In their constant efforts to assert Industrial Property protection, R&D-based pharmaceutical companies face several challenges through their subsidiaries in Mexico.
It is well known that the Mexican "linkage system" has helped to improve the communication network between both the Mexican Health and Industrial Property authorities by amending their respective Regulations, in order to prevent the issuance of health registration approvals for generic versions from medicaments still covered by valid patents.
Despite these relevant changes in the health and industrial property sectors, the situation has been just partly resolved to the R&D-based pharmaceutical industry. In solving certain issues, problems of other kinds arose. Particularly, the Mexican public institutions in charge of social security have misunderstood the real spirit of the linkage scheme, and regarding to government medicament purchases, they have made their bidding process available to the public in general instead of proceeding with a direct adjudication when the medicaments in question are covered by patents still in force.. In addition, the Mexican Institute of Industrial Property (IMPI) only publishes, the patents referred to the active substance or drug in the corresponding Special Edition of the Industrial Property Gazette, and it is excluding the formulation/composition patents or the new use patents, among others.
Another interesting aspect is that since the linkage scheme was enacted, the R&D-based pharmaceutical companies have been requesting the publication of every one of their patents, provided that they comply with the linkage requirements. This request has come, either from their main offices, or through their Mexican subsidiaries. In this context, we have found that there is a lack of communication between the R&D-based companies and their Mexican subsidiaries. In most of the cases Mexican subsidiaries do not know which medicaments are being protected by a patent, or which is the number of the Mexican patents covering a certain medicament.
When facing this situation, the Mexican subsidiaries call their patent attorneys for advice. However, giving counsel may become a difficult task because sometimes, as it is already mentioned, they do not have sufficient information regarding the medicament at issue. Normally they have only the name of the active substance (generic denomination) and/or the name of its registered mark (TM). This makes more difficult to know if there is one or more patents protecting this medicament..
Despite the complexity this lack of information represents, an expert in Intellectual Property matters is able to gather all the information he needs to know whether a medicament is patented or not, just with its generic denomination and/or Trademark, by performing a search of information.
Most of the time, searches provide information in a fast and trouble-free manner. When searches happen to be complicated, it is necessary to review and analyze several foreign patent documents prior to determine if the equivalent application was filed in Mexico. In addition, when one looks for the title of the invention, it may be that different foreign applications and their respective Mexican equivalents cover the same active substance, . Therefore, it is also necessary to analyze the set of claims of each Mexican equivalent, ruling out those referred to a process.
This analysis generally involves comparing the chemical structures and names of the substance in order to determine if the compound claimed in the Mexican patent document corresponds with the active substance being considered. If this is the case, the company is now in condition to request the inclusion of the Mexican patent in the Special Edition of the Industrial Property Gazette issued by the IMPI, according to the linkage system.
As it may be read from the above, even when the information is almost null, it is possible to find a Mexican patent or pending patent application covering a medicament, provided that such application has been filed in Mexico.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.