href="http://www.metrocorpcounsel.com/current.php?artType=view&EntryNo=1522">Part
II of this article appears in the August 2004 issue of
The
Metropolitan Corporate Counsel.This article discusses the most recent decision of the United States Court
of Appeals for the Federal Circuit on the question of whether Section 112,
paragraph 1, of the United States Patent Act, Title 35, contains a separate
"written description" requirement, apart from the requirements of enablement and
best mode. This issue has been the subject of substantial controversy, and the
Federal Circuit's latest decision addressing the issue in University of
Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004)
("Rochester"), concludes that Section 112, paragraph 1, of the Patent Act does
indeed contain a separate requirement that a patent contain a written
description of the invention "sufficient ...to show one of ordinary skill in the
art that the inventor possessed the claimed invention at the time of filing."
Rochester, 358 F.3d at 928. This issue has particular relevance to the
pharmaceutical and biotechnology industries, where the requirement has led to a
number of findings of patent invalidity when a claim broadly covers subject
matter but lacks a description of the specific compound or composition
subsequently alleged to infringe.
The Statute
Section 112, paragraph 1, of the Patent Act provides:
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, and shall set
forth the best mode contemplated by the inventor of carrying out his invention.
35 U.S.C. §112, 1. There has long been an assumption that the statute
contains three separate requirements for the specification of a patent: a
written description of the claimed invention; enablement to make and use the
invention; and a description of the best mode of carrying out the invention.
Failure to satisfy any of these requirements can result in invalidation of an
issued patent. For the written description requirement, the Federal Circuit has
explained that "the specification must describe every element of the claimed
invention in sufficient detail so that one of ordinary skill in the art would
recognize that the inventor possessed the claimed invention at the time of
filing." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir.
1991).
The validity of the long-presumed statutory requirement of a
"written description" separate and apart from the enablement requirement has
recently been the subject of controversy, beginning with Judge Rader's vehement
dissent from the Federal Circuit's denial of en banc review of its July 2002
decision in Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed.
Cir. 2002). In February 2004, the Federal Circuit in the Rochester case once
again reaffirmed the separate requirement of the written description in an
opinion by Judge Lourie. Before discussing the Rochester case, we summarize the
cases leading up to it.
Regents Of The University Of
California v. Eli Lilly & Co.
In Regents of the
University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir.
1997) ("Eli Lilly"), the patent specification described a general method for
producing human insulin cDNA based on the sequence and method for production of
rat insulin cDNA, as well as partial amino acid sequences of the human insulin.
The Federal Circuit, in an opinion by Judge Lourie, joined by Judges Newman and
Bryson, concluded that the patent claims directed to human insulin cDNA were
invalid for failure to satisfy the written description requirement, explaining:
An adequate description of a DNA, such as the cDNA of the recombinant
plasmids and microorganisms ... requires a precise definition, such as by
structure, formula, chemical name, or physical properties, not a mere wish or
plan for obtaining the claimed chemical invention. Accordingly, an 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.
Eli Lilly, 119
F.3d at 1566-67 (quotations omitted). The court specifically noted these
requirements to be distinct from enablement:
Whether or not it provides
an enabling disclosure, it does not provide a written description of the cDNA
encoding human insulin, which is necessary to provide a written description of
the subject matter of claim 5.
Id. at 1567. The court thus invalidated
the claims under the written description requirement.
Enzo
Biochem., Inc. v. Gen-Probe Inc.
In Enzo Biochem.,
Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002), the Federal Circuit,
in an opinion again authored by Judge Lourie, applied Eli Lilly, holding that
specific recitation of a genomic sequence is not the only means of satisfying
the written description requirement, but that deposit of organisms or constructs
containing the sequence may suffice as well.
The patent at issue in
Enzo was directed to nucleic acid probes that selectively hybridize to
the DNA of a certain bacteria. Enzo deposited the patented sequences with the
American Type Culture Collection in the form of a recombinant DNA in a bacterial
host. The claims covered the deposited sequences as well as the subsequences and
mutated variants having the claimed hybridization ratio for the bacteria.
