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June 17, 2005

JURIST SAYS BLOOD-THINNER MAKER LIED

By Lorelei Laird Daily Journal Staff Writer

LOS ANGELES - The makers of the blood thinner Lovenox misled a U.S. patent examiner, thereby forfeiting its corner of the drug's $1.6 billion market, a federal judge has ruled.

U.S. District Judge Robert J. Timlin of Riverside on Wednesday dismissed a patent-infringement lawsuit that the biotech giant Aventis Pharmaceuticals filed against Amphastar Pharmaceuticals of Rancho Cucamonga and Teva Pharmaceuticals of Israel.

Those two companies had started developing generic versions of Lovenox, which posts billions of dollars in sales worldwide.

Aventis, a French-based company, told the U.S. Patent and Trademark Office examiner that an expired patent it had on a drug sold in Europe was different from the patent it submitted for Lovenox.

Timlin ruled that, because the French company lied about the data it submitted, the patent office cannot determine whether the drugs are different, making the Lovenox patent unenforceable.

The dispute centered on Lovenox's half-life, or the time it takes to decay.

Timlin said Aventis compared different doses of Lovenox and the older European drug to skew the data on the determination of half-life.

"Whether the examiner would have concluded that this difference in half-life would 'distinguish the invention from the applied prior art' in a statistically significant way is unknown," Timlin wrote in his ruling. "It is unknown because Aventis deprived the examiner of this opportunity by repeatedly misrepresenting the evidence. This foregoing fact supports a strong inference of intent by Aventis to deceive the [Patent and Trademark Office]."

The drug, whose scientific name is enoxaparin, is used to prevent blood clots from forming in heart-attack patients, bedridden people and patients who've had lower-body surgery that prevents them from walking during recovery.

Aventis lead counsel Allen Sokal of Finnegan, Henderson, Farabow, Garrett & Dunner in Washington, D.C., could not be reached for comment.

Jan Weir of Stradling Yocca Carlson & Rauth and the lead counsel for Amphistar, said the drug is valuable to doctors because it's a low-molecular weight version of a substance called heparin that naturally occurs in the human body.

He said that, in its natural form, heparin is a mixture of large and small molecules. The large molecules are thought to prevent blood from coagulating, while the smaller molecules help prevent the formation of blood clots.

By cutting the molecules down to smaller sizes, drug makers are able to retain the beneficial anti-clot properties of heparin while reducing the chance that the anticoagulant properties will prevent wounds from healing over, according to Weir.

That property of Lovenox has allowed Aventis to virtually corner the market on anti-clotting drugs, Weir said.

"Lovenox right now does enjoy widespread use, and for the particular use it addresses, it's about 90 percent of the market," he said. "It has a huge, dominant position in the market for this anti-thrombotic kind of drug."

Amphastar and Weir declined to comment on how much money the company could make on a generic version of Lovenox.

But, according to the pharmaceutical-industry research organization IMS Health, Aventis posts revenues of $1.6 billion a year from Lovenox in the United States alone.

Timlin's decision invalidated two other motions for summary judgment and effectively ends the patent side of the case.

Amphastar still has an antitrust claim against Aventis. Weir said he would continue to pursue that part of the case in light of Timlin's ruling but declined to say how much money in damages he is seeking.

"The rules require that you have this affirmative duty to be candid with the patent office... even if that information is going to adversely affect your application," Weir said. "When that duty is breached and someone obtains a patent by not being forthright with the patent office, courts can find the patent is unenforceable.

"And that's the result that happened here."

NOTE:

The Amphastar summary judgment is the second big win in a month for our patent litigators. In May, Jan Weir, Steve Hanle and Jennifer Trusso prevailed for Tamarack Scientific Co., Inc. in a patent infringement case brought by competitor Ultratech, Inc. After two years of heated and protracted litigation and a month before trial, the Court granted Tamarack's motions for summary judgment and declared Ultratech's patent invalid. The patent involved technology used in the manufacture of semiconductors. The case was pending before the Honorable Charles R. Breyer, United States District Court Judge in the Northern District of California (San Francisco).