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Finding the asserted claims invalid for failure to meet the statutory written description requirement, the Court of Appeals for the Federal Circuit (CAFC) reversed the infringement verdict and the $1.67 Billion in damages awarded by the jury in the Eastern District of Texas (CAFC Decision).

The underlying patent (US No. 7,070,775) supports the production of pharmaceutical antibodies useful in treating arthritis. Specifically, patent owners Centocor Ortho Biotech, Inc. and New York University sued Abbott Laboratories and its Bio-research subsidiaries alleging that Abbot’s Humira® antibody infringes claims 2,3,14, and 15 of the patent titled “Recombinant A2-specific TNF-α specific antibodies” patent.

The Technology at Issue

In humans, overproduction of the small cell-signaling protein molecule known as “tumor necrosis factor alpha” (TNF-α) can lead to various autoimmune conditions, including arthritis. In normal circumstances, the human body does not produce antibodies to human TNF-α. Engineering antibodies of this type is, thus, a target for pharmaceutical companies seeking to produce drugs to treat arthritis and other inflammatory diseases.

For several reasons, the prior state-of-the-art mice antibodies to human TNF-α did not have:

• sufficient affinity – ability of the antibody to bind to the target protein
• neutralizing activity – binding in an effective way so as to produce the desired therapeutic effect
• reduced immunogenicity – lowering the patients’ immune response to the foreign antibodies

Abbott and Centocor took different paths towards solving these inadequacies. Simply put, Abbott’s researchers sought to discover what is termed the “variable region” of the target antibody by repeating the entire process used to develop the mouse antibodies. That research path led to a patent (No. 6,090,382) issued in 2000 and to marketing Humira® in 2002.

Centocor’s research focused on the “constant region” of the antibodies, by exchanging the “A2” mouse antibody’s constant region with a known human constant region producing what is called a “chimeric” antibody. These efforts led to a patent application filed in 1991, and subsequent USPTO rejections and Centocor continuations in part filed in 1994 which, the CAFC points out, did not present claims to human variable regions. Centocor filed the lawsuit in 2006, shortly after finally being issued the ‘775 patent. (Aadditional discussion of the technology can be found in the Decision and in J. Lefave’s post on the American University Law School IP Brief Blog.

The written description requirement

The first paragraph of Section 112 of USC Title 35 requires “…a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same…” On this basis, the central issue of validity rests on whether the Centocor patent provides an adequate written description for the claim on human variable regions in the original 1994 CIP applications.

Reversal on Appeal

In reviewing the adequacy of the written description, the CAFC found that, contrary to Centocor’s assertions, very little in the ‘775 patent supports the proposition that Centocor possessed the target invention: a high affinity, neutralizing, A2 specific antibody that also contained a human variable region, only the chimeric human/mouse antibody. In short, a PHOSITA (person having ordinary skill in the art) would not have been able to make a fully human antibody based on the description of the chimeric antibody and the rest of the information in the patent. The patent fails the CAFC test that a PHOSITA could “visualize or recognize” the claimed (human) antibodies based on the specification’s disclosures (constructive possession). Thus, Centocor does not fulfill the requirement to be granted a monopoly on an invention it has not really disclosed to the relevant public, i.e. its claims are beyond its disclosure. Since the jury lacked sufficient evidence for its verdict of the contrary, the district court erred in denying Abbott’s initial motion for Judgment as a Matter of Law that asserted this failure.

Therefore, the CAFC held that the asserted claims are invalid and the judgment was reversed.