By
Donald Zuhn —

In
anticipation of tomorrow's oral argument in the rehearing en banc of Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co. (scheduled to begin at 2:00 pm
(EST) in Courtroom 201), Patent Docs has
spent the past three weeks reviewing a number of the briefs submitted by
various amici.  By the November 20th filing deadline,
twenty-five amicus briefs had been
submitted (by our count), with nineteen briefs filed in support of
Defendant-Appellant-Respondent Eli Lilly & Co. and/or judgment of affirmance, six
briefs filed in support of neither party, and no amicus briefs filed in support
of Plaintiffs-Appellees-Petitioners Ariad Pharmaceuticals, Inc., Massachusetts
Institute of Technology, the Whitehead Institute for Biomedical Research, and
the Presidents and Fellows of Harvard College ("Ariad").  Amici
supporting Lilly and/or affirmance include:

• Abbott Laboratories
(see Patent Docs report);
• The American Intellectual
Property Law Association (AIPLA) (see
Patent Docs
report);
• Amgen Inc. (see Patent Docs report);
• Professor Christopher A.
Cotropia (brief);
• The Federal Circuit Bar
Association (see Patent Docs report);
• GlaxoSmithKline (see Patent Docs report);
• Google Inc., Verizon
Communications Inc., and Cisco Systems, Inc. (see Patent Docs report);
• Hynix Semiconductor Inc.
and Samsung Electronics Co., Ltd. (see Patent Docs report);
• The Intellectual Property
Owners Association (IPO) (see Patent Docs
report);
• Oskar Liivak (brief);
• Medtronic, Inc. (see Patent Docs report);
• Microsoft Corp. (see Patent Docs report);
• Monsanto Co. (see Patent Docs report);
• Public Patent Foundation
(PUBPAT) (brief);
• RealNetworks, Inc.
(see Patent Docs report);
• The Regents of the
University of California, Wisconsin Alumni Research Foundation, The University
of Texas System, University of Rochester, Rensselaer Polytechnic Institute,
STC.UNM, The Research Foundation of State University of New York, NDSU Research
Foundation, and Research Corporation Technologies, Inc. (discussed below);
• United States (see Patent Docs report);
• Washington Legal
Foundation (brief); and
•
William Mitchell College of Law (brief).

Amici supporting neither party
include:

• Professor Christopher M.
Holman (see Patent Docs report);
• Mark D. Janis and Timothy
R. Holbrook (brief);
• Dr. Roberta J. Morris (brief);
• The New York Intellectual
Property Law Association (brief);
• Novozymes A/S (see Patent Docs report);
and
• University of Kentucky
Intellectual Property Law Society, Universal Support Systems LLC, Polymer Construction
Products Ltd., and Safeteccs LLC (brief).

On
the eve of oral argument, we examine the amicus brief filed by The Regents of the University of California, Wisconsin Alumni
Research Foundation, The University of Texas System, University of Rochester,
Rensselaer Polytechnic Institute, STC.UNM, The Research Foundation of State
University of New York, NDSU Research Foundation, and Research Corporation
Technologies, Inc. in support of affirmance of judgment.  The university amici begin their brief by describing written description as a
doctrine once used only to police claims to priority of invention,
but having "evolved judicially into a separate and oftentimes insurmountable
requirement, particularly when applied to biological inventions."  The amici
argue that "[t]he Federal Circuit's creation of this separate barrier to patentability
. . . effectively imposes an actual reduction to practice requirement on
biotechnology inventions," and that "[s]uch a requirement prejudices universities
and research institutions that do not have the resources to reduce each
pioneering biotechnological innovation to a 'precise definition.'"

Stating
that "[t]here is no statutory support and certainly no policy rationale
for the technology-specific impact the current written description law has on
the university and scientific research community," the university amici contend that:

[T]he current incarnation of written description is not only at odds with the
Federal Circuit's
own jurisprudence bestowing broader patent protection to pioneering inventions,
it muddies clear federal policy with respect to the role of the patent
system.  Patent exclusivity granted
for pioneering biological inventions fuels the creation and recruitment of
commercial entities willing to undertake the huge investments necessary to
refine and develop foundational university research into medical and
biopharmaceutical products widely accessible to the general public.

The
amici suggest that the Federal
Circuit "take the opportunity now to realign the written description law
with the constitutional, statutory, and policy rationales that underlie the
patent system, and return the doctrine to its proper role of assessing new
matter rejections and claims to priority."

