Wednesday, August 16, 2006

US ROK FTA - Half Baked Analysis

I rarely pursue the Korean Herald anymore because of complicated login/subscription/payment model. Its just not worth it for what you get. Anyway in a column today  a partner of Hwang Mok and Park, Kim Seok-hyun, writes in the legal column about some of the IPR issues surrounding the Pharma controversy(read it while you can freely). He does a good job talking about the situation "buy the book", however as anybody can attest here in Korea (from mighty multi-national CEO to lowly english teacher) "the book" is only half the story.

What Mr. Kim ignores is the "off book" problem here is the Korean Food and Drug Administration has a history of registering drugs that violate patent rights (due to Korea's patent system for drugs). I unfortunately could not find the news article of a year or so ago that directly illustrates this, however I found the complaint in general terms arise in a number of forums:

A related issue is the lack of a direct link  between the KFDA, which is responsible for  safety and efficacy reviews, and KIPO. Insufficient coordination between the two does not adequately prevent competitors from marketing products that infringe on existing patents. Consequently, both foreign and domestic patent holders must resort to the court system once infringement has occurred. - US Korea Council, White Paper 2004

KFDA, while assuming responsibility for safety and efficacy review, apparently has abdicated any responsibility for ensuring that competitors do not market products covered by patents that could result from linkage to KIPO. Thus, instead of taking the opportunity to prevent infringement during the marketing approval process, the Government of Korea does not actively seek to rectify intellectual property violations that result from the failure of patent linkage which forces patent owners to resort to the court system after infringement has occurred.  - PhRMA "Special 301" Submission 2004, Korea, Pharmaceutical Research and Manufacturers of America.

The Government of Korea has taken steps over the years to remedy data or patent protection problems that affect pharmaceuticals, but problems remain, including the lack of coordination between Korean health and safety and intellectual property officials.  This lack of coordination results in the granting of marketing approval for products that may infringe existing patents.should be urgently considered. - Foreign Trade Barriers, Korea, US Trade Representatives Office, 2003

U.S. firms report that, although the release of business confidential information is forbidden by Korean law, government officials have not sufficiently protected submitted information and, in some cases, has been made available to Korean competitors or to their trade associations. - Korea Country Commercial Guide FY 2003 - Investment Climate Statement, US Commercial Service, US Dept. of State, 2003

international companies are concerned over the lack of data protection, which they consider an important barrier to trade and investment.   For example, it appears that the Korean Food & Drug Administration (KFDA) may still approve products that infringe a patent, whereas in other countries the drug’s approval is delayed until there is confirmation that there is no infringement. - Medicines access and innovation in developing countries, Europe Economics, September 2001

The [European Union Chamber of Commerce's] Pharma/IPR Committee has reported instances where an originator's technical data submitted to the Korean Food and Drug Administration (KFDA) has been used by generic competitors to gain registration. Published data has used to gain product approval by KFDA contrary to Korea's commitments under the World Trade Organization's TRIPs (Trade-related Aspects of Intellectual Property Rights) protocol. Furthermore, the committee noted the absence of coordination between health and safety officials at KFDA and intellectual property officials at KIPO. The committee thus called for a system linking product registration review at KFDA with the patent protection enforcement powers of KIPO, since the absence of such a system has resulted in granting approval for products that infringe existing patents. - La Lettre du Korea, KOTRA June 2001

So Mr. Kim I ask you, why did you not want to discuss this "off book" problem? There is much more to this than simple extension of a patent period in Korea.

posted by Dram Man @ 3:40 PM

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