THE MEXICAN LINKAGE SYSTEM
INNOVATIVE DRUGS OR GENERICS?
Two of Mexico’s authorities manage the patent-MA process for patenting drugs, but it is not always a simple matter, as Xavier Hadad reports.
strength and a stronger identity because it integrates two main functions in its structure: ensuring the health of the population in each state or country, and protecting and maximising scientific and technological developments to justify the introduction of a medicine to the population.
O
Ensuring the fundamental rights of inventors to recover the money and time invested in research to invent new products through patents is also necessary. Even so, there have been several problems for companies known to be innovative and the ones that are known for their generic medicines.
Additionally, there is a regulatory process in each country that does not always go hand in hand with the patent system, which makes it necessary to seek amendments to local laws to achieve a safe and effective governance system.
Because a patent provides a temporary monopoly that the state grants a company to exploit an invention and, because of the resulting benefits and special privileges, markets and industries in which such inventions are protected become attractive because of
the excellent economic income that the patent may represent for its owner. 34
ver the course of time, and in an increasingly globalised world, the pharmaceutical industry has gained
Applying this to the pharmaceutical industry, as it is throughout the world, the launch of an innovative drug generates a series of research protocols that reflect the company’s investment in many years of study and research, plus the investment of hundreds of millions of dollars, to come up with an innovative product that allows it to position itself as a leading company.
Te problem is that the investment of years, money and effort to obtain a patentable medicine must necessarily include proof that the medicine is safe and effective.
Even though the readers of this article will be global IP specialists, it may be worth discussing what the expression “safe and effective drug” means in Mexico. Effective means it is used to treat the disease for which it is indicated. Safe means it does not damage or cause side-effects in the patient.
The patent-marketing authorisation issue
In 2003 Mexico introduced a patent-marketing authorisation (MA) linkage system for pharmaceutical products. Tis system involves the collaboration of two Mexican authorities: the Patent and Trademark Office (IMPI) and the Mexican Commission for the Protection against Sanitary Risks (COFEPRIS). Te linkage system requires the IMPI to publish a
World Intellectual Property Review Annual 2014
so-called Linkage Gazette listing all patents granted and valid that cover mainstream drugs.
On the other side, COFEPRIS must study the linkages described in the Gazette and, in relevant cases, deny marketing authorisation for a drug that infringes any of the listed patents. Te regulatory template for this system is provided by two articles: Article 47 Bis of the Regulations of the Industrial Property Law (Mexico), that states the rules for including patents in the Gazette, and Article 167 Bis of the Health Products Regulations which, in turn, provide the patent rules for issuing and obtaining marketing authorisation for new drugs.
www.worldipreview.com
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