ARTICLES
INFRINGEMENT OF SECOND MEDICAL USE CLAIMS IN THE UK AND UPC
RICHARD BARKER, DUNCAN BLAIKIE AND SARAH WOODBURN
Slaughter and May, London

In Sanofi/Regeneron v Amgen, the Düsseldorf Local Division handed down the UPC’s first decision on infringement of second use medical claims. While the relevant EPC 2000 claim was found to be valid, it was also found that it had not been infringed, with the Düsseldorf Local Division proposing a two-pronged test for direct infringement, consisting of an objective and a subjective element. In the UK, the Supreme Court’s findings in Warner-Lambert v Generics remain strictly obiter, since the Swiss form claims said to have been infringed were all invalid. Given the different approaches being adopted between jurisdictions and depending on the type of claim in question, generic manufacturers should continue to act with caution.

DEVELOPING UPC CASE LAW ON PRELIMINARY INJUNCTIONS IN THE LIFE SCIENCES SECTOR
REBECCA LIMER, MEMUNAT BAKARE AND PAUL ENGLAND
Taylor Wessing, London

The UPC’s power to order preliminary injunctions against an alleged infringer is one of its most important and utilised remedies. In addition to assessing the applicant’s entitlement to commence proceedings, the patent’s validity and the likelihood of infringement under UPCA Article 62, the court will also consider issues of imminent infringement and balance of convenience issues, including objective urgency. As this article illustrates, the case law offers both opportunity and risk for patentees making, and alleged infringers defending, applications for such relief.

THE EU PHARMACEUTICAL PACKAGE: KEY CHANGES FOR THE LIFE SCIENCES INDUSTRY
DR MANJA EPPING AND MIRIAM STEINHART
Heuking, Munich

Following agreement by the EU Institutions in late 2025 on a comprehensive reform of European pharmaceutical law, the legislative process is now in its final phase, with formal endorsement by the EU Council and Parliament likely as early as autumn 2026. The article examines the core objectives of the reform, namely, improved access to medicinal products, strengthening innovation and competitiveness, security of supply, combating antimicrobial resistance and more efficient procedures.

CASE COMMENTS

SOWING THE SEEDS: THE FIRST SUBSTANTIVE UK DECISION ON ESSENTIALLY DERIVED VARIETIES
JON EDWARDS, HELEN CONLAN, FREYA CUMPSTY and CRISTINA GARRIGUES
Stephenson Harwood, London

Nador Cott Protection S.A.S. (‘NCP’) v (1) Asda Stores Limited (‘Asda’), (2) International Procurement and Logistics Limited (‘IPL’)
[2026] EWHC 553 (Pat) 

In a dispute concerning varieties of mandarin oranges, the UK Patents Court has handed down the first substantive judgment in the UK providing guidance on what it means for a plant variety to be ‘essentially derived’ from a protected variety and what constitutes a ‘reasonable opportunity’ to exercise UK PBRs where these protect against the unauthorised use of harvested material. These concepts have been subject to judicial interpretation and application only a limited number of times, and never before in the UK.

EUROPEAN AND AUSTRALIAN PATENT OFFICES CONSIDER REPRODUCIBILITY REQUIREMENTS FOR ON-SALE PATENTED PRODUCTS
CLAIRE GREGG
Davies Collison Cave, Melbourne

Under US law, the prior art base explicitly includes products on sale to the public before the effective filing date of the claimed invention (the ‘on-sale bar’) which is novelty-destroying. In Europe and Australia there is no such statutory exclusion. However, Australia’s secret use provisions also effectively act as an on-sale bar, while in Europe a product on the market is considered part of the state of the art, but its composition or internal structure is only part of the state of the art where it is analysable.

EUROPE’S INCREASED FOCUS ON THE ENVIRONMENT AND CORPORATE SUSTAINABILITY: AN EXPENSIVE GAME CHANGER FOR THE PHARMA INDUSTRY
TINE CARMELIET 
Life sciences and healthcare expert
MARIE BARANI
A&O Shearman, Brussels

Increased corporate sustainability in the pharma industry promises to be a costly compliance exercise for pharmaceutical companies, with the near simultaneous adoption of different legal instruments making it challenging to keep track of new requirements. This article provides an overview of key new environmental regulation, including the impact of the Urban Wastewater Treatment Directive on pharma companies operating in the EU.