Brief

Amgen notches another win in patent dispute with Sanofi, Regeneron

Dive Brief:

  • A federal judge on Tuesday rejected an attempt by Sanofi and Regeneron to reverse an earlier unfavorable decision in an ongoing patent dispute with rival Amgen, Inc over competing cholesterol drugs. 
  • U.S. District Judge Sue Robinson denied a motion by the Sanofi and Regeneron team for a new trial to reassess a federal jury's decision last March to uphold the validity of two Amgen patents. 
  • Amgen sued Sanofi and Regeneron in 2014, claiming their high cholesterol drug Praluent (alirocumab) infringed on two patents Amgen held for its own drug Repatha (evolocumab). Both drugs target an enzyme known as PCSK9 and have struggled to get off the ground despite impressive clinical results. 

Dive Insight:

The decision boosts Amgen's hopes to stop Sanofi and Regeneron from selling Praluent, or at least extract royalties or damages from the duo. 

"The court's ruling today is an important step in this case and confirms the jury's finding that the patents which protect Repatha are valid and infringed by Sanofi," a spokesperson for Amgen said in an emailed statement.

Sanofi and Regeneron plan to appeal, however.

"We are disappointed with the district court’s ruling. It is our longstanding position that Amgen’s asserted patent claims are invalid, and we intend to appeal today’s ruling," said the drugmakers in a joint statement. 

Praluent and Repatha were approved by the FDA only one month apart, in July and August of 2015. Despite high expectations and strong clinical data, payers have balked at the high price tags for the drugs. That pushback has impacted sales: over the first three quarters of 2016, neither drug cracked $90 million in sales.

The three drugmakers are testing their respective drugs' cardiovascular benefit. Positive results on this front could help give either of the drugs more of an edge over cheaper statin treatments for high cholesterol.

Amgen's FOURIER study is ongoing and could report preliminary results sometime this year. Sanofi and Regeneron's ODYSSY trial will also read out in 2017. 

The patent dispute between the two sides looks set to continue on an appeal. In the meantime, however, the drugmakers will have their hands full in boosting their respective drugs. 

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