August 11, 2020

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August 11, 2020

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August 10, 2020

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First Mailbox Appeal to be decided by the Federal Court of Appeals in Brazil

This is an update to our post of September 22, 2014 regarding ongoing litigation in Brazil regarding the invalidity of 222 mailbox patents (namely, patent applications filed between January 1, 1995 and May 14, 1997, under the terms of Article 70.8 of the TRIPS Agreement). According to the Brazilian Patent and Trademark Office (INPI), these patents should have received a term of 20 years from their filing date. However, these patents mistakenly received a term of 10 years from the date of grant.

Since June 2014, three mailbox cases have been decided by the Federal Judges (Judges) in Brazil. Two Judges ruled in favor of the patent holders and one against. Not surprisingly, the Judges each conveyed different points of view regarding the inefficiency of the INPI to examine patent applications in a reasonable time and to deal with its current backlog.

The Judges ruling in favor of the patent holders stated INPI violated the IP Statute when it failed to comply with the rule requiring examination of mailbox applications before 2004 (as required by the IP Statute). The Judges also stated that the lawsuits filed by INPI to invalidate these patents were a violation of the constitutional principle of “legitimate expectation,” which requires a certain amount of predictability and trust in the acts of the Public Administration.

The Federal Court of Appeals will hear the first appeal of a mailbox case on October 21, 2014. The appeal was filed by the INPI against the decision rendered by Judge Brandão who rejected the lawsuits stating that the suits were a violation of the “legitimate expectation” principle.  The panel will comprise the Reporting Appellate Judge Hon. Messod Azulay from the 2nd Panel of the Court of Appeals. The panel will also include Judges André Fontes and Ivan Athié.

It is anticipated that Judge Fontes will decide against the patent.  Moreover, he might go as far as to suggest “killing” the entire patent rather than just correcting its term.  In addition, Judge Athié, a member of the 1st Panel and is replacing Appellate Judge Simone Schreiber (who is on vacation), has previously rendered some decisions against patents.  For example, in 2013, Judge Schreiber decided against a 2nd medical use patent covering Strattera (from Eli Lilly) for a lack of inventive activity.  Additionally, he voted for the invalidity of a patent covering Kaletra (from then Abbott Laboratories) due to a lack of novelty.   Thus, it will not be surprising if the Judges Athié and Fontes join forces in deciding against the mailbox patent.

Based on the composition of the panel, the odds are against a favorable outcome for the patent.  In fact, Reporting Appellate Judge Azulay may represent the the last hope for the patent.  The parties and Interfarma (Brazilian Research-based Pharmaceutical Manufacturers Association), which has not yet submitted an amicus brief in connection with this lawsuit, will have to act fast next week if they hope to avoid an unfavorable outcome.

The BRIC Wall Blog is pleased to announce that Roberto Rodrigues of Licks Attorneys will be attending the hearing on October 21st.  Mr. Rodrigues will be sending live updates from the court which we will post as quickly as possible on October 21st.

Roberto Rodrigues of Licks Attorneys contributed to this article.

©2020 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume IV, Number 287


About this Author

Lisa Mueller, Michael Best, Patent application Attorney, intellectual property lawyer,
Partner, Industry Group Chair, Life Sciences

Lisa provides strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on patent protection, freedom to operate and invalidity of blockbuster drugs they aim to produce and distribute.

Lisa’s advice on the full spectrum of global intellectual property portfolio management includes patent prosecution, opposition and other post-grant proceedings