NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
FWP IP APS,
Appellant
v.
BIOGEN MA, INC.,
Appellee
______________________
2017-2109
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. 106,023.
______________________
Decided: October 24, 2018
______________________
KATHLEEN M. SULLIVAN, Quinn Emanuel Urquhart &
Sullivan, LLP, New York, NY, argued for appellant. Also
represented by CATHERINE MATTES, ERIC C. STOPS; KEVIN
ALEXANDER SMITH, San Francisco, CA.
CHARLES E. LIPSEY, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, Reston, VA, argued for appellee.
Also represented by BARBARA CLARKE MCCURDY, PIER
DEROO, Washington, DC.
______________________
2 FWP IP APS v. BIOGEN MA, INC.
Before PROST, Chief Judge, WALLACH and CHEN, Cir-
cuit Judges.
CHEN, Circuit Judge
This appeal arises from an interference proceeding 1 at
the United States Patent and Trademark Office, Patent
Trial and Appeal Board (Board) and involves a treatment
method for multiple sclerosis with a particular daily
dosage—480 mg—of fumaric acid esters (fumarates).
Appellee Biogen MA, Inc. (Biogen) owns U.S. Patent No.
8,399,514, which describes and claims this method of
treatment. Appellant FWP IP ApS (Forward) 2 is the
assignee of U.S. Patent Application No. 11/576,871, which
discloses controlled release compositions of fumarates.
Forward argues that its patent application describes the
specific treatment method in dispute. While the Board
found that Forward’s ’871 application had an earlier
priority date than Biogen’s ’514 patent, it granted Bio-
gen’s motion for judgment that the MS treatment For-
ward now seeks to claim is not supported by adequate
written description under 35 U.S.C. § 112 (2006). Be-
cause substantial evidence supports the Board’s finding
that Forward’s ’871 application does not adequately
disclose a method of treating MS with 480 mg of
fumarates per day, we affirm.
1 “A patent interference proceeding is conducted for
the purpose of determining priority of invention as be-
tween competing applicants for patent on the same inven-
tion.” Vas-Cath, Inc. v. Curators of Univ. of Mo., 473 F.3d
1376, 1378 (Fed. Cir. 2007) (citation omitted).
2 The original appellant in this case was Forward
Pharma A/S. Following the docketing of the appeal,
Forward Pharma assigned U.S. Patent Application
11/576,871 to a related entity, FWP IP ApS. We refer to
FWP IP ApS and Forward Pharma A/S as Forward.
FWP IP APS v. BIOGEN MA, INC. 3
BACKGROUND
Multiple sclerosis (MS) is an autoimmune disease af-
fecting the central nervous system. The disease attacks
the myelin sheath around neural axons, causing visual
loss, weakness, numbness, loss of coordination, and
cognitive dysfunction among other symptoms. Treatment
of MS seeks to reduce this neurodegeneration.
The MS treatment in dispute involves administering a
specific daily dosage (480 mg) of fumarates, specifically
dimethyl fumarate (DMF) and/or monomethyl fumarate
(MMF). Forward argues that it was the first to discover
and claim this method of treatment and that it has been
conducting research on the use of DMF for treating “in-
flammatory and neurological indications, including multi-
ple sclerosis.” 3 J.A. 9094. Forward and its predecessor
Aditech Pharma AB filed several patent applications, one
of which is the ’871 application. The ’871 application is
the U.S. national phase of Forward’s Patent Cooperation
Treat (PCT) application. The PCT application was filed
October 7, 2005, and claims priority to a Danish patent
application filed on October 8, 2004. Biogen, for its part,
owns the ’514 patent, which covers this particular method
of MS treatment, and markets its drug as Tecfidera®. The
’514 patent, which issued on March 19, 2013, claims
priority to a provisional application filed on February 8,
2007.
3 Forward points to a formulation it developed:
FP187. FP187 has gone through phase 1 and 2 of clinical
trials, and Forward is now implementing phase 3 clinical
trials to test its efficacy in patients with MS. Forward’s
own Securities and Exchange Commission (SEC) filing,
which was included on the record below, shows that phase
1 and 2 testing was on 300 psoriasis patients, not MS
patients.
