United States District Court, D. Maine
DECISION AND ORDER ON DEFENDANTS' MOTION TO AMEND
C. Nivison U.S. Magistrate Judge
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 U.S. Inc., True North Sales U.S. 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.)
matter is before the Court on Defendants' Motion for
Leave to Amend Their Answer. (ECF No. 214.) 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.” (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 patent.”
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
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.
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.)
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.)
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,
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
(Id. ¶¶ 19 - 21.)
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.)
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 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 Freshwater Feed is prior art to the
patents-in-suit. (Id. ¶ 33.) 6 Freshwater
Feed was used and offered for sale in the United States
before the priority date of the patents-in-suit.
(Id. ¶¶ 36 - 37.) 6 Freshwater Feed
contained more than 1% added sodium chloride. (Id.
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 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. (Id. ¶ 45.) Dr. Harris
explained that he did not disclose to the 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.
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 ...