Boryung Lenvima passed the first hurdle of the patent challe

Successful evasion of Lenvima crystalline patent

Eisai’s liver cancer drug Lenvima

Boryung succeeded in crossing the first hurdle in the patent challenge for Lenvima, a liver cancer treatment.

 

If the remaining two patents are avoided or invalidated, the early generic release is expected to be faster.

 

According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeals Board sided with Boryeong in a recent trial to confirm the scope of rights for a crystalline form of Lenvima, which Boryeong recently filed against Eisai.

 

Boryeong is single-handedly challenging Lenvima patents.

 

In November of last year, it filed a simultaneous request for a negative right scope confirmation trial and an invalidation trial for three Lenvima patents.

 

At the time, Daewoong Pharmaceutical joined the patent challenge, but soon voluntarily withdrew and left.

 

Lenvima is protected by five patents.

 

Substance patents expiring in April 2025, usage patents expiring in March 2028, crystalline form patents expiring in June 2028, formulation patents expiring in March 2031, and manufacturing method patents expiring in August 2035.

 

Among them, the manufacturing method patent that expires in 2035 has been listed in the Ministry of Food and Drug Safety Patent List since Boryeong started a patent challenge.

 

Boryung plans to release generics in time for substance patent expiration after avoiding or invalidating the rest of the patents except substance patents.

 

Subsequently, registered manufacturing method patents must be overcome by Boryeong.

 

However, in the case of this patent, it is analyzed that Boryeong can be avoided relatively easily by using a composition or salt different from the original.

 

If Boryung succeeds in the remaining patent challenges and releases Lenvima generics early, the anticancer drug portfolio is expected to expand further.

 

Boryeong is concentrating on the anticancer drug business after 2020.

 

Boryung's main strategy is to acquire the domestic copyright for the original product and release the first generic by overcoming patents.

 

Boryung announced plans to add 10 first-generic anticancer drugs by 2026 in its "five-year mid- to long-term plan" announced last year.

 

In July of last year, Fulvet was approved as the first generic of AstraZeneca's breast cancer treatment Faslodex.

 

In addition to Lenvima, ▲Ipsen's liver cancer treatment Cabometyx, ▲BMS' acute lymphocytic leukemia treatment Sprycel ▲Novatis' leukemia treatment Tasigna ▲Pfizer's breast cancer treatment Ibrance challenged patents.

 

However, the patent challenge to Tasigna was voluntarily withdrawn when Boryeong stopped developing generics.

 

In the case of Ibrance, it was defeated in the first trial and has appealed to the Patent Court.

 

The challenge to Sprycel came one step closer to the early release of generics after the usage patent expired in March 2024 as Boryung succeeded in avoiding the crystalline form patent in June of last year.

 

In the case of Cabometyx, although it lost in the first trial, it is analyzed that there is no problem with the early generic release strategy.

 

Ipsen, the original company, voluntarily deleted all claims that were the target of the patent challenge after Boryeong's request for judgment.

 

Boryeong lost in the trial, but in fact, it is in a situation where the patent is not infringed even if the generic is released before February 2032, when the patent expires.

 

Lenvima is Eisai's liver cancer drug.

 

It is used in the first-line treatment of liver cancer together with Nexavar and Tecentriq + Avastin.

 

According to IQVIA, a pharmaceutical market research institute, Lenvima's sales last year were 13.6 billion won.

 

It decreased by 14% compared to 15.8 billion won in 2021.

 

In the first quarter of this year, it posted sales of 2.3 billion won.