(Health Korea News / Lee Soon-ho) Samsung Bioepis has settled its patent dispute with Alexion Pharmaceuticals over its US drug ‘SOLIRIS (ingredient name: eculizumab)’. Accordingly, Samsung Bioepis’s ‘Soliris’ biosimilar ‘EPYSQLI’ is on the verge of launching in the US.
Samsung Bioepis withdrew all five patent invalidity trials (IPRs) related to ‘Soliris’ that were underway against Alexion at the United States Patent and Trademark Office (PTAB) on the 4th (local time).
On the same day, Alexion’s appeal of the patent infringement lawsuit and the preliminary injunction request against Samsung Bioepis were both dismissed. The dismissal of these two lawsuits was due to voluntary dismissal by both companies.
The patent agreement between the two companies is said to have been reached immediately after Samsung Bioepis received approval from the US FDA in July for EpisCly as a biosimilar interchangeable with Soliris. The specific terms of the agreement were not disclosed. However, given that Alexion could lose key patents for Soliris if it continued its fierce battle with Samsung Bioepis in trials and lawsuits, there is weight to the observation that Samsung Bioepis led the negotiations more favorably.
Currently, there are only two Soliris biosimilars approved by the US FDA: Amgen’s BKEMV and Samsung Bioepis’ Episcli. Amgen already concluded a patent agreement with Alexion in 2020, and can launch BKEMV after March 1, 2025.
If Samsung Bioepis reaches an agreement with Alexion to launch ‘Episclin’ around the same time as Amgen, competition in the US ‘Soliris’ biosimilar market is expected to begin in earnest in the first half of next year.
Last April, Samsung Bioepis filed a Biologics License Application (BLA) for ‘Episclin’ with the U.S. FDA, and a month later, filed an IPR (invalidation trial) against Alexion for five patents related to ‘Soliris’, including US9732149 (hereinafter referred to as Patent 149), US9718880 (hereinafter referred to as Patent 880), US9725504 (hereinafter referred to as Patent 504), US10590189 (hereinafter referred to as Patent 189), and US10703809 (hereinafter referred to as Patent 809).
Alexion also counterattacked Samsung Bioepis’ offensive. As soon as the sales restriction period for ‘Episcli’ under the US Biologics Price Competition and Innovation Act (BPCIA) ended, Alexion filed a patent infringement lawsuit against Samsung Bioepis in January of this year.
Alexion claimed that ‘EpisCly’ infringes on six patents owned by the company, including US9732149 (hereinafter Patent 149), US9718880 (hereinafter Patent 880), US9725504 (hereinafter Patent 504), US10590189 (hereinafter Patent 189), US10703809 (hereinafter Patent 809), and US9447176 (hereinafter Patent 176).
Alexion has countersued Samsung Bioepis’ IPR claim, alleging infringement of 176 patents related to “Methods and compositions for treating complement-associated disorders,” including five patents that Samsung Bioepis asserts are invalid.
Alexion also filed for a preliminary injunction to block the early launch of EpisCly, but the Delaware court denied Alexion’s request for a preliminary injunction in May, stating that “the validity of the Soliris patent claims faces substantial doubt and, accordingly, Alexion has failed to demonstrate a likelihood of success on the merits.”
Alexion was not convinced and immediately appealed the decision to the U.S. Court of Appeals for the Federal Circuit (CAFC), but the appeal was dismissed along with the main case two months later when the two companies reached a settlement.
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