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Wednesday, April 13, 2005

Ind. Decisions - Court to Rule on Lilly Zyprexa Patent

Reuters is reporting here this afternoon:

Eli Lilly and Co. said on Wednesday that a federal judge will issue his long- awaited decision on the validity of patents for Lilly's multibillion-dollar schizophrenia drug Zyprexa on Thursday afternoon. Lilly said it remains confident that Zyprexa's patent is valid and that the challenges brought by generic drugmakers are without merit.

While Lilly expects to prevail in the case, it said in a statement that an unfavorable outcome "would have a material adverse impact on the company's consolidated results of operations, liquidity, and financial position." * * *

The validity of the Zyprexa patent was challenged by Zenith Goldline Pharmaceuticals, a unit of Ivax Corp. and the first company to file an application to sell a generic version of Zyprexa. Similar lawsuits were later filed by Indian generic drug maker Dr. Reddy's Laboratories and Israel's Teva Pharmaceuticals .

The cases were consolidated before Judge Richard Young in U.S. District Court for the Southern District of Indiana in Indianapolis, where Eli Lilly is headquartered.

The trial was completed more than a year ago and the sides have been awaiting Young's ruling ever since.

The pivotal decision will come more than four years after a successful patent challenge virtually wiped out revenue from their previously best-selling antidepressant Prozac.

The generic drug makers argued that the Zyprexa patent in question was too similar to a previous patent held by Lilly and should be declared duplicative and invalid. They also challenged a toxicology study done on dogs that Lilly used to back up its argument for acquiring the patent on the drug, which has been on the market since 1996.

An appeal is expected from whichever side loses the patent dispute, meaning the battle could well drag on for another year or two.

For background, see this 2/8/04 ILB entry, titled "Federal Judge Young featured in STAR story today about Lilly bench trial"," and this 2/13/054 entry titled "Lilly Trial Goes to Judge."

Posted by Marcia Oddi on April 13, 2005 03:36 PM
Posted to Ind Fed D.Ct. Decisions