## United States Court of Appeals for the Federal Circuit

03-1304

UNIVERSITY OF ROCHESTER,

> Plaintiff-Appellant,

v\.

G.D. SEARLE & CO., INC.,

MONSANTO COMPANY, PHARMACIA CORPORATION,

and PFIZER INC.,

> Defendants-Appellees.

[Gerald P. Dodson]{.underline}, Morrison & Foerster, LLP, of Palo Alto,
California, filed a petition for rehearing en banc for
plaintiff-appellant. With him on the petition were [Emily A.
Evans]{.underline}, [Erica D. Wilson]{.underline} and [Erik J.
Olson]{.underline}.

[Gerald Sobel]{.underline}, Kaye Scholer LLP, of New York, New York,
filed an opposition to the petition for defendants-appellees. With him
on the opposition were [Richard G. Greco]{.underline}, [Sylvia M.
Becker]{.underline} and [Daniel L. Reisner]{.underline}. Of counsel on
the opposition was [Robert L. Baechtold]{.underline}, Fitzpatrick,
Cella, Harper & Scinto, of New York, New York.

[Daniel J. Furniss]{.underline}, Townsend and Townsend and Crew LLP, of
Palo Alto, California, filed an amici curiae brief for The Regents of
the University of California, et al. With him on the brief were [Susan
M. Spaeth]{.underline} and [Madison C. Jellins]{.underline}.

Appealed from: United States District Court for the Western District of
New York

Judge David G. Larimer

**United States Court of Appeals for the Federal Circuit**

03-1304

UNIVERSITY OF ROCHESTER,

> Plaintiff-Appellant,

v\.

G.D. SEARLE & CO., INC.,

MONSANTO COMPANY, PHARMACIA CORPORATION,

and PFIZER INC.,

> Defendants-Appellees.

ON PETITION FOR REHEARING EN BANC

[O R D E R]{.underline}

A petition for rehearing en banc was filed by the Appellant, and a
response thereto was invited by the court and filed by the
Appellees[^1].

This matter was referred first as a petition for rehearing to the merits
panel that heard this appeal. Thereafter, the petition for rehearing en
banc, response, and the amici curiae brief were referred to the circuit
judges who are authorized to request a poll whether to rehear the appeal
en banc. A poll was requested, taken, and failed.

Upon consideration thereof,

IT IS ORDERED THAT:

(1) The petition for rehearing is denied.

(2) The petition for rehearing en banc is denied.

> NEWMAN, [Circuit Judge]{.underline}, dissents in a separate opinion.
>
> LOURIE, [Circuit Judge]{.underline}, concurs in a separate opinion.
>
> RADER, [Circuit Judge]{.underline}, with whom GAJARSA and LINN,
> [Circuit Judges]{.underline}, join, dissents in a separate opinion.
>
> LINN, [Circuit Judge]{.underline}, with whom RADER and GAJARSA,
> [Circuit Judges]{.underline}, join, dissents in a separate opinion.
>
> DYK, [Circuit Judge]{.underline}, concurs in a separate opinion.
>
> The mandate of the court will issue on July 9, 2004.

FOR THE COURT

July 2, 2004 Jan Horbaly

\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date Jan Horbaly

Clerk

cc: Gerald P. Dodson, Esq.

Robert L. Baechtold, Esq.

Gerald Sobel, Esq.

Daniel J. Furniss, Esq.

James J. Kelley, Esq.

# **United States Court of Appeals for the Federal Circuit**

03-1304

UNIVERSITY OF ROCHESTER,

Plaintiff-Appellant,

v\.

G.D. SEARLE & CO., INC., MONSANTO COMPANY,

and PHARMACIA CORPORATION,

Defendants-Appellees,

and

PFIZER INC.,

Defendant-Appellee.

NEWMAN, [Circuit Judge]{.underline}, dissenting from the denial of
rehearing en banc.

I respectfully dissent from the court\'s decision not to resolve en banc
the burgeoning conflict in pronouncements of this court concerning the
written description and enablement requirements of the Patent Act. This
question has been promoted from simple semantics into a fundamental
conflict concerning patent scope and the support needed to claim
biological products. The appropriate forum is now the en banc tribunal,
not continuing debate in panel opinions applying divergent law.

I fully share Judge Lourie\'s understanding of the law. The continuing
attack on well-established and heretofore unchallenged decisions such as
[Vas-Cath Inc. v.]{.underline}

[Mahurkar]{.underline}, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (\"we
hereby reaffirm, that 35 U.S.C. §112, first paragraph, requires a
\'written description of the invention\' which is separate and distinct
from the enablement requirement\") and earlier cases such as [In re
Ruschig]{.underline}, 379 F.2d 990 (CCPA 1967) (written description is
one of three distinct requirements under 35 U.S.C. §112) is not only
unwarranted, but is disruptive of the stability with which this court is
charged. If precedent has become obsolete or inapplicable, we should
resolve the matter as a court and again speak with one voice.

The new biology has indeed raised new and important questions, with
implications for policy as well as law. However, the answer is not the
simplistic one espoused by some commentators; it is simply incorrect to
say that there is not now and never has been a \"written description\"
requirement in the patent law. It has always been necessary to disclose
and describe what is patented. It has never been the law that one can
claim what is not made known and set forth in the patent.

Various past decisions have been offered to support the exotic
proposition that it is not necessary for the inventor to describe the
patented invention, but that enablement alone suffices under the
statute. These cases concern traditional issues of generic disclosures
and specific examples, and questions of support and predictability for
scientific concepts and their embodiments. Such traditional law was
applied in [Regents of the University of California v. Eli Lilly &
Co.]{.underline}, 119 F.3d 1559 (Fed. Cir. 1997), a case that is
misdescribed in this debate, for [Lilly]{.underline} does not depart
from precedent in its holding that the written description requirement
can be fulfilled by \"a precise definition, such as by structure,
formula, chemical name, or physical properties.\" [Id.]{.underline} at
1565, quoting [Fiers v. Revel]{.underline}, 984 F.2d 1164, 1171 (Fed.
Cir. 1993).

If the nature of the subject matter is not amenable to precise
description, some alternative mode of disclosure is required, such as
deposit in a public depository. [Enzo Biochem, Inc. v. Gen-Probe,
Inc.]{.underline}, 323 F.3d 956 (Fed. Cir. 2002). However, the public
purpose of patents is seriously disserved by eliminating the description
requirement entirely. Federal Circuit law of written description has
become encumbered with inconsistent pronouncements, leading me to remark
that \"\[c\]laims to an invention that is not described in the
specification are an anachronism.\" [Housey Pharms., Inc. v. Astrazeneca
UK Ltd.]{.underline}, 366 F.3d 1348, 1357 (Fed. Cir. 2004) (Newman, J.,
dissenting). If the majority of this court is nonetheless sympathetic to
that position, there should be careful consideration of the implications
of precedent, for the law is that \"Section 112 requires that the
application describe, enable, and set forth the best mode of carrying
out the invention.\" [Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
Co.]{.underline}, 535 U.S. 722, 724 (2002).

The issue of whether patent law contains a separate written description
requirement has percolated through various panels of this court, on a
variety of facts. The differences of opinion among the judges of the
Federal Circuit, are, in microcosm, the \"percolation\" that scholars
feared would be lost by a national court at the circuit level.
Percolation is the great justifier of conflict among the regional
circuits. In the words of the Supreme Court:

> We have in many instances recognized that when frontier legal problems
> are presented, periods of \"percolation\" in, and diverse opinions
> from, state and federal appellate courts may yield a better informed
> and more enduring final pronouncement by this Court.

[Arizona v. Evans]{.underline}, 514 U.S. 1, 24 n.1 (1995). This question
has percolated enough; it is ripe for en banc resolution.

#### United States Court of Appeals for the Federal Circuit

03-1304

UNIVERSITY OF ROCHESTER,

Plaintiff-Appellant,

v\.

G.D. SEARLE & CO., INC.,

MONSANTO COMPANY, PHARMACIA CORPORATION,

and PFIZER INC.,

Defendants-Appellees.

LOURIE, [Circuit Judge]{.underline}, concurring.

I concur in the decision of the court not to rehear this case
[en]{.underline} [banc]{.underline}, just as previously the court also
declined to hear a written description case [en]{.underline}
[banc]{.underline}. [See]{.underline} [Enzo Biochem, Inc. v. Gen-Probe,
Inc.]{.underline}, 323 F.3d 956, 970-75 (Fed. Cir. 2002). That is
because this case was properly decided based on one of the grounds
relied on by the district court in invalidating the Rochester patent,
[see]{.underline} [Univ. of Rochester v. G.D. Searle & Co.]{.underline},
358 F.3d 916 (Fed. Cir. 2004), the analysis of which will not be
repeated here.

Contrary to the assertions of the appellant, certain amici, and some of
the dissenters, there is and always has been a separate written
description requirement in the patent law. The requirement to describe
one's invention is basic to the patent law, and every patent draftsman
knows that he or she must describe a client's invention independently of
the need to enable one skilled in the relevant art to make and use the
invention. The specification then must also describe how to make and use
the invention ([i.e.]{.underline}, enable it), but that is a different
task.

The requirements of the statute cannot be swept away by claiming that it
relates only to priority issues or that the prohibition on introduction
of new matter takes care of the need for a written description. The
statute does not contain a limitation that it pertains only to priority
issues. Moreover, the prohibition on introduction of new matter (35
U.S.C. § 132) is not a substitute for the written description
requirement. Section 282 of the Patent Act lists as a defense to an
infringement action invalidity arising from a failure to comply with a
requirement of section 112 of the Act, which includes written
description. In contrast, the new matter provision, section 132, appears
in a provision entitled \"Notice of rejection; reexamination.\" Failure
to comply with that section is not expressly listed in the statute as an
invalidity defense to infringement, although we have held that the
unsupported claims are invalid. [See, e.g.]{.underline}, [Quantum Corp.
v. Rodime, PLC]{.underline}, 65 F.3d 1577 (Fed. Cir. 1995) (invalidating
claims that were broadened in scope during reexamination in violation of
35 U.S.C. § 305, which is analogous to section 132).

The separate written description requirement poses no conflict with the
role of the claims. It is well established that the specification
teaches an invention, whereas the claims define the right to exclude.
[SRI Int'l v. Matsushita Elec. Corp. of Am.]{.underline}, 775 F.2d 1107,
1121 n.14 (Fed. Cir. 1985). While claims must be supported by the
written description, the latter contains much material that is not in
the claims. The written description contains an elucidation of various
aspects of an invention as well as material that is necessary for
enablement. Moreover, the written description often contains material
that an applicant intended to claim that has been rejected in
examination. Thus, the written description and the claims do not
duplicate each other.

The fact, if it is a fact, that written description has only been relied
upon in recent years as a ground of invalidity does not remove that
requirement from the statute. Legal holdings arise when they do because
litigants raise them and courts have to decide them. Contrary to what
has been asserted, the interpretation of the statute as containing a
separate written description requirement did not originate with
[Lilly]{.underline}. [See]{.underline} [Vas-Cath Inc. v.
Mahurkar]{.underline}, 935 F.2d 1555 (Fed. Cir. 1991); [In re
Ruschig]{.underline}, 379 F.2d 990 (CCPA 1967). It has always been
there. And if a particular scope of claim has not been sustained by the
courts for failure to comply with the written description requirement,
it is because the applicant did not describe, and presumably did not
invent, the subject matter of the scope sought.

Moreover, it is not correct, as has been asserted, that our decisions,
particularly [Regents of the Univ. of Cal. v. Eli Lilly &
Co.]{.underline}, 119 F.3d 1559 (Fed. Cir. 1997), have created a
\"heightened\" written description requirement for biotechnology
inventions. We have applied the written description requirement to cases
that are not in the fields of chemistry or biotechnology. [See,
e.g.]{.underline}, [In re Curtis]{.underline}, 354 F.3d 1347 (Fed. Cir.
2004) (dental floss); [Tronzo v. Biomet, Inc.]{.underline}, 156 F.3d
1154 (Fed. Cir. 1998) (artificial hip sockets); [Gentry Gallery, Inc. v.
Berkline Corp.]{.underline}, 134 F.3d 1473 (Fed. Cir. 1998) (sectional
sofas); [Lockwood v. Am. Airlines, Inc.]{.underline}, 107 F.3d 1565
(Fed. Cir. 1997) (automated sales terminals); [Vas-Cath]{.underline}
(double lumen catheters). The statute is the same for all types of
inventions, although it may be applied differently, based on the
technology and what is known by one of ordinary skill in the art at the
time an invention was made. Indeed, Rochester's claimed invention at
issue in the present case is not biotechnological. Although the
inventors apparently contemplated that the tools of biotechnology would
be used to determine whether a given drug is a COX-2 inhibitor insofar
as the specification of the '850 patent describes how to make cell lines
that express one or the other of COX-1 and COX-2, that method is claimed
in another patent. The claims of this patent are all directed to
pharmaceutical methods for selectively inhibiting a natural process in
the human body. That is not what one commonly refers to as
biotechnology.

