Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists.

In Case C-524/18, Dr.

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001.

PTC Therapeutics International Limited (“PTC”) had argued before the General Court that

On 14 July 2016, the Court of Justice of the European Union (CJEU) issued its decision in Case C-19/15 Verband Sozialer Wettbewerb v Innova Vital GmbH on the application of the Nutrition and Health Claims Regulation 1924/2006 (“NHCR”) to business-to-business (“B2B”) commercial communications.  The CJEU ruled that B2B communications that were promotional in nature came under the scope of the NHCR even though they are not specifically directed at “the final consumer”.
Continue Reading B2B or not B2B: Application of the NHCR to Business-to-Business Commercial Communications

In its 7 July 2016 Genentech judgment (Case C-567/14), the European Court of Justice (“ECJ”) ruled that Genentech had to pay royalties to Sanofi-Aventis Deutschland under its licence agreement. The Paris Court of Appeal requested a preliminary ruling on whether the provisions of Article 101 of the Treaty on the Functioning of the European Union (“TFEU”) preclude the imposition of an obligation to pay a royalty for the use of a patented technology for the entire duration of a licence agreement, in the event that the patents protecting the technology are revoked.  The ECJ concluded that Article 101(1) TFEU does not preclude the imposition of a requirement to pay royalties, provided that the licensee is free to terminate the agreement by giving reasonable notice.
Continue Reading Court of Justice Rules That Genentech Must Pay Royalties to Sanofi

On 10 July 2014, the Court of Justice of the European Union (CJEU) gave its judgment in a case involving “legal highs” that a substance which only influences physiological functions without any beneficial effects on human health, shall not be considered as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC (decision of the CJEU, dated 10 July 2014, joined cases C-358/13 and C-181/14 (criminal proceedings against Markus D. and G.)). The CJEU thus clarifies the scope of the definition of medicinal products under EU laws and overrules diverging case law at Member State level. This decision is potentially relevant for the regulatory classification of other borderline products.

This CJEU decision answered a request for a preliminary ruling issued by the German Federal Supreme Court on whether a product containing herbs and synthetic cannabinoids must be classified as a medicinal product. The product in question was sold in small bags and did not contain fixed quantities of active substances or any indications on the active substance or dosage guidance. However, it was proved in pre-experimental studies that these substances had a physiological effect, but did not have any desired health effects. The sellers declared those products to be “air fresheners” whose content was not suitable for human consumption.
Continue Reading EU Court Of Justice Further Clarifies Definition Of Medicinal Products – And Raises New Questions