4 FWP IP APS v. BIOGEN MA, INC.
On December 3, 2013, Forward filed an amendment to
the ’871 application, canceling all pending claims and
adding claims 55–70 that closely tracked Biogen’s then
recently issued ’514 patent claims. The Board declared an
interference between Forward’s application and Biogen’s
’514 patent on April 13, 2015. It designated Forward as
the senior party with a constructive reduction to practice
date of October 8, 2004.
On March 31, 2017, the Board granted Biogen’s mo-
tion for a judgment that Forward’s claims are not sup-
ported by adequate written description under 35 U.S.C.
§ 112. The Board found that the ’871 application’s focus
on “controlled release fumarate compositions” and “gen-
eral teaching of applicability of the fumarates to [the]
treatment of a variety of possible disease or conditions
and the teaching of a broad range of possible dosages
would not have conveyed possession or description of the
specific treatment of MS that [Forward] now claims.” J.A.
3. Using Forward’s newly-added claim 69 4 as illustrative,
the Board distilled the claims at issue into three limita-
tions: (1) an MS treatment, (2) by oral administration of a
4 Independent claim 69 provides:
A method of treating a subject in need of treat-
ment for multiple sclerosis comprising
(a) a therapeutically effective amount of dime-
thyl fumarate and
(b) one or more pharmaceutically acceptable
excipients, wherein the therapeutically effec-
tive amount of dimethyl fumarate is about
480 mg per day.
J.A. 9166. The other claims (55–68, 70) cover a method of
treatment that uses MMF or a combination of DMF and
MMF. J.A. 9165–66.
FWP IP APS v. BIOGEN MA, INC. 5
therapeutically effective amount of DMF and/or MMF, at
(3) a dosage of 480 mg per day. The Board then addressed
each limitation in turn.
Reviewing the ’871 application’s specification, the
Board found that the principal focus of the disclosure is
the minimization of gastro-intestinal side-effects through
the use of controlled release of fumarates. The title of
Forward’s ’871 application is “Controlled Release Phar-
maceutical Composition Comprising a Fumaric Acid
Ester.” ’871 application, col. 1, ll. 1–2. The specification
teaches that administering fumarates can cause certain
undesired gastro-intestinal effects, such as “fullness,
diarrhea, upper abdominal cramps, flatulence and nau-
sea.” Id. at col. 2, ll. 35–36. Forward’s ’871 application
purports to address these gastro-intestinal side effects by
teaching pharmaceutical compositions designed to “re-
lease the fumaric acid ester in a controlled manner so that
local high concentrations of the active substance within
the gastro-intestinal tract upon oral administration can
be avoided and, thereby, enabling a reduction in gastro-
intestinal related side-effects.” Id. at col. 1, ll. 4–10. The
specification is replete with examples of detailed con-
trolled release compositions (pH controlled release, pH
independent release, release over gradually shifting pH,
etc.) for both single and multiple daily administration. Id.
at col. 14 l. 17–col. 35 l. 19.
As to the treatment of specific diseases and condi-
tions, the Board found that Forward’s specification lists
over twenty diseases and conditions, and MS is not identi-
fied as of any particular interest. This laundry list of
diseases and conditions includes psoriasis; psoriatic
arthritis; neurodermatitis; inflammatory bowel disease;
neurodermatitis; autoimmune diseases (including MS as
one of the eleven listed); pain associated with radibu-
lopahty, neuropathy, or sciatica; organ transplantation;
sarcoidosis; necrobiosis lipoidica; and granuloma annula-
re. Id. at col. 37 l. 17–col. 38 l. 17. The only diseases that
6 FWP IP APS v. BIOGEN MA, INC.
the ’871 application discusses in any detail, however, are
psoriasis and conditions associated with psoriasis. The
two commercial compositions of fumarates the specifica-
tion identifies are Biogen’s Fumaderm® and TioFarma’s
Fumaraat 120®, both of which can be used for treating
psoriasis. Id. at col. 1, ll. 13–15. The ’871 application’s
specification defines “controlled release composition” as “a
composition that is designed to release the fumaric acid
ester in a prolonged, slow and/or delayed manner com-
pared to the release of the commercially available product
Fumaderm®.” Id. at col. 4, ll. 25–27.
