On October 15, 2015, Judge Caroline Somesom of the 31st Federal Court in Rio de Janeiro invalidated AstraZeneca’s Brazilian patent No. PI0107445-8 covering Faslodex® (fulvestrant). Faslodex® is used to treat metastatic breast cancer in women who have gone through menopause. Specifically, a nullity lawsuit was filed in 2013 by Eurofarma Ltda, a Brazilian generic company, against Astrazeneca and the Brazilian Patent and Tradmark Office. In its lawsuit, Eurofarma argued that the patent was obvious in view of EP Patent Application No. 346014, U.S. Patent No. 4,212,863 and several other publications from cancer research journals. Judge Somesom agreed with Eurofarma and held the patent invalid.
In May 2015, a court-appointed expert issued a formal report holding the patent invalid for lack of inventive step. According to the expert, the mere “adaptation” of a subcutaneous injectable formulation to an intramuscular injectable formulation would have been an obvious modification to a person of ordinary skill in the art. In his decision invalidating the patent, Judge Somesom agreed with the conclusions of the court-appointed expert. However, this is not the final word on the matter. Judge Somesom’s decision can be appealed to the Federal Court of Appeals for the Second Circuit.
For the second time in 2015, a patent covering of blockbuster drug of Astrazeneca’s has been invalidated. The first instance involved Astrazeneca’s Crestor patent.
This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys.