By
Donald Zuhn —

In
anticipation of the upcoming oral argument in the rehearing en banc of Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co., scheduled for December 7th, we have been reviewing a number
of the briefs submitted by various amici.  (We learned of an additional amicus brief that was filed last week, this one by William Mitchell
College of Law in support of Defendant-Appellant-Respondent Eli Lilly & Co.,
which brings the total number of amicus
briefs filed in the rehearing en banc to twenty-five, and the number filed in support
of Lilly and/or affirmance to nineteen.) 
Today, we examine the amicus brief filed by GlaxoSmithKline ("GSK") in support of Lilly.

GSK's
brief focuses primarily on the importance of the patent system to the
biotech/pharma industry, and the need by that industry for certainty that
comes from having well-settled requirements for patentability.  GSK opens the brief by noting that it invests
sizeable amounts of money in R&D — more than $6.5 billion in 2008 — and
that it protects this investment by seeking patent protection on its innovations
— filing more than 300 U.S. patent applications per year.  The pharmaceutical company explains that "[p]rotecting
and encouraging scientific investment like GSK's large research and development
effort is not possible without a long-term predictable, stable, legal system
that provides sufficient confidence to invest and sufficient time to recoup investment
and secure a reasonable return," and contends that "[r]etroactively
changing standards for patent protection, standards that for the most part have
been in place since at least the enactment of the 1952 Patent Act, introduces
uncertainty and instability, risks the invalidation of once valid
patents, and potentially nullifies investment-backed business decisions based
on then-correct interpretations of the law."

GSK
argues that changes in well-settled requirements for patentability will inject
uncertaInty and instability into long-term business decisions.  The company points to the Federal
Circuit's recent decision in In re Kubin
as illustrative of the impact resulting from a change in judicial law, stating
that "[l]ost with [the] patent application on that invention was any
chance to recover the research money and lost employee time invested in the
invention's discovery and development based on a good faith compliance with the
law in effect at the time the application was flIed."

After
providing a summary of several CCPA and Federal Circuit decisions that have
helped establish the current legal regime, including 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 Wilder, 736 F.2d 1516 (Fed. Cir. 1984); and Vas-Cath, Inc. v. Mahurkar, 935 F.2d
1555 (Fed. Cir. 1991), GSK notes that:

Since the Vas-Cath decision in June of 1991, more than 2.5 million patents
have been prosecuted and issued based on the fundamental premise that 35 U.S.C.
§ 112, first paragraph contains a written description section separate and
distinct from an enablement requirement. 
Should the Court change that well settled understanding of the law by
either removing the written description requirement from the current § 112
analysis or by changing the interpretation of the enablement requirement, some
patents that businesses thought were valid might now be considered invalid if
litigated, and patents that have been thought invalid might now be held
valid.  This particularly affects
pharmaceutical and biotech patents that seem to be more often the focus of a §
112 review.  Both outcomes can
change prior long-term investment-backed decisions with the potential result of
wasted capital and research or new-found patent infringement exposure.

Stating
that "the Supreme Court stresses that the doctrine of stare decisis is of
particular importance in patent law," GSK argues that "[w]here
corporations collectively have invested billions based on settled
interpretations of law, stare decisis counsels against departure from prior
interpretations of the law."

GSK
concludes its brief by stating that "[p]harmaceutical companies must be
able to trust that they can make long term decisions based on current law that
will remain correct over the 10-15 years needed to get a product approved and
then during its patented years," and asserting that "[f]or this reason,
the Court should protect the investment-backed expectations of patent holders
by ensuring the law remains stable and predictable, and is not
subject to dramatic changes in statutory interpretation."

For additional information regarding this topic, please see:
• "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
Donald Zuhn —

With
oral argument in the rehearing en banc
of Ariad Pharmaceuticals, Inc. v. Eli
Lilly & Co. scheduled for Monday, December 7, 2009, last
Friday marked the deadline for the filing of amicus curiae briefs.  Twenty-four
amicus briefs were submitted (by our
count), with eighteen briefs filed in support of Defendant-Appellant-Respondent
Eli Lilly & Co. and/or 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 (brief);
•
The American Intellectual Property Law Association (AIPLA) (brief);
•
Amgen Inc. (brief);
•
Professor Christopher A. Cotropia (brief);
•
The Federal Circuit Bar Association (brief);
•
GlaxoSmithKline (brief);
•
Google Inc., Verizon Communications Inc., and Cisco Systems, Inc. (see Patent Docs report);
•
Hynix Semiconductor Inc. and Samsung Electronics Co., Ltd. (brief);
•
The Intellectual Property Owners Association (IPO) (brief);
•
Oskar Liivak (brief);
•
Medtronic, Inc. (brief);
•
Microsoft Corp. (brief);
•
Monsanto Co. (brief);
•
Public Patent Foundation (PUBPAT) (brief);
•
RealNetworks, Inc. (brief);
•
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. (brief);
• United States (brief); and
•
Washington Legal Foundation (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 (brief); and
•
University of Kentucky Intellectual Property Law Society, Universal Support
Systems LLC, Polymer Construction Products Ltd., and Safeteccs LLC (brief).

