Log in or register
Share on LinkedInShare on LinkedIn

ARTICLE · 28 JUNE 2018

Proposed SPC Manufacturing Waiver

J A Kemp
J A Kemp
Contributor
J A Kemp

J A Kemp

J A Kemp is one of the largest European patent and trade mark attorney firms, with offices in...

View firm profile
Explore more from J A Kemp

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.

United KingdomIntellectual Property
J A Kemp LLP
J A Kemp LLP
Author LinkedIn connections

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

We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.

Register for freeORLog in

View source

Related Articles

Legal Intelligence Newsletters: sign up for the latest legal and regulatory news on your chosen topics

Read more about

Related Comparative Guides

See more popular content from

Article

AI, Deepfakes And Image Rights: Does English Law Protect Your Face, Voice And Likeness?

Generative AI has created a legal vacuum where synthetic images and deepfakes can be created and shared without consent, yet English law offers no standalone "image right" to protect individuals. With celebrities like Lisa Riley and over 80 performers demanding reform, the question is whether the UK's patchwork of intellectual property, data protection, and common law protections can adequately address this rapidly evolving threat to personal autonomy and reputation.
United KingdomIntellectual Property
Mills & Reeve LLP
Mills & Reeve LLP
Article

The Sound Of Ownership: Why AI Voice Cloning Is Raising New IP Questions

As AI voice cloning technology becomes increasingly sophisticated and accessible, the Save Our Voices Now campaign calls for statutory rights allowing individuals to own and control their voice as intellectual property. This article examines whether existing UK law sufficiently protects one of our most personal and recognisable attributes, exploring copyright, trade marks, passing off, and the practical steps individuals and businesses can take.
United KingdomIntellectual Property
Ashfords LLP
Ashfords LLP
Article

High Court Clarifies The Limits Of Copyright Claims Against Online Marketplaces

The UK High Court has delivered a landmark ruling on online marketplace liability, dismissing Shein's copyright infringement claims against Temu and clarifying when platforms can be held responsible for third-party content. The judgment examines the boundaries of copyright ownership in complex supply chains and establishes important precedents for how marketplace operators should respond to infringement allegations.
United KingdomIntellectual Property
HGF Law
HGF Law
Article

The Manchester Creative Industries AI Summit – The Government's Opportunity To Set Out A Policy Direction On Copyright And AI?

Prime Minister Andy Burnham has convened the Creative Industries AI Summit in Manchester to bring together rightsholders, regulators, platforms and AI labs to align on a common approach to copyright-protected works in AI development. The Summit will unveil the 'Manchester Principles', a framework establishing minimum conditions for using human creative work to train generative AI models.
United KingdomIntellectual Property
Lewis Silkin
Lewis Silkin
Article

UPC CoA Confirms Jurisdiction Over Pending European Patent Application

The UPC Court of Appeal has confirmed that the Unified Patent Court can exercise jurisdiction over European patent applications, provided they are granted before the defendant files their statement of defence. This landmark decision means patent holders may now be locked into the UPC system even before their patents are officially granted, fundamentally changing the strategic timing considerations for opting out of UPC jurisdiction.
United KingdomIntellectual Property
HGF Law
HGF Law
Article

Patents And University Spin-outs: Protecting Academic Innovation

Universities drive innovation across medicine, AI, materials, and clean tech, but academic researchers face a critical challenge: the need to publish conflicts with patent protection requirements for confidentiality. Understanding how to navigate publication deadlines, filing strategies, and IP development can determine whether groundbreaking research becomes a valuable commercial asset or loses protection entirely.
United StatesIntellectual Property
J A Kemp
J A Kemp
Article

UK High Court Upholds Novartis’s Sacubitril Valsartan SPC: What Is The Relevant “product”?

The UK High Court has rejected a challenge to Novartis's supplementary protection certificate for sacubitril and valsartan, addressing a fundamental question about how the "product" protected by an SPC should be defined. The decision clarifies whether a specific co-crystal formulation or the broader combination of active ingredients constitutes the relevant product under the SPC Regulation.
United StatesIntellectual Property
J A Kemp
J A Kemp
Article

UK High Court Upholds Takeda’s Lisdexamfetamine SPC: Will The CJEU Agree?

The UK High Court has ruled on whether lisdexamfetamine (LDX), a pro-drug with no therapeutic activity before conversion to dextroamphetamine, can be considered an "active ingredient" for supplementary protection certificate purposes. This decision addresses a critical question in pharmaceutical patent law that has produced divergent outcomes across European jurisdictions and is currently before the CJEU in multiple pending referrals.
United StatesIntellectual Property
J A Kemp
J A Kemp
Article

Court Of Appeal Update On Timing Of UPC Opt-outs

The Court of Appeal of the Unified Patent Court has confirmed that actions can be brought concerning pending European patent applications approaching grant, and that such actions render subsequently filed opt-outs ineffective. However, a critical question remains unresolved: while the UPC is competent to hear these pre-grant actions, their admissibility based on timing has yet to be determined, leaving patent applicants in uncertain territory regarding opt-out strategy.
United StatesIntellectual Property
J A Kemp
J A Kemp
Video

Navigating Freedom To Operate (FTO): Strategy, Searches And Risk Mitigation (Video)

This webinar explores the critical Freedom to Operate (FTO) process for life sciences companies, examining when FTO assessments are necessary and how to navigate the complex landscape of patent risks. From initial search strategies and cost considerations to evaluating potential infringement risks and implementing ongoing monitoring systems, the session provides practical guidance for managing intellectual property challenges in product development and commercialization.
United StatesIntellectual Property
J A Kemp
J A Kemp