By Donald Zuhn and Paul Berghoff —

Few substantive areas of patent law have engendered the
warmth of debate that routinely characterizes the written description
requirement.  The controversy begins with
the arguably ambiguous language of Section 112 (does a separate written
description requirement even exist?) and is only exacerbated by the factually
intensive nature of the legal inquiry.  Jurists who seek uniformity of law and predictability of application
should steer well clear of the written description requirement.  Those who must confront it should do so with
flexibility and good humor.

Section 112 of the Patent Act describes what must be
contained in a patent specification.  The
first paragraph of this section provides that:

[t]he 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, and shall set forth the best mode contemplated by the
inventor of carrying out his invention.(1)

This statutory language has been construed as mandating
satisfaction of three separate and independent requirements referred to as the
"written description requirement," the "enablement
requirement," and the "best mode requirement."(2)  An inventor, therefore, must both describe
the claimed invention adequately and enable its reproduction and use,(3) as well
as set forth the best mode of carrying it out.

The words "written description" first appeared
in the Patent Act of 1793.  Because
including claims in a patent did not become a statutory requirement until 1870,
the written description served "to distinguish [the invention] from all
other things before known or used."(4)  In 1822, the Supreme Court determined that the written description of a
patent served to enable an invention as well as to provide the public with
notice of that invention – the latter function being eventually assigned to the
claims.(5)  It was not until 1967, however,
that the Court of Customs and Patent Appeals (CCPA) interpreted the first
paragraph of section 112 as containing separate written description and
enablement requirements.(6)  As first set
forth by the CCPA, the written description requirement merely served to prevent
new matter from being introduced into claims by amendment, and therefore, was
no more than "a priority policeman."(7)  Since 1967, however, the purpose and meaning of the written description
requirement has evolved dramatically as the Court of Appeals for the Federal
Circuit and its predecessor courts have rendered decisions in cases where
compliance with this requirement has been at issue.  The body of recent case law addressing the
written description requirement has been described as one "that is of significant
importance to the biotech industry [that] affects how patent applications are
drafted, prosecuted and will be enforced in this and other areas of emerging
technology."(8)

The written description requirement has been interpreted
more broadly than merely requiring that an inventor explain in writing how to
make and use an invention.  Rather, the
requirement demands that the inventor "also convey with reasonable clarity
to those skilled in the art that, as of the filing date sought, he or she was
in possession of the invention."(9)  An inventor must describe an invention with such clarity that one of
ordinary skill in the art is convinced that, at the time the application was
filed, the inventor actually possessed that which is deemed worthy of patent
protection.(10)  In other words, the written
description requirement is satisfied when a patent specification describes an
invention in sufficient detail such that one skilled in the art can clearly
conclude that "the inventor invented the claimed invention."(11)  Viewed this way, the written description
requirement is more than just "a priority policeman;" it serves the
important purpose of preventing an applicant from asserting that he invented
that which he did not.(12)

Although the Federal Circuit has warned that each case
involving the issue of written description "must be decided on its own
facts" and, therefore, that "the precedential value of cases in this
area is extremely limited,"(13) three of the Court’s decisions have greatly
informed this area of U.S. patent law, and more particularly the issue of
written description in applications directed to biotechnological inventions:
Fiers v. Revel(14); Regents of the University of California v. Eli Lilly &
Co.(15); and Enzo Biochem, Inc. v. Gen-Probe Inc.(16)  The written description requirement in the
context of biotechnological inventions has been addressed more recently in
Amgen Inc. v. Hoechst Marion Roussel, Inc.(17); Noelle v. Lederman(18); and
University of Rochester v. G.D. Searle & Co.(19)

Fiers involved an appeal from a decision of the Patent
and Trademark Office Board of Patent Appeals and Interferences in a three-way
interference proceeding over claims to DNA encoding human fibroblast beta-interferon.  One of the three interference parties had disclosed in its application a
method for isolating a fragment of the DNA encoding beta-interferon and a method for isolating the mRNA encoding human
beta-interferon using this fragment, but had not disclosed the complete DNA sequence encoding human beta-interferon.  The Board determined that this party’s application did not contain a
written description of a DNA encoding human
beta-interferon since the application did not disclose the nucleotide sequence
or "an intact complete gene."(20)

