Paper No.
`Filed: August 6, 2015
`
`Filed on behalf of: Junior Party Biogen MA Inc.
`
`By: Michele C. Bosch
`Barbara C. McCurdy
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`michele.bosch@finnegan.com
`barbara.mccurdy@finnegan.com
`202-408-4193 tel
`202-408-4400 fax
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BIOGEN MA INC.,
`Junior Party
`Patent 8,399,514 B2,
`
`v.
`
`FORWARD PHARMA A/S,
`Senior Party
`Application 11/576,871.
`
`Patent Interference 106,023 (McK)
`Technology Center 1600
`
`BIOGEN MOTION 1
`
`(Lack of written description and enablement)
`
`Page 1 of 33
`
`Biogen Exhibit 2028
`Mylan v. Biogen
`IPR2018-01403
`
`

`

`
`
`I.
`
`II.
`
`III.
`
`IV.
`
`TABLE OF CONTENTS
`
`Page
`
`STATEMENT OF PRECISE RELIEF REQUESTED ....................................................... 1
`
`EVIDENCE SUPPORTING THE MOTION ..................................................................... 1
`
`INTRODUCTION .............................................................................................................. 1
`
`THE BOARD SHOULD ENTER JUDGMENT AGAINST FORWARD
`PHARMA BECAUSE THE ’871 APPLICATION FAILS TO DESCRIBE OR
`ENABLE THE CLAIMS IT COPIED FROM BIOGEN ................................................... 3
`
`A.
`
`B.
`
`C.
`
`Factual Background ................................................................................................ 3
`
`The ’871 Application Is Directed to “Controlled Release” Compositions
`That Allegedly Reduce GI Side Effects Associated with Fumaderm® ................... 5
`
`Forward Pharma’s Copied Claims Are Interpreted by Reference to
`Biogen’s ’514 Patent ............................................................................................... 7
`
`1.
`
`2.
`
`3.
`
`“Treating a subject in need of treatment for multiple sclerosis” ................ 8
`
`“Therapeutically effective amount” ............................................................ 8
`
`The Copied Claims ..................................................................................... 9
`
`D.
`
`The ’871 Application Fails to Provide Written Description Support for the
`Copied Claims ......................................................................................................... 9
`
`1.
`
`2.
`
`The ’871 Application Fails to Describe the Full Scope of the
`Copied Claims as an Integrated Whole ..................................................... 10
`
`Forward Pharma’s Erroneous Allegations of Written Description
`Support During Prosecution Cannot Save Its Copied Claims .................. 17
`
`E.
`
`F.
`
`G.
`
`H.
`
`Forward Pharma’s Copied Claims Separately Violate the Written
`Description Requirement Because They Are Not Limited to “Controlled
`Release” Compositions ......................................................................................... 19
`
`The ’871 Application Fails to Enable the Copied Claims .................................... 22
`
`Forward Pharma’s PCT Application Likewise Lacks Written Description
`and Enablement ..................................................................................................... 24
`
`Forward Pharma’s ’871 and PCT Applications Lack Written Description
`and Enablement of An Embodiment Within the Count and Are Not A
`Constructive Reduction to Practice ....................................................................... 24
`
`i
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`Page 2 of 33
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`

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`
`
`V.
