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Tuesday 16 September 2008

José Carlos Vaz e Dias

Federal Court of Appeals Declares Null Schering’s Contraceptive Patent and Opens the Possibility to Question Pipeline Patents

In a recent decision issued by the Federal Court of Appeal, involving the Brazilian company LIBBS FARMACÊUTICA and the German company SCHERING AG, Schering’s patent relating to the contraceptive pill sold under the brand name Yasmin was invalidated. This pill is currently one of the market sales leader and one of Schering’s top brands.

The patent was granted through the pipeline system, which allows the patentability of pharmaceuticals inventions already commercialized in other markets, without the prior examination of the industrial application, novelty and inventive step of the invention.

The commercial interest in nullifying Schering’s patent comes from the fact that LIBBS FARMACÊUTICA markets in Brazil a birth control pill, so-called Elani for a lower price (almost 30% less), using the same patented active ingredient. Back to 2004, LIBBS FARMACÊUTICA sought before the Federal Court the nullity of Schering’s contraceptive patent based on the argument that its active ingredient did not involve an inventive step (novelty) and it was a second use patent. The 38th Chamber of the Federal Court ruled initially in favour of SCHERING and decided that the industrial property law did not require the examination of the patentability requirements of patents granted under the pipeline system.

This decision has been reversed in the Federal Court of Appeal based on the expert opinion issued by the Brazilian Patent Office that affirmed the lack of inventiveness of Schering’s patent. Accordingly, the Federal Court of Appeal understood that it should and must be possible to examine the patentability requirements of a patent granted under the pipeline system. If not, this would mean that the protection conferred to this invention would be regarded as “absolute” without attending the patentability requirements. Thus, the Court found that Schering’s patent lacked inventiveness and declared it null.

This case is not yet closed, since Schering may still appeal to the Superior Court of Justice in Brasilia.

José Carlos Vaz e Dias

José Carlos Vaz e Dias