The Federal Circuit affirmed the Board’s determination,
holding that "[a]n adequate written description of a DNA requires more than a mere statement that it is part of the invention and
reference to a potential method for isolating it; what is required is a
description of the DNA itself."(21)  The disclosure of a method of isolating a DNA,
absent the disclosure of its complete sequence, therefore, failed to
"reasonably convey to the artisan that the inventor had possession at that
time of the . . . claimed subject matter."(22)  In reaching this decision, the Court reasoned
that the disclosure of a workable method for preparing a DNA did not establish a conception of the DNA,
and thus, could not satisfy the written description requirement. The Court, relying on its earlier decision in
Amgen Inc. v. Chugai Pharmaceutical Co., noted that "when an inventor is
unable to envision the detailed chemical structure of the gene so as to
distinguish it from other materials, as well as a method for obtaining it,
conception has not been achieved until reduction to practice has occurred,
i.e., until after the gene has been isolated."(23)  Thus, "if a conception of a DNA requires a precise definition, such as by structure, formula, chemical name, or
physical properties . . . then a description also requires that degree of specificity,"
since "one cannot describe what one has not conceived."(24)

The Fiers decision explicitly informed the decision of
both the District Court and the Federal Circuit in Eli Lilly.  In Eli Lilly, the Regents of the University of California appealed a lower
court’s finding that Eli Lilly’s production of recombinant DNA human insulin products did not infringe two University of California patents, and further,
that one of the patents was invalid.  At
trial, Eli Lilly asserted that the University of California’s claims to human
proinsulin DNA were invalid because the
inventors failed to provide the requisite written description of the claimed
subject matter.  The University of
California countered that by identifying the rat insulin DNA sequence, it was entitled to claim all vertebrate and mammalian insulin DNA sequences, and in particular that by disclosing the rat sequence, the human
amino acid sequence, and a method for isolating the human sequence, it was
permitted to claim human insulin DNA.  Thus, at issue was whether isolation and
characterization of one species allowed an inventor to claim a genus of which
that species is a member, as well as other species from that genus.(25)  The District Court determined that the
"patent [in suit] adequately describes only the rat insulin cDNA"
because "the isolation and characterization of the proinsulin cDNA from
one member of a genus is not sufficient to support claims to the insulin cDNA
of thousands and thousands of other species from that genus."(26)  As a consequence of its analysis, the
District Court found the University of California’s claims to
vertebrate, mammalian, and human insulin invalid.

In reviewing the lower court’s decision, the Federal
Circuit noted that "[d]escribing a method of preparing a cDNA or even
describing the protein that the cDNA encodes . . . does not necessarily
describe the cDNA itself."(27)  The
Court determined that since "a cDNA is not defined or described by the
mere name ‘cDNA,’ even if accompanied by the name of the protein that it
encodes," an adequate written description of that DNA often "requires a kind of specificity usually achieved by means of the
recitation of the sequence of nucleotides that make up the DNA."(28)  The Court found, therefore, that because the University of California’s specification did
not disclose the human insulin DNA sequence,
it did not fulfill the written description requirement in support of a claim to
human insulin DNA.

Turning to the question of whether the disclosure of the
rat insulin DNA sequence adequately
described the genus of vertebrate insulin DNA sequences or that of mammalian insulin DNA sequences, the Court held that "a generic statement such as ‘vertebrate
insulin cDNA’ or ‘mammalian insulin cDNA,’ without more, is not an adequate
written description of the genus because it does not distinguish the claimed
genus from others, except by function," and further, "does not define
any structural features commonly possessed by members of the genus that
distinguish them from others."(29)  The Court found that the University of California’s disclosure of a
single species did not adequately describe a broad genus, reasoning that in
cases "where there is unpredictability in performance of certain species
or subcombinations other than those specifically enumerated, one skilled in the
art may be found not to have been placed in possession of a genus."(30)  However, because inventors are not required
to disclose every species encompassed by their claims even in an unpredictable
art, the Court held that:

