Brazil Government Declares Gilead AIDS Drug Public Interest -Report
By Bernd Radowitz
Dow Jones Newswires
April 10, 2008
[READERS SHOULD TAKE NOTE THAT BRAZIL'S LATEST ACT WAS NOT RANDOM. IT OCCURRED IN THE SHADOW OF THE U.S. SENATE'S DEBATE OVER U.S. PATENT REFORM WHICH ENDED IN DEADLOCK OVER DAMAGE AWARDS. U.S. DEMOCRATIC SENATOR LEAHY ADVOCATED IN FAVOR OF LIMITED PATENT INFRINGEMENT DAMAGE AWARDS WHICH, IN EFFECT, WOULD WEAKEN U.S. PATENT RIGHTS, BOTH HERE IN THE U.S. AND ABROAD. THE BRAZILIAN GOVERNMENT HAS INFORMED THIS BLOGMASTER THAT IT HAS BEEN CLOSELY MONITORING THE U.S. SENATE PATENT REFORM DEBATE. THIS LEADS ONE TO CONCLUDE THAT THE BRAZILIAN GOVERNMENT HAS ACTED ONCE AGAIN OUT OF IP OPPORTUNISM IN SUPPORT OF THE U.S. DEMOCRATIC PARTY'S GOAL OF GIVING AWAY U.S. PATENT RIGHTS TO FOREIGN GOVERNMENTS THROUGH COMPULSORY LICENSING. ONE NEED ONLY LOOK AT THE OTHER BLOG ENTRIES IN THIS JOURNAL TO SEE HOW U.S. DEMOCRATIC CONGRESSMAN WAXMAN HAS WORKED ALONGSIDE U.S. DEMOCRATIC SENATOR LEAHY TO MORE BROADLY DEFINE COMPULSORY LICENSING AS A WIDELY ACCEPTED & LEGALLY SANCTION PRACTICE BY BOTH U.S. AND INTERNATIONAL LAW. THE OBVIOUS PROBLEM WITH THIS BEHAVIOR, HOWEVER, IS THAT IT EMBOLDENS FOREIGN GOVERNMENTS TO SYSTEMATICALLY VIOLATE U.S. CITIZENS' CONSTITUTIONALLY PROTECTED EXCLUSIVE PRIVATE PROPERTY RIGHTS, WITHOUT EVEN GIVING THE U.S. PUBLIC A 'SAY' IN THE MATTER. IN OTHER WORDS, IT VIOLATES THE CONSTITUTIONAL DUE PROCESS RIGHTS OF U.S. CITIZENS.]
RIO DE JANEIRO -(Dow Jones)- Brazil's health ministry has declared Gilead Sciences Inc.'s (GILD) anti-AIDS drug Tenofovir as of "public interest", the Estado de S.Paulo newspaper said Thursday.
After the move, it is likely that the drug won't be granted a patent in Brazil, the newspaper said.
U.S. authorities about a month ago denied a patent for Tenofovir, arguing the drug doesn't represent any innovation, Estado de S.Paulo said.
Tenofovir is being used by 30,000 patients in Brazil's government free anti-AIDS drug program and costs the government $1,387 per patient a year. The drug represents 10% of government spending for AIDS medications.
If health authorities deny Gilead a patent for Tenofovir, Brazil's government may import the drug from Indian generic producers, who can make it for $170 per patient a year.
Brazil's government a year ago issued a compulsory license to break the patent on the anti-retroviral AIDS drug Efavirenz made by U.S. pharmaceutical giant Merck & Co. (MRK).
AIDS non-governmental organizations welcomed the measure last year, while both Merck and business representatives sharply criticized it.
It was the first time Brazil broke a patent for an AIDS drug, after having threatened to do so for many years in order to obtain price cuts from pharmaceutical companies.
UPDATE 1-Brazil may reject Gilead's AIDS drug patent
Thu Apr 10, 2008 12:55pm EDT
(Adds data on Tenofovir use in Brazil, background)
By Maria Pia Palermo
RIO DE JANEIRO, April 10 (Reuters) - Brazil has decreed U.S. pharmaceutical firm Gilead's AIDS drug Tenofovir "in the public interest", signaling it may reject a patent request due to its high price and import a generic version.
The Health Ministry said in a decree published on Wednesday that patenting the drug in Brazil would generate "expectations of monopoly rights with an impact on the price of the product."
Latin America's largest country has an internationally-lauded AIDS prevention and treatment program, in which patients get free antiretroviral treatment.
The ministry said it had requested a priority examination of the patent filing by the company with the Brazilian INPI patent body, which will have to take into account the ministry's objections.
"If no patent is issued, Brazil will be free to negotiate prices of the drug, be it generic or brand name," a health ministry source told Reuters on Thursday, adding that the case was "not about compulsory licensing" or breaking patents.
[OUTRIGHT PATENT EXTORTION, WHICH IS AN ABUSE OF THE WTO TRIPS AGREEMENT].
A representative of Gilead Sciences Inc in Brazil declined to comment on the issue but said high-ranking Gilead officials were in contact with the ministry to discuss the case.
The Health Ministry said Tenofovir accounts for 10 percent of the money the government spends on its AIDS treatment program, which encompasses a cocktail of various drugs, including Tenofovir in some cases.