In
arguing that § 112, first paragraph, does not contain a written description
requirement separate from the enablement requirement, the university amici spend some time discussing In re Ruschig, 379 F.2d 990 (CCPA 1967),
a decision the amici contend was not
based on § 112, but rather concerned the issue of whether a new claim added
during prosecution was properly rejected as new matter.  The university amici believe it is "noteworthy that the cases after Ruschig purporting to
apply a separate written description requirement were limited to
those involving (1) the presentation of claims not presented in the application
when originally filed, (2) entitlement to the benefit of an earlier filing
date for claims in a later-filed application, and (3) interference proceedings,"
adding that "[e]ach of those 'written description' cases
involved evaluating the sufficiency of the claims in accordance
with statutes governing a patent claim's entitlement to priority and
the prohibition against adding new matter."  Noting the written description case for which one of the amici is closely associated, especially in the minds of biotech practitioners (i.e., The Regents of the University of California
is v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)), the brief states
that:

It was not until Lilly that a truly
separate written description requirement — untethered to any other patent
statute — was first created.  Beyond
evaluating the sufficiency of claims added during prosecution, written
description became a device for evaluating the sufficiency of disclosures in
already-issued patents.  There was,
however, no statutory change or legislative pronouncement to justify departing
from the previous thirty years of precedent that limited written description to
its corollary function of policing priority.

The
university amici also argue that there
was no need to expand written description, because through In re Wands, "[t]he enablement inquiry already considers
factors intended to assess the sufficiency of the disclosure."

Returning
to the impact of a separate written description requirement on universities,
the amici argue that the separate
requirement "operates to prejudice inventors at universities and other
research institutions who often make the most important basic scientific
discoveries," as "[u]niversities do not have the resources to support
the time and labor-intensive process of reducing every species of a genus to
practice or describing, for example, every possible amino acid or DNA sequence
in exhausting detail as needed to 'precisely define' and adequately describe a
biological invention." 
According to the university amici,
the impact of a separate written description requirement on universities also
frustrates federal patent policy:

A statutory interpretation of the written description requirement that unfairly
prejudices biotechnology and university inventions impedes . . . growth and
frustrates the goals of the patent system.  It limits universities' ability to obtain biotechnology
patents, depriving the public of the full economic benefits and potentially
life-saving products that flow from licensing relationships between universities
and private corporations.

The
amici also argue that a separate
written description requirement conflicts with the broad patent scope the
Federal Circuit has bestowed on pioneer patents, stating that "what this
Court grants to pioneering inventions with one hand, it takes away with the
other."  In particular, the
university amici contend that the
Federal Circuit has used the separate written description requirement to
invalidate some patents, "claiming the patent disclosures do not support
the breadth of their claims," and that "[s]uch a requirement values
minor incremental improvements well-suited to precise description over the
monumental advances in technology often incapable of precise written
description."  The amici state
that "[i]t is inconsistent for Federal Circuit jurisprudence to
acknowledge pioneer patents' entitlement to broad claims, while applying a
written description standard that invalidates them on those same grounds."

The
university amici conclude by asking
the Federal Circuit to return the written description requirement "to its
historic role in the priority context, ensuring that later-filed claims are supported
by the disclosures in an earlier-filed patent application."

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Briefs by Companies," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs in Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

    By Kevin E. Noonan —

Several companies have filed amicus curiae briefs
with the Federal Circuit on the questions presented by the en banc Court in the Ariad
case.  Although we have explored
the positions taken by some of these companies in detail, on
the eve of oral argument, we set forth here briefer synopses of the positions
taken by the remaining technology companies that have filed amicus
briefs.  While most of these companies
have taken positions supportive of Lilly on the question of the existence
of a separate written description requirement, one company (Novozymes) supports
Ariad's position and another (Monsanto) argues for the existence of a separate
written description requirement but at the same time maintains that the Federal
Circuit has misapplied the standard in Regents
of the University of California v. Eli Lilly & Co. and subsequent
cases.

Amgen:  Amgen has an interest in the outcome of this case insofar as Amgen filed a
declaratory judgment action against Ariad on the same patents at issue in Ariad v. Lilly.  Amgen prevailed in its action on
summary judgment of non-infringement, based inter
alia on the extracellular situs of the action of its Enbrel® product on
NF-kB activity.  Amgen filed its brief in support of affirmance of the judgment, and answers the first question
presented by the en banc Court in the affirmative, that 35 U.S.C. § 112, first
paragraph, contains a written description requirement separate from the
enablement requirement.  The brief
argues that the written description requirement promotes innovation by ensuring
that inventors "carry their work to fruition" before filing a patent
application.  The brief also
asserts the notice function of patents, so that the public can appreciate the
metes and bounds of the invention to determine its preclusive effects on their inventions.  The brief distinguishes both enablement
(requiring a disclosure that permits public to practice invention once patent
expires) and definiteness (which requires a precise delineation of the
boundaries of exclusive power granted to a patentee) from the written
description requirement, which ensures that an applicant had possession of the
invention at the filing date.  The
brief argues that:

Without
a written description requirement, there would be no reliable basis to assess
the future patent risk of continued research and development, and far less
enthusiasm or incentive to proceed.  In short, by requiring each applicant to
describe in writing and thereby delimit their professed invention, the written
description requirement promotes rather than quells innovation,

characterizing
this as an "objective standard" and citing Evans v. Eaton, O'Reilly
v. Morse, Schriber-Schroth, Festo, and Permutit v. Graver.

