Recently (April 17, 2019) the European Parliament has approved the amendment of the Regulation 469/2009 on Supplementary Protection Certificates (SPC) by including the so-called “Manufacturing waiver“.
SPCs intend to compensate the time lapse between the patent application and the granting of the marketing authorization of a product protected by said patent. This compensation can be up to 5 years and takes effect once the basic patent has expired. The modification as approved intends to exclude from the protection under SPC the manufacture of a product with the aim of exporting to countries outside the European Union (EU) where a SPC was not filed or has expired.
This amendment is of utmost importance for manufacturers of generic or biosimilar products since so far it was not possible for an EU manufacturer to manufacture medicines protected under SPC with the aim of exporting that product to a third country in which said protection under SPC did not exist or had expired. Obviously, this prevented the immediate commercialization of these generic and biosimilar products in these territories, involving thereby a significant economic disadvantage with respect to manufacturers from third countries in which protection under SPC was non-existent or had expired. For the purpose of implementing this exemption, the manufacturer must inform the holder of the SPC and the competent authorities of such intention of manufacturing for export purposes at least 3 months before said act, in addition to identify that the product is manufactured solely for this purpose.
According to previous studies prepared by the European Commission it is expected that this will have a significant economic impact that will result in more jobs, savings in the healthcare system and additional sales of active pharmaceutical ingredients.
The regulation will enter into force 20 days after it is published in the Official Journal of the European Union.
Article by Rafa Moreno.