`
`CONCLUSION ................................................................................................................. 25
`
`APPENDIX 1 – LIST CITED OF EXHIBITS ......................................................................... A1-1
`
`APPENDIX 2 – COPY OF AUTHORITY ............................................................................... A2-1
`
`
`
`
`
`ii
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`Page 3 of 33
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`

`

`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Agilent Techs., Inc. v. Affymetrix, Inc.,
`567 F.3d 1366 (Fed. Cir. 2009)..................................................................................................7
`
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ..................................................................................9
`
`Boston Scientific Corp. v. Johnson & Johnson,
`647 F.3d 1353 (Fed. Cir. 2011)..........................................................................................10, 13
`
`Centocor Ortho Biotech, Inc. v. Abbott Labs
`636 F.3d 1341 (Fed. Cir. 2011)................................................................................................12
`
`
`Enzo Biochem, Inc. v. Gen-Probe Inc.,
`323 F.3d 956 (Fed. Cir. 2002)............................................................................................10, 13
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1475 (Fed. Cir. 1998)................................................................................................19
`
`LizardTech Inc. v. Earth Resource Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005)....................................................................................19, 20, 23
`
`Novozymes A/S v. DuPont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013)........................................................................................ passim
`
`PIN/NIP, Inc. v. Platte Chem. Co.,
`304 F.3d 1235 (Fed. Cir. 2002)....................................................................................19, 21, 22
`
`Quake v. Lo,
`
`Intf. No. 105,920, Decision on Motion (P.T.A.B. Apr. 7, 2014) .................................10, 16, 17
`
`Rasmusson v. SmithKline Beecham Corp.,
`413 F.3d 1318 (Fed. Cir. 2005)................................................................................................23
`
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) ...............................................................................10, 11, 13, 16
`
`In re Spina,
`975 F.2d 854 (Fed. Cir. 1992)....................................................................................................7
`
`Statutes
`
`35 U.S.C. § 112 ...................................................................................................................... passim
`
`iii
`
`Page 4 of 33
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`

`

`Other Authorities
`
`37 C.F.R. § 41.201 ...........................................................................................................................1
`
`69 Fed. Reg. 49960 (Aug. 12, 2004)................................................................................................1
`
`iv
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`Page 5 of 33
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`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Biogen moves for judgment that all of Forward Pharma’s involved claims are
`
`unpatentable under 35 U.S.C. § 112, first paragraph, for lack of written description and
`
`enablement. Because Forward Pharma’s involved application fails to provide written description
`
`for the claims it copied from Biogen, it lacks standing to be in this interference. 37 C.F.R.
`
`§ 41.201. Additionally, while enablement is not expressly set forth as a threshold issue in 37
`
`C.F.R. § 41.201, Biogen submits it also should be considered threshold.1 Thus, Biogen requests
`
`that the Board grant this motion, enter judgment against Forward Pharma, dismiss Forward
`
`Pharma’s motions, and terminate the interference.
`
`II.
`
`EVIDENCE SUPPORTING THE MOTION
`
`Appendix 1 lists the exhibits relied upon in this motion.
`
`III.
`
`INTRODUCTION
`
`Forward Pharma unlawfully attempts to reap where it did not sow by copying Biogen’s
`
`claims directed to a specific and successful method of treating multiple sclerosis (MS) that
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`Forward Pharma did not invent, did not describe in its involved application, and has not enabled.
`
`If Forward Pharma invented, described, and enabled anything, it was only a “controlled release”
`
`composition alleged to reduce gastro-intestinal (GI) side effects associated with the known
`
`1 37 C.F.R. § 41.201 “permit[s] additional issues to be treated as standing issues.” 69 Fed. Reg.
`
`49960, 49991 (Aug. 12, 2004). Additionally, “[w]hether enablement is routinely such an
`
`[threshold/standing] issue is left to further development through adjudication” because
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`enablement “appears to be less frequently abused” by applicants provoking inferences than
`
`written description. Id. The close relationship between lack of written description and lack of
`
`enablement in this case supports also treating enablement as a threshold issue.
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`psoriasis treatment Fumaderm®. Indeed, Forward Pharma’s involved application conveys a
`
`single, explicit purpose: to prepare a controlled release composition that “release[s] [a] fumaric
`
`acid ester in a prolonged, slow and/or delayed manner compared to the release of the
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`commercially available product Fumaderm®.” Ex. 1001 at p. 4, lns. 25-27.
`
`Only after learning of Biogen’s success with Tecfidera® in treating MS, and eight years
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`after filing its own involved application, did Forward Pharma copy Biogen’s claims and
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`wrongfully attempt to cobble together disparate and unrelated aspects of its disclosure, which
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`fails to include a single mention of MS outside the context of a list of more than twenty untested
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`diseases and conditions, much less describe Biogen’s specific and innovative method of treating
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`MS. Such post hoc reconstruction in an attempt to lay claim to Biogen’s specific invention is
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`prohibited by the written description requirement of 35 U.S.C. §112, thus requiring entry of
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`judgment adverse to Forward Pharma. See Novozymes A/S v. DuPont Nutrition Biosciences APS,
`
`723 F.3d 1336 (Fed. Cir. 2013).
