O New York Times (18/06/2006) divulga a disputa judicial referente aos medicamentos genéricos nos Estados Unidos. Hoje, esse blog foi questionado se havia alguma documentação sobre os genéricos no Brasil. Não soube responder a contento. Agora, temos um relato muito interessando ocorrendo nos Estados Unidos refente ao clopidogrel, um medicamente anti-trombótico que em associação com a aspirina melhora o prognóstico de pacientes com infarto do miocárdio e angina instável.
Um comentário interessante: no período que morei nos Estados Unidos era regra as farmácias "esconderem" no setor "over the counter" (receita médica não-obrigatória), os medicamentos genéricos. Sempre ficavam na prateleira próxima ao chão, longe da vista dos clientes.
Um comentário importante: como apresentei no meu perfil participei de pesquisa envolvendo o uso de clopidogrel com patrocínio da Bristol-Myers Squibb.
Esse é o começo do artigo:
A federal court filing provided new details yesterday about accusations that a Bristol-Myers Squibb executive entered a secret side deal with a generic drug maker in hopes of preserving the lucrative monopoly over the anticlotting drug Plavix.
O restante do artigo poderá lido pelos inscritos do site do New York Times no endereço
http://www.nytimes.com/2006/08/18/business/18drug.html?pagewanted=2&_r=1&adxnnl=0&adxnnlx=1155913522-0Qs5wgHbfD6EUQr5ot2yeQ
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Caro Prof. Paulo
trabalho com jornalismo de saúde e acho muito importante a divulgação intensa do assunto, porque a saúde não pode existir sem a informação. Sentia falta mesmo desse tema no mundo dos blogs. Parabéns pela iniciativa.
Se quiser entrar em contato, meu e-mail é flaviasaad@gmail.com
Abraços,
Flávia Saad
NYT, September 1, 2006.
Generic of Plavix Is Blocked
By STEPHANIE SAUL
Published: September 1, 2006
A federal judge in Manhattan ordered a Canadian company yesterday to stop distributing its generic version of the blockbuster anticlotting drug Plavix, granting a reprieve to Bristol-Myers Squibb and Sanofi-Aventis, which co-market the brand-name drug.
Related
Preliminary Injunction (Sanofi v. Apotex)
Court Opinion (pdf)
The Plavix marketers had seen a drastic erosion of their United States sales since the Canadian company, Apotex, introduced its generic version on Aug. 8 in a challenge to the patent held by the big companies. Analysts say that the large supplies of the generic drug already on the market could continue to impinge on sales of Plavix for several months.
While ordering Apotex to stop shipments, United States District Judge Sidney H. Stein declined a request by Bristol-Myers and Sanofi to recall the generic pills already on the market. The judge ruled that the companies had negotiated away that right in their attempts earlier this year to settle the patent dispute with Apotex.
Judge Stein did say that the patent was likely to be enforceable, based on the evidence and testimony so far. He also observed that Bristol-Myers and Sanofi had suffered “irreparable harm” as a result of the patent infringement.
He nonetheless required Bristol-Myers and Sanofi to post a $400 million bond to compensate Apotex in the event the generic company won in a trial on the validity of the patent, now set to begin in his court next January.
Shares of Bristol-Myers were up more than 9 percent in after-hours trading on the New York Stock Exchange. Shares of Sanofi were little changed.
Bernard C. Sherman, the chief executive of Apotex, a private company based in Toronto, said yesterday that it planned to appeal. “We believe that the ruling is erroneous in many respects,” he said.
Mr. Sherman said that the volume of the Apotex drug already on the market amounted to about three months’ worth of sales, while some analysts have estimated the amount at even more. A spokesman for Bristol-Myers, Tony Plohoros, said the company was trying to assess the amount of generic inventory in wholesale channels. Neither Sanofi nor Bristol-Myers had issued any other statement about the ruling, but in a letter to employees being sent last night, the Bristol-Myers chief executive, Peter R. Dolan, said it was “certainly good news that the preliminary injunction has been granted, but unfortunately the economic and other consequences of the intrusion of the generic product that competes with Plavix in the U.S. market are impossible to fully reverse.”
A Deutsche Bank analyst, Barbara Ryan, said the ruling was relatively good news for Bristol-Myers, which derives 30 percent of its profit from sales of Plavix. The drug, used by 48 million Americans, primarily to prevent the recurrence of stroke and heart attack, had United States sales last year of $3.5 billion
na versão brasileira do Wall Street Journal (04/09/06) há menção que apesar da justiça ter sustado as vendas de Apotex, a quantidade desse medicamento nas farmácias permite vendas até 2007. O Apotex em 3 semanas assumiu 75% das vendas de clopidogrel. Como o clopidogrel é medicamento da Sanofi-Aventis, licenciado para a Bristo Myers Squibb, há divergência sobre o prazo de licença da patente. Esse é o motivo da disputa jurídica.
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