in-suit.
By way of example,
concerning the ‘792 Patent, Defendants allege:
That the fact tryptophan and NaCl were in the prior art feeds is material to
the patentability of claim 46, where claim 46 is directed to an aquatic food
composition that contains NaCl in a concentration of about 10,000 mg/kg to
about 100,000 mg/kg and tryptophan in a concentration of about 1 gm/kg to
about 10 gm/kg. (Id. ¶ 176.)
As to the intent to deceive, Defendants assert generally that individuals with a duty to
disclose failed to disclose material information with an intent to deceive the Patent Office.
(Id. ¶ 177.)
Defendants also assert a counterclaim of “infectious unenforceability.” According
to Defendants, inequitable conduct underlying the issuance of Patent ‘792 infects each of
the other patents-in-suit and renders then unenforceable because they are each either a
continuation of, share the same title with, or claim similar subject matter as Patent ‘792.
(Id. ¶¶ 230 – 238.) Finally, in the amended counterclaim, Defendants allege the case is
“exceptional” due to various circumstances. (Id. ¶¶ 230 – 243.)
Motion to Amend Standard
To amend their answer, Defendants first must demonstrate that they filed their
motion timely. Rule 15(a)(1) of the Federal Rules of Civil Procedure permits a litigant to
amend a pleading “once as a matter of course,” subject to certain time constraints. In the
case of an answer, freedom to amend without leave of court is permitted within 21 days of
the date on which the answer was filed. Fed. R. Civ. P. 15(a)(1)(A). Thereafter, leave of
court is required, though leave should be granted “freely . . . when justice so requires.”
Fed. R. Civ. P. 15(a)(2); see also Foman v. Davis, 371 U.S. 178, 182 (1962).
The standard is elevated when the motion seeking leave to amend is filed after the
deadline for amendment of the pleadings set forth in the scheduling order. A motion to
amend that is filed beyond the scheduling order deadline requires an amendment of the
To obtain an amendment of the scheduling order, a party must
demonstrate “good cause.” Johnson v. Spencer Press of Maine, Inc., 211 F.R.D. 27, 30
(D. Me. 2002); El–Hajj v. Fortis Benefits Ins. Co., 156 F. Supp. 2d 27, 34 (D. Me. 2001);
Fed. R. Civ. P. 16(b)(4). A court’s decision on good cause “focuses on the diligence (or
lack thereof) of the moving party more than it does on any prejudice to the party-opponent.”
Steir v. Girl Scouts of the USA, 383 F.3d 7, 12 (1st Cir. 2004). “Particularly disfavored are
motions to amend whose timing prejudices the opposing party by ‘requiring a re-opening
of discovery with additional costs, a significant postponement of the trial, and a likely
major alteration in trial tactics and strategy.’” Id. (quoting Acosta–Mestre v. Hilton Int’l
of P.R., Inc., 156 F.3d 49, 52 (1st Cir. 1998)). It falls to the court’s discretion whether to
grant a late motion to amend, and that discretion should be exercised on the basis of the
particular facts and circumstances of the case. Id.
Even if a party demonstrates good cause to file a late motion to amend, a court can
deny the motion if the court determines that the proposed amendment of the pleading in
question would be futile. Chiang v. Skeirik, 582 F.3d 238, 244 (1st Cir. 2009). “In
assessing futility, the district court must apply the standard which applies to motions to
dismiss under Fed. R. Civ. P. 12(b)(6).” Adorno v. Crowley Towing & Transp. Co., 443
F.3d 122, 126 (1st Cir. 2006). Accordingly, the Court must accept as true all well-pleaded
facts and draw all reasonable inferences in favor of Defendants to determine whether
Defendants, through their proposed counterclaim, have stated a claim for which relief may
be granted. Morgan v. Town of Lexington, Mass., 823 F.3d 737, 742 (1st Cir. 2016). A
pleading fails to state a claim upon which relief can be granted if it does not plead “enough
facts to state a claim to relief that is plausible on its face.” Bell Atlantic Corp. v. Twombly,
550 U.S. 544, 570 (2007). “The relevant question ... in assessing plausibility is not whether
the complaint makes any particular factual allegations but, rather, whether ‘the
[counterclaim] warrant[s] dismissal because it failed in toto to render [defendants’]
entitlement to relief plausible.’” Rodríguez–Reyes v. Molina–Rodríguez, 711 F.3d 49, 55
(1st Cir. 2013) (quoting Twombly, 550 U.S. at 569 n. 14).