The brief also recites the high cost of investment
and high rates of failure in developing biotech drugs, because "it is also important to ensure that
such innovation is not preempted by those who provide no solution but only
describe a problem and attempt to claim in a patent any or all solutions to the
problem."

Expanding
beyond the parochial scope of its own concerns, Amgen's brief cites the concern
of the "high technology" companies regarding "recasting the
claimed scope of his invention to dominate the innovations of others in the
field":

While
failure is an orphan, success knows many fathers.  Few patent-holders assert
their claims against products that fail in the clinic.  But when innovators are
successful after years of painstaking, costly research and development, others
with patent applications still pending often try to dominate that proven
success by claiming the innovator's success as their own invention.  The written
description requirement prevents patent applicants from treating their
disclosures as "a nose of wax."

The brief admits that courts and the Patent Office
may apply the written description requirement too stringently and that this could negatively impact
universities and small entities without the resources to rigorously establish
every detail of how their inventions work.  But the brief agrees with the position taken in the Intellectual
Property Owners amicus brief that the Court does not
write on a clean slate and has a body of well-developed case law to rely upon:

Amgen
agrees that requiring excessive detail or analysis in a patent disclosure
or narrowing the scope of claims to the precise details of the disclosure would
be injurious to the patent system and stifle innovation.  But, in our view, the
written description pendulum has not swung that far.

The
description requirement, as currently applied, walks the fine line between
rewarding a patentee for his/her actual invention and encouraging innovation by
a competitor by requiring that a specification reasonably convey to an
ordinarily skilled artisan "possession" of the claimed invention.  It
is only if this balance is tipped, as Ariad and some of the amici suggest, to
do away with the description requirement all together, or alternatively, to
require an actual reduction to practice in all instances, that innovation will
be quelled.

Medtronic:  Medtronic filed its brief in support of
Eli Lilly.  This brief emphasizes
the notice function of the disclosure, particularly with regard to medical
devices.  Pointedly maintaining that
its brief is not an "academic or intellectual exercise," the brief
asserts its "unique position as a large company straddling all areas of
technology, who deals with real world issues of intellectual property valuation
on a daily basis."  The brief
argues that "[t]he U.S. patent system is out of balance" due to
"uncertainty" that makes it "difficult to operate effectively in
the marketplace."  Eliminating the written description requirement would just make this
situation worse, they argue.

Reminiscent of Judge Rader's opinion in Sage Products v. Devon, the brief argues
that patent applicants are responsible for what they claim in their patents,
and that the notice function requires that the onus be placed on patentees to
describe commensurate with the scope of what they claim.  The brief argues that the written
description requirement is not only not being applied too stringently but is
not applied stringently enough, because applicants can (presently)
"combine disparate parts of the specification" to claim inventions
not disclosed at the time of filing.  The brief also asserts that at present the written
description requirement "allows applicants to broadly rename elements
during prosecution so as to give them a breadth not contemplated at
filing," resulting in the "peril of late claiming."

The brief lists three reasons why a separate
written description requirement is required in addition to enablement:  1) without it, an "enabled"
invention would enjoy "an indefinite, subjective boundary due to an
additional layer defined by the standard that a claim is enabled if it can be
practiced by the skilled worker 'without undue experimentation;'" 2) publication becomes "meaningless"
without a requirement that the specification sets forth an adequate written
description separate from the requirement for an enabling disclosure; and 3)
the "predicate basis" for assessing compliance with § 112, ¶ 2
"disappears."

The essence of the argument in this brief is
"notice, notice, notice."  Its absence "harms competition and innovation, seriously inhibits
the ability of companies to evaluate the value and breadth of its own and its
competitor's intellectual property, and reduced the predictability of success
in litigation."  The brief
proposes setting a limit of the originally-filed claims for public notice — the
"clearest written description," with amended claims being limited to
subject matter that finds "direct and unambiguous support in the
specification."  As
stated succinctly in the brief, claims should be limited to what was actually
"described in writing"
rather than what can be "derived
from the writing" (emphasis added)
and cites Kennecott Corp. v. Kyocera
for permitting what is inherent in the specification to be claimed.  The brief recites the benefits of
requiring clarity in this requirement as it would "improve the investment
decisions of businesses and promote better competition, improve the library of
prior art, and force a clearer and more predictable claim construction, thereby
reducing litigations and its related costs as well as its
unpredictability."

The brief cites three examples — from the computer (LizardTech), mechanical (Gentry Gallery) and chemical (In re Ahlbrecht) arts — where the Federal
Circuit has used the written description requirement to invalidate
"overbroad" claims.  This amicus argues that an important distinction between enablement and
the written description requirement is that written description precludes any experimentation with regard to what
is claimed as the invention, while enablement permits all but "undue"
experimentation.  The
importance of this distinction for the medical device industry depends on
"convergence of a wide range of technologies" required for these
inventions, which are frequently combinations of predictable and unpredictable
arts.  As a consequence, there can
arise the need to apply "inconsistent standards" of enablement should
the court eliminate a separate written description requirement.

