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Tuesday 12 July 2011

Patricia Covarrubia

INPI did it again - pipeline mechanism


The Brazilian Instituto Nacional da Propriedade Industrial (INPI) reports that last Wednesday, July 6th, obtained another victory in the courts related to pharmaceutical patents. The 1ª Turma do Tribunal Regional Federal da 2ª Região unanimously upheld the decision which keeps a pharmaceutical product in the public domain. The medicine in question was Dronedarone used to combat cardiac arrhythmias. The patent holder intended to extend its period of August 2010 to one year later.

If you have kept an eye in this blog, you may have notice that in Brazil many drug patents have generated lawsuits because of the controversy regarding the pipeline mechanism (for some examples click here, here, here and here). The current Industrial Property Law, published in 1996, included the pipeline to protect inventions of pharmaceutical and chemical patents that were not possible to be registered before due to Brazil no allowing these types of patents. Nonetheless, through this system, the patent holder would have a year to request to the INPI the said protection and when granted it will worth the time remaining in the country in which it was deposited first - the first filing abroad, as stated by the Law and confirmed by the Superior Court of Justice (STJ).

Patricia Covarrubia

Patricia Covarrubia


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12 July 2011 at 13:43 delete

Thanks for posting this very interesting news. I think, however, that the post is conflating two distinct issues related to the “pipeline” in Brazil, and these issues ought to be separated. One issue, which you posted about last week, regards obtaining a patent through the pipeline. Here the issue regards whether or not a firm re-filed its application according to the rules of the pipeline. A second issue, which I’m pretty sure the Dronedarone case is about (and others featured on the blog that you provide links to as well) is about extending the expiration date for patents granted under the pipeline, and that’s something different.

Suppose a patent was applied for in the US and France 1990. If granted it expires in 2010. If the patent was also granted in Brazil under the pipeline mechanism, it would also expire in 2010 in Brazil. But now suppose that the patent-holder receives an extension of the patent in the US or EU, say under orphan drug act or to compensate for delays in examination or some other reason, so that the expiration date is pushed back to 2012. The question here is whether or not the expiration date in Brazil is also pushed back to 2012. INPI tries to avoid granting these “extensions” (even the word is contested, the pharmaceutical sector calls these “adjustments”) and stick to the original expiration date. Or, to put it differently, by adopting a pipeline mechanism Brazil imports other countries’ examination outputs, but the INPI (supported by the courts) has determined Brazil will not also import other countries’ extension procedures.

12 July 2011 at 17:44 delete

You are correct, the case here refers to extending the 'expiration' date - as stated in the first paragraph. However the second paragraph refers to the pipeline mechanism in general to give a little bit of background to those new readers, or those that cannot remember perhaps what this is.
Anyway, thanks for pointing this out and I will try to make this issue more clear next time - as you say: these are two different matters.