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Friday, 15 April 2016

Will a virtual body be granting the future Unitary SPCs?

Somewhere under this umbrella, the AmeriKat
is thinking about Unitary SPCs....
On a bleak Friday afternoon in London, with the rain soaking into her paws and the wind messing with her perfectly coiffured fur coat, the AmeriKat was warmed by receiving an e-mail from Joan Scott of the European Crop Protection Association (ECPA) on one of her favorite topics - Supplementary Protection Certificates (SPCs).  Prompted by her report of Margot Fröhlinger's presentation on outstanding issues in the UPC at this year's Fordham IP conference (see here), which included the need to iron out details on SPCs based on unitary patents, ECPA had this to say:    
"As Margot pointed out, one of the many outstanding issues that still needs to be addressed before the unified patent system comes into force in January 2017, concerns the issue of Unitary Supplementary Protection Certificates (i.e. SPCs based on unitary patents).

When adopting the unitary patent package, no provisions were made as to how to obtain a SPC on the basis of European Patents with unitary effect - unitary patents (UPs).  For the pharmaceutical, crop protection and animal health industries, SPCs are of fundamental importance as they compensate the patent holder for the loss of effective patent term up to the grant of a marketing authorisation. 
While Margot pointed out that the creation of a unitary SPC may be as complicated as the UPC (which took 40 years), others within the pharmaceutical, crop protection and animal health sector are a bit more optimistic at the potential for correcting what seems to have been a major oversight by the legislators.

In June 2015, representatives from the European Crop Protection Association (ECPA), alongside the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation for Animal Health Europe (IFAH-Europe), submitted a Joint Position Paper to the European Commission supporting the concept of unitary SPCs being granted on the basis of a UP.  Adopting a pragmatic approach, the Joint Position Paper proposes ways in which it may be possible to address the issues of unitary SPCs without extensive delays. 
A golden opportunity for harmonization 
The UP creates an unique opportunity for the harmonization of the existing SPC systems of the EU Member States. Missing this opportunity would render the UP unattractive for the whole life sciences industry due to the lack of legal certainty with respect to obtaining valid SPCs. A harmonized SPC with Unitary Effect (SPCUE) could be implemented by amending the current SPC Regulation and could, for example, be granted by a virtual office made up of experts from the national patent offices of the Member States, either as a stand-alone institution or under the umbrella of an EU body such as the EU Intellectual Property Office.
Enforcement of the SPCUE would only be possible in the territory of a Member State for which a valid marketing authorization exists. This would allow for a SPCUE to be granted on the basis of different types of marketing authorizations for both pharmaceutical and agrochemical products.

SPCUE would therefore enhance legal transparency for all parties involved in the system and would greatly boost the prospects of the UP being used by inventors and enterprises. This in itself would foster innovation and industrial development in the European Union.

While discussions about a harmonized SPCUE system are certainly late in the game, ECPA greatly welcomes the European Commission’s commitment to push this topic through not least to provide clarity to all those who rely on the protection of SPCs. Quintessentially, proposals for SPCUEs would be tantamount to 'putting the cherry on top of the cake'. "
If you haven't read the Joint Position Paper, the AmeriKat recommends that you do so.  Annex 1 of the Joint Position Paper details the composition of the intended virtual SPCUE granting body and process for considering applications. Where is the power to set up a virtual body?  Articles 9(1) of the SPC Regulation, of course, which allows Member States to "designate another authority" for the purpose of granting SPCs - so as long as all Member States agree to designate another authority there is no need to wait around.  In summary, the virtual body would partly mirror the UPC panel - three examiners from different national patent offices, with one acting as the principal rapporteur who would decide whether to grant or refuse the SPC application.  The other two examiners would have a limited time to concur or object, with objections being dealt with by a dialogue mechanism until a consensus or majority is reached.  If the SPC application is rejected, an office action would be issued.  If the SPC is refused, an appeal would lie to a court (the UPC) who can refer questions to the CJEU (yay, more references....!).

In the meantime, we will await the output of the Commission's "Study on the legal aspects of the supplementary protection certificates in the EU" (the tender closed in February 2016).

8 comments:

Anonymous said...

Does anyone know who won the Commission's tender for a legal study on SPCs? The Commission's website does not seem to provide any information on the point.