The brief also proposes that the problem of initial
overclaiming can be handled by requirements of the oath/declaration,
regarding that the inventor swears is her invention.  Perhaps a little naively, the brief ties decisions about
claim breadth — something typically less understood by inventors than by their
attorneys — to penalties for false swearing including fines, imprisonment, and
patent unenforceability.  While
this might not be a very practical approach, its in terrorem consequence might be one that would appeal to a big
company with specifically-directed patents.

Abbott:  Abbott's brief also argues in favor of
a separate written description requirement.  The brief asserts that enablement and written description
are different and distinct requirements, wherein written description imposes an
independent duty "to describe the invention such that persons skilled in
the art will know that the applicant actually invented the subject matter
claimed" — "a critical check against overreaching by
inventors."  The danger,
according to this amicus, is applicants "prematurely claim[ing]
subject matter they did not invent"
or that they "lie in wait for others to discover it."  The brief characterizes Ariad's
logic as being equivalent to "throwing the baby out with the
bathwater" because eliminating the written description requirement would
also destroy it as a check against late claiming.  The brief calls contentions that the Federal Circuit has
fashioned a "heightened" standard for biotechnology inventions a
"caricature of [the Court's] decisions" on the subject, which
decisions the brief characterizes as an "appropriate standard" and a
"nuanced and flexible approach."

The company's brief is not overburdened with legal
argument, with most of it advancing policy rather than legal arguments for
interpreting § 112, 1st paragraph, as having a separate written
description requirement.  The brief
argues that enablement can be used to encompass "concurrent
accomplishments of [an applicant's] competitors" with regard to the level
of skill in the art, and thus extend what is claimed past what the applicant
actually invented, citing several academic law review articles to this point.

The written description requirement has independent
value for "polic[ing] priority," according to this amicus, who
asserts this as a reason for the en banc Court to reject Ariad's contention that there is no written description
requirement in § 112.  The brief
also addresses several specific contentions raised by Ariad, including the
argument that the enablement requirement and § 132 are sufficient for
priority policing.  These
provisions would not be enough, they say, citing purported deficiencies and
loopholes.  For example, the brief
refutes Ariad's contention that there is no case where something that is
enabled is not described, citing In re
Alonso and In re Curtis (and,
indeed, could have cited the Lilly case
as well) and Chiron v. Genentech,
since enablement did not invalidate these claims but the written description
requirement did (albeit in the context of a priority determination).  The brief cites In re Rasmussen to support its
contention that § 132 cannot supply the required priority policing function,
making a distinction between new matter added to an application (prohibited by
§ 132) and broadening a claim to encompass undisclosed subject matter (§
112, ¶ 1).  The brief also notes that the language of §§ 119 and 120 of the
patent statute don't support this use of § 132, since they refer to
compliance with § 112, not § 132.

The brief contends that the appropriate standard
for whether a specification provides an adequate written description of an
invention was the one enunciated by the Federal Circuit in Vas-Cath:  that the
disclosure must "convey with reasonable clarity to those skilled in the
art that, as of the filing date sought, he or she [i.e., the applicant] was in
possession of the invention."  The fact that this standard must be applied to each technology based on
its complexity and the "maturity" of the field and knowledge in the
art does not mean that requirement is improperly applied, amicus argues.

Abbott's particular concern is the decision in Noelle v. Lederman, which permits the
inventor of a novel antigen to claim all antibodies that bind to it.  The focus of this concern is the $1.67
billion judgment against Abbott in Centocor
v. Abbott over the company's Humira® product; the trial court in October
denied Abbott's motion for judgment as a matter of law and the company is
awaiting entry of final judgment so it can file its appeal with the Federal
Circuit.  Thus, in its
brief, this amicus argues that the Federal Circuit should clarify that Noelle does not stand for a per se rule that antibodies are always
described by a description of the antigen.

Hynix
and Samsung:  In
addition to the brief filed by Google, Verizon, and Cisco, four
other companies in the "high technology" or "information
technology (IT) industry filed amicus briefs in this action:  Microsoft, RealNetworks, and a
combined brief by Hynix and Samsung.  In their brief, these amici argue that there is a separate written description
requirement contained in 35 U.S.C. § 112, first paragraph.  In addition, like several other amici,
this brief argues that the written description requirement should be considered as a matter of law.  The
brief argues that U.S. patent law "appropriately rewards innovation and provides
protection from opportunistic claims by patentees," terming the latter
practice a "pernicious abuse of the patent system."  The brief does not cover new ground
here on the cases cited in support of a separate written description requirement — including Evans, Morse, Schriber-Schroth, and Permutit.  The brief skirts the semantic argument over the
grammatical structure of the statute by saying either interpretation is
plausible, and thus that the Court can and should adopt the interpretation most
consistent with promoting innovation.  The brief cites references to "settled
expectations" (Festo) and
"Congressional acquiescence" as reasons not to change statutory
interpretation requiring a separate written description requirement.  Finally, the brief bases its contention
that compliance with the written description should be a question of law for
the Court on analogies with the Federal Circuit and Supreme Court decisions in Markman v. Westview Instruments on
construing claims and in KSR International Co. v. Teleflex Inc.
on deciding whether an invention is obvious.