Good Cause Analysis
Defendants argue good cause exists for the timing of their motion because the
motion relies on newly-discovered evidence first obtained at the deposition of Dr. Harris.
(Defendants’ Motion for Leave to Amend, ECF No. 213-1.) Although the parties initially
contested the scope of the proposed amendment, i.e., whether it implicates claims other
than the representative claims and would necessitate a second claim construction hearing
(Defendants’ Reply, ECF No. 231-1, at 12; Plaintiffs’ Sur-Reply, ECF No. 253-1, at 1 –
2), Defendants subsequently agreed to limit the inequitable conduct defense/counterclaims
to the representative claims and claim 46 of the ‘792 patent, which limitation would not
require any further claim construction. (June 30, 2017, Letter of Michael McGraw.)
Defendants argue that prior art made Plaintiffs’ representations about “specially
made feed” specious because, at the time, commercially available feed contained the
additions described in the application for Patent ‘792.6 Defendants further contend that
Dr. Harris’s testimony supports the necessary inferences that Plaintiffs understood that
their application depended on methods that were already well established in the art, and
that their reply to the examiner’s rejection of the application for Patent ‘792 would not have
succeeded had they disclosed the prior art methods to the examiner. (Defendants’ Motion
at 7 – 8; Defendants’ Reply at 1 – 2.)
In support of their motion, Defendants include several prior art references. In particular, a 1993 MooreClark catalogue offered for sale its 6+6 feed, described as containing “special salts,” and recommended for
salmon being transferred from freshwater to saltwater. (ECF No. 215-3, PageID # 7795.) A soviet patent
application dated 1991 also teaches a fish feed formulation containing sodium chloride between 1 and 12
percent by weight, to “increase the survivability of Atlantic salmon smolt through adaptation to ocean
water.” (ECF No. 215-8, PageID # 7860 – 61.) Additionally, a 1993 publication titled “Nutrient
Requirements of Fish” includes tables indicating the “amino acid requirements” of various fish, including
specific amino acids as a percentage of dry diet. The tables specify 0.2 percent tryptophan, the amino acid
addition discussed in Patent ‘792, for juvenile chinook salmon and for juvenile coho salmon. (ECF No.
215-4, PageID # 7823, 7826.) For reference, Patent ‘792 states, “the methods also involve adding feed
having between about 1% and about 10% NaCl by weight and tryptophan in an amount between about 1
gm/kg and about 10 gm/kg to the freshwater and transferring the pre-adult anadromous fish to seawater.”
(Patent ‘792, col. 2, ll. 23 – 24.) Also material, Defendants argue, is a 1988 article entitled Effects of Food
Containing Betaine/Amino Acid Additive on the Osmotic Adaptation of Young Atlantic Salmon, Salmo salar
L. (Virtanen, et al., ECF No. 215-9.)
Because Dr. Harris was a principal inventor who directly participated in the patent
prosecution process,7 it was appropriate for Defendants to depose him before advancing a
claim of inequitable conduct. Baxter Int’l, Inc. v. CareFusion Corp., No. 15-CV-9986,
2017 WL 1049840, at *9 (N.D. Ill. Mar. 20, 2017). Given that Defendants’ proposed
amendment is based on information disclosed during the deposition of Dr. Harris, which
deposition was conducted at the close of the discovery period, and because the information
(i.e., Dr. Harris’s knowledge of the prior art) was unknown to Defendants before the
deposition, good cause exists to permit an amendment of Defendants’ answer to Plaintiffs’
complaint after the deadline for the amendment of pleadings.8
Futility of the Amendment
Plaintiffs argue that the inequitable conduct claim is futile because the allegations
are not sufficiently particularized, the allegedly omitted prior art was actually disclosed,
the alleged omissions were not material because they are cumulative of the disclosed prior
art, and the allegations do not support an inference of intent to deceive. (Id. at 16 – 19.)
Inequitable conduct claims are subject to the heightened pleading standard of Rule
9(b). Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1326 (Fed. Cir. 2009). “A
pleading that simply avers the substantive elements of inequitable conduct, without setting
forth the particularized factual bases for the allegation, does not satisfy Rule 9(b).” Id. at
1326 – 27. “Rule 9(b) requires identification of the specific who, what, when, where, and
See Defendants’ Motion at 4.
Plaintiffs’ contention that they would be prejudiced by the amendment is unconvincing. Insofar as the
amendment is based on information known to and disclosed by the principal inventor of one the patents-insuit, Plaintiffs were presumably aware of the information well before the deposition of Dr. Harris.
how of the material misrepresentation or omission committed before the PTO.” Id.
“Although ‘knowledge’ and ‘intent’ may be averred generally, [Federal Circuit] precedent,
like that of several regional circuits, requires that the pleadings allege sufficient underlying
facts from which a court may reasonably infer that a party acted with the requisite state of
mind.” Id. at 1327. Defendants seek to particularize their allegations of inequitable
conduct by reference to Dr. Harris’s deposition testimony. 9
The issue is whether
Defendants’ allegations are sufficiently particularized to support inferential findings of a
material nondisclosure of prior art and an intent to deceive the patent examiner.
Affirmative misrepresentations to the PTO typically satisfy the materiality standard
as one form of “affirmative egregious misconduct.” Id. at 1292. “After all, a patentee is
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.” Id. Defendants have not alleged any
affirmative allegations that would be actionable. Instead, Defendants’ allegations involve
the nondisclosure of prior art.
At his deposition, Dr. Harris testified that all feed contains tryptophan (ECF No. 231-2 at 105:12); that
Plaintiffs’ claimed invention is “about more than twofold higher than” the nutritional requirement for
tryptophan, which requirement he characterized as 0.02 percent (id. at 106:2 – 9); that the tryptophan used
by Plaintiffs is a “free amino acid” rather than a peptide, which difference he described as “very big … in
terms of PVCR modulators” (id. at 106:13 –16); that additions of calcium and magnesium to hatchery water
were used by “[s]ome hatcheries and under certain circumstances” (id. at 107:7 – 12); that he did not
disclose to the PTO that all feed had tryptophan, or that hatcheries raising salmon were already adding
calcium and magnesium to water, or that all feed had “some sodium chloride” (id. at 108:6 – 24); and that
he did not investigate the actual levels of sodium chloride and tryptophan in prior art feed before pursuing
the Patent (id. at 109:5 – 110:7).
For a nondisclosure to meet the materiality standard, the nondisclosure must be the
“but for” cause for issuance of the patent. Id. at 1291. Nondisclosure of prior art meets
this standard “if the PTO would not have allowed a claim had it been aware of the
undisclosed prior art.” Id. A patentee does not commit inequitable conduct by withholding
a reference if the patent examiner in fact considered the reference, Scripps Clinic &
Research Found. v. Genentech, Inc., 927 F.2d 1565, 1582 (Fed. Cir. 1991), overruled on
other grounds by Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009), or if the
allegedly withheld reference would have been less relevant than other information already
before the PTO, Larson Mfg. Co. of S. Dakota v. Aluminart Prod. Ltd., 559 F.3d 1317,
1327 (Fed. Cir. 2009).