[a] description of a genus of cDNAs may be achieved by
means of a recitation of a representative number of cDNAs, defined by
nucleotide sequence, falling within the scope of the genus or of a recitation
of structural features common to the members of the genus, which features
constitute a substantial portion of the genus."(31)

The next opportunity for the Court to explore the
contours of the written description requirement as it is applied to
biotechnological inventions was the Enzo Biochem case.  Enzo Biochem involved an appeal of a District
Court decision in an infringement action granting the accused infringers’
motion for summary judgment that Enzo Biochem’s claims were invalid for failure
to meet the written description requirement.  The subject matter of the patent at issue in
this case related to nucleic acid probes that selectively hybridize to the
genetic material of the bacteria that cause gonorrhea, Neisseria gonorrhoeae,
and not to the genetic material of a closely related bacterial species,
Neisseria meningitidis.  Enzo Biochem had
derived three such probes, and deposited the probes in the form of a
recombinant DNA molecule within an E. coli
bacterial host with a suitable biological depository (i.e., one complying with
37 C.F.R. § 1.803).  Enzo Biochem’s
claims were directed to a composition comprising the deposited probes,
compositions comprising probes that bind to N. gonorrhoeae in a preferential
ratio of "greater than about five" with respect to N. meningitidis (a
genus of compositions that includes the deposited probes), and assays for
detecting N. gonorrhoeae using these compositions.  The District Court determined that reference
to the deposited probes in the specification did not inherently disclose that
the inventors were in possession of the claimed sequences, and that a
composition of matter defined only by its biological activity or function
(i.e., the ability to hybridize to N. gonorrhoeae in a preferential ratio of
"greater than about five" with respect to N. meningitidis) did not
adequately describe that composition, and therefore, found the patentee’s
claims invalid.

The Federal Circuit initially upheld the District Court’s
determination that reference to the deposited probes in the specification did
not inherently disclose that the inventors were in possession of the claimed
sequences, asserting that "a deposit is not a substitute for a written
description of the claimed invention."(32)  The Federal Circuit also agreed with the lower court’s determination
that a composition of matter defined only by its biological activity or
function did not adequately describe that composition, asserting that the
"description of the ability of the claimed probe to bind to N. gonorrhoeae
may describe the probe’s function, [but] it does not describe the probe
itself."(33)  The Court noted that
Enzo Biochem was merely claiming "anything that works, without defining
what works."(34)

In a lengthy dissent, Judge Dyk questioned the majority’s
refusal to allow an inventor to satisfy the written description requirement by
making a biological deposit, contending that "[a] description by reference
to the deposited sample provides a precise and unmistakably clear description
of the invention that is accessible to the public."(35)  Judge Dyk also questioned the majority’s
determination that the ability of a probe composition to preferentially
hybridize to the DNA of a particular
bacterial species was only a description of that composition’s biological
activity or function.  Instead, Judge Dyk
argued that the distinguishing property of the claimed nucleotide sequences (to
hybridize to the DNA of a particular
bacterial species) was "a direct result of the structure of the nucleotide
sequence."(36)  Finally, Judge Dyk
also questioned the correctness of the Court’s earlier decision in Eli Lilly,
contending that the Court had departed from the general rule that an inventor
satisfies the written description requirement by "’convey[ing] with
reasonable clarity to those skilled in the art that, as of the filing date
sought, he or she was in possession of the invention,’ and imposing a unique
written description requirement in the field of biotechnology."(37)