It has been noted that genes can be described by their informational
function, not just by structure or physical or chemical properties, and
that a lesser written description may be adequate than is required for
other types of inventions. Maybe so. Technology progresses, and what one
skilled in the art would read from a particular disclosure may change.
The PTO has now provided guidelines that help to guide applicants in
preparing their patent applications.

It is obviously correct that genes convey information
([e.g.]{.underline}, to make other nucleic acids or to encode particular
proteins). That fact does not serve to deny the existence of a written
description requirement in the law. It only goes to whether, under the
facts of a particular case, the written description requirement has been
met. A fact-finder may have to decide whether claiming a material solely
by its information-conveying character results in a \"single means
claim\" purporting to claim everything that works, a dubious fulfillment
of the requirement to \"distinctly claim the subject matter\" of the
invention. 35 U.S.C. § 112. In any event, it is fact-intensive. But,
once again, these matters go to whether the written description
requirement has been met, not whether it exists.

As for the proposition that an original claim is part of the written
description, that is clear. [See]{.underline} [In re
Gardner]{.underline}, 475 F.2d 1389, 1391 (CCPA 1973). However, the
issue may still remain in a given case, especially with regard to
generic claims, whether an original claim conveys that one has
possession of and thus has invented species sufficient to constitute the
genus. Thus, the fact that a statement of an invention is in an original
claim does not necessarily end all inquiry as to the satisfaction of the
written description requirement. [See]{.underline} [Enzo]{.underline},
323 F.3d at 968-69 ("\[R\]egardless whether the claim appears in the
original specification and is thus supported by the specification as of
the filing date, § 112, ¶ 1 is not necessarily met. . . . If a purported
description of an invention does not meet the requirements of the
statute, the fact that it appears as an original claim or in the
specification does not save it. A claim does not become more descriptive
by its repetition, or its longevity.").

In sum, I concur in the decision of the court not to rehear this case
[en]{.underline} [banc]{.underline}. Our precedent is clear and
consistent and necessitates no revision of written description law.

United States Court of Appeals for the Federal Circuit

03-1304

UNIVERSITY OF ROCHESTER,

Plaintiff-Appellant,

v\.

G.D. SEARLE & CO., INC., MONSANTO COMPANY, PHARMACIA CORPORATION,

and PFIZER INC.,

Defendants-Appellees.

RADER, [Circuit Judge]{.underline}, dissenting from the court's decision
not to hear the case en banc, with whom Circuit Judges
[GAJARSA]{.underline} and [LINN]{.underline}, join.

By a narrow margin,[^2] this court has declined to take this case [en
banc]{.underline}. Thus, this court avoids the opportunity to clarify
and correct its confusing jurisprudence on the new written description
invalidity doctrine.

In 1997, this court for the first time applied the written description
language of 35 U.S.C. § 112, ¶ 1 as a general disclosure requirement in
place of enablement, rather than in its traditional role as a doctrine
to prevent applicants from adding new inventions to an older disclosure.
[Regents of the Univ. of Cal. v. Eli Lilly & Co.]{.underline}, 119 F.3d
1559 (Fed. Cir. 1997). In simple terms, contrary to logic and the
statute itself, [Eli Lilly]{.underline} requires one part of the
specification (the written description) to provide "adequate support"
for another part of the specification (the claims).[^3] Neither [Eli
Lilly]{.underline} nor this case

has explained either the legal basis for this new validity requirement
or the standard for "adequate support." Because this new judge-made
doctrine has created enormous confusion which this court declines to
resolve, I respectfully dissent.

Confusion in This New Validity Doctrine

A recent case illustrates well the confusion engendered by this new
doctrine. In [Enzo Biochem, Inc. v. Gen Probe, Inc.]{.underline}, 323
F.3d 956 (Fed. Cir. 2002), this court struggled over the scope of the
written description invalidity doctrine first created in 1997. [Eli
Lilly]{.underline}, 119 F.3d at 1559. In its original [Enzo]{.underline}
opinion, 285 F.3d 1013 (Fed. Cir. 2002), this court invalidated claims
to polypeptides that detect the gonorrhea bacteria. The inventor of
these DNA probes specifically disclosed them and deposited three
polypeptides at the American Type Culture Collection. Even for claims
limited in scope to the deposited material, this court invalidated the
patent for insufficient disclosure of the invention. [Id.]{.underline}
at 1022 (concluding that "a deposit is not a substitute for a written
description of the claimed invention" (quotation omitted)). This
decision correctly applied the 1997 [Eli Lilly]{.underline} doctrine
which requires a nucleotide-by-nucleotide recitation of the structure of
a biotechnological invention. [Eli Lilly]{.underline}, 119 F.3d at 1567.
Accordingly, the mere deposit of material did not satisfy that reading
of 35 U.S.C. § 112, ¶ 1. [Enzo]{.underline}, 285 F.3d at 1022.

That [Enzo]{.underline} opinion caused an immediate firestorm. [See,
e.g.]{.underline}, Brief of Amicus Curiae United States at 1, [Enzo
Biochem, Inc. v. Gen Probe, Inc.]{.underline}, 323 F.3d 956 (Fed. Cir.
2002). Within a few months, this court vacated its original opinion and
reversed the result. [See]{.underline} [Enzo Biochem, Inc. v. Gen Probe,
Inc.]{.underline}, 323 F.3d 956 (Fed. Cir. 2002). This flip-flop shows
the problem. The Director of the Intellectual Property program at the
George Washington University Law School stated it concisely: "\[S\]ince
the first panel opinion faithfully followed [Eli Lilly]{.underline}, and
the result is obviously wrong, the [Eli Lilly]{.underline} description
doctrine is itself misguided." Martin J. Adelman, [If Eli Lilly Is Good
Law, Didn't the Withdrawn Panel Opinion in Enzo Biochem Have It
Right?]{.underline}, at 2 (2003) (unpublished paper prepared for the
11th Annual Conference on International Intellectual Property Law and
Policy at Fordham University, April 24-25, 2003).

Following issuance, withdrawal, and reissuance of [Enzo]{.underline},
this court engaged in lengthy debate over the new disclosure validity
doctrine. [Enzo Biochem]{.underline}, 323 F.3d at 971-75 (Lourie, J.,
concurring in decision to not hear the case [en banc]{.underline});
[id.]{.underline} at 975 (Newman, J., concurring); [id.]{.underline} at
975-76 (Dyk, J., concurring); [id.]{.underline} at 976-87 (Rader, J.,
dissenting)[^4]; [id.]{.underline} at 987-89 (Linn, J., dissenting).
That debate continued in this court's subsequent cases. [See,
e.g.]{.underline}, [Moba B.V. v. Diamond Automation, Inc.]{.underline},
325 F.3d 1306, 1323 (Fed. Cir. 2003) (Rader, J., concurring) (explaining
that juries face the "cumbersome task" of deciding that "the patent's
disclosure can enable a skilled artisan to make and practice the entire
invention, but still not inform that same artisan that the inventor was
in possession of the invention").

Indeed a brief survey of the literature on this topic, an astounding
amount in a few short years, shows 31 articles criticizing the [Eli
Lilly]{.underline} doctrine, 7 articles defending the doctrine, and 16
neutrally commenting on the state of this evolving case law.[^5] In its
brief requesting [en banc]{.underline} reconsideration in [Enzo
Biochem]{.underline}, the United States issued a call for clarity, which
this court has yet to address:

> Although this Court has addressed the "written description"
> requirement of section 112 on a number of occasions, its decisions
> have not taken a clear and uniform position regarding the purpose and
> meaning of the requirement. . . . A review of the plain text of
> section 112, and the case law of this Court, reveals at least three
> different possible tests for an adequate "written description." . . .
> [En banc]{.underline} consideration of the written description
> provision is appropriate so that the court can provide inventors, the
> public, and the USPTO with an authoritative interpretation of the
> provision.
>
> Brief of Amicus Curiae United States at 4-5, 9.
>
> In sum, by any measure, the [Eli Lilly]{.underline} doctrine has
> engendered confusion. After all, [Eli Lilly]{.underline} created a new
> validity doctrine under 35 U.S.C. § 112, ¶ 1 separate from enablement
> and yet described it as "analogous to enablement." 119 F.3d at 1569.
> Unfortunately, this court has passed up another opportunity to resolve
> the confusion.
>
> Supreme Court's Role in the [Eli Lilly]{.underline} Doctrine
>
> In an effort to supply some coherent basis for its new validity
> doctrine, this court in [Rochester]{.underline} refers to an 1822
> Supreme Court case that discusses the written description language of
> the Patent Act. [Univ. of Rochester v. G.D. Searle & Co.,
> Inc.]{.underline}, 358 F.3d 916, 924 (Fed. Cir. 2004). An examination
> of [Rochester]{.underline}'s references to the Supreme Court in their
> proper historical context impeaches, rather than supports, the modern
> written description validity doctrine.

In 1793, the Patent Act, 1 Stat. 318, required an inventor to describe
the scope of the invention in the body of the specification; the Act did
not require any claims. Instead the Act required the inventor to provide
"a written description of his invention, and of the manner of using, or
process of compounding the same, in such full, clear, and exact terms,
as to distinguish the same from all other things before known, and to
enable any person skilled in the art or science . . . to make, compound,
and use the same. . . ." [In re Barker]{.underline}, 559 F.2d 588, 592
(CCPA 1977) (ellipses in original). Without citing this statutory
language, [Rochester]{.underline} recounts the Supreme Court's
explanation that this provision contained two requirements:

> > The specification, then, has two objects: one is to make known the
> > manner of constructing the machine (if the invention is of a
> > machine) so as to enable artizans to make and use it, and thus to
> > give the public the full benefit of the discovery after the
> > expiration of the patent. . . . The other object of the
> > specification is, to put the public in possession of what the party
> > claims as his own invention, so as to ascertain if he claim anything
> > that is in common use, or is already known, and to guard against
> > prejudice or injury from the use of an invention which the party may
> > otherwise innocently suppose not to be patented.

[Evans v. Eaton]{.underline}, 20 U.S. 356, 433-34 (1822). For obvious
reasons, [Rochester]{.underline} undertakes no further explanation of
the Supreme Court's language. In simple terms, the Supreme Court could
not have meant that the written description portion of the specification
must provide adequate support for the claims as this court's law
presently requires. Patents did not even contain claims in 1822.

In fact, even the Supreme Court's allusion to "two objects," the reason
for the [Rochester]{.underline} cite, takes on a different meaning under
careful legal analysis. The Supreme Court clearly linked its "other
object" of the specification disclosure to the portion of the statute
requiring the inventor "to distinguish the same from all things before
known." [Evans]{.underline}, 20 U.S. at 430. Significantly, that
language no longer appears in 35 U.S.C. § 112. Later in 1870, the Patent
Act first articulated the requirement that applicants define their
exclusive right in a distinctly drafted claim. Act of July 8, 1870, Ch.
230, 16 Stat. 198. Only one logical conclusion flows from this history.
When the Patent Act assigned the notice function to claims rather than
the written description, enablement became the sole 35 U.S.C. § 112, ¶ 1
standard for adequate disclosure of an invention.[^6] [See]{.underline}
[Enzo]{.underline} Biochem, 323 F.3d at 977. This observation about the
meaning of 35 U.S.C. § 112, ¶ 1 has been axiomatic patent law for
decades. In a decision of the Court of Customs and Patent Appeals that
is binding on this court, Judge Rich interpreted 35 U.S.C. § 112, ¶ 1 to
have only two requirements -- not enablement and the [Eli
Lilly]{.underline} written description doctrine, but enablement and best
mode! [In re Gay]{.underline}, 309 F.2d 769, 772 (CCPA 1962). In sum,
the [Eli Lilly]{.underline} written description doctrine has no basis in
this court's legal precedent. Thus, [Rochester]{.underline} cannot
explain the missing 1793 statutory language, the advent of the claim
requirement that replaced the 1822 description doctrine, the
inapplicability of the [Evans]{.underline} quote to a new 1997
invalidity doctrine, or the apparent conflict with binding CCPA
interpretations of 35 U.S.C. § 112, ¶ 1.

