Boosting Accessibility to Drug Patents for Production of Generics

The Mexican Institute of Industrial Property (IMPI) has worked to modernize procedures and move them from in-person to digital, with the goal of providing greater transparency, agility and confidence to the user. It has implemented platforms that allow the user to file a patent or a trademark digitally, which has benefited industrial property professionals and users, especially during the health crisis, so as not to interrupt industrial property management.

With these modifications and as a consequence of the publication on July 1 of the Federal Law of Industrial Property Protection (LFPPI), implemented on Nov. 5, 2020, IMPI, with the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), has implemented digital platforms that have eased procedures to allow a competitive generics market by providing greater accessibility to patent documents related to active ingredients for pharmaceutical use.

These platforms include the “Search Engine of Patents Related to Medicines,” with which IMPI provides access to the patents in force associated with the main ingredients that could be of interest to generics manufacturers. This allows users to view, relatively easily, the patents that will expire in the next 10 years and the different types of patents that could be related to the active ingredient (pharmaceutical composition, active ingredient, pharmaceutical use, for example.) The information provided is considered to be complementary to that which is published in the GAZETTE set forth by article 162 of the LFPPI, which states that IMPI will publish, at least every six months, a listing of patents related to inventions likely to be used in allopathic drugs.

With the information on the platform and in the GAZETTE, a generics manufacturer would have the knowledge that should be considered to avoid breaching the rights granted to the patent’s holders.

However, users should take note of the notice from last August, titled “Rules for the Production of Generic Drugs for the Benefit of the Population,” in addition to noting the elimination of the Bolar provision, wherein the elimination is supported by article 75 of LFPPI, in which the waiting times for a manufacturer to use, manufacture, offer for sale or import a product are eliminated exclusively for generating tests, information and experimental production that allows them to bear security, quality and effectiveness for obtaining a sanitary registration. 

On the other hand, this same notice states that second-use patents will not be allowed, which refers to a therapeutic indication. Confusion arises from this consideration because the IMPI search engine results and the gazette of patents related to the drugs do not exclude them. Therefore, a breach of the pharmaceutical second-use patent’s holders is generated, although it is granted in the LFPPI, in addition to being considered within the free trade agreement between the US, Mexico and Canada (USMCA[CN1] ).

The second tool that is available from IMPI to generics manufacturers is the platform “Response to COFEPRIS Patents,” which stores the responses that IMPI has sent to COFEPRIS as part of the existing bonding system (Linkage) between COFEPRIS and IMPI for assessing the possible breaches of a sanitary risk application with regard to a drug’s patents in force. This system seeks as much to provide certainty for the generics manufacturer’s investment as to provide certainty for the patent’s holders.

With these two tools, IMPI seeks to ease access to information regarding patents related to allopathic drugs and encourage the entrance of generic products.

IMPI believes that these actions, in concert with COFEPRIS, such as the bonding mechanism (Linkage), the elimination of the Bolar provision and the new search engine for patents related to drugs, will bolster cooperation among these institutions. This allows the authorities to have an accurate search platform to provide a concrete response and provide companies interested in obtaining a sanitary registration with information that allows them to perform the analysis of that information. In turn, they can plan with greater clarity and transparency their business strategies to deliver a generic pharmaceutical product once a patent’s term expires.

Together, these actions provide a new dynamic for the pharmaceutical industry with the expectation that industrial property is used as a tool for growth and not as a barrier.