The amicus brief filed by the United
States in support of Lilly begins by noting that "[a] complete and exact
description of the claimed invention is the sine
qua non of the patent system:  it
allows USPTO to examine applications, the courts to construe claims, and the
public to recognize and avoid the boundaries of the patentee's exclusive rights."  Stating that the Supreme
Court has "repeatedly recognized that the function of the written description
is not merely to enable, but also to describe the claimed invention itself and
thereby provide notice to the public of the boundaries of the patentee's rights,"
the United States asserts that "[t]o construe Section 112, ¶ 1 as a bare
enablement requirement would defy the text and history of the statute and
disregard nearly two hundred years of judicial and administrative interpretation."  Contending that the written description
requirement "is as venerable as the patent system and remains instrumental
to its operation," the United States asserts that "Petitioners identify
no basis for discarding it now."

The
United States devotes the first portion of its brief to an analysis of several
Supreme Court decisions interpreting the written description provision of the
1870 Act, including Gill v. Wells, 89
U.S. 1 (1874); Permutit Co. v. Graver
Corp., 284 U.S. 52 (1931); and Schriber-Schroth
Co. v. Cleveland Trust Co., 305 U.S. 47 (1938).  The United States then concludes that "[n]othing in the
new statute [i.e., the 1952 Act] or
its legislative history indicated that Congress intended to abrogate cases such
as Schriber-Schroth, Permutit, and Gill, or to break from
more than a century of accumulated decisions interpreting the disclosure
requirements of the patent laws."

With
respect to Ariad's argument that the grammatical structure of § 112 creates a
single description requirement whose sole measure is enablement, the United
States asserts that "it is petitioners who overread the statutory
text," adding that:

[N]othing in the statute requires
petitioners' additional inference that any
description that enables the invention will suffice.  That inference disregards two centuries of judicial and administrative
interpretation and collapses Congress's careful distinction in the statutory
text between a "written description of the invention" and a
description of the "manner and process of making and using the same"
— a dichotomy that, as noted, Congress has preserved in every iteration of the
patent laws since 1790.

The
United States points out that in Ariad's view:

[A]ny
description that enables others to make and use the invention is sufficient,
whether or not it describes "the invention" itself.  Thus, for example, if an applicant's
description of how to make and use a new chemical compound enabled others
skilled in the art to make and use five, fifty, or even five hundred thousand
additional compounds, it would be irrelevant that the applicant had neither
described those compounds nor provided any reason to believe they would
function as claimed.  The applicant
could claim them all — or, more likely, amend his claims later when it became
clear that a particular compound was commercially valuable.  . . .

Likewise, under petitioners'
construction of the statute, any scientist with a promising plan of research
need only file a patent application describing her research plan and its
expected outcome.  If the plan
produces the desired outcome, the application may have enabled others skilled
in the art to make and use the "invention."  And if the research plan fails, all that is lost is the
filing fee and the cost of preparing the patent application.  Such abusive tactics — which allow opportunistic
claimants to withdraw from the public domain entire fields of nascent scientific
endeavor while setting down a priority stake for all future work in the field
— cannot properly be attributed to the statutory design.

Noting
that "[p]etitioners argue that Section 112 requires not only a description
of how to make and use the invention, but also a description of 'what the invention is, for otherwise it
fails to inform a person of skill in the art what to make and use,'" the
United States observes that "the similarity between the enablement test
advocated by petitioners and this Court's written-description jurisprudence is
striking."  According to the
United States, "[t]hat petitioners prefer to characterize this inquiry as
a component of enablement, rather than as a distinct written-description
requirement, is irrelevant — nothing turns on the doctrinal labels."

The
United States also contends that the U.S. Patent and Trademark Office requires
a written description of the invention in order to carry out its examination
function:

Though [a biological or chemical
molecule claimed solely by reference to its function or effect] may be enabled,
USPTO is not an experimental laboratory: 
it lacks both the facilities and the statutory mandate to determine,
through empirical testing, whether any of millions of prior art inventions may
have exhibited the recited function. 
By insisting that each applicant provide a full and exact "written
description of the invention" as part of the specification, Congress
protected the ability of USPTO to perform its essential function of
distinguishing patentable inventions from the prior art.  Indeed, this is one of the original and
enduring purposes of the written description requirement:  to "distinguish the invention or
discovery from other things before known and used."

Noting
that written description principles are firmly embedded in the U.S. Patent
system, the United States asserts that:

[E]ven if Section 112 could have been
construed to require enablement only, the plain fact is that it has not
been.  The patent laws have been
understood to require more than bare enablement since the inception of the
patent system.  This Court alone,
by the government's count, has issued at least twenty precedential decisions
distinguishing between written-description and enablement.  When CCPA cases drawing the same
distinction are included, the total rises to at least thirty-five published decisions
issued over fifty years — an average of more than one precedential decision
every two years under the 1952 Patent Act.  That total, moreover, does not include the Supreme
Court and CCPA cases predating the 1952 Act.

The
United States concludes that "[i]t is rare that a federal court
contemplates upsetting statutory interpretations as settled as this, and only
the most extraordinary justification could warrant doing so."  With respect to Ariad's embrace of
Judge Markey's dissenting opinion in In
re Barker, 559 F.2d 588 (CCPA 1977), the United States argues that:

[P]etitioners' arguments were fully
aired and resolved more than thirty years ago.  In the subsequent decades, this Court has repeatedly
reaffirmed the holding in Barker, the
USPTO has examined millions of patent applications under the principles
established by this Court's precedents, and Congress has not intervened to change
the law.  Even if petitioners were
correct that Judge Markey's view should have carried the day in 1977, that
would not warrant reopening the question now.

Patent Docs
thanks David Forman of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
for kindly providing us with many of the amicus briefs.

For additional information regarding this topic, please see:
• "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 three members of the "high technology"
community named above have weighed in on the Federal Circuit's en banc review of the written
requirement and provide their own unique perspective on a debate that has raged
primarily in the biotechnology sector over the past several years (see amicus brief).  These companies are clear that they not
only believe there is a separate written description requirement, but that it
serves an important and unique purpose in preventing "overreaching"
by patentees.  And they are equally
clear that limiting or abandoning the written description requirement would
exacerbate the litigation difficulties they face that have motivated them to
promote sweeping "reform" of U.S. patent law.

These concerns arise in the amici's Statement of
Interest:

Having obtained a
number of patents based on their own extensive research and development
efforts, and having also been improperly charged with infringing others'
patented technology, amici have a strong interest in a fair and rational
patent system.  Amici have seen up close the important role that the
written description requirement plays in reducing uncertainty and distinguishing
legitimate from abusive patent applications.

Moreover:

Because the written
description requirement serves the vital purpose of reducing uncertainty posed
by ambiguous claims, its evisceration would stifle the very innovation the
patent laws are designed to encourage.  Such uncertainty creates opportunities
for speculative patent litigation that plagues high-technology companies and
diverts resources from research and development to legal budgets.  This problem
would get markedly worse if the written description requirement were
eliminated.

And reducing the requirement to enablement would
not suffice:

The purposes of the
written description requirement are not adequately served by the separate
enablement requirement, in part because enablement takes account of not only
the patent's specification, but also additional knowledge of a person skilled
in the art.  For that reason, an "invention" might be enabled by a
specification even if the patent applicant had not thought of it or intended to
claim it at the time the patent application was filed.

Perhaps wisely, the first section of the brief
essays Supreme Court precedent relating to the importance of the written
description as a requirement under U.S. patent law from the first years of the
Republic, citing Grant v. Raymond
(1832), Evans v. Eaton (1822) (the
written description must "put the public in possession of what the party
claims as his own invention") and O'Reilly
v. Morse (1853).  These cases
all stand for the same principle, they assert, that the written description is "the
cornerstone of the quid pro quo
underlying all patent rights:  a patent holder is entitled to exclusivity for a
period of years, but only for things the applicant actually invented and
disclosed to the public."  This focus on the correspondence between the scope of the claims and the
extent of the disclosure (and how the written description requirement acts to
ensure the correspondence thereof) is the principal theme of the brief.  The brief does not limit its citation
of precedent to 19th Century cases, citing Schriber Schroth Co. v. Cleveland Trust Co. (1938) for the
principle that "the patent monopoly does not extend beyond the invention
described . . . it cannot be enlarged by claims in the patent not supported by the description."  This citation supports their argument that the Court
has recognized a separate written description requirement, since in the Schriber Schroth case the patent was
invalidated because the accused infringing article "'was not the invention
which [the patentee] described' in the specification."  Morse
is cited for the same proposition, whereby amici argue that Morse's claims that
were invalidated sought to include "'a manner and process which he ha[d]
not described and indeed had not invented, and therefore could not describe
when he obtained his patent'."  Also cited is Festo Corp. v.
Shoketsu Kinzoku Kogyo Kabuchiki Co., where the Court opined that "the
patent application must describe, enable, and set forth the best mode of carrying
out the invention."  (Indeed, in view of the Federal Circuit's almost
obsequious adherence to Supreme Court precedent recently — in cases such as In re Bilski and in response to the
Court's decisions in KSR International Co. v. Teleflex Inc.
and Medimmune, Inc. v. Genentech, Inc.), this
argument may provide the majority with a rationale to let the Supreme Court
decide the question by merely upholding the status
quo.)  According to amici, this
statement "reinforces" the conclusion that the statute contains
separate enablement and written description requirements.  They also cite Festo as requiring that "[w]hat is claimed by the patent
application must be the same as what is disclosed in the specification;
otherwise the patent should not issue" (which they argue the Court found
to be a requirement separate and distinct from "the other requirements –
enablement and best mode – of §112").

