Log in or register
Share on LinkedInShare on LinkedIn

ARTICLE · 07 MAY 2026

Santen Revisited – CJEU Asked To Think Again On “first Authorisation” For SPCs

HGF Law
Explore more from HGF Law

A new referral to the Court of Justice of the EU will once again consider what is meant by the “first marketing authorisation” requirement of Article 3(d) of the EU medicines SPC Regulation. Specifically, the CJEU has been asked to clarify whether a veterinary marketing authorisation (MA) for a medicine can be considered the “first” MA for SPC purposes when there has been a prior MA for the same product as a human medicine.

United KingdomIntellectual Property
Garreth Duncan
Garreth Duncan
Author LinkedIn connections

A new referral to the Court of Justice of the EU will once again consider what is meant by the “first marketing authorisation” requirement of Article 3(d) of the EU medicines SPC Regulation. Specifically, the CJEU has been asked to clarify whether a veterinary marketing authorisation (MA) for a medicine can be considered the “first” MA for SPC purposes when there has been a prior MA for the same product as a human medicine. 

Background – SPC Regulation and earlier CJEU decisions on “first” marketing authorisation

Article 3(b) of the EU medicinal products SPC Regulation (469/2009) requires a valid marketing authorisation (MA) for the product for which an SPC is sought, under the relevant EU Directive (2001/83/EC for human medicines or 2001/82/EC for veterinary medicines).

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

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.

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

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

Samsung Ordered To Pay The Swatch Group US$11.6 Million In Damages For Trade Mark Infringement

The High Court has awarded the Swatch Group US$11.6 million in negotiation damages against Samsung for trade mark infringements involving watch face apps on the Galaxy App store. Rejecting both parties' extreme valuations of US$170 million and US$301, the court established important principles for assessing damages when brand owners don't license their marks and no comparable market royalties exist.
United KingdomIntellectual Property
Mishcon de Reya LLP
Mishcon de Reya 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

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

Patenting Performance: Protecting The Science Behind A Personal Best

Nomio, a broccoli-based sports supplement gaining popularity among endurance athletes, has secured patent protection for its innovative use of sulforaphane to enhance exercise performance and treat metabolic conditions. This analysis explores how the company leveraged university research to protect both therapeutic and non-therapeutic applications of their simple three-ingredient formula, demonstrating that even products with common ingredients can achieve robust patent protection through novel use claims.
United KingdomIntellectual Property
HGF Law
HGF Law
Article

UK Patents Court Reinforces The UK Threshold For Plausibility

The UK Patents Court has upheld Novartis' patent and SPC protecting Entresto, its blockbuster heart failure treatment combining valsartan and sacubitril, rejecting all validity challenges from generic manufacturer Accord Healthcare. The judgment provides crucial guidance on plausibility requirements where experimental data have been generated but not fully disclosed in the patent specification, clarifying when qualitative disclosure of positive results suffices without detailed numerical data.
United KingdomIntellectual Property
HGF Law
HGF Law
Article

UPC CoA Confirms “gold Standard” For Added Matter In Sibio v Abbott

The Court of Appeal of the Unified Patent Court recently issued a decision examining whether omitting an elastomeric sealing member from a patent claim constitutes added matter, applying the EPO's "gold standard" test while emphasizing the importance of functional and structural relationships between features. The ruling provides crucial insight into how the UPC approaches intermediate generalizations and whether its methodology differs from the notoriously strict EPO practice on added subject-matter.
LuxembourgIntellectual Property
HGF Law
HGF Law
Article

Trade Mark Changes In Jersey, And Why They Might Affect You

Jersey has completely overhauled its trade mark system, establishing its own Intellectual Property Office and abolishing the previous UK re-registration requirement. The new framework aligns closely with UK trade mark law while enabling Jersey to participate directly in the Madrid System for international registrations. These changes, effective August 1, 2026, include automatic cloning of existing UK designations into Jersey rights and signal further IP modernization ahead.
JerseyIntellectual Property
HGF Law
HGF Law
Article

Protecting The AI Drug Discovery Ecosystem: Building An IP Stack Around Targets, Molecules And Medicines

As computational biology and artificial intelligence reshape drug discovery, pharmaceutical companies face a critical challenge: how to protect not just the final therapeutic compound, but the entire ecosystem of datasets, models, and biological insights that enabled its creation. This article examines the evolving intellectual property landscape where 90% of clinical candidates still fail, yet the tools predicting their success are becoming as valuable as the medicines themselves.
United KingdomIntellectual Property
HGF Law
HGF Law
Article

Cleaning Up The Laundry: Innovations In Mitigating Microplastic Contamination From Man-made Fabrics

Microplastic contamination from synthetic textiles poses a growing environmental threat, with fibres from man-made fabrics entering water systems through washing machine effluent. As countries like France mandate microplastic filters in washing machines and the EU implements new wastewater treatment rules, innovative companies are developing filtration technologies and novel removal methods to combat this pervasive pollution problem.
United KingdomEnvironment
HGF Law
HGF Law