The [Rochester]{.underline} reference to the 1822 Supreme Court language
does, however, reveal some insights into the reasons that the [Eli
Lilly]{.underline} doctrine engenders confusion. As the 1822 Supreme
Court reference explains, the original statute required a written
description to warn "an innocent purchaser or other person using a
machine, of his infringement." [Evans]{.underline}, 20 U.S. at 434. In
other words, the statute incorporated a written description requirement
to define the scope of the invention for infringement and for
distinguishing the invention from prior art. [Eli Lilly]{.underline} and
its progeny convert that original infringement doctrine into a new
challenge to validity. Suddenly, all the difficulty and imprecision of
defining an invention in legal language, [see]{.underline} [Festo Corp.
v. Shoketsu Kinzoku Kogyo Kabushiki Co.]{.underline}, 535 U.S. 722, 731
(2002), becomes a validity doctrine.

In sum, a careful legal analysis of the language and history of 35
U.S.C. § 112, ¶ 1 shows that the [Eli Lilly]{.underline} doctrine has no
basis in the written description language of the original Patent Act.
Moreover, as this court's binding CCPA precedent shows, the statutory
language of 35 U.S.C. § 112, ¶ 1 has not changed in any way that
justifies "discovery" of a vast new validity doctrine over two hundred
years after the 1793 Act. To the contrary, the changes in the statutory
language of § 112, ¶ 1 since 1793 impeach the reasoning of
[Rochester]{.underline} and [Eli Lilly]{.underline}.

[Rochester]{.underline} also refers to the Supreme Court's listing of
patent requirements in [Festo]{.underline}. [Rochester]{.underline}, 358
F.3d at 921 (quoting [Festo]{.underline}, 535 U.S. at 736). In the first
place, the [Festo]{.underline} listing is just that, a passing reference
to some of the requirements of the Patent Act. The passing reference,
for instance, does not even mention some binding requirements, e.g.,
subject matter eligibility and claim definiteness. In fact, in another
post-[Eli Lilly]{.underline} listing of Patent Act requirements, the
Supreme Court acknowledged only enablement as the disclosure [quid pro
quo]{.underline} of the statute: "In addition \[to novelty, utility, and
nonobviousness\], to obtain a utility patent, a breeder must describe
the plant with sufficient specificity to enable others to 'make and use'
the invention after the patent term expires." [J.E.M. Ag Supply, Inc. v.
Pioneer Hi-Bred Int'l, Inc.]{.underline}, 534 U.S. 124, 142 (2001). A
careful analysis of the Supreme Court's passing recitations of patent
requirements does not support the [Eli Lilly]{.underline} doctrine.

Rochester's invocation of the [Festo]{.underline} listing of a
"disclosure" requirement, however, betrays a telling incompleteness in
its reasoning. The Supreme Court is entirely correct to acknowledge the
requirement of full "disclosure" [at the time of invention]{.underline}
that prevents updating the patent document with later inventions.
Beginning in 1967, this court and its predecessor applied the written
description language to achieve this vital purpose of the Patent Act --
tying disclosure to the time of invention. [In re Ruschig]{.underline},
379 F.2d 990 (CCPA 1967); [Vas-Cath Inc. v. Mahurkar]{.underline}, 935
F. 2d 1555 (Fed. Cir. 1991). In the words of Judge Rich, the first judge
to use the description requirement to police priority, "The function of
the description requirement is to ensure that the inventor had
possession, as of the filing date of the application relied on, of the
specific subject matter [later]{.underline} claimed by him." [In re
Wertheim]{.underline}, 541 F.2d 257, 262 (CCPA 1976) (emphasis added).
In fact, every application of the written description doctrine before
[Eli Lilly]{.underline} in 1997 applied the written description doctrine
for this important purpose and only for this important purpose.
[Enzo]{.underline}, 323 F. 3d at 984-87 (listing every written
description case in the CCPA and Federal Circuit). Thus, the
[Festo]{.underline} listing does not endorse the [Eli Lilly]{.underline}
innovation, but properly invokes the necessity of tying disclosure to
the time of invention. In its attempt to support the 1997 doctrine,
however, [Rochester]{.underline} invokes [Vas-Cath]{.underline} and
other Federal Circuit decisions without noting the proper context of
those decisions.

In sum, the Supreme Court offers no comfort to the [Eli
Lilly]{.underline} doctrine. Rather, in proper historical and legal
context, the Supreme Court's allusions to the description requirement
impeach both [Rochester]{.underline} and [Eli Lilly]{.underline}.[^7]

# The Hypothetical Policy Analysis

[Rochester]{.underline} refers to a situation where a patent can enable
an invention that is not described by the specification. In the words of
the opinion, "\[s\]uch can occur when enablement of a closely related
invention A that is both described and enabled would similarly enable an
invention B [if]{.underline} B were described." [Rochester]{.underline},
358 F.3d at 921 (emphasis original). This hypothetical seems to suggest
that the 1997 doctrinal creation closes a major gap in patent law. To
the contrary, this court only created the [Eli Lilly]{.underline}
requirement in 1997; the patent system had succeeded quite well for over
two hundred years without it. Moreover no other patent system in the
world has the [Eli Lilly]{.underline} requirement to this day. The
world's patent systems work quite well without it.

The hypothetical actually facilitates a policy analysis that explains
the reasons that the new 1997 requirement is both superfluous and
dangerous. In the first place, the hypothetical rarely, if ever,
happens. No actual case presents the hypothetical. In both [Eli
Lilly]{.underline} and [Rochester]{.underline}, for instance, the
invention A (rat insulin in [Eli Lilly]{.underline}; an assay for Cox 1
and 2 in [Rochester)]{.underline} was enabled and described, but the
invention B (human insulin in [Eli Lilly]{.underline}; a Cox 2 inhibitor
in [Rochester]{.underline}) was not enabled.

In understandable terms, the hypothetical says that an inventor invents
the radio, but his invention solves a problem that enables those of
ordinary skill in the art to know how to make and use both a radio and a
TV. His patent disclosure only describes a radio but he claims broadly
an "electrical receiver." Thus, his claims seem to encompass the TV
which his specification does not describe but would enable if it were
described. In that context, the reason the hypothetical does not occur
becomes obvious. If everyone of [ordinary]{.underline} skill in the art
knows from the disclosure how to make and use the TV, the exceptionally
talented inventor will also. To avoid any risk of losing the TV
invention, the inventor will fully disclose it and claim it, probably in
a separate application. For this very practical reason, no case has ever
presented the hypothetical. Inventors know when they have made an
invention and realize that they must properly disclose it or risk losing
it entirely.

Carrying the genuinely "hypothetical" hypothetical forward, however,
what happens if the radio inventor for some unfathomable reason does not
grasp that he has enabled a TV and later asserts the radio patent
against a TV maker? In simple terms, a court would properly interpret
the claim as limited to the radio. The TV maker would not infringe a
claim that covers only the radio. On the other hand, the [Eli
Lilly]{.underline} doctrine would instead invalidate the radio patent.
Is that the best result? After all, the inventor did invent the radio.
Should he lose everything because he did not disclose the TV?

The facts of [Eli Lilly]{.underline} itself illustrate the real problems
in this area of patent interpretation and enforcement. In simple terms,
the inventor in that case invented and disclosed rat insulin but not
human insulin. In fact, at the dawn of the biotechnological age in 1977,
the inventor could not make human insulin. Biotechnology was in its
infancy; it would have taken months, if not years, of experimentation to
make human insulin. Nonetheless the inventor claimed the rat insulin
invention broadly and later asserted it against human insulin. In this
setting, U.S. patent law (and world patent law in general) has two
complementary ways to prevent any injustice -- enablement and
traditional (not [Eli Lilly]{.underline}) written description (enforcing
the actual time of invention). If the inventor has not enabled human
insulin in the specification, the inventor has not enabled the full
scope of the claim. By the way, as noted earlier, if the rat insulin
inventor had invented human insulin as well, he surely would have
disclosed it. In other words, a lack of disclosure is a dead give-away
for enablement problems. Alternatively, or likely in conjunction, the
traditional written description requirement as applied by this court and
its predecessor beginning in 1967 will prohibit any addition of new
matter to the patent document to "update" the claims to cover human
insulin. [See, e.g.]{.underline}, [Chiron Corp. v. Genentech,
Inc.]{.underline}, 363 F.3d 1247 (Fed. Cir. 2004).

In sum, our patent law (and the world's patent law) has worked well for
200 years because the law already possesses ample remedies for the
[Rochester]{.underline} hypothetical, which, as a practical matter,
never occurs. Neither [Eli Lilly]{.underline} nor
[Rochester]{.underline} explains the legal policy that supports the new
doctrine.

The Practical Problems

By its terms, the [Eli Lilly]{.underline} doctrine stated: "An adequate
written description of a DNA . . . 'requires a precise definition, such
as by structure, formula, chemical name, or physical properties.'" 119
F.3d at 1566 (quoting [Fiers v. Revel]{.underline}, 984 F.2d 1164, 1171
(Fed. Cir. 1993)). In sum, [Eli Lilly]{.underline} asserts a new
free-standing validity requirement. Based on the absence of a
nucleotide-by-nucleotide recitation in the specification of the human
insulin cDNA, the court determined that the applicant had not adequately
described the invention. Thus, the failure to actually sequence the
nucleotides prevents an applicant from claiming a new and useful
polypeptide.

This new 1997 rule changes the established rules of claiming and
disclosing inventions. Many biotechnological inventions predate [Eli
Lilly]{.underline}. Before the 1997 change, no inventor could have
foreseen that the Federal Circuit would make a new disclosure rule.
Without any way to redraft issued patents to accommodate the new rule,
many patents in the field of biotechnology face serious and unavoidable
validity challenges simply because the patent drafter may not have
included the lengthy nucleotide sequences. After all, the sequences are
often routinely available (albeit at some cost) to those of ordinary
skill in this art.

The [Eli Lilly]{.underline} doctrine also seems to impose some illogical
requirements on patent drafters today. Must a software patent disclose
every potential coding variation that performs a claimed function? Must
a biotechnological invention list every amino acid variation for a
particular protein or protein function -- a task conceivably as
impractical as the software disclosure requirement? Must a university or
small biotech company expend scarce resources to produce every potential
nucleotide sequence that exhibits their inventive functions? Perhaps
more important for overall patent policy, must inventors spend their
valuable time and resources fleshing out all the obvious variants of
their last invention instead of pursuing their next significant advance
in the useful arts? Again [Eli Lilly]{.underline} and
[Rochester]{.underline} appear to have given little thought to these
unintended consequences.

This court, however, is not even the only judicial institution that must
deal with the unintended consequences of the 1997 doctrine. Under this
new disclosure test, every case where the written description does not
specifically disclose some feature of the claimed invention will give
rise to a validity challenge. Thus, trial courts will have to empanel
juries to inquire whether one of skill in the art would have known that
the inventor "possessed" the full invention. In a sense, the [Eli
Lilly]{.underline} doctrine converts this court's confusing case law
about the role of the specification in defining the invention into a
validity question. Thus, trial courts as well must struggle to discern
the standard for sufficient disclosure of an invention.

[Rochester]{.underline} emphasizes that this new disclosure doctrine is
different from enablement. [Rochester]{.underline}, 358 F.3d at 921.
Thus, a trial court, as in this case, must first ask its jury whether
the specification provides sufficient information to enable one of
ordinary skill in the art to make and use the invention. Then the trial
court must ask the jury again to look at the same specification for
information that an inventor of extraordinary skill "possessed" the
invention. Under this court's law, a patent disclosure could apparently
enable one of ordinary skill to make and practice the entire invention,
but still not inform that same artisan that the inventor was in
possession of the invention. Moreover, the trial court must give
separate instructions and entertain separate witnesses on these
inseparable patent rules to ensure adequate disclosure. Viewed in the
practical terms of trial procedure and jury understanding, this 1997
doctrine unnecessarily complicates and prolongs patent enforcement. In
sum, [Rochester]{.underline} does not resolve any of the confusion or
provide a sound legal basis for the [Eli Lilly]{.underline} doctrine.
For these reasons, this court should have reviewed this case [en
banc]{.underline}.