And with respect to the fumarate content, the Board
found that, while the ’871 application’s specification
teaches the active ingredient can be any fumarate, it does
separately identify DMF, MMF, and their combination for
use in treatment formulations such that a skilled artisan
would have recognized that the inventors had considered
those fumarates to be significant.
As for the claimed 480 mg/day dosage, the ’871 appli-
cation’s specification refers to a 480 mg/day dosage three
times, twice in a paragraph teaching possible daily dosag-
es and once as an interim dose in an “up-scale” table. See
id. at col. 36 l. 1. The daily dosage paragraph teaches
that the dosage can be from 240 to 360 mg, 360 to 480 mg,
480 to 600 mg, 600 to 720 mg, 720 to 840 mg, 840 to
960 mg, or 960 to 1080 mg, given in one to three admin-
istrations. Id. at col. 36 ll. 13–23. The 480 mg/day dose
thus is identified as both the low and high end of ranges
within a broader, overall disclosed dosage range of 240 to
1080 mg/day. Id. Importantly, this paragraph specifical-
ly teaches that the daily dosage to be administered “de-
pends 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.” Id. at col. 36
ll. 13–16. The disclosed up-scale table, on the other hand,
is designed to minimize the side-effects of ingesting
FWP IP APS v. BIOGEN MA, INC. 7
fumarates by increasing the dose gradually over time to
allow the patient to acclimate. The table proposes scaling
up the daily dosage level over a nine-week period, with
the 480 mg/day dosage occurring during week seven. Id.
at col. 35 l. 21–col. 36 l. 5. So, while 480 mg/day dosage is
expressly mentioned three times in the specification, the
Board found that there “is no discussion that would guide
one skilled in the art to treat MS with a therapeutically
effective dose of 480 mg/day, or any other therapeutically
effective dose within the ranges disclosed.” J.A. 22.
Next, the Board rejected Forward’s arguments based
on Snitzer v. Etzel, finding that, unlike the invention in
Snitzer, Forward’s case requires selection and combina-
tion of claim elements from more than a single limited
list: selection of MS from a list of diseases and selection
of 480 mg/day from a large range of possible dosages. 465
F.2d 899, 903 (CCPA 1972). “[S]uch necessary picking
and choosing to arrive at the claimed invention . . . does
not indicate it was described.” J.A. 27. The Board also
rejected Forward’s arguments based on Falkner v. Inglis,
448 F.3d 1357, 1366–68 (Fed. Cir. 2006), and Streck, Inc.
v. Research & Diagnostic Sys., Inc., 665 F.3d 1269, 1285–
87 (Fed. Cir. 2012), for using the prior art to satisfy gaps
in the written description. Forward pointed to publica-
tions to establish that the treatment of MS with
fumarates was well known as of 2004. In Forward’s view,
a skilled artisan would have realized that the disclosure
of the 480 mg/day dose in an up-scale table tied the dose,
active ingredient, and disease together as an integrated
whole. The Board found to the contrary. Unlike Falkner
and Streck, where the prior art was used to show that a
generic claim element was well-known to those working in
the field, the Board found that our case law requires the
specification itself to provide the blaze marks necessary to
guide a skilled artisan to the claimed invention. J.A. 28
(citing Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010)).
8 FWP IP APS v. BIOGEN MA, INC.
Thus, the Board concluded that Forward’s claims 55–
70 failed to meet the written description requirement.
The Board found that, even though each required claim
element is mentioned separately in Forward’s specifica-
tion, the specification did not disclose the claimed inven-
tion in a manner that adequately describes the now-
claimed MS treatment to a skilled artisan
Forward appeals. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(4)(A) and 35 U.S.C. § 141.
DISCUSSION
Whether a patent claim is supported by an adequate
written description is a question of fact, which we review
for substantial evidence. ULF Bamberg v. Dalvey, 815
F.3d 793, 797 (Fed. Cir. 2016). A Board decision is sup-
ported by substantial evidence if “a reasonable mind
might accept the evidence to support the finding.” Red-
line Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435,
449 (Fed. Cir. 2015) (citation omitted). A decision is
supported by substantial evidence even if the record
would reasonably support contradictory conclusions. In re
Jolley, 308 F.3d 1317, 1320 (Fed. Cir. 2002).
