BoxInterferences@uspto.gov
`Tel: 571-272-4683
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`Entered: March 31, 2017
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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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`BIOGEN MA INC.
`Junior Party Patent 8,399,514 B2,
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`v.
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`FORWARD PHARMA A/S
`Senior Party Application 11/576,871.
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`Patent Interference No. 106,023
`Technology Center 1600
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`Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
`DEBORAH KATZ, Administrative Patent Judges.
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`SCHAFER, Administrative Patent Judge.
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`Decision - Motions - 37 C.F.R. § 41.125(a)
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`This interference is between Biogen’s Patent 8,399,514 (the ’514 patent) and
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`Forward Pharma’s (FP) Application 11/576,871 (the ‘871 application).
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`Biogen’s patent was also the subject of IPR2015-01993.
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`Biogen’s involved patent issued on March 19, 2013. Ex. 2001A, p. 1.
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`Subsequently, on December 3, 2013, FP filed an amendment in its application
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`cancelling all its previously filed claims, adding claims substantially copied from
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`Biogen’s patent and requesting an interference with the patent. Application
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`Page 1 of 30
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`Biogen Exhibit 2030
`Mylan v. Biogen
`IPR2018-01403
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`

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`Interference 106,023
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`11/576,871, papers filed December 3, 2013. After additional prosecution, an
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`examiner determined that FP’s copied claims (claims 55 – 70) were allowable but
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`for the outcome of the interference, and requested that this Board declare an
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`interference between ’871 application and Biogen’s ’514 patent.
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`I.
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`
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`The parties’ substantive motions are before us for consideration. The
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`following motions are pending:
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`1.
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`Biogen Motion 1 (Paper 171) for judgment that FP’s involved claims are not
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`supported by either an adequate written description or an enabling disclosure.
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`2.
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`Biogen Motion 3 (Paper 174) attacking the accorded benefit of the filing date
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`3.
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`4.
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`5.
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`of FP’s Danish Application PA 2004 01546.
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`Biogen Motion 4 (Papers 556 and 557) for priority of invention.
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`Biogen Motion 7 (Paper 797) to exclude certain of FP’s evidence.
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`FP Motion 3 (Paper 172) to be accorded the benefit of the filing dates of its
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`Danish Application PA 2004 01736, Danish Application. PA 2005 00211,
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`Danish Application PA 2005 00419, and U.S. Provisional Application
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`60/691,513, filed June 16, 2005.
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`6.
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`FP Motion 7 (Paper 167) for a judgment that Biogen’s involved claims are
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`unpatentable over certain prior art.
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`7.
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`FP Motion 10 (Paper 168) for a judgment that Biogen’s involved claims are
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`unpatentable under 35 U.S.C. § 112, ¶ 1, for lack of adequate written
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`description support.
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`II.
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`
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`The subject matter of this interference relates to the treatment of multiple
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`sclerosis (MS) by administrating a therapeutically effective dose of about
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`480 mg/day of certain fumarate compounds. Fumarates are also referred to as
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`fumaric acid esters. The claims limit the fumarates to dimethyl fumarate (DMF),
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`Page 2 of 30
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`Interference 106,023
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`monomethyl fumarate (MMF), or their combinations. The therapeutically effective
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`dose is limited to 480 mg/day (FP’s claims) or “about” 480 mg/day (Biogen’s
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`claims). FP Clean copy of claims, Paper 7; Biogen Clean copies of claims,
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`Paper 14.
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`The parties’ subject matter is represented by Count 1:
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`A method of treating a human in need of treatment for
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`multiple sclerosis comprising orally administering to the human
`a pharmaceutical composition consisting essentially of
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`(a) a therapeutically effective amount of dimethyl
`fumarate, monomethyl fumarate, or a combination thereof, and
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`(b) one or more pharmaceutically acceptable excipients,
`wherein the therapeutically effective amount of dimethyl
`fumarate, monomethyl fumarate, or a combination thereof is
`about 480 mg per day.
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`Declaration, Paper 1, p. 5.
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`III.
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`
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`For the reasons detailed below, we grant Biogen’s Motion 1. We are
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`persuaded that one skilled in the art would not have recognized that the FP’s
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`inventors had possession of, and described, the specific treatment method claimed.
