MEXICO Law and Practice Contributed by: Heidi Lindner and Humberto Vega, Arochi & Lindner
or biosimilar medicine. Therefore, follow-up regarding the public lists mentioned or a request for Freedom of Information may be necessary to obtain this infor ‑ mation. Finally, it is important to stress that in Mexico the pric ‑ ing and bidding processes for patented medicines, including those with second medical-use patents, are generally not specific regarding the particular thera ‑ peutic indication, although there are some exceptions. Regarding the reimbursement system for medicines, there is no system as such in Mexico; the public pur ‑ chase of medicines is done through bidding or direct awards in the case of patented medicines to satisfy social needs. 3. Biosimilar Market Entry 3.1 Infringing Acts There is no distinction between generic and biosimilar patents in Mexico. 3.2 Data and Regulatory Exclusivity There is no distinction between generics and biosimi ‑ lars in Mexico. 3.3 Acceptable Pre-Launch Preparations In Mexico, there is no distinction between generics and biosimilars. 3.4 Publicly Available Drug and Patent Information There is no distinction between generics and biosimi ‑ lars in this jurisdiction. 3.5 Reimbursement and Pricing/Linkage Markets In Mexico, no distinction is made between generics and biosimilars.
directly attributable to the IMPI and result in more than five years between the filing date of the application in Mexico and the granting of the patent, a Complemen ‑ tary Term Certificate (CTC) may be granted to adjust the product’s validity at the request of the interested party. The main provisions to consider are as follows. • The maximum validity that a CTC may have is five years. • Once the applicant is informed of the admissibility of the patent grant (notice of allowance), they will have two months to submit the CTC application. • The CTC request must demonstrate that the delays in granting the patent are unreasonable and directly attributable to the IMPI. • Along with the CTC application, proof of payment of the corresponding fee, which is set annually by the IMPI, must be submitted (in 2023, the rate was around USD1,600). • When deciding the admissibility of the CTC, the IMPI must do the following: (a) verify that the patent process exceeded five years (otherwise, the petition will be dismissed); (b) if the processing of the patent exceeded this period, the IMPI will determine the period of time that corresponds to the reasonable delays and subtract it from the processing period; (c) if the resulting period is less than five years, the IMPI will reject the request; and (d) if the resulting period is greater than five years, the IMPI will determine the number of days that correspond to an unreasonable delay, which will result in a CTC for one in every two days of unreasonable delay. • Once the IMPI has informed the applicant of the admissibility of the CTC, the applicant has a period of one month to submit proof of payment, which is set annually by the IMPI (in 2023, the rate was around USD177). It is important to keep in mind that CTCs are avail ‑ able for all types of patents. The LFPPI does not dis ‑ tinguish between different products under the same patent, or a product protected by multiple patents. If the previously mentioned requirements are met and the existence of unreasonable delays – directly attrib ‑
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates The LFPPI establishes that when there are unrea ‑ sonable delays in the processing of a patent that are
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