During the Covid pandemic, manufacturers, health care institutions and even private individuals have reacted to the shortage of protective medical equipment by manufacturing personal protective equipment (PPE) and medical devices (MD) despite legal and regulatory risks.
3D printing is an additive manufacturing technique which projects resin, plastic or metal in successive layers from 3D plans that allows to produce, in small quantities and without a factory, all kinds of customized objects.
Intellectual property rights issues
3D printing applies nearly to all areas of intellectual property, including copyright, patent law, design law and even geographical indications. This technique makes it possible to reproduce almost any object, with or without the authorization of the owner of the rights on the object (eventually leading to copyright infringement). However, rights' holders should be mindful of the negative reputational consequences if they threaten legal action to prevent the manufacture of medical devices in this context. One of the solutions is to negotiate a license to manufacture products faster and safer. Besides, Article L. 613-16 of the Intellectual Property Code authorizes the Minister in charge of Industrial Property, at the request of the Minister in charge of Public Health, to impose a compulsory license on right holders.
The design, manufacture and launch of PPE and MDs on the European market must comply with EU Regulations and norms. The European Commission has announced that it is working on more flexible legislation to protect those involved in the development of these products. In the meantime, the Commission introduced the postponement of certain binding provisions to 26 May 2021. It also recommended that the supervisory authorities allow the release on the market of MDs and PPE compliant with the regulatory requirements, but for which the certification procedure has not been finalized and no EU marking has been affixed.
The National Agency for the Safety of Medicines and Health Products (ANSM) in France published guidelines to assist project leaders, industrialists, and health establishments or associations. For instance, in Nantes, the "Makers for Life" group is developing an emergency artificial respirator with printable components, whose designs would be freely available.
Please note this blog post was written by a Clifford Chance LLP employee. Clifford Chance LLP is the parent company of Clifford Chance Applied Solutions (CCAS). The content within this post does not constitute legal advice.