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XALATAN PATENT AFFIRMED BY APPEALS COURT

August 22, 2005

The U.S. Court of Appeals for the Federal Circuit has affirmed a 2004 district court ruling that Par Pharmaceutical's generic version of Pfizer's glaucoma drug Xalatan infringed on a Pfizer patent for the product.

Par had appealed part of the earlier court decision by the U.S. District Court for the District of New Jersey that upheld two Xalatan (latanoprost) patents, one set to expire in July 2006 and one set to expire in March 2011. Par appealed the portion of the court's decision that upheld the patent set to expire March 2011. "Patent protection is vital to the development of life-saving medicines and we are pleased that the appeals court affirmed the lower court decision that will leave the patent in place until 2011," said Bryant Haskins, a Pfizer spokesman.

District Court Judge Stanley Chesler had also ruled that Pfizer's third patent was unenforceable because of "inequitable conduct" by Pharmacia, a drug company that is now part of Pfizer. The district court said Pharmacia failed to submit important patent information. However this decision doesn't allow Par to enter the market with a competing product.

Pfizer stands to lose a significant revenue source once Xalatan loses patent protection, as the drug is one of the company's top selling drugs as well as the top selling glaucoma treatment worldwide. Worldwide sales of Xalatan sales skyrocketed 84 percent from 2003 to 2004, rising from $668 billion to $1.23 billion. Pfizer's second quarter financial report shows worldwide sales up 17 percent from $291 million to $341 million, year over year.

Par isn't the only party that has recognized the generic potential of Xalatan. The popular drug is expensive, and the fact that Xalatan was invented with the aid of government funding has spurred advocates to push for Xalatan's generic licensing to make it more accessible to the taxpayers who paid for it.