Boryung wins the Pomalyst patent challenge for the 2nd time

Generic version will be released

Despite winning patent avoidance in 2021, the company filed claims to confirm the scope of a right again

Seems like the development method had changed…finished applying for approval of generics and may secure a priority sale

Boryung has once again challenged the Pomalyst patent and won.

Boryung won the second attempt to avoid the substance patent of ‘Pomalyst (pomalidomide),‘ a treatment for multiple myeloma.

 

Despite winning the infringement trial for the same patent in 2021, Boryung had not released generic versions.

 

It seems that Boryung changed the method of generic development and rechallenged the patent.

 

The analysis suggests that Boryung is on a countdown to releasing Pomalyst generic following the second-time success of the patent infringement challenge.

 

It has been confirmed that Boryung has already applied for marketing approval for four doses of pomalidomide.

 

According to pharmaceutical industry sources on June 10th, Boryung received the decision in its favor regarding the claims to confirm the scope of a right for the Pomalyst substance patent.

 

Interestingly, Boryung has already won the previous challenge for the same patent.

 

In July 2020, Boyung filed claims to confirm the scope of a right for the Pomalyst substance patent and won the claim in February.

 

At that time, Kwang Dong Pharmaceutical also challenged the patent and won.

 

However, Kwang Dong Pharmaceutical and Boryung have not released the generic version.

 

Although the patent holder did not appeal the loss of the first trial, neither company released the generics.

 

In three years, Boryung filed a claim with the Intellectual Property Trial and Appeal Board (IPTAB) again.

 

The target for claiming a trial and the type of claim were the same as before.

 

Regarding this, the pharmaceutical industry suggested that both companies attempted to develop Pomalyst generics using a method approved by the IPTAB but faced challenges.

 

Boryung might have developed a generic using a different method.

 

Developing a generic with a new method may have required a new trial decision to confirm whether it does not fall under the scope of the rights of the Pomalyst patent.

 

Consequently, the company may have rechallenged the same patent and won.

 

It has been confirmed that Boryung has already applied for marketing approval for its four doses of generics.

 

The pharmaceutical industry anticipates that Boryung will secure a right to priority of sale for Pomalyst generic exclusively.

 

Celgene’s Pomalyst was approved in 2014 for the treatment of multiple myeloma.

 

According to a pharmaceutical market research firm IQVIA, Pomalyst’s sales reached KRW 22.8 billion last year, up 17% from KRW 19.5 billion in 2022.