Pfizer Wins Viagra Patent, Moves to Block Competition
By SCOTT HENSLEY
Staff Reporter of THE WALL STREET JOURNAL
Pfizer Inc. received a broad U.S. patent Tuesday covering the way Viagra works to treat impotence and immediately filed two lawsuits to block rivals from selling competing products relying on the same biological mechanism.
The bold suits, filed Tuesday in U.S. District Court in Wilmington, Del., came only a day after President Bush assailed the drug industry for blocking generic competition by gaming the patent system.
Pfizer, New York, takes a slightly different tack and seeks to stop the introduction of competing brand-name drugs to treat impotence. The defendants in one suit are Bayer AG and its partner GlaxoSmithKline PLC, which expect to co-market Levitra in the U.S. next year.
The other defendants are Eli Lilly & Co., Icos Corp. and a joint venture they have formed to develop and market Cialis, another impotence remedy expected to be launched in 2003. Both drugs are awaiting Food and Drug Administration approval.
The Pfizer patent, in force until 2019, is of a new type that covers the broad use of chemicals, for example, to affect a biological system.
These so-called use patents represent a new frontier for protection of intellectual property in the drug industry.
By essentially staking a claim on a method for influencing biology, Pfizer's patent is designed to cover any medicine that acts through a particular biological pathway.
Traditionally, pharmaceutical firms have patented only specific chemicals and their manufacture. More recently they have also sought patents on the means for delivering the drugs into the body.
For important new drug types, these barriers were insufficient to prevent competitors from racing to market with "me-too" drugs that were only slightly different from the original.
Pfizer, which garners more than $1 billion in sales from Viagra annually, asserts that its newly issued patent covers the use of drugs that treat erectile dysfunction by inhibiting an enzyme called phosphodiesterase-5, or PDE5, including those invented by other companies.
Levitra, discovered by Bayer, and Cialis, discovered by Icos, work on that enzyme.
A spokeswoman for London-based GlaxoSmithKline declined to comment because the company hadn't seen Pfizer's complaint. Bayer, of Germany, couldn't be reached for comment.
A spokeswoman for Icos, Bothell, Wash., said the company "will vigorously defend our rights in this litigation."
She said that Pfizer's claim to a use patent on PDE5 inhibitors has been invalidated before the European patent office and in United Kingdom courts.
Pfizer said the U.S. Patent Office "fully considered the information and arguments raised" in those cases and "resolved them in Pfizer's favor" in deciding to issue the patent.
A spokesman for Eli Lilly, Indianapolis, echoed the comments from Icos.
For Pfizer, the latest suits relying on use patents are a turnabout in the intellectual-property game. Two years ago, the University of Rochester in New York received a patent that it says covers the lucrative arthritis drugs known as Cox-2 inhibitors, which include Celebrex, a blockbuster drug that Pfizer co-markets with Pharmacia Corp.
The university asserted it was entitled to royalties on sales of Celebrex and filed suit against G.D. Searle, now part of Pharmacia, and Pfizer to drive them to the bargaining table. Neither side has commented on how those discussions have gone.
On Monday, the FDA proposed a rule that limits drug makers to seeking a single 30-month delay before a generic competitor can be introduced after a patent expires. Until now, some pharmaceutical firms have received more than one 30-month delay in connection with the same medication.
--Antonio Regalado and David Hamilton contributed to this article.
Write to Scott Hensley at scott.hensley@wsj.com
Updated October 23, 2002
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