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`We think (1) the focus of FP’s specification on controlled release fumarates to
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`reduce gastrointestinal impact compared to the prior art fumarate compositions and
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`(2) the general teaching of the applicability of the fumarates to treatment of a
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`variety of possible diseases or conditions and the teaching of a broad range of
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`possible dosages would not have conveyed possession or description of the specific
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`treatment of MS that FP now claims.
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`
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`Because FP lacks support for its copied claims, FP is not in position to
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`challenge Biogen’s entitlement to the subject matter claimed in the ’514 patent.
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`We therefore do not reach FP’s motions. See 37 C.F.R. §41.201 (definition of
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`threshold issue). Because we hold that FP’s claims are unpatentable, it is
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`Page 3 of 30
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`Interference 106,023
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`unnecessary to reach Biogen’s other motions or to determine priority. We
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`terminate this interference with a judgment against FP’s claims in a separate paper.
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`IV.
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`A.
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`Biogen Motion 1 (Biogen Mot. 1) asserts that all of FP’s current claims lack
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`written descriptive and enabling support as required by 35 U.S.C. § 112, ¶ 1.
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`Biogen Mot. 1, Paper 171. FP opposed (FP Opp. 1, Paper 739) and Biogen replied
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`(Biogen Rep. 1, Paper 778).
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`FP’s ’871 application includes claims 55 - 70. FP Clean copy of claims,
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`Paper 7. All of FP’s claims require treatment of a patient in need of treatment for
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`MS with a therapeutically effective amount of 480 mg/day of DMF and/or MMF.
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`Id. Claims 55, 65 and 69 are independent. Id. In claims 60, 63, 64, and 66-70, the
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`pharmaceutical composition used for treatment “consists essentially of” DMF. Id.
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`Claim 61 specifies treating with a pharmaceutical composition “consisting
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`essentially of” MMF. Id.
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`
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`We reproduce, as illustrative, FP’s claim 69:
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`69. A method of treating a subject in need of treatment for
`multiple sclerosis comprising
`orally administering to the subject a pharmaceutical
`composition consisting essentially of
`(a) a therapeutically effective amount of
`dimethylfumarate and
`(b) one or more pharmaceutically acceptable
`excipients,
`wherein the therapeutically effective amount of
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`dimethylfumarate is 480 mg per day.
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`FP Clean copy of claims, Paper 7, 3:20 – 4:2 (paragraphing added).
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`Interference 106,023
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`B.
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`Because FP substantially copied the claims of Biogen’s patent, to the extent
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`necessary, we construe FP’s claims in light of Biogen’s disclosure. Agilent Techs.,
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`Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1375 (Fed. Cir. 2009).
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`C.
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`1.
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`We have reviewed FP’s as-filed specification (Ex. 1001). Our review
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`indicates that a principal focus of FP’s disclosure is the minimization of gastro-
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`intestinal side-effects through use of controlled release of fumarates.
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`The title of FP’s as-filed application1 is “Controlled Release Pharmaceutical
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`Composition Comprising a Fumaric Acid Ester.” Ex. 1001, p. 1.
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`The specification notes that administering fumarates causes certain
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`undesired side-effects:
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`[T]herapy with fumarates . . . frequently gives rise to gastro-
`intestinal side effects such as e.g. fullness, diarrhea, upper
`abdominal cramps, flatulence and nausea.
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`Ex. 1001, 2:34-36. The specification identifies these side effects as the problem
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`addressed by the invention:
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`The problem the invention solves is related to the appearance of
`gastro-intestinal side-effects upon oral administration of
`fumaric acid esters.
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`Ex. 1001, 9:8-9.
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`The specification describes certain prior art commercial preparations
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`containing fumarates. Ex. 1001, 1:12 – 2:33. The products discussed include
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`1 The title was changed to “Controlled Release Pharmaceutical Composition
`Comprising a Fumaric Acid Ester (‘480 mg per day dosing’)” by an amendment
`filed January 21, 2014. Application 11/576,871, “Specification” filed
`January 21, 2014 (italics shows subject matter added by amendment to the title).
