Decision on the Request for Adjudication for the Grant of a Non-Exclusive License

Original Korean Text of the Decision in PDF format
 

1. Petitioners:


 


 




 
 

 

Korean Pharmacists for Healthy Society
(Representative: Byeong-Do LEE)
2nd Fl., 8-4 Myungryundong 2-ga, Jongro-gu, Seoul

Association of Physicians for Humanism
(Representative: Chang-Ui HONG)
2nd Fl., 8-4 Myungryundong 2-ga, Jongro-gu, Seoul

People's Health Coalition for Equitable Society
(Representative: Kyun-Bae PARK)
Shinsung B/D. 4th Fl., 8-48 Galwol-dong, Yongsan-gu, Seoul

Attorneys: Hee-Seob NAM & Sunng-Ho PARK

 

2. Respondent:




 

Novartis AG
Schwartzwaldallee 215 CH-4058 Basel, Switzerland

Attorneys: Yeong-Jun YANG, Man-Gi BAEK,
                   Yeong-Hwan YANG & Bo-Hyun PARK

 

3. Indication of the Case:

 

Request for Adjudication for Grant of a Compulsory Non-Exclusive License for Korean Patent No. 261366 under Article 107, Paragraph 1(3) of the Patent Act

 

4. Text of the Decision:

The Request Is Rejected.

5. Grounds for the Decision:

The Petitioners requested adjudication for the grant of a compulsory non-exclusive license for the invention (Glivec) claimed in Korean Patent No. 261366 under Article 107, Paragraph 1(3) of the Patent Act, seeking a finding that Glivec can be imported from India “for the public interest,” on the ground that many chronic myeloid leukemia (CML) patients in Korea cannot afford to continuously obtain Glivec prescription because of the unstable supply and high price of Glivec.

The Korean Intellectual Property Office (“KIPO”) solicited an opinion from the Mediation Committee for Industrial Property Disputes (“MCIPD”) under Article 109 of the Patent Act. In consideration of the opinion from the MCIPD and the arguments of both parties, the KIPO makes the following ruling.

1) If Glivec is imported at a lower price, it will be possible to reduce the financial burden of patients who desperately require Glivec to treat leukemia. However, CML is not a disease that is infectious or may cause an extremely dangerous situation in our nation or society. If nevertheless a compulsory non-exclusive license is granted for Glivec merely due to its high price, the basic purport of the patent system, which is to grant an exclusive right and interest to an inventor, thereby inspiring the public with inventive mind and striving for the development of technology and industry, will then become meaningless. Accordingly, the two conflicting interests above should be considered to determine whether a compulsory non-exclusive license should be granted for Glivec.

2) All of the CML patients (including those who in chronic phase) are currently covered by health insurance. The patients actually bear about 10% of the price fixed and announced by the Ministry of Health & Welfare. The supply of Glivec is now stable. Also, it is possible to import pharmaceutical products for self-care purposes according to Article 14 of the Foreign Trade Act and Article 7 of the Foreign Trade Management Regulations. In consideration of such present situations relating to the supply of Glivec, a compulsory license for the patented invention (Glivec) is not considered to be necessary for the public interest as prescribed in Article 107, Paragraph 1(3) of the Patent Act.

Therefore, a decision is hereby rendered to the effect as stated in the Text of the Decision.

February of 2003

The Commissioner of the Korean Intellectual Property Office