Microsoft:  In its brief in support of Lilly,
Microsoft contends that there is a separate written description requirement in
the statute and agrees with Hynix and Samsung (and others) that compliance with
the requirement should be decided as a matter of law.  The brief emphasizes the role of the written description in
the "quid pro quo" aspect
of the patent "bargain," saying that the written description
requirement prevents the patentee from claiming more broadly that she
discloses.  The brief
addresses and rejects Ariad's grammatical reconstruction of the statute, saying
that courts do not construe statutes by "pars[ing] each word or clause in the statute or focus[ing] on
'statutory phrases in isolation,' but rather must 'read [the] statute[] as a
whole,'" citing U.S. v. Morton:

In this
analytical framework, statutory interpretation is not a search for hidden
meanings or embedded requirements, which can, when unearthed, then be numbered
and categorized and reduced to formulae and checklists.  Rather, statutory
interpretation discerns the intent of the legislature, as revealed, of course,
in the words of particular provisions, but understood in the context of the
purpose motivating the statute as a whole.

The brief relies on O'Reilly v. Morse for the proposition that the enablement
requirement is not enough, also citing Johns
Hopkins v. CellPro, Invitrogen v.
Clontech, and Spectra Physics v.
Coherent Technologies for the proposition that broad claims can be enabled
by disclosure of a single embodiment, but that this is a different and distinct
requirement from requiring disclosure of the invention as broadly as it is
claimed.  The brief
analogizes software claiming concerns with genus/species issues in the chemical
arts, insofar as it may be possible to enable production of a genus by
disclosure of a single species, but that disclosure of a single species may not
disclose invention of the genus.  The brief also looks to the provisions of § 112, 6th paragraph, for evidence of Congressional intent requiring consistency between what is
claimed and what is disclosed (although this is not a particularly effective argument in view of the
purpose of § 112, 6th paragraph, for permitting functional
claiming and overturning a Supreme Court decision (the Halliburton case) to the contrary).

As in the Hynix and Samsung brief (and others),
this amicus argues that the written description requirement should be decided as
a question of law, similarly analogizing written description with the
jurisprudential considerations raised over claim construction in Markman and regarding definiteness and
compliance with § 112, ¶ 2, and citing academic commentary (including two articles written by Judge
Moore prior to her taking the bench).

RealNetworks:  This brief supports Lilly and
argues for a separate written description requirement without taking a position
on the validity of Ariad's claims.  The brief asserts that there is "longstanding" Supreme Court,
CCPA, and Federal Circuit precedent on the question, parsimoniously citing O'Reilly v. Morse, In re Ruschig, and Vas-Cath
in support of this contention.  The
brief also notes several cases where claims can be enabled yet not adequately
disclosed throughout their scope, including University
of Rochester v. G.D. Searle, In re
Alonso, In re Curtis, In re Wertheim, In re Ahlbrecht, and In re
Ruschig.

The brief makes the policy argument that a separate
written description requirement furthers the objectives of the patent system:  "the protection of legitimate inventions by preventing overreaching by
patentees, and encouraging further inventive activity by the patentee and
others in the industry."  "A separate written description requirement
balances the need to reward legitimate invention while preventing overreaching,
and encouraging innovation," this amicus asserts.  RealNetworks argues that while broad
disclosure supports broad claims, citing In
re Sus, patentees are not entitled to claims broader than the
disclosure, citing Morse.  The brief also contends that requiring
evidence of possession protects technology companies from being accused of
infringing patents having no evidence of the claimed "invention"
asserted against these companies.

Novozymes:  This brief argues against the existence
of a separate written description requirement and contends not only that the
existence of original claims is enough, but that functional description of the
claimed invention is sufficient to satisfy the disclosure requirements of §
112.  The issue for this amicus is
the ease of "designing around" biotechnology claims limited in scope
by the application of the written description requirement by the Patent Office
in view of the Federal Circuit's jurisprudence in this area.  The problem identified by this amicus
is the ability of a competitor to make "insubstantial changes" in a
claimed biomolecule and successfully design around claims as they are currently
issued (i.e., too narrowly).

