Judge hands Amgen major patent victory over PCSK9 rivals

Dive Brief:

  • Amgen on Thursday won a major legal victory in its patent battle with Sanofi and Regeneron over the companies' competing high cholesterol drugs, likely securing control of the still promising PCSK9 market. 
  • In a surprise decision, federal judge Sue Robinson granted Amgen's request for a permanent injunction against Sanofi and Regeneron, effectively banning sales of their drug Praluent (alirocumab) in U.S. markets.
  • Sanofi and Regeneron said they would immediately appeal the ruling and would seek a suspension of the injunction during the appeals process. 

Dive Insight:

Importantly, Judge Robinson ruled that monetary damages, such as royalties or damages, would be insufficient to remedy the harm suffered by Amgen from sales of Praluent. 

"Monetary damages will not suffice under the present circumstances, as plaintiffs intended to use their patent to maintain market exclusivity. Moreover, the developing PCSK9 inhibitor market, together with the reputational harm, make monetary damages speculative," Judge Robinson wrote in her order.

A ban on Praluent, if it stands, would be an embarrassing and costly blow to Sanofi and Regeneron. While sales of both Praluent and Amgen's Repatha (evolocumab) have disappointed to date, the competing sides have sunk billions of dollars (at least according to the court) into development and marketing of the drugs. 

Sanofi had even used a coveted priority review voucher, which it paid $67.5 million to obtain from BioMarin, to leapfrog Amgen and win U.S. approval of Praluent a month before Repatha.

Judge Robinson did find that public interest favored Sanofi and Regeneron's case, as removing Praluent from market would make Repatha the only PCSK9 drug currently approved in the U.S.

But that was not enough to outweigh other considerations. Robinson concluded Amgen sufficiently demonstrated "irreparable harm" and that the remedies at law favored an injunction rather than monetary damages. 

Robinson did, however, delay the injunction from taking effect for 30 days to give Sanofi and Regeneron time to appeal or negotiate an agreement with Amgen. 

Analysts at Jefferies, an investment firm, believe Amgen likely won't negotiate with the injunction now in hand. A stay while the appeals process unwinds could delay the removal of Praluent from markets for a year, Jefferies analyst Biren Amin said in a note.

"We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position," said Joseph LaRosa, general counsel and secretary at Regeneron.

Amgen shares climbed by about 4% in early Friday trading, while Regeneron stock fell by over 6%. Sanofi was down 3%. 

A ban on Praluent likely will boost the momentum behind Repatha. And if Amgen's cardiovascular outcomes study for the drug reads out positive, sales might begin to live up to original expectations. 

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