Section 112 ¶ 1 provides that “[t]he specification shall
contain a written description of the invention.” 35 U.S.C.
§ 112. The written description requirement examines
“whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as
of the filing date.” Ariad, 598 F.3d at 1351. To demon-
strate possession, the inventor must provide enough
description in the specification to demonstrate that he
actually invented what has been claimed—a “mere wish
or plan for obtaining the claimed invention” is not enough.
Centrocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d
1341, 1348 (Fed. Cir. 2011). “[T]he test requires an
objective inquiry into the four corners of the specification
from the perspective of a person of ordinary skill in the
FWP IP APS v. BIOGEN MA, INC. 9
art. Based on that inquiry, the specification must de-
scribe an invention understandable to that skilled artisan
and show that the inventor actually invented the inven-
tion claimed.” Ariad, 598 F.3d at 1351. The written
description requirement is particularly important when,
as here, claims are added later during prosecution in
response to development by others. Agilent Techs., Inc. v.
Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009)
(“[T]he purpose of the written description requirement is
to prevent an applicant from later asserting that he
invented that which he did not . . .”).
The interference count between Biogen and Forward
comprises three limitations: (1) a treatment for MS that
involves administering (2) DMF, MMF, or a combination
of the two fumarates at (3) a dosage of 480 mg per day.
As an initial matter, the Board found that Forward’s
written description “does not reveal an express descrip-
tion of a method that includes the specific elements now
claimed connected as required by the claims.” While the
Board acknowledged that a skilled artisan would have
recognized that Forward had considered DMF and/or
MMF to be significant in treating the conditions listed in
the application (including MS), it found that, contrary to
Forward’s position, the up-scale table did not identify
480 mg/day as a therapeutically effective dose, and the
specification did not adequately tie the up-scale table to
the treatment of MS. 5
5 Relatedly, Forward argued that the Board misap-
plied written description law by applying a “heightened”
blaze marks analysis. This is not so. First, the blaze
marks analysis is part of the written description inquiry;
it is not a heightened inquiry. The blaze marks analysis
is a useful guide for evaluating laundry-list disclosures,
like the one in Forward’s ’871 application. See Fujikawa
10 FWP IP APS v. BIOGEN MA, INC.
On appeal, Forward argues that the count is disclosed
as an unified whole in the up-scale table because the up-
scale table (1) discloses a 480 mg/day dosage, (2) is rea-
sonably directed at using DMF to treat the listed condi-
tions, and (3) is linked to the treatment of MS. And at
oral argument, Forward again asserted that the kits for
administration of fumarates over the up-titration sched-
ule (up-scale table) tie together the dose, drug, and dis-
ease. Oral Arg. at 5:25–5:50, available at
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20
17-2109.mp3. We are not persuaded. For the same
reasons set forth by the Board, we agree that the ’871
application does not disclose the now-claimed MS treat-
ment as a unified whole. Below, we first discuss why the
specification does not disclose the 480 mg/day therapeuti-
cally effective dosage for MS limitation of the count 6 and
v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) (“In
the absence of such blazemarks, simply describing a large
genus of compounds is not sufficient to satisfy the written
description requirement as to particular species or subge-
nuses.”). Recently in Nike, Inc. v. Adidas AG, we ex-
plained that the written description requirement “serves
the same function as ‘blaze marks on the trees’ to help
‘find[] one’s way through the woods.’” 812 F.3d 1326, 1347
(Fed. Cir. 2016) (quoting In re Ruschig, 379 F.2d 990, 995
(CCPA 1967)). Second, Forward’s argument against the
application of a blaze marks analysis is premised on the
interference count being disclosed as a unified whole in
the ’871 application, which the Board found was not the
case. We observe no unified disclosure of all three limita-
tions of the interference count in the ’871 application and
thus see no reason to disturb the Board’s finding.
6 The parties spend considerable briefing analogiz-
ing to and distinguishing from our written description
cases such as Novozymes A/S v. DuPont Nutrition Biosci-
ences APS, 723 F.3d 1336, 1346 (Fed. Cir. 2013), In re
FWP IP APS v. BIOGEN MA, INC. 11
then address Forward’s arguments regarding the original
claims of the ’871 application.
