Mediaboss Marketing

19 May 2023

Herbert Smith Freehills

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As we reported last week (27 April 2023), theEuropean Commission has issued proposals for a new SPC regimeacross the EU. Under the new proposal, i) a new centralisedprocedure for the grant of SPCs is introduced for medicinalproducts that have been centrally authorised, and ii) a new unitarySPC to complement the Unitary Patent is introduced. The key pointsto note in this regard are as follows:

This route will only be available to medicinal products thathave been authorised centrally SPC applications on thebasis of decentralised and national authorisations cannot takeadvantage of this route:

Once the Unitary Patent comes into effect from 1 June 2023, itwill also be possible to seek a Unitary SPC on the basis of aUnitary Patent via the same centralised application procedurementioned above:

The changes to the SPC regime attempt to resolve problemsencountered owing to the variation in approach of national patentoffices in their assessment of SPC applications, and are aimed atsimplifying and streamlining the process for applicants. In theCommission's own words:

The cost of seeking additional protection will be greatlyreduced: estimated savings of 137 000 per applicant forreceiving EU27 wide, five-year-long SPC protection, bringing the EUcloser to its main trading partners. The increased transparencyresulting from this centralised procedure will also make it easierfor generics manufacturers to be informed of the protection statusof a given product across the EU, and to make business plansaccordingly.

The proposal requires the repeal and recast of the twoRegulations that currently deal with SPCs for medicinal productsand plant protection products, as well as the introduction of twonew Regulations creating a new unitary SPC, one each of medicinaland plant products. The proposed Regulations will still need to bediscussed and agreed by the European Parliament and the Council ofthe European Union in view of their adoption and entry intoforce.

What is an SPC? An SPC provides an extensionterm for a patent of up to five years, for a human or veterinarymedicinal product, or a plant protection product, that has beenauthorised by regulatory authorities. It provides a compensatoryextension of the monopoly to allow for the time it takes to getproducts to market via the regulatory system. SPCs are currentlyawarded at a national level individually for eachterritory. This has led to some variation in application of thecriteria for awarding SPCs, creating legal uncertainty, proceduralinefficiencies, and many referrals to the CJEU. It had also been asource of concern for stakeholders that in respect of the newEuropean patent with unitary effect (the unitary patent (UP) whichwill become available as an option at grant for European patentsfrom 1 June 2023 when the UPC comes into effect) as no SPC righthad been proposed to accompany the new unitary patent right.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

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