Request for Compulsory License for Fuzeon Denied

Short Chronicle of the Fuzeon Compulsory License case in Korea

  • 2008. 12. 23: Request for Compulsory License Received by KIPO
  • 2009. 6. 8: Decision on the Request for Compulsory License Made

The Korean Intellectual Property Office (KIPO) made a decision on the request for compulsory license on Fuzeon, a drug for HIV.

Conclusion: Request for compulsory license for Fuzeon is denied.

Rationale:

(1) The reason why Fuzeon was not distributed in Korea was that the negotiation between the Ministry of Health and Roche over the price of the drug failed. This fact alone is not enough ground for granting a compulsory license because, if we do otherwise, the essential scheme of the patent system might be undermined.

(2) The possibility of achieving the goal of a compulsory license should also be considered. The petitioners failed to submit how they will produce the drug once they were granted the compulsory license, for example whether they will directly produce the drugs, outcontract the production or import them. Therefore, the petitioners failed to show that they could provide Fuzeon to HIV patients, which is the goal of the requested compulsory license.

(3) According to the pharmaceutical industry, other drugs for treating HIV are being developed in Korea or abroad.

(4) The respondant (Roche) began providing Fuzeon for HIV patient for free under its Compassionate Program. This Program resolved the access to Fuzeon issue and the urgency of granting the compulsory license has significantly been reduced.

Above is my rough translation of the decision.

Below is my thought.

I think Number (4) is the strongest reason for not granting the compulsory license. Other reasons are not very convincing.

Number (1) is an abstract statement that does not help enlighten this foggy area of compulsory license.

Number (2) is a novel criteria. Nowhere in the Patent Act of Korea or its implementing decree or ordinance is the ‘possibility of achieving the goal’ provided. I am not sure if the petitioner must show that a certain pharmaceutial company which has necessary production facilities has agreed to produce the drugs once the compulsory licnese is granted. Would it be enough if the petitioner shows that he will contract out for the production of the drugs?

Number (3) is not very convincing. The time for completing FDA process is usually 5 years or more. The decision says other companies ARE developing, meaning they haven’t even completed a drug. Let’s say they make a drug that is claimed to be effective in a year, FDA’s clock will only start ticking then. During the more than 1 plus 5 years period, patients are left with only Fuzeon.

There haven’t been a lot of requests for compulsory license in Korea. There haven’t been an established set of criteria for granting a compulsory license. I had a hard time finding old decisions on compulsory license. Maybe this case will help a little for future requests.

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Facts of the case are as follows:

Patents at issue
(1) KIPO Reg. No. 10-0355407-0000 – Synthetic Petide Inhibitors of HIV Transmission
PCT Pub. No. WO 1994/28920 (1994.12.22)
Priority No. US09/045,920 (1998.3.23), US09/071877 (1998.5.1)

Assignee: Trimeris, Inc.
Inventors: KANG, Myung-Chol, BRAY, Brian, LICHTY, Maynard, MADER, Catherine, MERUTKA, Gene

Abstract (on the PCT application)

The present invention relates to peptides which exhibit potent anti-retroviral activity. The peptides of the invention comprise DP-178 (SEQ ID:1) peptide corresponding to amino acids 638 to 673 of the HIV-1LAI gp41 protein, and fragments, analogs and homologs of DP-178. The invention further relates to the uses of such peptides as inhibitory of human and non-human retroviral, especially HIV, transmission to uninfected cells.

(2) KIPO Reg. No. 633214 – Methods and Compositions for Peptide Synthesis
PCT Pub. No. 1999/48513 (1999.9.30)
Priority No. US09/045920 (1998.3.23), US09/071,877 (1998.5.1)

Assignee: Trimeris, Inc.
Inventors: KANG, Myung-Chol, BRAY, Brian, LICHTY, Maynard, MADER, Catherine, MERUTKA, Gene

Abstract (on the PCT application)

The present invention relates, first, to methods for the synthesis of peptides, in particular T-20 (also referred to as “DP-178”; SEQ ID NO:1) and T-20-like peptides. Such methods utilize solid and liquid phase synthesis procedures to synthesize and combine groups of specific peptide fragments to yield the peptide of interest. The present invention further relates to individual peptide fragments which act as intermediates in the synthesis of the peptides of interest (e.g., T-20). The present invention still further relates to groups of such peptide intermediate fragments which can be utilized together to produce full length T-20 and T-20-like peptides.

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