A
Both parties agree that the key limitation of the
method of treatment in dispute is the therapeutically
effective dosage of 480 mg of fumarates per day to treat
MS. See Oral Arg. at 29:39–30:00, 36:24–50. Forward
contends that the up-scale table in the ’871 application
expressly discloses this dosage during the seventh week of
a contemplated nine-week scale-up period. A skilled
artisan looking at the up-scale table, Forward argues,
would have recognized that all of the listed dosages in
that nine-week up-scale table are therapeutically effective
dosages for all of the conditions and diseases listed else-
where in the specification. The Board disagreed, finding
that the up-scale table does not discuss therapeutically
effective dosages at all, much less the specific dosage of
480 mg of fumarates per day as being therapeutically
effective for treating MS. Rather, the Board interpreted
the up-scale table as simply providing guidance on gradu-
al dosing over a period of several weeks to help patients’
gastro-intestinal systems acclimate to the side-effects of
fumarates.
The Board’s interpretation is more than reasonable in
light of the ’871 application’s own disclosure stating that
the up-scale table is designed to help patients in “situa-
tions where increasing dosage is required over time.” ’871
Driscoll, 562 F.2d 1245, 1250 (CCPA 1977), and Snitzer,
465 F.2d at 902. But because the Board found the ’871
application does not disclose 480 mg of fumarates per day
to be a therapeutically effective treatment for MS—a fact
finding supported by substantial evidence—we need not
opine on whether this case is most like Novo-
zymes/Ruschig or Driscoll/Snitzer.
12 FWP IP APS v. BIOGEN MA, INC.
application, col. 35 ll. 23–25. The 480 mg/day disclosure
in week seven is an interim dosage, and Forward has not
presented persuasive evidence why a skilled artisan
would have understood the week seven interim dosage to
be therapeutically effective. On the other hand, Biogen’s
expert testified that, because MS is a chronic disease, a
skilled artisan would not have viewed a one week, interim
dosage in the middle of a nine week up-scale schedule as
an adequate treatment dosage, let alone one for a particu-
lar disease, such as MS. 7 Substantial evidence supports
the Board’s finding that Forward’s ’871 application lacks
adequate written description support for the claimed
treatment method.
Moreover, we also note that the ’871 application
states that its compositions and kits are merely “contem-
plated to be suitable to use in the treatment of one or
more of the following conditions.” Id. at col. 37 ll. 17–18
(emphases added). A reasonable understanding of this
statement is that the inventors of the ’871 application had
not yet firmly concluded that fumarates at a particular
daily dosage were in fact effective for treating the entire
list of enumerated conditions, which included MS, partic-
7 The ’871 application’s specification also teaches,
as noted supra, that the daily dosage of fumarate may be
in the range of 240 to 1080 mg/day and lists 480 mg/day
dosage twice in two different ranges within this broader
range (discussed supra). ’871 application col. 36 ll. 13–23.
Forward does not rely on this disclosure in its written
description arguments. In any case, this disclosure is not
helpful to Forward because none of the dosages are specif-
ically associated with any particular fumarate; the speci-
fication states that choosing a daily dosage is dependent
on a number of factors including the underlying cause of
the condition or disease to be treated; and none of the
doses are identified as being therapeutically effective.
FWP IP APS v. BIOGEN MA, INC. 13
ularly in light of the disparate pathophysiologies of the
listed diseases and the wide variability of the organ
systems affected by them. J.A. 18298 ¶47 (“Given the
disparate pathophysiologies of the listed conditions and
the wide variability in the organ systems affected by
them, a person of ordinary skill reading [the ’871 applica-
tion] would not have expected possible doses of a fumaric
acid ester to similarly apply across the wide range of
disease classes or even within the various classes, includ-
ing within the large subclass of autoimmune diseases.