[BRAZIL HAS BECOME A WEALTHY EMERGING ECONOMY AND HAS NO NEED TO DECLARE DRUGS NONPATENTABLE OR TO ISSUE COMPULSORY LICENSES TO REDUCE ITS HEALTHCARE COSTS. IT NEED ONLY SPEND THE FOREIGN DIRECT INVESTMENT IT HAS ACQUIRED WISELY, TO REMOVE MILLIONS OF QUALIFIED AND ABLE-BODIED WORKERS FROM HIS PENSION WELFARE SYSTEM, AND TO CLEAN UP ITS MASSIVE PUBLIC CORRUPTION PROBLEMS.]
It said that this year, 31,300 Brazilians would be treated with Tenofovir at a cost of $1,387 per patient. The annual cost per patient, for some 180,000 people treated under Brazil's AIDS program, is about $2,500 worth of medicines a year.
[THE BRAZILIAN GOVERNMENT'S EFFORTS TO EVOKE INTERNATIONAL EMOTION FOR THOSE OF ITS CITIZENS WHO CONTINUE TO INFLICT THEMSELVES WITH HIV/AIDS IS MISPLACED. PERHAPS THE WORLD'S CITIZENS SHOULD BE OUTRAGED ABOUT HOW THE BRAZILIAN GOVERNMENT DOES LITTLE TO NOTHING TO GENERATE INVESTMENTS IN DOMESTIC DRUG INNOVATIONS THROUGH PROTECTION OF PRIVATE PROPERTY RIGHTS, INCLUDING PATENTS AND TRADE SECRETS. THE FAILURE TO CONSISTENTLY RECOGNIZE AND ENFORCE PRIVATE PROPERTY RIGHTS IS THE TRUE CAUSE OF BRAZIL'S HEALTHCARE DILEMMA.]
The Health Ministry source said the case was different from last year's bypassing of a patent on Merck & Co Inc AIDS drug Efavirenz.
[IT MAY APPEAR DIFFERENT, BUT THE RESULT IS THE SAME - DISREGARD OF THE TRIPS AGREEMENT. ACTUALLY, BRAZIL TRIED THIS SAME TRICK BACK DURING 2005. See Slavi Pachovski and Lawrence Kogan, "The Wolf and the Stork", at: http://www.itssd.org/White%20Papers/TheWolf_and_theStork-Brazil_snon-patentabilitylaw.pdf .]
Last May, President Luiz Inacio Lula da Silva authorized Brazil to sidestep the patent on Efavirenz and import a generic version from India. It was the first time Brazil bypassed a patent to acquire cheaper drugs for its AIDS program.
That process also started with the government declaring the drug "in the public interest" and saying it was too expensive.
If the Tenofovir patent is rejected, Brazil may choose to import generic drug using a clause in World Trade Organization rules to flout drug patents in the name of public health.
Other countries, including Canada, Italy and Thailand, have also used the WTO clause to gain access to cheaper AIDS drugs.
The World Health Organization considers Brazil's AIDS strategy -- which also includes large-scale distribution of free condoms as well as free and fast testing for the HIV virus -- a model for developing nations.
Brazil's AIDS infection rate, after climbing until the early 1990s, has steadied and even reversed course. The prevalence of the HIV virus dropped to 0.5 percent in 2006 from 0.6 percent in 2005, its first fall in seven years. The numbers of new AIDS cases and AIDS deaths have also been declining. Brazil has an estimated 600,000 people infected with HIV/AIDS. (Additional reporting by Pedro Fonseca and Andrei Khalip) (Writing by Andrei Khalip; Editing by Tim Dobbyn)
Kaiser Daily HIV/AIDS Report
Monday, April 14, 2008
Drug Access - Brazil Decrees Gilead's Tenofovir in 'Public Interest'
Brazil's Ministry of Health on Wednesday issued a decree signaling that it might reject Gilead's patent request for its antiretroviral drug tenofovir due to its high cost and import a generic version of the drug, Reuters reports. The decree declared the drug "in the public interest," adding that patenting the drug in the country would generate "expectations of monopoly rights with an impact on the price of the product."
The health ministry said that it had asked for a priority review of the patent filing with the Brazilian patent agency INPI, which must consider the ministry's objections. If Brazil rejects the tenofovir patent, the country could decide to use a World Trade Organization agreement allowing generic importation of patented drugs during public health emergencies, according to Reuters. A health ministry source said Thursday that the case was "not about compulsory licensing" or breaking patents, adding, "If no patent is issued, Brazil will be free to negotiate prices of the drug, be it generic or brand name." A representative of Gilead in Brazil would not comment on the situation but said top Gilead officials were in talks with Brazilian leaders.
[A GOVERNMENT'S DECLARATION THAT A DRUG IS NONPATENTABLE BECAUSE IT IS OF 'PUBLIC INTEREST' IS PER SE ILLEGAL UNDER THE WTO TRIPS AGREEMENT.]
According to the health ministry, tenofovir accounts for 10% of the government's spending on its HIV/AIDS treatment program. The government provides antiretrovirals at no cost to people living with HIV/AIDS in Brazil. This year, 31,300 people in Brazil are expected to be treated with tenofovir at a cost of $1,387 per person. The annual cost per person for the 180,000 people included in Brazil's HIV/AIDS program is about $2,500 worth of medicines each year, Reuters reports (Palermo, Reuters 4/10).
Monday, April 21, 2008
Brazil's IP Opportunism Shines Thru Again in Shadow of Senate Deadlock Over US Patent Reform: Cites Public Interest in Declaring US Drug NonPatentable