PHARMACEUTICAL REGULATION AND PATENT LINKAGE

05 / 12 / 2012

The development of new medicines is a long, hard and costly process, important so as to improve the quality of life of the population. Patents of Invention have proved to be an efficient tool to encourage these kind of innovations, since, on the one hand they give a market exclusivity which enables the owner to recover its investment, on the other hand, they also guarantee that once the exclusivity period is over such knowledge will pass over to public domain.

A long-term discussion has taken place on whether Sanitary Registration, required to commercialize these products in the marketplace, has the nature of a marketing Authorization or not. This discussion has no other purpose that to overcome the obligation assumed by Chile in the Free Trade Agreement with the US, which expressly establishes the obligation not to grant sanitary authorizations to third parties before the expiration of the patent.

Some have understood that it is enough to state that such an authorization has a sanitary and non-commercialization nature so as to argue that there is no risk of not fulfilling with the international obligations assumed by Chile in this regard.

In our opinion, it does not matter how this kind of authorization is named, it must be understood as a commercialization authorization, simply because in its absence the commercialization of the product is forbidden.

Thus, it is necessary to improve the linkage between the Patent Office and the National Health Institute (ISP), which today does not exist.

In January 2012 a bill was sent to the Congress so as to create “Patent Linkage System”. However, this bill is not sufficient since it only refers to “active principle” of patents , which by the way are very restrictively defined, excluding from the scope of protection, all the rest of pharmaceutical patents that our patent system allows. Consequently, although the bill represents a good effort, at least in its current presentation seems insufficient.

For more information please contact Pamela Fitch: pfitch@villaseca.cl.