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`Interference 106,023
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`some sold by Biogen under the tradename Fumaderm®. Ex. 1001, 9:12-14. The
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`Fumaderm® products are registered for treatment of psoriasis. Id.at 7:9-12. The
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`Fumaderm® products include DMF and the calcium, magnesium and zinc salts of a
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`different fumarate—ethylhydrogenfumarate. Ex. 1001, 1:16-23.
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`The specification characterizes the invention as relating to pharmaceutical
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`compositions that include as an active ingredient “one or more fumaric acid esters”
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`[w]hich - upon oral administration and in comparison to that
`obtained after oral administration of Fumaderm® tablets in an
`equivalent dosage - gives a reduction in GI (gastro-intestinal)
`related side-effects.
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`Ex. 1001, 3:25-30 (emphasis added). The section of the specification titled “Field
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`of the invention” describes the invention as follows:
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`The present invention relates to controlled release
`pharmaceutical compositions comprising a fumaric acid ester
`as an active substance. The compositions are suitable for use in
`the treatment of e.g. psoriasis or other hyperproliferative,
`inflammatory or autoimmune disorders and are designed to
`release the fumaric acid ester in a controlled manner so that
`local high concentrations of the active substance within the
`gastrointestinal tract upon oral administration can be avoided
`and, thereby, enabling a reduction in gastro-intestinal related
`side-effects.
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`Ex. 1001, 1:4-10. (emphasis added). The written description also notes the
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`benefits of controlled release formulations:
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`By prolonging and/or delaying the release of the active
`substance from the composition it is envisaged that the local
`concentration of the active substance at specific sites of the
`gastro-intestinal tract is reduced (compared with that of
`Fumaderm®) which in turn leads to a reduction in gastro-
`intestinal side-effects. Accordingly, compositions that enable a
`prolonged and/or a slow release of a fumaric acid ester as
`defined above are within the scope of the present invention.
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`Ex. 1001, 9:9-14.
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`Interference 106,023
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`The specification then goes on to express the goals of the invention with
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`respect to administering fumarate preparations: (1) improved efficacy with reduced
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`gastro-intestinal side-effects and (2) a product with fewer fumarates that still has
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`adequate efficacy:
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`Accordingly, there is a need to develop compositions
`comprising one or more therapeutically or prophylactically
`active fumaric acid esters that provide an improved treatment
`with a reduction in gastro-intestinal related side effects upon
`oral administration.
`Furthermore, the present commercially available
`products contain a combination of two different esters of which
`one of the esters (namely the ethylhydrogenfumarate which is
`the monoethylester of fumaric acid) is present in three different
`salt forms (i.e. the calcium, magnesium and zinc salt). Although
`each individual form may have its own therapeutic profile, it
`would be advantageous to have a much simpler product, if
`possible, in order to obtain a suitable therapeutic effect.
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`Ex. 1001, 3: 1-9. The inventors then explain that their response to the perceived
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`need is a treatment regimen using a controlled release preparation that delivers the
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`active substance in a controlled manner that is prolonged or delayed compared to
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`the commercial fumarate products:
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`The present inventors contemplate that an improved treatment
`regimen may be obtained [through] administration of a
`pharmaceutical composition that is designed to deliver the
`active substance in a controlled manner, i.e. in a manner that is
`prolonged, slow and/or delayed compared with the
`commercially available product. Furthermore, it is
`contemplated that instead of using a combination of different
`fumaric acid esters, a suitable therapeutic response may be
`achieved by use of a single fumaric acid ester alone such as
`dimethylfumaric acid.
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`Ex. 1001, 3:10-16 (emphasis added). The desired reduction in GI side-effects is
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`compared to those observed with Fumaderm®:
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`Interference 106,023
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`[A] reduction of GI related side effects is intended to denote a
`decrease in severity and/or incidence among a given treated
`patient population, compared to the GI side effects observed
`after administration of the composition according to the
`invention compared with that of Fumaderm®.
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`Ex. 1001, 6:25-28. More specifically, the controlled release compositions provide
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`“fumeric acid ester in a prolonged, slow and/or delayed manner compared to the
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`release of the commercially available product Fumaderm® when tested under
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`comparable conditions . . . .” Ex. 1001, 4:25-28. FP specification says
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`“prolonged” means
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`that the active substance is released during a longer time period
`than Fumaderm® such as at least during a time period that is at
`least 1.2 times, such as, e.g., at least 1.5 times, at least 2 times,
`at least 3 times, at least 4 times or at least 5 times greater than
`that of Fumaderm®.