As it turns out, Judge Dyk’s views, at least with regard
to the deposit and hybridization questions, ultimately prevailed.  A little more than three months after
reaching the decision affirming the District Court’s finding of invalidity, the
Federal Circuit granted Enzo Biochem’s petition for rehearing, vacated its
earlier decision, and remanded the case back to the lower court to determine
whether Enzo Biochem had adequately described the claimed probe compositions
and assays.(38)  With regard to its earlier
assertion that a biological deposit could not satisfy the written description
requirement, the Court held that "reference in the specification to a
deposit in a public depository, which makes its contents accessible to the
public when it is not otherwise available in written form, constitutes an
adequate description of the deposited material sufficient to comply with the
written description requirement."(39)  Moreover, with regard to its earlier assertion that the ability of a
probe composition to preferentially hybridize to the DNA of a particular bacterial species was only a description of that composition’s
biological activity or function, the Court noted that "[i]t is not correct
. . . that all functional descriptions of genetic material fail to meet the
written description requirement."(40)  In fact, the Court was now of the belief that under the Patent and Trademark
Office’s Written Description Guidelines,(41) Enzo Biochem could satisfy the
written description requirement for all of its claims "if the functional
characteristic of preferential binding to N. gonorrhoeae over N. meningitidis
were coupled with a disclosed correlation between that function and a structure
that is sufficiently known or disclosed."(42)

Concurrent with the Federal Circuit’s decision to vacate
its earlier decision, the Court also declined to hear the case en banc.(43)  This opinion, having no precedential value
outside the Enzo Biochem litigation, is nonetheless instructive of the Federal
Circuit judges’ view of the present state of written description
jurisprudence.  Judge Lourie, who
authored both of the Court’s Enzo Biochem opinions, reasserted that
"simply acknowledging the presence of a DNA that serves a particular function, whose existence has been postulated since,
perhaps, Mendel, plus a general process for finding it, is not a description of
the DNA," but rather "is a
research plan at best, and does not show ‘possession’ of any
invention."(44)  Judge Lourie also
asserted that "written description law . . . is sound and does not need
revision,"(45) a position countered by Judge Rader’s opinion that both Eli
Lilly and Enzo Biochem "have purported to create a new disclosure doctrine
[from the written description requirement] that supplants [the] enablement
[requirement]."(46)  Judge Dyk once
again questioned the correctness of the Court’s decision in Eli Lilly, but
believed that the Court would "benefit from further percolation of these
issues."(47)  Judge Linn noted that
because the Court had not taken a clear and uniform position regarding the
purpose and meaning of the written description requirement, "the panel [in
Enzo Biochem] conflates and perpetuates the confusion our precedent has
engendered between written description as a separate requirement
("possession of the invention") – an issue relevant to priority – and
enablement – an issue relevant to the sufficiency of the disclosure."(48)  Perhaps of greater interest to an inventor
(or attorney) wishing to draft a patent application that satisfies the written
description requirement, Judge Lourie outlined a process by which such an
application might be prepared:

[W]hat one usually does first in making or isolating a
chemical or chemical-related invention is to obtain a specific material or
materials.  One then broadens the concept
to extend it as far as one envisions that other materials will have the same utility
and can be similarly made.  That
broadened concept becomes the genus in a patent application that is both the
broadest statement constituting a written description and usually claim 1.  One then elaborates to fill in the genus with
representative examples of compounds or substances that fall within the
genus.  That is part of the written
description needed to support the generic claim.(49)

This has not been the last word from the Federal Circuit
on the written description question: the Court has more recently addressed the
issue in several other decisions, each of which further explicate the Court’s
views.  One such case is Amgen Inc. v.
Hoechst Marion Roussel, Inc., where Hoechst Marion Roussel, Inc. and
Transkaryotic Therapies, Inc. appealed a lower court’s finding that, inter alia,
Amgen’s claims for producing human erythropoietin in vertebrate and mammalian
cells were not invalid.  The District
Court determined that the detailed descriptions in Amgen’s application of
erythropoietin production in cell lines derived from two mammalian species
(i.e., monkey COS-1 and hamster CHO cells) informed those of skill in the art
that Amgen possessed an invention encompassing erythropoietin production in all
mammalian cells grown in culture.(50)  In
affirming the lower court’s determination, the Federal Circuit noted that the
instant case could be distinguished from both Eli Lilly and Enzo Biochem
"because the claim terms at issue here are not new or unknown biological
materials that ordinarily skilled artisans would easily miscomprehend."(51)  In comparing the generic language of the
claims in Eli Lilly (i.e., vertebrate insulin cDNA and mammalian insulin cDNA)
with the generic language of the claims in this case (i.e., vertebrate cells
and mammalian cells), the Court determined that only in the latter situation do
"the words ‘vertebrate’ and ‘mammalian’ readily ‘convey[] distinguishing
information concerning [their] identity’ such that one of ordinary skill in the
art could ‘visualize or recognize the identity of the members of the genus.’"(52)

