In
This Issue
· Federal
Circuit Distinguishes PTO’s Written Description Guidelines re: antibodies.
· Biotech Notes
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Centocor Patent Invalid for Lack
of Written Description (Distinguishing PTO’s Written Description Guidelines)
In Centocor Ortho Biotech, Inc. v. Abbott Laboratories (Fed. Cir. 2011), the
Federal Circuit invalidated Centocor’s U.S. Patent
No. 7,070,775 based on lack of written description as required by 35 U.S.C.
§112, vacating a $1.67 billion jury verdict against Abbott Laboratories’ Humira® product, which is an antibody used to
treat arthritis.
Centocor developed a TNF-α antibody by identifying a
mouse antibody to human TNF-α, then changing certain portions to make it
more human. Abbott, on the other hand, developed a fully human
antibody, which led to Humira®.
After Abbott launched its product, Centocor filed claims
to cover fully human antibodies, which issued as the ‘775 patent. Cenocor sued
Abbott, who argued that Centocor’s fully human
antibody claims lacked adequate written description.
Centocor argued that its patent satisfied § 112 because it
disclosed the antigen (TNF-α protein) and the PTO’s March 24, 2008 Written
Description Guidelines indicate that disclosing an antigen can provide § 112
support for any antibody that binds to that antigen. Centocor also
pointed to a 2004 Federal Circuit case that stated "as long as an
applicant has disclosed a ‘fully characterized antigen’ . . . the applicant
can then claim an antibody by its binding affinity to that described
antigen." Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004).
The Federal Circuit
disagreed with Centocor and distinguished Noelle and the PTO guidelines by
stating that disclosing an antigen may provide §112 support for an antibody,
but only where creating the antibody is routine. In this case, creating the antibody was far
from routine and the claimed antibody had specific
properties. Centocor did not establish that generating a fully-human antibody as claimed would be
within the knowledge of one skilled in the art.
§ NOTES
Fujifilm Holdings Corp. announced
in February that it would buy Merck BioManufacturing Network in a deal reportedly worth $490 million
Lycera Corp., a biotech
spinoff from the University of
Michigan, entered into an agreement with Merck that could pay Lycera more than
$300 million to develop and commercialize small molecule drugs that target
T-helper cells, which play an important role in autoimmune-related diseases. |
| |
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