[2021 Pharmaceutical Patent Settlement] The target is Dukarb

45 companies at the same time

Twenty-four companies will challenge the five patents of Enresto

This year, a total of 68 pharmaceutical companies challenged 20 patents

Generics' challenge was found to have been concentrated on patents for Boryung's hypertension complex "Dukarb," Novartis' heart failure treatment "Entresto," and Hanmi Pharmaceutical's asthma treatment "Monterizine.

 

The number of companies targeting the patent alone amounts to 45 Dukarb companies, 24 Entresto companies, and 22 Monterizine companies.

 

◆Focus on requesting a trial on Dukarb, Entresto, and Monterizine patents According to the pharmaceutical industry on the 22nd, referees have been filed for 20 patents for 9 drugs so far this year.

 

A total of 68 companies have requested patent trials.

 

Patent attacks were concentrated on Boryung's Dukarb.

 

After Arlico filed a passive trial to confirm the scope of rights for patents for complex composition in February, 44 more companies challenged.

 

Analysts say that as the expiration of material patent of Kanarb (Fimasartan) is just two years away, it is scrambling to target patents for composite drugs.

 

The material patent expires in February 2023.

 

If the Dukarb patent's challenge is successful, generic companies will be able to release generics early in time for the expiration of the material patent.

 

Dukarb has the highest prescription sales among Kanarb combinations.

 

According to UBIST, a pharmaceutical market research firm, Dukarb was prescribed 36.1 billion won last year, followed by 30.2 billion won by the third quarter of this year.

 

Five companies in the second half of the year gave up their challenge.

 

Yuyu Pharmaceutical, Hanwha Pharmaceutical, Daehan New pharm, Kims, and PharmGen Science chose to give up their challenge one after another.

 

The pharmaceutical industry is paying keen attention to whether more companies will give up patent challenges, citing the fierce competition in the ARB+CCB-based high blood pressure second-drug market.

 

Twenty-four companies challenged Novartis' Entresto.

 

In January, after Elyson Pharmaceutical filed a passive rights scope confirmation trial for a decisive patent, a passive rights scope confirmation trial and invalidation trial were filed for five patents registered in Entresto.

 

In the case of Entresto, Hanmi Pharmaceutical, Daewoong Pharmaceutical, Daewon Pharmaceutical, Dasan Pharmaceutical, Shinil Pharmaceutical, MFC, Kyperions and Corepharmbio voluntarily withdrew the passive trial to confirm the scope of rights filed in the decisive patent.

 

Hanmi Pharmaceutical, Daewoong Pharmaceutical, and Daewon Pharmaceutical plan to continue challenging patents for use, composition patents, and pharmaceutical patents.

 

In the case of Entresto, there is no separate material patent.

 

Instead, patents for use and composition, which expire in 2027, are serving as material patents.

 

Twenty-two companies have also challenged Hanmi Pharmaceutical's asthma treatment Monterizine.

 

Monterizine is protected by four patents that expire in 2032.

 

In September, Hanwha Pharmaceutical filed a passive rights scope confirmation trial for all four patents, followed by 21 companies joining the dispute.

 

However, as Genuonescience voluntarily withdrew, the dispute is expected to lead to a showdown between 21 companies and Hanmi Pharmaceutical.

 

◆Genuone, Kyung Dong, Mothers; Tenelia MSR patent avoidance, generics can be released next year Alvogen Korea and Samsung Bioepis have filed for invalidation of three patents for Roche's targeted anticancer drug Avastin (Bevacizumab).

 

Both companies are participating in the development of Avastin biosimilars.

 

Alvogen Korea is said to be developing biosimilars at the global headquarters level, not at its Korean subsidiary.

 

Daewoong Pharmaceutical filed a passive trial to confirm the scope of rights in Amgen's psoriasis treatment Otezla drug.

 

Daewoong Pharmaceutical also filed a request for a trial on one other drug patent and a patent for use last year.

 

At that time, Daewoong won the first trial in the patent trial.

 

However, the case is still underway with Amgen's appeal.

 

The dispute over patents for use has not yet ended.

 

A patent challenge on BMS's leukemia treatment "Sprycel" also continued.

 

Daewoong Pharmaceutical filed a trial for invalidation of the Sprycel patent in January.

 

Boryung Pharmaceutical filed a trial on the same patent last year, and in December this year, it filed a passive trial to confirm the scope of rights for a crystalline patent.

 

Genuonescience, along with Mothers Pharmaceutical and Kyungdong Pharmaceutical, requested a passive rights scope confirmation trial for a patent for Handok's diabetes complex "Tenelia M SR." With the victory of the dispute in May this year, they can launch generics after October 2022 when the material license of Tenelia, a single drug, expires.

 

BCWORLD challenged Chong Kun Dang's two patents of Telminuvo.

 

They won in October and November.