< Back to latest news & events

News

EU SPC waiver for generic pharmaceuticals producers

May 2019

The awaited regulation which will introduce a “manufacturing waiver” for EU SPCs relating to medicinal products has been formally adopted by the EU Council and is expected to enter into force on 1 July 2019 (dependent on the date of publication of the Regulation in the EU’s Official Journal).

Broadly speaking, the regulation will introduce an exception to the protection granted to an original medicine by an SPC for export purposes and/or for stockpiling, provided that particular conditions are met.

Initially, the regulation will affect only SPCs that are applied for on or after the date of entry into force of the regulation. However, three years after the date of entry into force, the regulation will also affect SPCs applied for before that date, but which have become effective after that date.

In summary, the exception applies to:

  • manufacture of a product for the purposes of export to third countries (where protection of the original medicine does not exist or has expired) and to related acts which are strictly necessary for that manufacture or export; and
  • only in the last six months of validity of the SPC, manufacture of a product for the purposes of storing in the Member State of manufacture (in order to market the product in the EU after expiry of the SPC) and any related acts strictly necessary for that manufacture or storage.

The exception will only operate if certain conditions are met. For example, key requirements are that:

  • the maker (the person on whose behalf the relevant manufacture takes place) has provided certain information required by the regulation to both the authorities of the Member State of manufacture and to the SPC holder at least three months in advance of manufacture or an earlier related act;
  • the maker has duly informed others involved in the commercialisation of the product who are performing excepted acts; and
  • the maker has affixed to the packaging of the product the specific logo provided for by the regulation indicating clearly that it is only for export.

In its press release the Council said that “The regulation will remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets.”

This update was prepared by Karen Russell, Senior Patent Attorney. If you have any queries about the regulation, please contact Karen. Alternatively, you can contact your usual HGF representative or visit our Contact page to get in touch with your nearest HGF office.

Latest updates

IP Ingredients, Part 15: How and when to use trade secrets to protect your food or drink innovations

Some of the food and drink industry’s most successful products are protected as trade secrets: the recipes for Coca Cola, Heinz ketchup and Krispy Kreme donuts to name just a …

Read article
Event - 11th June 2024

HGF are proud sponsors of the Quantum Investors Network: LtW Summit.

The Quantum Investors Network: LtW Summit will be held in London on 11th June 2024, where Matt Cassie will be speaking on the panel ‘Talent, IP, Standards: moats – past …

Event details

IAM Patent 1000 2024

The IAM Patent 1000 World Leading Patent Professionals 2024 has been published and we have received another fantastic result with 31 of our attorneys being recognised as world-class individuals. As …

Read article

Romania will become 18th country to participate in the UPC and UP - EPO announce possibility to delay the registration of unitary effect

From 1 September 2024 Romania will become the 18th country to participate in the UPC following ratification of the UPC Agreement. This means that any Unitary Patents registered on or …

Read article

WTR Global Leaders 2024

The sixth edition of WTR Global Leaders has been published and we are proud to have four of our attorneys recognised and listed. The guide brings together the world’s foremost …

Read article

Managing Intellectual Property firm rankings - IP Stars 2024

We are pleased to announce that HGF has been prominently featured in the Managing IP Stars European rankings for 2024. Our firm’s continued excellence in the field of intellectual property …

Read article