The Federal Circuit reaffirmed that § 112, first paragraph, contains a written description requirement separate from enablement.
The court reversed the district court’s denial of JMOL and held the asserted claims of the ’516 patent invalid for failure to meet the statutory written description requirement.
Opinion: www.cafc.uscourts.gov/opinions/08-1248.pdf
patent in suit http://www.google.com/patents?vid=USPAT6410516
Overview from the opinion:
Ariad Pharmaceuticals, Inc., et al, Massachusetts Institute of Technology, theBelow are some sections of the opinion.
Whitehead Institute for Biomedical Research, and the President and Fellows of Harvard
College (collectively, “Ariad”) brought suit against Eli Lilly & Company (“Lilly”) in the
United States District Court for the District of Massachusetts, alleging infringement of
U.S. Patent 6,410,516 (“the ’516 patent”). After trial, at which a jury found infringement,
but found none of the asserted claims invalid, a panel of this court reversed the district
court’s denial of Lilly’s motion for judgment as a matter of law (“JMOL”) and held the
asserted claims invalid for lack of written description. Ariad Pharms., Inc. v. Eli Lilly &
Co., 560 F.3d 1366 (Fed. Cir. 2009).
Ariad petitioned for rehearing en banc, challenging this court’s interpretation of
35 U.S.C. § 112, first paragraph, as containing a separate written description
requirement. Because of the importance of the issue, we granted Ariad’s petition and
directed the parties to address whether § 112, first paragraph, contains a written
description requirement separate from the enablement requirement and, if so, the scope
and purpose of that requirement. We now reaffirm that § 112, first paragraph, contains
a written description requirement separate from enablement, and we again reverse the
district court’s denial of JMOL and hold the asserted claims of the ’516 patent invalid for
failure to meet the statutory written description requirement.
The asserted claims, rewritten to include the claims from
which they depend, are as follows:
80. [A method for modifying effects of external influences on a eukaryotic
cell, which external influences induce NF-κB-mediated intracellular
signaling, the method comprising altering NF-κB activity in the cells such
that NF-κB-mediated effects of external influences are modified, wherein
NF-κB activity in the cell is reduced] wherein reducing NF-κB activity
comprises reducing binding of NF-κB to NF-κB recognition sites on genes
which are transcriptionally regulated by NF-κB.
95. [A method for reducing, in eukaryotic cells, the level of expression of
genes which are activated by extracellular influences which induce NF-κB-
mediated intracellular signaling, the method comprising reducing NF-κB
activity in the cells such that expression of said genes is reduced], carried
144. [A method for reducing bacterial lipopolysaccharide-induced
expression of cytokines in mammalian cells, which method comprises
reducing NF-κB activity in the cells so as to reduce bacterial
lipopolysaccharide-induced expression of said cytokines in the cells]
wherein reducing NF-κB activity comprises reducing binding of NF-κB to
NF-κB recognition sites on genes which are transcriptionally regulated by
NF-κB.
145. [A method for reducing bacterial lipopolysaccharide-induced
expression of cytokines in mammalian cells, which method comprises
reducing NF-κB activity in the cells so as to reduce bacterial
lipopolysaccharide-induced expression of said cytokines in the cells],
carried out on human cells.
The claims are thus genus claims, encompassing the use of all substances that achieveThe Court stated the following with respect to whether originally filed claims met the written description requirement:
the desired result of reducing the binding of NF-κB to NF-κB recognition sites.
Furthermore, the claims, although amended during prosecution, use language that
corresponds to language present in the priority application. Specifically, the asserted
claims recite methods of reducing NF-κB activity, and more specifically reducing binding
of NF-κB to NF-κB recognition sites, in cells in response to external influences like
bacterial lipopolysaccharides. The specification filed on April 21, 1989, similarly recites
the desired goal of reducing NF-κB activity and binding to NF-κB recognition sites in
cells in response to such external influences. See ’516 patent col.3 l.59–col.4 l.19;
col.31 l.65–col.32 l.11; see also id. at col.2 ll.54-59. The specification also hypothesizes
three types of molecules with the potential to reduce NF-кB activity in cells: decoy,
dominantly interfering, and specific inhibitor molecules. Id. at col.37 l.43–col.38 l.22.