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`Ex. 1001, 6: 7-11. “Delayed,” means release of the chosen fumarate starts later in
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`time than would occur with Fumaderm®:
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`“[D]elayed” is intended to indicate that the release of the active
`substance starts at a later point in time compared with that of
`Fumaderm® (such as at 30 min or more later such as, e.g.,
`45 min or more later, 1 hour or more later or 1.5 hours or more
`later, alternatively, that the initial release during the first
`2 hours is much less compared with that of Fumaderm® (i.e.
`less than 80% w/w such as, e.g., less than 70% w/w, less than
`60%w/w or less than 50% of that of Fumaderm®).
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`Ex. 1001, 6:15-20.
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`The specification describes, in significant detail, different types of controlled
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`release compositions for different types of dose administration. Ex. 1001, 14:17 –
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`35:19. The specification notes that those compositions are designed to provide
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`suitable controlled release of the active ingredients:
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`In the following is given a description of various compositions
`according to the invention that are designed to obtain a suitable
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`Interference 106,023
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`release of the fumeric acid ester. Based on the description
`above and handbooks within the field of controlled release of
`pharmaceutics, a person skilled in the art will know how to
`choose different formulation principles in order to achieve the
`required release profile.
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`Ex. 1001, 14:17-21.
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`The specification details various controlled release compositions designed
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`for both single and multiple daily administration. The specification refers to
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`“pH controlled release,” “pH independent release,” “release over gradually shifting
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`pH,” and “slow release.” Ex. 100, 14:22 - 35:19. For each category the
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`specification provides exemplary fumarate controlled release profiles. For
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`example, with respect to composition designed for pH controlled release, the
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`specification teaches the following:
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`In a further aspect of the invention a controlled release
`pharmaceutical composition for oral use . . . characterized in
`that it consists of a controlled release dosage form adapted to
`release . . . over a predetermined time period, according to
`a[n ]in vitro profile of dissolution when measured according to
`USP in hydrochloric acid during the first 2 hours and then
`0.05 M phosphate buffer at a pH 6.5-6.8, wherein
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`at the most 5 % w/w of the total amount of the fumaric
`acid ester contained the composition is released within the first
`2 hours after start of the test,
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`wherein from 20% to about 75% w/w of the total amount
`of the fumaric acid ester contained in the composition is
`released within the first 3 hours . . . ,
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`wherein from about 50% to about 90% w/w of the total
`amount of the fumaric acid ester contained in the composition
`is released within the first 4 hours . . . ,
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`wherein from about 60% to about 90% w/w of the total
`amount of the fumaric acid ester contained in the composition
`is released within the first 5 hours . . . ,
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`wherein from about 70% to about 95% w/w of the total
`amount of the fumaric acid ester contained in the composition
`is released within the first 6 hours . . . ,
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`Interference 106,023
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`wherein from about 75% to about 97% w/w of the total
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`amount of the fumaric acid ester contained in the composition
`is released within the first 7 hours . . . , and
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`wherein at least 85% w/w of the total amount of the
`fumaric acid ester contained in the composition is released
`within the first 8 hours . . . .
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`Ex. 1001, 18:10-31 (paragraphing added). The written description also describes
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`many additional controlled release profiles. Ex. 1001, 4:7-24, 15:1-18, 15:30 –
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`18:9, 18:32 – 21:7, 21:19 – 25:9, 26:14 – 29:3, 29:15 – 30:26, 31:1-18.
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`The typical composition according to the invention is said to be designed to
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`deliver the active substance “in a prolonged manner.” Ex. 1001, 31:19-22. The
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`written description notes, that while the maximum serum concentration for the
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`active ingredient resulting from the administration of the controlled release
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`composition should be similar to the known values for the previously marketed
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`versions reported in the literature, it is an aim of the invention to prolong the time
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`that the concentration is within the therapeutic window. Ex. 1001, 31:19 – 32:2.
