ARTICLE
15 July 2019

SPC Manufacturing Waiver Regulation Will Enter Into Force On 1 July 2019

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J A Kemp LLP

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J A Kemp is a leading firm of European Patent and Trade Mark Attorneys. We combine independent thinking with collective excellence in all that we do. The technical and legal knowledge that we apply to the protection of our clients’ patents is outstanding in its breadth and depth. With around 100 science and technology graduates in the firm, including 50 PhDs, no area of science or technology is outside our scope. Our Patent Attorneys have collective in-depth expertise in patent law and procedure in every country of the world. The team of professionals who advise our clients on trade mark and design matters have backgrounds in major international law firms and hold qualifications as Chartered UK Trade Mark Attorneys, Solicitors and European Trade Mark Professional Representatives. Dedicated to this specialist area of intellectual property protection, the team has the expertise and resources to protect trade marks and designs in any market worldwide.
On 11 June 2019, the EU published Regulation (EU) 2019/933, which amends Regulation (EC) 469/2009 concerning supplementary protection certificates (SPCs).
European Union Consumer Protection

On 11 June 2019, the EU published Regulation (EU) 2019/933, which amends Regulation (EC) 469/2009 concerning supplementary protection certificates (SPCs).

The amendments to the SPC regulation will permit third parties to manufacture a medicinal product protected by an SPC for the exclusive purpose of export to countries outside the EU. The amendments will also permit third parties to stockpile such a medicinal product up to six months prior to SPC expiry, for the purpose of day one release in the EU after expiry of the SPC.

The amendments will enter into force on 1 July 2019. The following transitional provisions will apply.

  • An SPC granted and in force prior to 1 July 2019: the waiver will not apply.
  • An SPC granted on an SPC application filed on or after 1 July 2019: the waiver applies.
  • An SPC granted on an SPC application filed prior to 1 July 2019, but where the SPC is not in force until on or after 1 July 2019: the waiver only applies from 2 July 2022.

In view of the above, it is advisable where possible to file new SPC applications prior to 1 July 2019.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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