Generics companies will soon be able to manufacture SPC-protected drugs for export outside the EU under new manufacturing waiver provisions. In the last six months of the SPC lifetime, it will also be allowable to manufacture generics for stockpiling for “day one” entry to the European market after the SPC expires.
Following approval by the European parliament, an SPC manufacturing waiver will be introduced to European Union law. Regulation (EU) 2019/933 was published in the Official Journal of the European Union on 11th June 2019. The Regulation will have direct effect across all Member States from the 20th day following publication, i.e. 1st July 2019.
Supplementary Protection Certificates (SPCs) are a form of protection in the EU used to extend the market exclusivity provided by a patent for up to five years for medicinal products. SPCs seek to compensate for the time lost between filing a patent application and gaining market authorisation. Currently, an SPC provides similar protection to that granted by the patent on which it is based.
The new EU Regulation seeks to curtail the effect of an SPC to some extent by ending protection against the manufacturing of any active ingredients protected by the SPC and of any corresponding medicinal products, so long as these are manufactured (i) for export to countries outside the EU, or (ii) for the purpose of stockpiling for “day one” entry to the EU market immediately after the SPC expires. The latter of these purposes will only be allowed in the final six months before expiry the SPC, whereas manufacture for export outside the EU will be allowed throughout the lifetime. The SPC holder must be directly informed three months prior to any activity that is taking advantage of this manufacturing waiver. National patent offices must also be notified and will be required to publish information relating to any such notifications.
The manufacturing waiver will apply to all new SPCs filed on or after 1 July 2019. An SPC already in effect by 1 July 2019 will not be affected by this waiver; however, for SPCs filed before 1 July 2019 but that are not yet in effect by this date, the manufacturing waiver will initially not apply but will become applicable three years after the waiver enters into force, i.e. July 2022.
If this Regulation may be relevant to a company’s business activities, it is important to remember that an SPC comes into effect immediately following expiry of the patent on which it is based; if a patent expires before 30 June 2019, the SPC will come into effect before 1 July 2019 and the manufacturing waiver will not apply. Where possible, new SPC applications should be filed before 30 June 2019 in order to benefit from the three year transitional period.
Finally, the Regulation requires the European Commission to evaluate the manufacturing waiver by 1 July 2024 and then every five year thereafter in order to assess the impact of the provisions. It is therefore possible that, for example, the six month period for stockpiling for “day one” entry to the European market may be extended if this is found to be an inadequate period.