Tag Archives: fuzeon

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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Free Fuzeon For How Long?

Continuing from Roche Will Provide Fuzeon (HIV/AIDS drug) For Free.

As far as I heard from a source,

  1. Fuzeon is for patients in the terminal phase.
  2. There are 155 HIV/AIDS patients in Korea. The Korean government is maintaining a list of HIV/AIDS patients. The number 155 is from the government’s list.
  3. Patients get Fuzeon for free under Roche’s Expanded Access Program (EAP) (also called the Compassionate Program by the patients’ group)
  4. Fuzeon therapy costs $25,000 per year in the U.S.
  5. It is said that the Korea Orphan Drug Center has not received a single requestfor Fuzeon. is giving Fuzeon to two HIV-resistant patients. (as of April 22, 2009)

According to press, the patientts group was planning to request for compulsory license in March 2009 on the basis of failure to work a patent. Article 107(1)(2) of the Patent Act of Korea provides that non-working of a patent for 3 years can be a ground for requesting for a compulsory license.

1. How many patients in Korea need to have Fuzeon?

It might be that there is no single HIV/AIDS patient in the terminal phase in Korea, judging from the fact that the Korea Orphan Drug Center (KODC) has not received a single request. The HIV/AIDS patients is said to form a community and if a patient is in need of Fuzeon, which means the patient is in terminal condition, other patients will surely tell the patient to get Fuzeon from the KODC.

But, as we don’t seem to have a drug that stops the progression of HIV/AIDS, a number of patients will reach the terminal phase sooner or later.

2. National Health Insurance system

The Ministry of Health wants put Fuzeon in the National Health Insurance system just as in the Glivec case. But it couldn’t strike a deal with Roche on the price. The Ministory of Health wants 25,000 KRW per pill, while Roche’s bottom line is 30,000 KRW.

Under the National Health Insurance system, the insurance will cover 80 – 90% of the drug price. The remaining 10 – 20% will be borne by patients. In Glivec case, Novartis compensates CML patients for the 10% share in the drug price that is not covered by the insurance.

The problem of patients is that there is no guarantee that Roche will compensate patients for the deductible-equivalent portion of the drug price (10%) as Novartis is doing in the Glivec situation. 10% of 25,000 USD is not egregiously much but is still burdensome for patients who are in most cases without a regular job.

So, the patients are requesting a permanent Expanded Access Program so that they can access the drug at no cost.

3. How likely is it that KIPO will grant a compulsory license?

The patients’ groups are using the compulsory license as a negotiation leverage. But how likely is the Korean Intellectual Property Office going to grant a compulsory license? As far as my note says, there is a single case KIPO granted a compulsory license. It was 29 years ago. KIPO has not granted a compulsory license ever since.

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Roche Will Provide Fuzeon (HIV/AIDS drug) For Free

Intellectual Property Left (IP Left) of Korea made a statement on Roche’s Compassionate Programme of Fuzeon for HIV/AIDS Patients in South Korea.

A Brief Chronicle

  • Fuzeon (generic name Enfuvirtide) is an HIV fusion inhibitor.
  • The development of Fuzeon was originated at at Duke University. The researchers formed a pharmaceutical company known as Trimeris and entered into a partnership with Hoffmann-La Roche to complete the development of the drug.
  • FDA Approval – March 13, 2003, as the first HIV fusion inhibitor.
  • Patent No.
    • 5464933 (Synthetic peptide inhibitors of HIV transmission)
      • Inventors: Dani P. Bolognesi, Thomas J. Matthews, Carl T. Wild
      • Assignee: Duke University
      • Filing Date: June 7, 1993.
    • 6133418 (Synthetic peptide inhibitors of HIV transmission)
      • Inventors: Dani P. Bolognesi, Thomas J. Matthews, Carl T. Wild
      • Assignee: Duke University
      • Filing Date: November 6, 1995
    • 6475491 (Treatment of HIV and other viral infections using combinatorial therapy)
      • Inventors: M. Ross Johnson, Dennis Michale Lambert
      • Assignee: Trimeris, Inc.
      • Filing Date: May 29, 1998
      • PCT Filing Date; June 06, 1996
      • PCT No.: PCT/US96/09499

‘491 Patent is on treatment methodology of HIV and other viral infections using Fuzeon. It’s worth noting that the U.S. is almost the only nation which grants patent on treatment or surgery methods. The U.S. has requested its counterparts in most Free Trade Agreement negotiations to incorporate the protection of treatment/surgery methods under their patent regimes, in most cases to no avail.