`
`Having failed through its written description to guide one of skill in the art to Biogen’s
`
`innovative method for treating MS, Forward Pharma likewise failed to disclose to persons of
`
`ordinary skill how to use that specific method. This failure violates the enablement requirement
`
`of 35 U.S.C. § 112, further requiring entry of judgment adverse to Forward Pharma.
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`If Forward Pharma’s application were incorrectly viewed as an adequate disclosure under
`
`§ 112 for the claims it now seeks, nothing would stop Forward Pharma from also declaring
`
`possession and enablement of methods for treating each of the more than twenty listed diseases
`
`and conditions using each disclosed possible dose of each mentioned active agent. For decades,
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`the fundamental tenets of patent law have prohibited such a result, and Forward Pharma’s
`
`attempt here should likewise be rejected.
`
`2
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`Page 7 of 33
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`
`
`IV.
`
`THE BOARD SHOULD ENTER JUDGMENT AGAINST FORWARD PHARMA
`BECAUSE THE ’871 APPLICATION FAILS TO DESCRIBE OR ENABLE THE
`CLAIMS IT COPIED FROM BIOGEN
`
`A.
`
`Factual Background
`
`Biogen’s U.S. Patent No. 8,399,514 (’514 patent) is directed to therapeutically effective
`
`treatments for MS. As disclosed in the specification, the inventors of the ’514 patent understood
`
`that administering 480 mg per day of dimethyl fumarate (DMF), monomethyl fumarate (MMF)
`
`or a combination thereof would be therapeutically effective for treating MS. Ex. 2001A at
`
`18:52-64. During its Phase III clinical trial involving MS patients, Biogen not only confirmed
`
`the inventors’ understanding that 480 mg per day of DMF is safe and effective for treating MS in
`
`humans, but also found, quite surprisingly, that it had similar efficacy to a much higher 720 mg
`
`per day dose. See, e.g., Ex. 2031 at p. 1, 1st para.; Ex. 2032 at p. 1, 1st para. This unexpected
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`efficacy held great clinical significance because the lower 480 mg per day dose, while being
`
`similarly effective, would improve patient compliance (twice daily dosing vs. three times daily
`
`dosing), which is important for treatment of MS, a chronic disease. Biogen subsequently
`
`obtained the ’514 patent with claims focused on a method of treating MS by oral administration
`
`of a pharmaceutical composition consisting essentially of a therapeutically effective amount of
`
`about 480 mg per day of DMF, MMF or a combination thereof, and one or more
`
`pharmaceutically acceptable excipients.
`
`DMF is the active ingredient found in Tecfidera®, which is covered by the Orange Book-
`
`listed ’514 patent. Ex. 2033 at p. 1. Tecfidera® is marketed by Biogen in the U.S., Canada,
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`Australia and Europe, and a number of other jurisdictions, as an oral dose of 480 mg per day of
`
`DMF for the treatment of MS. Id. Tecfidera® became the leading oral MS therapy in the U.S.
`
`after only six months on the market. Ex. 2034 at p. 2, 2nd para. From launch in April 2013
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`through June 2015, Tecfidera® generated global sales of $5.49 billion. Ex. 2035 at p. 1, 8th para.;
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`Ex. 2036 at p. 1, 7th para.; Ex. 2037 at p. 1, 6th para.
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`Before Biogen’s development of Tecfidera®, DMF had been used in combination with
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`three separate active ethyl hydrogen fumarate salts in a psoriasis treatment called Fumaderm®.
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`Marketed in Germany since 1994 (see Ex. 2038 at p. 3, 7th para., last ln), Fumaderm® is
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`administered to psoriasis patients via an upward titration regimen to improve tolerability, namely
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`30 mg of DMF and 75 mg of the ethyl hydrogen fumarate salts per day in week one followed by
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`an incremental increase to a final dose of 720 mg of DMF and 570 mg of the ethyl hydrogen
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`fumarate salts per day in week nine. Ex. 2039 at p. 1, section 2; id. at p. 1-2, section 4.2; Ex.
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`2044 at ¶¶ 15, 31-32.
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`In 2004, Aditech Pharma AB allegedly began developing a controlled release
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`composition of fumaric acid esters seeking to improve tolerability compared to Fumaderm®. Ex.
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`2038 at p. 3, 3rd para., last ln. On October 8, 2004, Aditech filed Danish Patent Application No.
