Relevant decision on patent validity and compensation

By Dumont

A decision from the Supreme Court of Justice of the Nation (SCJN) allowed a 3-year extension for Sorafenib, a patent registered by German pharmaceutical Bayer.

The Court upheld an amparo action filed by Bayer in 2019 against the Mexican Institute of Industrial Property (IMPI), by which the company requested the compensation of the time of patent protection lost due to IMPI’s administrative delay in the registration of Sorafenib.

"In order to comply with the rights of legal certainty and access to an impartial justice, an extension of the period of protection should be foreseen in order to compensate for delays originated in administrative procedures for the approval of a patent," the SCJN states in its ruling.

The decision was highly criticized by the Mexican generics industry, which described it as a “negative precedent” that brings legal uncertainty for pharmaceutical companies producing generic drugs and discourages investment throughout the country.
The Court’s ruling was supported by the recently signed United States-Mexico-Canada Agreement (USMCA), which specifies that a Party shall provide adjustment of the term of a patent to compensate for Patent Office delays in issuing patents. Patent term adjustment may accrue if a patent issues more than five years from the date the application is filed, or three years after examination is requested, whichever is later.

Sorafenib (co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar), is a kinase inhibitor drug approved for the treatment of primary kidney cancer, advanced primary liver cancer and radioactive iodine resistant advanced thyroid carcinoma.
The decision extends Sorafenib’s protection in Mexico until January 12, 2023. In a press release, Bayer Mexico welcomed the criteria established by the Court to grant compensation for the time lost in the patent's registration.

“With strict adherence to national and international laws, Bayer Mexico reiterates its trust in public institutions and confirms that this decision, in addition to providing legal certainty to pharmaceutical innovation, strengthens the right to health of the Mexican population, since it contributes to accelerate access to new treatment alternatives for the benefit of patients who require them for the improvement of their health and quality of life,” Bayer’s statement says.

Based on the Court’s ruling, Bayer has requested a new amparo action to extend the protection for its patent Rivaroxaban, an anticoagulant medication used to treat and prevent blood clots.