Celltrion wins, Samsung loses Eylea patent trial

Generic companies see conflicting preliminary injunction results

Bayer applies for preliminary injunction to prevent patent infringement... application for Celltrion's rejected, application for Samsung Bioepis accepted

Samsung-Samil discontinues sale of Afilivu…Celltrion and Kukje continue sale of Eydenzelt

Samsung Bioepis “Existing stock can be prescribed... We will file an appeal”

Companies have seen mixed results regarding the preliminary injunction applications over the biosimilar version of the macular degeneration drug Eylea (aflibercept).

 

While Samsung Bioepis lost the preliminary injunction application for patent infringement filed by Bayer, Celltrion won its case.

 

The conflicting results have also led to conflicting reports on whether or not the Eylea biosimilar will be sold in Korea.

 

Sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued in Korea after the existing inventory.

 

On the other hand, Celltrion and Kukje Pharm will be able to continue selling Eydenzelt as before.

 

According to industry sources on the 12th, the Seoul Central District Court's 60th Civil Division recently reached conflicting conclusions in the preliminary injunction applications for patent infringement filed by Bayer and Regeneron against Samsung Bioepis and Celltrion.

 

On July 30, 2019, Bayer filed a petition with the court for a preliminary injunction against Samsung Biologics, Samsung Bioepis, and Samil Pharmaceutical for infringement of the patent on the composition of Eylea along with Regeneron.

 

On the same day, Bayer also filed a petition with the court for a preliminary injunction against Celltrion and Kukje Pharm.

 

Their request was to discontinue sales of Samsung Bioepis and Celltrion’s Eyelea generics as they infringe on Eylea’s unlisted patents.

 

On the 7th, the court made a decision.

 

It decided to “acknowledge” Bayer's claims in the petition for a preliminary injunction against Samsung Bioepis.

 

On the other hand, it decided to “dismiss” the petition for a preliminary injunction against Celltrion.

 

The conflicting court decisions have rendered sales of the two companies biosimilars in Korea in opposite positions.

 

Furthermore, Samil Pharmaceutical and Kukje Pharm, which have signed joint sales contracts with the two companies, are also experiencing mixed fortunes.

 

Samsung Bioepis has been jointly selling Afilivu with Samil Pharmaceutical.

 

Celltrion has been jointly selling Eydenzelt with Kukje Pharm.

 

Due to the court’s decision, sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued.

 

Samsung Bioepis received approval for Afilivu in February last year and began joint sales with Samil Pharmaceutical in May.

 

However, the company explained that the remaining stock can be prescribed to patients.

 

“We will file an objection to the preliminary injunction,” said an official at Samsung Bioepis.

 

‘We cannot carry out any additional sales activities, but the stock that is already in circulation in the market can be prescribed to patients.’ On the other hand, Celltrion and Kukje’s Eydenzelt from Kukje Pharmaceutical can continue to be sold.

 

Celltrion received approval for Eydenzelt in May last year.

 

Kukje Pharm signed a joint sales agreement with Celltrion in April last year.

 

It then began full-scale sales in September last year.

 

The industry estimates that Samsung Bioepis and Samil Pharmaceutical, which launched their products one step ahead, have gained an advantage in the competition.

 

However, the court's decision to grant a preliminary injunction is expected to accelerate the pace of the latecomers, Celltrion and Kukje Pharm’s product, in their pursuit.