Regeneron, a US biotechnology company, owns EP 23 58 756, a composition-of-matter patent covering the drug alirocumab, which is also marketed in Europe by Sanofi under the brand name Praluent.
It is a monoclonal antibody that belongs to the PCSK9 inhibitor class and prevents cholesterol formation. Because the drug treats a variety of cardiovascular conditions, it has a sizable market value in Europe.
Furo Ventures challenged the patent in 2016 as part of the EPO's opposition proceedings.
The patent was upheld by the Opposition Division, and the Dutch company appealed the decision. The appeal has now been dismissed by the Technical Boards of Appeal following a recent hearing (case ID: T1669/19-3.3.04).
Furo Ventures, based in the Netherlands, assists companies, inventors, and institutions in the life sciences and pharmaceuticals industries with patent enforcement and invalidation, among other things. According to its website, the firm specialises in litigation against pharmaceutical companies' existing patents, frequently acting on behalf of an unnamed sponsor. Furo Ventures is unknown who attempted to invalidate Regeneron's patent on their behalf.
Furo Ventures challenged the Regeneron patent on the basis of added matter, as well as the patent's priority claim's scope. However, the Technical Boards of Appeal determined that EP 756 did not add material.
Furo Ventures also asserted that the patent lacked inventive step, citing two previously published international patent applications WO 2008/125623 ("D7") and WO 2008/057459 ("D8"). According to the minutes of the November 3 oral hearing, these patents also cover cholesterol inhibitors. However, according to the international patents, the effectiveness of D7 and D8 is between 30% and 50%, respectively.
Regeneron contended that Praluent has a 100% efficacy rate and that a skilled person could not expect to achieve such a rate of inhibition.
Cholesterol inhibitors have previously been the subject of patent litigation.
Regeneron was recently named as a co-defendant in a similar dispute with Amgen at the Higher Regional Court Düsseldorf, alongside its European distributor Sanofi.
Amgen accused the parties of infringing on its patent for Repatha, a cholesterol-lowering medication.
Amgen had been attempting to prevent Sanofi from selling the drug in six European countries, as well as the United States and Japan, with varying degrees of success since 2016.
The infringement case was dismissed by the Higher Regional Court Düsseldorf after the Technical Boards of Appeal confirmed a decision to uphold, but substantially limit, Amgen's patent (case ID: T0845/19-3.304). This meant that Sanofi and Regeneron could keep distributing Praluent in Germany.
In March of this year, Regeneron was involved in a long-standing dispute with Amgen that resulted in the full revocation of two Amgen patents.
This EPO decision follows a ruling in Sanofi and Regeneron’s favor in August 2019 by the U.S. District Court for the District of Delaware which found as a matter of law that certain of Amgen’s asserted patent claims for antibodies targeting PCSK9 are invalid based on lack of enablement.
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