IPTango: patent term extension

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Wednesday, 28 October 2015

Reforming Paten Law: the debate continues

Patricia Covarrubia October 28, 2015 No comments:

On 20th October, the Associação Brasileira da Propriedade Intelectual (ABPI)’s president spoke at a public hearing at the Comissão de Constituição e Justiça e Cidadania (Committee on Constitution, Justice and Citizenship) of the House of Representatives. In the speech it was clear that the ABPI opposed to reform to be brought by Bill 139/1999 and 5402/13 due to these not having sufficient technical analysis and without the necessary analysis discussions with parties involved such as the pharma industry and researchers. The proposed changes are according to ABPI, substantial changes to Brazilian Patent Law N. 9279 of 14 May 1996 (Law 9279/96).

What is going on?

What my mum think I do!

On 4th October our tanguera and Brazilian friend Magda Voltolini, wrote a guest post on the topic ‘Brazilian Politicians will vote for new Pharma Laws’. Here she notes that the Bill aims to modify “the provisions concerning rights awarded by the patent and conditions that grant compulsory licenses including those relating to pharmaceutical products and processes.” (full post here).

ABPI’s position
ABPI’s opposing to the reforms, points out the “technical failures of each of the ten amendments proposed in the Bills that, if approved, will impact negatively on the country's economy on innovative initiatives and investments in R & D”.

Rebutting allegations of patent abuse, ABPI’s president noted that the present Law already contains safeguards against abuses by patent. She pointed out that in Brazil there exist a misunderstanding with the term ‘extension’ referring to the term of patents, noting that ‘extension’ is an act of public administration, and “only granted when there is a fulfilment of all legal requirements”. Finally, she emphasized that any debate on patent should always be aimed at the modernization of IP infrastructure and R & D.

Source ABPI.

Brazil: Monsanto defeated

Patricia Covarrubia June 04, 2013 No comments:

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: no patent extension for medicines

Patricia Covarrubia February 19, 2013 2 comments:

The Fourth Chamber of the STJ unanimously upheld the appeal brought by the Brazilian Insituto Nacional da Propiedade Industrial (INPI) regarding the dismissal to extend three pharmaceutical patents.

While this decision appears to have taken place back in December, it has recently been published by the Brazilian Superior Court (STJ). The decision goes in line with previous ones and confirms the understanding of the pipeline system used by the patent system in Brazil i.e. term of the patent is to be count from the first application abroad even in circumstances in which such application was abandoned or extended in another country. We may recall that Brazil did not grant patent protection to pharmaceutical and agricultural products BUT because of its commitments as part of the TRIPS agreement, there was the need to accommodate the national system.

The drugs:

1. - drug used for cardiovascular disorders; active ingredient sildenafil citrate. Patent to expire on 09/07/2011, extension sought until 02/07/2012.
2. - drug used as a veterinary anti-parasitic; active ingredient selamectin. Patent to expire on 18/01/2013; extension sought until 12/01/2014.
3.-drug for migraine; active ingredient bromide eletriptan. Patent to expire on 15/10/2010; extension sought until 13/08/2013.

Source INPI.

Brazil court reviews patent term extension under TRIPS

Jeremy March 23, 2009 No comments:

The 3rd Chamber of the Superior Court of Justice of Brazil (STJ) issued an important decision last Tuesday (March 17, 2009) after examining Special Appeal no. 960.728 – RJ filed by EI DU PONT DE NEMOUR AND COMPANY against the Brazilian Patent and Trade Mark Office (BPTO). The matter under examination involved essentially the reference date from which the TRIPS Agreement would be enforceable in Brazil. The judges of the 3rd.Chamber determined unanimously that patents granted under the previous IP legislation cannot be extended from the original 15 year term to 20 years from the filing date, as stipulated by Article 70.2 of the TRIPS Agreement.

The dispute was initiated by the controversies derived from the different interpretations of this matter adopted by IP owners and the BPTO. IP owners understood that TRIPS was applicable as from January 1, 1995, due to Decree 1,335/1994. This interpretation is founded on the immediate applicability of the Agreement in Brazil, considering that there was no formal Government application to the WTO to request the delay for the TRIPS entry, as provided by Article 65.2.

BPTO’s examiners were however of the opinion that TRIPS would be enforceable only as from January 1, 2000. Their viewpoint was based on the applicability of Articles 65.1 and 65.2. Thus developing countries have the right to delay the enforcement of TRIPS for an additional five years from the date of the Agreement’s signature. While Article 65.1 of TRIPS determined that no member state is obliged to apply the provisions of TRIPS before one year from execution of the Agreement, Article 65.2 stipulated the possibility for developing countries to delay for 4 years the date of TRIPS application, which would add to 5 years in total.

BPTO’s understanding was the basis for rejections of administrative requests of patent extension and resulted in the commencement of court actions against it before the Federal Court in the city of Rio de Janeiro and the STJ.

The 3rd Chamber of the STJ's decision was based on the argument that the wording of Article 65.2 surely granted the benefit to Brazil (as a developing country) to extend the applicability of TRIPS independently of any written and prior request to the WTO. Further, it considered that TRIPS is not an international agreement with a direct and literal application to private relations. Instead, it is directed to member states, serving solely as guidance to the implementation of a new IP law.

Following the 3rd. Chamber’s rationale, TRIPS would be applicable in Brazil as from January 1, 2000 and the 20 years term would be secured to patents granted after the current IP Law (Law 9,279/96), thus not applying to those patents granted before the current IP Law.

This decision of the STJ interferes substantially with the owners’ rights of patents granted under the previous Industrial Property Law (Law 5,771 of 1972).

The decision is a novelty, especially if one considers previous decisions of the 4th Chamber and the recognition by the 3rd Chamber of STJ that the applicability of TRIPS commenced from January 1, 1995 and, therefore, permitted the extension of the patent term to those granted under the previous IP Law. It is surely a turn-round from the STJ position on the matter of patent extension, which had been long regarded as settled in that court and a matter no longer discussed in Brazil.

This decision will certainly incite new discussions and court motions by patent owners, especially those in the herbicide and pharmaceutical industries.

Source: article by IP Tango team member José Carlos Vaz e Dias