Sanitary Registration
Generic Medicaments

In1998 the national market of generics was created in the health sector in Mexico. Since then the industrial rights of some pharmaceutical companies have been infringed. This is the because 'pirate' laboratories manufacture pharmaceuticals even when they are protected by a patent. However, this is not always a case of deliberate patent infringement. Sometimes it is very difficult to tell if a drug has been patented or not.

In order to understand this issue it is important to bear in mind two different issues. These are sanitary registration and interchangeable generic medicaments.

Sanitary Registration

Sanitary registration is issued by the Mexican health authority. This certifies the efficacy and safety of the drug. It is one of several requirements with which pharmaceuticals must comply in order to be sold commercially. This registration is issued without reference to the validity and effect of other laws or the faculties of other governmental dependencies, such as the Mexican Industrial Property Law and the Mexican Institute of Industrial Property (IMPI). This means that the health authority cannot reject the sanitary registration of any pharmaceutical to any laboratory, provided that the drug satisfies certain health requirements. Unfortunately the registration is issued without taking into account whether the pharmaceutical is protected by a patent or a pending patent application.

Generic Medicaments

It is well known that a pharmaceutical product is considered a 'generic medicament' when it is in the public domain, that is, when the patent term has lapsed. After this time any laboratory can manufacture the drug.

Accordingly the health authority issues two publications in the Official Journal. The first is the Interchangeable Generic Medicaments Catalogue, which is periodically reviewed. The other refers to a list of "pharmaceutical drugs likely to be included in the interchangeable generic medicaments catalogue". The drugs listed in this second publication are not protected by a patent.

If a pharmaceutical appears in the second list and subsequently complies with the biocompatibility tests, it is included in the generic medicaments catalogue. As a result of this it may be manufactured by any competitor.

Problems in the market of generics arise because the health authorities issue a sanitary registration without taking into account whether the pharmaceutical is protected by a patent or by a pending patent application. There are no appropriate channels of communication between the health authority and the IMPI to check if patent protection exists.

In addition to this the patent titles for pharmaceutical products are based on the chemical name of the drugs and not on the commercial name of the active substances.

A combination of confusing names and poor communications mean that it is neither easy nor quick to determine whether a pharmaceutical product is protected by a patent. As a result of this many patent infringements occur.

For further information on this topic please contact Patricia Becerril or Oscar González-González at Becerril, Coca & Becerril SC by telephone (+525 55 254 0400) or by fax (+525 55 254 5152) or by e-mail ([email protected]).

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