By Kevin E. Noonan —

The Intellectual Property Owners Association
(IPO) has filed an amicus brief in the rehearing en banc of Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co., supporting
neither party but arguing in favor of a separate written description
requirement as part of 35 U.S.C. § 112, first paragraph.  The IPO's brief is significant, if only
because the organization represents inventors across the spectrum of American
industry (from sole inventors to Fortune 100 companies) and thus may represent
a consensus of the views of its disparate membership.

IPO's précis of its argument is simple.  A separate written description
requirement exists according to traditional and settled judicial interpretations
of the statute.  The requirement
serves two related purposes:  it
requires a patentee to show that she had possession of the claimed invention on
its filing date and it serves a public notice function of what the inventor
believes is her invention.  In these
respects the written description requirement comprises part of the quid pro quo
of the patent right, so that a patentee's disclosure is sufficiently certain to
entitle the patent grant.  Merely
providing an enabling disclosure is not enough, IPO's brief argues, since there
could be situations where the specification enables a broader scope than the
inventor described, and thus the ensuing scope of protection would be "unfairly
broad."

But IPO does not advocate that claims should be
limited to the disclosed embodiments or "that unclaimed details of such
embodiments should necessarily be used to limit claim scope."  IPO further argues that it would be
inappropriate to craft a "bright line rule" of what constitutes an
adequate written description.  This
determination should be performed on a case-by-case basis, will depend on the
technology and the state of development of that technology.  The brief recognizes that this
increased the potential for uncertainty, but an inflexible rule "would
either be too stringent for incremental improvements in well-developed
technologies or too lenient for ground-breaking discoveries in undeveloped
technologies."

IPO's argument for the existence of a separate
written description requirement relies heavily on Supreme Court precedent as
well as case law from the CCPA and Federal Circuit, and of course comparisons
of the statutory language in its various incarnations (the 1790, 1836, 1870, and
1952 Acts).  The brief cites
pre-1952 Act cases including Evans v.
Eaton, O'Reilly v. Morse, and In re Moore.  Turning to the
1952 Act, the brief cites In re Ruschig
for the proposition that the statute requires "blaze marks" setting
forth the metes and bounds of what the patentee believes to be her
invention.  This case also
exemplifies the distinction between written description and enablement,
wherein enablement was said to be "beside
the point for the question is not whether he would be so enabled but whether
the specification discloses the compound to him, specifically, as something
appellants actually invented."  The brief is also quick to mention (in a footnote) that it would be a
misinterpretation of the judicial record to think that Ruschig was somehow the genesis of the concept of the distinctly
different enablement and written description requirements, citing In re Lund and In re Cavallito as additional, earlier judicial expressions of the
same principle.  Citing more recent cases from both the Supreme Court and the Federal Circuit, the
brief then advocates for stare decisis:

This Court should not disrupt over 200
years ofprecedent beginning with the Patent Act of
1790 and continuing until today.  Accordingly, this Court should hold that
Section 112 does set forth a written description requirement separate from the
enablement requirement.

Turning to the concept
of the quid pro quo, the brief once
again cites Supreme Court precedent, specifically Bonito Boats, Inc. v. Thunder Craft Boats, Inc. (the first instance of Supreme Court
review of the Federal Circuit) for the proposition that "[t]he federal patent
system . . . embodies a carefully crafted bargain for encouraging the creation
and disclosure of new, useful, and nonobvious advances in technology and design
in return for the exclusive right to practice the invention for a period of
years."  The brief then ties
this proscription in favor of disclosure as the basis for the exclusive patent
grant to the written description requirement, citing University of Rochester v. G.D. Searle that "'[t]he written description requirement serves as
a teaching function, as a 'quid pro quo' in which the public is given
meaningful disclosure in this carefully crafted bargain."

This requirement can be further broken
down into two features:  that the inventor had possession of the claimed subject matter on the
filing date, and that the public is fairly put on notice by the disclosure in the
patent specification as to what the inventor thinks her invention
encompasses.  For the first point,
the brief argues that an inventor is entitled to the exclusionary right "on
only that subject matter that he has actually invented" (emphasis in original), supported by
citation to abundant recent Federal Circuit precedent (of dubious applicability
in view of the en banc Court's
interest in deciding whether these cases have been properly decided in the
first place).  As to the
public notice function, the brief turns to more fruitful Supreme Court precedent,
specifically Evans v. Eaton and, of
course, Judge Rich's decision in Ruschig.  The brief brings the discussion somewhat into the modern era
by arguing that the public notice function of the specification "begins"
upon publication of the application, and "provides a reasonable guide to
the likely scope of claimed that will ultimately issue."  The brief argues that since the claims
in the published application are frequently broader than the claims that
ultimately issue, focusing on the scope of the written description helps
prevent innovation from being "stifled" out of fear of overbroad
published claims.