Amici take the opportunity in this portion of the
brief to address — and rebut — Ariad's contention that the Supreme Court's
earlier precedent stemmed from the form of patents prior to the 1836 Act,
whereby patents did not include "peripheral" claims — i.e., that the
Court's emphasis on the description was due to inventions being described
solely by the description in the patent.  This argument does not refute the clear indication in Schriber-Schroth, Morse, and Festo, they
argue.  Nor has anything been
changed in the current form of the statute, according to amici, here refuting
the "misplaced comma" argument advanced by Ariad (that proper
sentence construction makes significant the comma following the word "invention"
in the portion of the statute that reads:  "The specification shall contain
a written description of the invention, and of the manner and process of making
and using it, . . .").  According to this portion of amici's
argument, Ariad's construction would render superfluous the phrase "and of
the manner and process of making and using it," because if the intent was
merely to require enablement, the remainder of the statutory language would
accomplish that without this phrase.  Since statutory construction eschews interpretations that make language
mere surplusage, amici argue that Ariad's interpretation must be erroneous.

The next portion of the argument regards the role
of the written description requirement in preventing patentees from claiming
what they have not invented.  This
behavior takes two forms:  first,
advocating claim construction that extends beyond what is supported by the
specification, and second pursuing claims that likewise are beyond the scope of
what the inventors have invented.  The
risk of abolishing the written description requirement would be to encourage
patentees to "disclose narrowly and claim broadly," say amici.  The consequence according to amici would
be "[a] zone of uncertainty which enterprise and experimentation may enter
only at the risk of infringement claims [that] would discourage invention only
a little less than unequivocal foreclosure of the field," citing United Carbon Co. v. Binney & Smith Co.
(1942).  This ambiguity is a real
threat, the amici assert, because claims and their interpretation do not "provide
reasonable certainty."  Citing
the Federal Circuit's Phillips v. AWH
Corp. and Exxon Research & Eng'g
Co. v. United States, they argue that even claims that are not "insolubly
ambiguous" can give rise to "difficult issue[s] of claim
construction," and that the specification is the source of public notice
of what a patent "does and does nor claim."

These amici then argue that they have had "first
hand experience with the problems stemming from overbroad and ambiguous patent
grants."  They cite academic
commentary to the effect that software patent claims are particularly difficult
to properly construe and that "[n]umerous ambiguous patent claims are asserted
against amici and other high tech companies each year."  Indeed, they state that the very
possibility that claims may be broadly construed "inflates the valuation"
of such patents (citing Lemley and Shapiro, 2005) and they cite the FTC Report
(2003) and Michael Heller's book (2008) that the need to confront "the jaw
dropping number of patents" impedes innovation (under the current interpretation of the written
description requirement).  This
situation makes difficult if not impossible the task of determining whether there is freedom to
operate, and that "technology
companies are regularly forced to defend against litigation involving patents with
ambiguous claim scopes."  Litigation, of course, is costly, and these costs "divert resources
from innovation" and represent "wasteful transaction costs."  The role of the written
description requirement in mitigating such adverse consequences in "critical,"
amici argue.  Indeed, that it
may be difficult to accurately put into words the metes and bounds of patent
claims "is a reason to require more description, not less," they
say.  And citing Schriber-Schroth, this is why the
Supreme Court has required a written description "to ensure that the
patent grant does not exceed the inventor's disclosed contribution."

In addition to the role of the written description
requirement to proscribe construction of claims that exceeds the extent of the
disclosure in the specification, amici argue that the requirement also prevents
an applicant from "abusing" amendment and continuation practice in
the Patent and Trademark Office.  Such abuse was famously the thesis of Professor Lemley and (now) Federal
Circuit Judge Moore and was the theoretical underpinning of the Office's
ill-fated and now-withdrawn claim and continuation rules that were the subject
of judicial challenge in Tafas v. Kappos.  Amici argue that the written
description requirement is the guardian against such "overreaching"
by patent applicants.  They cite
the practice of "seemingly endless continuations" made (according to
them) "in order to hold them open for future amendments."  (Like Lemley and Moore, amici fail to
recognize that such continuations are frequently necessary, especially in
complex arts like biotechnology, to obtain claims having a scope appropriate to
the applicant's written description and to which their specification entitles
them.)  They also argue that
applicants assert the right (purportedly improperly) to submit claims in such
continuation applications that encompass subject matter not disclosed in the
specification and in fact developed by their competitors.  "[T]he amendment and continuation
practice, without the discipline of the written description requirement,
engenders significant potential for abuse" they argue, citing another
Lemley and Moore paper on the subject.  This role for the written description requirement is supported by amici
with a quotation from Schriber-Schroth,
that "the patent . . . cannot be enlarged by claims in the patent not
supported by the description."

In another savvy argument, amici contend that
Congress has endorsed this aspect of the written description requirement when
establishing the priority right for provisional, divisional, and continuation
applications:  in each instance the
statute requires that a priority date will be granted only if the invention is
disclosed in the manner provided by the first paragraph of section § 112 (35
U.S.C. § 119(e)(1) and 35 U.S.C. § 120).  They further argue that these statutory provisions
refute Ariad's assertion that Congress intended the written description
requirement to be limited to "subsequent and not original claims,"
since the priority requirements in the statute do not differentiate between
claims present in the application as filed and those submitted by amendment
thereafter.

