Eli Lilly Prozac patent challenge starts Jan. 25
Friday January 22, 7:12 pm Eastern Time
By Greg Jefferson
INDIANAPOLIS, Jan 22 (Reuters) - The lawsuit threatening Eli Lilly and Co.'s (NYSE:LLY - news) patents on its blockbuster antidepressant drug Prozac, which brings in about a third of its revenues, is set to open on January 25 in U.S. District Court in Indianapolis.
The patents are being challenged by generic drug makers Barr Laboratories Inc. (NYSE:BRL - news) and Geneva Pharmaceuticals Inc. The patent on the drug itself, fluoxetine hydrochloride, currently expires in 2001. The other, covering its use, ends at the end of 2003.
The trial ''is extremely important for Lilly,'' said drug industry analyst James Keeney of ABN AMRO in New York.
Prozac provided Lilly with $2.6 billion of its $8.5 billion in revenues in 1997, and more than $2 billion in the first nine months of 1998. Lilly has not yet reported 1998 year results.
The litigation has been in the works for nearly two years.
Barr filed with the U.S. Food and Drug Administration to market a generic version of the antidepressant in December 1996. The following April, Lilly sued to block the Pomona, New York-based firm.
Later in 1997, Lilly filed a separate lawsuit against Geneva, a Colorado-based subsidiary of Swiss pharmaceutical company Novartis AG . Geneva had also filed with FDA to sell generic fluoxetine.
The cases were later consolidated.
In a sheaf of pretrial rulings handed down on January 12, U.S. District Judge Sarah Evans Barker narrowed the case, throwing out Barr's claims against the double-patenting of Prozac and allegations that Lilly did not supply the U.S. Patent Office with the ''best mode'' for making Prozac.
Many industry watchers interpreted these rulings as favoring Lilly.
Remaining are Barr's claim that Lilly scientists did not invent fluoxetine and the charge of ''inequitable conduct'' on Lilly's part in securing the Prozac patents.
''It looks like this trial will be in Lilly's favor,'' said Cynthia Beach, a pharmaceuticals industry analyst for Gerard Klauer Mattison in New York. ''Their strongest claim -- on double-patenting -- won't even be heard.''
Lilly spokesman Ed West contends Barr will have a heavy burden in court.
''We believe -- and we believe past patent cases bear this out -- that the allegation of inequitable conduct is very difficult to prove,'' West said. ''That's a very difficult standard for Barr to meet.''
Barker will rule on the two claims. But her decisions will probably not be the last word in the case.
The January 12 rulings could be fodder for an appeal by Barr if the company loses the trial, expected to last two weeks.
''From my understanding, the (dismissal) of the double-patenting issue is very appealable,'' said Barr spokeswoman Carol Cox. ''I anticipate we'll appeal on both.''
In a January 21 conference call, Barr Chairman, President and Chief Executive Officer Bruce Downey, told investors an appeal is likely, Cox said. Word spread that day and Lilly's share price dropped $4.19 to $78.06.
In Lilly's camp, attorneys are concentrating only on winning the case, West said.
"We will address any other scenario at a future time," he added.
|
