European Union: Healthcare

The European Patent Office's Technical Board of Appeal examined whether a medical intervention control system using AI and expanded datasets could be patented, focusing on whether data analysis that assists physicians constitutes a technical effect or merely an intellectual activity.

Legal professionals Klaus Thönißen and Leif Born explore the essential legal frameworks that facility managers must understand to ensure compliant operations. This comprehensive guide addresses the regulatory landscape governing institutional leadership and operational management in healthcare and social service settings.

The European Commission has authorized EUR 400 million in German State aid to Sanofi to secure insulin supply within the EEA, marking a significant development in European pharmaceutical policy.

The European Commission has launched its first formal antitrust investigation in the medical devices sector, examining whether Align Technology may have abused its dominant position by restricting interoperability between its Invisalign clear aligners and competing intra-oral scanners. The investigation focuses on allegations that the company created a closed ecosystem, forcing dental professionals to purchase iTero scanners to access Invisalign products for their patients.

The Dutch government has announced a significant shift in healthcare regulation, moving away from a fragmented prohibition on profit distribution toward a uniform 'cap-and-conditions' regime that will apply to all healthcare and youth aid providers. This new approach permits profit distribution up to a maximum percentage of invested capital, but only under strict conditions including quality standards, financial health requirements, and enhanced governance measures. The proposed changes also introduce tight

A European Patent Office Technical Board of Appeal decision examines when algorithmic features in medical monitoring systems can support inventive step claims. The case centers on a blood glucose variability measurement system where the technical effect depends critically on the observation period, raising fundamental questions about claim scope and technical contribution.

Polycystic Ovary Syndrome has been officially renamed Polyendocrine Metabolic Ovarian Syndrome following a 14-year global medical consensus. The new terminology better reflects the condition's complex hormonal, metabolic and reproductive nature, moving beyond the misleading reference to ovarian cysts. What does this fundamental shift in medical understanding mean for patent applications and intellectual property strategy in women's health innovation?

Less than a year before the transposition of the revised Product Lability Directive1, the Court of Justice of the European Union (“CJEU”) has provided some welcome clarification on the application of the limitation periods...

With the recently announced healthcare reform, the German Federal Government intends, for the first time, to codify the concept of so-called partial incapacity for work.