Proposed SPC Manufacturing Waiver

30 May 2018

On 28 May 2018 the European Commission published a proposal for a change in the law which would permit third parties to manufacture a medicinal product protected by a Supplementary Protection Certificate. The Commission aims to have the Regulation in place by 2019.

Manufacturing Permitted by the Proposed Amendment Legislation

The proposed amendment to the SPC Regulation would permit third parties to manufacture a medicinal product protected by an SPC for the exclusive purpose of export to countries outside the EU. 

The rights of manufacture include authorisation for ancillary activities which are “strictly necessary” to enable the manufacture and export of the product. These would include, for example, the importation of API into the EU to enable the preparation of a formulated medicinal product and the temporary storage of product within the EU for the exclusive purpose of exporting the product. Rights will also extend to contract manufacturing organisations and distributors acting on behalf of the party which is exporting the medicinal product.

The proposed legislation will impose some formal requirements on any party seeking to take advantage of this exemption from the infringement positions. These formal requirements include an obligation to notify the national Patent Office in the EU state where manufacturing is to take place, including the provision of details of the product to be manufactured and the countries to which the product will be exported. That information will be published.

Transitional Provisions

The current proposal is that the new legislation will only apply to SPCs which had not been granted on the first day of the third month following the date of publishing the Regulation in the Official Journal.

Acceleration of Pending SPC Applications

If the proposed legislation takes effect in the form proposed thus far, it would clearly be advantageous to have all possible SPC applications granted before the legislation takes effect. SPC applicants with pending applications in the EU may therefore wish to consider expediting the prosecution of their SPC applications before national Patent Offices.

It is not always straightforward to persuade national Patent Offices to expedite SPC applications. J A Kemp has been in contact with national Patent Offices to explore how best to achieve accelerated processing of SPC applications and would be pleased to assist applicants with such requests.

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