U.S. District Judge Sue Robinson of Delaware ()
U.S. District Judge Sue Robinson of Delaware surprised financial markets and the pharmaceutical industry Thursday by ordering an FDA-approved cholesterol drug off the market.
Shares of Amgen Inc. jumped 4 percent Friday morning after Robinson granted its request for a permanent injunction that blocks Sanofi and Regeneron Pharmaceuticals Inc. from marketing Praluent, a biological drug that treats high LDL cholesterol. Amgen, which markets the competing biologic Rapatha, prevailed in a patent infringement trial against Sanofi last year.
Robinson noted in her order the billions of dollars at stake in the case, and said that balancing the public interest put her “between a rock and a hard place.” She stayed her order for 30 days to let Sanofi seek expedited review from the U.S. Court of Appeals for the Federal Circuit.
Injunctions for patent infringement have been rare since the Supreme Court’s ruling a decade ago in eBay v. MercExchange. But Robinson becomes at least the third federal judge to issue an injunction in a life science patent case since last summer.
U.S. District Judge William Alsup of San Francisco ordered Qiagen N.V. to stop marketing a gene sequencing machine last September that infringes Illumina Inc. patents. The Federal Circuit is scheduled to hear Qiagen’s appeal Jan. 12.
Also in September, U.S. District Judge Kevin McNulty of New Jersey enjoined Fera Pharmaceuticals and two other companies from proceeding with an Abbreviated New Drug Application for a thyroid medication that infringes Fresenius Kabi USA LLC’s intellectual property.
There are key differences between the three cases, but Morrison & Foerster partner Michael Jacobs said they could signal the beginning of a shift in district court willingness to enjoin infringers, at least in life science cases.
“It may be easier than in electronics cases to demonstrate irreparable harm,” Jacobs said. It also could be that lawyers are getting savvier at making their cases for injunctions, he said.
Finnegan Henderson Farabow Garrett & Dunner partner Sanya Sukduang said that he’s not sure about a trend, but Robinson’s order in Amgen v. Sanofi stands out because it’s between two branded pharma companies who independently developed their biologic drugs. “It is fairly rare to take an FDA drug off the market, particularly one that is not a generic,” he said.
Sukduang said Robinson was doing it in a careful way by giving the parties a month to appeal.
Robinson wrote in her order that Amgen and Sanofi have spent “billions of dollars and over a decade of work to bring their respective products to market.”
Amgen is suffering irreparable harm both to market share and reputation by being forced to compete against an infringing drug, she wrote. Because the market for PCSK9 inhibitors is almost brand new, money damages are not an adequate remedy.
Those two factors outweighed the public interest, which Robinson said is difficult to gauge. “Being a patent holder and a verdict winner should be a meaningful factor in the balancing test, but taking an independently developed, helpful drug off the market does not benefit the public,” Robinson wrote.
But even if the public interest favors Sanofi, Robinson concluded that the injunction should issue because of the other factors favoring Amgen.
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