On 11 June 2019, Regulation (EU) 2019/933 was published in the Official Journal of the European Union (available here). This amends Regulation (EC) No 469/2009 (the “SPC Regulation”) by excluding certain acts from the protection conferred by a Supplementary Protection Certificate (SPC).
The new Regulation allows makers of generics and biosimilars established in the European Union (EU) to:
- manufacture in the EU an SPC protected product for the purpose of export to third countries in which protection does not exists or has expired, and/or
- manufacture an SPC protected product during the final six months before expiry of the SPC for the purpose of storing it in the Member State of manufacture, in order to place that product on the UE market upon expiry of the corresponding SPC (“EU day-one entry”).
This waiver also extends to related acts strictly necessary for that manufacture or for the actual export or actual storing, such as possessing, offering to supply, supplying, importing, using or synthesizing an active ingredient for the purpose of making a medicinal product, or temporary storing or advertising for the exclusive purpose of export to third countries.
In order to benefit from the waiver, the makers of generics or biosimilars must:
(i) notify the competent industrial property office of the Member State in which the manufacture is to take place, and inform the SPC holder, of their intention to manufacture a generic or biosimilar version of the protected product, no later than three months before the start date of the manufacture in that Member State or no later than three months before the first related act prior to that manufacture,
(ii) where the product is made for the purpose of export to third countries, ensure that the specific EU export logo is affixed to the outer packaging of the product and, where feasible, to its immediate packaging, and
(iii) ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who performs acts falling under the waiver is fully informed and aware that acts other than those covered by the waiver could infringe the SPC.
The new Regulation will enter into force on 1 July 2019 and will immediately apply to SPCs applied for on or after 1 July 2019. It will not apply to SPCs that have already taken effect before 1 July 2019. For SPCs filed before 1 July 2019 but that have not taken effect by that date, the waiver will only apply from 2 July 2022.
Agreement between European Parliament and Council on Commission proposal to introduce an export and stockpiling waiver to SPC legislation was previously reported here