Sanofi, Regeneron prevail against Amgen at EPO
French drugmaker Sanofi and US biotechnology company Regeneron have secured a victory at the European Patent Office, which has sided in their favour by ruling that a patent belonging to rival Amgen is invalid.
The EPO decision is the latest development in a global battle that has seen courts give varied rulings in different jurisdictions.
In August 2019, the US District Court for the District of Delaware held that claims for Amgen’ patent US number 2 215 124, which covered antibodies for its cholesterol product, Repatha, were invalid.
The court ruled that the patents failed due a lack of enablement, meaning that the filed application would not have been sufficient to teach a skilled person how to make and/or use the full scope of the claimed invention without undue experimentation. However, this decision overturned an earlier jury ruling at the same court that upheld Amgen’s patent.
Furthermore, Amgen’s Praluent is not available in Germany, following an injunction granted by the Düsseldorf Regional Court in July 2019, which found that Sanofi and Regeneron had infringed one of Amgen’s patents. Sanofi has appealed against the decision and a hearing is scheduled for November 5.
The dispute arose in 2014, when California-based Amgen sought to block Sanofi and Regeneron from selling their rival drug, Praulent, accusing the companies of patent infringement. Both Repatha and Praulent are used to treat adults whose cholesterol cannot be controlled by diet and statin treatment.
Following the EPO’s decision, Karen Linehan, executive vice president, legal affairs and general counsel, Sanofi, said: “We are pleased with today’s decision by the EPO, which upholds the rigorous standard for pharmaceutical patents that we argued for in this case, affirming that Amgen’s asserted claims against Sanofi in Europe are invalid. This decision validates our years-long commitment to vigorously defending this case.”
According to an agreement announced in December 2019, Sanofi possesses sole rights for Praluent outside the US, while Regeneron has sole rights for Praluent inside the US.
Following this week’s ruling, Praluent will continue to be available in European countries where it is approved
Praluent is approved in more than 60 countries worldwide across the European Union, North and South Americas, Asia, Africa and Australia.
According to Amgen, Repatha had worldwide sales of $152 million in the second quarter of 2019, while Regeneron reported Praluent sales of $73.7 million for the same period.
LSIPR has approached Amgen for comment.
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