UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`AKER BIOMARINE AS and ENZYMOTEC LTD.
`Petitioners
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`______________________
`
`CASE IPR2014-000031
`U.S. Patent No. 8,278,351 B2
`______________________
`
`
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. § 42.64
`
`
`1 Case IPR2014-00556 has been joined with this proceeding.
`
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`AKER BIOMARINE AS and ENZYMOTEC LTD.
`Petitioners
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`______________________
`
`CASE IPR2014-000031
`U.S. Patent No. 8,278,351 B2
`______________________
`
`
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. § 42.64
`
`
`1 Case IPR2014-00556 has been joined with this proceeding.
`
`
`
`Patent Owner’s Motion to Exclude
`IPR2014-00003
`Pursuant to 37 C.F.R. § 42.64 and the parties’ stipulation regarding Due Dates 1-5
`
`(Paper 63),2 Patent Owner Neptune Technologies & Bioressources Inc. (“Neptune”) moves to
`
`exclude AKBM Ex. 1107. Neptune timely served notice of its objections pursuant to 37 C.F.R.
`
`§ 42.64(b)(1).3
`
`I.
`
`Legal Standards
`
`
`
`With limited exceptions, the Federal Rules of Evidence apply in IPR proceedings. See
`
`37 C.F.R. § 42.62. Accordingly, irrelevant evidence is not admissible. Fed. R. Evid. 402. To
`
`be relevant, evidence must make a fact, which is “of consequence in determining” the issues
`
`in dispute, “more or less probable than it would be without the evidence.” Fed. R. Evid. 401.
`
`Even if evidence is relevant, it may still be excluded if its probative value is outweighed by a
`
`danger of unfair prejudice or wasting time. Fed. R. Evid. 403.
`
`II.
`
`The Board Should Exclude AKBM Ex. 1107
`
`
`
`AKBM Ex. 1107 includes selected correspondence between Neptune and the FDA in
`
`2002 regarding planned Neptune products, including Neptune Krill Oil, Aquateine, LyO-Krill,
`
`and Krill Euphasia. See AKBM Ex. 1107 at 2. The correspondence resulted from a
`
`2 The Board accepted the parties’ stipulation regarding Due Dates 1-5. See IPR2014-00556,
`
`Paper 19.
`
`3 Petitioners served AKBM Ex. 1107 with Petitioners’ Reply on September 18, 2014 (see
`
`Paper 85 at 17), and Neptune served its objections on September 23, 2014. See Exhibit
`
`2065.
`
`1
`
`
`
`Patent Owner’s Motion to Exclude
`IPR2014-00003
`submission Neptune made to the FDA on February 28, 2002 (which itself is not included in Ex.
`
`1107). See id. at 2. In response to Neptune’s submission, the FDA requested further
`
`information, including information regarding the “extraction procedure” used to make the
`
`Neptune products at issue. See id. at 2, 94-147. To provide information regarding its
`
`extraction procedure, Neptune submitted the issued Beaudoin I patent in lieu of disclosing the
`
`trade secret details of its proprietary manufacturing process at the time.
`
`
`
`Petitioners rely on AKBM Ex. 1107 to assert that Neptune “told the FDA it used
`
`Beaudoin to make its claimed invention.”4 See Petitioners’ Reply, Paper 84, at 5 (Sept. 18,
`
`2014).
`
`
`
`AKBM Ex. 1107 is irrelevant to the alleged express or inherent anticipation by
`
`Beaudoin and so should be excluded under Federal Rule of Evidence 402. “[I]nvalidity by
`
`anticipation requires that the four corners of a single [ ] prior art document describe every
`
`element of the claimed invention.” TriMed, Inc. v. Stryker Corp., 608 F. 3d 1333, 1343 (Fed.
`
`Cir. 2010) (internal citation omitted). Aker does not and cannot contend that Neptune’s
`
`correspondence with the FDA sheds any light on what the Beaudoin reference itself discloses
`
`or how the reference relates to the patent claims at issue in this proceeding. See MPEP
`
`2131.01 (only one reference should be used to make an anticipation rejection unless the
`
`additional documents cited prove enablement or inherency, or explain the meaning of terms
`
`4 This contention is not only irrelevant, it is also not responsive to any argument raised in
`
`Neptune’s Patent Owner Response. See 37 C.F.R. 42.23(b).
`
`2
`
`
`
`Patent Owner’s Motion to Exclude
`IPR2014-00003
`used in the primary reference). Thus, Neptune’s correspondence with the FDA is irrelevant.