While the brief argues that there is a requirement
that an applicant describe her invention, this amicus contends that the Federal
Circuit has transformed this requirement into a heightened requirement
differentially applied to biotechnology claims, particularly of nucleic acids
and polypeptides.  This heightened
requirement is identified by the "representative number" of species
required to be disclosed to entitle an applicant to claims to a genus of
molecules, here particularly those comprising the genus of sequence variants of
a disclosed (and usually deduced) amino acid sequence as encoded by a claimed nucleic
acid.  The solution urged by
this amicus to the en banc Court is to "restore" the written description requirement to its
"traditional" limits of preventing amended claims to extend past the
disclosure as filed, citing In re Ruschig
and In re Robins in support of this
interpretation.

The brief maintains that traditionally, and
properly, the question of whether an applicant has complied with the written
description requirement arises in only three instances:  "1) when an
applicant presents a claim which is not present in the application as filed; 2)
when an applicant claims the benefit of the filing date of an earlier-filed
foreign of U.S. application for claims in a later-filed application; and 3)
when an applicant presents a claim corresponding to an interference
count."  The brief cites In re Gardner, In re Koller, In re Wertheim, and In re DiLeone in support of the
proposition that an originally filed claim is itself sufficient to satisfy the
requirement.  The brief in
particular attacks the three pillars of the Federal Circuit's application of the written
description requirement to biotech cases directly, saying that the written
description requirement does not require "a precise structural
definition" as recited in Fiers v.
Revel because that was an interference case directed to priority to a
specific nucleic acid sequence and in the context of an interference, where the
requirement is reduction to practice of a single species.  Thus, amicus argues, the case cannot stand
for a requirement of a "precise definition" of a genus.  The brief also contends that the
holding in Lockwood v. American Airlines
was limited to a priority situation, one of the "traditional" uses
for the doctrine, and distinguishes the other cases relied upon by the Lilly panel (In re Smythe, In re Grimme)
as being limited to priority situations.  Finally, as for the "representative number of
species" requirement, enunciated in Lilly,
the brief says it constitutes a "super-enablement" requirement
differentially applied to biotechnology inventions (interestingly, Professor
Lemley is the source of that characterization) (and while this argument is not
well supported by citations, the brief does cite Judge Rich in the Robins case).

As for functional claiming and the purported
prohibition thereof contained in Lilly,
this amicus contends that functional claiming properly falls within the scope
of adequate written description, citing the "convention" in
biotechnology that what something is can be conceptualized by what it does,
citing In re Wallach and Capon v. Eshar in support.  The brief is least convincing when
contending that in Lilly, production
of a human insulin cDNA may not have been enabled but was disclosed, based (it
appears) on the knowledge (or disclosure) of the amino acid sequence.  The brief also cites Invitrogen v. Clontech for the
proposition that disclosure of one sequence is enough to claim any polypeptide
having a specific function, and Enzo v.
Genprobe, regarding satisfaction of the written description requirement by a
deposit.

The brief contends that in biotechnology,
"cDNAs, enzymes, and other biomolecules may properly be described solely
by reference to their specific biological functions," a stance directly at
odds with the Court's written description jurisprudence and one unlikely to be
particularly persuasive if the en banc Court is interested in answering the written description requirement question
broadly over all technologies.

Monsanto:  Monsanto's brief takes the (on first
blush) paradoxical position that there is a separate written description as
part of the statute and that this requirement was properly interpreted by
the courts prior to the Federal Circuit's Lilly
opinion.  Thus the brief argues in
favor of a "traditional" written description requirement that is
different from the requirement that the Court and the Patent Office have applied since the Lilly case.

The brief emphasizes the notice function of the
written description requirement, consistent with arguments made by other amici,
so that it and other biotech companies will be able to "accurately
determine whether a future patent will impede either research and development
or commercial use of its innovations."  Where Monsanto takes an original approach is in arguing that
the "traditional" written description requirement is sufficient to
satisfy this need, "if applied correctly and coupled with vigorous
enforcement of the separate enablement requirement."  The basis for this contention is that
this amicus needs to "obtain suitably broad patent claims to prevent competitors
from simply designing around its inventions."  Like Ariad and amici supporting Ariad, Monsanto argues
that the Federal Circuit's written description jurisprudence since the Lilly case is an improper
"enhanced" requirement that "imposes a severe burden on
biotechnology innovators" because it offers insufficient scope of claims
to prevent designing around.

The brief argues that the written description
requirement, properly applied, would be satisfied per se by any claim disclosed in
haec verba in the patent specification.  Original claims and original
disclosure should be enough (citing In re
DiLeone, In re Gardner, In re Wertheim, and In re Koller), and there is room even for satisfaction of the
written description requirement when in
haec verba support is lacking if one of skill in the art would
"immediately discern the limitation at issue," citing Purdue Pharma v. Faulding and In re Robins.  The written description
requirement should be limited to new matter and claiming aggregates of words
and phrases in the specification to encompass inventions not contemplated by
the patentee at the time of filing, according to this amicus.  The brief analogizes the use of the
written description requirement to prevent such "cobbling" of words
and phrases to encompass inventions not identified in the original
specification to anticipation cases where the elements must be recited as they
are recited in the claims.