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`As a result, “the controlled release composition according to the invention may
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`lead to a reduced frequency of dosing and/or a reduced average total daily dose,
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`and/or an increased efficacy at the same total daily dose of the active substance
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`compared to Fumaderm®.” Ex. 1001, 32:8-11.
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`The specification includes a number of examples describing the preparation
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`of controlled release tablets, granules and microcrystals. Ex. 1001, Examples 1-29,
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`44:19 – 52:29. While all the examples do not expressly state that the preparations
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`are controlled release, each is described as being enteric coated or includes a
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`component such as ethylcellulose (e.g. Ethocel® NF premium). Id. Enteric
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`coatings and ethylcellulose are conventionally used to impart controlled release
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`properties to pharmaceutical compositions. Examples 30 and 31 describe the tests
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`for determining the controlled release dissolution profiles for capsules and tablets
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`Interference 106,023
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`respectively. Ex. 1001, 53:1-32. Examples 32-34 are directed to the controlled
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`release profiles for the tablets of Example 5 and the capsules of Examples 16 and
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`17, respectively. The controlled release profiles are graphically shown in
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`Figures 1-3. The profiles shown in Figure 1 were determined as described in
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`Example 30. The profiles for Figures 2 and 3 were determined as described in
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`Example 31. Ex. 1001, 53:33 – 54:10.
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`FP’s original claims are directed to pharmaceutical compositions that give “a
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`reduction in [gastro-intestinal] side effects” (claim 1), “controlled release
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`pharmaceutical compositions” (claims 2-43), and the method and use of the
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`compositions of claims 1-43 composition to treat a listing of diseases (claims 44
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`and 45). Ex. 1001, 55:1 – 60:45.
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`2.
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`With respect to the treatment of specific diseases and conditions, FP’s
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`specification lists uses of the described fumarate formulations as well as possible
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`doses. For possible conditions and diseases FP’s written description lists the
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`following:
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`The compositions and kits according to the invention are
`contemplated to be suitable to use in the treatment of one or
`more of the following conditions:
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`a. Psoriasis
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`b. Psoriatic arthritis
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`c. Neurodermatitis
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`d. Inflammatory bowel disease, such as
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`i. Crohn's disease
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`ii. Ulcerative colitis
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`e. autoimmune diseases:
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`i. Polyarthritis
`ii. Multiple sclerosis (MS)
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`iii. Juvenile-onset diabetes mellitus
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`iv. Hashimoto's thyroiditis
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`v. Grave's disease
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`vi. SLE (systemic lupus erythematosus)
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`vii. Sjogren's syndrome
`viii. Pernicious anemia
`ix. Chronic active (lupoid) hepatitis
`x. Rheumatoid arthritis (RA)
`xi. Optic neuritis
`Moreover, the novel composition or kit according to the
`invention may be used in the treatment of
`1. Pain such as radicular pain, pain associated with
`radiculopathy, neuropathic pain or sciatica/sciatic pain
`2. Organ transplantation (prevention of rejection)
`3. Sarcoidosis
`4. Necrobiosis lipoidica
`5. Granuloma annulare
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`Ex. 1001 37:17 – 38:17 (emphasis added). The same listing of conditions and
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`disease appears in FP’s original claims 44 and 45, referenced above. Treatment of
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`psoriasis and conditions associated with psoriasis are the subject of additional
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`discussion. E.g., Ex. 1001, 1:12-15, 2:23-34, 7:9-17, 38:18-27, 39:21 – 40:7. MS
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`is not identified as of any particular interest compared to the other diseases and
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`conditions listed.
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`With respect to the fumarate content of the formulations, the specification
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`teaches that the active ingredient can be any fumarate:
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`The active substance in a composition of the invention is any
`fumaric acid ester. In one embodiment of the invention the
`fumaric acid ester is preferably selected from the group
`consisting of dimethylfumarate, diethylfumarate,
`dipropylfumarate, dibutylfumarate, dipentylfumarate, methyl-
`ethylfumarate, methyl-propylfumarate, methyl-butylfumarate,
`methyl-pentylfumarate, monomethylfumarate,
`monoethylfumarate, monopropylfumarate, monobutylfumarate
`and monopentylfumarate, including pharmaceutically
`acceptable salts thereof.
