Wednesday, October 24, 2018

Forward loses multiple sclerosis drug case to Biogen

From the decision:

This appeal arises from an interference proceeding1 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 Biogen’s
motion for judgment that the MS treatment Forward
now seeks to claim is not supported by adequate
written description under 35 U.S.C. § 112 (2006). Because
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.

Of the law:

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 supported
by substantial evidence if “a reasonable mind
might accept the evidence to support the finding.” Redline
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 demonstrate
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).

From footnote 5:

Relatedly, Forward argued that the Board misapplied
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.


Recently in Nike, Inc. v. Adidas AG, we explained
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 limitations
of the interference count in the ’871 application and
thus see no reason to disturb the Board’s finding.

Of multiple dependent claims:

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, depends
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 dependent
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.

keyword: Tecfidera


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