Wednesday, February 23, 2011

Written description has teeth: CAFC smacks down J&J, NYU

In a key decision on the written description requirement of 35 USC 112, the CAFC wrote:

Because the asserted claims
of the ’775 patent lack written description under 35
U.S.C. § 112, we need not reach Abbott’s other invalidity
arguments, its infringement arguments, or the question of
damages. We reverse the district court’s denial of JMOL
on this ground and hold the asserted claims invalid for
failure to meet the statutory writment.

Bottom line: Infringement defendant Abbott wins; J&J (Centocor Ortho Biotech) and
New York University lose.
Judge T. John Ward of ED Texas gets reversed. WILLIAM F. LEE, Wilmer Cutler Pickering Hale and
Dorr LLP, of Boston, Massachusetts wins. DIANNE B. ELDERKIN, of Akin Gump Strauss Hauer &
Feld LLP, of Philadelphia, Pennsylvania, arguing for plaintiffs-appellees, loses.

Yes, the University of Rochester case on COX-2 inhibitors arose:

Compliance with the written
description requirement of 35 U.S.C. § 112, ¶ 1 is a ques-
tion of fact, and “‘we review a jury’s determinations of
facts relating to compliance with the written description
requirement for substantial evidence.’” Id. at 1355 (quot-
ing PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235,
1243 (Fed. Cir. 2002)). A patent also can be held invalid
for failure to meet the written description requirement
based solely on the face of the patent specification. Univ.
of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927 (Fed.
Cir. 2004); PIN/NIP, 304 F.3d at 1247-48 (reversing the
district court’s denial of JMOL because no reasonable
juror could have concluded that the asserted claim was
supported by adequate written description).

And, yes, New York University lost the case on written description
grounds, just as the University of Rochester did. And just as the academics
in the case Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1354
(Fed. Cir. 2010) also lost.

The CAFC elaborated that a plan for an invention is distinct
from an invention itself:

To satisfy the written description requirement, “the
applicant must ‘convey with reasonable clarity to those
skilled in the art that, as of the filing date sought, he or
she was in possession of the invention,’ and demonstrate
that by disclosure in the specification of the patent.”
Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541
F.3d 1115, 1122 (Fed. Cir. 2008) (quoting Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)).
Assessing such “possession as shown in the disclosure”
requires “an objective inquiry into the four corners of the
specification.” Ariad, 598 F.3d at 1351. Ultimately, “the
specification must describe an invention understandable
to [a person of ordinary skill in the art] and show that the
inventor actually invented the invention claimed.” Id. A
“mere wish or plan” for obtaining the claimed invention is
not adequate written description.
Regents of the Univ. of
Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir.

The key issue in the case involved assertions of priority:

The pivotal issue in this case concerns whether the
’775 patent provides adequate written description for the
claimed human variable regions. As noted above, Cento-
cor first sought claims to human variable regions and
fully-human antibodies in 2002. At that time, Abbott had
already discovered and patented a fully-human antibody
to TNF-α that had high affinity and neutralizing activity.
To ensnare Abbott with later-filed claims, Centocor must
use a priority date from an earlier application. Because
Abbott’s application was filed in 1996, Centocor relies on
a priority claim to the 1994 CIP applications. Thus, in
order for Centocor to prevail, the asserted claims must be
supported by adequate written description in the 1994
CIP applications.

Abbott's game plan was clear:

To underscore
the inadequacy of Centocor’s written description, Abbott
points out that the specification does not disclose any
fully-human, high affinity, neutralizing, A2 specific
antibody. Moreover, the specification does not disclose a
single human variable region. Abbott argues that the
only described antibody is the chimeric antibody, which
has a mouse variable region. Abbott also argues that
Centocor has merely disclosed tools that might be used in
an attempt to make the claimed invention—essentially,
that Centocor’s disclosure is no more than a mere wish or
plan for how one might search for a fully-human antibody
that satisfies the claims.
Finally, Abbott points to testi-
mony from Centocor’s inventor indicating that the disclo-
sure did not include examples about making a human
antibody because “it was never [Centocor’s] intention to make
a human antibody.”

The punchline of the CAFC:

At bottom, the asserted claims constitute a wish list of
properties that a fully-human, therapeutic TNF-α anti-
body should have: high affinity, neutralizing activity, and
the ability to bind in the same place as the mouse A2
antibody. The specification at best describes a plan for
making fully-human antibodies and then identifying
those that satisfy the claim limitations. But a “mere wish
or plan” for obtaining the claimed invention is not suffi-
See id. at 1566. At the time the 1994 CIP applica-
tions were filed, it was entirely possible that that no fully-
human antibody existed that satisfied the claims. Be-
cause Centocor had not invented a fully-human, high
affinity, neutralizing, A2 specific antibody in 1994,
reasonable jury could not conclude that it possessed one.

The end result:

We hold that claims 2, 3, 14, and 15 of the ’775 patent
are invalid for lack of written description. The judgment
below is reversed.


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