Hoping to assist pharmaceutical innovation and competitiveness, Stockholm is advocating for a Unitary Patent System. Sweden is certainly one of eleven EU Member States pushing the Danish Presidency to finalise an EU system for enhanced patent safety for medicines.
Supplementary Safety Certificates (SPCs) have been in place for a number of a long time within the European Union. They’re an mental property proper that grants a patentholder a further 5 years of patent safety, primarily for drugs patents.
Thus far, every Member State has to implement such safety nationally, leading to various outcomes between international locations.
Nevertheless, a unitary system was proposed by the EU Fee in 2023. Below this proposal, a unitary SPC can be related within the 18 EU states which have at the moment joined the so-called Unitary Patent System.
“A unitary SPC can be an vital piece of the puzzle to finalise the Unitary Patent System and a reform that may increase innovation and competitiveness”, Louise Petrelius, a senior advisor on the Swedish Ministry of Justice, informed Euractiv.
She explains that the system is anticipated to streamline the extension of patent safety for each medicinal and plant safety merchandise (e.g. pesticides) within the EU by introducing a single, unified process throughout collaborating member states.
“This goals to simplify the present system, which requires separate functions in every nation, decreasing prices and administrative burden for candidates.”
Longer time to market
In accordance with Petrelius, SPCs purpose to compensate patent holders for the additional time it takes to carry their merchandise to market, as a result of obligatory prolonged testing and medical trials required previous to acquiring regulatory advertising and marketing approval.
The safety for patents within the EU is 20 years. An SPC may lengthen such a patent proper for a most of 5 years.
Because the SPC mechanism extends the market exclusivity of a patented drugs past the preliminary patent time period, it may delay the entry of generic or biosimilar competitors and keep increased costs for an extended interval within the EU.
In accordance with the Swedish Mental Property Workplace (PRV), firms producing generics and biosimilars are solely allowed to begin manufacturing and storing a medication throughout the additional five-year safety interval if their merchandise are to be exported outdoors the EU.
Civil society organisations, as Médecins Sans Frontières (MSF), have beforehand known as upon the EU to abolish the SPC mechanism, saying it contributes “to excessive drug costs and hinders entry to important medicines by delaying the provision of generic and biosimilar alternate options”.
No worth evaluation
Johan Pontén, Worldwide Coordinator on the Swedish Dental and Pharmaceutical Advantages Company (TLV), informed Euractiv that “TLV agrees with the Swedish authorities {that a} centralised SPC system creates extra uniform and easier administration inside the EU, which is optimistic,” including, nonetheless:
“We have now not been tasked with analysing how a modified system may have an effect on the costs of medicines and due to this fact can’t touch upon it”.
In the meantime, in line with the Swedish Ministry of Justice, there is no such thing as a ongoing dialogue within the EU that hyperlinks increased costs to the SPC proposal.
“Because the query of the existence of SPCs is just not topic to negotiation, it isn’t mentioned on this challenge. On the whole, my view is that Sweden is in favour of a system that promotes innovation and attractiveness on the pharmaceutical facet, the place mental property safety is a vital element,” Petter Söderbäck, additionally a senior authorized advisor on the Swedish Ministry of Justice, informed Euractiv.
Euractiv has requested a remark from the Danish Presidency, however has not acquired a response to date.
[Edited by Vasiliki Angouridi]
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