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KIPO positively supports the ‘drug approval-patent linkage system (News Letter No. 239)

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KH

Post Date 

2012-05-04

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1. KIPO positively supports the ‘drug approval-patent linkage system’

The Korean Intellectual Property Office (KIPO) plans to positively support the Korea Food and Drug Administration (hereinafter, referred to as “KFDA”) for an early settlement of the drug approval-patent linkage system.

As the Korea-US Free Trade Agreement (FTA) went into effect on March 15, 2012, the drug approval-patent linkage system has been in effect. (Article 18.9.5 of the Korea-US FTA)

The approval-patent linkage system provides that, when a request for approval of a generic (copy) drug is submitted to KFDA, the fact of the request for approval is sent to the patentee of the relevant new drug. And the procedures to prevent infringement are being prepared for the patentee of the new drug to determine whether the generic drug infringes its own drug. The notification to the patentee of a new drug has been enforced at the same time that the Korea-US FTA went into effect. However, the preparation of the procedures to prevent infringement is suspended for three (3) years after the Korea-US FTA went into effect.

A patent list collection (corresponding to the “Orange Book” of USA), so-called “Green List”, needs to be formed in order for a person who requests approval of a generic drug to notify that approval request to the patentee of the relevant new drug. When a patentee files a request for registering a new drug patent, a list of the new drug patent is examined by KFDA and is registered in the Green List. The patentee of the registered new drug patent is notified of the request for approval of a generic drug.

The work of registering a drug patent is to determine whether or not to register a new drug patent in the Green List by comparing and examining the materials for drug approval and the patent claims. Therefore, this work requires well-versed knowledge and specialization in both KFDA’s drug approval work and KIPO’s patent examination work.

Accordingly, one KFDA person and one KIPO examiner of the pharmaceutical examination team joined to work in a T/F team to operate the drug approval-patent linkage system (hereinafter, referred to as a ‘T/F team’). This T/F team has been recently established by KFDA for the operation of the approval-patent linkage system. The T/F team’s major work includes the enactment and amendment of the relevant regulations and the support for drug patent-related litigation in addition to the registration of drug patents.

When a patentee of a new drug files a trial in relation to the drug approval-patent linkage system, KIPO will process it promptly so that the approval procedures fast proceed and therefore any damage to a domestic drug manufacturer may be minimized.


2. A process for your trademark to be easily registered in other countries

KIPO and the World Intellectual Property Organization (WIPO) held a ‘Local Tour Seminar for the Madrid System for the International Registration of Marks’ in Gwangju, Busan, Daejeon and Seoul from April 24 to May 3, 2012.

WIPO prepared the seminar expecting Korean use of the Madrid System to progressively increase to improve businessmen’s understanding.

In the seminar, Mr. Jong-Ahn Kim, a director of the Madrid Information Promotion Department, a first Korean attained a high rank of WIPO at the end of last year, introduced the outline and current states of the Madrid System. A KIPO person provided useful information of the procedures to file an application under the Madrid System and the PCT international patent system.

People in charge of intellectual property in companies, patent attorneys, and anyone that is interested in filing trademark and patent application in other countries attended the seminar which was held without any fees.


3. China and US trends regarding LTE standard patents

KIPO analyzed 5,323 LTE standard patents reported in the European Telecommunications Standards Institute (ETSI). As a result, Chinese standard patent securing strategies and US companies’ litigation strategies are to be watched. Also, the standard patent competition is expected to accelerate in the technology after LTE-Advanced.

China is now the world’s third LTE standard patent owning country, based on ZTE with 320 cases (6.0%), Huawei with 304 cases (5.7%) and CATT with 279 cases (5.2%). This is considered as a result that the 4G wireless broadband national standard technology, so-called TD-LTE, which was self-developed by China, is included in LTE-Advanced which is the European telecommunications standards.

In the case of US, it seems to be the country owning the most LTE standard patents by the self-efforts of the companies, such as InterDigital, Qualcomm, etc. Specially, since InterDigital which is a patent management expert company (Non-Practicing Entity: NPE) owns the most LTE standard patents, large-scale patent litigation is predicted in LTE standard patents like 2G and 3G mobile telecommunications standard patents.

As a result of analyzing the standard patents of the LTE technology in general, classified by countries, the US owns 35.8%, the Republic of Korea owns 21.1% and China owns 16.9%. Classified by companies, InterDigital owns 780 cases (14.7%), taking the 1st place, followed by Samsung Electronics owning 679 cases (12.7%) taking the 2nd place, Qualcomm owning 625 cases (11.7%) taking the 3rd place, LG Electronics owning 385 cases (7.2%) taking the 4th place, and Ericsson owning 362 cases (6.8%) taking the 5th place.  

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KIPO strengthens the exchange and cooperation of intellectual property rights with a local Chinese government (News Letter No. 240)

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The settlement of patent disputes will be faster (News Letter No. 238)