Newport Beach’s Stradling Yocca Carlson & Rauth won a not-so generic trial earlier this month.
The law firm defended generic drug maker Amphastar Pharmaceuticals Inc. of Rancho Cucamonga in a patent infringement suit brought by France’s Sanofi-Aventis.
A federal judge invalidated Sanofi’s patent for Lovenox, a blood thinner used to fight blood clotting and heart attacks. Sanofi committed “inequitable conduct” to get its patent, the judge said.
Lovenox does about $2 billion in U.S. sales a year and an additional $750 million abroad. Its patent was set to expire in 2012.
Sanofi plans to appeal.
The ruling stems from a three-year case in which Sanofi sued Amphastar and Israeli partner Teva Pharmaceuticals Industrials Ltd., which has major operations in Irvine, when they started developing a generic version of Lovenox.
Amphastar prevailed after U.S. District Judge Mariana R. Pfaelzer in Los Angeles ruled there was evidence Sanofi had intended to deceive the U.S. Patent Office when it applied for a Lovenox patent in 1991. Pfaelzer said Sanofi’s patent was “unenforceable on the ground of inequitable conduct.”
Stradling’s Jan Weir, lead trial lawyer, and partners Steven Hanle and Jennifer Trusso have represented Amphastar since the start of litigation in 2003.
The lawyers initially set out to prove the makeup of Sanofi’s drug wasn’t unique versus other generic blood thinners, such as Amphastar’s enoxaparin, which is awaiting regulatory approval.
Switched Course
The team’s defense took a turn in 2004 when the lawyers said they found that Sanofi may have failed to disclose information about dosage sizes in the data submitted to patent examiners.
In 2005, U.S. District Judge Robert J. Timlin in Riverside dismissed the case after deciding Sanofi misled patent examiners to believe Lovenox lasted 250% longer than other drugs without disclosing the drugs were tested at different dosages.
A federal appeals court sent the case back to trial in 2006 to determine whether Sanofi intended to mislead patent examiners.
Amphastar and Teva showed “clear and convincing evidence” that Sanofi intentionally deceived patent examiners for financial gain, Judge Pfaelzer said, rejecting the notion that Sanofi withheld information through negligence.
The company’s intentions were “too egregious, too obvious and too consistently committed over too long a period of time,” Pfaelzer said.
One of the biggest challenges was to prevent Sanofi’s attorneys from slowing the case, the Stradling lawyers said.
“We tried to not let the case get bogged down with the brand company trying to convince the judge and the jury that the case was too complex or scientific to examine,” Hanle said.
The lawyers said they benefited from the other side’s “memory loss.”
“The lawyers made the mistake of letting their clients have amnesia during the deposition and that really hurt them,” Trusso said.
The case shows how Orange County’s law firms have evolved, according to Trusso.
“The pharmaceutical industry tends to use more attorneys on the East Coast,” she said. “Our work on this case is definitely new territory, not just for Southern California but for Orange County.”
