Wednesday, 25 November 2009

Venezuela Annuled Two Bayer's Pharmaceutical Patents


The country’s Minister of Trade, Eduardo Saman, declared that the Government invalidated two registered pharmaceutical patents for the antibiotic moxiflocaxin produced by multinational Bayer.

The move comes after Bayer initiated civil lawsuits against two national companies that were producing generic copies of moxiflocaxin. The accused infringers alerted the Minister of Trade and the Servicio Autónomo de la Propiedad Intelectual (SAPI). Proceedings started challenging the validity of the patents.

The SAPI’s director Arlen Piñate declared that the requirements were not fulfilled. The requirements for granting a patent in Venezuela are 3: the invention must be new, no obvious and industrially applicable. Piñate said that the forms did not contain the reason why they were granted. She continues explaining that the first patent was registered in 1992. To this effect, she said that at the time, the Industrial Property Law 1956 excluded pharmaceutical patents. The second patent was granted in 1996 when the law was amended as to allow this type of patents. However, Piñate mentioned that the requirement of novelty failed because of the first patent (there was prior publication).

Criticism
Sadly, the Venezuelan view is political rather than explaining legal grounds. The declaration made by the Director appears to be focus on a socialist campaign (see SAPI’s declaration here – in Spanish). She starts by saying that ‘Bayer is putting into risk public health’. The thought that cross my mind was ‘side effects’ but I was wrong. Most of her statement is based on the dislike of transnational companies: they prevent generic alternatives, high prices for medications, and so on. However the blog is not about politics, therefore I need to proceed with IP.
Two points I have:
1.- Bayer’s first registration nullity; Bayer’s original registration fulfilled all requirements and was granted. Unfortunately, it does not have any legal ground because of the fact that pharmaceutical medicines could not be obtained under the said legislation. How this happens?
2.-Bayer’s second registration; novelty, clearly the invention was known and used in the country; there was also a printed publication (the one in the register). Therefore, there was, we can say, a prior publication. However, should not be a defence that relates to the malfunction of the system (in this case, the Patent Office). I am afraid I do not know any case, so please free to post any comments and ideas.

On a final note, ‘moxiflocaxin’ is not listed as an essential medicine by World Health Organisation (WHO), so I question, why is Bayer risking public health?

WHO model list of essential medicines here.

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