By Kevin E. Noonan —
It's settled, then — unless the Supreme Court
decides to weigh in, there is a
separate written description requirement in 35 U.S.C. § 112, first paragraph. The precedent developed since Regents of the University of California v.
Eli Lilly & Co. is good law. This is the judgment of the Federal Circuit in an opinion by the en banc Court, written (appropriately)
by Judge Lourie, and joined by every member of the Court except (predictably)
Judge Linn and soon-to-be Chief Judge Rader.
The en banc
opinion addressed all of Ariad's arguments, and found in favor of Lilly. Ariad helped the Court in arriving at
this decision, in how it framed its responses to the questions presented by acknowledging
that the statute contained a requirement for a written description. Ariad's position, according to the opinion, was that the measure of whether the written description was
satisfied was enablement, and here the Court parted ways with Ariad's argument. The Court characterized this situation
as the parties agreeing that the specification must contain a written
description of the invention, but disagreeing on the standard for fulfilling it
(as well as whether the requirement applies to originally-filed claims). The Court discussed Ariad's
grammatical construction of 35 U.S.C. § 112, first paragraph, and particularly
the argument regarding the significance of the comma after the phrase "and
the manner and process of making and using it," and decided that Lilly's
interpretation is the correct one. Specifically, the Court held that § 112, first paragraph, contains two separate description
requirements: a written
description of the invention and a written description of how to make and use
it. The Court dismissed the
grammatical argument thusly:
[W]e see nothing in the statute's
language or grammar that unambiguously dictates that the adequacy of the "written
description of the invention" must be determined solely by whether that
description identifies the invention so as to enable one of skill in the art to
make and use it.
The argument rests on the parallelism of the
language (an analysis that forms one of the bases for Judge Rader's dissent,
joined by Judge Linn). The Court
also dismissed Judge Linn's position, that enablement is sufficient to satisfy
the requirement of § 112, first paragraph, but on the backs of several of the
amici's arguments (Judge Linn makes his "enablement is enough"
argument in a separate dissent, joined by Judge Rader). According to the en banc opinion, this
reading of the statute renders either "and the manner and process of
making and using it" or "[a written description] of the invention"
as surplusage, "violating the rule of statutory construction that Congress
does not use unnecessary words," citing U.S. v. Menasche, 348 U.S. 528, 538-39 (1955). The Court completed this portion of its
analysis by citing previous versions of the Patent Act, as well as first
principles: "[e]very patent
must describe an invention. It is
part of the quid pro quo of a patent; one describes an invention, and, if the
law's other requirements are met, one obtains a patent."
The en banc Court then reviewed the several instances of Supreme Court precedent raised by
the parties, including Evans v. Eaton,
O'Reilly v. Morse, Schriber-Schroth Co. v. Cleveland Trust Co.,
and Festo Corp. v. Shoketsu Kinzoku Kogyo
Kabushiki Co., agreeing with Lilly that this precedent recognizes a written
description requirement that is separate from the enablement requirement of § 112,
first paragraph. And the Court
rejected the argument that interpreting § 112, first paragraph, as containing a
separate written description requirement conflicts with § 112, second
paragraph, saying that the claims "define the subject matter that, after
examination, has been found to meet the statutory requirements for patent";
their purpose is not to describe the invention, but "to provide notice of
the boundaries of the right to exclude and to define [the] limits" of the
invention.
The Court also held that stare decisis principles required its decision. Having expounded on the existence of a
separate written description requirement for over forty years, the Court held
that they must "tread lightly"
in upsetting the "settled expectations" of the patenting
community. "If the law of
written description is to be changed, contrary to sound policy and the uniform
holdings of this court, the settled expectations of the inventing and investing
communities, and PTO practice, such a decision would require good reason and
would rest with Congress." The Court also opined that, while its use of the term "possession"
regarding the written description requirement has "never been very
enlightening," at the same time the Court had consistently applied the law
in this area. And any
inconsistencies in the application of the law in this area arose, according to
the Court, because satisfaction of the written description requirement is a
question of fact, and the different facts in each case (and arguments based on
those facts) produced (not unexpectedly) varied conclusions. Thus, the Court did not intend to attempt
to set forth any "bright line rules," for example, with regard to the
number of species required to adequately describe a genus (thus dashing any
hopes that this particular area of uncertainty would be settled by this
opinion). However, there were "a
few broad principles" that the Court said "hold across all cases":
We have made clear that the written
description requirement does not demand either examples or an actual reduction
to practice; a constructive reduction to practice that in a definite way
identifies the claimed invention can satisfy the written description
requirement. Falko-Gunter Falkner v.
Inglis, 448 F.3d 1357, 1366-67 (Fed. Cir. 2006). Conversely, we have
repeatedly stated that actual "possession" or reduction to practice
outside of the specification is not enough. Rather, as stated above, it is the
specification itself that must demonstrate possession. And while the description
requirement does not demand any particular form of disclosure, Carnegie Mellon Univ. v. Hoffmann-La Roche
Inc., 541 F.3d 1115, 1122 (Fed. Cir.
2008), or that the specification recite the claimed invention in haec verba, a description that merely
renders the invention obvious does not satisfy the requirement, Lockwood v. Am. Airlines, 107 F.3d 1565,
1571-72 (Fed. Cir. 1997).
