An upcoming en banc rehearing before the U.S. Court of Appeals for the Federal Circuit has the potential to reverse a written description requirement for patents that the court imposed a dozen years ago. Owners of broadly written patents such as those covering life sciences innovations are watching closely.
The en banc court will tackle whether the patent code requires a specific "written description" of the claimed invention in addition to enabling language, which explains how to make and use it.
The law applies to all patents, but lawyers contend that biotechnology innovators especially need broad patent protection to prevent competitors from designing around specific protein or compound sequences. Requiring a written description on top of the enabling language tends to narrow the scope of patent protection because it requires applicants to provide greater detail about what the invention is designed to do.
On Friday, the Federal Circuit agreed to rehear Ariad Pharmaceuticals Inc. v. Eli Lilly and Co. en banc. An April 3 decision in the case had deemed several claims of a patent -- licensed by Harvard University, the Massachusetts Institute of Technology and the Whitehead Institute for Biomedical Research to Ariad -- invalid because the patent application lacked a written description. Ariad's suit alleged that Eli Lilly's osteoporosis drug Evista and its sepsis treatment Xigris infringed on different claims of the patent.
The en banc rehearing order asked parties and amici to brief the court on two questions. The first is whether the patent code mandates a written description of the invention separate from the enabling language, which allows someone skilled in the art to make and use the invention. The court also wants parties who argue that the code requires a separate written description to outline its "scope and purpose."
The question is hotly debated across the intellectual property community, said Ariad's lawyer, John Whealan, an associate dean for intellectual property law studies at the George Washington University Law School.
"Some people believe [the Federal Circuit has] added a requirement and a standard not in the statute and in some instances, like this case, has invalidated patents because of it," Whealan said. "If the law is changed back to enablement, patents will be judged on that standard. It will be the right way to analyze the issue."
Whealan also said a close reading of the statute requires "a written description to enable someone to make it and use it."
Eli Lilly's lawyers at Washington, D.C.-based Finnegan, Henderson, Farabow, Garrett & Dunner referred calls to the company. Eli Lilly did not respond to requests for comment.
Debate about the issue dates back to the Federal Circuit's 1997 decision in University of California v. Eli Lilly and Co., "which expanded the very modest written description requirement," said Ken Burchfiel, a partner at Washington, D.C., intellectual property firm Sughrue Mion.
On behalf of Novozymes A/S, a Danish maker of enzymes used in industrial and commercial products, Burchfiel submitted an amicus brief in favor of the en banc rehearing, supporting the petition filed by Whealan and attorneys at New York's Fried, Frank, Harris, Shriver & Jacobson.
"Broad patent coverage is essential to provide adequate protection against 'designing around' by competitors who are easily able to make insubstantial changes in patented biomolecules, avoiding the scope of narrow claims while obtaining the benefit of valuable biotechnology inventions," stated Burchfiel's brief.
The Federal Circuit's 2002 ruling and dissents in Enzo Biochem Inc. v. Gen-Probe Inc., which upheld the separate written description requirement, highlighted the ongoing debate on the court, Burchfiel said. But the Federal Circuit declined a petition for an en banc rehearing of Enzo.