Amici then rebut Ariad's argument that other
sections of the statute — notably, the enablement provisions of § 112 — can be
sufficient to satisfy the proper limitation on claim scope.  In addition to arguing that such
an interpretation is contrary to proper statutory construction principles and
prior Supreme Court precedent, amici distinguish the roles of the enablement
and written description requirements based on the scope of the considerations
applied to determine compliance with each of them.  Written description analysis is confined to what is
contained within the four corners of the patent document, they argue, while
enablement also takes into consideration what is known to one having ordinary
skill in the art.  Once again
citing Schriber-Schroth, amici argue
that a specification may "enable" an invention "even if the
patent applicant never thought of it and never meant to claim it,"
something that is particularly likely in the "more predictable arts such
as engineering and computer programming."  They cite both Gentry
Gallery and Tronzo (the most
(in)famous non-biotech written description cases) as examples of instances
where what was enabled is greater in scope than what was disclosed.  In addition to requiring the enablement
statute to "take more weight than it can bear," amici argue that
Section 101's "overbreadth doctrine" would also be implicated in
addressing sufficiency of disclosure questions raised by elimination of the
written description requirement, citing as an example the test enunciated in Gottschalk v. Benson.  However, this test "has not always
proven easy to apply," they say, and "there would be costs to
overburdening that test."  In
short, amici argue that there is "no reason to turn to other doctrines to
take the place of the foundational written description requirement."

In the final portion of the brief, amici argue that
if there have been problems associated with application of the written
description requirement to biotechnology claims, the solution is to address
these problems by improving application of the requirement to such claims
rather than "jettisoning the longstanding requirement altogether."  They cite a dozen cases concerning "claims
of all stripes" that the Federal Circuit has held invalid since 2006 in
support of their argument that the written description requirement has not been
confined merely to biotechnology claims:  In
re Reiffin, 199 F. App'x. 965,
2006 WL 2860589 (Fed. Cir. 2006) (multithreading computer application); Adang v. Umbeck, No. 2007-1120, 2007 WL 3120323 (Fed. Cir. Oct. 25, 2007)
(transformed cotton plantlet); Zenon Envtl.,
Inc. v. U.S. Filter Corp., 506 F.3d 1370
(Fed. Cir. 2007) (ball bearings); Ziarno
v. Am. Nat'l. Red Cross, 55 F. App'x.
553, 2003 WL 57060 (Fed. Cir. 2003) (internet-based fundraising system); McMullin v. Carroll, 153 F. App'x. 738, 2005 WL 2840281 (Fed. Cir. 2005) (golf shoe
cleat); LizardTech, Inc. v.
Earth Res. Mapping, Inc., 424 F.3d 1336
(Fed. Cir. 2005) (method for eliminating edge artifacts); Energizer Holdings, Inc. v. ITC, 275 F. App'x. 969, 2008 WL 1791980 (Fed. Cir.
2008) (mercury free alkaline batteries); In
re Curtis, 354 F.3d 1347 (Fed.
Cir. 2004) (dental floss); McKechnie
Vehicle Components USA, Inc. v. Lacks Indus., Inc., 122 F. App'x. 482, 2005 WL 121840 (Fed. Cir.
2005) (automobile wheel covering); PIN/NIP,
Inc. v. Platte Chem. Co., 304 F.3d
1235, 1248 (Fed. Cir. 2002) (tuber sprout growth inhibitor); Williams v. Gen. Surgical Innovations, Inc., 60 F. App'x. 284, 2003 WL 932449 (Fed. Cir.
2003) (removal of tissue expander during
surgery).

Interestingly, amici note that Ariad does not cite
a single biotechnology case that had
been decided incorrectly based on an application of the written description
requirement except its own.  Ariad
argues that the claims in earlier biotechnology cases may have been invalid on
enablement grounds, something Judge Linn (in concurring on the panel majority's
opinion) opined may also be the case for Ariad's claims.  In this regard they make an
important point:  the written
description requirement is a question of fact, and fact-based inquiries "will
necessarily vary depending on the nature of the invention claimed," citing
Enzo Biochem Inc. v. Gen Probe Inc.  "Even if Ariad were correct that this Court's
written description jurisprudence had been too rigid for some biotechnology
inventions, the solution would be to apply the requirement more contextually,
on a case-by-case basis, to such inventions — not to eviscerate completely this longstanding
and foundational requirement for all inventions."

In a brief colored
heavily by their own industry's particular concerns, these amici raise for the Federal Circuit's analysis several important considerations that apply (perhaps to
varying degrees) to all technologies.

For additional information regarding this topic, please see:
• "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 —

Christopher M. Holman, Associate Professor of Law
at the University of Missouri-Kansas City (and proprietor of Holman's Biotech
IP Blog), has filed an amicus brief in support of
neither party in Ariad Pharmaceuticals, Inc. v. Eli Lilly
& Co.  While not arguing on
behalf of either party, Ariad would benefit if the Federal Circuit adopts Professor
Holman's position:  he not only
advocates that there is no separate written description requirement in 35
U.S.C. § 112, first paragraph, but asserts that the requirement is
differentially (and improperly) applied to biotechnology inventions.