The enablement
requirement is insufficient to police the boundary between the scope of the
claims and the extent of the disclosure, according to amicus, because
situations can arise where enablement may be satisfied even though the
specification provides "no evidence that the inventor was in possession of
the invention" throughout the scope of the granted claims.  The brief cites In re DiLeone for this proposition, specifically a "hypothetical
example" recited in the case to illustrate the different purviews of the
written description and enablement requirements:

For greater clarity on this point,
consider the case where the specification
discusses only compound A and contains no broadening language of any
kind.  This might very well enable one skilled in the art to make and
use compounds B and C; yet the class consisting of A, B, and C has not
been described.

The brief also
cites In re Ahlbrecht, where the
issue involved entitlement to a priority claim (the traditional ambit of
applications of the written description requirement).  (In Ahlbrecht, the
range of methylene groups claimed (2 to 12) was broader than the range of
methylene groups disclosed (3 to 12), and thus the written description
requirement was not satisfied.)

The brief then
argues that it would be a mistake for the en banc Court to attempt to construct
a "bright line rule" for the extent of disclosure that satisfies the
written description requirement, perhaps being leery of the Court's ancient and
recent propensity along those lines (and particularly its perverse
perserverence in the practice, as illustrated by the en banc decision in In re
Bilski in the face of a decade of Supreme Court opinions to the effect that
the Court does not condone bright line rules in this (or perhaps any)
area).  The brief reminds the Federal Circuit
of the Supreme Court's displeasure with this practice, citing KSR International Co. v. Teleflex Inc., albeit only after
arguing that the better reason for avoiding a bright line rule for the written description requirement is
the impracticability of such a rule.  Instead, amicus argues, "[t]he sufficiency of written description
should therefore be evaluated under a flexible standard on a case-by-case
basis, with an understanding that what is sufficient to satisfy the written
description requirement will vary according to the art to which the invention
pertains and as the knowledge of those skilled in the art develops."  The brief is also careful that the en banc Court does not read this
argument as advocating that claims be limited to those embodiments actually
carried out (perhaps being mindful of the restrictive decision on enablement
rendered by a panel of the Court in the In
re '318 Patent Litigation case).  The brief even goes so far as to set forth what it
characterizes as "[s]everal well-established tenets" for "delineating
the boundaries of the written description requirement."  These include:

1.  Examples:  "[E]xamples
[explicitly covering the full scope of the claim language] are not necessary to
support the adequacy of a written description."  Falko-Gunter Falkner v. Inglis,
448 F.3d 1357, 1366 (Fed. Cir.
2006); see also
LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005).

2.  Actual Reduction to Practice:  "[A]n
actual reduction to practice is not required for written description."  Falkner, 448 F.3d at 1366; see
also University of Rochester, 358
F.3d at 922, n.5 (although "[c]onstructive reduction to practice" is
sufficient so long as the application "describe[s] the claimed subject
matter in terms that establish that [the applicant] was in possession of the . . . claimed invention, including all of the elements and limitations.") (alteration in original) (citation omitted).

3.  Literal
Support for the Claimed Invention:  The disclosure need not match the claim word
for word to satisfy the written description requirement.  See Purdue Pharma
L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) ("the
disclosure as originally filed does not have to provide in haec verba support
for the claimed subject matter at issue."); see also Martin v. Johnson,
454 F.2d 746, (C.C.P.A. 1972) (noting that "the description need not
be in ipsis verbis to be sufficient").

4.  Identical
Type or Depth of Disclosure for Each Invention:  The written description
requirement does not require "that every invention must be described in
the same way.  As each field evolves, the balance also evolves between what is
known and what is added by each inventive contribution."  Capon, 418
F.3d at 1357-58.

5.  Express
Disclosure of Each and Every Species in a Genus:  "Mention of representative
compounds encompassed by generic claims language clearly is not required by §112
or any other provision of the statute.  But, where no explicit description of a
generic invention is to be found in the specification, "mention of representative
compounds may provide implicit description upon which to base generic claim language."  In re Robins, 429 F.2d 452, 456-57 (C.C.P.A. 1970).

Finally, IPO argues
that, however the en banc Court
rules, claims should not be limited to their specifically-disclosed
embodiments.  "The separate written description requirement also should
not undermine the courts' reluctance to narrow claim scope by importing
limitations appearing in the specifications," amicus argues in its brief, under that
well-established principle of claim construction.

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