Boryung speeds up Lenvima patent challenge

Patent invalidation trials for its generic launch 70% complete

Successfully challenged 4 out of the 5 registered patents...only 1 remains

Raises expectations for 2025 launch...Boryung is the only domestic company to challenge Lenvima’s patents

Boryung's challenge against Eisai’s blockbuster anticancer drug Lenvima is gathering pace.

 

As the only domestic pharmaceutical company to continue the patent challenge, Boryung’s journey has passed the 70% mark.

 

With only one patent remaining, expectations of the company’s launch of the Lenvima generic in 2025 are rising.

 

According to industry sources on the 1st, the Intellectual Property Trial and Appeal Board ruled in favor of Boryung that it had filed to invalidate Eisai’s anticancer drug Lenvima (lenvatinib)’s patent for "high purity quinoline derivatives and methods of manufacturing the same.”

#The patent that had been in question was registered by Eisai in June 2023 for Lenvima and was set to expire on August 26, 2035.

 

The IPTAB’s ruling is noteworthy because it marks the nearing end of Boryung's ongoing patent hurdle clearings for Lenvima.

 

In fact, in addition to the patent in question, Lenvima also has a patent for ▲"nitrogen-containing aromatic derivatives" (expiring April 4, 2025), ▲"antitumor agent for thyroid cancer" (expiring March 4, 2028), ▲"Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same” (expiring June 7, 2028), and ▲“High-purity quinoline derivative and method for manufacturing same” (expiring on March 19, 2031).

 

Boryung is the only domestic company to challenge all these patents and independently develop a generic version of the original drug.

 

Daewoong Pharmaceutical had challenged 3 patents together with Boryung, except for the last registered patent, but later chose to withdraw all of them.

 

In the end, only Boryung challenged all 4 patents except for the one that expires in 2025, cleared 3 of the patent barriers, and is raising expectations of its generic’s launch in Korea.

 

In fact, Boryung won all of its trials to confirm the passive scope of rights that preceded the patent invalidation trial.

 

First, it received a favorable ruling in June of last year for the patent "Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same” (which expires on June 7, 2028) and in August of last year for the patent ▲“High-purity quinoline derivative and method for manufacturing same” (which expires on March 19, 2031).

 

In particular, in the case of the patent being invalidated this time, Boryung et al.

 

have conquered one more barrier of Lenvima’s that had been built by the Eisai, in less than a year since its patent registration.

 

However, Boryung has filed another invalidation trial for the “Antitumor agent for thyroid cancer” patent, which expires on March 4, 2028, and is awaiting for its results.

 

If the remaining patent is also invalidated, the company will be able to launch its drug after April 4, 2025, when the last “Nitrogen-containing aromatic derivatives” patent expires.

 

Ultimately, Boryung’s decision not to challenge the last patent suggests that it expects to launch its generic version in 2025.

 

Therefore, it remains to be seen whether the company will be able to overcome the last remaining patent barrier and succeed in launching its generic drug in 2025.