Another recent Federal Circuit case, Noelle v. Lederman,
involved an appeal from a decision of the Board of Patent Appeals and
Interferences in an interference proceeding related to an antibody (CD40CR
antibody) that represses cell-to-cell signaling interaction between helper
T-cells and B-cells.  The Court affirmed
the Board’s rejection of Noelle’s claims to the human CD40CR antibody, noting
that while Noelle’s specification provided an adequate description of the mouse
CD40CR antibody, it failed to satisfy the written description requirement for
the human antibody because it did not disclose the structural elements of the
human CD40CR antibody or its antigen.(53)  The Court stated that Noelle was "attempt[ing] to define an unknown
by its binding affinity to another unknown."(54)

While the Court in Noelle acknowledged that "a
patentee of a biotechnological invention cannot necessarily claim a genus after
only describing a limited number of species because there may be
unpredictability in the results obtained from species other than those
specifically enumerated," it also recognized the suggestion set forth in
Enzo Biochem that the written description requirement could be met for all of
the claims in a patent if the functional characteristic of the claimed
invention were coupled with a disclosed correlation between that function and a
structure that is sufficiently known or disclosed.(55)  In the eyes of the Noelle Court, the Enzo
Biochem Court had "adopted the [Written Description] Guidelines as persuasive
authority for the proposition that a claim directed to ‘any antibody which is
capable of binding to antigen X’ would have sufficient support in a written
description that disclosed ‘fully characterized antigens.’"(56)  As a result, the Court determined that
"as long as an applicant has disclosed a ‘fully characterized antigen,’
either by its structure, formula, chemical name, or physical properties, or by
depositing the protein in a public depository, the applicant can then claim an
antibody by its binding affinity to that described antigen."(57)  Because Noelle had not disclosed a fully
characterized human CD40CR, he was prohibited from claiming the human CD40CR
antibody by its binding affinity to that antigen.

The most recent case informing the Court’s interpretation
of the meaning of the written description requirement is University of Rochester v. G.D. Searle &
Co.  In this case, the University of
Rochester appealed the District Court’s finding that its patent was
invalid.  The patent in suit related to a
novel pain relief medication that does not produce certain undesirable side
effects, particularly stomach irritation, associated with many other pain
relievers including such staples as aspirin, acetominophen, and ibuprofen.  Researchers at the University of Rochester
had discovered the existence and separate functions of two distinct enzymes
(cyclooxygenases), referred to as COX-1 and COX-2.  While COX-1
is expressed in and serves a beneficial role in the stomach, COX-2
is expressed in response to inflammatory stimuli and is thought to be
responsible for the inflammation and accompanying pain associated with diseases
such as arthritis.  University of
Rochester researchers, therefore, theorized that if a method were found for
inhibiting the activity of only COX-2,
without affecting COX-1 activity, it would
be possible to provide relief from pain and inflammation without the
gastrointestinal side effects associated with conventional pain relievers that
affect the activity of both COX-1 and COX-2. The claims of the patent in suit are directed
to a "method for selectively inhibiting PGHS-2 [COX-2]
activity in a human host" in which "the activity of PGHS-1 [COX-1]
is not inhibited."  On the day that
the University of Rochester patent issued, the University sued G.D. Searle
& Co., Inc., Monsanto Co., Pharmacia Corp., and Pfizer Inc., alleging that
the defendants’ sale of its COX-2 inhibitors
CELEBREX and BEXTRA for treatment of inflammation infringed the University of
Rochester patent.

