Brazil: Monsanto defeated

We hear from Brazil that the Third Chamber of the Superior Court of Justice (STJ) had denied an appeal brought by Monsanto Technology LLC to extend the term of the patent for genetically modified soybeans in Brazil. The court confirmed that the patent expired on August 31, 2010, i.e. 20 years after the date of its first abroad application.

Monsanto argued that the validity of the patent should extend as to match the foreign patent where it was granted. It is disputed that the remaining term of protection for the patent should be counted from the date of filing in Brazil and not the foreign application held abroad. Monsanto also argued that the trial of the case by the STJ should be suspended because a pending decision in the Supreme Court regarding a direct action of unconstitutionality which address the patent filing (Articles 230 and 231 of Law 9,279/96 (Industrial Property Law).

THE PIPELINE SYSTEM

A number of developing countries did not previously provide patent protection on certain products. When these countries became member of the TRIPS they were required to provide patent protection to such products and some took advantage of a transition period. Yet, during this period the developing country was required to accept ‘mailbox applications’ to be later examined when their national patent law would recognize the product as patentable. This system provides patents to inventions that were 'in the pipeline' of development. The pipeline protection enables individuals (natural or legal) to obtain patent protection on some products that would have otherwise been barred from consideration. At this stage is worth mentioning that a patent office evaluates whether an invention is ‘new’ as compared to the prior art before the date of application, which is usually the date of the patent application. Without this provision, individuals would be denied patents in countries that have only newly adopted patent laws because the invention is no longer new.

HERE COMES THE PROBLEM: PATENT PROTECTION AND TERM
 Some developing countries such as Brazil, Thailand, Argentina and Uruguay have provided pipeline patent protection BUT they parameters do differ. Yet we have seen steadiness in Brazil regarding the patent term. Since 2010, the Brazilian Instituto Nacional da Propriedade Industrial (INPI) together with Brazilian courts, have applied an established rule i.e. ‘the twenty year patent term should not begin with the date the pipeline patent was granted but rather the earlier abroad filing date’. Clearly the term of specific pipeline patents has been effective and thus, some of the most successfully pharmaceutical companies have seen their drugs with shorter terms of protection e.g. Pfizer’s Viagra and Lipitor and Novartis’ Gleevec.
In 2011, Monsanto was also defeated by the same rule in Brazil: Monsanto unsusceffully brought a claim to extend two patents which involved the herbicide Roundup (here).


JUNE 2013
In this particular case I read another interesting fact: if the application made abroad was abandoned, this still will be the relevant date for calculating the term from which the 20yrs should run. The court's statement goes as follows: "the protection offered to foreign patents, called pipeline patent, lasts for the remaining term of protection in the country where it was deposited/first request, to the maximum term of protection granted in Brazil - 20 years - from the date of the first filing abroad, even if subsequently abandoned.”

Finally, the STJ noted that the pending trial in the Supreme Court that discusses the constitutionality of the Industrial Property law does not suspend any other actions that are handled at the STJ.

Brazil: to promote and increase patents

Today I bring you several news regarding patents in Brazil. In a recent post, INPI declares that Brazil “is the world's seventh largest economy and 13th largest producer of science, but only occupies the 26th position among the countries that applied for patents in the United States.” It appears then that the country has a strong scientific and technological production, but yet does not materialize works into patents.

Due to this situation INPI, seeking to incentive the public, had arranged a debate called "The law of patents and the future of innovation technology in Brazil" taking place last Thursday 27th October. [You can have more information of what happen in the debate here – from academic perspective to agricultural products]

On the same week INPI exchanged information with the Chinese counterparts holding meetings on the 21st [oops! that is not the same week] and 24th October [ok, this one is]. Representatives of the Regional Patent Offices of Shanghai and Guangdong, attended the meeting. INPI informs that the reunion focused on exchange of information including use of information technology in Brazil and China.

Now getting the dates right, the previous week INPI noted that ‘Innovation and intellectual property’ were to be entered on the agenda of the Brazilian academic. To this effect the Universidade Federal do Rio de Janeiro (UFRJ) Innovation Agency has signed a cooperation agreement with INPI -- the goal of the partnership, signed on October 21, 2011, is to further expand the use of IP in the university, which was the sixth largest patent applicant at the INPI between 2004-2008 with 141 applications, followed by Petrobras, Unicamp, USP, UFMG and Whirlpool.
The partnership will include awareness - raising seminars on the subject, training in intellectual property, and a course on intellectual property issues in graduate courses in Biotechnology conducted by UFRJ.

Justice denies extension of anti-cancer drug patent [does this one promotes?]
INPI notified that it has another victory against a pharmaceutical. On October 26, 2011, the Federal Court of the 2nd Region (TRF-2) denied unanimously the appeal that sought to extend the validity of the patent medicine called ‘capecitabine’, used to treat cancer of the colon, rectum, breast, stomach, pancreas and gullet. The appellants hoped to increase the validity of the patent until December 2013, but the court agreed to keep the deadline set by INPI -- December 2012.

Price mechanism or pipeline mechanism?

On 16 August 2011, the Brazilian Superior Court of Justice (STJ) held unanimously against the extension of the patent related to Actos(pioglitazone), a drug used to combat type 2 diabetes. This is another victory for the Instituto Nacional da Propriedade Industrial (INPI) against an international laboratory.

The laboratory was seeking to extend the patent from January 2005 to January 2011 using the mechanism established by Brazilian legislation called pipeline. Through the mechanism, the patent would have a year to be made to INPI and worth the time remaining in the country in which it was first filled without extensions. This is the understanding that the STJ has also held in other cases (check here and here).

This sentence holds special implications to the country where local manufacturers receive significant support from its government. A patent expiration would enable local manufacturers to produce and sell Actos at nearly half the price of the original drug.

Source INPI.

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).

Brazil: ruling gives security to production of generic Gemzar

Patent applications filed in Brazil before 1996 which did not use the pipeline system cannot be granted. INPI’s practice was confirmed on June 30, 2011 by the1st Section Specialist of the Federal Court of the 2nd Region, in Rio de Janeiro.

According to INPI’s report the sentence gives “greater security to the production of generics and thus, expanding public access to treatment”. The aforesaid case relates to the examination of the drug Gemzar, used to treat certain types of cancer, and filed in 1993. INPI asserts that such a patent could only be examined if the applicant used the pipeline system. However, as the manufacturer has not made a new request through the pipeline, such claims should be dismissed because the previous legislation prevented the protection of such innovations.

This information is given by INPI and also found on the Advocacia-Geral da União; yet, there is no link to the case as such and/or at least more details. If you come across it, please share by the usual method –comment or send an e-mail to our team, thanks.

Monsanto’s intentions dismissed by Regional Court

Last Thursday, March 31, 2011, a Brazilian Specialized Federal Regional Court upheld the action for rescission brought by INPI to overturn the extension of two patents owned by Monsanto, which involves the herbicide Roundup.

Monsanto had previously obtained a court order for the extension of such patents for 2007 and for 2012; however the decision of the Court retook the dates established by INPI - 2005 and 2010, respectively.

The court’s decision accords with the pipeline system -- a mechanism established by Brazilian legislation. The current Industrial Property Law (1996) included the pipeline to protect inventions like pharmaceutical and chemical areas which were not protected before (previous legislation did not protect these type of inventions). The pipeline system allowed manufacturers/inventors to apply to INPI within a year; however the term of patent validation was made considering the remaining term of the date it which the first filing was made abroad. INPI argues that the protection in Brazil cannot extend 20 years being counted from the first deposit/application.