Market Of Generics In Mexico

In view of the enactment of the new Health Law in 1998, a national market of generics has been created in Mexico, which initially caused serious concern amongst the pharmaceutical companies, because said law was completely silent with respect to the pharmaceuticals protected by a patent or by a patent application, for which of course no generics should be permissible.

The market of generics has been established through the publication of lists of generic products periodically issued by the Health Authorities, with an alleged absence of any product covered by a patent or by a patent application, since apparently no generics to these protected products will be included in the lists generated by the Mexican Health Authorities.

The real problem in the above respect resides on the fact that the Health Department has not developed an appropriate communication network with the Mexican Patent Office in order to determine when a drug is protected by a patent or by a patent application. Therefore, errors may be expected unless the Health Department is properly advised of the fact that a valid patent exists for protecting a drug.

It is extremely fortunate, however, that the Health Department is most willing and even grateful to accept notices presented by the owners of Mexican patents for new drugs or their attorneys, advising them that a drug is protected by a patent. These advises will have the effect of preventing the inclusion of patented drugs in the lists of generics periodically issued by the Health Department and will also permit the removal of any such drug that might have been erroneously included in a published list.

The content of this article is intended only to provide general guidelines related to this particular matter. For your specific circumstances, full specialist advise is recommended.