In a setback for Gilead Sciences, Brazilian authorities have rejected a patent for its Sovaldi hepatitis C treatment. And the decision could pave the way for generic competition in the country, which could lead to price cuts, according to one of the advocacy groups that filed a challenge.
In reaching its decision, the National Agency of Health Surveillance, or Anvisa, decided that the Gilead patent application does not meet patentability criteria established in Brazilian law, according to the advocacy groups. The groups took this action because they argue the pricing Gilead charges for its hepatitis C medicines impedes access.
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The article says the patent is rejected, but it then indicates that this is a decision by health agency, not the patent office.
Hi Pharmapatents,
Thanks for the note and good question. As I understand, the health authority in Brazil, which is known as Anvisa, approves medicines. However, Brazil has a mechanism called prior consent, in which Anvisa participates in analyzing patent applications with the National Institute of Industrial Property. Anvisa’s prior consent is obtained in issuing decisions and would then be adopted by the patent office. I hope to obtain the official document shortly and will post that if and when I do as a link to this story.
Hope this helps,
ed at pharmalot