Brazil Issues Compulsory License for Efavirenz

Kaletra Compulsory Licensing Dispute


June 24, 2005. Minister of Health Humberto Costa announces that a compulsory license will be issued for Lopinavir+Ritonavir in 10 days. (Negotiations for Efavirenz and Tenofovir are continuing.) Farmanguinhos will produce the drug for USD 0.68 per unit, compared to Abbott's price of USD 1.17 a unit.

July 8, 2005. Abbott and Brazil announce that a last-minute deal has been reached. Abbott will supply the drug at a lower price than it currently charges, though the cost-per-pill was not specified. Brazil will not issue the compulsory license.

July 14, 2005. Brazil's new Minister of Health announces that deal is not valid and that negotiations are still underway.

Negotiations over Licenses for Lopinavir+Ritonavir, Efavirenz, and Tenofovir

Legislation to Exempt AIDS Drugs from Patentability

On June 1, 2005, the Chamber of Deputies (the lower house of the legislature) unanimously approved Bill Number 22/03, which will make AIDS drugs unpatentable if it becomes law. In order to become law, the legislation now must be approved by the Federal Senate, and then be ratified by the President. Bill Number 22/03 would amend Article 18 of Brazil's patent law (Law Nº 9.279, of May 14, 1996), which lists exceptions to patentability. Article 18 begins with the phrase "The following shall not be patentable..." and then lists three common exeptions. Bill Number 22/03 adds the following:

"IV - the medication, together with its respective procurement procedure, specifically for the prevention and treatment of the Acquired Immunodeficiency Syndrome SIDA/Aids"

Negotiations Over Price of Lopinavir, Efavirenz and Nelfinavir (2003)

International Cooperation Program for HIV and AIDS Prevention and Control Activities for Other Developing Countries

Brazil and Roche Reach Discount Deal After Announcement of Compulsory License for Antiretroviral Drug Nelfinavir

On August 22, 2001, Brazilian Health Minister Jose Serra announces that the Brazilian government will issue a compulsory license for the manufacture of the antiretroviral drug nelfinavir (sold under the brand name Viracept by Roche) to the Brazilian pharmaceutical producer Far Manguinhos. This announcement comes after unsuccessful negotiations between the Brazilian government and Roche. On August 28, the two parties resume talks, and on August 31, they reach an agreement; Roche will sell the drug in Brazil at an additional 40% discount, and Brazil will not issue the compulsory license.

US Withdraws Its WTO Panel Against Brazil Concerning the Local Working Provision in its Patent Law

June 25, 2001. Today the US withdrew its WTO panel against Brazil concerning the local manufacture of HIV/AIDS drugs. Under the agreement, this and other disputes will be negotiated through a bilateral "Consultative Mechanism," and Brazil will notify the US government in advance if in the event that it finds it neccesary to issue a compulsory license under Article 68 of its patent law.

Special 301 Report of the US Trade Representative, April 30, 2001

Documents Relating to the US/Brazil WTO Case

Documents Submitted to the World Trade Organization Dispute Settlement Body in Geneva

October 6, 1999. Presidental Decree on compulsory licenses issued for non-commercial use, national emergency, or public interest.

Statements on the Trade Dispute

Policy Papers

News Items Regarding the trade dispute
Brazilian Patent Law

Brazil's Resolution at the UN Commission on Human Rights

On April 23, 2001, the UN Commission on Human Rights passed a resolution promoting access to pharmaceuticals proposed by Brazil titled Access to Medication in the Context of Pandemics Such As HIV/AIDS. The 53-member body passed the resolution by a 52-0 vote, with the United States abstaining.

Brazil Negotiates Price Cut from Merck

Research Papers

PhRMA submissions on Brazil

  • PhRMA's February 18, 2000, 301 submission on Brazil.
  • PhRMA's December 3, 1999, 2000 NTE submission on Brazil.
  • PhRMA's February 16, 1999, 301 submission on Brazil.
  • PhRMA's December 4, 1998, 1999 NTE submission on Brazil.

  • PhRMA's 1987 petition to USTR.
    "On June 11, 1987, the Pharmaceutical Manufacturers Association filed a petition complaining of Brazil's lack of process and patent protection for pharmaceutical products as an unreasonable practice that burdens or restricts US commerce.

    "On July 23, 1987, USTR initiated an investigation and requested consultations with Brazil (52 FR 28223). Consultations were held on Feb. 29, 1988, and additional discussions resulted in no resolution. On July 21, 1988, the President determined Brazil's policy to be unreasonable and a burden and restriction on US commerce, and he directed USTR to hold public hearings (See 53 FR 28100 and 30894) on certain products exported from Brazil. Hearings were held September 8-9, 1988. On October 20, 1988 the President used section 301 authority to proclaim tariff increases to 100 % ad valorem on certain paper products, non-benzenoid drugs, and consumer electronics items, effective October 30, 1988 (53 FR 41551).

    "On June 26, 1990, the Government of Brazil announced that the President of Brazil had decided to seek legislation to provide patent protection for pharmaceutical products and the process of their production. The Brazilian Administration will ensure the presentation of a bill to the Brazilian National Congress for this purpose by March 20, 1991, and will seek its approval and implement such legislation immediately after it comes into force. The USTR therefore determined that Brazil was taking satisfactory measures to eliminate the practices that were determined by the President to be unreasonable and a burden or restriction on U.S. commerce. On June 27, 1990, the USTR announced that she had determined that it was in the interest of the United States to terminate the application of the increased duties imposed by Proclamation No. 5885, pursuant to the authority granted to the USTR in that Proclamation. Such termination was made effective with respect to articles entered, or withdrawn from warehouse for consumption, on or after 12:01 a.m. on July 2, 1990 (55 FR 27324) The USTR also announced that she would monitor closely the Government of Brazil's efforts to enact such legislation.

Atazanavir Discount
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