For example, a person of ordinary skill in the art reading
[the ’871 application] would not have expected that a dose
of an agent for potentially treating one of the many listed
non-neurological diseases would also treat a neurological
disease such as MS.”). In the sixty-seven page applica-
tion, MS is mentioned only a handful of times, three times
as part of a list of over twenty diseases (’871 application,
col. 37 l. 27, col. 39 l. 3, col. 39 l. 15) and twice in the
original claims (claim 44 and 45). There is no mention of
the symptoms or etiology of MS. The only conditions the
’871 application’s specification discusses in any detail are
psoriasis and conditions associated with psoriasis. ’871
application, col. 1 ll. 12–15, col. 2 ll. 23–34, col. 7 ll. 9–17,
col. 38 ll. 18–27, col. 39 l. 21–col. 40 l.7. Given the brief
references to MS and the lack of recognition of 480 mg/day
as a therapeutically effective daily dosage, we agree with
the Board’s finding that there “is no discussion [in the
’871 application] that would guide one skilled in the art to
treat MS with a therapeutically effective dose of
480 mg/day. . . .” J.A. 22. 8
8 The Board found that the focus of Forward’s ap-
plication “is ameliorating the gastro-intestinal side-effects
due to the administration of fumarates by using con-
trolled release preparations.” J.A. 21–22. Forward ar-
gues that this finding is legal error because there is no
14 FWP IP APS v. BIOGEN MA, INC.
Forward’s attempt to use the prior art to supply the
link between the therapeutically effective dose of
480 mg/day and MS is similarly unpersuasive. Forward
attempts to analogize to Streck, Falkner, and Union Oil
Co. of California v. Atlantic Richfield Co., 208 F.3d 989
(Fed. Cir. 2000), which in each case found that the prior
art provided sufficient background knowledge such that a
skilled artisan would understand that the specification, in
the context of that background knowledge, adequately
described the claimed invention.
The problem in this case for Forward is that, even if
we allow Forward to rely on the prior art for establishing
a prior, known link between MS and fumarates, the prior
art does not teach the key limitation of the count: the
480 mg daily dosage. As discussed supra, both parties
identified this as the key limitation in the count. Biogen
argued that it was only during its phase 3 clinical trials
when it confirmed that 480 mg/day of DMF is effective for
requirement for a specification to place “focus” on an
invention to meet the written description requirement,
and in imposing such a requirement, the Board improper-
ly ignored the embodiments disclosed in the ’871 applica-
tion that do not involve controlled research formulations.
Forward’s argument is unpersuasive because it misunder-
stands the Board’s opinion. The Board did not find that
the ’871 application was limited to controlled release
formulations. Rather, the Board found that the main
thrust of the specification was aimed at controlled re-
leased formulations to reduce the gastro-intestinal side-
effects of fumarates. And then the Board made the addi-
tional finding—which is supported by substantial evi-
dence—that nothing in the specification supported
Forward’s assertion that a skilled artisan would under-
stand the specification as disclosing a method of treating
MS using a fumarate at a dosage of 480 mg/day.
FWP IP APS v. BIOGEN MA, INC. 15
treating MS and, unexpectedly, that it had a similar
efficacy to the much higher dosage of 720 mg/day. This
discovery—by Biogen—was significant because it allowed
patients to take lower doses of the medication, which is
important in treating a chronic disease like MS. In
addition to the dosage amount problem, even if the link
between MS and fumarates had been known in the prior
art, that does not necessarily mean that a skilled artisan
would have understood the ’871 application as demon-
strating that the inventor contemplated using fumarates
to treat MS, given the application’s open-ended language
that fumarates are merely “contemplated to be suitable to
use in the treatment of one or more” of several listed
conditions. In view of the foregoing, Forward’s prior art-
based argument does not undermine the substantial
evidence that supports the Board’s finding that the ’871
application does not disclose 480 mg of fumarates per day
as a therapeutically effective dosage for treating MS.
B
Lastly, Forward briefly argues that the ’871 applica-
tion’s original claims—which it canceled and replaced
with new claims to provoke the interference proceeding—
adequately describe the MS treatment it now seeks to
claim. Specifically, Forward’s argument is premised on
piecing together elements of several of the claims—claims
27, 28, 30, 32, 33, 37, and 44. The Board rejected this
argument, finding that, “to arrive at the specifically
claimed subject matter, a person skilled in the art would
need to pick and choose from the certain of [Forward’s]
claims without guidance from the written description.”