[Appendix]{.underline}

Defending [Eli Lilly]{.underline} Written Description

  ----------------------------------- -----------------------------------
  Citation                            Quotation

  Paula K. Davis, [Questioning the    By strictly requiring written
  Requirement for Written             description of the invention, the
  Description: Enzo Biochem v.        public is guaranteed that the
  Gen-Probe and Overly Broad Patent   inventor was in possession of the
  Cases]{.underline}, 37 Ind. L. Rev. invention when the patent
  467, 500 (2004)                     application was filed. In effect,
                                      the written description defines the
                                      scope of the invention- the metes
                                      and bounds that will be given
                                      exclusivity.

  F. Scott Kieff, [The Case for       The U.S. Court of Appeals for the
  Registering Patents and the Law and Federal Circuit\'s strong reading
  Economics of Present                of the written description
  Patent-Obtaining                    requirement to put the public on
  Rules]{.underline}, 45 B.C. L. Rev. clear notice of what will infringe
  55, 99 (2003)                       and what will not makes sense
                                      because the patentee, as the
                                      drafter, is the least-cost avoider
                                      of such ambiguities. This legal
                                      development was controversial to be
                                      sure; yet it marks an important
                                      weapon in the system\'s arsenal for
                                      fighting social cost.

  Cynthia M. Lambert, Note: [Gentry   Although there may be negative
  Gallery and the Written Description effects resulting from a stricter
  Requirement]{.underline}, 7 B.U. J. written description standard,
  Sci. & Tech. L. 109, 139 (2001)     including narrowed patent scope and
                                      a potential tragedy of the
                                      anticommons, the stricter standard
                                      is the better choice in terms of
                                      fairness to the public because it
                                      prevents inventors from
                                      overreaching.

  Daniel P. Chisholm, Note: [The      Absent this heightened
  Effect of the USPTO\'s Written      interpretation, broadly construed
  Description Guidelines on Gene      claims would allow applicants to
  Patent Applications]{.underline},   obtain exclusive rights to products
  35 Suffolk U. L. Rev. 543, 570      in which they do not actually
  (2001)                              possess. Granting such broad claims
                                      would stifle the very purpose of
                                      the United States patent system:
                                      preserving incentives for continued
                                      innovations.

  Margaret Sampson, Comment: [The     The use of a heightened written
  Evolution of the Enablement and     description requirement by the
  Written Description Requirements    Federal Circuit to define and limit
  Under 35 U.S.C. 112 in the Area of  the scope of claimed inventions
  Biotechnology]{.underline}, 15      preserves incentives for continued
  Berkeley Tech. L.J. 1233, 1273      innovation.
  (2000)                              

  Mark J. Stewart, Note: [The Written Through application of the written
  Description Requirement of 35       description requirement, courts can
  U.S.C. 112(1): The Standard After   distinguish between claims to
  Regents of the University of        technologies that are too broad or
  California v. Eli Lilly &           basic to justify patent protection,
  Co.]{.underline}, 32 Ind. L. Rev.   and those dealing with other types
  537, 563 (1999)                     of technologies that are more
                                      predictable and may justify broader
                                      protection.

  Emanuel Vacchiano, Comment: [It\'s  Fortunately, the CAFC narrowly
  a Wonderful Genome: The             construes patent rights based on
  Written-Description Requirement     disclosures of DNA sequences, and
  Protects the Human Genome from      as a result, will likely invalidate
  Overly-Broad Patents]{.underline},  patent claims based on EST
  32 J. Marshall L. Rev. 805, 832     disclosures that contain a broad
  (1999)                              scope of protection encompassing a
                                      gene or even an entire
                                      protein-coding segment of a cDNA.
  ----------------------------------- -----------------------------------

