Thursday, September 08, 2016

CAFC in UCB v. Yeda. Estoppel can apply without claim amendment.

In UCB v. Yeda, Judge Newman authored a precedential opinion related to
patentability of antibody claims.

In this declaratory judgment action, UCB, Inc. sued
Yeda Research and Development Co. in the United States
District Court for the Eastern District of Virginia, requesting
a declaration that UCB’s Cimzia® brand antibody
does not infringe Yeda’s U.S. Patent No. 6,090,923
(“the ’923 Patent”); UCB also sought a declaration that
the ’923 Patent is invalid. Yeda counterclaimed for infringement.
The district court granted summary judgment
of non-infringement, holding that, based on the
specification and prosecution history, the monoclonal
antibodies claimed in the ’923 patent are not infringed by
the chimeric or humanized antibodies of the Cimzia®
product.1 We affirm the district court’s judgment.

This case was at the summary judgment stage:

The issue on summary judgment was presented as a
question of claim construction. Claim construction is a
matter of law, based on underlying facts. Teva Pharm.
USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015). Summary
judgment may be appropriate when there is no
genuine dispute as to any material fact and the movant is
entitled to judgment as a matter of law. Fed. R. Civ. P.
56; Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48

Of the history

The district court held that all the claims, correctly
construed, exclude chimeric or humanized antibodies, the
court stating that “[e]xamination of the prosecution
history reveals that for the first ten years of prosecution,
neither Yeda nor the examiner understood the term
‘monoclonal antibodies’ to include chimeric or humanized
antibodies. Like the evidence in the specification, the
prosecution history weighs towards a construction of
‘monoclonal antibodies’ which does not include chimeric or
humanized antibodies.” Dist. Ct. Op. at 770. On this
ground, the court found non-infringement.


Yeda is correct in that generic terms in claims are
construed in light of that which is already known. However,
the content of the specification and actions and
arguments during prosecution must also be considered, in
defining the scope of a generic term in a claim. See Advance
Transformer Co. v. Levinson, 837 F.2d 1081, 1083
(Fed. Cir. 1988) (“Positions taken in order to obtain allowance
of an applicant’s claims are pertinent to an understanding
and interpretation of the claims that are granted
by the PTO . . . and may work an estoppel as against a
subsequent different or broader interpretation.”).
During prosecution, Yeda submitted new claims specific
to “rat, hamster and human antibodies and chimeras
thereof” as well as claims specifically encompassing
“chimeras of” mouse monoclonal antibodies and “nonmurine”
monoclonal antibodies. Yeda argued that its invention
is not limited to murine antibodies to human
cytotoxin, and “should encompass chimeric monoclonal
antibodies produced by a genetically engineered cell line.”
Amendment Letter of March 10, 1999 at 2, 3. The Examiner
rejected the proposed claims on the ground of new
matter not supported in the specification. Yeda then
withdrew the proposed specific claims, and the application
was passed to issuance. The district court held that
Yeda cannot now obtain a claim construction that recovers
claim scope that was yielded in order to obtain issu-
ance of the patent, and construed the claims as excluding
chimeric and humanized antibodies.
Yeda argues that this construction is incorrect at least
as to claim 1, which recites “monoclonal antibody” but
does not specify any specific form or source of antibody.
Yeda states that chimeric or humanized monoclonal
antibodies were known at the time its priority application
was filed, December 20, 1984, and thus should be included
in the monoclonal antibodies of claim 1.


Yeda argues that absent a narrowing amendment to
the proposed claim that is now claim 1, there can be no
prosecution estoppel to the scope of claim 1, merely because
some proposed different claims were rejected by the
examiner and then dropped by the applicant. That is not
a correct general principle. Although each claim in a
patent warrants independent consideration in light of its
particular facts and history, the general rule is that a
patent applicant cannot later obtain scope that was
requested during prosecution, rejected by the Examiner,
and then withdrawn by the applicant.
Such estoppel was reasonably applied to claim 1 by
the district court, although claim 1 had not been amended.
In Builders Concrete, Inc. v. Bremerton Concrete
Products Co., 757 F.2d 255, 259 (Fed. Cir. 1985), the court
rejected the argument that “file wrapper estoppel cannot
arise without an amendment,” and explained that the
“position must be evaluated in the context of this specific
case.” In Wang Laboratories, Inc. v. Mitsubishi Electronics
America, Inc., 103 F.3d 1571, 1578 (Fed. Cir. 1997),
the court again explained: “We examine the statements
and actions of the patentee before the PTO during prosecution
. . . and ask what a competitor reasonably may
conclude the patentee surrendered to gain issuance of the
patent.” (internal citations omitted).

link to CAFC:


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