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`PA 2004 01546 (DK ’546) directed to the preparation of “controlled release” compositions that
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`allegedly reduce gastro-intestinal side effects compared to those of Fumaderm®. Ex. 1008; Ex.
`
`2043 at ¶ 9. On October 7, 2005, Aditech filed a PCT application claiming priority to DK ’546,
`
`describing the same “controlled release” compositions. Ex. 1006; Ex. 2043 at ¶ 15. In fact, the
`
`PCT application defines “controlled release compositions” as those “designed to release the
`
`fumaric acid ester in a prolonged, slow and/or delayed manner compared to the release of the
`
`commercially available product Fumaderm®.” Ex. 1006 at p. 4, lns 25-27.
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`Forward Pharma, which acquired rights in this patent family from Aditech, “was founded
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`in 2005 for the purpose of exploiting [Aditech’s patent family].” Ex. 2038 at p. 3, 8th para. In
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`2007, Aditech’s PCT application entered the U.S. national phase as the involved ’871
`
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`application. Ex. 1001. Like the “controlled release” compositions described in the ’871
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`application, Forward Pharma’s proposed controlled release product, called “FP187,” was
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`designed to reduce side effects associated with the psoriasis treatment Fumaderm®. Ex. 2038 at
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`p. 3, 3rd para., last ln. Indeed, Forward Pharma has stated that its historical research and
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`development costs have focused on the development of FP187 for the treatment of psoriasis. Id.
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`at p. 6, 4th para., 1st ln. And as it confirmed just a few months ago, Forward Pharma has not
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`performed any clinical work involving MS patients. Id. at p. 4, 5th para., last ln.
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`Nonetheless, in December 2013, after learning of Biogen’s invention as disclosed and
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`claimed in the ’514 patent and of the tremendous success of Tecfidera®, Forward Pharma
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`targeted Biogen’s invention. Abruptly changing the course of prosecution of its involved ’871
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`application, Forward Pharma cancelled all pending claims—which related to controlled release
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`compositions—and copied Biogen’s patent claims. Ex. 2040 at p. 2-3. Thus, more than eight
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`years after filing its involved application, Forward Pharma, through hindsight, is now attempting
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`to piece together support from its disclosure, which is directed to a different invention, and claim
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`as its own Biogen’s invention directed to a particular treatment for multiple sclerosis, namely a
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`combination of three elements: (i) the treatment of MS; (ii) by orally administering a
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`therapeutically effective amount of DMF, MMF, or a combination thereof; and (iii) wherein the
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`therapeutically effective amount is about 480 mg per day. Not only does Forward Pharma’s
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`involved application fail to describe Biogen’s specific MS treatment, it is directed to an entirely
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`different purported invention.
`
`B.
`
`The ’871 Application Is Directed to “Controlled Release” Compositions That
`Allegedly Reduce GI Side Effects Associated with Fumaderm®
`
`Forward Pharma’s ’871 application does not describe as its invention any new
`
`therapeutically effective amount of an active agent for treating any particular condition. Ex.
`
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`2044 at ¶ 13. Rather, as repeatedly stated throughout the specification, the application’s sole
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`objective is to reduce GI side effects associated with the prior-art product Fumaderm® by
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`formulating “controlled release” compositions. Ex. 1001 at p. 3, ln 25 – p. 4, ln 3; Ex. 2043 at ¶
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`15; Ex. 2044 at ¶ 13. In particular, the ’871 application identifies the following problem that it
`
`seeks to address: “[T]herapy with fumarates like e.g., Fumaderm® frequently gives rise to
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`gastro-intestinal side effects such as e.g. fullness, diarrhea, upper abdominal cramps, flatulence
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`and nausea.” Ex. 1001 at p. 2, lns 34-36; Ex. 2043 at ¶ 51; Ex. 2044 at ¶ 13. Under the heading
`
`“Disclosure of the invention,” the specification states:
`
`[T]he present invention relates to a pharmaceutical composition
`. . . which – 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. . . . [T]he present inventors contemplate that a
`suitable way of reducing the gastro-intestinal related side-effects is
`by administration of the active substance in the form of a
`controlled release composition.
`
`Ex. 1001 at p. 3, ln 25 – p. 4, ln 3 (emphasis added); Ex. 2043 at ¶ 52; Ex. 2044 at ¶ 13.