Criticizing [Eli Lilly]{.underline} Written Description

+-----------------------------------+-----------------------------------+
| Citation                          | Quotation                         |
+-----------------------------------+-----------------------------------+
| Stephen J. Burdick, Note: [Moba   | [Moba]{.underline} illustrates    |
| v. Diamond Automation, Inc.:      | the problems associated with the  |
| Questioning the Separate Written  | separate written description      |
| Description                       | requirement. The judge-made       |
| Requirement]{.underline}, 19      | doctrine does not contribute any  |
| Berkeley Tech. L.J. 133, 151      | additional value to the other     |
| (2004)                            | patentability requirements. Its   |
|                                   | effects are redundant with the    |
|                                   | enablement and new matter         |
|                                   | requirements of patent law.       |
|                                   | Additionally, the written         |
|                                   | description requirement creates   |
|                                   | confusion and discourages         |
|                                   | patenting and innovation. The     |
|                                   | Federal Circuit should dispose of |
|                                   | the separate written description  |
|                                   | requirement entirely.             |
+-----------------------------------+-----------------------------------+
| Martin J. Adelman, 3-2 Patent Law | \[T\]he original panel opinion in |
| Perspectives § 2.9 (2004)         | [Enzo Biochem]{.underline} is     |
|                                   | correct if we assume that [Eli    |
|                                   | Lilly]{.underline} is sound law,  |
|                                   | since [Eli Lilly]{.underline}     |
|                                   | holds that the failure to         |
|                                   | actually detail the sequence of   |
|                                   | nucleotides of a polypeptide      |
|                                   | prevents an applicant from        |
|                                   | claiming it. Obviously merely     |
|                                   | depositing a polypeptide does not |
|                                   | disclose its sequence without a   |
|                                   | sequencing operation. Thus a      |
|                                   | disclosure that effectively puts  |
|                                   | the polypeptide in possession of  |
|                                   | the public by virtue of providing |
|                                   | a set of directions for obtaining |
|                                   | it should not be treated          |
|                                   | differently than an inventor who  |
|                                   | puts the polypeptide in a         |
|                                   | depository without sequencing it. |
|                                   | Since this is a result that is    |
|                                   | difficult do defend, it proves    |
|                                   | that the [Eli Lilly]{.underline}  |
|                                   | doctrine is itself misguided. It  |
|                                   | is thus time to formally overrule |
|                                   | it along with [In re              |
|                                   | Deuel]{.underline} another case   |
|                                   | that holds that the act of        |
|                                   | sequencing is the key to          |
|                                   | patentability.                    |
+-----------------------------------+-----------------------------------+
| Harold C. Wegner, [The Disclosure | The first problem here is the     |
| Requirements of the 1952 Patent   | judicial activism from several    |
| Act: Looking Back and a New       | panel opinions that created a     |
| Statute for the Next Fifty        | \"written description\"           |
| Years]{.underline}, 37 Akron L.   | requirement apart from the        |
| Rev. 243, 244 (2004)              | original \"new matter\"           |
|                                   | proscription.                     |
+-----------------------------------+-----------------------------------+
| Jennifer L. Davis, Comment: [The  | The court has not issued clear    |
| Test of Primary Cloning: A New    | and consistent standards. In      |
| Approach to the Written           | fact, the court itself appears    |
| Description Requirement in        | confused over the proper          |
| Biotechnological                  | standards by which to judge the   |
| Patents]{.underline}, 20 Santa    | adequacy of a written description |
| Clara Computer & High Tech. L.J.  | as reflected by the recent        |
| 469, 487-88 (2004)                | decision in [Enzo I]{.underline}  |
|                                   | followed by a reversal upon       |
|                                   | rehearing in [Enzo                |
|                                   | II]{.underline}. . . .            |
+-----------------------------------+-----------------------------------+
| Martin J. Adelman, [If Eli Lilly  | \[S\]ince the first panel opinion |
| Is Good Law, Didn't the Withdrawn | \[in [Enzo]{.underline}\]         |
| Panel Opinion in Enzo Biochem     | faithfully followed [Eli          |
| Have It Right?]{.underline}, at 2 | Lilly]{.underline}, and the       |
| (2003) (unpublished paper         | result reached is obviously       |
| prepared for the 11th Annual      | wrong, the [Eli                   |
| Conference on International       | Lilly]{.underline} description    |
| Intellectual Property Law and     | doctrine is itself misguided.     |
| Policy at Fordham University,     |                                   |
| April 24-25, 2003).               |                                   |
+-----------------------------------+-----------------------------------+
| Duane M. Linstrom, [Spontaneous   | In sum, the latest                |
| Mutation: A Sudden Change in the  | [Enzo]{.underline} decision has   |
| Evolution of the Written          | shifted the direction of the      |
| Description Requirement as It     | development of the written        |
| Applies to Genetic                | description requirement for DNA   |
| Patents]{.underline}, 40 San      | patents, but it has also left us  |
| Diego L. Rev. 947, 970 (2003)     | with even more uncertainty in the |
|                                   | law than before the ruling.       |
+-----------------------------------+-----------------------------------+
| Jennifer Gordon, Ph.D.,           | Until the dissenters can persuade |
| [Preparing and Prosecuting a      | the Court to review the           |
| Patent That Holds Up in           | [Lilly]{.underline} written       |
| Litigation]{.underline}, 766      | description rule en banc, the     |
| PLI/Pat 873, 907-08 (2003)        | Federal Circuit can continue to   |
|                                   | apply the [Lilly]{.underline}     |
|                                   | standard to invalidate any        |
|                                   | patent, regardless of whether     |
|                                   | priority is an issue, where the   |
|                                   | written description does not show |
|                                   | possession of the invention at    |
|                                   | the time of filing.               |
+-----------------------------------+-----------------------------------+
| Rachel Krevans and Cathleen       | The Federal Circuit doctrine that |
| Ellis, [Preparing for Biotech     | makes enablement a separate       |
| Patent Litigation]{.underline},   | requirement from the written      |
| 760 PLI/Pat 529, 555-56 (2003)    | description requirement           |
|                                   | contradicts the plain language of |
|                                   | the statute.                      |
+-----------------------------------+-----------------------------------+
| John C. Stolpa, Case Comment:     | The Federal Circuit should take   |
| [Toward Aligning the Law with     | the next available opportunity to |
| Biology? The Federal Circuit\'s   | overrule the [Eli                 |
| About Face in Enzo Biochem, Inc.  | Lilly]{.underline} decision       |
| v. Gen-Probe, Inc.]{.underline},  | through an [en banc]{.underline}  |
| 4 Minn. Intell. Prop. Rev. 339,   | hearing and return enablement as  |
| 366 (2003)                        | the sole substantive disclosure   |
|                                   | requirement of [35 U.S.C.         |
|                                   | 112,]{.underline} paragraph 1.    |
|                                   | The heightened written            |
|                                   | description standard applied to   |
|                                   | biotechnology inventions after    |
|                                   | [Eli Lilly]{.underline} ignores   |
|                                   | fundamental biological principles |
|                                   | and focuses too much attention on |
|                                   | the structure of a DNA or         |
|                                   | protein. In addition, the         |
|                                   | standard is inflexible to         |
|                                   | technological changes and         |
|                                   | requires constant updating that   |
|                                   | leads to uncertainty over patent  |
|                                   | validity. Finally, the heightened |
|                                   | requirement fails to meet the     |
|                                   | constitutional purpose behind the |
|                                   | patent laws by discouraging full  |
|                                   | disclosure of biological          |
|                                   | inventions. Simply returning to   |
|                                   | the enablement disclosure         |
|                                   | standard that was in effect prior |
|                                   | to [Eli Lilly]{.underline} would  |
|                                   | solve the bulk of these problems. |
+-----------------------------------+-----------------------------------+
| Laurence H. Pretty, Patent        | The term \"written description\"  |
| Litigation § 1:3.3, Defenses      | appears grammatically as the      |
| Against Patent Validity, 1-44     | subject for the verb \"enable\"   |
| (2003)                            | in the enablement section of 35   |
|                                   | U.S.C. § 112. However, the        |
|                                   | written-description requirement   |
|                                   | has been judicially construed to  |
|                                   | have a separate and additional    |
|                                   | purpose.                          |
+-----------------------------------+-----------------------------------+
| Stephen R. Albainy-Jenei and      | While [Rochester]{.underline} is  |
| Karlyn A. Schnapp, [Early-Stage   | on appeal to the U.S. Court of    |
| Companies Face New Challenges     | Appeals for the Federal Circuit,  |
| Rochester Case Limited the        | it is likely that such            |
| Patentability Of Reach-Through    | reach-through claims will remain  |
| Claims]{.underline}, 12/8/03      | severely restricted, possibly     |
| Nat\'l L.J. S3, col. 1, S3, col.  | hurting the value of intellectual |
| 1+ (2003)                         | property for many early- stage    |
|                                   | biotechnology companies.          |
|                                   |                                   |
|                                   | \* \* \*                          |
|                                   |                                   |
|                                   | In addition, the overall cost in  |
|                                   | legal fees for drafting and       |
|                                   | prosecuting more carefully        |
|                                   | crafted, fully detailed           |
|                                   | biotechnology applications will   |
|                                   | only increase for complex         |
|                                   | inventions.\                      |
|                                   | While big pharmaceutical          |
|                                   | companies will have the money to  |
|                                   | spend in such endeavors, it will  |
|                                   | be the universities and the small |
|                                   | biotech start-ups that will most  |
|                                   | certainly be affected since these |
|                                   | institutions historically do not  |
|                                   | have the resources, both          |
|                                   | financial and in personnel, to    |
|                                   | overcome this new set of          |
|                                   | obstacles in trying to obtain     |
|                                   | patent protection for their       |
|                                   | scientific contributions in an    |
|                                   | ever-changing landscape.          |
+-----------------------------------+-----------------------------------+
| Dan L. Burk and Mark A. Lemley,   | In biotechnology, however, the    |
| [Policy Levers in Patent          | doctrine has been applied as a    |
| Law]{.underline}, 89 Va. L. Rev.  | sort of \"super-enablement\"      |
| 1575, 1652-54 (2003)              | requirement, forcing biotech      |
|                                   | patentees to list particular gene |
|                                   | sequences in order to obtain a    |
|                                   | patent covering those sequences.  |
|                                   | \                                 |
|                                   | The written description doctrine  |
|                                   | as currently applied is a macro   |
|                                   | policy lever. The Federal Circuit |
|                                   | has applied the doctrine to       |
|                                   | biotechnology cases in a way that |
|                                   | would be inconceivable in other   |
|                                   | industries, such as software. The |
|                                   | effect is to narrow the scope of  |
|                                   | biotechnology patents\--or at     |
|                                   | least DNA patents \--rather       |
|                                   | dramatically.                     |
+-----------------------------------+-----------------------------------+
| Warren D. Woessner, ["Do-Over!" - | It is time for the court to       |
| The Federal Circuit Takes a       | deliver [Lilly]{.underline} and   |
| Second Look at Enzo v.            | [Enzo (I)]{.underline} to the     |
| Gen-Probe]{.underline}, 85 J.     | doctrinal scrap heap where        |
| Pat. & Trademark Off. Soc\'y 275, | holdings like                     |
| 285 (2003)                        | [Durden]{.underline} and          |
|                                   | [Druey]{.underline} ended up, and |
|                                   | let the evolution of              |
|                                   | biotechnology patent law continue |
|                                   | in a productive direction.        |
+-----------------------------------+-----------------------------------+
| Robert L. Harmon, [Must a Patent  | In the meantime, however, we are  |
| Describe an Accused               | confronted with a welter of       |
| Infringement?]{.underline}, 85 J. | confused and confusing precedent  |
| Pat. & Trademark Off. Soc\'y 153, | that not only defies restatement, |
| 154 (2003)                        | but renders analysis and          |
|                                   | synthesis distinctly              |
|                                   | unmanageable. The only approach   |
|                                   | the author has found to making    |
|                                   | some sense of the situation is to |
|                                   | ask what the motivation of the    |
|                                   | Federal Circuit is in its efforts |
|                                   | to restrict this once             |
|                                   | well-recognized tenet of patent   |
|                                   | law.                              |
+-----------------------------------+-----------------------------------+
| Sven J.R. Bostyn, [Written        | The third way is to limit the     |
| Description After Enzo Biochem:   | application of the written        |
| Can the Real Requirement Step     | description requirement to cases  |
| Forward Please?]{.underline}, 85  | where priority issues are         |
| J. Pat. & Trademark Off. Soc\'y   | involved, and limiting it to      |
| 131, 151 (2003)                   | these issues, leaving the bulk of |
|                                   | the disclosure evaluation to the  |
|                                   | enablement requirement, the key   |
|                                   | feature of the quid pro quo of    |
|                                   | the patent system. In the         |
|                                   | author\'s view, that ought to be  |
|                                   | the optimal solution, leading to  |
|                                   | a coherent and stable patent      |
|                                   | system, both for patent           |
|                                   | applicants and for patent offices |
|                                   | and courts. In this light, it     |
|                                   | would have been a good            |
|                                   | opportunity to hear the           |
|                                   | [Enzo]{.underline} case [en       |
|                                   | banc]{.underline}.                |
+-----------------------------------+-----------------------------------+
