In May 2018, the European Commission proposed a regulation to create an “export manufacturing waiver” relating to SPCs for medicinal products, with the objective of promoting the European generics and biosimilars industry. This regulation is now on its way to being adopted by the European Parliament, following a series of amendments. In short, the waiver provides an exception to infringement of the SPC in certain defined situations where the drug is either for export outside of Europe or the SPC is going to expire imminently.
The European institutions have now agreed a single draft text for such a waiver which is now expected to pass the final legislative steps in the next few months. To put it in the European Parliament’s favoured train analogy, the train has departed and is on its way to arrival in April 2019.
The proposed waiver
The proposed waiver would allow generics and biosimilar manufacturers (“makers”) to manufacture medicines, which are protected by an SPC, for exporting them to markets outside the European Economic Area (EEA) where protection does not exist or has expired.
In addition, the waiver will allow makers to make and stockpile medicines that are protected by an SPC in the member states, thus allowing them to launch the product in the EEA on the day after expiry of the SPC. Making and stockpiling for use inside the EEA will be allowed during the six months before expiry of the SPC.
The suggested waiver includes a number of safeguards which aim to protect the SPC holders’ rights. Makers will be required to notify both the competent SPC granting authorities as well as the SPC holder of their intention to manufacture under the waiver. Interestingly, the notification needs to contain only information which is “necessary and appropriate for the certificate holder to assess whether the rights conferred by the certificate are being respected”. Confidential or commercially sensitive information does not need to be provided.
Makers are further put under an obligation to inform those in its supply chain that the product is covered by an SPC and that it is intended for export to non-EU markets or stockpiling only. A maker who does not comply with this requirement cannot benefit from the exception.
Another safeguard the proposal envisions is that any medicines produced under the waiver are labelled with an EU export logo to show that the medicines are for export only. This logo needs to be affixed to the outer packaging and, where feasible, to its immediate packaging. In addition, makers are required to ensure that the medicine does not bear the active unique identifier required to market the medicine in the EU.
Which SPCs will the waiver apply to?
An earlier draft of the regulation provided for the application of the waiver to all SPCs granted three months after its envisaged entry into force, which led to concerns that patent office delays in granting SPCs may affect those SPCs covered by the waiver. The latest draft deviates from this earlier proposal and states that the manufacturing waiver will apply to:
- All SPCs which are applied for on or after the entry into force of the waiver regulation, and
- After 1st July 2022, to all SPCs which were applied for before the waiver regulation came into force and which take effect on or after the date of entry into force of the waiver regulation.
Therefore, we expect the waiver to become applicable to many SPCs over the next few years, should the waiver regulation come into force.
The European Parliament is expected to adopt the proposal by April 2019 with the waiver regulation likely to come into effect shortly thereafter, possibly as early as summer 2019.
 The European Economic Area is made up of the 28 EU states plus Iceland, Liechtenstein and Norway.