Centocor Ortho Biotech, Inc. v. Abbott Laboratories

On February 23, the Federal Circuit issued a decision in Centocor Ortho Biotech, Inc. v. Abbott Laboratories, reversing a district court ruling on invalidity and thereby discarding a $1.67 billion damages award.

Leading up to this case, Centocor filed a 1991 patent application disclosing and claiming a certain type of mouse antibody and a corresponding mouse-human chimeric antibody for treating arthritis. Centocor then filed a series of continuation-in-part (“CIP”) applications claiming priority to the 1991 application. The USPTO rejected some of the pending claims in one of these CIP applications in 1993. In rejecting the claims, the USPTO stated that the patent specification only disclosed antibodies with variable regions, the portions of antibody molecules that bind to other substances and therefore determine antibody affinity, coming completely from mouse antibodies. Because the USPTO determined that the claims encompassed antibodies with variable regions that were not entirely from mice, the USPTO rejected the claims. Centocor filed another CIP application and abandoned its application with rejected claims. The USPTO issued the same rejected that CIP application in the same way. In 1994, Centocor filed more CIP applications, this time adding new matter, but not claiming human variable regions. After a further series of applications, Centocor filed a 2002 application claiming priority to this chain of applications and claiming human variable regions and fully-human antibodies. This patent issued in 2006 as U.S. Patent No. 7,070,775 (“the ‘775 patent”).

Meanwhile, Abbott was using entirely different methods to engineer a fully-human antibody that would bind to the same chemical to which Centocor’s antibodies bind. Abbott filed a patent application for its fully-human antibody in 1996 and was granted U.S. Patent No. 6,090,382 (“the ‘382 patent”) in 2000. Only after Abbott’s patent issued and after Abbott received regulatory approval of its antibody did Centocor file the application claiming human variable regions and fully-human antibodies. Centocor later filed this infringement suit, relying on its earlier disclosure in the 1994 CIP application to establish that its ‘775 patent had priority over the ‘382 patent that had issued to Abbott.

At trial in the U.S. District Court for the Eastern District of Texas, the jury rejected Abbott’s invalidity contentions and found Abbott liable for $1.67 billion in damages. The court then granted judgment as a matter of law (“JMOL”) that Abbott did not willfully infringe, but denied Abbott’s other motions for JMOL, including such a motion on the issue of invalidity.

The Federal Circuit reversed the denial of JMOL on invalidity, finding the asserted claims invalid due to inadequate written description. Because the ‘775 patent claimed priority to the 1994 application, the disclosure in the 1994 application needed to adequately provide written description for the claims of the ‘775 patent. In ruling for invalidity, the Federal Circuit looked to the four corners of the 1994 application and found little to support several of the limitations in the asserted claims of the ‘775 patent. The 1994 application disclosed an amino acid sequence for a single mouse variable region, which the court found did not “serve as a stepping stone” to identifying the human variable region of the ‘775 patent. The court rejected Centocor’s suggestion that written description came from the claim language itself, finding that that language did not appear until the 2002 application that issued as the ‘775 patent.

The Federal Circuit also addressed Centocor’s arguments based on USPTO guidelines regarding written description of antibodies and Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004). Precedent and guidelines establish that disclosing a newly-characterized antigen can provide adequate written description for corresponding antibodies created through routine methods. However, the court found that the antigen here and some antibodies for it were previously known, and that the claims of the ‘775 patent included further limitations for the antibodies that would not be straightforward developments for one of ordinary skill in the art in 1994. Thus, the guidelines and Noelle did not make the written description in Centocor’s 1994 application adequate.

Having found the ‘775 patent invalid for lack of written description, the Federal Circuit declined to address other issues of invalidity, infringement, or damages.

Patent application specifications must adequately describe all of the limitations of any claimed subject matter, both for that application as well as for any future applications claiming priority to it. The failure of Centocor’s 1994 application to adequately disclose the limitations of the ‘775 patent meant the loss of both the $1.67 billion in damages and the validity of the patent. However, without relying on the 1994 application, the ‘775 patent would likely have met with novelty or nonobviousness problems with respect to the ‘382 patent.