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`The ’871 application defines “controlled release composition” as “a composition that is
`
`designed to release the fumaric acid ester in a prolonged, slow and/or delayed manner compared
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`to the release of the commercially available product Fumaderm®.” Ex. 1001 at p. 4, lns 25-27;
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`Ex. 2043 at ¶ 50. It further proposes hypothetical clinical trials to monitor GI side effects of the
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`disclosed controlled release compositions compared to Fumaderm®. Ex. 1001 at p. 6, ln 25 – p.
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`7, ln 29; Ex. 2043 at ¶ 53; Ex. 2044 at ¶ 25. For instance, the application states that reducing GI-
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`related side effects “is intended to denote a decrease in severity and/or incidence among a given
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`treated patient population, compared to the GI side effects observed after administration of the
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`composition according to the invention compared with that of Fumaderm®.” Ex. 1001 at p. 6,
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`lns 25-28; Ex. 2043 at ¶ 53; Ex. 2044 at ¶ 25. Consistent with its repeated comparison of its
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`controlled release compositions to Fumaderm®, the application states that the trials should be
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`performed on psoriasis patients and nowhere explains that such trials should include, much less
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`focus on, MS patients, or use a dose of 480 mg per day of any active agent, let alone DMF, MMF
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`or a combination thereof. Ex. 1001 at p. 7, lns 9-17; Ex. 2044 at ¶ 25.
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`During prosecution, Forward Pharma confirmed that the scope of the ’871 application
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`was limited to reducing GI side effects compared to Fumaderm®. Ex. 2043 at ¶¶ 59-60. In the
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`Amendment filed on December 20, 2011, Forward Pharma stated “not any ‘delayed-release
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`composition’ falls under the definition of ‘controlled release composition’ according to the
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`instant claims, but only those that are ‘prolonged, slow and/or delayed in comparison with
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`Fumaderm®.” Ex. 2041 at p. 10 (emphasis in original); Ex. 2043 at ¶¶ 59-60.
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`C.
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`Forward Pharma’s Copied Claims Are Interpreted by Reference to Biogen’s
`’514 Patent
`
`The ’514 patent should be used to construe Forward Pharma’s claims because they were
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`substantially copied from the ’514 patent to provoke this interference. In re Spina, 975 F.2d 854,
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`856 (Fed. Cir. 1992); Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366 (Fed. Cir. 2009).
`
`The constructions set forth below, however, are consistent with how one of ordinary skill in the
`
`art would interpret these claim terms without reference to Biogen’s ’514 patent. Ex. 2044 at ¶ 19.
`
`Forward Pharma’s independent claim 55 recites:
`
`A method of treating a subject in need of treatment for multiple sclerosis
`comprising orally administering to the subject in need thereof a pharmaceutical
`composition consisting essentially of (a) a therapeutically effective amount of
`[DMF], [MMF], or a combination of [DMF] and [MMF] in a weight ratio of
`between about 1:10 and 10:1, and (b) one or more pharmaceutically acceptable
`excipients, wherein the therapeutically effective amount of [DMF], [MMF], or a
`combination of [DMF] and [MMF] is 480 mg per day.
`
`Ex. 1002 at p. 1, lns 3-10 (emphasis added). Forward Pharma’s remaining independent claims—
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`claims 65 and 69—are substantially similar. Id. at p. 2, lns 10-13; id. at p. 2, ln 20 – p. 3, ln 2.
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`1.
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`“Treating a subject in need of treatment for multiple sclerosis”
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`All of Forward Pharma’s copied claims require “treating a subject in need of treatment
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`for multiple sclerosis.” Ex. 1002. Biogen’s ’514 patent identifies some important known goals
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`for the treatment of MS, including preventing and/or reducing inflammation of the CNS and
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`preventing and/or reducing neurodegeneration, such as by preventing or reducing axonal loss and
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`neuronal death. Ex. 2001A at 1:15-49; Ex. 2044 at ¶ 20. The ’514 patent states that those “in
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`need of treatment” include individuals “already having a specified disease and those who are at
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`risk for acquiring that disease.” Ex. 2001A at 5:49-51; Ex. 2044 at ¶ 20. The patent further
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`recognizes that treatment “results in at least one of prevention or delay of onset or amelioration
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`of symptoms of a neurological disorder in a subject or an attainment of a desired biological
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`outcome, such as reduced neurodegeneration (e.g., demyelination, axonal loss, and neuronal
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`death) or reduced inflammation of the cells of the CNS.” Ex. 2001A at 5:52-59; Ex. 2044 at ¶
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`20. In light of the ’514 patent specification, the broadest reasonable interpretation of “treating a
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`subject in need of treatment for multiple sclerosis” is achieving in a subject who has or is at risk
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`of developing MS at least one of prevention or delay of onset or amelioration of symptoms of
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`MS or attainment of a desired biological outcome, such as reduced neurodegeneration (e.g.,
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`demyelination, axonal loss, and neuronal death) or reduced inflammation of the cells of the CNS.
