[Ip-health] Sanofi asked for compulsory license on Prauluent patents in Germany, but failed.

James Love james.love at keionline.org
Mon Jul 15 06:09:39 PDT 2019

According to this story, Sanofi asked for a compulsory license on patents
relating to Praluent in Germany, but failed.

* "They also attempted to persuade the German authorities to issue a
compulsory licence for Praluent, but that failed too."


Amgen gets block on sales of Repatha rival in Germany
Part of ongoing battle with Sanofi and Regeneron

Amgen has chalked up a win in its legal disputes with Sanofi and Regeneron
over their cholesterol-lowering drugs, winning a sales injunction in

The Dusseldorf Regional Court found that Sanofi and Regeneron’s Praluent
(alirocumab) infringed a European patent (No. 2,215,124) that covers
Amgen’s rival drug Repatha (evolocumab), and promptly agreed to a block on
the manufacture, sale and marketing of Praluent in Germany.

For the injunction to go into effect, Amgen must enforce it by posting a
bond, according to Sanofi, which said for now Praluent remains on the
market and that the judgment doesn’t affect any other European markets.

The company added it was disappointed with the decision and “continues to
believe that patients and physicians should have a choice of
cholesterol-lowering therapies in order to achieve optimal lipid-lowering
for patients.”

The lawsuit over the intellectual property for the PCSK9 inhibitor drugs
dates back to 2016 when Amgen filed its patent infringement complaint
shortly after Repatha was approved for marketing. Praluent was the first of
the two drugs to be approved in Europe.

It’s first blood to Amgen in the European patent battle, and Repatha’s
developer also seems to be out in front in US litigation as well. It won an
injunction against Repatha sales in the US in 2017, which was overturned by
an appeals court later that year, but Sanofi and Regeneron have also
negotiated with Amgen with a view agreeing a license deal to settle the
disputes, but that effort was abandoned without a deal.

They also attempted to persuade the German authorities to issue a
compulsory licence for Praluent, but that failed too.

Both antibody drugs are designed to be used in patients who struggle to
control their cholesterol levels using statin drugs, or who have inherited
disorders that cause elevated cholesterol.

They were also both tipped as having blockbuster potential when they were
first launched. Since then however sales have struggled to grow, largely
due to resistance by payers to the new costly drugs at a time when the
statins market has become generic and commoditised.

Their developers have had to reduce prices dramatically to try to gain some
traction, and are hoping that new clinical data showing they can improve
cardiovascular outcomes will help build momentum.

Repatha posted sales of $141m in the first quarter of 2019, with Praluent
trailing on $64m for the three-month period.

James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
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