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`Ex. 1001, 7:31-37 (emphasis added). The specification, however, does separately
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`identify DMF, MMF and their combination for use in treatment formulations.
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`Ex. 1001, 8:10 – 9:6. Additionally, preparations containing DMF are discussed in
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`many of the examples. E.g., Ex. 1001, Example 17, 49:10-24.
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`
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`FP’s written description teaches that the daily dosage of fumarate may be in
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`the range of 240 to 1080 mg/day and that the dosage will depend on a number of
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`factors including the specific condition or disease to be treated:
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`The daily dosage of the controlled release pharmaceutical
`composition according to the invention that is administered to
`treat a patient depends on a number of factors among which are
`included, without limitation, weight and age and the underlying
`causes of the condition or disease to be treated, and is within
`the skill of a physician to determine. In one aspect of the
`invention the daily dosage can be e.g. from 240 to 360 mg
`active substance given in one to three doses, in another aspect
`from 360 to 480 mg active substance given in one to three
`doses, in another aspect 480 to 600 mg active substance given
`in one to three doses. In another aspect 600 to 720 mg active
`substance given in one to three doses. In another aspect 720 to
`840 mg active substance given in one to three doses, in another
`aspect 840 to 960 mg active substance given in one to three
`doses and in yet another aspect 960 to 1080 mg active
`substance given in one to three doses.
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`Ex. 1001, 36:13-23 (emphasis added). None of the stated dosages are specifically
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`associated with any particular fumarate (e.g., DMF or MMF). While recognizing
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`that daily dosage will depend on the specific condition or disease to be treated,
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`none of the dosages cited are identified as related to any particular disease or
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`condition. None of the dosages are identified as therapeutically effective.
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`
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`FP’s written description also discusses dosages that may be provided in the
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`form of a kit for use when the dosage must be increased over time. Ex. 1001,
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`35:21-24. A table shows a “normal up-scale” schedule for increasing the dosage of
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`DMF for each week over a nine-week period. An “up-scale” dosing is used to
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`limit the side effects that often occur during treatment with fumarates. Ex. 1099A,
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`¶ 118. The dosage is increased in weekly increments from the initial dose of
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`Interference 106,023
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`30 mg/day to 720 mg/day in week 9. Ex. 1001, bridging pp. 35 and 36. The table
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`shows using two formulations of DMF containing 30 mg (“Strength A”) and
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`120 mg (“Strength B), respectively. Ex. 1001, 35:24 – 36:5. The table shows
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`administering an initial dose of Strength A once a day (30 mg/day) for the first
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`week, increasing to 2 doses per day of Strength A (60 mg/day) in the second week,
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`increasing to 2 doses per day of Strength B (240 mg/day) in week 3, progressing to
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`3 doses of Strength B (360 mg/day) in week 6, 4 doses (480 mg/day) in week 7 and
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`5 and 6 doses (600 and 720 mg/day) in weeks 8 and 9, respectively. Ex. 1001,
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`35:24 – 36:5.
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`The dosage of 480 mg/day, while specified as an intermediate up-scale dose,
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`is not identified as a therapeutically effective dose or of any particular significance
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`within the broad range of possible treatment doses.
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`V.
`
`A.
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`Biogen argues that FP’s written description fails to provide written support
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`required by 35 U.S.C. § 112, ¶ 1, for the subject matter of FP’s claims. Biogen
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`presents two main points on this issue: (1) that FP’s written description does not
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`describe the claimed subject matter as an integrated whole and (2) that FP’s written
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`description provides support only for “controlled release compositions.” Biogen
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`Mot. 1, Paper 171, 9:15 - 22:6
`
`Biogen recognizes that each of the three elements required by FP’s claims,
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`i.e., the treatment of MS patients, the administration of the specified fumarates and
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`the use of a dosage of 480 mg/day are individually taught in the specification.
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`However, relying on Novozymes A/S v. DuPont Nutrition Biosciences APS, 723
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`F.3d 1336 (Fed. Cir. 2013), Biogen argues that the written description does not
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`show possession of the claimed subject matter as an integrated whole and does not
`
`provide “blaze marks to guide a reader through the forest of disclosed possibilities
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`Interference 106,023
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`toward the claimed [method of treating MS].” Biogen Motion 1, Paper 171, 11:16-
`
`23 (bracketed material original) . Thus, Biogen argues
`
`because certain individual words of the copied claims are
`mentioned in disparate sections of the ’871 application,
`Forward Pharma attempts to piece together—through hindsight
`picking and choosing without any instruction or guidance—
`Biogen’s claimed method of treating MS.