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`Ex. 2044 at ¶ 20.
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`2.
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`“Therapeutically effective amount”
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`The ’514 patent defines the term “therapeutically effective amount” as the amount of a
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`compound that accomplishes the treatment described above. Ex. 2001A at 5:52-59; Ex. 2044 at
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`¶ 21. Thus, within the context of the ’514 patent specification, the broadest reasonable
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`interpretation of the claim term “therapeutically effective amount” is an amount of a compound
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`that results in at least one of prevention or delay of onset or amelioration of symptoms of MS in
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`a subject or an attainment of a desired biological outcome, such as reduced neurodegeneration
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`(e.g., demyelination, axonal loss, and neuronal death), or reduced inflammation of the cells of the
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`CNS. Ex. 2044 at ¶ 21. Specifically, the copied claims require oral administration of 480 mg
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`per day of DMF, MMF or a combination thereof (or just DMF in the case of claims 69 and 70).
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`See Ex. 1002 at p. 1, lns 3-10.
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`3.
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`The Copied Claims
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`In view of the teachings and interpretations described above, all of Forward Pharma’s
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`copied claims require orally administering to a subject who has or is at risk of developing MS
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`480 mg per day of DMF, MMF or a combination thereof (or just DMF in the case of claims 69
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`and 70) and achieving at least one of prevention or delay of onset or amelioration of symptoms
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`of MS in the subject or an attainment of a desired biological outcome, such as reduced
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`neurodegeneration (e.g., demyelination, axonal loss, and neuronal death), or reduced
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`inflammation of the cells of the CNS of the subject. Ex. 2044 at ¶ 22. Forward Pharma’s ’871
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`application fails to describe or enable such a method of treatment.
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`D.
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`The ’871 Application Fails to Provide Written Description Support for the
`Copied Claims
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`The specification must contain a written description of the invention. 35 U.S.C. § 112.
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`The test for sufficiency is whether the application’s disclosure reasonably conveys to those
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`skilled in the art that the inventor had possession of the claimed subject matter as of the filing
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`date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
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`This assessment requires an objective inquiry into the four corners of the specification. Id. The
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`touchstone is “possession as shown in the disclosure,” which requires that the specification
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`describe an invention understandable to one of ordinary skill and show that the inventor actually
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`invented the claimed invention. Id. (emphasis added).
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`It is not enough that an application merely recite in ipsis verbis the words of individual
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`claim terms. Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir.
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`2011); Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002) (“The
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`appearance of mere indistinct words in a specification or a claim, even an original claim, does
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`not necessarily satisfy [the written description requirement].”). To satisfy the written description
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`requirement, the application must describe the claimed subject matter “as an integrated whole
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`rather than as a collection of independent limitations.” Novozymes, 723 F.3d at 1349; see also
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`Quake v. Lo, Intf. No. 105,920, Decision on Motion, at 21-22 (P.T.A.B. Apr. 7, 2014). Indeed,
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`without sufficient “blaze marks” to guide one to the claimed combination among “a slew of
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`competing possibilities,” an application cannot satisfy the written description requirement.
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`Novozymes, 723 F.3d at 1349; see also In re Ruschig, 379 F.2d 990, 994-95 (C.C.P.A. 1967).
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`This requirement safeguards against an applicant’s tactic of “[w]orking backward . . . by
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`hindsight” to attempt to piece together the invention of another. Novozymes, 723 F.3d at 1349;
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`see also Quake, Intf. No. 105,920, Decision on Motion, at 21-22. As is clear from the deficient
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`disclosure in its application and its actions after witnessing Biogen’s successful invention,
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`Forward Pharma is attempting to work backward to piece together an invention that it never
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`invented, much less described and enabled.
