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`Filed: December 17, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`Petitioner,
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`v.
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`BIOGEN MA, INC.
`Patent Owner.
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`Patent No. 8,399,514
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`Inter Partes Review IPR2018-01403
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`REPLY IN SUPPORT OF PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 8,399,514
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`Biogen attempts to leverage out-of-context quotes from the Federal Circuit’s
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`decision in FWP IP APS v. Biogen MA Inc. to argue against institution. There, the
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`Federal Circuit held that the specification of Forward Pharma IP ApS’s (FP)
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`Publication No. WO 2006/0037342 (WO ’342) did not provide written description
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`support for the claims recited in Biogen’s U.S. Patent No. 8,339,514 (’514 patent).
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`No. 17-2109, 2018 WL 5292070 (Fed. Cir. Oct. 24, 2018). The Federal Circuit did
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`not consider WO ’342 as an obviousness reference. Nor did it hold that
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`unexpected results render the claims of the ’514 patent nonobvious. That is
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`unsurprising. The parties did not argue obviousness or unexpected results on
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`appeal. The disputed issue was written description. Biogen’s overreading of the
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`Federal Circuit’s decision should not impact the Board’s institution decision here.
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`I.
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`THE FEDERAL CIRCUIT’S WRITTEN DESCRIPTION ANALYSIS
`DID NOT CONSIDER OBVIOUSNESS OR WEIGH ANY
`SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS.
`Biogen overreaches in attempting to bolster its unexpected results case. The
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`Federal Circuit did not decide whether the ’514 patent was obvious, or consider
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`arguments concerning any supposed secondary evidence of non-obviousness. The
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`issue on appeal was written description. As the Board noted in the interference
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`decision that the Federal Circuit affirmed, there is a significant difference between
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`evaluating written description, on the one hand, and “what might have been
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`obvious,” on the other. Decision at 28, Biogen MA Inc. v. Forward Pharma A/S,
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`Interference 106,023 (PTAB Mar. 31, 2017), Paper 813. “Using the prior art in the
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`way urged by FP may show that the claimed subject matter, when considered with
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`the prior art, might have been obvious to one skilled in the art,” even if it “fails to
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`show . . . that FP’s inventors had possessed and described the specific treatment
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`method they now claim.” Id. (emphasis added); see also id. at 24 (“[T]he written
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`description requirement is met by describing the invention . . . not by merely
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`describing that which would make the invention obvious.”).
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`The distinction is critical, and the Federal Circuit only analyzed written
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`description, not obviousness. On appeal, Biogen repeatedly criticized FP for
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`taking an “obviousness-type approach[] to written description.” Brief of Appellee
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`at 50, FWP IP APS v. Biogen MA Inc., No. 17-2109 (Fed. Cir. Nov. 16, 2017),
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`ECF No. 31 (“Biogen Br.”); see also id. at 19, 23-24. Faced with changed
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`circumstances, Biogen should not be permitted to take a written description
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`approach to obviousness here.
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`II. THE PARTIES DID NOT ARGUE, AND THE FEDERAL CIRCUIT
`DID NOT DECIDE, THE MERITS OF UNEXPECTED RESULTS.
`The appeal record also does not support Biogen’s argument that the Federal
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`Circuit “confirmed” that Biogen’s purported unexpected results are “significant.”
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`Paper 7 at 2. The parties did not argue the merits of unexpected results on appeal.
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`For example, because it had no occasion to consider obviousness, the Federal
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`Circuit did not consider whether any purported unexpected results were “different
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`in kind and not merely in degree from the results of the prior art,” as is required for
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`unexpected results to be “probative of nonobviousness.” Galderma Labs., L.P. v.
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`Tolmar, Inc., 737 F.3d 731, 739 (Fed. Cir. 2013) (citation omitted).
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`Tellingly, on unexpected results Biogen’s appeal brief cites only the Board’s
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`previous inter partes review decision, Biogen press releases, and its own motion.
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`Biogen Br. at 5-6. The Federal Circuit’s use of the term “unexpectedly,” in turn, is
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`limited to characterizing Biogen’s arguments. FWP, 2018 WL 5292070 at *6.
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`Importantly, the Federal Circuit did not have the evidence presented in Mylan’s
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`Petition demonstrating that prior to the filing of the ’514 patent, skilled artisans
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`would have understood that administering 480 mg/day of DMF was likely to be
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`similarly efficacious in treating MS as 720 mg/day (see e.g., Paper 2 at 54-55, 58-
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`59), and that Biogen’s unexpected results evidence is contradicted by other
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`publications (see also e.g., id at 55-58).
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`Different records often lead to different results. Here, not only are the
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`records different, the substantive law is too. Biogen should not be allowed to
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`bootstrap dicta from the Federal Circuit’s decision in a case involving different
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`evidence and legal issues to argue for non-institution of inter partes review.
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`***
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`The Federal Circuit’s written description holding does not support denial of
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`institution of this inter partes review.
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`3
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`Dated: December 17, 2018 Respectfully submitted,
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`PERKINS COIE LLP
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`By: /s/ Brandon M. White
` Brandon M. White
` Reg. No. 52,354
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`4
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e), I certify that I caused to be served a true
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`and correct copy of the foregoing: REPLY IN SUPPORT OF PETITION FOR
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`INTER PARTES REVIEW OF U.S. PATENT NO. 8,399,514 by email to the
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`electronic service addresses for Patent Owner:
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`barbara.mccurdy@finnegan.com;
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`erin.sommers@finnegan.com; and
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`pier.deroo@finnegan.com.
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`Dated: December 17, 2018
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`/s/ Brandon M. White
`Brandon M. White
`Registration No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
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