Updates

Modernised Dutch Patents Act: From Rubber Stamp to Examination

A proposal for the modernisation of the Dutch Patent Act (Rijksoctrooiwet 1995) is currently under consideration by the Parliament. In this article, we briefly outline the most important implications for the Dutch life sciences sector and, in particular, for university spinouts.

From pet food to veterinary medicines: we want the best for our companion animals

Premium pet food is booming, marketed with language borrowed straight from the food aisle. But legally, pet food is not food at all: it is feed, governed by an entirely different set of EU rules on labelling, ingredients and claims. Where exactly is the line between a bag of kibble, a specialised nutritional feed and a veterinary medicinal product, and how easily can a bold marketing claim push a product across it?

New working arrangements between Dutch Food Safety Authority and Inspection Board Health Products

In the Netherlands, advertising disputes over health products rarely reach the civil courts. Instead, self-regulation by the Inspection Board plays a central role, working hand in hand with the Dutch Food Safety Authority (NVWA). New working arrangements between the two bodies, in force until the end of 2027, set out exactly when a case stays within self-regulation and when NVWA steps in directly. With the line between a lawful health claim and an unauthorised medical claim often razor-thin, knowing which route applies matters.

Oat beta-glucans and the glucose peak: a new health claim is on its way

That familiar afternoon slump after a carb-heavy lunch is not just a matter of energy levels, it is now also a matter of EU food law. Positive outcomes in the EU health claim authorisation process are rare, which makes a new EFSA opinion on oat beta-glucans and the glucose peak all the more remarkable, especially since it was obtained via a route that has produced only a handful of successes. The wording of the new claim also differs slightly but significantly from an already authorised 2012 claim, with real legal and commercial consequences.

As a partner of StartLife, Axon assisted a feed company with the regulatory qualification of its technology. Our reasoned opinion serves as a key document for the company’s funding activities.

Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.

We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.

Axon assisted a French VC company investing in a food tech start-up. We reviewed the target’s regulatory strategy under the EU novel foods framework, assessed its feasibility and outlined potential risks and how to mitigate these.

Axon regularly acts as a sub-contractor for leading international firms to assist in regulatory due diligence in our fields of expertise: pharma, medical technology and food.

Axon regularly provides specialist due diligence support on a variety of corporate transactions in the life sciences sector.