Life Sciences Report May 2022

We have the pleasure of presenting the latest issue of Setterwalls’ Life Sciences report. The report presents our view on selected current issues with respect to life sciences.

We hope you will find the report of interest.

The new European patent system
On 19 January 2022, the last piece of the puzzle fell into place for the provisional application of the Unified Patent Court Agreement (UPCA) to begin (as reported here). Preparations are now fully under way to recruit judges, implement case management systems and resolve other practical issues. A realistic timeframe is that the Unified Patent Court (UPC) will be operational at the start of 2023. Continue reading.

The new regulation on in vitro diagnostic medical devices becomes applicable
After several years of waiting, the new EU regulation on in-vitro diagnostic medical devices will now become applicable. In this article, we provide an overview of IVDR implementation and compliance. Continue reading.

Privacy Shield 2.0 or a potential Schrems III?
On 25^th March 2022, the European Commission announced that the European Union and the United States had, in principle, reached an agreement regarding a new data transfer framework. The new agreement was intended to replace the Privacy Shield framework that was abolished by the Court of Justice of the European Union in the Schrems II decision. Continue reading.

Single procedure for the granting of SPCs
The forthcoming implementation of the Unitary Patent System (see separate article) also has the potential to change the Supplementary Protection Certificate (SPC) system. The Unitary Patent System could enable the granting of unitary SPCs for unitary patents. However, such a change would require adjustments to the SPC system. Continue reading.

New regulations in the field of marketing and consumer law – how companies in the life sciences sector are affected
The advance of digitalised platforms has driven a paradigm shift in trade, with more consumers and companies purchasing goods and services digitally, instead of in physical stores. Against that background, the Swedish government has proposed a series of amendments in the field of marketing and consumer law, all of which are expected to enter into force on 1 September 2022. Continue reading.

Compensation for legal costs in the administrative process
In a recent judgment, the Supreme Administrative Court clarified the principles of the procedural framework for awarding legal costs to the successful party in administrative proceedings. In this article, Setterwalls’ Johan Reimer and Anja Siöstedt explain the implications for companies in the life science sector.Continue reading.

TLV presents methods for health economic evaluations for new therapies
The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has been commissioned by the Swedish government to develop methods for evaluating the health economics of precision medicines and payment models for advanced therapy medicinal products (ATMP). TLV has now presented its second report on the subject. The report highlights outcome-based payment models, effects for relatives and how volume can affect the price. Continue reading.

The legal framework for food contact materials
The Swedish Food Act was recently amended to include materials and products that come into contact with food products, in order to supplement existing EU law with national provisions to strengthen public control and enable sanctions against violations. In this article, Setterwalls’ Johan Reimer and Lovisa Dahl Nelson offers a brief overview of the legal framework for food contact materials, together with an insight into the possible implications of the new regulations. Continue reading.

What information under Swedish market rules do listed pharmaceutical companies have to provide regarding their operations?
Numerous pharmaceutical companies are listed on the Swedish stock market. In fact, from a global perspective, the significance of the stock market as a source of financing for Swedish companies in the life sciences industry has historically been unique. However, the market rules in Sweden may provide challenges regarding obligations for disclosures of inside information that may be particularly sensitive for pharmaceutical companies in development phase. Continue reading.

Use of nutrition and health claims in trademarks and brand names
Many food products have trademarks or labels/names indicating that they have a positive effect on health. Such names can be interpreted as nutrition or health claims and may only be used if accompanied by a related nutrition or health claim in that labelling. Continue reading.