The brief begins by arguing that the Federal Circuit "established
a novel interpretation of the written description requirement" in Regents of the University of California v.
Eli Lilly & Co.  His
argument is not only that this requirement was new (and unnecessary), but that
the Court has applied it in a manner "that is essentially redundant to the
enablement requirement" and that acts as a super-enablement requirement
for biotechnology claims reciting protein and DNA subject matter.  Citing Enzo Biochem, Inc. v. GenProbe Inc., he argues that the Court has applied the
requirement in an arbitrary and inconsistent manner that lacks any basis in
science and can, in some instances, preclude adequate patent protection for
biotechnology inventions.  The
enablement requirement, grounded in the "objective" considerations
exemplified by the factors enunciated in In
re Wands, is the proper method for assessing whether the specification
describes the invention sufficiently, according to Professor Holman.

His argument falters somewhat when he discusses the
requirement that at least one species must be disclosed to support a claim, as
opposed to the necessity under the written description requirement for "something
more" as interpreted under the Lilly
precedent.  The problem with this
argument is that while priority of invention requires merely that the
specification teaches how to make and use "at least one" species
falling within the scope of the claim (Hahn
v. Wong, 892 F.2 1028
(Fed. Cir. 1989)), enablement requires a claim to be supported by a specification
that enables the skilled person in the art to make and use the claimed
invention throughout its scope (M.P.E.P. § 2164.08; In re Wright, 999 F.2d 1557 (Fed. Cir. 1993)).  He illustrates what he considers to be
a major inconsistency in the Court's written description jurisprudence by
contrasting the Court's decisions in Noelle
v. Lederman (for proteins) and Falkner
v. Inglis (for DNA species) with the strict interpretation of the Lilly decision.  In Noelle, the Court upheld the validity of claims
to antibodies where the specification describes only their cognate antigens, while in Falkner, the Court upheld the validity of
claims directed to virus species having non-specific deletion mutations
resulting in an observable phenotype.  These cases are inconsistent with Lilly,
according to Professor Holman, in that Lilly
requires "super-enablement" disclosure of human insulin while Noelle and Falkner permit patenting of undisclosed proteins (antibodies in Noelle) or DNAs (viruses in Falkner).

This argument misses the reasoning behind the
seeming inconsistency.  In
both Noelle and Falkner, the patentees were claiming species that could be reliably
produced by one having skill in the art, wherein the impediment to producing
the invention was overcome by the patentees.  (For example, in Noelle, the Court required there to be a novel antigen disclosed in the specification in
order for generic antibody claims to be patentable.)  In Lilly, on the
other hand, the patentees were claiming a species — human insulin DNA — that they
neither possessed, conceived, nor described.  In Lilly,
permitting the patentee to bootstrap its cloning of the rat insulin gene to
support a claim for human insulin would violate several long-standing
principles, priority of invention being but one of them.

Professor Holman also cites the Enzo debacle, and makes an interesting
argument.  He posits that Enzo I was a literal reading of the Lilly precedent, and as a consequence,
reversal of the initial panel decision in Enzo
II was a repudiation of the "super-enablement" written
description requirement enunciated in Lilly.  Another way of viewing the situation is
that Enzo I was an
over-interpretation of the Lilly
precedent, ignoring the portion of that decision that said (emphasis added):

Thus, as we have previously held, a cDNA is not
defined or described by the mere name "cDNA," even if accompanied by
the name of the protein that it encodes, but requires a kind of specificity
usually achieved by means of the recitation of the sequence of nucleotides that
make up the DNA . . . .  A description of a genus of cDNAs may be achieved by
means of a recitation of a representative number of cDNAs, defined by
nucleotide sequence, falling within the scope of the genus or of a recitation
of structural features common to the members of the genus, which features
constitute a substantial portion of the genus . . . .  This is analogous to
enablement of a genus under § 112, P 1, by showing the enablement of a
representative number of species within the genus.  We will not speculate
in what other ways a broad genus of genetic material may be properly described,
but it is clear to us, as it was to the district court, that the claimed genera
of vertebrate and mammal cDNA are not described by the general language of the '525
patent's written description supported only by the specific nucleotide
sequence of rat insulin.

Considering this language, the decision in Enzo I was in error not for applying the
Lilly test properly, but for
disregarding the fact that a deposit satisfies both the written description and the enablement requirements because
it places the public in possession of the claimed embodiment directly.

Another case Professor Holman cites as evidence of
the error of the Lilly decision is In re Wallach, where the applicant had
disclosed an enabling method for producing protein embodiments of the claimed
invention (which the Court found to be patentable) but did not disclose the
nucleic acid encoding the protein (claims to which were unpatentable for
failure to satisfy the written description requirement).  According to Professor Holman, the Court's
decision in In re Kubin points out
the error in the Wallach
decision.  In Kubin, the Court held that claims to a DNA encoding a known protein
were obvious, in view of the routine nature of cloning methods in the art and
the existence of both the known protein and a probe (a monoclonal antibody)
specific for the protein.  The Court held that the Supreme Court in KSR International Co. v. Teleflex Inc. had repudiated the Federal Circuit's earlier
jurisprudence on the question of the obviousness of a nucleic acid encoding a
known protein as set forth in In re Deuel.  That jurisprudence was based on
traditional rubrics of chemical obviousness, wherein invalidating prior art
disclosed a compound having a structure sufficiently related to the claimed
structure to render the latter obvious.  Spurred on by its interpretation of KSR,
the Kubin panel instead determined
that the claimed nucleic acid was obvious substantially because it satisfied
the enablement standard — that it could be obtained from the prior art without
undue experimentation.

