Last summer, the European Commission announced a legal study into the workings of the supplementary protection certificate (SPC) system, as proposed in the tender documents here. As part of this study, a workshop was held to discuss the issues facing the SPC Regulation to review the current situation and possible options for change. The workshop in Munich was arranged by the Max Planck Institute, who are currently completing the study, and it was well attended by a wide range of representatives from industry, private practice and the patent offices (including Matthew Georgiou and David Holland from Carpmaels). The day included a wide-ranging discussion of possible changes to the SPC system, which included a number of concrete proposals.
The workshop confirmed that there continues to be enthusiasm for establishing a unitary SPC (uSPC) to work hand in hand with a Unitary Patent (UP, see our guidance here). This uSPC system is seen as a logical extension of the UP system with the aim of reducing duplicated administration and costs for all parties. Like UPs, uSPCs would fall under the exclusive jurisdiction of the Unified Patent Court (UPC), so are unlikely to be a popular choice initially given the unknowns associated with the UPC. Unlike UPs, the uSPC system might not operate with a fixed geographical scope (the so-called “partial uSPC” option) to allow uSPCs to expand in geographical scope as national marketing authorizations are granted. This would allow uSPCs to be granted based on national marketing authorizations, rather than restricting uSPCs to medicinal products authorised via the centralized route provided by the European Medicines Agency.
The question of who would grant the uSPCs and from where the examiners would be drawn was discussed at length during the workshop. It was suggested that the grant of uSPCs might be entrusted to the European Patent Office (EPO) or to a “virtual” office of examiners drawn from the national patent offices. Both of these options attracted considerable support from parts of the audience. At present, the EPO has no involvement in SPCs, but it will soon play a part in the new UP system. The virtual office was first suggested by a group of industry bodies in a joint proposal. The examiners would remain in their national patent offices and work together remotely to examine uSPC applications. The proposal suggests that refusals should be appealable to the UPC as a court of first instance, which would also permit a further appeal to the UPC Court of Appeal and then a final appeal to the Court of Justice of the European Union (CJEU) – mirroring the tiered appeal process in the UK at present. Discussions about the uSPC system are still at an early stage, so this development is likely still several years away. In the meantime, discussions at the workshop confirmed that the current national SPC route will likely remain open for UPs, so one UP could fragment into a number of national SPCs (applied for nationally, as we do today).
A second initiative discussed in detail was some form of manufacturing or export waiver for generics to manufacture in a country where an SPC is still in force, provided the product is going to be sold only in a different state where there is no pending protection. The European Parliament is apparently keen on this proposal, based on research which suggested that generic manufacturers based in the EU are currently late to market for certain valuable non-EU markets. Of course, that raises the question of how this waiver will be policed to avoid sale in the EU countries where there is still SPC protection, which is likely to be a major topic for debate as the legislation is drafted.
On the procedural side a range of proposals were suggested, including requiring substantive examination in all states and harmonising how examination is carried out in practice. For example, it was suggested that stays for SPC examination could be harmonised, perhaps requiring that SPC applications should be put on hold when there is a relevant EPO opposition or CJEU referral. It was also suggested that there should be mandatory consideration of third party observations, along with harmonised publication requirements to make preparing such observations more straightforward.
The next step in the legal study is a detailed questionnaire, which will shortly be sent to all interested parties (if you are interested in receiving a copy of the questionnaire, please let your normal contact at Carpmaels know). It is likely that the anonymous replies to this questionnaire, along with the pending study into the economic aspects of the SPC Regulation, will feed into the Commission’s thoughts as it looks to update the SPC Regulation for the first time in over 20 years.