Linkage System for Pharmaceutical Patents
Deadline: DECEMBER 28, 2011
The equivalent to the US Orange Book in Mexico is known as the Linkage Patent System.
This system aims to prevent sanitary registrations for pharmaceutical products that are covered with a valid patent from being granted. The Mexican Patent Office (PTO) publishes an extraordinary Gazette which contains all those valid patents that cover allopathic pharmaceutical products, while the Sanitary Authorities (COFEPRIS) analyzes the published pharmaceutical patents and rejects any application for market approval of patented pharmaceutical products, other than to the patentee or to its recorded licensee. Patent applications cannot be included in the Gazette.
This extraordinary Gazette is published twice a year, generally in early December and late May. The Gazette publishes the name of the patentee, the title of the invention, the most relevant claims, the generic name of the pharmaceutical product, information on the recorded licensee and the validity term of the patent.
Once a given patent is published, COFEPRIS must not grant any sanitary registrations (market approval) to any legal entity other than to the patentee or its recorded licensee.
It must be remarked that process patents are expressly excluded from publication in the Gazette. However, there has been extensive controversy and debate with regard to other types of pharmaceutical patents, as the Mexican PTO has refused to publish patents covering pharmaceutical compositions, second use patents and other forms of patent protection for pharmaceutical products such as dosage patents.
The Mexican PTO sustains that the linkage system must be limited to patents covering an active ingredient. Contrary to this position, the Federal Courts have consistently ruled against it and have ordered the Mexican PTO to publish patents covering pharmaceutical compositions, second use patents and even dosage patents. The Supreme Court has also addressed this issue and has rendered a decision that resulted from a contradiction raised from two contradictory decisions issued by the Collegiate Courts. This decision by the Supreme Court has been widely questioned as it failed to resolve the controversy clearly, although a majority would interpret the same to mandate publication of all pharmaceutical patents, with the exception of process patents.
The most effective legal remedy against the non-publication of a given patent in the extraordinary Gazette is the Amparo Procedure and it must be filed before the non-extendable deadline of December 28, 2011 with regard to the latest extraordinary Gazette, which was published on December 7, 2011. Therefore, if you would like to ensure that no sanitary registrations or market approvals are granted for a product covered by any of your valid patents, click here to access the electronic version of the Gazette and determine if the given pharmaceutical patent has or has not been published.
We will be very pleased to provide any further information and to actively assist you on how to effectively enforce the linkage system with regard to not active ingredient patents, at your request.