Although many original claims will satisfy the written description requirement, certain claims may not. 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.
Recognizing this, we held in Eli Lilly that an adequate written description of a
claimed genus requires more than a generic statement of an invention’s boundaries.
119 F.3d at 1568. The patent at issue in Eli Lilly claimed a broad genus of cDNAs
purporting to encode many different insulin molecules, and we held that its generic
claim language to “vertebrate insulin cDNA” or “mammalian insulin cDNA” failed to
describe the claimed genus because it did not distinguish the genus from other
materials in any way except by function, i.e., by what the genes do, and thus provided
“only a definition of a useful result rather than a definition of what achieves that result.”
Id.
We held that a sufficient description of a genus instead requires the disclosure of
either a representative number of species falling within the scope of the genus or
structural features common to the members of the genus so that one of skill in the art
can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained
that an adequate written description requires a precise definition, such as by structure,
formula, chemical name, physical properties, or other properties, of species falling
within the genus sufficient to distinguish the genus from other materials. Id. at 1568
(quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that
functional claim language can meet the written description requirement when the art has
established a correlation between structure and function. See Enzo, 323 F.3d at 964
(quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the
outer limits of a purported genus is not an adequate substitute for describing a variety of
materials constituting the genus and showing that one has invented a genus and not
just a species.
Slip. Op. at 20 -21.
Written Description standard:
Since its inception, this court has consistently held that § 112, first paragraph,Op at 23. (Bold added)
contains a written description requirement separate from enablement, and we have
articulated a “fairly uniform standard,” which we now affirm. Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1562-63 (Fed. Cir. 1991). Specifically, the description must “clearly
allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Id. at 1563 (citing In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)). In
other words, the test for sufficiency is whether the disclosure of the application relied
upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Id. (quoting Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985)); see also In re Kaslow, 707 F.2d
1366, 1375 (Fed. Cir. 1983).
Standard for Written description: “possession as shown in the disclosure” Op. at 24.
Thus, “possession as shown in the disclosure” is a more completeGuidance for meeting the written description requirement:
formulation. Yet whatever the specific articulation, the test requires an objective inquiry
into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.
There are, however, a few broad principles that hold true across all cases. WeOp at 25. (Bold added)
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. 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).
No “Super enablement” standard for Chemical and Biotech. Op. at 26
The court evaluated the patent for compliance to the written description:
In accordance with Rochester, the ’516 patent must adequately describe theAfter reviewing the spec for support:
claimed methods for reducing NF-κB activity, including adequate description of the
molecules that Ariad admits are necessary to perform the methods. The specification of
the ’516 patent hypothesizes three classes of molecules potentially capable of reducing
NF-κB activity: specific inhibitors, dominantly interfering molecules, and decoy
molecules.
We review the specification’s disclosure of each in turn to determine whether there is substantial evidence to support the jury’s verdict that the written description evidenced that the inventor possessed the claimed invention.
Whatever thin thread of support a jury might find in the decoy-moleculeConclusion:
hypothetical simply cannot bear the weight of the vast scope of these generic claims.
See LizardTech, 424 F.3d at 1345 (holding that “[a]fter reading the patent, a person of
skill in the art would not understand” the patentee to have invented a generic method
where the patent only disclosed one embodiment of it); Reiffin, 214 F.3d at 1345-46
(noting that the “scope of the right to exclude” must not “overreach the scope of the
inventor’s contribution to the field of art as described in the patent specification”); Fiers,
984 F.2d at 1171 (“Claiming all DNA[s] that achieve a result without defining what
means will do so is not in compliance with the description requirement; it is an attempt
to preempt the future before it has arrived.”); cf. Carnegie Mellon, 541 F.3d at 1126
(holding that the narrow description of the E. coli polA gene did not adequately support
a broad claim to the gene from any bacterial source). Here, the specification at best
describes decoy molecule structures and hypothesizes with no accompanying
description that they could be used to reduce NF-κB activity. Yet the asserted claims
are far broader. We therefore conclude that the jury lacked substantial evidence for its
verdict that the asserted claims were supported by adequate written description, and
thus hold the asserted claims invalid. (Op. at 37)
For the foregoing reasons, we hold that the asserted claims of the ’516 patent are invalid for lack of written description, and we do not address the other validity issues that were before the panel.
