Large companies more actively engage in patent challenges

Polarization of patent challenges.. the larger the company, the more patent challenges it takes on

Companies with sales ranging from KRW 100 bil-300 bil apply for generic exclusivity the most in 2021

By average number of applications per company, companies that post sales of KRW 300 bil or more filed the most, 7.7 on average

Pharmaceutical and bio companies with annual sales of more than KRW 300 billion were found to be most actively engaging in patent challenges.

 

As of 2021, pharmaceutical companies with sales exceeding KRW 300 billion applied for an average of 7.7 generic exclusivity approvals per company.

 

The average number of applications for generic exclusivity filed by each company was smaller for smaller companies.

 

In Bum Kim, the expert consultant at Kim & Chang, introduced the above statistics at the ‘2023 Pharmaceutical Intellectual Property Policy Forum’ held at the intellectual Property Protection Agency in Seoul on the afternoon of the 16th.

 

According to statistics, a total of 112 pharmaceutical companies applied for 792 generic exclusivity rights in 2021.

 

Due to the strict requirements required when applying for generic exclusivity, it is used as an indicator of how actively generic companies have challenged original drug patents.

 

To apply generic exclusivity, the company must be the first to request a trial or lawsuit to challenge the original drug’s patent, the first to apply for marketing authorization, and the first to win a trial or lawsuit.

 

In general, the larger the pharmaceutical company, the more applications it had filed for generic exclusivity on average.

 

21 pharmaceutical companies with sales exceeding KRW 300 billion applied for 216 generic exclusivity rights in 2021.

 

This renders the average number of applications for generic exclusivity filed by each company to become 7.7.

 

The most number of applications filed by a single pharmaceutical company was 49.

 

A total of 38 pharmaceutical companies with sales between KRW 100 billion to 300 billion field a total of 347 generic exclusivity applications.

 

This renders the number of applications filed per company to 7.1.

 

27 pharmaceutical companies with sales between KRW 50 billion to 100 billion filed 142 generic exclusivity applications.

 

This renders the number of applications filed per company to 4.6.

 

In the case of small pharmaceutical companies with sales of less than KRW 50 billion, 26 companies filed 87 generic exclusivity applications.

 

This renders the number of applications filed per these companies to 2.8.

 

In terms of the total number of applications, mid-sized pharmaceutical companies with sales ranging from KRW 100 to 300 billion have most actively challenged the original drug’s patents, but the average number of applications per pharmaceutical company shows that large pharmaceutical companies with sales exceeding KRW 300 billion most actively engaged in patent challenges.

 

Kim explained, “To receive first generic exclusivity, you have to make a lot of preparations to meet the strict conditions.

 

So the statistics indicate that companies more actively engage in patent challenges when they are of a certain size.