Anonymous said...

This virtual body looks silly. Why not a real body like the EPO, with any appeals being handled by the UPC, but just like appeals against EPO decisions in unitary patent matters.

A basis in the EPC for doing so can easily be found, see Articles 63(4), 143 and 149a(1) EPC. Note that in Article 149a(1) EPC, whatever follows "such as" is non-limiting and can be skipped.

As regards fees and costs, the EPO should get its costs reimbursed, following the principles of Art. 146 EPC. For the remainder, the fee income can be distributed by the EPO among the participating states in the same way as their share in the unitary patent income.

As regards the law to be applied, changing the present SPC regulations will just result in long delays. So, it is better to accept the preset SPC regulations, and to look for any improvements later on.

The above could easily be handled in a relative small amendment of the unitary patent regulation 1257/2012, as it is a logical consequence of the decision to allow a subgroup of EU states to cooperate in unitary patent matters. Doing so would automatically result in jurisdiction for the UPC to handle appeals under Article 32(1)(i) UPC Agreement.

Just like with unitary patents, the new SPC provisions in the unitary patent regulation would be supplemented by decisions of the Select Committee.

Kant said...

As an EU organisation, the EUIPO would appear to be better suited to the task than the EPO. One wonders why they were not chosen to handle the unitary patent registration procedure.

Anonymous said...

@ Anon 16 April - use the EPO? Are you serious? That is one sure way of losing all of the collective knowledge of the national offices that has been gained over the last 20+ years regarding how to examine SPCs. How about we instead try to improve upon what already exists (e.g. by creating a virtual body), rather than throwing out the baby with the bathwater?

Another thing - unless and until a way is found to improve the governance of the EPO (including ensuring full compliance with fundamental principles of employment legislation in the EU), I would be very uncomfortable with the EPO gaining control of the examination of yet another highly valuable IP right.

Anonymous said...

Come on: back in 1978 the EPO had 0 experience with patent examination. Yet it could start and flourish because it hired experienced examiners from national offices, and because it built on the Institut International des Brevets in Rijswijk.
The same holds for the UPC: when it starts, it will have 0 experience itself. Yet, nobody needs to be afraid of silly judgments because the UPC judges will be drawn from experienced national courts.
So, no doubt that the EPO will do just fine if it were (t)asked to examine SPC applications.

Governance will be the big issue with any virtual office: it will need real governance structures. Especially when you consider appeals: any decision from the appeal body will have to be implemented by the first instance, so again real governance is needed to ensure that this indeed happens.
So, it is better to involve a real body rather than a virtual one.

The EUIPO is an EU organization, that is true, but it has no knowledge of patents and technical things. Would that really be a more preferable solution for handling SPCs?

The employment issues at the EPO do not prevent it from examining patent applications as usual. Also, the EPO Board of Appeal issues are irrelevant for unitary SPCs if SPC appeals are handled by the UPC rather than by the EPO Boards of Appeal,just like the UPC handled administrative unitary patent appeals.

Kant said...

An alternative would be to allow an applicant to request an SPC before any patent office of an EU state with this then extending to the EU as a whole in the same way that a national court can act as an EU court in design matters.

Proof of the pudding said...

@Anon 11:56 - you have clearly failed to grasp the perils of throwing the baby out with the bathwater when it comes to experience in examining SPCs. Starting at ground zero with the EPO really would be a disaster for applicants - especially given the complexity of the (case) law.

Your perspective is so pro-EPO, can you please confirm whether you are on BB's payroll before commenting again? As you may guess, I can confirm that I am not.

Proof of the pudding said...

I should add that there are already not enough experienced SPC examiners to go around, and so it would be a disaster if the EPO were to hire a significant number of them.

For various reasons, national SPCs will be with us for a long time yet (perhaps indefinitely). Thus, the national offices will continue to represent important venues (perhaps the most important venues) for SPC applicants. To eviscerate their examining capability would therefore be doing applicants a serious disservice.

The alternative (a virtual body) would make the best of what already exists, whilst allowing national offices to retain their skilled staff. What's not to like about that?

Anon, you argue that "The employment issues at the EPO do not prevent it from examining patent applications as usual". However, handing responsibility for uSPCs over to the EPO at present would be akin to rewarding a problem child for appalling behaviour.

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