`
`Biogen Mot. 1, Paper 171, 10:22 – 11:1. In Biogen’s view, FP’s original written
`
`description “never integrates these elements to describe such an invention. Nor
`
`does it offer any ‘blaze marks to guide a reader through the forest of disclosed
`
`possibilities toward the claimed [method of treating MS].’” Biogen Mot. 1,
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`Paper 171, 11:20-22 quoting Novozymes, 723 F.3d at 1346.
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`Biogen relies on Dr. Buckle’s testimony. Biogen Mot. 1, Paper 171, 13:20-
`
`22. Dr. Buckle testifies that he has reviewed FP’s involved application and
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`pending claims. Buckle Test., Ex. 2044A, ¶ 9. Dr. Buckle further testifies that MS
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`is mentioned only in the context of a list of more than twenty diseases and
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`conditions. Buckle Test., Ex. 2044A, ¶ 26. He notes that none of the diseases or
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`conditions on the list, including MS, are associated with any particular dose or any
`
`particular active agent. Buckle Test., Ex. 2044A, ¶ 26. He specifically notes the
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`language in the written description that the formulations disclosed therein “are
`
`contemplated to be suitable to use in the treatment of one or more” of the
`
`conditions listed. Buckle Test., Ex. 2044A, ¶ 26. He then opines that “at best, this
`
`language signifies a mere speculation that the disclosed compositions might be
`
`suitable to treat ‘one or more,’ i.e., perhaps just one, condition out of the list,
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`highlighting none in particular. Buckle Test., Ex. 2044A, ¶ 26. He goes on to state
`
`that in his opinion
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`Interference 106,023
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`There is no teaching in the ’871 application relating to MS
`outside the context of the list. The ’871 application does not
`direct a person of ordinary skill in the art toward a treatment
`for MS.
`
`Buckle Test., Ex. 2044A, ¶ 27. He further opines that
`
`the ’871 application does not reasonably convey to a person of
`ordinary skill in the art at the time the application was filed that
`Forward Pharma had possession of a method of treating a
`subject in need of treatment for MS by orally administering
`480 mg per day of DMF, MMF or a combination thereof.
`
`Ex. 2044A, ¶ 29. Dr. Buckle testifies that in order to arrive at FP’s claimed subject
`
`matter
`
`a person of ordinary skill in the art, without being provided any
`guidance, would need to (1) select MS from a list of more than
`twenty diseases and conditions, which would require (a)
`selecting autoimmune diseases out of the several listed disease
`classes and (b) selecting MS out of the sub-list of 11
`autoimmune diseases; (2) select DMF, MMF or a combination
`thereof from the disclosed fumarate esters; and (3) select
`480 mg per day from the ladder of indiscriminate possible
`doses, despite the application’s direction to up-titrate to a
`720 mg per day dose for, at best, treating psoriasis, and then
`conclude that the selected agent in the selected amount would
`be therapeutically effective for treating the selected condition
`(i.e., MS). All the while, one would need to ignore, without any
`reason to do so, the application’s explicit focus on providing
`controlled release compositions for allegedly reducing the side
`effects associated with a known psoriasis treatment.
`
`Buckle Test., Ex. 2044A, ¶ 37.
`
`B.
`
`
`
`FP responds that its written description describes and shows possession of
`
`its claimed subject matter. FP Opp. 1, Paper 739, 8:6 – 24:14. FP refers to its
`
`involved application as “FP7.” FP argues: “FP7 describes the use of oral
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`pharmaceutical compositions of fumaric acid esters, and in particular, DMF and/or
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`
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`MMF, for treating psoriasis or other hyperproliferative, inflammatory or
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`autoimmune disorders, including MS.” FP Opp. 1, 8:16-18. FP notes that its
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`written description “highlights the use of DMF and/or MMF as the preferred
`
`fumaric acid esters of the p