LG Chem appeals... starts 2nd patent trial for Zemiglo

Generic companies win both the patent evasion and invalidation trials

The patent dispute over the use of DPP-4 inhibitor class diabetes drug Zemiglo (gemigliptin) is heading on to its second round.

 

Generic companies have succeeded in winning both the evasion and invalidation trials regarding Zemiglo's use patent, after which LG Chem has appealed to the Intellectual Property High Court of Korea.

 

According to industry sources on the 11th, LG Chem filed a lawsuit to cancel the ruling made at the first invalidation trial for Zemiglo’s patent to the Intellectual Property High Court of Korea.

 

The patent for Zemiglo is set to expire in October 2039.

 

It covers the combination of insulin and gemigliptin.

 

In addition to the use patent, Zemiglo has a product patent that expires in January 2030 and a salt and crystalline form patent that expires in October 2031.

 

In the case of Zemimet (gemigliptin+metformin), it owns two composition patents that expire in October 2033 and May 2039, respectively.

 

Generic companies have filed a trial to confirm the passive scope of rights (evasion) and invalidation of Zemiglo’s use patent, respectively.

 

Starting with Shing Poong Pharm, Boryung, Jeil Pharmaceutical, Korea Prime Pharmaceutical, Daewha Pharmaceutical, DongKoo Bio&Pharma, Samchundang Pharm, and Celltrion Pharm filed for the evasion trials.

 

The Intellectual Property Trial and Appeal Board has ruled in favor of the generic companies since March this year.

 

In July, the court issued a partial ruling on the patent invalidity challenge.

 

Celltrion Pharm was the first of the 6 companies to win the invalidation trial.

 

Boryung, Jeil Pharmaceutical, DongKoo Bio&Pharma, Genuone Science, and Daewha Pharmaceuticals, which filed challenges around the same time, are yet to receive a ruling.

 

LG Chem, which lost the first trial, chose to appeal both the evasion and invalidation trials.

 

Industry insiders believe that LG Chem chose to take an aggressive defense strategy against patent challenges from generic companies.

 

As additional challenges from generic companies are expected not only for the use patent but also for the remaining salt-crystalline and composition patents, the company seems to be attempting to get a start on the situation early on.

 

The Intellectual Property High Court’s decision on Zemiglo’s use patent dispute is expected to serve as a turning point for early generic launches in the future.

 

If the generic companies win both the first and second trials, the timeline for generic Zemiglo will be significantly accelerated.

 

While there is still a possibility that LG Chem will appeal to the Supreme Court, the back-to-back victories in the first and second trials are expected to give the patent challengers a major boost to launch generics early.

 

According to the market research institution UBIST, prescriptions for Zemiglo and Zemimet were worth KRW 70.1 billion in the first half of last year.

 

The two posted the highest sales amongst DPP-4 inhibitor class diabetes drugs.

 

Zemiglo-Zemimet rose to the ranks and became the top-selling diabetes drug in Q3 last year.