By Don J. DeBenedictis
Daily Journal Staff Writer
A federal judge has invalidated the patent on a $3 billion drug, concluding that French pharmaceutical giant Sanofi-Aventis "intended to deceive" the U.S. Patent Office in its application. The decision is a victory for an Inland Empire drug maker and the generic drug industry.
In a dense but blistering written opinion issued late Thursday, U.S. District Judge Mariana R. Pfaezler of Los Angeles held that Sanofi-Aventis' committed "inequitable conduct" in obtaining a patent on top-selling anti-coagulant Lovenox and that the patent therefore is unenforceable. Aventis Pharma S.A. v. Amphastar Pharmaceuticals Inc., EDCV03-887 (C.D. Cal., filed Aug. 4, 2003).
Lovenox
Pfaezler found that an Sanofi expert who convinced a reluctant U.S. Patent Office to grant a patent on Lovenox had failed to disclose key facts about his assumptions and reasoning. The expert's explanation for why he did so "suffers from a total absence of indicia of credibility," the judge wrote.
To claim those omissions were inadvertent "is simply implausible," Pfaezler wrote.
"Consistently omitting so many references involves the application of diligence, not the commission of negligence," she wrote.
French Firm
One of the winning attorneys, Steven M. Hanle of Stradling Yocca Carlson & Rauth in Newport Beach, called the judge's decision "a very big victory for our client ... and important in the generic-pharmaceuticals industry."
Hanle and partner Jan P. Weir represent Amphastar Pharmaceuticals in Rancho Cucamonga, which has applied with the patent office to produce a generic version of Lovenox, also known as enoxaparin.
The drug is used extensively during orthopedic surgery to prevent serious blood clots and after heart attacks.
According to news reports, Sanofi-Aventis earns $2 billion a year from Lovenox sales in the United States and $750 million a year more from sales in the rest of the world. Its patent on the drug was set to expire in 2012.
Sanofi, the world's third-largest pharmaceuticals group, told Reuters that it is reviewing its options and intends to continue defending vigorously its intellectual property rights.
Attorneys for the company, Allen M. Sokal and Bryan C. Diner of Finnegan, Henderson, Farabow Garrett and Dunner in Washington, D.C., did not return calls seeking comment Friday afternoon.
Along with Amphastar, Israeli drug-maker Teva Pharmaceuticals, fought Sanofi over the patent. Edith Ramirez of Quinn Emanuel Urquhart Oliver & Hedges, who represented Teva, could not be reached late Friday.
Weir and Hanle said it is unusual to defeat a patent on the ground that the patent holder obtained it through inequitable conduct.
"It's difficult to prove because you have the extra element of specific intent to deceive," Weir said.
But Pfaezler clearly was convinced. She found the company's expert, a highly regarded international scientist, "stands before the Court in the same position as he would if no evidence of subjective good faith had been offered" and that defendants Amphastar and Teva had shown "clear and convincing evidence" of his intent to deceive the patent office.
Sanofi Aventis had obtained a European patent on the drug and others like it in 1984, but that patent was revoked in 1990. Nevertheless, the company sought a U.S. patent in 1991. After years of work and three rejections by the patent office, the company won its patent in 1995.
The key issue was whether the new drug was different from other drugs, all derivatives of the anti-coagulant heparin, that are covered by earlier patents. Dr. Andre Uzan offered reports and declarations stating Lovenox is different because, among other reasons, it lasts 250 percent longer in the bloodstream.
Uzan, however, did not tell the patent examiner that he had compared a 60-mg dose of one drug to a 40-mg dose of the other. Although those doses might be appropriate in actual clinical use, Pfaezler wrote, the difference largely invalidates Uzan's contention the drugs are different compositions.
Further, she found, Uzan and Sanofi persisted in not pointing out the dosage difference during five years of patent prosecution before the patent office.
She rejected any notion that a scientist of Uzan's caliber could have made these mistakes through negligence, even gross negligence.
"They were too egregious, too obvious, and too consistently committed over too long a period of time," the judge wrote.
Pfaezler also criticized "the memory loss of the Aventis Patent Department regarding" the omissions.
She concluded, "This is a case involving a statistical analysis designed post-hoc and rationalized in hindsight to fit a hoped-for result."
Hanle said he could not comment on when Aphastar might bring a generic version of Lovenox to the market. The drug must win Food and Drug Administration approval first, and analysts told Reuters that could be a difficult process.
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Intellectual Property 