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Sanofi loses German patent case against Amgen over cholesterol drug

KARLSRUHE, Germany (Reuters) – Germany’s highest civil court on Tuesday rejected French drugmaker Sanofi’s bid to fend off a legal challenge by U.S. rival Amgen against Sanofi’s cholesterol drug Praluent.

In the latest setback for Sanofi in the drawn-out patent dispute with Amgen, which is selling its rival drug Repatha, the German court ruled that Sanofi was not entitled to a special license that would have protected its Praluent business.

Officials at Sanofi did not have an immediate comment.

Amgen had initially sued Sanofi in Germany as part of a legal campaign in various jurisdictions, claiming the French group had violated its patent on Repatha.

Both drugs belong to a class of PCSK9 inhibitors, used against persistently high cholesterol levels in the blood, and aimed at the millions of people who don’t benefit from statins such as Pfizer Inc’s Lipitor.

With Amgen’s challenge ongoing, Sanofi opened a new legal front and petitioned the German patent court to be granted a license to use Amgen’s patent to secure Praluent’s continued market presence in Germany, Europe’s largest drug market.

After its bid was rejected by the patent court in September, Sanofi turned to the higher court but the case was turned down again on Tuesday.

Praluent will, however, remain on the German market as long as Amgen’s legal challenge against the drug’s patent continues.

A U.S. jury in February confirmed the validity of Amgen’s patents on Repatha, rejecting a challenge by Sanofi and its partner Regeneron Pharmaceuticals Inc in the protracted dispute.

Reporting by Ursula Knapp; Writing by Ludwig Burger; editing by David Evans

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