Battle for Prozac Patent Stressful
INDIANAPOLIS (AP) _ Some people are getting pretty stressed out about the world’s best-selling antidepressant.
Lawyers from 11 firms are due in court on Monday as two competitors challenge Eli Lilly and Co.’s patents on the drug Prozac. At stake are U.S. sales for the world’s favorite antidepressant, a market estimated to reach $2.5 billion this year.
Barr Laboratories and Geneva Pharmaceuticals are bucking long odds in trying to convince U.S. District Judge Sarah Evans Barker to throw out two Lilly patents on Prozac so they can introduce their own cheaper, generic versions.
Pretrial rulings this month in the case have favored Indianapolis-based Lilly, and some industry observers said it had a clear advantage heading into the trial, expected to last about two weeks.
``It’s still there to be tried,″ responded Carol Cox, a spokeswoman for Pomona, N.Y.-based Barr. ``While it might be more difficult to prove (our case), it’s not unprovable.″
Representatives for Broomfield, Colo.-based Geneva, a division of the Swiss drug giant Novartis AG, declined to comment on the case.
New York-based Gruntal & Co. stock analyst David Saks, who recommends buying both Lilly and Barr, said the trial puts Lilly and its lucrative Prozac franchise clearly at risk. ``Anytime you go into war, the outcome is uncertain.″
At issue are Lilly’s patent on fluoxetine, the active ingredient in Prozac, which expires in February 2001, and a second patent on how Prozac works, due to expire in December 2003.
Of the remaining claims against Lilly, one alleges Lilly fraudulently withheld data or gave misleading information on its two patents, and the other challenges whether Lilly provided enough information on the 2003 patent.
If the defendants can prove the difficult fraud claim, generic competition could enter the U.S. market as early as next year.
Much of the case, including witness lists, has remained under seal, and all the parties were reluctant to discuss specifics during the days leading up to the trial.
Barr and Geneva this month waived their rights for a jury to hear part of the case, so Barker will decide it all. She will likely issue her rulings weeks after the trial ends, and appeals could drag on for months or years.
The outcome will be felt by not only the litigants, but also the millions of Americans who pay for Prozac to treat depression, bulimia, obsessive-compulsive disorder and other ills. Children and even pets down it to make their lives cheerier. A new indication for Prozac to treat a type of premenstrual syndrome is pending before regulators.
Prozac, which costs about $60 for a month’s worth of pills, has brought in more than $15 billion for Lilly since the drug’s launch in 1987. It carried Lilly through the turbulent early 1990s, a time marked by the turnovers of two chief executives, a $1 billion cost-cutting program, and the first quarterly loss ever in four decades as a publicly traded company.
As long as its patents hold, Prozac will bring in at least $3 billion a year for Lilly for years to come, stock analysts predict. Lilly last month struck a deal for an enhanced version of Prozac that promises a more effective treatment, possibly without some of Prozac’s troubling side effects such as sexual dysfunction. It’s under patent until 2015.
But if Barker tosses out the patents under challenge in her court, Barr, Geneva and other generic drug companies will roll out cheaper versions and start carving up the key U.S. market for the drug before Lilly can introduce the new ``super″ Prozac, which is still in clinical trials.
Sales projections published last month by S.M. Scala of SG Cowen Securities Corp. show that without generic competition, annual Prozac sales will reach $3.45 billion by 2002. With competition, they fall off to $2.04 billion, dragging down Lilly’s annual earnings per share by 70 cents.
Already, generic competition has eroded Prozac sales overseas, causing a drop of more than 14 percent from a high of $627.4 million in 1995 to $538.1 million in 1997. Lilly is expected to announce year-end figures for 1998 on Thursday.