The Written Description Requirement Revisited, Giving Caution to Biotech Patent Owners

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On February 23, 2011, in Centocor Ortho Biotech, Inc. v. Abbott Labs., No. 2010-1144, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) applied the written description requirement set forth in 35 U.S.C. § 112, first paragraph, to invalidate Centocor’s U.S. Patent No. 7,070,775 (the ‘775 patent).

The case came before the Federal Circuit on appeal after the district court granted Abbott’s motion for judgment as a matter of law (JMOL) to set aside the jury’s finding of willfulness damages in the amount of $1.67 billion, but denied Abbott’s JMOL motions on the issues of infringement and validity. The Federal Circuit reversed the district court’s denial of JMOL as to the validity of the ’775 patent, holding that claims 2, 3, 14, and 15 (the asserted claims) were invalid.

In 1991, Centocor filed a patent application disclosing two therapeutic antibodies (the A2 mouse and chimeric antibodies) for neutralizing tumor necrosis factor a (TNF-a), the overproduction of which can lead to autoimmune conditions such as arthritis. The A2 mouse and chimeric antibodies contain mouse variable regions and human constant regions, and are not considered “fully-human” because the variable region is determinative of antibody type. The patent application described the difficulties associated with making a fully-human antibody to a human protein like TNF-a.

Centocor subsequently filed a series of continuation-in-part (CIP) applications in 1994 that added new matter which Centocor relied on as evidence of the written description for the asserted claims. After Abbott was granted a patent in 2000 and received regulatory approval in 2002 of Humira®, a fully-human antibody to TNF-a, Centocor filed claims to human variable regions and fully-human antibodies as part of a thirteenth application in the still-pending patent family disclosing the A2 mouse and chimeric antibodies. The subject ‘775 patent issued in 2006, and shortly thereafter, Centocor filed this action alleging that Humira® infringed the asserted claims.

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