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Pharma patent lifetime truncated in Brazil

In a surprising and, for pharmaceutical companies, alarming development, the Brazilian Supreme Court has recently accepted recommendations by the National Intellectual Property Watchdog and ruled that Pfizer’s patent for Viagra (patent number BR9102560), a drug worth nearly £80 million per year in Brazil, will expire a year earlier than Pfizer expected.

The debate over the expiry date arose due to the manner in which this application was filed and subsequently granted. First filed with the UKIPO on 20 June 1990, a European application was then filed on 19 June 1991 and the original British application was abandoned. The 20-year lifetime of the European patent (covering the UK) runs from the European filing date, and so the European patent will not expire until 2011.

Initially a patent application could not be filed in Brazil as, prior to 1996, Brazil did not allow the patenting of chemical substances, compositions and products. When the law regarding this was changed, the somewhat controversial Pipeline System was introduced in order to allow the patenting of substances that, while not new, were not previously patentable. The patents granted through this system were valid for a period equal to but not exceeding that remaining on the patent granted in the country where the application was first filed, in this case the UK.

When the question over the expiry date of the Viagra patent was first raised, the Federal Regional Court of Rio de Janeiro initially maintained the validity of the Viagra patent until June 2011. However, the new ruling by the Supreme Court has overturned this decision and ruled that the patent will expire in June 2010, ie 20 years from the UK priority date, rather than from the European filing date.

In defending their patent Pfizer claimed that, though the patent was initially applied for in the UK in June 1990, that application was later abandoned and registration was only completed in 1991 in the European Patent Office. They argued that this should therefore be the point from which the 20 year term of protection is calculated. The opposing view was that, just because the patent effectively received an extension in its country of origin due to a peculiarity of the European patent system, does not mean that it should be entitled to the same extension in Brazil.

With regards to the pipeline system, Article 230(5) of Brazilian patent law reads:

A patent granted on the basis of this article will be guaranteed the remainder of the term of protection in the country where the first application was filed, counted from the date of filing in Brazil and limited to the term defined in article 40 [20 years]…

This Article appears to state that a patent granted through the pipeline system enjoys a lifetime equivalent to that remaining on the patent in the country of origin. This implies that the Brazilian patent expires on the same date as the patent from which it claims priority; in this case the British patent, originally filed in 1990 but proceeding to grant through the European patent filed in 1991.

This ruling by the Brazilian court has been the source of much debate, and Pfizer may well appeal against the decision. The ruling is crucial not just for Pfizer, but also for the owners of at least 30 other drugs in the same situation who will find that their patent protection expires sooner than expected.


28 May 2010

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