The connection between the chemical obviousness
cases and written description is made by Professor Holman by way of a quotation from Lilly, citing In re Deuel and In re Bell to
the effect that if a chemical structure must be disclosed in the prior art to
render a nucleic acid obvious, "a
fortiori, a description that does not render a claimed invention obvious
does not sufficiently describe that invention for purposes of §112, ¶1."  For Professor Holman, the intervening Kubin decision destroys this rationale,
since for the Kubin court, a prior art
description no longer requires disclosure of a chemical structure to render a
nucleic acid claim obvious.  This
argument fails to consider two relevant facts, however.  First, even the Patent Office conceded
that the factual underpinnings in Kubin
were vastly different from the facts in Deuel,
and that the obviousness of the Kubin claims was directly related to those
differences (including the existence of a specific antibody probe, advances in
the level of skill in the art, and a non-prior art example of cloning the mouse
homolog using a combination of the antibody probe and routine methods in the
art).  Second, the written
description and obviousness prohibitions are not competitive but
complementary:  the concept of
obviousness precludes patenting for an invention that does not sufficiently "promote
the progress" of the relevant art, while the written description
requirement, as applied under the Lilly
precedent, does not permit a patentee to claim what the patentee has not actually
obtained.  The fact that it could have been obtained is deemed
insufficient.

The brief castigates the Federal Circuit for
inconsistencies in applying the written description requirement, and as a
consequence asserts that this has prevented the Patent Office from arriving at
proper standards for assessing the patentability of biotechnology claims.  Professor Holman discusses the Written
Description Training Materials promulgated in March 2008 in this regard and
contrasts the treatment of nucleic acid claims in Wallach with antibody claims (under the Noelle case precedent; Example 13), with regard to the "billions"
of variants in the (appropriately-named) variable region and the laxity with
which the Office applies the written description requirement (essentially
providing no barrier to patentability despite the complete absence of a
description of any actually-produced antibody).  Correctly, he characterizes this treatment as being
inconsistent and rejects the policy reasons for these differences as discussed
above and enunciated by the Office.  He argues that the existence of variable regions in antibodies provides
just as much uncertainty as the sequence of an unknown nucleic acid, and
permitting antibodies to be patented with little or no disclosure of structure
provides the basis for the inconsistency.  This basis, of course, is (ironically) rooted in the enablement
requirement, because antibodies inherently select just those (generally
unknown) sequences that specifically bind their cognate antigen by the way they
are produced.  This specificity is
not inherently a part of cloning methods used to produce nucleic acids, thus
raising the heightened description requirement for such claims.

The Carnegie-Mellon University
v. Hoffman-LaRoche Inc. case is also discussed in the brief with regard to how
the written description requirement is inconsistently applied.  In this portion of the brief, Professor Holman makes an
interesting argument that turns on their heads traditional rationales against
broad variant nucleic acid claims.  He asserts, based on several scientific treatises, that it is "generally
possible to substantially alter a protein's structure without necessarily
destroying its function.  For
example, in some cases 50% or more of the amino acids in a protein can be
altered while still maintaining function."  He then acknowledges the more conventional bases for
requiring actual written descriptions of such functional variants, because "a
single amino acid change can sometimes result in loss of function," citing
his own scientific work.  He also
correctly identifies the latter situation as the basis for requiring a priori "some level [of]
disclosure of the structure-function relationship" that would permit the
skilled worker to appreciate "which variants" will retain function.  This he properly characterizes as an "impossible"
standard.  Given the very large
number of variants for even a small (300 amino acid) protein (10²²⁶),
this results in claims that cannot properly protect their inventions, since it
is relatively easy for an infringer to produce a (presumably non-infringing)
functional amino acid sequence variant.

To illustrate, he contrasts the court's decisions
in Capon v. Esshar (regarding
recombinant antibodies) and Carnegie-Mellon
(regarding DNA polymerase I enzymes).  In Capon, the Court held that
a description of "well-known" sequences encoding alternative
antigen-binding portions of proteins expressed at the surface of an immune
system cell that triggers proliferation thereof was not necessary to satisfy
the written description requirement.  In contrast, the Court in Carnegie-Mellon
invalidated claims to recombinant constructs for producing bacterial DNA
polymerases because the specification disclosed only the polymerase from E. coli, and only two other bacterial DNA
polymerases were known in the art at the time the invention was made.  For Professor Holman, the
existence of "thousands" of mouse antibody-derived antigen-binding
species in the art has but "superficial appeal" as a rationale, in
view of the great amino acid sequence variability in antibodies, and the
structural similarity of bacterial polymerases.  He maintains that polymerases being enzymes all have substantially the same
function, and makes the reasonable presumption that this function is dictated by
structure (conferred by the protein's amino acid sequence) and thus "there
is a relatively strict correlation between structure and function in the class
of bacterial DNA polymerase I proteins."  This he contrasts with the recognized hypervariability of
antigen-binding portions of antibodies as further examples of the inconsistent
application of the written description requirement.

