`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`AKER BIOMARINE AS and ENZYMOTEC LTD.
`Petitioners
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`v.
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`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`______________________
`
`CASE IPR2014-000031
`U.S. Patent No. 8,278,351 B2
`______________________
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`
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`PATENT OWNER’S REPLY IN SUPPORT OF
`MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. § 42.64
`
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`1 Case IPR2014-00556 has been joined with this proceeding.
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`Patent Owner’s Reply In Support of Motion to Exclude
`IPR2014-00003
`Unable to cure the deficiencies of its alleged Beaudoin “recreation” experiments, Aker
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`admits it offered Ex. 1107 to support its theory of inherent anticipation. Ex. 1107 contains
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`correspondence regarding a 75-day premarket notification for Neptune Krill Oil, which Neptune
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`submitted to the FDA in February 2002. Aker contends that Ex. 1107 contains relevant
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`“admissions” about the manufacture of Neptune Krill Oil. But the inherent anticipation analysis
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`requires comparing the prior art to the claim limitations, not to commercial embodiments.
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`Furthermore, Aker is not relying on any actual “admission” in Ex. 1107, but merely using this
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`exhibit to insinuate that there must not be differences between Neptune’s manufacturing
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`process and the Beaudoin patent because if there were, Neptune “presumably would have”
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`explained such differences to the FDA. Aker’s assertions are facially implausible and far afield
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`of the prior art issues before the Board. Aker fails to establish any relevance of Ex. 1107 and
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`the Board should exclude it.
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`I. Commercial Embodiments Are Irrelevant to the Alleged Anticipation.
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`Inherent anticipation analysis is “a two-step procedure”: (1) construing the claim
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`limitations; and (2) “determining whether the limitations of the claims as properly interpreted
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`are met by the prior art.” E.g., TI Grp. Auto. Sys. (N. Am.), Inc. v. VDO N. Am., L.L.C., 375
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`F.3d 1126, 1139 (Fed. Cir. 2004) (internal citation omitted). As emphasized in the Telemac
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`decision Aker cites, recourse to extrinsic evidence is proper only to determine “whether a
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`feature, while not explicitly discussed, is necessarily present in a reference.” Telemac Cellular
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`Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1328 (Fed. Cir. 2001).
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`1
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`Patent Owner’s Reply In Support of Motion to Exclude
`IPR2014-00003
`The FDA correspondence in Ex. 1107 is about Neptune Krill Oil, not the allegedly
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`anticipatory Beaudoin reference. Aker is erroneously trying to prove inherent anticipation by
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`comparing the prior art to a commercial embodiment. Courts have rejected evidence exactly
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`like Ex. 1107 as evidence of inherent anticipation.
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`For example, in Arthrocare Corp. v. Smith & Nephew, Inc., the court excluded 510(k)
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`FDA submissions that compared the patentee’s product “to a predicate product which is
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`already on the market.” 310 F. Supp. 2d 638, 667, n12 (D. Del. 2005). The challenger sought
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`to use the 510(k) submissions as evidence that “the commercial embodiments of the patents
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`in suit have the same principles of operation as prior art devices.” Id. at 667. The court ruled
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`that the 510(k) submissions were “irrelevant to invalidity,” because “[a]nticipation is determined
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`by comparing the limitations of the asserted claims, not of commercial embodiments as
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`described in 510(k) submissions, to the disclosure found in a single piece of prior art.” Id.
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`The Arthrocare court’s reasoning is directly on point. It makes no difference that, as
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`Aker notes, the Arthrocare defendant argued inherent anticipation based on a prior art device
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`and Petitioners allege inherent anticipation based on a prior art process.2 (See Opp. at 13.)
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`Ex. 1107 is irrelevant to inherent anticipation and the Board should exclude it.
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`2 Aker further argues that Ex. 1107 “would readily indicate to a person of ordinary skill in the
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`art” that the Beaudoin patent inherently anticipates (Opp. at 10), but tellingly, not one of
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`Petitioners’ numerous experts was willing to rely or give any opinion on this exhibit.
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`2
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`Patent Owner’s Reply In Support of Motion to Exclude
`IPR2014-00003
`II. Aker’s Unfounded Allegations About What Neptune “Should” or “Should
`Not” Have Told the FDA Are Irrelevant and Prejudicial.
