Richter Gedeon
Évszázados felelősséggel az egészségért A Richter, amely az elmúlt évszázad óta folytatott eredeti kutatásokat, továbbá jelentős erőforrásokat áldozott a világ egyik legteljesebb nőgyógyászati portfoliójának kiépítésére, kézenfekvő módon a második, azaz a specializációs modellt választotta.
ID: 898671629334-81
Lobbying Activity
Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure
4 Apr 2022
Gedeon Richter welcomes the chance to provide feedback on the proposal to reduce fragmentation in the SPC system.
The Call offers several policy options to achieve specific policy objectives such as to increase legal certainty about the procedure for granting SPCs, to provide unitary SPC protection in relation to unitary patents.
Among these policy options Gedeon Richter supports option c.1): creation of a centralized system for SPC protection in the EU, with a view to reducing the cost and burden and making the procedure for granting SPCs more predictable. This centralized system could consist of a combination of
• a unitary SPC complementing the future unitary patent, but it should be granted only when the product is covered by a European marketing authorisation granted by EMA and
• a unified procedure for granting (bundles of) national SPCs,
but no double SPC protection (national & unitary) should exists in a single Member State.
The need for an EU-wide protection should also be emphasized, therefore the new SPC regulation should be based on EU legislation and target a uniform EU IP title especially from territorial aspect, vis a vis legal construction like the European Patent Convention. It would be desirable to avoid any territorial fragmentation which is still the case of the Unitary Patent Court Agreement that has not been become operational since 2012 and will not include significant number of EU Member States for several years to come. Instead, a uniform IP right which is applicable in all Member States of the European Union should be targeted as it is the case for Community Plant Variety, European Trade Mark, Community Design or even the EU Geographical Indications.
The system delivering unitary SPCs and SPCs based on “classical” European patents should rely on a single centralized granting body to achieve the necessary harmonization. The granting authority in both cases should be a virtual patent office created based on new EU rules and composed of examiners from national patent offices having existing expertise. To ensure quality of granted SPCs, the system should foresee a pre-grant opposition mechanism.
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, thus consolidating jurisdiction for the grant of (unitary) SPCs as well as for infringement and validity in the same forum. In addition, it is not possible for the EPO to turn to CJEU.
The European Commission and the European Parliament should have oversight of the granting body: any granting body should be fully accountable and under the oversight of the European Parliament and the European Commission.
Option c.2): targeted amendments of the SPC Regulations are also welcome based on the best practices of national patent offices and CJEU case law.
The main complications related to the SPC derive from the different interpretations given by the CJEU on the scope of the SPC. Even with a unified grant mechanism these uncertainties would remain. One granting body would reduce the burdens for SPC applicants, but it would not solve the issues around the scope of protection of the SPC.Removing multiple litigation & conflicting court decisions is considered essential to ensure of timely entry of generic/biosimilar medicines on the market.
However, the Unitary Patent Court doesn’t seem to be the best way forward as long as it cannot show several years of existence and balanced practice in the area of unitary patents. SPC’s are of high commercial value, therefore it would be more secure to leave jurisdiction for enforcement at national levels where national court and judges are experienced in SPC litigation.
The involvement of UPC should be considered when the EU unitary SPC regulation will be subject to revision by the European Commission in the light of already gained experience.
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