BRAZIL: LIFE-CYCLE INSIGHTS 

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IPD’s Brazilian subscription helps you understand this large and immensely unique market, including:

  • Easy-to-use Brazilian brand,

       biosimilar, and generic drug

       launch tracking schedules

  • Brazilian litigation tracking and

      in-the-courtroom coverage with

      real-time email updates

  • Personalized consults with local Brazilian intellectual property analysts​

  • ƒWeekly updates including trending Brazilian drug topics, recent publications, and loss-of-exclusivity information

  • Complete drug information with locally reviewed Brazilian indications

  • Comprehensive Brazilian clinical development tracking in

      every major disease class

"Can you give us a brief overview on how this region
is unique...

 

...in my opinion, there are three major differences that we can highlight when we talk about the Brazilian patent system and the U.S. patent system. The first of them is the so-called 10-year rule, which relates to the expiration date of patents in Brazil. The INPI, the Brazilian patent office, takes a long time to issue patents. It actually takes more than 10 years on average, based on the 2018 statistics of the old patent office. This means that the term of protection to Brazilian patents will not necessarily be counted from the filing date, but maybe from the issuance. Whenever the INPI takes more than 10 years to examine and issue a patent, such a patent will expire 10 years after issuance, which means there are really old applications standing at the INPI, as well as really old technologies still covered by patents in Brazil. And there are several brand drugs in Brazil that do not face generic competition because of that group. It is important to note that in Brazil, there are no patent terms.

 

A second feature, which is very different about Brazil, is that the Brazilian judiciary is very generous in granting preliminary and permanent injunctions. Actually, it's all about injunctions in Brazil, as we don't see a lot of cases settling or a lot of patent owners receiving damages for infringement. Preliminary injunctions are actually very common, and it's possible to retain ex parte preliminary injunctions, which means one side is talking to the judge without the other party’s knowledge.

 

And another feature that we may list as relevant and different is the fact that there is no regulatory data protection or exclusivity in Brazil, meaning that it's all about patents."

Our International Legal Analysts discuss the ins and outs of the Brazilian patent and regulatory system, including:

  • Unique features of the Brazilian patent and regulatory system

    • 10-year rule 

    • Preliminary and permanent injunctions

    • Regulatory data protections

  • Pathways to approval

  • Generic vs. similar drugs

  • Litigation

    • Pre-grant oppositions

    • Post-grant oppositions

    • Infringement lawsuits

    • Bi-furcated system

    • Expert opinions

    • Trial timing

    • Preliminary injunctions

      • Preventing competition

      • Ex parte injunctions

Listen to our podcast to learn more about the Brazilian patent and regulatory system