In April 2022 the Industrial Property Office of Portugal has published the first notifications under the Regulation (EU) 2019/933 that introduced the “manufacturing and export waiver” concerning supplementary protection certificates (SPC).
The Regulation (EU) 2019/933 amended Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products to introduce a manufacturing and stockpiling waiver for EU-based generic and biosimilar manufacturers.
The waiver to SPC
The rational behind the waiver is explained by the European Commission proposal. The protection of SPC since 1992 has had the unintended consequence of preventing makers of generics and biosimilars established in the Union from manufacturing or storing those products in the Union, even for the purpose of export to third-country markets in which protection does not exist or has expired.
Those circumstances make it more difficult for those EU manufacturers, in contrast to the manufacturers in third countries where protection does not exist or has expired, to enter the Union market immediately after expiry of the certificate, given that they are not in a position to build up production capacity for the purpose of export or for the purpose of entering the market of a Member State until the protection provided by that certificate has expired.
Acts covered by the waiver
A SPC still confers the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. However in derogation to this rule an SPC will not be infringed by:
- the making of a product, or a medicinal product containing that product, for the purpose of export to outside the EU; or
- the making, no earlier than 6 months before the expiry of the SPC, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate;
- any related act that is strictly necessary for the above purposes provided that such related act is carried out no earlier than 6 months before the expiry of the SPC.
Notification and information requirements
The waiver Regulation requires the manufacturer to notify the national Patent Office in the country where the product will be made and informs the SPC holder no later than 3 months before the start date of the making or related acts (e.g. importing ingredients for manufacturing).
The notification that should be published by the Patent Office follows a standard form containing the following:
- the name and address of the maker;
- an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;
- the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place;
- the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and
- for medicinal products to be exported to third countries, the reference number of the marketing authorization, or the equivalent of such authorization, in each third country of export, as soon as it is publicly available.
SPCs covered by waiver
The waiver Regulation entered into force on 1 July 2019. However it is not surprising that notifications to the PTO have started only now since not all SPCs were immediately covered by the waiver.
The waiver applies to all SPCs that were applied for after 1 July 2019. The waiver does not cover SPCs that were granted and came into effect before 1 July 2019. SPCs that were granted before 1 July 2019 but came into effect after that date, will benefit from a transitional period since the waiver only applies to them after 2 July 2022.