Patent Dispute Winds Down

Harvard and three other parties are facing off against pharmaceutical giant Eli Lilly in federal court over a patent dispute that could have implications on the validity of certain kinds of biotechnology patents.

The University and co-plaintiffs MIT, the Whitehead Institute for Biomedical Research, and Ariad Pharmaceuticals are seeking royalties from two of Eli Lilly’s drugs, Evista and Xigris. The institutions claim the drugs infringe on a patent they were jointly awarded in 2002.

The trial began April 10 in U.S. District Court for the District of Massachusetts. Closing arguments are scheduled to take place tomorrow.

The patent covers methods of treating diseases by modulating the activity of the molecule NF-kB, a “transcription factor” involved in protein production.

Scientists from Harvard, MIT, and the Whitehead Institute discovered these methods in the 1980s, and the institutions licensed the patent exclusively to Cambridge-based Ariad.

The four parties filed suit against Eli Lilly on the same day the patent was awarded, according to Laurie A. Allen, senior vice president for legal and business development at Ariad.

Eli Lilly, maker of the popular antidepressant Prozac, disputes the claims and asserts that the suit is without merit.

“We believe Ariad’s patent is invalid, not infringed and unenforcable,” spokeswoman Terra Fox wrote in a statement.

In a court brief, Eli Lilly argues that the institutions had patented “natural, scientific principles,” making their claims invalid.

The scientists’ discovery, Eli Lilly states in court filings, is “simply a discovery of a natural, scientific principle that has existed in Nature for more than 200 million years.”

If the plaintiffs are successful and win damages from Eli Lilly, a percentage of those royalites will go to Harvard.

But Arti K. Rai ’87, a professor of law at Duke Law School who specializes in patent law and the biopharmaceutical industry, said yesterday that a win for the plaintiffs would be a “long shot.” She cited an unsuccessful patent claim brought by the University of Rochester against Pfizer and Pharmacia in 2000.

A win for Ariad and the co-plaintiffs, Rai said, would favor patent holders making claims on other drugs that use the same signaling pathways to a particular molecule.

According to Science magazine, a recent paper said more than 200 compounds use NF-kB signaling, aspirin among them.

“NF-kB ought to be available to anybody who wants to make a drug against it, and the terms should not be unreasonable,” Roger Brent, president of the nonprofit Molecular Sciences Institute, told Science.

“It’s potentially quite significant, although I think Ariad’s going to lose,” Rai said in an interview yesterday.

A decision from the jury is expected on May 1 or shortly therafter, according to Eli Lilly.

Harvard spokesman Joe Wrinn declined to comment on the litigation.

—Staff writer Nicholas M. Ciarelli can be reached at ciarelli@fas.harvard.edu.