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ICOS faces patent lawsuit

Published 9:00 pm Friday, August 19, 2005

BOTHELL – Three researchers at Vanderbilt University in Nashville, Tenn., are claiming in a new lawsuit that their names were left off ICOS Corp.’s patents for the erectile dysfunction drug Cialis.

The suit, filed in U.S. District Court in Delaware, asks that the researchers be named as co-inventors on the patents, which were granted in 1999 and 2000. The lawsuit doesn’t explicitly ask for any monetary damages.

There’s more than scientists’ pride at stake, however, as naming the wrong inventor or omitting co-inventors can bring into question the validity of a patent, according to intellectual property experts.

Cialis is ICOS Corp.’s only drug on the market and has generated sales of more than $1 billion in less than two years, so the drug’s patents are crucial to the company’s success.

“We will evaluate the allegations in the complaint,” said Lacy Fitzpatrick, spokeswoman for Bothell-based ICOS. But she added that the company also will “vigorously defend” its patent rights.

In its recent quarterly filing with the U.S. Securities and Exchange Commission, ICOS added that it is “premature to assess what, if any, impact the lawsuit might have on our business, financial position, results of operations and cash flows.”

Vanderbilt’s general counsel could not be reached for comment on the lawsuit Friday.

The university’s suit claims that Jackie Corbin, Sharron Francis and Sekhar Konjeti all conducted research in the 1980s on how the class of drugs Cialis belongs to, PDE-5 inhibitors, work in the body.

Some of the work was done for Glaxo Group Research Ltd. In 1994 and 1995, Glaxo filed for patents for tadalafil, Cialis’ active ingredient, but named only one inventor, Glaxo scientist Alain Daugan. Glaxo later sold its patent rights for the drug to ICOS.

The suit asks the court to order ICOS to list Corbin, Francis and Konjeti as co-inventors on the patents.

Karel Lambert, a Seattle patent agent who once worked for Bothell’s Sonus Pharmaceuticals, said the case isn’t likely to become a big deal for ICOS. Even when researchers can prove they are co-inventors of a drug or product, a judge is likely to do little besides order that their names be added to the patent.

“Right now, there’s a very limited penalty for failing to name a co-inventor,” Lambert said.

This is not the first time ICOS’ rights to Cialis have been legally questioned. Pfizer, the maker of Viagra, has claimed in a lawsuit that its patent covers the basic mechanism that works in its competitors, Cialis and Levitra. That suit still has not been resolved in the United States.

Reporter Eric Fetters: 425-339-3453 or fetters@heraldnet.com.