The U.S. Court of Appeals for the Federal Circuit has overturned a $1.67 billion patent infringement jury verdict that Johnson & Johnson unit Centocor Ortho Biotech Inc. won against Abbott Laboratories in a Texas federal court.

The Feb. 23 unanimous ruling reversed 2009′s largest jury verdict, finding the patent at issue to be invalid based on the written-description requirement.

An Eastern District of Texas jury in June 2009 found that Abbott had infringed four claims of a patent on an antibody developed jointly by Centocor and New York University. NYU granted Centocor an exclusive license under the 2006 patent. The verdict amount in the case, Centocor Ortho Biotech Inc. v. Abbott Laboratories, was based on Abbott’s sales of the allegedly infringing product, the autoimmune drug Humira. The court’s final judgment boosted Centocor’s award to $1.85 billion with prejudgment interest.
Humira and Centocor’s Remicade treat autoimmune disorders such as rheumatoid arthritis by neutralizing a protein called tumor necrosis factor, an immune system protein that plays a role in inflammation.

At the lower court, Abbott argued that it was the first to produce a fully human antibody. Centocor claimed that its predecessor application for the patent at issue included a written description of the human antibodies and so-called “enabling language” that would allow someone skilled in the technology to make and use the invention.

The Federal Circuit ruling, authored by Judge Sharon Prost, reversed the lower court’s order, finding that the asserted claims of Centocor’s patent lacked the written description required by patent law. Based on that conclusion, the panel ruled that it did not need to address Abbott’s other arguments. Judge William Bryson and Senior Judge Raymond Clevenger III joined the ruling.

Prost wrote that the pivotal issue in the case concerns whether Centocor’s patent “provides adequate written description for the claimed human variable regions” of the antibodies.

“There is nothing in the [patent] specification that conveys to one of skill in the art that Centocor possessed fully-human antibodies or human variable regions that fall within the boundaries of the asserted claims,” she wrote. “At bottom, the asserted claims constitute a wish list of properties that a fully-human, therapeutic TNF-a anti-body should have: high affinity, neutralizing activity, and the ability to bind in the same place as the mouse A2 antibody. The specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations.”

Prost went on to state that “Centocor’s argument that an inventor need not physically make an invention to claim it misses the mark.”

“Indeed, we have repeatedly indicated that the written description requirement does not demand either examples or an actual reduction to practice,” wrote Prost. “What it does demand is that one of skill in the art can ‘visualize or recognize’ the claimed antibodies based on the specification’s disclosure. In other words, the specification must demonstrate constructive possession, and the [patent]‘s specification fails to do so.”

Centocor is “disappointed by the decision,” said Rob Bazemore, Centocor’s president in a written statement. “We are considering whether to ask for reconsideration by the panel or by the court of appeals as a whole,” Bazemore stated.

Centocor’s trial attorney, Dianne Elderkin, and other lawyers from Akin Gump Strauss Hauer & Feld on the case did not respond to requests for comment.

Abbott’s lawyer, William Lee, a Boston litigator who serves as co-managing partner of Wilmer Cutler Pickering Hale and Dorr, referred questions to Abbott.

In an e-mailed statement, Abbott spokeswoman Adelle Infante said the company is “very pleased with the appeals court’s decision. The evidence clearly showed that Abbott was first to invent a fully human anti-TNF antibody, HUMIRA.”

The Federal Circuit ruling is significant partly because of the size of the jury verdict, but it leaves legal questions unanswered, said Cornell Law School assistant professor Oskar Liivak, who submitted an amicus brief in the case in support of Abbott’s position. Liivak’s brief argued that patent claims “cannot exceed the disclosed invention.”

The Federal Circuit ruling doesn’t resolve ambiguities in the law relating to antibodies, Liivak said. Antibodies are the one area of the law where patent claims are “allowed to extend much further than [what] had been invented.”

One question the Federal Circuit ruling didn’t tackle was: “If you invent and disclose specific variable regions, how broadly can you then claim [them] in your patent afterwards?,” Liivak said. There’s no other Federal Circuit case directly on point, he said.

Ultimately, the Federal Circuit had two ways to resolve this case, Liivak said. The simpler, more conservative way was to rule that the patent specification didn’t show possession of any humanized antibodies, Liivak said. The more radical route would have been to say that Centocor’s patent specification “didn’t show that they had invented any other variable regions than the one single variable region than was disclosed in the specification,” Liivak said. Ultimately the FC chose that more conservative route because it wasn’t forced to rule on the larger question, Liivak said.

“This is a very important issue,” Liivak said. “There’s huge amounts of money riding on these cases.”

The ruling “suggests that patentees need to be very clear in their [patent] specifications to show that they are in possession of the invention,” said Michael Albert, chairman of the litigation group at Boston-based Wolf, Greenfield & Sacks. Albert isn’t involved in the case.

“One thing that the court is doing is making clear that written description and enablement are distinct requirements [for patenting],” Albert said. “Here there was no dispute that the invention was enabled. The court separately held that there was this written description requirement.”
This story originally appeared in The National Law Journal, a Corporate Counsel sibling publication.