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Marical Inc. v. Cooke Aquaculture Inc.

United States District Court, D. Maine

July 31, 2017

MARICAL INC., et al., Plaintiffs
v.
COOKE AQUACULTURE INC., et al., Defendants

          DECISION AND ORDER ON DEFENDANTS' MOTION TO AMEND ANSWER

          John C. Nivison U.S. Magistrate Judge

         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 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.)

         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.” (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.”[2]

         Following a review of the record, and after consideration of the parties' written arguments, the Court grants the motion.

         Background

          “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]

         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.

         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 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.[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 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 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. ΒΆ 61.) Defendants alleged that Dr. Harris misled the PTO by referring ...


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