Professor Holman returns to the PTO Training
Materials with regard to Examples 11A and 11B, which he evocatively characterizes
as "junk science."  Specifically, he raises the apparent paradox between what the Office
considers unpatentable (Example 11A) and patentable (Example 11B) claims to
amino acid sequence variants, based on disclosure of structure-function
relationships of the variants in the supporting specification.  The claims in both examples recite a
nucleic acid encoding an amino acid sequence 85% identical to the disclosed
sequence.  The difference in the
patentability of the claims is that the specification supporting the claim in
Example 11A provides no evidence of any structure-function relationship, while
the specification supporting the claim in Example 11B discloses a deletion
variant that identifies two domains "critical" for the protein's
function.  The "Catch-22"
nature of these examples has been discussed on Patent Docs previously (see "An Analysis of the New Written Description Training Materials – DNA Hybridization & Percent Identity" and "Docs at BIO: 'Gotcha' Games Continue at USPTO"); here,
Professor Holman asserts that "[t]he PTO's analysis fails to recognize the
complex and unpredictable relationship between protein structure and function,
and thus fails to comport with scientific reality."  (Of course, the irony is that these
examples are an attempt, however flawed, to do just what Professor Holman
contends that they do not do.)  The
basis for Professor Holman's contention is that the general tendency of non-conservative
substitutions to be more likely than not to result in loss-of-function is "anything
but hard and fast rules," because while the scientific literature is
replete with examples consistent with Patent Office assumptions, it is also the
case that there are several examples to the contrary, e.g., where mutations at one site can correct or compensate for
mutations at another, spatially-distinct site, or where a conservative
substitution results in a greater loss of function than a non-conservative one (citing
several scientific references including one of his own).  "The bottom line," according
to Professor Holman, is that the deletion studies in Example 11B of the
Training Materials are "but the slightest tip of the iceberg, and [do] not
identify regions of the protein that could or could not be altered without a
loss of function."  Finally,
he correctly notes that the "patentable" claim of Example 11B is not
limited to conservative substitutions or mutations outside the identified
functional domains, and thus are likely to include non-described, inoperative
embodiments.

In the penultimate portion of the brief, Professor
Holman discusses the history of the development of the written description
requirement, from the "simultaneous conception and reduction to practice"
concept announced by the court in Amgen Inc.
v. Chugai Pharmaceutical Co., to the decision in Fiers
v. Revel that a nucleic acid claim must be supported by an actual
description of the claimed nucleic acid in order to show possession, and
finally to the Lilly decision.  (He also mentions In re Smythe, but dismisses it as being "not even a chemical
case.")  He asserts that the Court has "never articulated a rational justification" for the
written description requirement as it has been applied to "some"
nucleic acid and protein inventions.  In conjunction with the argument (discussed above) that the Court's Kubin decision rebuts the legal basis
for the Lilly decision, he also
attacks the basic premise of that decision:  according to Professor Holman, a claim to a "gene that
controls blood sugar" would be a functional definition, while a claim to "human
insulin" is not, since the latter "describes" a "specific
gene that was known to exist at the time of the patent application."  While this is true, the argument
appears to miss the point that while the gene existed, the patentee did not
know or disclose its structure.

Finally, Professor Holman argues that the
enablement requirement is sufficient to ensure "adequate disclosure across
all technologies."  He
notes instances where the enablement requirement has been used to "police"
the scope of biotechnology claims, and asserts that the "well-developed"
body of enablement case law is more suited to the task than the Court's written
description jurisprudence.  (He
doesn't mention that, as a question of law, such consistency should be more
likely than for questions of fact, such as whether the written description
requirement is met.)  He consigns
the outcomes of "the Amgen–Fiers–Lilly trilogy" to being appropriate under the "unpredictability
of cloning technology at the time," but says this is no longer warranted
in view of the technology having become "conventional and relatively
predictable," citing Kubin and
argues:

Just as in Kubin
this Court chose to discard the strict requirement of structural disclosure in
the obviousness determination arguably required by Bell and Deuel, it should
do away with LWD [Lilly written description] and its irrational focus on
structure, and employ the more adaptable and appropriate enablement requirement
to assess adequate disclosure of biotechnological and other inventions.

Professor Holman cites almost as many law reviews
and opinions of other legal scholars as he does Federal Circuit and CCPA
precedent in support of his arguments.  Noticeably missing from the citation list, however, are the cases cited
in Lilly to support its formulation
of the written description requirement, including In re Wilder, 736 F.2d 1516 (Fed. Cir. 1984); In re Robins, 429 F.2d 452 (CCPA 1970); In re Grimme, 274 F.2d 949 (CCPA 1960); In re Angstadt, 537 F.2d 498 (CCPA 1976) and In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989).  This deficiency may compromise the
persuasiveness of Professor Holman's otherwise thought-provoking brief.

For additional information regarding this topic, please see:
• "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
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.