The brief also asserts, in agreement with Ariad and
other amici, that the enablement requirement is sufficient to police
overclaiming.  In the instant case,
the brief argues that Ariad has failed to provide an adequate written
description of the invention because it claimed all ways of reducing NF-kB
activity using functional language that lack enablement.  The brief also cites In re Hyatt for prohibition of
"single means claims" (which the brief contends properly
characterizes Ariad's claims in suit) and asserts that prohibitions against
such claims, based on failure to satisfy the enablement requirement, is sufficient
to address the important policy considerations of the scope of patent
disclosure without invoking the need for a separate written description
requirement.

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs for Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009

    By Kevin E. Noonan —

The American Intellectual Property Law
Association (AIPLA) has joined the chorus of patent bar groups opining on
whether there is a separate written description requirement contained in 35
U.S.C. § 112, first paragraph, in an amicus curiae brief filed in the rehearing en banc
of Ariad Pharmaceuticals, Inc. v. Eli
Lilly & Co.  The AIPLA agrees with
other amici that there is such a requirement, but emphasize that properly
construed, such a requirement must be assessed in the "context" of the
entirety of 35 U.S.C. § 112 (but, in reality, that "entirety" extends
no further than the second paragraph).  Similar sentiments were expressed by the Federal Circuit Bar Association
in its amicus brief, but the basis of
the argument is uniquely the AIPLA's. 
The AIPLA also notes that it does not take a position on the validity of
Ariad's patent-in-suit.

The brief argues that the written description
requirement should be construed to ensure that the patent specification "advances
the well-recognized patent policies of disclosure," defining these as:

(1) particularly and
distinctly identifying the invention,
(2) putting the
invention in the hands of the public at the end of the patent term as part of
the quid pro quo bargain for exclusive rights,
(3) ensuring that the
applicant was in possession of his/her invention at the time of filing to limit
any exclusive rights to the subject matter he/she actually invented, and
(4) informing the public
of the patent scope so that potential competitors know how to avoid
infringement and can reasonably design around the claimed invention.

The brief argues that the written description
requirement, as construed as being part of § 112, first paragraph, by the Court's
jurisprudence, satisfies these different but related roles.  Enablement, the amicus argues, "serves
a different and distinct purpose" — providing a disclosure that would
permit the worker of ordinary skill to practice the invention.  The brief also
notes, as have others, that the requirements differ in that the enablement
inquiry includes the knowledge and skill of the worker of ordinary skill in the
art, and that these can be "very different from any invention identified
by the inventor as his/her own."

In discussing the statute at length, the brief
counsels the Court to "resist the temptation to dwell on parsing the
statutory language to the point of drawing legal conclusions based on the
placement of commas."  "Instead,"
they counsel, the Court should employ an "as a whole" rationale that
would be "faithful to the statute's literal language and policy
objectives."  The amicus also
asks the Court not to make a "radical departure" from precedent and reminds the Federal Circuit to
be sure to "conform to Supreme Court precedent."  The brief asserts that the CAFC should
adopt a "sufficiently flexible" approach that will avoid an "unfair
standard of compliance that fails to take account of inherent differences in
technologies and claim formats."

The brief does admit that "statutory language,
legislative history and judicial precedent" — all the tools the Court
would normally employ in deciding this question — "fail to solve the
puzzle."  Policy may be what
ultimately drives (or should drive) the Court's conclusions, and the policy
requires that the specification must:

1) Sufficiently
identify the invention;
2) Put the
invention in the hands of the public at the end of the patent term as part of the
quid pro quo bargain for exclusive rights;
3) Ensure that the
applicant was in possession of his/her invention at the time of filing to limit
any exclusive rights to subject matter he/she actually invented; and
4) Inform the
public of the patent scope so that potential competitors know how to avoid
infringement and can reasonably design around the claimed invention,

citing Festo
Corp. v. Shoketsu
Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002); Bonito Boats, Inc. v. Thunder
Craft Boats, Inc., 489 U.S. 141, 150-51
(1989); McClain v. Ortmayer, 141 U.S. 419, 424 (1891); Praxair,
Inc. v. ATMl, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008); Purdue
Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000); and Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473,
1479 (Fed. Cir. 1998).

Amicus argues
that the question before the Court can be resolved by not considering the "number
of distinct disclosure requirement[s] that must be met," but by using the totality
of the specification to determine what was disclosed.  This "as a whole" approach they analogize with
various "claims as a whole" provisions such as § 103.  Thus:

[F]or purposes of determining whether a patent
is invalid for failing to comply with the disclosure requirements, a
specification should be judged by the sufficiency of the disclosures in the
application as filed, taken as a whole, not by the sufficiency of the portion
of a specification deemed the "written description" or the separate
portion deemed the "enabling disclosure."