J.A. 24. Substantial evidence supports the Board’s find-
ing.
The ’871 application had 45 original claims. Those
claims are mainly directed to controlled release composi-
tions of numerous fumarates and pharmaceutically ac-
ceptable salts. Some claims recited numerous possible
16 FWP IP APS v. BIOGEN MA, INC.
dosing schedules (claims 30–32) and dosages (claims 33–
38). And others replicate the laundry list of diseases and
conditions enumerated in the specification (claims 44 and
45). This large number of disease conditions, dosages,
dosing schedules, active ingredients, pharmaceutical
formulations for controlled release, and combinations
thereof covered by the original claims detracts from
Forward’s argument that it possessed and invented the
now-claimed, specific MS treatment. See Ariad, 598 F.3d
at 1351. Rather, what the scale of the claims demonstrate
is that Forward possessed, as of the 2004 critical date, a
mere wish for obtaining some type of fumarate formula-
tion to treat any one of a number of diseases and condi-
tions, one of which was MS, using almost any possible
daily dosage.
The task of locating the now-claimed subject matter
within the original claims is made uncommonly more
difficult by the original claims themselves, which are
written in a cascading, multiple dependencies manner
such that many of them generically refer back to any one
of the preceding claims. For example, claim 44, which
contains a laundry list of diseases and conditions, de-
pends on “any one of claims 1–43.” Other claims use
similar language including “any one of the preceding
claims” (claims 11, 27, 28) and “any one of the claims 3–
12” (claim 13). In addition, claim 33 is a multiple depend-
ent claim, and it is effectively serving as the basis for
claim 37 and subsequently, claim 44. Title 35 forbids this
type of claim drafting because it can—as here—lead to
bizarrely complex chains of cross-referencing claims in
which one multiple dependent claim impermissibly serves
as a basis for other multiple dependent claims, and so on.
See 35 U.S.C. § 112 ¶ 5 (“A claim in multiple dependent
form shall contain a reference, in the alternative only, to
more than one claim previously set forth and then specify
a further limitation of the subject matter claimed. A
multiple dependent claim shall not serve as a basis for
FWP IP APS v. BIOGEN MA, INC. 17
any other multiple dependent claim. A multiple depend-
ent claim shall be construed to incorporate by reference
all the limitations of the particular claim in relation to
which it is being considered.”). Finding a treatment for
MS with 480 mg of DMF and/or MMF per day in the
morass of possible combinations of the impermissibly-
drafted original claims would—as Judge Learned Hand
observed in a different but related context—take “the
patience of a yogi to decipher their meaning, as they
stand.” Victor Talking Mach. Co. v. Thomas A. Edison,
Inc., 229 F. 999, 1001 (2d Cir. 1916).
While Forward contends that locating the now-
claimed invention requires just simple tracing through its
now cancelled original claims, the task itself is monumen-
tal due to the complex network of cross-referencing and
chain of multiple dependencies in the original claims that
must be navigated. A review of the claims and their
intermixing dependencies presents an overall picture of a
set of claims designed to preempt a conspicuously large
number of different dosage regimens for a large variety of
conditions using a long list of formulations, which is
disconnected from a written description that is far more
limited in its disclosure. As the Board correctly observed,
a skilled artisan would need to pick and choose from
Forward’s claims without any guidance from the written
description. Forward provides no explanation as to why a
skilled artisan would be able to cobble together selected
elements from several different claims and thus recognize
the now-claimed 480 mg/day of DMF and/or MMF for the
treatment of MS from these 45 claims covering a broad
scope of subject matter. This is all the more true given
that the original claims, now cancelled, are drafted in a
way that is barred by the Patent Act. The Board thus
reasonably found that these original claims do not provide
a basis for a written description of the now-claimed sub-
ject matter.
18 FWP IP APS v. BIOGEN MA, INC.
CONCLUSION
Because the ’871 application does not disclose 480 mg
of fumarates per day as a therapeutically effective dose
for treating MS, substantial evidence supports the
Board’s finding that the MS treatment Forward now
claims is not supported by adequate written description
under 35 U.S.C. § 112. We have considered Forward’s
other arguments and find them unpersuasive. Therefore,
we affirm the Board’s decision.
AFFIRMED