Boryung and Kwangdong overcome MM drug Pomalyst patent

Intellectual Property Trial and Appeal Board announces decision in negative confirmation of patent scope

Targeting the anticancer generic market valued at 14 billion won

A product image of Pomalyst

Boryung Pharmaceutical and Kwangdong Pharmaceutical have successfully evaded the composition patent on Celgene’s multiple myeloma treatment Pomalyst (Pomalidomide).

 

Overcoming the biggest barrier to receive the preferential sales approval, the two South Korean companies can now release the generics early in January 2024, immediately after the original’s product patent expires.

 

The industry predicts the two companies assertively strengthening the oncology pipeline would be able to even further expand their anticancer treatment line-up with the patent evasion.

 

On Mar.

 

1, a pharmaceutical industry source told the Intellectual Property Trial and Appeal Board has approved of Boryung Pharmaceutical and Kwangdong Pharmaceutical requesting for a negative confirmation of the patent confirmation against Celenge.

 

On July 31 last year, Boryung Pharmaceutical filed a patent challenge case to evade Pomalyst’s composition patent.

 

Also, Kwangdong Pharmaceutical followed suit on Aug.

 

12.

 

As Kwangdong Pharmaceutical filed the case within 14 days of Boryung Pharmaceutical’s case, Kwangdong Pharmaceutical would qualify to win the preferential sales rights as well.

 

Ultimately, the seven-month patent dispute concluded with the board ruling in favor of those generic makers.

 

Pomalyst can only protect the product patent expiring in January 2024, as the two South Korean companies have successfully evaded the composition patent expiring in July 2030.

 

The post-marketing surveillance (PMS) period for Pomalyst is to end in June 2023, and the two companies are to release their generics after January 2024 when the original’s product patent expires.

 

The two companies can now consolidate their anticancer pipeline with the latest patent challenge.

 

A pharmaceutical market research firm IQVIA reported Pomalyst has generated 13.8 billion won last year.

 

The growth has been steep compared against 8.4 billion won made in 2019.

 

Boryung Pharmaceutical and Kwangdong Pharmaceutical have been approaching the oncology business assertively for last few years.

 

Among the South Korean pharmaceutical companies, Boryung Pharmaceutical continues to top the market share.

 

It owns line-ups like Genexol, Gemzar, Campto and Oxalitin.

 

Genexol is a generic version of Bristol Myers Squibb’s (BMS) Taxol (Paclitaxel).

 

Since 2017, Boryung Pharmaceutical has been selling Genexol developed by Samyang Biopharmaceuticals.

 

Two years into the sales, Genexol’s sales volume exceeded that of the original from 2018.

 

IQVIA reported Taxol made 9.5 billion won last year, when Genexol made 21.4 billion won.

 

The South Korean company concentrated on propelling the oncology business last year by independently separating the sector.

 

As a result, it licensed in the South Korean sales rights of Eli Lilly’s Gemzar (gemcitabine).

 

Kwangdong Pharmaceutical is also actively growing their oncology business.

 

The company’s star anticancer treatments are Revlimid (lenalidomide) generic Lenaldo, and Afinitor (everolimus) generic Erinito.

 

Especially with the newest success in the patent challenge, Kwangdong Pharmaceutical gets to fully complete the multiple myeloma treatment line-ups.

 

Lenaldo, released to the market since 2018, is used to treat multiple myeloma in first and second-line therapies.

 

The Pomalyst generic that overcame the patent would be used as a third-line therapy for patients with multiple myeloma.