Pharmbio wins over Novartis’ Revolade in patent dispute

following the 1st trial

Received the patent court, IPTAB, decision to establish its claim…Succeeded in avoiding three formulation patents following SK Plasma

Pharmbio Korea already received a generic BLA, but its product launch date is unclear…May face challenge by Norvartis’ appeal

Pharmbio Korea has won the first trial in a patent dispute over Novartis' 'Revolade.'

Pharmbio Korea has won the first trial in a patent dispute against 'Revolade (eltrombopag olamine),' a treatment for primary immune thrombocytopenia (ITP), following SK Plasma.

 

Pharmbio Korea received a generic biological license application (BLA) prior to winning the first trial, but the company may face a high risk in launching the product.

 

It is highly possible that the patent holder, Novartis, will appeal to the verdict.

 

According to industry sources on the 22nd, the Intellectual Property Trial and Appeal Board (IPTAB) decided on the validity of three Revolade formulation patents brought by Pharmbio Korea against Novartis, issuing a favorable ruling on the claim validity on the 19th.

 

There are five patents for Revolade, including two substance patents and three formulation patents.

 

The substance patents expired in August 2021 and May of last year, while the remaining three formulation patents are set to expire in August 2027.

 

In July last year, Pharmbio Korea filed for passive confirmation of scope of rights for three patents.

 

SK Plasma filed a similar suit in the same month, following Pharmbio Korea.

 

While Pharmbio Korea was the first to file the petition, SK Plasma secured a victory decision two months before.

 

On January 31, SK Plasma received the decision to establish their claim.

 

Pharmbio Korea has already obtained a generic BLA for Revolade.

 

In March last year, it received a BLA for two doses of 'Korea Pharmbio Eltrombopag Olamine Tab.' SK Plasma has not yet completed the development of the generic.

 

Pharmbio Korea has secured a BLA for a generic product, but launching it may pose challenges despite winning the first trial.

 

This is because Novartis is anticipated to appeal.

 

Novartis has already filed a lawsuit to cancel the decision after the first trial against SK Plasma in a similar patent dispute.

 

Given Novartis' loss to Pharmbio Korea in the same patent dispute, there are similar expectations that Novartis will appeal to the IPTAB in the pharmaceutical industry.

 

Revolade is a primary immune thrombocytopenic purpura (ITP) treatment developed by Novartis.

 

ITP is an autoimmune disease in which the immune system attacks platelets as if they were foreign substances.

 

Revolade treats this disease by stimulating platelet production.

 

Initially developed by GSK, Revolade's patent and product rights were transferred to Novartis when GSK sold its oncology division to Novartis.

 

In 2010, Revolade was approved in Korea as a treatment for patients with ITP, and in 2018, it was additionally approved for severe aplastic anemia indications.

 

The following year, Revolade's sales saw significant growth after its reimbursement scope expanded to include severe aplastic anemia.

 

According to pharmaceutical market research firm IQVIA, Revolade's sales, which were less than KRW 4 billion until 2018, increased to KRW 4.9 billion in 2019, KRW 7.6 billion in 2020, KRW 8 billion in 2021, and KRW 8.6 billion in 2022.

 

Last year, it recorded sales of KRW 9 billion, a 5% increase from the previous year.