Companies obtain generic for exclusivity in proportion

companies with large sales

Sungkyunkwan University Industry-Academic Cooperation Group's "2021 Patent-approval linkage system Impact Assessment Results"

Among pharmaceutical companies that use generic for exclusive in the licensed patent linkage system that took effect in 2015, it was found that companies with large sales are more likely to obtain generic for exclusivity.

 

As a result, it was suggested that small and medium-sized pharmaceutical companies need more support such as consulting.

 

Sungkyunkwan University's Industry-Academic Cooperation Group made the remarks in the "2021 Pharmaceutical Patent-approval linkage system Impact Assessment Research Service Result Report".

 

The result report was released by the MFDS on the 29th of last month.

 

This study is conducted annually to establish a stable patent-approval linkage system and minimize side effects, which has been fully implemented since March 2015, as a revision of the Pharmaceutical Affairs Act to implement follow-up measures to the FTA.

 

Through research, the relevant status and status are identified, and the impact of the implementation of the system is analyzed and evaluated annually.

 

The basis for the impact assessment is specified in Article 50-11 of the Pharmaceutical Affairs Act.

 

As of 2020, the analysis targets the current status of obtaining generic for exclusivity of 171 domestic pharmaceutical companies with finished products.

 

As a result of the evaluation, when other variables were controlled, companies with large sales were more likely to obtain generic for exclusivity.

 

As of 2019, 20 pharmaceutical companies with annual sales of more than 300 billion won applied for generic for exclusivity (28.7%), 31 pharmaceutical companies with sales of more than 100 billion won (40.2%), 22 pharmaceutical companies with sales of more than 50 billion won to less than 100 billion won (17.1%), and 31 pharmaceutical companies with less than 50 billion won (14.0%).

 

If the sales of the applied pharmaceutical company are more than 300 billion won, the average number of applications is 11.0, and the average number of applications tends to increase as sales increase.

 

There was a high probability that a company with a large number of items would obtain generic for exclusivity.

 

Through this, the researchers analyzed that companies with large sales and a large number of items are more likely to obtain generic for exclusivity.

 

In response, the researchers said, "As large-scale pharmaceutical companies tend to gain generic for exclusivity, it is required to strengthen SMEs' capabilities in first-generation development.

 

Consulting support for SMEs is needed to encourage SMEs to obtain patent challenges and approval." The researchers also analyzed the impact of generic for exclusivity on generics before and after the introduction of the parent-approval linkage system (March 14, 2015) in terms of market share.

 

As a result of the evaluation, the number of items significantly decreased due to the introduction of the system.

 

However, there was no significant change in the duration of generics' entry into the market.

 

However, it was found that the period of entry into the market was shortened in the case of generic for exclusivity.

 

The researchers said, "Unlike concerns at the time of introduction, stable operation continues, and it is evaluated to have a slight positive effect on health policies and employment in the pharmaceutical industry."