Abbott Laboratories had reason to thank Eli Lilly & Co. when the U.S. Court of Appeals for the Federal Circuit overturned a record $1.67-billion jury verdict that Abbott's Humira infringed a Johnson & Johnson patent.

On Feb. 23, the court ruled that the patent claims were invalid because they did not include an adequate written description of what the patent covered. Thus, the court said, J&J could not show that it had invented a fully-human antibody.

Central to the case, Centocor Ortho Biotech Inc. v. Abbott Laboratories, was the Federal Circuit's ruling last year in Ariad Pharmaceuticals v. Lilly. In Ariad the court limited how broadly patent claims can be written (Also see "Patent Claims Must Be Written Narrowly, Federal Circuit Reaffirms In Ariad v. Lilly" - Pink Sheet, 22 March, 2010.). The court cited the decision repeatedly in finding the J&J patent invalid.

"The Ariad case was the case that confirmed what the law is," said Abbott attorney William Lee, a partner at Wilmer Cutler Pickering Hale and Dorr. "As a practical matter you shouldn't be able to patent what you didn't invent."

The decision was not only a relief for Abbott, but also further clarified the scope of patent rights in the field of therapeutic antibodies.

The J&J patent, No. 7,070,775, claims antibodies and antibody fragments that bind tumor necrosis factor-alpha. The patent was issued to Centocor Ortho Biotech, now a division of J&J, and New York University in 2006 and NYU granted an exclusive license to Centocor. Abbott launched Humira (adalimumab), a fully-human monoclonal antibody that binds TNF-α, for treatment of rheumatoid arthritis in 2002. J&J's Remicade (infliximab) is a chimeric monoclonal antibody that binds TNF-α.

Decision Hinged On 1994 Applications

A jury in the U.S. District Court for the Eastern District of Texas Marshall Division had awarded J&J $1.16 billion in lost profits and $504,000 for a reasonable royalty (Also see "Abbott's Humira Defense Hinges On Appeal - And A Countersuit in Massachusetts" - Pink Sheet, 30 June, 2009.).

The Federal Circuit said Centocor had developed a chimeric antibody with a mouse "constant region" and human "variable region" (Remicade) while Abbott engineered a fully-human antibody (Humira). After Abbott obtained approval to market Humira, Centocor filed claims to fully-human antibodies.

"The pivotal issue in this case concerns whether the '775 patent provides adequate written description for the claimed human variable regions," the Federal Circuit stated. "To ensnare Abbott with later-filed claims" Centocor must rely on 1994 continuation-in-part applications.

The court concluded that the claims in these applications do not disclose any relevant identifying characteristics for fully-human antibodies or even a single human variable region.

"At bottom, the asserted claims constitute a wish list of properties that a fully-human, therapeutic TNF-α antibody should have," the court stated. "Because Centocor had not invented a fully-human, high affinity, neutralizing, A2 specific antibody in 1994, a reasonable jury could not conclude that it possessed one."

"As in Ariad," the court said, "we conclude that the jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description."

In a release announcing the decision, Rob Bazemore, president of Centocor Ortho Biotech, said the company is considering whether to ask for reconsideration by the panel or by the court of appeals as a whole.

Lilly Argued Case Could Chill Antibody R&D

Harold McElhinny, a partner at Morrison & Foerster, said the Centocor ruling is one in a series of Federal Circuit decisions on written description. He noted that Lilly won a seminal case in 1997 when the court ruled in The Regents of the University of California v. Eli Lilly that the claims in a UC patent were invalid because they failed to provide an adequate written description. The patent related to recombinant plasmids and microorganisms that produce human insulin.

McElhinny, who represented the university in that case, said the Federal Circuit applies a unique written description rule in biologic patents that claim chemical proteins.

Lilly not only laid the groundwork for Abbott's victory, it also filed an amicus brief in support of Abbott. It argued that Abbott's appeal was significant "because an unjustified and unwarranted scope of patent rights in the area of antibody therapeutics, as with any other emerging technology, may chill continued research and development."

Lilly noted that 19 monoclonal antibody drugs have been introduced in the U.S. market since 1994 and approximately 500 antibodies are currently in clinical trials.

"It is imperative that traditional patentability principles, applied for over 200 years to all fields of technology, apply to antibody patents," Lilly stated in its brief. In this case, the inventors of patent '775 "described nothing more than preexisting knowledge about the TNF-α antigen and a novel amino acid sequence of a single variable region from a mouse antibody that bound this well-characterized antigen."

It is clear in guidance the court has provided, Lilly continued, that "an antibody claim, like any other chemical compound claim, having only functional limitations purporting to identify the claimed antibodies, does not meet the written description requirement."

By Brenda Sandburg

Lilly Laid Groundwork For Abbott's Defeat Of J&J's Patent Verdict On Humira

More from Archive

More from Pink Sheet