The aftermath of stricter generic regulations?

↓ 90% of applications for generic for exclusivity

The number of applications for generic for exclusivity is from 272 in 2020 to 26 cases in 2021,

It was found that the number of applications for generic for exclusivity decreased sharply.

 

Experts agree that the implementation of the 1+3 system has affected the decrease in the number of generic for exclusivity applications.

 

Lee Myung-hee, a senior researcher at KIIP, introduced the number of generic for exclusivity applications in 2020 and 2021 at the 2022 Pharmaceutical Intellectual Property Policy Forum held on the 15th.

 

According to him, the number of generic for exclusivity, which reached 272 in 2020, plunged to 26 in 2021.

 

The implementation of the 1+3 system is likely to be the reason for the sharp drop in the number of applications for generic for exclusivity.

 

Lee Myung-hee said, "The 1+3 system has been in effect since July 2021.

 

The number of generic for exclusivity applications has decreased significantly compared to the previous year, he said.

 

"We need to accumulate more data to see if it is the result of the implementation of the system, but we believe that the implementation of the system has affected the decline in a number of generic for exclusion applications." Until now, the pharmaceutical industry has consistently pointed out that the effectiveness of the system is poor due to the acquisition of generic for exclusivity.

 

It was criticized that it did not fit the purpose of introducing the system to induce patent challenges by granting exclusive sales rights.

 

In the case of Jardiance Duo, 99 generics obtained generic for exclusivity.

 

45 generics for Amosartan, and 33 generics for Janumet won generics.

 

Lawyer Lee & Ko, an example, pointed out, "As many generics acquire generic for exclusivity at the same time, pharmaceutical companies have repeatedly challenged patents due to economic losses due to non-acquisition rather than economic benefits from acquiring generic for exclusivity." A lawyer said, "Since the 1+3 system was implemented in July 2021, BA test data have not been available indefinitely," adding, "As a result, the number of applications for generic for exclusivity seems to have decreased sharply.

 

"In 2022, the acquisition of generic for exclusivity is expected to decrease further," he said.

 

"However, as the effectiveness of the generic for exclusivity increases, it is necessary to examine whether the 1+3 system hinders generic development or hinders generic companies' patent challenges," a lawyer stressed.

 

Attorney Kim Ji-hee said, "A close analysis is needed to see if the implementation of the 1+3 system has actually affected the reduction of generic for exclusivity."