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lies in defining what is regarded as “possession of the
invention”, for the written description requirement,
and if and how the written description is separate from
the enablement requirement. It is to be noted that the
enablement requirement can be met also by presenting
enabling data during prosecution, namely, after the filing
of the patent application, whereby a written description
requirement is restricted to the description of the
invention in the application as originally filed. In view
of this ambiguity, the 35 U.S.C. § 112, first paragraph
requirement has been the subject (and challenge) of
many case laws in the United States. Thus, several
important decisions of the Federal Circuit deal with
the written description and enablement requirements,
and, particularly, with the question of whether these
requirements, as prescribed in the 35 U.S.C. § 112, first
paragraph, of the statute, are separate from one another.
The most recent Federal Circuit ruling in this regard was
issued on March 22, 2010, in Ariad Pharmaceuticals Inc.
vs. Eli Lilly & Co. The Federal Circuit confirmed en
banc that the 35 U.S.C. § 112, first paragraph, contains a
written description requirement that is separate from the
enablement requirement. This case and the decision’s
impact on institutions engaged in early and basic
research are discussed herein.
The Holding:
On March 22, 2010, the Federal Circuit confirmed en
banc that 35 U.S.C. § 112, first paragraph, contains a
written description requirement that is separate from
the enablement requirement [Ariad Pharms., Inc. v. Eli
Lilly & Co., No. 2008-1248 (Fed. Cir. March 22, 2010)].
The lengthy (72-page) decision is based on statutory
interpretation, citations of U.S. Supreme Court precedent
and previous Federal Circuit decisions and attempts to
provide guidance concerning what is needed to comply
with the written description requirement. Importantly,
although the case involved a biotechnology patent, its
holding should not be viewed as in any way limited to
the biotechnology area.
The Patented Technology:
The Ariad case involved the technology of gene
regulation, and specifically the transcription factor NFκB.
NF-κB was first identified as playing a role in the
expression of genes involved in the immune system,
Invited Scientific Contributions
specifically in the regulation of the expression of the
gene encoding the kappa immunoglobulin gene in B
cells, which are specialized immune cells. One of the
inventors of the Ariad Patent, Dr. David Baltimore,
from the Massachusetts Institute of Technology, and his
collaborators, have uncovered that NF-κB did much more
than regulate a single immune protein, playing a crucial
role in the precise control of the expression of various
genes and their protein products that are responsible
for the response of cells to various and disparate
stimuli, including bacterial lipopolysaccharides, certain
cytokines, and even sunlight. In view of these findings,
NF-κB is now known to be involved in expression
of proteins that are associated with many different
processes, including the inflammatory response and
regulation of the immune system.
In the mid-1980s, Drs. David Baltimore, Philip Sharp,
Thomas Maniatis, and ten other scientists at the
Massachusetts Institute of Technology, the Whitehead
Institute for Biomedical Research, and Harvard
University, filed several patent applications related
to their work identifying and characterizing NFκB.
These separate applications, with Dr. Baltimore
(at right) as the only common thread, were combined
in a single application filed on November 13, 1991.
Eventually, on June 5, 1995, the application that gave
rise to the patent-at-issue was filed, claiming priority
to this previous application and containing essentially
an identical specification. The applicants, in this June
1995 application, sought claims for artificially reducing
NF-κB activity in cells in order to prevent the problems
when NF-κB activity runs amok.
In the end, after a lengthy prosecution, U.S. Patent No.
6,410,516 (‘516) issued with broad claims directed to
methods for reducing the activity of transcription factor
NF-κB by reducing its binding to certain gene recognition
sites, which encompassed the use of any substance that
would achieve that claimed result. Notably, none of
these claims indicated how NF-κB was to be reduced
or altered. The specification hypothesized three types
of molecules that had the potential to reduce NF-κB
activity: decoy, dominantly interfering, and specific
inhibitor molecules.
The litigation process:
The litigation History: The litigation history dates
back to June 25, 2002, when Ariad filed its complaint
2010 רבוטקוא ,25 רפסמ ןוילג | הימיכל תילארשיה הרבחה ןואטב
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