Regeneron successfully defends patent for cholesterol inhibitor at the EPO

US biotechnology company Regeneron is the owner of EP 23 58 756, a composition-of-matter patent covering the drug alirocumab, which is also sold in Europe by Sanofi under the brand name Praluent.

It is a monoclonal antibody that belongs to the group of PCSK9 inhibitors and prevents the formation of cholesterol. The drug treats a range of cardiovascular conditions and, as a result, has a significant market value across Europe.

In 2016, Furo Ventures challenged the patent as part of opposition proceedings at the EPO. The Opposition Division upheld the patent and the Dutch company appealed the decision. Following a recent hearing, the Technical Boards of Appeal have now dismissed the appeal (case ID: T1669/19-3.3.04).

Complete inhibition

The Netherlands-based Furo Ventures assists companies, inventors and institutions in the life sciences and pharmaceuticals industries in enforcing and invalidating patents, among other things. According to its website, the company specialises in litigation against the existing patents of pharmaceutical companies, often acting on behalf of an undisclosed sponsor. It is not known on whose behalf Furo Ventures attempted to invalidate Regeneron’s patent.

Furo Ventures challenged the Regeneron patent on the grounds of added matter, as well as attacking the scope of the patent’s priority claim. But the Technical Boards of Appeal concluded that EP 756 did not add matter. 

Furo Ventures also claimed the patent lacked inventive step, citing two pre-published international patent applications WO 2008/125623 (“D7”) and WO 2008/057459 (“D8”). According to the minutes of the oral hearing on November 3, these patents also pertain to cholesterol inhibitors. However, the rate of effectiveness of D7 and D8 as detailed in the international patents is between 30% and 50%, respectively.

Regeneron argued that Praluent has an effectiveness of 100% and that the skilled person could not expect to achieve such a rate of inhibition. 

Last time in Düsseldorf 

Cholesterol inhibitors have been the subject of patent litigation in the past. Regeneron was recently co-defendant alongside its European distributor Sanofi in a similar dispute against Amgen at the Higher Regional Court Düsseldorf. Amgen accused the parties of infringing its patent for a cholesterol-lowering drug, sold under the brand name Repatha.

Amgen had been trying to prevent Sanofi from selling the drug across six European countries, as well as the US and Japan, since 2016, with varying success.

Stephen Duffield

However, after the Technical Boards of Appeal confirmed a decision to uphold, but substantially limit, Amgen’s patent (case ID: T0845/19-3.304), the Higher Regional Court Düsseldorf dismissed the infringement case. This meant Sanofi and Regeneron could continue to distribute Praluent in Germany.

18 years of Carpmaels & Regeneron 

Regeneron was represented by a cross-national team from Carpmaels & Ransford, led by Stephen Duffield from the Munich office. Emily Nikolic assisted from the London branch. Carpmaels has worked with Regeneron since 2004 and has been instrumental in much of its litigation before the EPO. In March of this year, Duffield and Nikolic represented the company in a long-standing dispute with Amgen that resulted in the full revocation of two Amgen patents. 

Patent attorney Markus Breuer of the Munich-based patent attorney firm, Breuer Friedrich Eisenberg represented Furo Ventures. The firm has a good reputation for pharmaceutical cases. One of its partners was recently appointed as a technically qualified judge at the Unified Patent Court. Rainer Friedrich will rule on biotechnology cases when the new court opens its doors next year.

For Regeneron
Carpmaels & Ransford (Munich & London): Stephen Duffield (partner); associate: Emily Nikolic.

For Furo Ventures
Breuer Friedrich Eisenberg (Munich): Markus Breuer (partner)

European Patent Office, Technical Boards of Appeal, (19-3.3.04)
Paul de Heij (Chairman), Ashok Chakravarty, Regina Hauss.