By
Donald Zuhn —

Last
week, Defendant-Appellant Eli Lilly & Co. filed its principal brief
for the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly
& Co., which is scheduled for December 7th.  (Patent Docs
provided a summary of Ariad's principal brief, which was filed on October 5th,
last Tuesday; see "Next Up: Ariad v. Lilly Rehearing En Banc.")  In response to the two questions
presented by the Federal Circuit's en
banc order — i.e., whether 35
U.S.C. § 112, first paragraph, contains a written description requirement
separate from an enablement requirement, and if so, what the scope and purpose
of that requirement is — Lilly answered that "there has always been
a robust written description requirement separate from enablement that is
supported by almost two hundred years of precedent," and that the
requirement "applies to both original and amended claims and ensures that
inventors have actually invented the subject matter claimed in their patents."

Lilly
begins its brief by observing that in the U.S., "[t]he statutory scheme has
always been a delicate balance between providing an incentive for innovation
and protecting the public's right to use technology that does not qualify for
the incentive."  In addition
to excluding from the incentive that which is old, obvious, or non-enabled, Lilly
contends that "subject matter that the patent application shows had not
been invented by the applicant, i.e., was not within his possession, at the
time the application was filed" is also excluded from the incentive.  According to Lilly, this last
exclusion, known as the written description requirement, exists "for good
reason," because:

Even inventors as distinguished as
Samuel Morse have fallen prey to the temptation to preempt the future before it
has arrived.  See O'Reilly v. Morse, 56 U.S. 62 (1853).  Based on little more than an outline of the research program
that would be required to make the invention, patent applicants have sought
broad, dominating patent protection covering every means of attaining a desired
result.  When others later succeed
in attaining the sought after result, it is alleged that the research plan was
"enabling," confirming the validity of the preemptive claim.  From at least as early as the nineteenth
century, however, the courts have recognized that the patent statute requires
something more.

Stating
that "there is and always has been a written description requirement separate
from enablement, and Ariad's arguments to the contrary are simply wrong,"
Lilly points out that "[t]he statute itself says so, requiring a
description of the invention and of the manner of making and
using it, and no amount of parsing can read that conjunction out of the
statute."

Lilly
spends the bulk of its brief reviewing a number of cases that it believes support
its argument for the existence of a separate written description requirement.  Among the Supreme Court decisions that Lilly
discusses are Evans v. Eaton, 20 U.S.
356 (1822), where the Court "explained that the written description
requirement protects the public from an inventor who may 'pretend[] that his
invention is more than what it really is'"; O'Reilly v. Morse, 56 U.S. 62 (1853), where the Court
"explain[ed] that Morse claimed 'an exclusive right to use a manner and
process which he has not described and indeed had not invented,
and therefore could not describe when he obtained his
patent'" (emphasis in Lilly's brief); and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722
(2002), where "the Court made abundantly clear that § 112, first paragraph,
has three
requirements: '[T]he patent application must describe, enable,
and
set forth the best mode of carrying out the invention" (emphasis in
Lilly's brief).  Following its
summary of Supreme Court precedent, Lilly states that "[t]he above cases
consistently indicate the existence of a separate and robust written
description requirement, and Ariad has not cited a single Supreme Court case
that says otherwise."

Lilly
next moves to the U.S. Court of Customs and Patent Appeals, contending that
"[c]onsistent with the above Supreme Court precedent, the C.C.P.A. repeatedly
held that § 112 contains a separate written description requirement, and Ariad
has failed to cite a single case from the C.C.P.A. that states otherwise."  In support of its argument for a
separate written description requirement, Lilly cites In re Moore, 155 F.2d 379 (C.C.P.A. 1946); In re Sus, 306 F.2d 494 (C.C.P.A. 1962); Jepson v. Coleman, 314 F.2d 533 (C.C.P.A. 1963); In re Ruschig, 379 F.2d 990 (C.C.P.A.
1967); In re DiLeone, 436 F.2d 1404
(C.C.P.A. 1971); In re Moore, 439
F.2d 1232 (C.C.P.A. 1971); Fields v.
Conover, 443 F.2d 1386 (C.C.P.A. 1971); and In
re Barker, 559
F.2d 588 (C.C.P.A. 1977).  With
respect to Ruschig, which Ariad cites
in support of its argument that there is no separate written description
requirement, Lilly states that:

Ariad's strained reading of this case
to argue that this inquiry was part of "enablement" should not be
accepted, and, to this date, has been rejected by many judges on this
Court.  Enzo [Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 971 (Fed. Cir.
2002)] (Lourie & Newman, JJ., concurring); id. at 977-78 (Rader, J., dissenting and writing that Ruschig applied a separate written
description requirement); Moba[, B.V. v. Diamond Automation, Inc., 325 F.3d
1306, 1327] (Bryson, J., concurring).

