Boryung fails 3 of 5 patent challenges

Suffers growing pains amid efforts to expand its anticancer drug business

Fails first trial filed for the patent dispute between Cabometyx and Ibrance... voluntarily withdrew Tasigna

Should it readjust its plan to secure 10 first-generic anticancer drugs by 2026?

Boryung's omnidirectional patent challenge strategy on orignial anticancer drugs has been making slow progress.

 

Since the end of 2021, Boryung filed patent challenges on 5 anticancer drugs, and lost or voluntarily withdrew 3 of those claims.

 

Despite the strong drive it has been making for its anticancer drug business with plans to launch generics earlier by avoiding or invalidating patents, industry analysis is that the company would inevitably have to change its plans as it failed to cross the threshold of the first trial for several of its challenges already.

 

◆ Boryung fails first trial for Cabometyx but succeeds in deleting the original company’s patent paragraphs #iAccoridng to industry sources on the 13th, the Korea Property Trial and Appeals Board decided to dismiss the claims Boryung filed to invalidate the substance patent of Ipsen’s liver cancer treatment ‘Cabometyx (cabozantinib).’ Although it was Boryung’s loss on the surface, the analysis is that this is not the case in reality.

 

This is because Ipsen, the original company, voluntarily deleted all of the paragraphs that were subject to the IPTAB’s review.

 

Boryung initially sought to invalidate Cabometyx’s formulation patent paragraphs 1 to 25.

 

Amid the ongoing dispute, Ipsen corrected the patent.

 

Among paragraphs 1 to 27 in its patent, Ipsen voluntarily deleted paragraphs 1 to 25, which Boryung claimed were invalid.

 

Due to the deletion, the subject to rule upon disappeared and the related disputes came to an end.

 

Externally, the trial ended with IPTAB dismissing Boryung's request for trial as the subject itself to claim invalidity has disappeared and the company’s request did not meet the formal requirements.

 

Industry analysis is that although Boryung lost on the surface, it succeeded in removing the risk factor for patent infringement.

 

This means that even if a generic is released before the patent expires in February 2032, Boryung will not be infringing on the original drug’s patent.

 

However, from Boryung's point of view, it is regrettable as the company cannot receive the generic exclusivity rights by winning the patent trial.

 

To make up for this, Boryung is known to be considering requesting an additional trial to challenge Cabometyx’s two remaining patents.

 

The remaining two crystalline patents expire in January and April 2030, respectively.

 

If the company succeeds in invalidating or avoiding either patent, it will obtain one of the requirements for generic exclusivity.

 

◆Boryung loses first patent trial over Ibrance and appeals...

 

voluntarily withdraws claims for Tasigna Since 2021, Boryung has filed patent trials for five anticancer drugs including Cabometyx.

 

The other 4 include Eisai's liver cancer treatment 'Lenvima (lenvatinib)', BMS' acute lymphocytic leukemia treatment 'Sprycel (dasatinib)', Novartis' leukemia treatment 'Tasigna (nilotinib)', and Pfizer's breast cancer treatment 'Ibrance (palbociclib).’ Among the trials, the company failed the first trial after challenging Ibrance's crystalline patent.

 

Boryung originally planned to release the generic early after avoiding Ibrance's crystalline patent, which expires in February 2034, but the plan was put to a stop with the failed trial.

 

This is why Boryung appealed the decision of the first trial and dragged the case on to receive a second trial.

 

The patent challenge to Tasigna ended with Boryung's voluntary withdrawal of its claims.

 

In April last year, Boryung requested an omnidirectional trial on Tasigna’s four patents.

 

However, in March, Boryeong voluntarily withdrew its trial.

 

The pharmaceutical industry pointed to the company’s discontinuation of Tasigna’s generic drug development as the cause.

 

On the other hand, the company won the challenge for the patent for the crystalline form of Sprycel.

 

In June last year, Boryung ruled in favor of its trial to confirm the passive scope of rights for the patent.

 

With the ruling, Boryung became one step closer to the early release of its Sprycel generic.

 

In addition, the company had challenged Lenvima's patent but has not received results.

 

As a result, the company has failed 3 of 5 the patent challenges it had filed against original anticancer drugs.