REGULATORY UPDATE  /  MONTHLY

September 2026

DEVELOPMENTS
29
TOPICS
16
OPEN DEADLINES
2

Every LS Law Monthly Regulatory Update is researched, curated and written by our legal experts. Drawing on hands-on, in-house experience across the life sciences sector, they look beyond what has changed to consider what matters, why it matters and what it could mean in practice.

AUTHOR’S NOTE
Welcome to our new LS Law Regulatory Update. We hope you have had an excellent summer and if you have been away, have come back fully refreshed. Our new update will continue to deliver all the key legal developments as previously, but we are now moving to a monthly update, with additional commentary on some of the most important and interesting developments over the last month and a monthly podcast. Our new monthly podcast series, The Regulatory Question Bomb, will look in more depth at the key developments from the previous month and provide practical opinion and commentary from our most experienced industry lawyers. We hope you enjoy our new format and will download the monthly instalments of The Regulatory Question Bomb podcast series, which will be available for download each month.
 
Although it has been holiday season, there has been no shortage of news over the last month including delivery of some important judgements and announcements. In the UK, the government has just announced three amendments to the Health Bill, which represent structural shifts and political concessions ahead of the crucial report stage on 7th September. We have also seen the PMCPA announce a consultation on proposed changes to its Consstitution and Procedure, which aims to expand the abridged complaints procedure, formalise limitation periods and ensure accountability for joining/leaving companies as well as give greater scrutiny powers to the PMCPA and enhanced powers to order specific audits. The MHRA has also published a policy paper, clarifying the UK licensing route for microbiome-based medicines.
 
There have been several important intellectual property decisions delivered over the last month both in the UK and Dutch Courts, as well as a landmark Court of Appeal decision in Illiquidx Ltd v Altana Wealth Ltd, which provides guidance on the precise definition of 'public domain' in the context of non-disclosure agreements. Finally, the Court of Justice of the European Union (CJEU delivered an important clarificatory decision in Zentrale zur Bekämpfung unlauteren Wettbewerbs Frankfurt am Main eV v Diagramm Halbach GmbH & Co KG, regarding the boundaries of the definition of a medical device under the EU Medical Devices Regulation. We will be looking at both these decisions and their practical implications in more detail in our new podcast and hope you join us on The Regulatory Question Bomb to learn more. Enjoy this latest edition.
Rebecca
15 September 2026

Advertising

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The Prescription Medicines Code of Practice Authority (PMCPA) has launched a public consultation on proposed changes to its Constitution and Procedure.

The proposed changes include amendments aimed at streamlining and improving the complaints procedure, formalisation of a limitation period for complaints, changes to strengthen accountability for companies joining or leaving self-regulation and enhancing the PMCPA’s scrutiny powers. The consultation is open until 21 September 2026. See here for further information, including how to respond to the consultation.
RESPOND BY 20 SEP 2026

Artificial Intelligence (AI)

2 ITEMS

Clinical Trials

2 ITEMS

Competition Law

1 ITEM

Confidentiality

1 ITEM

The Court of Appeal unanimously dismissed Altana Wealth and Brevent Advisory’s appeal in July 2026 (Illiquidx Ltd v Altana Wealth and Ors [2026] EWCA Civ 874), upholding the earlier decision that the defendants misused Illiquidx’s confidential information and trade secrets when launching a competing distressed-debt fund.

The Court of Appeal confirmed that ‘public domain’ in a professional non-disclosure agreement means information that is generally accessible to the public, not merely information selectively or confidentially circulated to a limited group of potential investors. See judgement for further information.

Health Data

1 ITEM

Intellectual Property

3 ITEMS

On 5th August 2026 the District Court of the Hague granted Novo Nordisk a preliminary injunction stopping Ceban Ziekenhuisfarmacie from selling an unapproved compounded semaglutide nasal spray sold as Semanova (C/09/704955 /KG ZA 26-494).

The Court found that the nasal spray infringed Novo Nordisk’s Dutch Supplementary Protection Certificate (SPC) for semaglutide. Ceban argued the preparation was covered by the pharmacy exemption under Article 54c (e) of the Dutch Patent Act. However, the Court rejected this; the spray was resold to other pharmacies and listed in the official Dutch drug database, pointing to large-scale use and going beyond individual small-scale preparation. Please see judgement (in Dutch) for further information.

The Court of Appeal in the Hague has revoked the Dutch part of Bayer’s European Patent 1845961 on the anticoagulant drug rivaroxaban specific dosing regimen.

After generic manufacturers sought to enter the market after Bayer’s SPC expired in April 2024, Bayer leveraged the dosage patent EP 1845961 to block generic entry. Generic manufacturers argued that the specific once-daily dosing regimen was obvious to a person skilled in the art and lacked ‘inventive step’. The Court accepted that a Phase II study patient information booklet distributed without express confidentiality constituted ‘prior art’ and that the skilled person would have arrived at the claimed subject matter without inventive effort. The Dutch judgement adds to a divergent set of decisions across Europe as well as damages proceedings. It is not known whether Bayer will appeal to the Supreme Court in the Netherlands. See judgement (in Dutch) for further information.

The UK High Court has ruled in favour of Novartis by dismissing an attempt from Accord Healthcare to invalidate the patent and SPC for the heart failure medication Entresto.

The Court rejected Accord’s arguments on a number of fronts, including obviousness over two prior art references, lack of plausibility, collocation and lack of technical contribution and ruled that Accord’s proposed generic product would infringe the SPC. As a result, generic market entry is blocked until January 2028. See Accord Healthcare Limited v Novartis AG [2026] EWHC 2127 (pat) for further information.

Market Access

2 ITEMS

Medical Devices

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Medicines Supply

2 ITEMS

Microbiome-based Medicinal Products

1 ITEM

Packaging

1 ITEM

Regulatory

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The government has tabled three amendments to the Health Bill aimed at modernising the legislative framework for the regulation of medicines and medical devices in the UK.

The proposed amendments focus on legal powers to share specific information about medicines and medical devices with relevant government organisations and global regulatory partners, measures to make medicines and medical devices legislation easier to update and powers to provide the MHRA with enabling powers for the development of a future medical device licensing regime. See MHRA press release for further information.

Research and Development

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Safety

1 ITEM

Strategy, Policy and Trade

2 ITEMS

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