Defendants’ materiality argument is premised on the basic assertion that essentially
any prior art feed used in salmon aquaculture would have contained NaCl and tryptophan
in amounts sufficient to come within the minimum ranges set forth in the representative
claims (1% NaCl and 0.1% tryptophan) and that the patent examiner would have denied
the claims if this information had been disclosed. For example, with respect to the
representative claims involving tryptophan, the salient omitted reference is Nutrient
Requirements of Fish, which states that feeds for juvenile salmon should have 0.2 percent
tryptophan. The tryptophan / feed ratio set forth in the patent teaches a range between
1gm/kg (0.1 percent) and 10gm/kg (1 percent) tryptophan.
“A finding of inequitable conduct as to ‘any single claim renders the entire patent
unenforceable’ and may “render unenforceable other related patents and applications in the
same technology family.” U.S. Water Servs., 843 F.3d at 1352 (quoting Therasense, 649
F.3d at 1288). Arguably, Defendants’ claim of inequitable conduct with the most potential
involves the tryptophan element of claim 46 of the ‘792 Patent.
Upon review of the claim, the Court concludes that Defendants have adequately
alleged materiality based on Nutrient Requirements of Fish (1993). As alleged, the
tryptophan nutritional requirements for juvenile salmon are within the scope of the
tryptophan requirements taught in the claim. Additionally, for purposes of pleading, i.e.,
for purposes of assessing the available reasonable inferences, the Nutrient Requirements
of Fish is not cumulative. In short, there is a plausible inference that “the PTO would not
have allowed [claim 46] had it been aware of the undisclosed prior art.” Therasense, 649
F.3d at 1291. 10
Intent to deceive 11
“The relevant ‘conditions of mind’ for inequitable conduct include: (1) knowledge
of the withheld material information or of the falsity of the material misrepresentation, and
Exergen, 575 F.3d at 1327.
(2) specific intent to deceive the PTO.”
‘knowledge’ and ‘intent’ may be averred generally, … the pleadings [must] allege
sufficient underlying facts from which a court may reasonably infer that a party acted with
the requisite state of mind.” Id. For example, the pleadings should include facts from
which it would be reasonable to infer that a particular person subjectively believed a
Dr. Harris testified that he understood prior art feeds to contain only .02 percent tryptophan and that the
claimed invention involved additions of a “free amino acid” rather than a peptide.
“Intent and materiality are separate requirements.” Therasense, 649 F.3d at 1290. A strong showing of
materiality will not demonstrate intent to deceive. Id.
disclosure would prevent a patent from issuing. Cf. id. at 1328 (“knowledge …, standing
alone, was not enough to infer that the [applicant] also subjectively believed” (discussing
analogous inquiry in trademark context)). Facts depicting gross negligence or negligence
will not suffice. Therasense, 649 F.3d at 1290.
Contrary to Plaintiffs’ contentions, Defendants have alleged facts with sufficient
particularity and facts that support a plausible claim for relief. Twombly, 550 U.S. at 570.
Intent can be established inferentially. Here, Defendants have alleged facts from which a
fact finder could conclude that one of the principal inventors (Dr. Harris) was aware of the
prior art, including that the minimum specifications for NaCl and amino acid content in the
feed necessarily encompassed prior art feed, was aware that the prior art was relevant to
Claim 46 of Patent ‘792, and did not disclose the prior art due to concerns that a candid
disclosure regarding the scope of the NaCl and amino acid feed specifications would
undermine the applications.
Based on the foregoing analysis, the Court grants Defendants’ motion to amend.
(ECF No. 214). Defendants shall file amended answer and counterclaim within seven days
of the date of this order.
Any objections to this Order shall be filed in accordance with Federal Rule
of Civil Procedure 72.
/s/ John C. Nivison
U.S. Magistrate Judge
Dated this 31st day of July, 2017.
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