`
`
`
`Even if Ex. 1107 has some marginal relevance, it should nevertheless be excluded
`
`under Federal Rule of Evidence 403 because the risk of unfair prejudice and waste of time
`
`outweighs any probative value of the documents. Aker is offering these documents in an
`
`attempt to mislead the Board into believing that Neptune “t[old] the FDA it used Beaudoin to
`
`make its claimed invention.” But as discussed above, Neptune merely provided the Beaudoin
`
`patent as an expedient way to satisfy the FDA’s inquiry regarding extraction method, and did
`
`not indicate that Beaudoin relates to Neptune’s post-extraction refinement steps or any other
`
`aspect of Neptune’s manufacturing process.5 Moreover, the anticipation analysis requires a
`
`comparison of the prior art to the limitations of the patented claims, not commercial
`
`embodiments. See Arthrocare Corp. v. Smith & Nephew, Inc., 310 F. Supp. 2d 638, 667 (D.
`
`Del. 2004), vacated in part on other grounds, 406 F.3d 1365 (Fed. Cir. 2005) (“Anticipation is
`
`determined by comparing the limitations of the asserted claims, not of commercial
`
`embodiments as described in [FDA] 510(k) submissions, to the disclosure found in a single
`
`piece of prior art.”). It would unfairly prejudice Neptune to have this FDA correspondence
`
`considered as evidence of alleged anticipation.
`
`
`
`It is also a waste of the Board’s time to delve into the hundred of pages of
`
`correspondence contained in Ex. 1107 in attempt to understand a Neptune FDA submission
`
`5 Such post-extraction refinement steps may include, for example, solvent removal. See
`
`Patent Owner Response, Paper 66, at 19 (July 1, 2014).
`
`3
`
`
`
`Patent Owner’s Motion to Exclude
`IPR2014-00003
`that is only partially included in the exhibit and that, in any event, has no bearing on what
`
`Beaudoin does or does not disclose.
`
`III. Conclusion
`
`
`
`For these reasons, the Board should exclude AKBM Ex. 1107 pursuant to Federal
`
`
`
`Respectfully submitted,
`
`COOLEY LLP
`
`
`
`By:
`
`
`
`/J. Dean Farmer /
`J. Dean Farmer, Ph.D.
`Reg. No. 57,917
`
`4
`
`Rules of Evidence 402 and/or 403.
`
`
`Dated: September 25, 2014
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W.
`Suite 700
`Washington, DC 20004-2400
`
`Tel: (617) 937-2370
`Fax: (202) 842-7899
`
`
`
`
`
`Patent Owner’s Motion to Exclude
`IPR2014-00003
`
`
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e), 42.205(b)
`I, J. Dean Farmer, Ph.D., hereby certify that the foregoing PATENT OWNER’S
`
`MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. § 42.64 AND EXHIBIT NEPN 2065 was
`served electronically (as consented to by Petitioners) on September 25, 2014, the same day
`as the filing of the above-identified document in the United States Patent and Trademark
`Office (USPTO), upon:
`
`Amanda Hollis
`amanda.hollis@kirkland.com
`Hand delivery address:
`KIRKLAND & ELLIS
`300 North LaSalle
`Chicago, IL 60654
`Telephone: 312-862-2011
`Facsimile: 312-862-2200
`Reg. No. 55,629
`
`J. Mitchell Jones
`jmjones@casimirjones.com
`docketing@casimirjones.com
`Hand delivery address:
`CASIMIR JONES SC
`2275 Deming Way, St. 310
`Middleton, WI 53562
`Telephone: (608) 662-1277
`Facsimile: (608) 662-1276
`Reg. No. 44,174
`
`
`
`Dated: September 25, 2014
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W.
`Suite 700
`Washington, DC 20004-2400
`Tel: (617) 937-2370
`Fax: (202) 842-7899
`
`
`
`Elizabeth J. Holland
`eholland@goodwinprocter.com
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Telephone: (212) 813-8800
`Facsimile: (212) 355-3333
`Reg. No. 47,657
`
`Cynthia Lambert Hardman
`chardman@goodwinprocter.com
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Telephone: (212) 813-8800
`Facsimile: (212) 355-3333
`Reg. No. 53,179
`
`
`
`
`
`
`Respectfully submitted,
`
`COOLEY LLP
`
`By:
`
`
`
`/J. Dean Farmer/
`J. Dean Farmer, Ph.D.
`Reg. No. 57,917
`
`
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