| David Kelly, Comment: [The        | The Federal Circuit\'s decision   |
| Federal Circuit Transforms the    | in [Lilly]{.underline}, however,  |
| Written Description Requirement   | has fashioned the description     |
| into a Biotech-Specific Hurdle to | requirement into a barrier to     |
| Obtaining Patent Protection for   | scientific progress in the field  |
| Biotechnology                     | of biotechnology. This heightened |
| Patents]{.underline}, 13 Alb.     | standard, applied exclusively to  |
| L.J. Sci. & Tech. 249, 270 (2002) | biotechnology patents, will       |
|                                   | likely have an adverse effect on  |
|                                   | the progress of biotechnological  |
|                                   | innovations.                      |
|                                   |                                   |
|                                   | Rather than awarding patent       |
|                                   | protection to the discoverers of  |
|                                   | new and useful genes,             |
|                                   | [Lilly]{.underline} rewards those |
|                                   | who first sequence the gene       |
|                                   | accurately. The result will be    |
|                                   | patent protection to those who    |
|                                   | can sequence DNA the fastest, not |
|                                   | to those who invested their       |
|                                   | life\'s work locating the gene.   |
+-----------------------------------+-----------------------------------+
| Eli A. Loots, [The 2001 USPTO     | Some conflict between patent      |
| Written Guidelines and Gene       | prosecution and patent litigation |
| Claims]{.underline}, 17 Berkeley  | is inevitable. However, the       |
| Tech. L.J. 117, 134 (2002)        | current conflict has been         |
|                                   | recognized as a widening gulf     |
|                                   | between the norms of the          |
|                                   | scientific community and those of |
|                                   | the legal system.                 |
+-----------------------------------+-----------------------------------+
| Limin Zheng, [Purdue Pharma L.P.  | The court\'s continuing use of an |
| v. Faulding Inc.]{.underline}, 17 | inconsistent and often            |
| Berkeley Tech. L.J. 95, 103       | overly-stringent written          |
| (2002)                            | description requirement leaves    |
|                                   | inventors, especially those in    |
|                                   | the pharmaceutical industry, with |
|                                   | little incentive to disclose, and |
|                                   | is likely to discourage inventors |
|                                   | from seeking patent protection.   |
+-----------------------------------+-----------------------------------+
| Jeffie A. Kopczynski, Note: [A    | Recent Federal Circuit patent     |
| New Era for 112? Exploring Recent | cases have held biotechnology     |
| Developments in the Written       | inventions to a higher written    |
| Description Requirement as        | description standard than         |
| Applied to Biotechnology          | inventions in other areas, such   |
| Inventions]{.underline}, 16 Harv. | as the mechanical arts. \... This |
| J. Law & Tech. 229, 230 (2002)    | perception of unpredictability    |
|                                   | has caused the Federal Circuit to |
|                                   | apply a heightened written        |
|                                   | description requirement to        |
|                                   | biotechnology patents. This paper |
|                                   | argues that the written           |
|                                   | description requirement for       |
|                                   | patents should not be applied     |
|                                   | differently to inventions in      |
|                                   | different disciplines.            |
+-----------------------------------+-----------------------------------+
| Shraddha A. Upadhyaya, [The       | The postmodern trilogy            |
| Postmodern Written Description    | unjustifiably departs from        |
| Requirement: An Analysis of the   | precedent in order to meet the    |
| Application of the Heightened     | increasing intellectual           |
| Written Description Requirement   | difficulties of biotechnology     |
| to Original Claims]{.underline},  | patents. The sophisticated        |
| 4 Minn. Intell. Prop. Rev. 65,    | obviousness function simply will  |
| 120-21 (2002)                     | not bar biotechnology patents,    |
|                                   | but a simple written description  |
|                                   | requirement will. This anomaly is |
|                                   | troublesome. The written          |
|                                   | description requirement cannot    |
|                                   | and should not serve any function |
|                                   | other than to guarantee that      |
|                                   | subsequently filed claims are     |
|                                   | entitled to the benefit of the    |
|                                   | original application.             |
+-----------------------------------+-----------------------------------+
| Sheila R. Arriola, [Biotechnology | The problem created by the        |
| Patents After Festo: Rethinking   | Federal Circuit could be remedied |
| The Heightened Enablement and     | by overruling the prior           |
| Written Description               | biotechnology enablement and      |
| Requirements]{.underline}, 11     | written description case law that |
| Fed. Circuit B.J. 919, 951 (2002) | heightened these requirements on  |
|                                   | the basis of the state of         |
|                                   | technology at the time of those   |
|                                   | decisions. The USPTO could then   |
|                                   | relax the enablement and written  |
|                                   | description requirements with     |
|                                   | respect to proteins and their     |
|                                   | analogs. Not only would this      |
|                                   | shift the determination of patent |
|                                   | scope from judges back to the     |
|                                   | USPTO\'s biotechnology examiners, |
|                                   | but it would force patentees to   |
|                                   | protect their inventions          |
|                                   | proactively through continuations |
|                                   | and CIPs, rather than reactively  |
|                                   | through the doctrine of           |
|                                   | equivalents. On balance, the      |
|                                   | long-term costs of this proposed  |
|                                   | approach are far less than those  |
|                                   | that [Festo]{.underline} and the  |
|                                   | heightened enablement and written |
|                                   | description requirements will     |
|                                   | have on patent protection, and    |
|                                   | ultimately, on the biotechnology  |
|                                   | industry as we know it.           |
+-----------------------------------+-----------------------------------+
| Robert A. Hodges, Note: [Black    | The Federal Circuit\'s imposition |
| Box Biotech Inventions: When a    | of a heightened standard for the  |
| "Mere Wish Or Plan" Should Be     | written description of DNA        |
| Considered an Adequate            | inventions in [Eli                |
| Description of the                | Lilly]{.underline} increases the  |
| Invention]{.underline}, 17 Ga.    | gap between the written           |
| St. U.L. Rev. 831, 860 (2001)     | description requirement for       |
|                                   | biotech inventions and the        |
|                                   | realities of how such inventions  |
|                                   | are produced.                     |
+-----------------------------------+-----------------------------------+
| Alison E. Cantor, [Using the      | If courts are strengthening the   |
| Written Description and           | written description and           |
| Enablement Requirements to Limit  | enablement requirements in order  |
| Biotechnology                     | to limit biotechnology patents,   |
| Patents]{.underline}, 14 Harv. J. | this fact raises concerns about   |
| Law & Tech. 267, 313 (2000)       | creating special standards for    |
|                                   | particular areas of technology.   |
|                                   | If it is the courts that impose   |
|                                   | these standards, pioneering       |
|                                   | scientists in a new field will be |
|                                   | unable to determine, when         |
|                                   | applying for patents, to what     |
|                                   | standard their patents will       |
|                                   | eventually be held when they are  |
|                                   | litigated.                        |
+-----------------------------------+-----------------------------------+
| Mark D. Janis, [On Courts Herding | As a first step, the Federal      |
| Cats: Contending with the         | Circuit might simply admit that   |
| \"Written Description\"           | the written description           |
| Requirement (and Other Unruly     | requirement is redundant of       |
| Patent Disclosure                 | enablement. This would at least   |
| Doctrines)]{.underline}, 2 Wash.  | allow for a more forthright       |
| U. J.L. & Pol\'y 55, 107 (2000)   | exploration of the question       |
|                                   | whether redundancy in patent      |
|                                   | disclosure requirement remains    |
|                                   | tolerable. The Federal Circuit    |
|                                   | could reach the conclusion,       |
|                                   | perhaps, that the written         |
|                                   | description requirement simply    |
|                                   | provides a fail-safe mechanism    |
|                                   | that judges (or examiners) may    |
|                                   | use in their discretion in hard   |
|                                   | cases.                            |
+-----------------------------------+-----------------------------------+
| Salima Merani, [Hyatt v.          | Admittedly, the Federal Circuit   |
| Boone]{.underline}, 14 Berkeley   | has used different expressions in |
| Tech. L.J. 137, 146 (1999)        | describing a sufficient written   |
|                                   | description. Judge Newman,        |
|                                   | however, \"\[did\] not view these |
|                                   | various expressions as setting    |
|                                   | divergent standards for           |
|                                   | compliance with \[section\]       |
|                                   | 112.\" She emphasized that, in    |
|                                   | all cases, the purpose of the     |
|                                   | written description requirement   |
|                                   | was to ensure that the inventor   |
|                                   | had possession of the claimed     |
|                                   | invention at the time of the      |
|                                   | application filing date. Analysis |
|                                   | of historical and policy          |
|                                   | rationale of section 112 supports |
|                                   | Judge Newman\'s view of the       |
|                                   | written description requirement.  |
+-----------------------------------+-----------------------------------+
| Zhibin Ren, Note: [Confusing      | In [Lilly]{.underline}, the       |
| Reasoning, Right Result: The      | Federal Circuit deviated from the |
| Written Description Requirement   | well-established traditional      |
| and Regents of the University Of  | written description standard and  |
| California v. Eli Lilly &         | adopted an ad hoc approach to     |
| Company]{.underline}, 1999 Wis.   | conduct a written description     |
| L. Rev. 1297, 1324 (1999)         | analysis for DNA claims. This     |
|                                   | approach allows the court to use  |
|                                   | whatever is handy to justify the  |
|                                   | result it wants to reach.         |
+-----------------------------------+-----------------------------------+
| Arti K. Rai, [Intellectual        | In essence, the                   |
| Property Rights in Biotechnology: | [Lilly]{.underline} court used    |
| Addressing New Technology, 34     | the written description           |
| Wake Forest L. Rev. 827, 835      | requirement as a type of elevated |
| (1999)]{.underline}               | enablement requirement. An        |
|                                   | ordinary enablement challenge to  |
|                                   | the University of California's    |
|                                   | claim was not raised (and, if     |
|                                   | raised, probably would have       |
|                                   | failed) because it would have     |
|                                   | been relatively easy for a person |
|                                   | of ordinary skill in the art to   |
|                                   | use the rat insulin cDNA that     |
|                                   | Lilly had already sequenced to    |
|                                   | "fish out" the human cDNA from a  |
|                                   | cDNA library.                     |
+-----------------------------------+-----------------------------------+
| Janice M. Mueller, [The Evolving  | The [Lilly]{.underline} decision  |
| Application of the Written        | may profoundly limit the scope of |
| Description Requirement to        | protection available for new gene |
| Biotechnological                  | inventions;. . .                  |
| Inventions]{.underline}, 13       | [Lilly]{.underline} aptly         |
| Berkeley Tech. L.J. 615, 615-16   | illustrates the increased         |
| (1998)                            | widening of the gulf between the  |
|                                   | norms of the business and         |
|                                   | scientific communities and the    |
|                                   | U.S. patent system, as users of   |
|                                   | the latter come to understand     |
|                                   | that the patent system no longer  |
|                                   | reflects the realities of         |
|                                   | scientific contribution.          |
+-----------------------------------+-----------------------------------+
| Michael Delmas Plimier,           | The written description           |
| [Genentech, Inc. v. Novo Nordisk  | requirement only allows very      |
| & University of California v. Eli | narrow patents, so narrow and     |
| Lilly and Co.]{.underline}, 13    | easily dodged as to be almost     |
| Berkeley Tech. L.J. 149, 161      | worthless.                        |
| (1998)                            |                                   |
+-----------------------------------+-----------------------------------+
| Harris A. Pitlick, [The Mutation  | The recent decision in [Regents   |
| on the Description Requirement    | of the University of California   |
| Gene]{.underline}, [80 J. Pat. &  | v. Eli Lilly and                  |
| Trademark Off. Soc\'y 209, 209-10 | Co.]{.underline}, on top of       |
| (1998)]{.underline}               | [Fiers v. Revel]{.underline},     |
|                                   | decided only a few years before,  |
|                                   | are such extreme departures from  |
|                                   | conventional description          |
|                                   | requirement jurisprudence that    |
|                                   | the need for new thinking about   |
|                                   | the issue is now even more        |
|                                   | manifest. One problem may be      |
|                                   | nomenclature. As demonstrated     |
|                                   | later in the text, the term       |
|                                   | \"description requirement\" is a  |
|                                   | misnomer.                         |
+-----------------------------------+-----------------------------------+
| Kevin S. Rhoades, [The Section    | \[T\]here is in fact no           |
| 112 "Description Requirement" --  | justification for carving out a   |
| A Misbegotten Provision           | separate "description"            |
| Confirmed]{.underline}, 74 J.     | requirement from the "enablement" |
| Pat. & Trademark Soc'y 869,       | requirement in Section 112, first |
| 869-70 (1992)                     | paragraph, that the specification |
|                                   | contain an enabling disclosure of |
|                                   | how to make and use the           |
|                                   | invention. In brief, the language |
|                                   | and history of the statute        |
|                                   | support no such separate          |
|                                   | requirement, which fulfills no    |
|                                   | function or purpose not already   |
|                                   | served by the traditional         |
|                                   | enabling disclosure standard.     |
+-----------------------------------+-----------------------------------+