The issue at trial was "whether a written
description of a claimed method of treatment is adequate where a compound that
is necessary to practice that method is described only in terms of its
function, and where the only means provided for finding such a compound is essentially
a trial-and-error process."(58)  The
District Court determined that such a description was not adequate, and that
the University of Rochester’s
specification lacked "any suggestion that the inventors had identified so
much as one compound that would be suitable for use in practicing the claimed
invention."(59)  The Court added that
the specification "contains no information by which a person of ordinary
skill in the art would understand that the inventors possessed the claimed
invention," and at best, "simply indicates that one should run tests
on a wide spectrum of compounds in the hope that at least one of them will
work."(60)  The Court stated that:

It means little to "invent" a method if one
does not have possession of a substance that is essential to practicing that
method.  Without that substance, the
claimed invention is more theoretical than real; it is, as defendants argue,
akin to "inventing" a cure for cancer by utilizing a substance that
attacks and destroys cancer cells while leaving healthy cells alone. Without possession of such a substance, such
a "cure" is illusory, and there is no meaningful possession of the
method.(61)

Finally, the Court noted that it was not persuaded by the
University of Rochester’s contention that because the claims of the patent in
suit were directed to a method of selectively inhibiting COX-2
activity rather than to a DNA sequence, the
written description standards set forth in Fiers, Eli Lilly, and Enzo Biochem
did not apply.(62)

In affirming the lower court’s determination of
invalidity, the Federal Circuit agreed with the University of Rochester that the University’s
case differed from Fiers, Eli Lilly, and Enzo Biochem because those cases
related to genetic material and one before the Court did not.  However, the Court found this distinction to
be unhelpful since "[i]t is irrelevant; the statute applies to all types
of inventions."(63)  In analyzing the
compounds of the claimed methods in view of the structure-function test set
forth in Enzo Biochem and reasserted in Noelle, the Court noted that in
contrast to complementary nucleotide sequences, which may be readily envisioned
given the sequence of a single strand of DNA or RNA, "[e]ven with the
three-dimensional structures of enzymes such as COX-1
and COX-2 in hand, it may . . . not be
within the ordinary skill in the art to predict what compounds might bind to
and inhibit them."(64)

Although the Federal Circuit has warned that each case
involving the issue of written description, "must be decided on its own
facts," and therefore, that "the precedential value of cases in this
area is extremely limited,"(65) in fact, the Court’s decisions in these
cases (Fiers, Eli Lilly, Enzo Biochem, Amgen Inc., Noelle, and University of
Rochester), have added greatly to our understanding of how the Court will apply
the written description requirement in applications directed to
biotechnological inventions.  However, it
is also clear that the written description issue is far from being settled law,
and that in applications directed to biotechnological inventions, it will no
doubt "benefit from further percolation,"(66) if not long-term brewing.

