Patentability of polymorphs

Since 2001 the Health National Surveillance Agency (ANVISA) –- regarded as the Brazilian equivalent of the US's FDA -- has examined patent applications when the subject matter relates to pharmaceutical drugs and processes, along with the examination carried by the Brazilian Patent and Trademark Office (BPTO). Academics, patent agents and some industrial representatives have considered since then that ANVISA’s new role represents an interference with the BPTO’s powers to examine the patentability requirements, creating a double examination procedure.

Rivalry between the BPTO and ANVISA heated up with the debate started last year over the patentability of polymorphs. According to ANVISA, the patentability of polymorphs may lead to monopolies and represent an obstacle to universal access to medicines, as provided by the Doha declaration. For the BPTO, polymorphs are patentable: this approach gives pharmaceutical companies the confidence to keep on investing in research and development of new drugs.

It appears that neither party is willing to back away from its initial position, thereby generating a problem to patent applicants. Further, there is before the Brazilian Parliament a bill proposing that polymorphs should not be considered as an invention and thus not patentable. The same bill also addresses the issue of second medical use claims, whereby they are considered merely as discoveries. At this point, it seems that ANVISA's position is so far prevailing over the BPTO’s understanding on polymorph patentability, but the controversy is far from ending.

Source: Jorge Miguel Arruda da Veiga (Di Blasi Parente Vaz e Dias & Associados). More on polymorphism here