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