The brief then explicates further its understanding
of the totality approach, using 
the equally-compelling rubric of faithfulness to the statutory scheme
taken as a whole, in the context of criticizing the panel for failing to
utilize the approach.  Here,
amicus argues, the panel considered whether Ariad's specification contained an
adequate written description, concluded it did not, and ended the inquiry.  The error was the belief that the
written description requirement could be "viewed in isolation from the
other requirements of Section 112."  Had the Federal Circuit applied the AIPLA's "as a whole" approach, the
brief argues, it could have performed "a practical evaluation of the
sufficiency of the disclosure" as understood by one of ordinary skill in
the art, "taking into account the interaction and codependence of [all of]
the Section 112 requirements."  By analogy, the brief compares (favorably!) this approach with the "common
sense" approach to obviousness imposed by the Supreme  Court in KSR International Co. v. Teleflex Inc.  However, the amicus argues that this "as a whole" approach "does
not relieve [the patent owner] of identifying in the patent a 'written
description' of the invention commensurate with the scope of the claims at
issue," citing Tronzo v. Biomet.  Ultimately, what is required is
that the specification properly puts the public on notice "of what the
inventor contemplates as the invention encompassed by the claims at issue."

The brief emphasizes that the approach must be
employed with sufficient flexibility to be able to adapt to different
technologies.  This, the brief
asserts, is the flaw in the argument that the enablement requirement is sufficient — there will be some instances where enablement simultaneously satisfies the
written description requirement, and other instances (and technologies) when this
will not be the case.  A particular
example cited in the brief is genus/species claims, where it can certainly be
the case that the specification enables making and using species within a
claimed genus, but does not provide a written description "for a claim
covering . . . a particular species."  On this point the brief concludes:

In the end, it is
the dynamic interaction of the Section 112 requirements that produce the kind
of disclosures necessary to advance the policies recited above.  Whatever the answer on the sufficiency
of the written description or enabling disclosure in the case, the proposal here
would not allow the court to simply stop the analysis after examining only one
of the requirements in isolation, and to ignore the others.  It would
rather permit a party to point the court to the disclosure as a whole, which
would be evaluated in light of the patent policies.

The "as a
whole" approach to assessing the sufficiency of disclosure in a
specification proposed by AIPLA's brief is consistent with the statute, because
the requirement for a written description, an enabling disclosure and a claim
that "particularly points out and distinctly claims the subject matter the
applicant regards as his invention" must be considered together, amicus
argues.  Amicus ignores the best
mode requirement (understandably, perhaps) but builds its "as a whole" argument
by combining two of the requirements from the first paragraph of Section 112
with the "claims" requirement from the second paragraph of Section
112.  While this has been done by
other amici, its consequence is to expand the scope of § 112, 2d ¶, from its
traditional role of providing a statutory basis for the peripheral claiming
requirement to being part of the sufficiency of disclosure requirement of § 112, 1st ¶.  The brief supports this interpretation
of the statute by arguing, first, "there is no requirement that the
written description of the invention be in a separately designated section of
the specification, nor that the enablement be in a separately designated
section," further saying that
both requirements are "intertwined" in some specifications.  Second, the requirements of  §112, 1st ¶, must be
evaluated in the context of what is claimed according to §112, 2d ¶, saying
that this has "always" been the requirement for enablement, citing Christianson v. Colt Indus. Operating Corp., 870
F.2d 1292, 1299 (1989).  "Taking ¶
1 and ¶ 2
together, it is not the written description requirement but the claim,
interpreted in light of the specification and the patent file-history, that
identifies the invention," amicus asserts.  Third, a claim can and will very often identify the
invention without 'describing' it," says this amicus, citing Koito Mfg. Co. v. Turn-Key-Tech,
LLC, 381 F.3d 1142,
1154 (Fed. Cir. 2004).  This
argument relates to the "legal" wording of a claim, in contrast to
the language used in a specification (which the brief contends is directed not at a lawyer
but a person of ordinary skill in the art).  This argument appears to envision a "translation"
function of the written description requirement, between the legal wording of
the claim and the technical wording of the specification.  Finally, the brief appeals to the
"inherent circularity" of the analysis, which they argue "points
to the necessity for an 'as a whole' analysis," wherein the specification
must be assessed in light of the "invention" and the claimed
invention must be assessed in view of the description in the
specification.

Adopting this
approach would not change the "content" of each individual
requirement, the brief argues, but rather would affect "only the ultimate
determination of the sufficiency of the disclosure."  Using the approach advocated by this
amicus would require establishing the "context" of the "invention"
in terms of the circularly-dependent claims and specification, and ultimately
resulting in an approach that may make up in "common sense" what it
seems to lack in analytical vigor.  Its greatest advantage may be that it is more consistent with the
Supreme Court's "totality of the circumstances" approach to patent
jurisprudence than the traditional efforts by the Federal Circuit to bring
clarity to the application of U.S. patent law.

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs for Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009