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`1.
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`The ’871 Application Fails to Describe the Full Scope of the Copied
`Claims as an Integrated Whole
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`As detailed above, the ’871 application is directed to controlled release compositions that
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`allegedly reduce GI side effects associated with the prior-art psoriasis treatment Fumaderm®.
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`Ex. 1001 at p. 3, ln 25 – p. 4, ln 3; Ex. 2043 at ¶ 15; Ex. 2044 at ¶ 13. Yet, because certain
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`individual words of the copied claims are mentioned in disparate sections of the ’871 application,
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`Forward Pharma attempts to piece together—through hindsight picking and choosing without
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`any instruction or guidance—Biogen’s claimed method of treating MS. This tactic contravenes
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`established precedent and should be rejected.
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`Indeed, the facts here are analogous to those in Novozymes, which turned on an
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`applicant’s failure to describe claim elements as an integrated whole. Novozymes, 723 F.3d at
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`1349. The claims in Novozymes were directed to an alpha-amylase variant with the following
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`three features: (1) a parent sequence having at least 90% homology with BSG alpha-amylase; (2)
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`an amino acid substitution at position S239; and (3) increased thermostability at 90ºC, pH 4.5,
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`and 5 ppm calcium. Id. at 1341. The application at issue mentioned the individual claim terms
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`by: (1) listing BSG as one of seven disclosed parent alpha-amylase enzymes; (2) including amino
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`acid position 239 among a group of 33 positions that could be mutated; and (3) stating that the
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`disclosed alpha-amylase variants should function at high temperatures, low pH, and low calcium
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`concentrations. Id. at 1348. Critically, however, the application “never presented [those
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`limitations] together in any particular embodiment.” Id. at 1341-42. Nor, as the Court
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`emphasized, did the application provide sufficient “blaze marks” that would guide one toward
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`the specifically claimed combination among the “slew of competing possibilities.” Id. at 1349.
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`Similarly, Forward Pharma’s copied claims recite a combination of three specific
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`elements: (i) treatment of MS, (ii) by orally administering a therapeutically effective amount of
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`DMF, MMF, or a combination thereof, and (iii) wherein the therapeutically effective amount is
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`480 mg per day. See, e.g., Ex. 1002 at p. 1, lns 3-10. As detailed below, like the fatally deficient
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`disclosure in Novozymes, the ’871 application never integrates these elements to describe such an
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`invention. Nor does it offer any “blaze marks to guide a reader through the forest of disclosed
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`possibilities toward the claimed [method of treating MS].” Novozymes, 723 F.3d at 1346 (citing
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`Ruschig, 379 F.2d at 994-95).
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`More specifically, after 36 pages of disclosure directed to controlled release compositions
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`that allegedly reduce GI side effects associated with the psoriasis treatment Fumaderm®, the
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`’871 application includes a list of more than twenty untested diseases and conditions for which it
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`asserts its controlled release compositions might be used, of which MS is but one. Ex. 1001 at p.
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`37, ln 19 – p. 38, ln 17; Ex. 2044 at ¶ 26. The long list includes a variety of conditions ranging
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`from sciatic pain to ulcerative colitis and spans a variety of disease classes, MS merely included
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`as one of eleven listed conditions under the subcategory “autoimmune diseases.” Ex. 1001 at p.
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`37, ln 19 – p. 38, ln 17; Ex. 2044 at ¶ 26. No disease or condition in this list, much less MS
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`specifically, is associated with any particular dose of any particular active agent. Ex. 2044 at ¶
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`26. In fact, the ’871 application implicitly concedes that its disclosure is nothing more than a
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`shopping list, admitting that the disclosed compositions might be suitable to treat only “one or
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`more” of the conditions. Ex. 1001 at p. 37, ln 18 (emphasis added); Ex. 2044 at ¶ 26. This
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`language, at best, signifies a mere speculation that the disclosed compositions might be suitable
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`to treat “one or more,” i.e., perhaps just one, condition out of the list, highlighting none in
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`particular. Ex. 2044 at ¶ 26; see Centocor Ortho Biotech, Inc. v. Abbott Labs., 636