Complicated patent extension period than foreign countries

The Korean Intellectual Property Office fixes it

Adjustment of the number of patents that can be extended per item in the direction of reorganization of the patent extension system

Only one patent per item in the U.S., Europe vs. Korea can be extended per patent

The current system is advantageous for multinational companies, and many domestic companies welcome reorganization.

 

The system for extending the duration of drug patents is expected to be reorganized.

 

The Korean Intellectual Property Office established a related TF and prepared an improvement plan, and recently inquired about opinions in the pharmaceutical bio industry.

 

The direction of improvement of the system, which has sharp interests between the original and generic companies, is largely in international harmony with the United States and Europe.

 

◆Xeljanz patent period, 27 years in Korea, 25 years in the U.S.

 

and Europe...From institutional differences The Korean Intellectual Property Office has come up with a total of four improvement plans, and as one of them, it is known that it is considering allowing it to extend only one of the several patents registered in one drug, such as the U.S.

 

and Europe.

 

According to the pharmaceutical bio industry on the 14th, Pfizer's rheumatoid arthritis treatment Xeljanz has a patent duration of 25 years in the United States.

 

This is the result of an extension of five years, which was delayed by clinical trials or permission and examination by regulatory agencies, for 20 years of the typical patent period.

 

In the case of Europe, a 25-year patent period is guaranteed.

 

Xeljanz has a patent duration of 27 years in Korea.

 

This is because the basic patent period is 20 years, but the extended patent duration is different.

 

The reason why the extended patent duration of the U.S., Europe, and Korea is different despite the same drug and the same patent is due to differences in institutions between countries.

 

The original company registers as many patents as possible when it develops a single drug.

 

About 10 patents are also attached to one drug, including material patents, usage patents, usage and capacity patents, formulation patents, and crystalline patents.

 

This is because the more patents there are, the more advantageous it is to defend the challenges of generic companies.

 

In the United States and Europe, only one of the several patents registered in one drug item is selected and extended.

 

In fact, Pfizer applied for an extension of the duration (up to five years) for two material patents and one legal patent in Korea, respectively.

 

In the process of recognizing the extension of the duration of the three patents, overlapping occurred between each period.

 

As a result, the patent period for Xeljanz in Korea was set to be about two years (732 days) longer than that of the United States and Europe.

 

◆Each of several patents can be extended…Original company patent period is 1~2 years longer Each company is very active in extending the duration of patent rights in Korea because the longer the patent period is, the more advantageous it is to the original company.

 

A total of 24 new drugs were newly licensed in Korea last year.

 

As in the case of Xeljanz, two to three patents were registered per item, and the entire patent period was extended by applying for an extension of the duration of each patent.

 

The problem is that while registration is easy in the case of the duration of the drug patent, it is very difficult to overcome the generic.

 

According to the Korean Intellectual Property Office, from 1999 to last year, when the patent extension system was implemented, the number of applications for the extension of the patent period by original companies totaled 750.

 

Among them, a total of 612 cases were registered, 65 were rejected, and 22 were returned or withdrawn.

 

The remaining 48 cases are under review as of the end of last year.

 

It means that if the original company applies for the extension of the patent period, 9 out of 10 cases will succeed.

 

The results of generic to the extended patent duration are pessimistic.

 

There have been challenges over the duration of patents extended from 2015 to last year, but they have not been completely overcome once.

 

◆ Domestic pharmaceutical company 'yes' vs multinational pharmaceutical company 'no'…Delivering Opinions to the Korean Intellectual Property Office Multinational pharmaceutical companies are opposed to the reorganization plan, given that the current system is favorable to the original company.

 

In fact, it is known that the KRPIA conveyed its opposition to the Korean Intellectual Property Office.

 

A local pharmaceutical company official said, is "patent an extended duration that it is impossible to overcome the Patent and Trademark Office in the direction is welcome and reform the system." and "A release of significant impact on NHS finances in the process of the delay." Another pharmaceutical industry official said, "The current patent extension system is quite similar to Japan's system." "As the global pharmaceutical bio-industry environment has changed, it seems meaningful to reorganize Korea's system in the U.S.

 

and European ways," he said.