Patent litigation in medical devices
Medical devices combine mechanics, electronics, software and materials, often within a single product. Disputes draw on each of these technologies, in a sector where innovation is often incremental and where players, from start-ups to large groups, compete head to head.
Issues specific to the sector
Methods for treatment of the human body by surgery or therapy and diagnostic methods practised on the human body are excluded from patentability (Article 53(c) of the European Patent Convention). Protection therefore attaches to the device itself, and claim drafting drives the infringement analysis: a device designed for a given use, a function defined by its effects, a system combining hardware and software.
Regulatory timelines weigh on strategy. Placing on the market requires CE marking under Regulation (EU) 2017/745 and clinical evaluation. An injunction may affect patient care, which the assessment of proportionality must take into account, particularly before the Unified Patent Court.
How we act
- Infringement and nullity actions, for claimants and defendants, before the Paris Judicial Court and the Unified Patent Court.
- Saisies-contrefaçon and evidence preservation measures, including at trade fairs.
- Freedom-to-operate and validity analyses ahead of a launch or a funding round.
- Disputes over employee inventions and know-how, common in young companies in the sector.
Is a competing device coming to market? Let us discuss it.
Go further
Selected matters
Medical devices: infringement action before the UPC
Representing a medical device manufacturer in an infringement action before the Unified Patent Court, alongside a foreign firm. Work on the analysis of the patent, the demonstration of the alleged infringement and the measures sought.
Medical consumables: risk analysis before marketing
Advising a medical device company on the risks of marketing compatible consumables. Analysis of the patents asserted, their remaining term and other possible grounds of claim, to guide the checks before launch.
Further reading and publications
Frequently asked questions
How should a device with many components be analysed?
Each claimed feature must be mapped to the device or process concerned. Drawings, instructions and testing help distinguish material functions from differences in presentation.
Does regulatory compliance resolve patent risk?
Regulatory market access and patent rights are distinct questions. Launch preparation should include a separate assessment of potentially relevant patents.
What records should be retained across the manufacturing chain?
Product versions, drawings, supplier documentation and marketing dates help reconstruct the facts and assess responsibilities.