11 companies won consecutive patent disputes for Betmiga

Patent Court of Korea dismisses appeal of Astellas

There is a high possibility that Astellas will lead the case to the Supreme Court

In the patent dispute over Betmiga PR (Mirabegron), an overactive bladder treatment with an annual prescription amount of ￦65 billion, generic companies won the first trial.

 

From the standpoint of generic companies, including Hanmi and Chong Kun Dang, which have already launched generics, and are about to release generics, the obstacles related to patents have disappeared.

 

However, It is highly likely that the original company Astellas will choose to go to the Supreme Court.

 

◆Use patent·crystal patent invalidated On the afternoon of the 22nd, the Patent Court of Korea ruled against the plaintiff (Astellas) in a lawsuit filed by Astellas against 11 companies including Hanmi and Chong Kun Dang.

 

Following the first trial, the second trial also took the side of generics.

 

Original and generic companies have been fighting over Betmiga PR's crystal patent and use patent.

 

Legal disputes have been fierce for four years since Hanmi and others filed an invalidation trial in March 2015.

 

In the end, the conclusion of the first trial was concluded in December 2019.

 

Generic companies won use patents and some won crystal patents.

 

As a result, Astellas took the case to the second trial, and at the second trial decided that both patents were invalid.

 

◆Generic exclusivity expires next month The ruling was to sell generics for Betmiga.

 

the material patent expired in May last year.

 

The composition patent, which expires in 2029, has also been successful by Hanmi.

 

This trial decision was confirmed without appeal to Astellas.

 

The patent invalidation was confirmed in the second trial following the first trial, making it easier for generic companies to sell generics.

 

There are currently two products on the market.

 

Hanmi and Chong Kun Dang received generic exclusivity and launched Mirabek and Selebeta respectively in June and July of last year.

 

By the end of last year, the two companies had recorded outpatient prescriptions of ￦2.8 billion and ￦1 billion respectively.

 

The generic exclusivity of the two companies expires on February 3, this year.

 

After the expiration of generic exclusivity, 9 companies including Daewoong can participate in the generic market.

 

However, if Astellas disagrees with the second trial decision and decides to go to the Supreme Court, it will be a burden for companies preparing to release generics.

 

Regarding this, a pharmaceutical industry patent official said, "There is a high possibility that Astellas will lead the case to the Supreme Court."