Pharmaceutical Patents Mexico
Continuing with Lawyer Monthly’s focus on Pharmaceutical Patents this month, we take a look at Mexico, and the issues surrounding this ever-changing industry there. To this end, we speak to Carlos Pérez De La Sierra, who, after completing his degree from the Universidad Iberoamericana School of Law in 1982, founded the Intellectual Property Law Firm Calderon y De La Sierra, based in Mexico City.
What are the common challenges faced by your clients when involved in pharmaceutical patent infringement and how has/can your firm assist the client when such challenges arise?
The firm only represents pharmaceutical companies which invest in and develop their own drugs for the market, and not generic drug companies which attempt to ‘free ride’ on the discoveries of others. Therefore much of our litigation work is directed to defending the patents of pharmaceutical companies from such generic drugs companies. In Mexico there are a large number of generic drugs companies and therefore we are frequently involved in such cases. The government is often inclined to support companies providing cheaper alternatives to patented drugs and grants sanitary registrations to such companies which infringe on the patent rights of the pharmaceutical companies that we represent. We have therefore been forced to enter into legal procedures with the Health organization in Mexico responsible for the granting of sanitary registrations. In cases such as these, and in other more straightforward litigation cases, we often obtain the expert testimony of a certified specialist in the field in order to strengthen our position and provide the judge with technical information which they will consider reliable. At times we will go as far as to obtain further experimental proof to demonstrate that the infringer is trespassing on the patent which we are defending.
Recent reports show that the number of patents filed by major pharmaceutical companies has dropped dramatically in recent years. Why do you think this is?
The expense associated with the development of a drug is phenomenal, and for each drug that succeeds to the market, there are many which
fail to pass the necessary in vivo tests or to make it to the final stage of clinical trials. Over the past few years major pharmaceutical companies have not been able to maintain the cost of such research and development sites and they have been forced to shut many of them down. This has led to a decrease in drug development and consequently a decrease in the number of drug candidates requiring patent protection.
What will be the effects of this in the Pharmaceutical Industry?
With a reduction in the development of new drugs and with patents of high commercial value approaching their expiry date, companies will be forced into attempting to maintain their monopoly rights over the active compound which they developed using patents which protect the use of their drug or its pharmaceutical composition, rather than the active agent itself. We have handled a number of cases in which we have fought against generic drugs companies marketing drugs containing the active agent of an expired patent by using a patent protecting the pharmaceutical composition of the active agent or its use.
With the changing and fluid nature of trademarks law, how can clients avoid the potential pitfalls? do you foresee the need for legislative change in the next 12-24 months, if so why?
The key to ensure optimum trademark protection in México is to seek and obtain a registration before actual use of the mark takes place in our country. Although trademark rights can result from usage of a mark, enforcement may prove quite complicated and burdensome without a registration. On the other hand, quite needed legislative change has now been triggered by
the adherence of México to the Madrid Protocol. Although yet to be effectively available, the Madrid Protocol will need substantial legislative changes to be properly implemented. For instance, trademark opposition may now finally be introduced into our trademark system. Other issues such as multiple class applications, secondary meaning, a supplementary registry, limited coverage to actual goods / services on which a mark is used may now experience substantive debate towards a major amendment to current Trademark Law in México. LM
carlos Pérez de La Sierra Senior Partner and Founder calderón y de La Sierra y cia., S.c. Paseo de la Reforma 115, 8th floor col. Lomas de chapultepec 11000 Mexico, d.F.
tel: (5255) 5249-8460 Fax: (5255) 2623-1131