In
view of the above C.C.P.A. decisions, Lilly concludes that "there is simply
no basis in the precedent of the C.C.P.A. for the proposition that a separate written
description requirement does not exist."

Lilly
finishes its discussion of relevant case law with an analysis of Federal
Circuit precedent, which "also makes clear that there is a separate
written description requirement." 
Many of the cases cited by Lilly should be quite familiar to patent
practitioners, and include:  In re Alonso, 545 F.3d 1015 (Fed. Cir.
2008); Carnegie Mellon University v.
Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008); LizardTech, Inc. v. Earth Resource Mapping,
Inc., 424 F.3d 1336 (Fed. Cir. 2005); University of Rochester v. G.D.
Searle & Co., 358 F.3d 916 (Fed. Cir. 2004); Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir.
2002); Gentry Gallery, Inc. v. Berkline
Corp., 134 F.3d 1473 (Fed. Cir. 1998); Regents
of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559
(Fed. Cir. 1997); Fiers v. Revel, 984
F.2d 1164 (Fed. Cir. 1993); and Vas-Cath
Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991).  Lilly notes that "[t]he existence of a separate written
description requirement has been so clearly established by this Court's
precedent that Ariad did not argue at the merits stage of this appeal that a
separate written description requirement does not exist," and states that
"Ariad's en banc brief relies on
dissenting opinions and fails to cite even a single panel decision from this Court
supporting its position."

In
response to Ariad's statutory construction of 35 U.S.C. § 112, first paragraph
(see "Next Up: Ariad v. Lilly Rehearing En Banc"),
Lilly contends that the first paragraph of § 112 contains three requirements
(emphasis in Lilly's brief):

(1) "The specification shall contain a written description of the invention,
and"
(2)
"The specification shall contain a written description . . . of the manner
and process of making and using it, in such full, clear, concise, and exact
terms as to enable any person skilled in the art to which it pertains, or with
which it is most nearly connected, to make and use the same, and"
(3)
"The specification . . . shall set forth the best mode contemplated by the
inventor of carrying out his invention."

Lilly
notes that "[t]he principal argument advanced by Ariad (and its supporting
amici) for why this Court should abandon its long-standing precedent is based
upon a fine grammatical parsing of the statute."  However, Lilly points to Judge Rich's concurrence in In re Barker, and argues that Judge Rich
"wrote separately because he did not agree that § 112 should be construed
by parsing the language of the statute and examining whether words were
superfluous," but rather, believed that "construction of 112 should
be based on the precedent interpreting the statute over the last hundred or so
years."

As
for Ariad's argument that the statute does not provide a standard for written
description, Lilly counters that "as is often the case with statutes, the
legal standards for applying them are developed by courts over time, particularly
with respect to a statute such as § 112 where the words were specifically
retained to preserve the previously existing precedent."  Lilly also notes that:

Ariad does not seem troubled by the
fact that the statute also does not state that enablement must be measured at
the time of the filing of the application, that the specification must enable
the ''full scope" of the claim, and that a specification is not enabling
if it takes more than "undue experimentation" to practice the
invention's full scope — to say nothing of the omission of the factors under In re Wands, 858 F.2d 731,737 (Fed. Cir.
1988).  Similarly, there is nothing
in the first paragraph of § 112 that specifies when the best mode analysis is
conducted or whether an inventor has an obligation to supplement the best mode
in continuing applications.  That
these standards were developed by previous and subsequent case law does not
mean that the applicable statutory requirement does not exist.

With
respect to whether the written description requirement should apply to both
original and amended claims, Lilly states that:

For
both original and amended claims, a written description of the invention may
either be satisfactory or deficient depending on whether the patent specification,
including the original claims, provides a demonstration that the patent
applicant actually invented and was in possession of the claimed subject
matter.  In cases where an original
claim provides an adequate written description of the claimed invention, the inquiry
need not go any further.  Where an
original claim read in light of the specification fails to provide an adequate
written description of the invention because, for example, it claims the
invention by what it does rather than what it is, then the original claim is
invalid.  An amended claim warrants
the same inquiry, and there is no logical reason to treat such claims differently.

Lilly
also argues that if written description precedent is to be changed, such a
change should be made by Congress and not the Federal Circuit sitting en banc.  In support of this argument, Lilly cites
Warner-Jenkinson Co. v. Hilton Davis
Chemical Co., 520 U.S. 17 (1997), and Festo
Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002), where
"the Supreme Court explicitly stated that this Court should not
upset the settled expectations of the patent community."  Noting that "Congress has amended
the patent statute many times and is currently in the process of changing the
statute yet again," Lilly concludes that "[i]f Ariad is truly correct
that all of the above precedent is wrong or unwise, it should be changed by
Congress, not this en banc Court."

Patent Docs
thanks David Forman of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
for kindly providing us with a copy of Lilly's Principal Brief.