EU Draft Legislation on Export Manufacturing Waiver for SPCs: Key Updates and Implications

The 2015 EU Single Market Strategy envisioned a sweeping overhaul of Europe’s intellectual‑property regime, including a “recalibration” of patent and Supplementary Protection Certificate (SPC) protection and the potential launch of a unitary SPC title. After a thorough legal and economic assessment, the groundwork for such a reform seemed solid.

In practice, the European Commission has taken a narrower path: a focused proposal to introduce an “export manufacturing waiver” aimed at boosting the competitiveness of European generic and biosimilar manufacturers. The Commission’s regulation amending Regulation (EC) 469/2009 on SPCs for medicinal products (COM(2018) 317 final) was published on 28 May 2018 and has already been the subject of discussion on this blog.

Recent developments from the European Parliament’s Committee on Legal Affairs add significant safeguards for SPC holders. The Committee’s draft report (published 30 October 2018, PDF) was debated in a committee meeting on 20 November 2018 (see the video recording). Key proposals include:

• Manufacturers planning to produce an SPC‑protected medicinal product solely for export to a non‑EU country must notify the national patent office in each EU member state where manufacturing will occur and must also provide written notice to the SPC holder.
• Any subsequent changes—such as shifts in target export markets—must be reported in the same manner to both the national patent office(s) and the SPC holder.
• Notification must occur no later than three months before the intended start of manufacture, extending the original 28‑day requirement.
• A standard notification form (included in a new annex) will streamline submissions to the competent national patent office(s).
• Confidential or commercially sensitive information disclosed to the national patent office(s) will remain unpublished and will not need to be shared with the SPC holder.
• The export manufacturing exemption applies to all SPCs whose underlying basic patent expired on or after 1 January 2023.

These changes, if adopted, represent a substantial improvement in protecting SPC holders from potential abuse of the export manufacturing waiver. Requiring manufacturers to notify SPC holders directly removes the burden from the holders to monitor all national patent office publications. Extending the notification window to three months gives holders ample time to assess whether the exemption conditions are satisfied.

Furthermore, tying the exemption’s applicability to the expiration date of the basic patent ensures a uniform legal framework for all SPCs coming into force after 1 January 2023. This approach avoids the fragmentation that would arise if the exemption were linked to the grant date of individual SPCs, a situation that can result in significant disparities across member states.

One shortcoming remains: the current proposals do not mandate that manufacturers affix the “EU export” logo to both the outer and inner packaging of products destined for export—a measure that could help prevent unlawful re‑imports.

The legislative journey continues. The Committee on Legal Affairs will vote on the draft report on 23–24 January 2019, after considering further amendments. The report will then go to a plenary session, followed by trilogue negotiations with the Commission and the Council. The deadline for a provisional agreement is spring 2019, but events such as the May 2019 European elections or Brexit could cause delays until the new Parliament and Commission convene.

We will keep you updated on the progress of the export manufacturing waiver in forthcoming posts.

Dr. Alexa von Uexküll and Oswin Ridderbusch, partners at the IP‑specialised law firm Vossius & Partner, are the editors of the new handbook European SPCs Unravelled: A Practitioner’s Guide to Supplementary Protection Certificates in Europe, published by Wolters Kluwer in November 2018.