|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.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....!).
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'. "
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).
Will a virtual body be granting the future Unitary SPCs? Reviewed by Annsley Merelle Ward on Friday, April 15, 2016 Rating: