miércoles, 3 de abril de 2013

"Glivec story"

"Otra cosa es el daño a la imagen del Big Pharma, 
 siempre en entredicho: 
ya tiene otra herida que restañar." 
Emilio de Benito/EL PAIS 

Lo que Novartis ha intentado es que se considere la sal de imantinib como un producto completamente nuevo. Argumenta que de otra manera no habría podido producirlo ni distribuirlo, y probablemente la forma de sal sea la más estable y la más fácil de usar. Pero se ha pasado de exigente. Ha intentado forzar la mano. Brasil, Tailandia y China ya se habían resistido a jugadas similares, aunque más en el campo de crisis sanitarias como el VIH. India no se iba a quedar atrás.
La definición de novedad/Emilio de Benito, EL PAÍS 2.4.2013

This story is all over the news today, but it's my impression that most of the stories leave out crucial details. This is not just a big multinational drug company being put in its place by Indian courts, nor is it some crazy ruling with no basis in fact. Here's the story, as best I understand it. 

 Novartis has never had a patent for imatinib (Glivec/Gleevec) in India. I'm not completely sure why that is, but I would think it's because that back when the compound was being developed was the era when Indian drug patents did not exist. As the country has entered the WTO, it's had to comply with the world's intellectual property framework, and it's safe the say that the dust has not yet settled from this process. 

 So when Novartis filed for an imatinib patent in India, it was for a different polymorph of the drug, which they hoped would be patentable chemical matter. The Indian patent office disagreed in 2006, saying that this was merely a reformulation of an existing compound (which had been approved in the US back in 2001), and rejected the application. Novartis has been appealing that decision through the Indian court system ever since, and this latest ruling is the last, from the Indian Supreme Court. As the court's decision says: 

 In the application it claimed that the invented product, the beta crystal form of Imatinib Mesylate, has (i) more beneficial flow properties: (ii) better thermodynamic stability; and (iii) lower hygroscopicity than the alpha crystal form of Imatinib Mesylate. It further claimed that the aforesaid properties makes the invented product “new” (and superior!) as it “stores better and is easier to process”; has “better processability of themethanesulfonic acid addition salt of a compound of formula I”, and has a “further advantage for processing and storing.”

Novartis Loses the Glivec Patent Fight in India                                                        Derek Lowe

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