Neutrally Commenting on [Eli Lilly]{.underline} Written Description

+-----------------------------------+-----------------------------------+
| Citation                          | Quotation                         |
+-----------------------------------+-----------------------------------+
| Robert Greene Sterne et al., [The | It is clear that the written      |
| Written Description               | description requirement applies   |
| Requirement]{.underline}, 37      | to all technologies covered by    |
| Akron L. Rev. 231, 241 (2004)     | patent applications and is not    |
|                                   | limited to the unpredictable or   |
|                                   | \"complex\" arts. The impact of   |
|                                   | this principle is that the cost   |
|                                   | and difficulty of drafting patent |
|                                   | applications in any art has risen |
|                                   | significantly in recent years to  |
|                                   | adequately protect all variations |
|                                   | and permutations of the           |
|                                   | invention.                        |
+-----------------------------------+-----------------------------------+
| Sean A. Passino et al., [Written  | To avoid a § 112, first paragraph |
| Description Traps For Antibody    | rejection under the holding of    |
| Claims]{.underline}, 86 J. Pat. & | [Noelle]{.underline}, an          |
| Trademark Off. Soc\'y 317, 318-19 | applicant for a U.S. patent may   |
| (2004)                            | want to disclose a fully          |
|                                   | characterized antigen if the      |
|                                   | applicant wants written           |
|                                   | description support for a claim   |
|                                   | to an antibody defined by its     |
|                                   | binding affinity to the antigen.  |
|                                   | Broader antibody coverage may be  |
|                                   | obtained by demonstrating the     |
|                                   | claimed antibody\'s ability to    |
|                                   | recognize isoforms of the antigen |
|                                   | from one or more different        |
|                                   | species or by mapping the epitope |
|                                   | recognized by the antibody.\      |
|                                   | Furthermore, [Noelle]{.underline} |
|                                   | has implications wider than §     |
|                                   | 112, first paragraph rejections.  |
|                                   | The doctrine may be used against  |
|                                   | the USPTO, infringers alleging    |
|                                   | invalidity, and parties of a      |
|                                   | contested case. Under 35 U.S.C. § |
|                                   | 102, a patent or printed          |
|                                   | publication will not anticipate a |
|                                   | claim unless it \"describes\" the |
|                                   | claimed invention. If the courts  |
|                                   | take the position that a patent   |
|                                   | or printed publication fails to   |
|                                   | describe an embodiment for the    |
|                                   | purposes of § 112, first          |
|                                   | paragraph, then it is difficult   |
|                                   | to believe that the same patent   |
|                                   | or printed publication describes  |
|                                   | the same embodiment for the       |
|                                   | purposes of § 102.                |
|                                   |                                   |
|                                   | . . . Clearly, this area of the   |
|                                   | law is evolving.                  |
+-----------------------------------+-----------------------------------+
| Robert M. Schulman, [A Review of  | In the written description area,  |
| Significant 2003 Federal Circuit  | 2003 represented the first year   |
| Decisions Affecting Chemical,     | in which the court signaled a     |
| Pharmaceutical, and Biotech       | reversal of the trend it          |
| Inventions]{.underline}, 16 No. 3 | established in 1997, requiring    |
| J. Proprietary Rts. 1, 1 (2004)   | provision of specific sequences   |
|                                   | for applicants claiming           |
|                                   | biological molecules. The Federal |
|                                   | Circuit is not quite ready to     |
|                                   | reverse its                       |
|                                   | \"written-description-plus\"      |
|                                   | requirement for biotech           |
|                                   | inventions.                       |
+-----------------------------------+-----------------------------------+
| Lewis R. Clayton, [Inadequate     | Though the Rochester inventors    |
| Descriptions]{.underline}, 4/5/04 | made, as the district court       |
| Nat\'l L.J. 12, col. 1, 12, col.  | noted, \"significant discoveries  |
| 1+ (2004)                         | in this field,\" they did not     |
|                                   | take \"the last critical step\"   |
|                                   | of isolating the necessary        |
|                                   | compound, or \"developing a       |
|                                   | process through which one skilled |
|                                   | in the art would be directly      |
|                                   | led\" to it. Absent a reversal en |
|                                   | banc, those efforts will not be   |
|                                   | compensated under the patent      |
|                                   | laws.                             |
+-----------------------------------+-----------------------------------+
| Chandra Garry, [Enzo Biochem,     | The Federal Circuit in            |
| Inc. v. Gen-Probe,                | [Enzo]{.underline} decided for    |
| Inc.]{.underline}, 18 Berkeley    | the first time that the written   |
| Tech. L.J. 195, 208 (2003)        | description requirement may be    |
|                                   | satisfied by a biological         |
|                                   | deposit. At first glance, it      |
|                                   | appears that [Enzo]{.underline}   |
|                                   | lowers the written description    |
|                                   | standard applied by the court in  |
|                                   | [Lilly]{.underline}, as deposit   |
|                                   | seems an easy way to satisfy the  |
|                                   | written description requirement.  |
|                                   | Any such lowering of the written  |
|                                   | description standard, however, is |
|                                   | by and large illusory. The        |
|                                   | decision in [Enzo]{.underline}    |
|                                   | will likely be strictly limited   |
|                                   | to its facts. If not limited to   |
|                                   | its facts, the court\'s redefined |
|                                   | written description is not        |
|                                   | sufficiently explained by the     |
|                                   | court so as to provide an easily  |
|                                   | workable standard for future      |
|                                   | decisions.                        |
+-----------------------------------+-----------------------------------+
| Jeffery M. Duncan et al.,         | In the last six years, several    |
| [Practitioners Be Wary: The       | patents to biotech inventions     |
| Dangers of Functional             | that were otherwise valid have    |
| Descriptions in Biotech           | been struck down because the      |
| Inventions]{.underline}, 15 No.   | description of the invention,     |
| 10 Andrews Ent. Indus. Litig.     | often by functional terms, was    |
| Rep. 21 (2003)                    | found wanting.\                   |
|                                   | One difficulty for biotech patent |
|                                   | practitioners is that there are   |
|                                   | no bright line rules prescribing  |
|                                   | what is or is not an adequate     |
|                                   | written description. Instead, as  |
|                                   | the U.S. Court of Appeals for the |
|                                   | Federal Circuit has repeatedly    |
|                                   | stated, the satisfaction of the   |
|                                   | written description requirement   |
|                                   | is a fact- specific inquiry,      |
|                                   | decided on a case-by-case basis.  |
+-----------------------------------+-----------------------------------+
| [After Determining That a Seller  | This case \[[Moba]{.underline}\]  |
| of a Egg Processing Machine May   | highlights the state of flux at   |
| Have Induced Infringement of      | the Federal Circuit concerning    |
| Patent Claiming a Method Directed | the written description           |
| High-Speed Egg Processing, the    | requirement.                      |
| Federal Circuit Address the       |                                   |
| Written Description Requirement   |                                   |
| and the Lilly Case                |                                   |
| Again]{.underline}, 13 Fed.       |                                   |
| Circuit B.J. 179, 182 (2003)      |                                   |
+-----------------------------------+-----------------------------------+
| Andrea G. Reister, [Enablement &  | [Enzo]{.u                         |
| Written Description: Friend or    | nderline}/[Gen-Probe]{.underline} |
| Foe in Litigation?]{.underline},  | exemplifies the difficulty in     |
| 766 PLI/Pat 383, 405-6, 409       | annunciating the Federal          |
| (2003)                            | Circuit\'s standard for written   |
|                                   | description, and the dispute      |
|                                   | within the court over the purpose |
|                                   | of the written description        |
|                                   | requirement and how it relates to |
|                                   | the enablement requirement.       |
|                                   |                                   |
|                                   | \* \* \*                          |
|                                   |                                   |
|                                   | It remains to be seen whether the |
|                                   | [Lilly]{.underline}/[Enzo]{.u     |
|                                   | nderline}/[Gen-Probe]{.underline} |
|                                   | requirements for written          |
|                                   | description will survive, and     |
|                                   | supplant the cases that have      |
|                                   | dealt with written description in |
|                                   | the context of disputes relating  |
|                                   | to priority.                      |
+-----------------------------------+-----------------------------------+
| Janet E. Reed et al., [Written    | In its most recent treatments of  |
| Description: A Looser             | the first paragraph of 35 U.S.C.  |
| Requirement? The Federal Circuit  | 112, the U.S. Court of Appeals    |
| Has Been Edging Away from the     | for the Federal Circuit has edged |
| Heightened Standard That It Set   | away from the heightened written  |
| Out in the 1997 \"Lilly\'         | description requirement for       |
| Case]{.underline}, 6/16/03 Nat\'l | biotechnology patents articulated |
| L.J. S1, col. 1, S1, col. 1+      | in [Regents of the Univ. of       |
| (2003)                            | Calif. v. Eli Lilly &             |
|                                   | Co.]{.underline}, 119 F.3d 1559   |
|                                   | (Fed. Cir. 1997). This process    |
|                                   | has revealed dissenting opinions  |
|                                   | among the Federal Circuit judges, |
|                                   | which may only be resolved by en  |
|                                   | banc review of the written        |
|                                   | description requirement as a      |
|                                   | whole. As a result, the standard  |
|                                   | for satisfying the written        |
|                                   | description requirement remains   |
|                                   | elusive, leaving practitioners    |
|                                   | struggling to determine the level |
|                                   | of written description that will  |
|                                   | be deemed \"adequate\" to support |
|                                   | biotechnology patent claims.      |
|                                   |                                   |
|                                   | \* \* \*                          |
|                                   |                                   |
|                                   | Though en banc review of the      |
|                                   | written description requirement   |
|                                   | seems timely, the disparate       |
|                                   | perspectives of the Federal       |
|                                   | Circuit judges make the outcome   |
|                                   | difficult to predict. It is       |
|                                   | uncertain whether a major         |
|                                   | overhaul of statutory             |
|                                   | interpretation is in the works,   |
|                                   | or whether the current            |
|                                   | interpretation will remain        |
|                                   | substantially intact. The patent  |
|                                   | bar and the biotechnology         |
|                                   | industry will no doubt eagerly    |
|                                   | await resolution of the current   |
|                                   | ambiguity, accompanied, it is to  |
|                                   | be hoped, by pronouncement of a   |
|                                   | clear standard for written        |
|                                   | description to be applied by the  |
|                                   | PTO during patent prosecution and |
|                                   | by the courts in patent           |
|                                   | litigation.                       |
+-----------------------------------+-----------------------------------+
| Mary S. Consalvi, [The Enablement | With this decision \[[Enzo        |
| and Written Description           | Biochem]{.underline}\] and the    |
| Requirements]{.underline}, 766    | decision in [Amgen Inc. v.        |
| PLI/Pat 349, 377, 381 (2003)      | Hoeschst Marion                   |
|                                   | Roussel]{.underline}, 314 F.3d    |
|                                   | 1313 (Fed. Cir. 2003), it is      |
|                                   | clear that written description is |
|                                   | still in a state of uncertainty   |
|                                   | and ambiguity.                    |
|                                   |                                   |
|                                   | \* \* \*                          |
|                                   |                                   |
|                                   | The law of enablement and written |
|                                   | description under 35 U.S.C. §     |
|                                   | 112, first paragraph is           |
|                                   | constantly evolving and emerging. |
|                                   | At the present time, there is     |
|                                   | still a lot of uncertainty in the |
|                                   | area.                             |
+-----------------------------------+-----------------------------------+
| Anne Y. Brody, Ph.D., [Rochester  | This case touches on many         |
| v. Searle: Complying with the     | uncharted areas of biotechnology  |
| Written Description and           | patent law. With the emerging     |
| Enablement Requirements in        | fields of genomics and            |
| Early-Stage Drug                  | proteomics, the law has to keep   |
| Discovery]{.underline}, 22        | up with biotechnological          |
| Biotechnology L. Rep. 472, 474    | advances. In the University of    |
| (2003)                            | Rochester\'s pending appeal to    |
|                                   | the CAFC, the real issue for the  |
|                                   | written description requirement   |
|                                   | may depend on where in the time   |
|                                   | line of research and development  |
|                                   | a discovery turns into an         |
|                                   | invention. Is such a method of    |
|                                   | treatment claim valid only when a |
|                                   | selected group of compounds is    |
|                                   | identified? Or are the solutions  |
|                                   | (e.g., the drug compounds and     |
|                                   | their screening methods) obvious  |
|                                   | once the source of the problem is |
|                                   | determined? The determinative     |
|                                   | factor in the enablement          |
|                                   | requirement may be contingent on  |
|                                   | the definition of \"undue         |
|                                   | experimentation\" in the field of |
|                                   | drug development. The amount of   |
|                                   | guidance and what is undue        |
|                                   | experimentation change as         |
|                                   | technologies progress to          |
|                                   | standardize many laboratory       |
|                                   | techniques. For example, in       |
|                                   | recent years, high-throughput     |
|                                   | screening technologies have       |
|                                   | reduced time and effort           |
|                                   | scientists expend to conduct      |
|                                   | numerous parallel experiments     |
|                                   | simultaneously. Selecting a       |
|                                   | starting material and creating a  |
|                                   | pool of its variants for          |
|                                   | screening are now conventional    |
|                                   | procedures among the researchers  |
|                                   | in biotechnology.                 |
+-----------------------------------+-----------------------------------+
| Todd M. Oberdick, [Section 112,   | In light of [Gentry               |
| Paragraph 6 - Means Claim and     | Gallery]{.underline} and [Johnson |
| Limitation to Specific            | Worldwide]{.underline}, a patent  |
| Algorithm - Is This a Stricter    | practitioner may be tempted to    |
| Standard Than Gentry Gallery and  | omit a precise description of a   |
| Related Mechanical                | preferred embodiment of the       |
| Cases?]{.underline}, 22 Pace L.   | invention for fear of making      |
| Rev. 385, 390 (2002)              | \"crystal clear\" that a narrow   |
|                                   | claim interpretation was          |
|                                   | intended.                         |
+-----------------------------------+-----------------------------------+
| Lisa A. Karczewski, Comment:      | The Federal Circuit\'s trilogy of |
| [Biotechnological Gene Patent     | landmark biotech decisions in the |
| Applications: The Implications of | past decade have made an obvious  |
| the USPTO Written Description     | mark with respect to the future   |
| Requirement Guidelines on the     | of obtaining patent protection    |
| Biotechnology                     | for genetically engineered        |
| Industry]{.underline}, 31         | products and the specificity      |
| McGeorge L. Rev. 1043, 1086       | required for satisfying the       |
| (2000)                            | written description requirement.  |
|                                   | Having incorporated the reasoning |
|                                   | from these decisions into the     |
|                                   | methodology of its guidelines,    |
|                                   | only time will tell whether the   |
|                                   | USPTO\'s efforts will impede the  |
|                                   | patent application process for    |
|                                   | the biotechnology industry.       |
+-----------------------------------+-----------------------------------+
| Scott A. Chambers, ["Written      | While some practitioners and the  |
| Description" and Patent           | Patent and Trademark Office (PTO) |
| Examination Under the US Patent   | cannot ignore the law as          |
| and Trademark Office              | interpreted by the Court of       |
| Guidelines]{.underline}, IP       | Appeals for the Federal Circuit   |
| Litigator 9, 9(Sept./Oct. 2000)   | and must respond in a manner that |
|                                   | continues to protect the          |
|                                   | intellectual property interests   |
|                                   | of their clients. Moreover, the   |
|                                   | Federal Circuit's clarification   |
|                                   | of the written description        |
|                                   | requirement suggests that some    |
|                                   | broadly drawn patents may be      |
|                                   | vulnerable to attack for lack of  |
|                                   | written description.              |
+-----------------------------------+-----------------------------------+
| Cindy I. Liu, [Gentry Gallery,    | In [Gentry Gallery, Inc. v.       |
| Inc. v. Berkline                  | Berkline Corp.]{.underline}, the  |
| Corp.]{.underline}, 14 Berkeley   | Federal Circuit narrowed the      |
| Tech. L.J. 123, 123 (1999)        | scope of patents through the      |
|                                   | written description requirement   |
|                                   | of section 112 by announcing an   |
|                                   | omitted element test.             |
+-----------------------------------+-----------------------------------+
| Laurence H. Pretty, [The Recline  | It remains to be seen whether     |
| and Fall of Mechanical Genus      | [Gentry Gallery]{.underline} will |
| Claim Scope Under \"Written       | become a more influential         |
| Description\" in the Sofa         | precedent than [Utter v.          |
| Case]{.underline}, 80 J. Pat. &   | Hiraga]{.underline} in permitting |
| Trademark Off. Soc\'y 469, 479-80 | attack upon a genus claim in the  |
| (1998)                            | predictable arts by limiting      |
|                                   | patent protection to the species  |
|                                   | disclosed. . . . It may also be   |
|                                   | advisable to include a claim of   |
|                                   | extreme breadth as the first      |
|                                   | filed original claim even at the  |
|                                   | risk of presenting a claim that   |
|                                   | is highly likely to be rejected,  |
|                                   | in order to negate any inference  |
|                                   | that \"written description\" will |
|                                   | bar any broader claim later.      |
+-----------------------------------+-----------------------------------+

# **United States Court of Appeals for the Federal Circuit**

03-1304

UNIVERSITY OF ROCHESTER,

> Plaintiff-Appellant,

v\.

G.D. SEARLE & CO., INC., MONSANTO COMPANY,

PHARMACIA CORPORATION, and PFIZER INC.,

> Defendants-Appellees.

LINN, [Circuit Judge]{.underline}, with whom RADER and GAJARSA, [Circuit
Judges]{.underline}, join, dissenting from the court's decision not to
hear the case en banc.

The panel opinion in this case perpetuates the confusion our precedent
in [Lilly]{.underline} and [Enzo]{.underline} has engendered in
establishing "written description" as a separate requirement of 35
U.S.C. § 112, paragraph 1, on which a patent may be held invalid. That
precedent should be overturned. Accordingly, I respectfully dissent from
the court's decision not to hear this case en banc.

Section 112 of Title 35 of the United States Code requires a written
description of the invention, but the measure of the sufficiency of that
written description in meeting the conditions of patentability in
paragraph 1 of that statute depends solely on whether it enables any
person skilled in the art to which the invention pertains to make and
use the claimed invention and sets forth the best mode of carrying out
the invention. The question presented by 35 U.S.C. § 112, paragraph 1,
is not, "Does the written description disclose what the invention is?"
The question is, "Does the written description describe the invention
recited in the claims---themselves part of the specification---in terms
that are sufficient to enable one of skill in the art to make and use
the claimed invention and practice the best mode contemplated by the
inventor?" That is the mandate of the statute and is all our precedent
demanded prior to [Regents of the University of California v. Eli Lilly
& Co.]{.underline}, 119 F.3d 1559 (Fed. Cir. 1997).