Footnotes:
(1) 35 U.S.C. § 112 (2003).
(2) University of Rochester v. G.D. Searle & Co., 358
F.3d 916, 921 (Fed. Cir. 2004).
(3) Amgen Inc. v.
Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1330 (Fed. Cir. 2003).
(4) Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed. Appx.
439, 446 (Fed. Cir. 2002) (Rader, J., dissenting) (citing Patent Act of 1793).
(5) Id. (citing Evans v. Eaton, 20 U.S. 356 (1822)).
(6) In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967).
(7) Enzo Biochem, Inc., 42 Fed. Appx. at 447 (Rader, J.,
dissenting).
(8) Id. at 458 (Linn, J., dissenting).
(9) Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64
(Fed. Cir. 1991) (emphasis added).
(10) University of Rochester v. G.D. Searle & Co., 249
F. Supp. 216, 218 (W.D.N.Y. 2003), aff’d, 358 F.3d 916 (Fed. Cir. 2004).
(11) Regents of the University of California v. Eli Lilly
& Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997) (citing Lockwood v. American
Airlines, Inc., 107 F.3d 1565, 1572 (1997)).
(12) Amgen Inc., 314 F.3d at 1330.
(13) Vas-Cath Inc., 935 F.2d at 1562.
(14) 984 F.2d 1164 (Fed. Cir. 1993).
(15) 119 F.3d 1559 (Fed. Cir. 1997).
(16) 296 F.3d 1316 (Fed. Cir. 2002).
(17) 314 F.3d 1313 (Fed. Cir. 2003).
(18) 355 F.3d 1343 (Fed. Cir. 2004).
(19) 358 F.3d 916 (Fed. Cir. 2004).
(20) Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993).
(21) Id.
(22) Id. (citing Vas-Cath Inc., 935 F.2d at 1563).
(23) Id. at 1169 (citing Amgen Inc. v. Chugai
Pharmaceutical Co., 927 F.2 1200, 1206 (Fed Cir. 1991)).
(24) Id. at 1171.
(25) Regents of the University of California v. Eli Lilly
& Co., 39 U.S.P.Q.2d (BNA) 1225 (S.D. Ind. 1995), aff’d in part, rev’d in
part, 119 F.3d 1559 (Fed. Cir. 1997).
(26) Id.
(27) Regents of the University of California, 119 F.3d at
1567.
(28) Id. at 1568-69.
(29) Id. at 1568.
(30) Id. (citing In re Smythe, 480 F.2d 1376, 1383
(C.C.P.A. 1973)).
(31) Id. at 1568-69.
(32) Enzo Biochem, Inc. v. Gen-Probe Inc., 62 U.S.P.Q.2d
(BNA) 1289, 1295 (Fed. Cir. 2002), vacated, 296 F.3d 1316 (Fed. Cir. 2002).
(33) Id. at 1292.
(34) Id. at 1293.
(35) Id. at 1299 (Dyk, J., dissenting).
(36) Id. at 1298 (Dyk, J., dissenting).
(37) Id. at
1297 (Dyk, J., dissenting).
(38) Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316
(Fed. Cir. 2002).
(39) Id. at
1325.
(40) Id. at
1324.
(41) Guidelines for Examination of Patent Applications
Under the 35 U.S.C. 112, P1, "Written Description" Requirement, 66
Fed. Reg. 1099 (2001)
(42) Enzo Biochem, Inc., 296 F.3d at 1324-25.
(43) Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed. Appx.
439 (Fed. Cir. 2002).
(44) Enzo Biochem, Inc., 42 Fed. Appx. at 443 (Lourie, J.,
concurring).
(45) Id. at
440 (Lourie, J., concurring).
(46) Id. at
453 (Rader, J., dissenting).
(47) Id. at
445 (Dyk, J., concurring).
(48) Id. at
457 (Linn, J., dissenting).
(49) Id. at
443-44 (Lourie, J., concurring).
(50) Amgen Inc. v. Hoechst Marion Roussel, Inc., 126 F.
Supp. 2d 69, 148-49 (D. Mass. 2001), aff’d in part, vacated in part, 314 F.3d
1313 (Fed. Cir. 2003).
(51) Amgen Inc., 314 F.3d at 1330, 1332.
(52) Id. at
1332 (citing Regents of the University of California,
119 F.3d at 1567-68).
(53) Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir.
2004).
(54) Id.
(55) Id. at
1349-50.
(56) Id. at
1349.
(57) Id.
(58) University of Rochester,
249 F. Supp. at 221.
(59) Id. at
225.
(60) Id. at
224.
(61) Id. at
225.
(62) Id. at
228.
(63) University of Rochester,
358 F.3d at 925.
(64) Id.
(65) Vas-Cath Inc., 935 F.2d at 1562.
(66) Enzo Biochem, Inc., 42 Fed. Appx. at 445 (Dyk, J.,
concurring).

This article was originally presented at the Midwestern Biotech Intellectual Property Law Symposium on June 3-4, 2004.