`Even if the Board thinks Neptune Krill Oil has some relevance, it should still exclude
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`
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`Ex. 1107. This exhibit shows merely that Neptune provided an appendix labeled “Extraction
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`Procedures” that contained the Beaudoin patent. See AKBM Ex. 1107, p. 95. This is
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`unremarkable, given that the ’351 patent incorporates the Beaudoin patent by reference, and
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`a far cry from “admitting” that the Beaudoin process “necessarily results” in the Neptune Krill
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`Oil product. Aker is insinuating this so-called “admission” through a flawed chain of reasoning,
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`i.e., if Neptune’s manufacturing process differed in any way from the Beaudoin process,
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`Neptune “should have given,” “should have told,” or “presumably would have” explained such
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`differences to the FDA. (See, e.g., Opp. at 7, 9.)
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`
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`Aker’s insinuation is baseless. In the first place, the Board does not have the actual
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`submission Neptune made to the FDA in in February 2002 and so cannot determine what
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`Neptune did or did not provide.3 Second, it is logical and expected that Neptune would not
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`disclose the trade secret or novel aspects of its product in a public regulatory submission.
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`Third, the relevant regulation does not require submission of manufacturing details, and so
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`Aker has no basis to argue that Neptune should have provided exhaustive manufacturing
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`information to the FDA. See 21 C.F.R. § 190.6(b) (listing requirements for 75 day-notification
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`3 Neptune’s counsel is unaware of exactly what the February 2002 submission contained, but
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`understands it was more voluminous than the follow-up submission contained within Ex. 1107.
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`3
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`Patent Owner’s Reply In Support of Motion to Exclude
`IPR2014-00003
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`from dietary supplement manufacturer).
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`Aker is also wrong that Neptune “use[d] Beaudoin (and nothing more)” “for purposes of
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`showing that its claimed invention is safe to be marketed and used by humans as a dietary
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`supplement.” (Opp. at 7.) To establish the safety of its product (which was later named
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`NKO™), Neptune made a separate Generally Recognized as Safe (“GRAS”) submission to
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`the FDA. Neptune’s GRAS submission does not reference Beaudoin but indicates that NKO™
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`differs from Beaudoin’s krill oil fractions in many respects. Compare, e.g., NEPN Ex. 2008, p.
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`000009, 000012 (showing NKO™ contains less than 0.9% humidity and less than10 mg/kg of
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`acetone) with AKBM Ex. 1002, Beaudoin Table 13 (krill oil fractions contain 10% and 6.8%
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`volatile matter and moisture).
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`III. Conclusion
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` Regardless of what Neptune provided to the FDA, the Board must decide patentability
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`by comparing the Beaudoin patent to the claimed limitations. Ex. 1107 has no bearing on this
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`analysis. Attempting to glean any information from Ex. 1107 would be prejudicial and a waste
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`of the Board’s time. For these and the reasons stated in Neptune’s opening brief, the Board
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`should exclude AKBM Ex. 1107 pursuant to Federal Rules of Evidence 402 and/or 403.
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`Respectfully submitted,
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`COOLEY LLP
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`
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`/J. Dean Farmer /
`J. Dean Farmer, Ph.D.
`
`By:
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`4
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`Dated: October 14, 2014
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`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W.
`Suite 700
`
`
`
`Patent Owner’s Reply In Support of Motion to Exclude
`IPR2014-00003
`
`
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`Reg. No. 57,917
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`Washington, DC 20004-2400
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`Tel: (617) 937-2370
`Fax: (202) 842-7899
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`
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`5
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`Patent Owner’s Reply In Support of Motion to Exclude
`IPR2014-00003
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`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 REPLY
`
`IN SUPPORT OF MOTION TO EXCLUDE PURSUANT TO 37 C.F.R. § 42.64 was served
`electronically (as consented to by Petitioners) on October 14, 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
`
`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
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`Respectfully submitted,
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`COOLEY LLP
`
`/J. Dean Farmer/
`J. Dean Farmer, Ph.D.
`Reg. No. 57,917
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`
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`By:
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`
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`
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`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: October 14, 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
`
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`111030689 v1
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