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5 June 2019Big Pharma

German court deals blow to Sanofi over cholesterol drug

A German court has rejected a bid from French pharmaceutical company Sanofi to have a patent infringement case dismissed.

In a judgment yesterday, June 4, the Federal Court of Justice said Sanofi must face the legal challenge brought by its US-based rival Amgen. The case concerns Sanofi’s treatment for high cholesterol, Praluent (alirocumab).

Amgen, which sells a rival drug named Repatha, sued Sanofi in Germany claiming that Praluent infringes its patent on Repatha.

Both Praluent and Repatha are used in the treatment of persistently high cholesterol levels in the blood.

The case dates to 2016, when Amgen filed a patent infringement suit at the Higher Regional Court Düsseldorf, alleging that Praluent infringed its patent (EU number 2,215,124,B1) for Repatha.

Sanofi then sought to acquire a licence from Amgen and both companies engaged in licensing negotiations, but an agreement was not reached.

In response, Sanofi petitioned the German Patent Court to grant it a compulsory licence for the distribution of Praluent, but this was dismissed.

In its reasoning, the patent court said Sanofi’s could have started its licensing attempts much earlier, and the offer to licence the Repatha patent was a last minute request. Additionally, it said Sanofi failed to demonstrate that Praluent had any benefits which other drugs on the market did not.

The case then moved to the Federal Court of Justice which delivered the same verdict.While Amgen’s case against Sanofi continues, Praluent will remain on the German market.

The litigation between the two companies is not restricted to Germany. In February, LSIPR reported that a US district court had upheld the validity of Amgen’s patents for Repatha (US numbers 8,829,165 and 8,859,741) after they were challenged by Sanofi and US-based company Regeneron Pharmaceuticals.

The challenge was brought by Sanofi and Regneron after Amgen accused the duo of infringing its patents.

Sanofi and Regeneron argued that the patents didn’t adequately describe the invention or explain how to make the full scope of antibodies the patents cover, but the jury rejected these arguments.

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More on this story

Big Pharma
12 July 2019   A German court has found that Sanofi’s high-cholesterol treatment, Praluent, infringes one of Amgen’s patents.
Americas
15 August 2019   Sanofi secured a win at the US Court of Appeals for the Federal Circuit yesterday, August 14, after the appeals court concluded a lower court lacked authority to invalidate claims of a patent covering a prostate cancer drug.
Americas
29 August 2019   A US judge yesterday, August 28 ruled in favour of Sanofi and Regeneron in the pharmaceutical companies’ long-running patent dispute with Amgen over the cholesterol drug Praluent.

More on this story

Big Pharma
12 July 2019   A German court has found that Sanofi’s high-cholesterol treatment, Praluent, infringes one of Amgen’s patents.
Americas
15 August 2019   Sanofi secured a win at the US Court of Appeals for the Federal Circuit yesterday, August 14, after the appeals court concluded a lower court lacked authority to invalidate claims of a patent covering a prostate cancer drug.
Americas
29 August 2019   A US judge yesterday, August 28 ruled in favour of Sanofi and Regeneron in the pharmaceutical companies’ long-running patent dispute with Amgen over the cholesterol drug Praluent.

More on this story

Big Pharma
12 July 2019   A German court has found that Sanofi’s high-cholesterol treatment, Praluent, infringes one of Amgen’s patents.
Americas
15 August 2019   Sanofi secured a win at the US Court of Appeals for the Federal Circuit yesterday, August 14, after the appeals court concluded a lower court lacked authority to invalidate claims of a patent covering a prostate cancer drug.
Americas
29 August 2019   A US judge yesterday, August 28 ruled in favour of Sanofi and Regeneron in the pharmaceutical companies’ long-running patent dispute with Amgen over the cholesterol drug Praluent.