MEXICO Law and Practice Contributed by: Heidi Lindner and Humberto Vega, Arochi & Lindner
2. Generic Market Entry 2.1 Infringing Acts
In Mexico, parallel imports in general are allowed, including in the pharmaceutical sector, as long as the products have been placed on the market for the first time by the patentee or with their consent. 2.2 Regulatory Data and Market Exclusivity In Mexico, data exclusivity is lightly regulated, with the primary source being international treaties such as the Agreement on Trade-Related Aspects of Intel ‑ lectual Property Rights (TRIPS) and the United States– Mexico–Canada Agreement (USMCA). For example, COFEPRIS has no pre-established procedural mecha ‑ nism to request data protection recognition or to chal ‑ lenge the recognition granted, which means that in most cases, this protection is granted by court order. As such, there is no special regulation for orphan or paediatric drugs. In terms of the aforementioned inter ‑ national treaties, in particular what is established in the USMCA, the Mexican state must grant protection to undisclosed tests or data for a period of not less than five years, provided that such information is a condition to prove the security and efficacy of the drug for the granting of the respective MA and it refers to a new chemical entity that has not previously been approved, which involves considerable effort. New indications have also been afforded Regulatory Data Protection (RDP) in various court cases. There is no clear regulation in Mexico, so there are no specific deadlines to request and obtain data protec ‑ tion recognition. As mentioned, to obtain protection of undisclosed data in Mexico, it is commonly nec ‑ essary to initiate strategic litigation with the purpose of compelling the health authority to grant protection in compliance with the international treaties signed by Mexico. This type of litigation can take up to 18 months. Data exclusivity for variations in the formulation of the product or for new indications is mainly obtained through strategic litigation, which is not public and, therefore, not visible to third parties. Thus, it is com ‑ plicated and uncommon for third parties to chal ‑ lenge said protection in a timely manner. In any case, a challenge to official data exclusivity recognition would have to be done through a federal contentious trial before the TFJA, or if said protection was previ ‑
In Mexico, the acts that enable the owner of a patent to file an infringement action in relation to pharmaceu ‑ tical products, whether small molecules or biologics, include: • the importation of the patented product or the basic components necessary for its production; • the offer for sale of the pharmaceutical product, both in the private market and in tender processes; • the granting of MA; • the storage and manufacture of a patented prod ‑ uct; • the circulation or use of products that incorporate a patented invention without the consent of its owner or the respective licence; • the use of patented processes without the consent of the patentee or the respective licence; and • the offer for sale or putting products into circulation that are the result of the use of patented process ‑ es, without the consent of the patentee or whoever had a licence of exploitation. It is important to highlight that the rights conferred by a pharmaceutical patent have no effect against those who use, manufacture, offer for sale, or import a prod ‑ uct with a valid patent exclusively to generate tests, information and the experimental production neces ‑ sary to obtain MAs of medicines for human health. Regarding patents for a second medical use, there are no restrictions or special considerations related to them or to labelling in Mexico, as long as the label mentions the patent-free therapeutic indication. According to the LFPPI, an offer for sale general ‑ ly refers to any commercial proposal that makes a product available and is addressed to third parties. In the case of patented pharmaceutical products, this includes the marketing or advertising of the product both in private sales channels and in public tenders. The offer for sale is considered an infringement if the product offered is protected by a valid patent and if the offer is made without the consent of the patentee.
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