The
majority opined that while there may be many instances where there is "little
difference" between describing an invention and enabling it, that will not
always be the case, particularly in the chemical and biotechnological
arts. A separate written
description requirement "plays a vital role in curtailing claims that that
do not require undue experimentation to make and use, and thus satisfy
enablement, but that have not been invented, and thus cannot be described." And "particularly for the
biological arts," having a separate written description requirement "ensures
that when a patent claims a genus by its function or result, the specification
recites sufficient materials to accomplish that function."
Turning
to the distinction, if any, between amended claims and original claims, the Court held that the analytical differences espoused by the parties with regard
to the case law concerning amended claims — Ariad contending that the distinction was
based on enablement and Lilly on written description — were semantic differences
that did not change the outcome. Regarding original claims, the Court agreed with Lilly that, although
rare, even original claims could encompass subject matter not sufficiently
described to satisfy the disclosure requirements of § 112, first
paragraph. There is "no
principled basis" for distinguishing the requirements of original claims
versus amended claims, or for restricting the written description requirement
to policing priority (including nothing in the statutory language to support
such a limitation). The "truism"
that the claims are part of the original specification, as advocated by Ariad,
does not mean that the invention has been sufficiently described merely by
reciting it in an original claim:
For example, a generic claim may define the boundaries of a
vast genus of chemical compounds, and yet the question may still remain whether
the specification, including original claim language, demonstrates that the
applicant has invented species sufficient to support a claim to a genus. The
problem is especially acute with genus claims that use functional language to
define the boundaries of a claimed genus. In such a case, the functional claim
may simply claim a desired result, and may do so without describing species
that achieve that result. But the specification must demonstrate that the
applicant has made a generic invention that achieves the claimed result and do so
by showing that the applicant has invented species sufficient to support a
claim to the functionally-defined genus.
"[G]eneric claim language appearing in ipsis verbis in the original
specification does not satisfy the written description requirement if it fails
to support the scope of the genus claimed." The Court also rejected Ariad's argument that the written
description requirement was disproportionately applied to biotechnology
inventions: generic language
in an application as filed does not automatically satisfy the written
description requirement in instances such as Fiers v. Revel, Eli Lilly
and Enzo v. Genprobe.
The majority also rejected Ariad's argument that the Court applied the written description requirement disproportionately to basic research
and inventions by academics and universities. This result is not inconsistent with sound
policy that "basic" research may not lead to patentable inventions,
characterizing the difference between "academic theories, no matter how
groundbreaking," which are not patentable with inventions having a
practical use, citing Brenner v. Manson
that "[a] patent is not a hunting license. It is not a reward for the search, but compensation for a
successful conclusion." While
this situation may decrease incentives for university research, the Court is
mindful of disincentives on "downstream research"; the goal, according to the Court, is to
strike the right balance, which the majority believes it does: "giving
the incentive to actual invention and not 'attempt[s] to preempt the future
before it has arrived,'" citing Fiers.
Turning to the subject matter of the appeal, the
Federal Circuit reversed the District Court's denial of JMOL, on the basis that
no reasonable jury could have found for Ariad based on the facts adduced at
trial. Specifically, the CAFC
held that Ariad's evidence was either directed to the wrong priority date (the
jury having found that the patent-in-suit was entitled to a priority date in
1989 while the majority of the evidence did not extend earlier than 1991) or
was insufficient to support the "vast scope of these generic claims,"
especially in view of the "gaping holes in its disclosure" and the "primitive
and uncertain" state of the art (considerations that, admittedly, resonate
with the Wands factors used to assess
compliance with the enablement requirement). The Court specifically disapproved Ariad's strategy of
avoiding reciting any NF-kB inhibitor molecules in the claims in an effort to
avoid the court's holding in University
of Rochester v. G.D. Searle (that claims were invalid for failure to
satisfy the written description requirement based on the failure to support a
claim term for an inhibitor of COX-2).
Judges Newman and Gajarsa filed separate concurring
opinions, Judge Newman addressing the need to protect early-stage technologies
such as those developed by universities, and Judge Gajarsa opining that the
majority's statutory construction was "reasonable" but not the only
(or even a preferable or necessary) way to construe the statutory disclosure requirements
(calling the text of 35 U.S.C. § 112, first paragraph, "a model of
legislative ambiguity"). Judge Linn dissented based on his opinion that enablement is a
sufficient measure of the proper extent of disclosure, and Judge Rader
dissented (vigorously) based on his entirely contrary interpretation of the
statute.
Regardless of these disparate voices, the Court
majority affirmed the existence of a separate written description
requirement. This opinion puts to
bed one of the many recurring examples of uncertainty that have crept into its
jurisprudence in recent years (at least until sufficient members of the Court
have accepted senior status and new judges bring their views to bear on the
question).
Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co.
(Fed. Cir. 2010) (en banc)
Before: Chief Judge Michel and Circuit Judges Newman, Mayer, Lourie, Rader, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore
Opinion by Circuit Judge Lourie, joined by Chief Judge Michel and Circuit Judges Newman, Mayer, Bryson, Gajarsa, Dyk, Prost, and Moore; additional views by Circuit Judge Newman; concurring opinion by Circuit Judge Gajarsa; dissenting-in-part and concurring-in-part opinion by Circuit Judge Rader, joined by Circuit Judge Linn; dissenting-in-part and concurring-in-part opinion by Circuit Judge Linn, joined by Circuit Judge Rader
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