  • December 23, 2008
    • IP Left and other civic movement groups held a press conference to announce their intent to file a request (with the Commissioner of the Korean Intellectual Property Office) for compulsory license on Fuzeon.
      • As a procedural matter, the Commissioner of the Korean Intellectual Property Office has the authority decide on requests for compulsory license.
  • February 25, 2009
    • Roche informed IP Left and other related civic movement groups of their plan to provide Fuzeon in Korea under the Compassionate Programme.

Belowe is the statement by Korean PLWHA (which seems like a contigent organization of various patients groups) and Civil Society.

Korean PLWHA and Civil Society Statement on Roche’s Compassionate Programme of Fuzeon for HIV/AIDS Patients in South Korea

Fuzeon is an essential medicine for HIV/AIDS treatment, but since 2005 Roche has been withholding the distribution of the drug in Korea. We, PLWHA and AIDS activists around the world have been protested against Roche’s murderous policy. However, Roche’s only response was that they would not supply Fuzeon until the South Korean government accepts the unreasonably high price of Fuzeon. To solve this problem, Korea HIV/AIDS Network of Solidarity and Intellectual Property Left requested a compulsory license of Fuzeon in December 2008.

In February 25 2009, Roche surprisingly informed their plan to provide Fuzeon in Korea under Compassionate Programme. Considering the patients’ severe pain and loss due to the absence of medicine, we welcome Roche’s decision and value it as an important step for improving access to AIDS treatment.

It is a significant change compared to the Roche’s previous position who has alleged that poor patients in poor country have no right to access Fuzeon. Undoubtedly, the Roche’s compensation program is resulted from the worldwide actions and public pressure organized by diverse groups in Korean civil society and world AIDS communities. However, the program suggested by Roche is still far from fulfilling the request of PLWHA and AIDS activists.

First of all, Roche notify that they introduce the compassionate program “as a temporary measure until a more sustainable solution for access in South Korea could be found,” because Roche cannot distribute the Fuzeon though the Korean national health care system. But, it is evident that Roche is the one who have blocked the distribution of the drug through the regular system. The main reason of Roche’s withholding the drug is that Korean government did not accept the price as the same level as the advanced seven countries. We point out that Roche’s new program is a just temporal measure and the essential problem of Fuzeon is still remained.

Secondly, we conclude that Roche’s compassionate program is a strategic and calculative action aiming the incapacitating of compulsory licensing. PLWHA and activists in Korea requested a compulsory licensing of Fuzeon in December 2008 to stop the Roche’s life threatening policy. Through a Novatis’s Gleevec case, we already watched how the multinational drug company abused the compassionate program. In the Gleevec case, Novatis refused the price approved by Korean government and disregarded the legitimate and regular channel for drug distribution. Multinational drug companies including Novatis have been using the deceitful tactics to influence patients for the purpose of increasing their negotiating power in the drug pri! ! cing process. As the result of this abused program, the price of Gleevec is still high. If Roche keep avoid the regular drug distribution s! ystem in Korea, the new compassionate program is nothing but a fraudulent measure to secure their profit.

We demand a public apology from Roche for their fraudulent practices and profiteering in Korea. It is undeniable that Roche have neglected the supply of essential medicine to Korean AIDS patients over the 4 years even though Roche insist that they take their “role to improve access to medicines very seriously”. There is no apology for the suffering and death Roche had caused to PLWHA in Korea and around the world.

We also strongly urge Roche to seek a fundamental solution for the immediate needs of drugs instead of abusing a temporal expedient. Roche already admitted that they had no ability to produce enough Fuzeon to meet the demands of PLWHA all over the world. Because of the patent on Fuzeon, no one can start the production of generic form of it and numerous PLWHA around the world have been denied access to the drug. Roche must renounce to its patent on Fuzeon and voluntarily issue technology transfer. This is the only solution to make Fuzeon available for everyone.

March 4, 2009.

Korea HIV/AIDS Network of Solidarity / Nanuri+, HIV/AIDS Human Rights Advocacy Group of Korea / Public Pharmaceutical Center / Solidarity for Lesbian Gay Bisexual Transgender Human Rights of Korea / Korean Gay Men’s Human Rights Group / Sarangbang, Group for Human Rights / Health Right Network / Korean Federation of Medical Groups for Health Rights / Association of Korea Doctors for Health Rights / Association of Physicians for Humanism / Korea Dentists Association for Health Society / Korea Health and Medical Workers Union / Korean Pharmacists for Democratic Society / People’s Solidarity for Social Progress / Intellectual Property Left / Korean Progressive Network Jinbonet / Korea Leukemia Patient Group / Solidarity for New Progressive Party

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