INPI WINS THE BATTLE AGAINST THE PATENT EXTENSION FOR LIPITOR

On August 27, 2010 the Brazilian Patent and Trademark Office (INPI) made public in its Portal (www.inpi.gov.br/noticias)the decision rendered by the 1st. Specialized Section of the Federal Court of Appeal of the 2nd Region on which INPI’s arguments were taken into consideration and the patent extension for Lípitor (atorvastatina), a medicine that controls cholesterol, was reduced. Accordingly, the Federal Court of Appeal affirmed unanimously (5 X 0) on Augaust 26 that the patent validity for Lípitor ended back in 2009, 20 years after the first registration in the US, not this year or in 2014.

This matter refers to the pipeline system, which granted to applicants the possibility for patenting chemical substances, compositions and products, in particular for the chemical, pharmaceutical and food industry although they were already known. The protection was secured under Articles 230 and 231 of the Brazilian IP Law. To obtain such protection and circumvent the novelty requirement, the applicant had to show to INPI that the (i) patent subject matter had not been marketed in Brazil, whether by the holder of by any third party with his consent, (ii) that no serious efforts were made by third parties to exploit such substance or composition in Brazil until 1996, (iii) that the patent was granted in the territory where the first application was filed and (iv) the patent application had to be filed by within 1 year, counting from the publication of the Intellectual Property Act in 1996.

Soon after the requirements were attended, patent holder passed to afford a protection term of 20 years, counting from the patent application filed abroad. However, this understanding was strongly opposed by the INPI, as it defends that the protection of such substances, compositions and products should count as from the first filing abroad and the validity period should not surpass 20 years after its first filing.

The end of the patent validity for Lípitor has been celebrated by INPI as this agency was the party who filed the reviewing appeal at the Federal Court of Appeals. Further to that, consumers are expected a drop of Lipitor's price of up to 35% of the actual price. Also, this decision followed the understanding previously dictated by the Superior Court of Justice in the Viagra case.

This is the second patent that Pfizer loses this year, but the representatives of this company already informed that they will appeal thereby holding back a little bit longer the dreams of the local companies. An interesting fact was posted on the news yesterday: It has been informed that hours after the decision was rendered on August 26, Pfizer announced an agreement with the local generic company so-called Eurofarma for the launch of a cheaper version of Lípitor. This product will enter the market this coming September. It is going to be generic or not?