MEXICO Law and Practice Contributed by: Heidi Lindner and Humberto Vega, Arochi & Lindner
ously obtained via judicial mandate, it would have to be done through an Amparo trial as an extraordinary means of defence. In this scenario, the health author ‑ ity becomes the defendant, and the owner of the test data protection becomes the interested third party. 2.3 Acceptable Pre-Launch Preparations The use, manufacture, offering for sale, and import of a patented invention will be permitted as long as said activities are carried out exclusively to generate tests, information, and the experimental production neces ‑ sary to obtain medicinal MA. It is important to mention that in terms of the new LFPPI, the Bolar clause is not limited time-wise. However, the Regulation of Health Supplies establish ‑ es a Bolar period of three years for generic medicines and eight years for biosimilar medicines. Even though the LFPPI is more recent and has a superior normative hierarchy, the health authority (COFEPRIS) has been applying the three- and eight-year restrictions of the Bolar Exemption. 2.4 Publicly Available Drug and Patent Information In Mexico there is no “Orange Book” per se through which the health authority publishes relevant informa ‑ tion on approved reference medicines, the status of the respective patents, or data exclusivity. The closest equivalent to an “Orange Book” is a gazette of pharmaceutical patents that must be taken into account within the linkage process when request ‑ ing MAs for medicines. As established by the appli ‑ cable regulations, this list should only include those patents with an active substance or ingredient. How ‑ ever, this list also includes composition and formula ‑ tion patents by virtue of a binding precedent issued by the Supreme Court of Justice. Second-use patents have recently been included in this list. Process pat ‑ ents are excluded. Despite the above, it is a regular practice of the IMPI, when linking, to analyse all the pharmaceutical pat ‑ ents related to the medicine that is the subject of the application for an MA, without limiting itself to those patents published in the aforementioned gazette.
In Mexico, the health authority periodically publishes information on MA applications for medicines. These publications are made approximately every month, aimed at providing transparency and public access to general information about the applications in process. In addition, the health authority, approximately every month, publishes a list of granted MAs. This means that general information for both MA applications and MAs already granted is available to the public, facilitating the monitoring of and consultation using this information, without the need to establish special monitoring in the jurisdiction, or to make requests for freedom of information. Only the generic name of the medicine, its pharma ‑ ceutical form, as well as the name of the applicant are disclosed in these public lists. If more details about the application or the medication are required, it is neces ‑ sary to formally request access to this information; however, information such as the qualitative–quanti ‑ tative formula, indications, etc, is usually confidential, and cannot be disclosed to third parties. Finally, it is necessary to point out that, in practice, there is no difference in the treatment of the linkage and the Bolar clause between generic and biosimilar medicines, even though the Regulation of Health Sup ‑ plies expressly provides for the linkage of generics, and omits biosimilars. 2.5 Reimbursement and Pricing/Linkage Markets In Mexico, the reimbursement system does not exist as such. According to the Law on Acquisitions, Leas ‑ ing and Services of the Public Sector, direct awards are made for patented medicines. This means that the patentee has greater freedom to set the price of their products, especially since the Co-ordinating Com ‑ mission for the Negotiation of Medicines and Health Supplies Prices ceased operating in 2018. However, the price may be subject to a market analysis by the corresponding agency in the case of tenders. On the other hand, the relevant list in Mexico is the National Compendium of Health Supplies, which is public and accessible through the General Health Council. The owner of the MA of the reference prod ‑ uct is not notified about an application for a generic
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