As we reported last week (27 April 2023), the European Commission has issued proposals for a new SPC regime across the EU. Under the new proposal, i) a new centralised procedure for the grant of SPCs is introduced for medicinal products that have been centrally authorised, and ii) a new unitary SPC to complement the Unitary Patent is introduced. The key points to note in this regard are as follows:

Centralised application process:

This route will only be available to medicinal products that have been authorised centrally – SPC applications on the basis of decentralised and national authorisations cannot take advantage of this route:

  • Under the proposed legislation, a central examination authority shall carry out the examination of the centralised application.The current proposal is for the EUIPO to be this body. The substantive examination shall be carried out by a panel of an EUIPO member, together with two examiners from national patent offices experienced in SPCs.
  • Another key aspect of the proposed changes is that the new legislation formalises the ability of third parties to file observations and oppositions during the examination process.
  • Decisions of the central authority may be appealed to the Board of Appeal of the EUIPO, followed by the General Court and CJEU.
  • The applicant has the ability to choose which states to designate for the bundle of SPCs sought following the central application procedure.
  • The intention of the central examination authority is intended to be binding on the designated national states.
  • The substantive grounds for the evaluation and grant of an SPC application (e.g. Art 3 of the SPC Regulation 469/2009) are not intended to change.

New Unitary SPC

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

  • A "combined application" may be made to obtain a Unitary SPC in member states that are participating in the UPC system, as well in those that have chosen not to participate.
  • It will not be possible to obtain a Unitary SPC as well as a national SPC in the same member state.

The changes to the SPC regime attempt to resolve problems encountered owing to the variation in approach of national patent offices in their assessment of SPC applications, and are aimed at simplifying and streamlining the process for applicants. In the Commission's own words:

The cost of seeking additional protection will be greatly reduced: estimated savings of €137 000 per applicant for receiving EU27 wide, five-year-long SPC protection, bringing the EU closer to its main trading partners. The increased transparency resulting from this centralised procedure will also make it easier for generics manufacturers to be informed of the protection status of a given product across the EU, and to make business plans accordingly.

The proposal requires the repeal and recast of the two Regulations that currently deal with SPCs for medicinal products and plant protection products, as well as the introduction of two new Regulations creating a new unitary SPC, one each of medicinal and plant products. The proposed Regulations will still need to be discussed and agreed by the European Parliament and the Council of the European Union in view of their adoption and entry into force.

What is an SPC? An SPC provides an extension term for a patent of up to five years, for a human or veterinary medicinal product, or a plant protection product, that has been authorised by regulatory authorities. It provides a compensatory extension of the monopoly to allow for the time it takes to get products to market via the regulatory system. SPCs are currently awarded at a national level – individually for each territory. This has led to some variation in application of the criteria for awarding SPCs, creating legal uncertainty, procedural inefficiencies, and many referrals to the CJEU. It had also been a source of concern for stakeholders that in respect of the new European patent with unitary effect (the unitary patent (UP) which will become available as an option at grant for European patents from 1 June 2023 when the UPC comes into effect) as no SPC right had been proposed to accompany the new unitary patent right.

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