Following Eli Lilly, the district court invalidated the patent
on summary judgment for failure to satisfy the written description requirement
because "the claimed composition of matter was defined only by its biological
activity or function." Enzo, 323 F.3d at 962. The Federal Circuit
initially affirmed. However, following a motion for reconsideration, the panel,
in an opinion by Judge Lourie, joined by Judges Dyk and Prost, reversed itself,
concluding that "[i]t is not correct ...that all functional descriptions of
genetic material fail to meet the written description requirement." Id. at 964.
On rehearing, the court instead adopted the standard set forth in the Patent and
Trademark Office Guidelines for Examination of Patent Applications Under the 35
U.S.C. 112, P1 "Written Description" Requirement, 66 Fed. Reg. 1099 (Jan. 5,
2001), concluding that a written description requirement may be met by "showing
that an invention is complete by disclosure of sufficiently detailed, relevant
identifying characteristics," which may include "functional characteristics when
coupled with a known or disclosed correlation between function and
structure...." Enzo, 323 F.3d at 964. The panel thus concluded 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 a
written form, constitutes an adequate description of the deposited material
sufficient to comply with the written description requirement of §112 1." Id. at
965.
Judge Rader's Dissent From Denial Of En Banc
Review
Judge Rader, in a dissenting opinion joined by Judges
Gajarsa and Linn, dissented from the court's decision denying en banc review.
Claiming that the statutory language of section 112 does not create a separate
written description requirement, but only a requirement of description
sufficient to enable the making and using of the invention, Judge Rader further
expressed the view that "[t]he more important problem is disregard for the case
law that originated the written description requirement and applied it for over
thirty years." Id. at 976. Judge Rader also stated that enablement has always
been "the only purpose of the [statutory] 'written description' language." Judge
Rader reasoned that In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967), marked the
"creat[ion] for the first time [of] a new written description doctrine to
enforce priority," and that "the written description doctrine, at its inception
had a very clear function - preventing new matter from creeping into claim
amendments." "In sum," Judge Rader reasoned, "written description was a new
matter doctrine, a priority policeman." Id. at 978 (quotation omitted).
According to Judge Rader, Eli Lilly marked "the first time this court purported
to apply written description as a general disclosure doctrine in place of
enablement, rather than as a priority doctrine." Id. at 979-80.
According to Judge Rader, the patent disclosure in Eli Lilly
"undoubtedly warranted rejection for lack of enablement" because the patentee
failed to show one of skill in the art of how to make human insulin cDNA, but
that "[i]nstead of invalidating under the statutory test for adequacy of
disclosure, i.e., enablement, the Lilly court purported to create a new doctrine
for adequacy of disclosure that it labeled incorrectly 'written description.'"
Id. at 980.
Judge Lourie's Concurrence In Denial Of En Banc
Review
Judge Lourie, in a separate concurring opinion joined by
Judge Newman, supported the court's decline of en banc review. Judge Lourie
explained the existence of a separate written description requirement as "the
quid pro quo for the grant of a patent," rejecting the argument that "the
written description requirement outside of the priority context was novel until
several years ago":
Maybe so, maybe not; certainly such a holding was
not precluded by statute or precedent. New interpretations of old statutes in
light of new fact situations occur all the time. I believe these issues have
arisen in recent years for the same reason that more doctrine of equivalents
issues are in the courts, viz., because perceptions that patents are stronger
tempt patent owners to try to assert their patents beyond the original
intentions of the inventors and their attorney. That is why the issues are being
raised and that is why we have to decide them. Claims are now being asserted to
cover what was not reasonably described in the patent.
Enzo,
323 F.3d at 971-72. Judge Lourie further explained:
The statute does not
say 'a written description of the invention for purposes of policing priority.'
While it has arisen primarily in cases involving priority issues, Congress has
not so limited the statute, and we have failed to so limit it as well. As for
the lack of earlier cases on this issue, it regularly happens in adjudication
that issues do not arise until counsel raise them, and, when that occurs, courts
are then required to decide them. ... Interpretation of written description as
this court has done furthers the goal of the law to have claims commensurate in
scope with what has been disclosed to the public.
Id. at
972.
Published July 1, 2004.
