Life Sciences Report November 2020

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.

In this edition, we also treat you to a chronicle by Jonas Svennberg. Jonas is a design strategist at Zenit Design, an agency with 26 years’ experience of developing a wide range of physical and digital products and services, such as design work for the medical field.

We hope you will find the report of interest.

Chronicle

User-centred design for health tech products and systems – Chronicle by Jonas Svennberg, design strategist at Zenit Design
Ask users what they want? No, we have to understand the needs of various stakeholders and users, and cater for those needs when developing new solutions. These needs are often unknown to the users and to the experts developing the systems, as well as to the designers involved. Continue reading.

Articles

Recent interpretation of EU law allows sale of insects as food on the Swedish market
Following a highly anticipated judgement from the Court of Justice of the European Union (C-526/19, Entoma SAS vs. Ministre de l’Économie et des Finances and Ministre de l’Agriculture et de l’Alimentation), whole insects can now be sold as food on the Swedish market during a transition period. This article describes the background to the judgement, as well as its implications for the insect-based food industry in Sweden. Continue reading.

Collaboration Strategy: Develop, Claim, Share, Repeat
Closed innovation projects seem to be a thing of the past, with collaboration the new normal. For collaborations to reach their full potential, certain levels of openness need to be applied not only in day-to-day cooperation but also to intellectual property (IP) and trade secrets. How should companies combine open collaboration with appropriate protection of their strategic intellectual assets? This article proposes a methodical approach to each step of IP sharing in innovation collaboration. Continue reading.

Is your Business Prepared for the Implications of Brexit?
The Brexit transition period will end on 31 December 2020. In this article we highlight some of the implications this may have for companies’ intellectual property (IP) rights. The question is – are your EU IP rights protected? Continue reading.

Legal challenges facing companies transferring personal data outside the EU
It is safe to say that the GDPR has had a significant impact on both EU companies and EU citizens. For many citizens in the EU, the GDPR is a welcome initiative underlining the importance of protecting citizens in relation to the processing of their personal data. On the other hand, the GDPR has forced EU companies to design, or redesign, their business models with a privacy-centred mindset. Continue reading.

LIF Calls for Review of Parallel-import Clauses in Side Agreements
The trade association for the research-based pharmaceutical industry in Sweden (Sw. Läkemedelsindustriföreningen or “LIF”) has written to the Ministry of Social Affairs calling for the Dental and Pharmaceutical Benefits Agency (“TLV”) to investigate how parallel-import (“PI”) clauses can be abolished. Continue reading.

Placing a medical app on the Swedish market
Applications for smart devices continue to rise in popularity and have arguably become a necessity for coping with everyday life. Today many things can be found in app format, available for instant download by anyone with a smart device. Continue reading.

Implementation of the Unfair Trading Practices Directive in the food supply chain
Directive (EU) 2019/633 on unfair trading practices in business-to-business relationships in the agricultural and food supply chain (“UTP Directive”) was approved on 17 April 2019, and is to be implemented in member states by 1 May 2021. Despite the minimum harmonisation approach of the UTP Directive, the Swedish legislator has proposed that the rules should extend beyond the UTP Directive. Setterwalls guides you to the proposed implementation. Continue reading.

The Santen judgment: CJEU denies SPC for further therapeutic application of previously approved active ingredients
After a decade of debate and divergent case law at both national and European level, the question of whether supplementary protection certificates (SPC) should be available for further therapeutic application of previously approved active ingredients may finally have been settled. Setterwalls provides a recap and walkthrough of the Santen judgment (C-673/18) and its implications in the life sciences industry. Continue reading.

New Rules on Tariff Rate Quotas for Importing Agricultural Products
The European Union (EU) uses a system of tariff rate quotas for the import of agricultural products from countries outside the EU. A tariff rate quota allows for a predetermined quantity of certain products to be imported at lower import duty rates than the normal duty rate for a particular type of product. To import at the reduced tariff rate, an importer must apply for allocations within the tariff rate quotas. The EU has now issued new rules for the application for allocations within tariff rate quotas. Continue reading.

Increased Restrictions on the Use and Manufacture of Products Containing PFOA
A new EU regulation concerning the use and manufacture of perfluorooctanoic acid (PFOA), its salts and related compounds, came into effect on 4 July 2020. Continue reading.