Regulation 2019/933 was signed by the European Parliament and the Council on May 20, 2019.
The relevant amendments
The amendments to Regulation 2009/469 have introduced a derogation from the protection given by the SPC for specific operations. Specifically, manufacturers of a product, or of a medicine, containing that product, that are established in a Member State, will be allowed to produce a generic or biosimilar medicinal product which is still covered by the SPC, for the sole purpose of export to third States in which the patent protection is non-existent or has expired. At the same time, they will be allowed to carry out any operation that is strictly necessary for its manufacture in the EU for export purposes, or for carrying out the export.
Secondly, the above-mentioned subjects will be able to start the manufacturing of the generic or biosimilar version of a medicine with the purpose of storing it in the Member State where it is manufactured, for the six months before the expiry of the SPC. In this way, manufacturers will be able to place the product on the markets of Member States as soon as the validity of the SPC has expired, making themselves more competitive in relation to those pharmaceutical companies that are located in third Countries. This provision was added to the proposal for Regulation 2019/933 which was submitted by the European Commission on May 28, 2018, and it embraces the suggestions made by generic and biosimilar manufacturers. Even in this case, the conduct for the manufacture of, and storage operations for, are permitted provided that these activities are carried out within the six months before the expiry date of the SPC.
Regulation 2019/933 introduces obligations for manufacturers, which are requirements for the legitimation of those operations. Specifically, the manufacturer has to notify the competent industrial property office of the Member State in which the manufacture will be undertaken, and must communicate to the owner of the SPC the information that is listed in paragraph 5 of the amended Article 5 of Regulation 469/2009, in accordance with Regulation 2019/933, i.e., the name and address of the manufacturer and the indication of the exclusive export/storage manufacturing purpose. Such information shall be communicated no later than three months before the expiry date of the SPC.
The manufacturer shall also affix a specific logo, a sample of which is attached to Annex I of Regulation 2019/933, in a visible manner, on the external packaging of the products that have to be exported.
The purpose of Regulation 2019/933: general remarks
As illustrated in the Recitals to Regulation 2019/933, the amendments to the SPC legal framework that limit the exclusive right which is recognized as that of the SPC’s owners, have the purpose “[of] promot[ing]the competitiveness of the Union, thereby enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions” (Recital 8).
For this reason, there has been am aim to reach a balance between the safeguarding of exclusive rights and the alignment of the trading conditions of the manufacturer operating in UE and those who operate in third states, in which the patent has expired and thus the SPC does not apply.
Specifically, by enabling the production of generic and biosimilar medicines for the purpose of export during the SPC’s period of validity, the European legislator aims to encourage investments in this specific sector. At the same time, the possibility of producing a generic or biosimilar version of a medical product in the six months before the expiry date of the SPC have a double purpose: to render the EU-based manufacturer more competitive in comparison to third country-based pharmaceutical companies, and to increase competition within the pharmaceutical market in order to facilitate the faster and more economically efficient access to medicine for EU patients.
The transitional period
The regulatory provisions laid down in Regulation 2019/933 will be effective for those certificates that are applied for on or after July 1, 2019.
The only exception relates to those certificates that are applied for before July 1, 2019 and that will take effect on or after this date. In such a case, the provisions contained in Regulation 2019/933 shall apply to such certificates from July 2, 2022.
Regulation 2019/933 cannot apply to certificates that take effect before July 1, 2019.