Reading into paragraph 1 of section 112 an independent written
description requirement, divorced from enablement, sets up an inevitable
clash between the claims and the written description as the focus of the
scope of coverage. This is ill-advised. Surely there is no principle
more firmly established in patent law than the primacy of the claims in
establishing the bounds of the right to exclude. [See,
e.g.]{.underline}, [Aro Mfg. Co. v. Convertible Top Replacement
Co.]{.underline}, 365 U.S. 336, 339 (1961) ("\[T\]he claims made in the
patent are the sole measure of the grant."); [McClain v.
Ortmayer]{.underline}, 141 U.S. 419, 424 (1891) ("'The rights of the
plaintiff depend upon the claim in his patent, according to its proper
construction.'" (quoting [Masury v. Anderson]{.underline}, 16 F. Cas.
1087, 1088 (C.C.S.D.N.Y. 1873))); [White v. Dunbar]{.underline}, 119
U.S. 47, 52 (1886) ("The claim is a statutory requirement, prescribed
for the very purpose of making the patentee define precisely what his
invention is; and it is unjust to the public, as well as an evasion of
the law, to construe it in a manner different from the plain import of
its terms."); [Burns v. Meyer]{.underline}, 100 U.S. 671, 672 (1879)
("\[T\]he terms of the claim in letters-patent . . . define\[\] what the
office, after a full examination of previous inventions and the state of
the art, determines the applicant is entitled to."); [Merrill v.
Yeomans]{.underline}, 94 U.S. 568, 570 (1876) ("This distinct and formal
claim is, therefore, of primary importance, in the effort to ascertain
precisely what it is that is patented."); [Johnson & Johnston Assocs.
Inc. v. R.E. Serv. Co.]{.underline}, 285 F.3d 1046, 1052 (Fed. Cir.
2002) (en banc) ("Consistent with its scope definition and notice
functions, the claim requirement presupposes that a patent applicant
defines his invention in the claims, not in the specification. After
all, the claims, not the specification, provide the measure of the
patentee's right to exclude."); [SRI Int'l v. Matsushita Elec. Corp. of
Am.]{.underline}, 775 F.2d 1107, 1121 n.14 (Fed. Cir. 1985)
("Specifications teach. Claims claim."). The statute itself makes clear
that Congress intended the claims to define the scope of coverage. 35
U.S.C. § 112, ¶ 2 (2000) ("The specification shall conclude with one or
more claims particularly pointing out and distinctly claiming the
subject matter which the applicant regards as his invention.").

The primary role of the written description is to support the claims,
assuring that persons skilled in the art can make and use the claimed
invention. [Id.]{.underline} ¶ 1 ("The specification shall contain a
written description of the invention, and 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."); [see
also]{.underline} [Kennecott Corp. v. Kyocera Int'l, Inc.]{.underline},
835 F.2d 1419, 1421 (Fed. Cir. 1987) ("The purpose of the \[written\]
description requirement . . . is to state what is needed to fulfil the
enablement criteria."); [cf.]{.underline} [In re Barker]{.underline},
559 F.2d 588, 594 (CCPA 1977) (Markey, C.J., dissenting) ("The attempt
to create historical and current statutory support for a 'separate
description' requirement, which was solely a judicial (and unnecessary)
response to chemical cases in which appellants were arguing that those
skilled in the art 'might' make and use a claimed invention, is
mistaken.").

Construing section 112 to contain a separate written description
requirement beyond enablement and best mode creates confusion as to
where the public and the courts should look to determine the scope of
the patentee's right to exclude. Under the panel's analysis, a court
looks to the written description to determine the parameters of the
patentee's invention---under guidelines yet to be articulated---and then
determines if the claims, as properly construed, exceed those
parameters. [See]{.underline} [Univ. of Rochester v. G.D. Searle &
Co.]{.underline}, 358 F.3d 916, 922-23 (Fed. Cir. 2004) ("While it is
true that this court and its predecessor have repeatedly held that
claimed subject matter 'need not be described in haec verba' in the
specification to satisfy the written description requirement, it is also
true that the requirement must still be met in some way so as to
'describe the claimed invention so that one skilled in the art can
recognize what is claimed.'" (citations omitted)). There is simply no
reason to interpret section 112 to require applicants for patent to set
forth the metes and bounds of the claimed invention in two separate
places in the application. That is the exclusive function of the claims.

The burden of [Lilly]{.underline} and [Enzo]{.underline} has fallen on
the biotech industry disproportionately, but, as this decision makes
clear, the new-found written description requirement will affect all
fields of emerging technology. [Univ. of Rochester]{.underline}, 358
F.3d at 925 (rejecting a limitation of the [Lilly]{.underline} written
description doctrine to genetic inventions on the ground that "the
statute applies to all types of inventions"). When patent attorneys set
out to write patent applications, they do so for an educated
audience---those skilled in the art---and attempt to describe the
invention in a way that enables those of ordinary skill to make and use
the invention as claimed. Before the decision in [Lilly]{.underline},
the practicing bar had accepted and found workable the notion elucidated
in our precedent that § 112 requires a written description sufficient to
enable one of ordinary skill in the art to make and use the claimed
invention---i.e., enablement. [Lilly]{.underline} changed the landscape
and set in motion the debate the panel opinion in this case perpetuates.

As I commented in my dissent from the court's decision not to hear the
[Enzo]{.underline} case en banc, "Some have praised [Lilly]{.underline}
for maintaining the integrity of patent disclosures and for curbing
patent filings for inventions that have not yet been made but are just
nascent ideas. Others have been sharply critical of
[Lilly]{.underline}." [Enzo Biochem, Inc. v. Gen-Probe
Inc.]{.underline}, 323 F.3d 956, 989 (Fed. Cir. 2002) (Linn, J.,
dissenting). That debate continues to leave uncertain how inventions are
protected, how the United States Patent and Trademark Office discharges
its responsibilities, and how business is conducted in emerging fields
of law. These uncertainties will remain unless resolved by this court en
banc or by the Supreme Court. The issue is important, is ripe for
consideration, and deserves to be clarified, one way or the other. For
these reasons, I respectfully dissent from the court's refusal to
consider this case en banc.

####  {#section .unnumbered}

#### United States Court of Appeals for the Federal Circuit

03-1304

UNIVERSITY OF ROCHESTER,

Plaintiff-Appellant,

v\.

G.D. SEARLE & CO., INC., MONSANTO COMPANY, PHARMACIA CORPORATION, and
PFIZER INC.,

> Defendants-Appellees.

DYK, [Circuit Judge]{.underline}, concurring in the court's decision not
to hear the case [en]{.underline} [banc]{.underline}.

In my view the question of whether 35 U.S.C. § 112 contains a written
description requirement (separate from the enablement requirement) does
not merit [en]{.underline} [banc]{.underline} review. For the reasons
set forth in the panel opinion and in Judge Lourie's opinion concurring
in the denial of [en]{.underline} [banc]{.underline} review, I think it
is clear that the statute contains such a requirement -- applicable both
in the context of priority and validity disputes. In this particular
case the failure to satisfy that requirement was not even a close case.
The appellant simply did not invent, much less describe, what was
claimed.

My vote to deny [en]{.underline} [banc]{.underline} review, however,
should not be taken as an endorsement of our existing written
description jurisprudence. In my view we have yet to articulate
satisfactory standards that can be applied to all technologies. Future
panel opinions may provide the necessary clarity. If not, there may be a
time when [en]{.underline} [banc]{.underline} consideration of the
proper written description standards will be appropriate. But this is
neither the right time, nor the right case, in which to consider those
difficult questions.

[^1]: The Regents of the University of California, et al. filed an amici
    curiae brief.

[^2]: Circuit Judges Newman, Rader, Bryson, Gajarsa, and Linn voted in
    favor of [en banc]{.underline} reconsideration. Chief Judge Mayer
    and Circuit Judges Michel, Lourie, Clevenger, Schall, Dyk, and Prost
    voted against [en banc]{.underline} reconsideration.

[^3]: This new validity requirement conflicts with binding precedent
    because the CCPA made clear that original claims are part of the
    original disclosure of an invention and thus have no "description"
    problems. [In re Koller]{.underline}, 613 F.2d 819, 823 (CCPA 1980)
    ("\[O\]riginal claims constitute their own description."); [In re
    Smith]{.underline}, 481 F.2d 910, 914 (CCPA 1973) ("Where the claim
    is an original claim, the underlying concept of insuring disclosure
    as of the filing date is satisfied, and the description requirement
    has likewise been held to be satisfied."); [In re
    Gardner]{.underline}, 475 F.2d 1389, 1391 (CCPA 1973) ("Claim 2,
    which apparently was an original claim, in itself constituted a
    description in the original disclosure . . . . Nothing more is
    necessary for compliance with the description requirement.")

[^4]: This opinion will not repeat the points made earlier about the
    legal sufficiency of the [Eli Lilly]{.underline} doctrine. Some of
    those points include: First, the statutory language and legal
    precedents make enablement the only substantive test (other than
    best mode) in the first paragraph of § 112. [Enzo
    Biochem]{.underline}, 323 F.3d at 977. Second, this court's
    predecessor first separated written description from enablement in
    1967, but only to police priority. [Id.]{.underline} Third, this
    court and its predecessor consistently limited the written
    description requirement to priority cases, expressly equating the
    proscription on new matter with written description.
    [Id.]{.underline} at 977-79. Lastly, the vague and ill-defined
    written description requirement threatens to supplant the
    well-established enablement requirement, which disproportionately
    affects biotech inventions. [Id.]{.underline} at 981-83. 

[^5]: An appendix to this opinion summarizes this academic commentary.

[^6]: Indeed the United States notes that the current statute requires
    "a written description of the invention, and [of the manner and
    process of making and using it]{.underline}, in such full clear,
    concise, and exact terms [as to]{.underline} enable \[the
    invention\]." 35 U.S.C. § 112, ¶ 1 (emphasis added). As the United
    States noted, "A straightforward reading of the text of section 112
    suggests that the test for an adequate written description is
    whether it provides enough written information for others to make
    and use the invention." Brief of Amicus Curiae United States at 5,
    [Enzo Biochem, Inc. v. Gen Probe, Inc.]{.underline}, 323 F.3d 956
    (Fed. Cir. 2002).

[^7]: Moreover, the pre-1967 CCPA cases mentioned in
    [Rochester]{.underline} also shed little light on the modern written
    description requirement. For instance, [Jepson]{.underline} does not
    evince support for [Eli Lilly]{.underline}. Rather,
    [Jepson]{.underline}, which does not expressly mention written
    description at all, decided an interference -- a priority dispute --
    between an application with an earlier filing date and an issued
    patent with a later filing date. The CCPA held that because the
    earlier application did not support the claims that were copied from
    the later patent, the patent was entitled to priority. [Jepson v.
    Coleman]{.underline}, 314 F.2d 533 (CCPA 1963). Thus,
    [Jepson]{.underline}, if at all relevant to written description, was
    a priority case in the traditional mode of written description
    jurisprudence. The CCPA decided the [Moore]{.underline} case on
    obviousness grounds; the description commentary in that case is
    dicta. [In re Moore]{.underline}, 155 F.2d 379, 381 (CCPA 1946)
    (noting that the claims were "properly rejected on the prior art").
    The CCPA decided the [Sus]{.underline} case under paragraph 2 of §
    112, not paragraph 1. [In re Sus]{.underline}, 306 F.2d 494, 496
    (CCPA 1962). The reason [Sus]{.underline} and [Moore]{.underline} do
    not appear on the "written description" landscape is because
    subsequent case law made it clear that, outside the priority
    context, the substantive test for compliance with the first
    paragraph of § 112 is enablement. [In re Borkowski]{.underline}, 422
    F.2d 904, 909 (CCPA 1970). Indeed, [Rochester]{.underline} seems to
    do a disservice to the CCPA's own acknowledgement that Judge Rich
    inaugurated the written description requirement to police priority
    in 1967. [In re Rasmussen]{.underline}, 650 F.2d 1212, 1214 (CCPA
    1981).