Establishing a unitary SPC is one of the recommendations of the study carried out by the Max Planck Institute for Innovation and Competition for the European Commission. Either an (existing or a future) EU authority or the European Patent Office can be charged with granting these unitary SPCs.

According to the study, the choice between an EU authority and the EPO is a matter of policy that is up to the legislature. ‘However, one important aspect to consider is that if an EU authority is put in charge, appeals must be directed to the General Court, whereas in the case of the EPO being mandated, it would be possible to direct appeals to the UPC [Unified Patent Court, ed], thus consolidating jurisdiction for the grant of (unitary) SPCs as well as for infringement and validity in the same forum.’

Although the first option is more easily implemented, the second option ‘appears preferable from the point of view of expertise and consistency of the system’, according to the researchers. ‘The majority of the stakeholders consulted in the Study favoured a system in which (i) a team of experts from the NPOs (virtual office or virtual Unitary SPC Division) examines the application and grants the certificate, and (ii) the UPC hears appeals lodged against decisions rejecting the application.’

‘In addition to creating a unitary SPC system, we recommend that guidelines in the form of soft law as well as implementing regulations (to be issued by the European Commission) be developed in order to bolster the evolution of consistent and transparent practice in the Unitary SPC Division and the national offices.’

Concerning the language regime, the study points out that: ‘As the purpose of the legislation is to create a unitary title, account must be taken of Art. 218 TFEU, including the unanimity requirement of Art. 218(2) TFEU with regard to languages. This may require that the prerequisites of enhanced cooperation have to be observed anew.’

The study furthermore recommends creating a unitary SPC with dynamic territorial scope. It is ‘feasible, in accordance with proposals advanced by stakeholders, to grant a unitary SPC on the basis of a bundle of national MAs [market authorizations], with its territorial scope being restricted accordingly. Within this model two options are explored: the option of an SPC with static territorial scope that could be combined with national SPCs; and the option of a unitary SPC with a dynamic territorial scope that could extend to any other Member State where an MA is granted before the expiration date of the patent.

In the field of plant protection products for which no Union authorisation is available, the model of a unitary right with dynamic territorial scope is clearly recommended. With respect to medicinal products, the choice is less obvious. In most cases it will be possible for the applicant to make use of the centralised procedure. For the remaining cases it may be acceptable to resort to a bundle of national SPCs.’

The option for creating a manufacturing waiver for SPCs, also discussed in the Max Planck study, was the issue of this and this post on the Kluwer Patent Blog.

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  1. I agree with the MPI. It is time to get rid of national IP rights in favor of European solutions and this proposal goes into this direction. Very offtopic, but sometimes I wonder how the IP world were if the WIPO could grant “World Patents” (often requested by ambitious individuals who made their first invention) and correponding SPCs for all designated countries.

  2. Question: what is a “Unitary” SPC with a “dynamic territorial scope”. If it is unitary, why should it have a variable territorial scope? The explanations given are not convincing. It looks as it would best suit “stakeholders”, that is pharmaceutical companies, but this is not a reason good enough for such a choice. It is for the legislator to impose his views, not the other way round.

    When reading about a unitary SPC with a dynamic territorial scope a question appears: should for the same token national prior rights under the UPC as well be of dynamic scope? That would probably be in the interest of the stakeholders, i.e. the big European and non-European industry. But shall we then still have a “unitary patent”?

    The important question of a Unitary SPC for EU member states should be left to an EU institution. As the Unitary SPC is linked directly with an MA authorisation why not use the EMA as unitary granting authority?

    If the Unitary SPC should be granted by “a team of experts from the NPOs (virtual office or virtual Unitary SPC Division)” it is difficult to see what role should be devolved to the EPO, as SPC are not a field covered by the EPC, cf. Art 1 EPC. At least the EPC should then be amended.

    If it is in order to at one point involve the UPC, then another reason should be found. But the UPC will always have the drawback as not being a court common to all EU member states but only for some.

    As far as enforcement/validity is concerned, it does not seem that the present situation where the final questions are discussed at the CJEU is prejudicial to the system, or are the stakeholder dissatisfied with the opinions of the AG, and would like to short circuit it?

    On a political level, the EPO is not an EU institution it should thus not play an even more important role within the EU. It does not have the expertise required. If necessary a technical opinion in the meaning of Art 25 EPC, or something similar could be established. That should suffice.

    And the UPC must first show that it is up to the expectations before loading it upfront with further competences.

    The MPI study looks quite impressive, but is it also convincing? Doubts are authorised and they should not to be whisked away, but thoroughly discussed in an open manner.

    Techrights: FINGERS OFF!!!

  3. Interesting. The new EU institution looks by far the better bet… not least because it would require far less “tinkering” with new / modified (international) agreements. Also, it would avoid that awkward question arising about whether the fact that the EPO operates outside of EU laws (meaning, in particular, that it is in no way beholden to / controlled by EU legislation and courts) is a bit of a non-starter for an organisation seeking to grant / refuse rights that are solely a creature of EU law.

    Aside from doubts over (possibly) shaky legal basis for it, I have practical concerns about the EPO’s proposed involvement in SPCs.

    The first of my practical concerns is the loss of (SPC-examining) expertise that currently resides in the national offices. The EPO has ZERO expertise in examining SPCs, and it is hard to imagine that many, if any, national examiners having useful SPC expertise would be keen to move to Munich and sign up as EPO employees.

    My second concern is that the EPO would presumably be unable to examine SPC applications based upon national (as opposed to EP) patents, meaning that the examination system would become fragmented… to the detriment of quality (gained through regular exposure to SPC cases) at the national offices and courts.

    Thus, getting the EPO involved would likely lead to a new SPC-examining system that has both a shaky legal basis and very little in the way of experience / expertise. It could also have a detrimental effect upon the current system for examining SPCs based upon national patents. From this perspective, the EPO’s involvement in SPCs does not look like the best of ideas.

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