Daxas' generic by Sama succeeded in patenting

The IPT (the Intellectual Property Trial and Appeal Board), confirmation of passive scope of right

Sama Pharm succeeded in avoiding the patent for Daxas (Roflumilast), a treatment for chronic obstructive respiratory disease (COPD).

 

Sama Pharm's success in avoiding this patent attracts attention because large companies have failed in succession.

 

The IPT took the side of a generic company in a trial to confirm the passive scope of the patent for Daxas that was patented by Sama Pharm against AstraZeneca on the 31st of last month.

 

Daxas is the only oral medication used for COPD.

 

Most COPD treatments are in the form of inhalers.

 

However, the sales were not excellent because it is used only for severe patients.

 

Last year, the outpatient prescription amounted to ₩900 million.

 

Daxas, developed by Takeda, was taken over by AstraZeneca in 2015.

 

Dong-A ST Hanmi Chong Kun Dang Yuhan Yungjin BCWorld Pharm, Ahn-gook, Boryung Daxas has received patent challenges from many domestic pharmaceutical companies.

 

In 2015, Dong-A ST, Hanmi Pharm, Chong Kun Dang, Yuhan Corporation, Yungjin Pharm, BCWorld Pharm, Ahn-gook, and Boryung Pharm challenged.

 

As a result, in the patent dispute that lasted for over 2 years, all pharmaceutical companies failed to attack.

 

they were denied the claim, or withdrew theirselves.

 

In this situation, Sama attempted a patent in May, later than other pharmaceutical companies.

 

However, the approach method was different from the previous pharmaceutical companies.

 

Dong-A ST, etc., challenged the formulation patent through an invalidation trial.

 

Sama attempted to evade formulation patents through defensive confirmation trial for the scope of a right.

 

Sama's strategy was right.

 

Although the trial has not been released yet, it is presumed to have succeeded in overcoming some patent items in a narrower range than the invalidation trial.

 

As a result, Sama succeeded in half done of the early launch of generic for Daxas.

 

As the substance patent expires in July, it will be able to be a generic if it exceeds two formulation patents.

 

This is one of the two patents that Sama succeeded.

 

The other one is currently proceeding with trial.

 

If Sama succeeds in evading the remaining one patent, it will be possible to release generics two and a half years before the expiration of the formulation patent (February 19, 2023).