Similar to pharmaceutical products, medical devices play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. From the patent law perspective both, pharmaceutical products and a medical apparatus, product or device can be patented if they meet the patentability requirements, which are novelty, inventiveness and entail industrial applicability. However, regulatory issues also impact on the whole cycle of the innovation. At a European level, enhancing competitiveness while ensuring public health and safety is one of the key objectives of the European Commission. This article undertakes literature review of the current and incoming regulatory framework governing medical devices with the aim of highlighting how these major changes would affect the industry at issue. The analysis is made in the framework of an on-going research work aimed to determine whether SPCs are needed for promoting innovation in the medical devices industry. A thorough analysis the aforementioned factors affecting medical device’s industry will allow the policymakers to understand the root cause of any optimal patent term and find appropriate solutions.

In the last decade a trend towards more ‘openness’ in terms of collaborations and access to knowledge has been observed in many different sectors and contexts. Along the spectrum of openness one can find many different varieties, such as open innovation, co-creation, open science (combined with open access and open data) and open source. Even traditionally rather ‘closed’ actors, such as publishing houses and the pharmaceutical industry, are gradually catching up and are trying to develop mechanisms to cope with this trend towards openness. Both public and private actors encounter challenges in combining this trend towards openness with the management of intellectual property rights (IPRs). Although a strong willingness may exist to collaborate, open up and share knowledge and data, IPRs often create boundaries and limitations towards cutting-edge collaborations and initiatives for openness and sharing. Over time, companies, universities, public research organisations, etc. have developed certain models to allow for openness while safeguarding ways to protect their IPRs. Yet the legal framework is often lagging behind and does not appear to reflect the socio-economic trend towards openness; in many jurisdictions, changes to IP legislation have rather focused on strengthening of the rights of IP owners. But this is not necessarily a problem as stakeholders tend to find workarounds in their day-to-day practice. This special issue aims to further the discussion about modern governance of IPRs in Europe and to explore different perspectives on how openness could be operationalised within the context of IP protection.