News

Decision on patent application related to Sofosbuvir

BRAZIL

On last Sunday, September 23rd, a Brazilian court granted an injunction against a Gilead Sciences patent application which had been allowed last week.

Application No. PI 0410846-9 (national phase of PCT/US2004/012472) relates to sofosbuvir intermediates. Sofosbuvir is sold by Gilead in Brazil for hepatitis C treatment under brand name SOVALDI®.

Despite several attempts to prevent the allowance of this patent application, including several third-party observations and even a lawsuit brought before an administrative decision on the matter, the Brazilian PTO published its allowance last week. The Brazilian PTO has analyzed the application based on the provisions of the Brazilian IP Law, not considering the sale price.

However, social movements and media outlets continue to pressure the government not to grant the patent under the allegation that the sale price would be too high, making it difficult to eradicate hepatitis C from the country.

The decision is a result of a preliminary injunction requested on last Thursday by a presidential candidate. According to some news published on Monday, this action was influenced by the course of the presidential election campaign, based on a supposed reduction of the costs for patients as local pharmaceutical manufactures would have the right to produce a significantly cheaper, generic version of the drug.

The decision determines the cancellation of the allowance and the review of the application by the Brazilian PTO taking into account the public interest.

It should be noted that this decision may be appealed by Gilead and/or by the Brazilian PTO, the defendants of the case.

We are monitoring this matter and will inform you of any important developments.

In case you require additional information, feel free to reach Ms. Caroline Golfeto (cgolfeto@clarkemodet.com.br)