A judgment rendered by the federal appeals court that handles patent cases could make it harder for universities to patent basic research. And the ruling made it clear that the judges were aware of the implications of their decision. The U.S. Court of Appeals for the Federal Circuit ruled 9-2 in favor of Eli Lilly in a patent dispute with Ariad Pharmaceuticals. The ruling upheld a decision rendered in December in an ongoing fight over the validity of a patent issued in 2002 on a technique for identifying how a messenger protein regulates how cells function.

 

“The patent law has always been directed to the ‘useful arts,’ meaning inventions with a practical use,” the judges wrote in their decision. “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.”

 

The rehearing concerned a 2007 judgment that held Lilly liable for infringement of four claims of U.S. Patent No. 6,410,516 (the ‘516 patent). The Federal Circuit held that the four patent claims are invalid due to inadequate written description.

 

The ‘516 Patent, issued in 2002, covers methods of treating human disease by regulating NF-κB cell-signaling activity and is based on the pioneering discoveries made by research groups led by Professors David Baltimore, Phillip Sharp and Tom Maniatis at the Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research and Harvard University. ARIAD is the exclusive licensee of the technology and patents.

 

Immediately upon issuance of the patent, the co-plaintiffs, including Harvard University, the Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and Ariad Pharmaceuticals sued Eli Lilly claiming that two of its drugsEvista for osteoporosis, and Xigris for sepsis—infringed the patent. That trial ended in favor of the plaintiffs and Lilly was ordered to pay $62.5 million in damages plus royalties on future sales, which a federal court upheld in 2007.

 

Lilly appealed, however, arguing that the patent was invalid because it did not adequately demonstrate how to actually make the new technique. Lilly used a previous case in which the University of Rochester had brought a patent-infringement suit against Pharmacia and Pfizer over the arthritis drug Celebrex. Pfizer had won that suit because the university's patent was not specific enough.

 

The federal appeals court judges recognized that universities may be disadvantaged in not having the resources to work out practical uses for an invention but said that was “no failure of the law's interpretation but its intention.”

 

“We are reviewing the ruling issued today by the Federal Circuit to assess our options in the case,” said Harvey J. Berger, chairman and chief executive officer of Ariad.