Originally published May 17, 2011
Centocor Ortho Biotech, Inc. (Centocor) filed a patent
infringement suit in the Eastern District of Texas alleging that
Abbott's Humira® antibody infringed claims of its U.S.
Patent No. 7,070,775 (the '775 patent). After a $1.67 billion
jury verdict finding Abbott liable for willful infringement, Abbott
moved for judgment as a matter of law (JMOL) on invalidity,
noninfringement, damages, and willfulness. The district court only
granted the motion for JMOL on willfulness, denying the others, and
Abbott appealed. In Centocor Ortho Biotech, Inc. v. Abbott
Laboratories, the Federal Circuit reversed and held that
the asserted claims were invalid for lack of written
description.
The technology at issue in this case involved antibodies to human
TNF-α, overproduction of which can lead to several
autoimmune diseases. Centocor and Abbott both developed antibodies
to neutralize human TNF-α using different approaches.
Centocor started with a mouse antibody that had high affinity and
high neutralizing activity, and then modified it to make it look
more human to reduce the problem of immunogenicity. Centocor filed
a patent application disclosing its A2 mice antibodies and chimeric
antibodies, with mouse variable regions and human constant regions,
in 1991. Centocor subsequently filed several continuation-in-part
(CIP) applications. The asserted claims of the '775 patent,
directed to human variable regions, were first filed in 2002 and
claimed priority to an application filed in 1994.
Abbott pursued an alternative path, engineering a fully human
antibody that did not have immunogenicity problems, and worked to
improve the binding affinity and the neutralizing activity. Abbott
filed a patent application disclosing their fully human antibody in
1996. The patent issued in 2000 as U.S. Patent 6,090,382, and
Abbott obtained regulatory approval to market Humira® in 2002.
Centocor's claims to fully human antibodies were not filed
until after this time, and ultimately issued in 2006 as the
'775 patent.
The Court stated that the pivotal issue in the case was whether the
'775 patent provided adequate written description for the
claimed human variable regions using the test as confirmed in Ariad. As noted above, the asserted
claims of the '775 patent directed to human variable regions
were not filed until 2002, after Abbott had already patented a
fully-human antibody to TNA-α. Since Abbott's claims
were filed in 1996, Centocor relied on the priority claim to the
1994 CIP application, which meant the asserted claims of the
'775 patent needed to find written description support in the
1994 CIP application.
The specification of the 1994 CIP application did not disclose a
fully human antibody or a single human variable region. The court
found that a few sprinkled references to human antibodies or human
variable regions did not reasonably suggest that Centocor was in
possession of these antibodies. Nor was the fact that a fully human
antibody could be made sufficient to show that the inventors of the
'775 patent possessed such an antibody. At best, the
specification described a plan, when what was required is
constructive possession. The written description requirement does
not demand either examples or an actual reduction to practice, but
it does demand that one of skill in the art can "visualize or
recognize" the claimed antibodies based on the
specification's disclosure.
One of Centocor's arguments was that an earlier Federal Circuit
decision, Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir.
2004), and the United States Patent and Trademark Office's
written description guidelines support the view that disclosing a
protein, in this case human TNF-α, provides adequate
written description for any antibody that binds to that protein.
The Court clarified that this reasoning only applies to disclosure
of newly characterized antigens where creation of the claimed
antibodies is routine. Here, both the human TNF-α protein
and antibodies to it were already known. The claimed invention in
the instant case is a class of antibodies containing a human
variable region that have the particularly desirable therapeutic
properties of high affinity, neutralizing activity, and A2
specificity. Claiming antibodies with specific properties can
result in a claim that does not have written description support,
even if the human TNF-α protein is disclosed, since
antibodies with those properties have not been adequately
described.
The Court overturned the jury award, finding that there was
inadequate written description for the fully human antibody and
noting that Centocor could not "overreach the scope of [its]
contribution to the field of art as described in the patent
specification." While this case does not represent any
significant departure from existing written description law, it
does underscore a predicament in the "unpredictable"
arts: while narrow claims tend to limit the value of patent
protection, broad claims may be susceptible to invalidity attack on
written description grounds. Some commentators view this decision
as indicative of a trend at the Federal Circuit to use the written
description requirement to prevent overreaching by holders of
broad, pioneering biotech patents, a trend which may soon expand
into the more "predictable" arts.
This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.