Sweden, Westerberg & Partners Advokatbyrå Ab updates

Healthcare & Life Sciences

Contributed by Westerberg & Partners Advokatbyrå Ab
Biosimilars still not subject to mandatory substitution
  • Sweden
  • 08 April 2020

Both the Medical Products Agency and the Dental and Benefits Agency (the authority which decides on reimbursement) have long held the position that biosimilars are not interchangeable or substitutable with their reference products, which has been reiterated in different policy papers since 2007. This position has now been supported by an administrative court of appeal in a case relating to glatiramer acetate products used for the treatment of multiple sclerosis.

Marketing authorisation holder lacks standing to challenge off-label prescription for unlicensed products
  • Sweden
  • 11 December 2019

The Swedish system for medicinal products is generally product based. Prescriptions as such are product based (ie, by brand name or generic product name) and the indication for which the product is intended cannot be filled in anywhere by the prescriber. Off-label prescriptions are therefore not generally possible in the 'official' prescription system. However, when it comes to accessing unlicensed medicinal products, the system for licences on a named-patient basis works differently.

Heavily discounted starter pack considered unethical grant to healthcare
  • Sweden
  • 30 October 2019

The Committee for the Review of Pharmaceutical Information recently confirmed the strict approach to the marketing of medicinal products in relation to pricing. The committee's findings serve as a reminder that companies should consider not only the intended purpose of offering a discount on a product, but also its actual effects. The case under review illustrates that an intended discount on a product may be considered contrary to the Ethical Rules for the Pharmaceutical Industry.

Cannabis causes confusion in Sweden
  • Sweden
  • 14 August 2019

The Supreme Court has ruled that cannabidiol (CBD) oils containing tetrahydrocannabinol (THC) which originates from legally cultivated hemp constitute illegal narcotics. The court argued that since CBD oil can be defined as a preparation in accordance with the Convention on Psychotropic Substances and contains THC, it is an illegal substance. This decision is likely to affect several aspects of Swedish healthcare regulation, including that relating to medicinal products.

Trilogue negotiations: originator company compensation for parallel imported products
  • Sweden
  • 27 February 2019

The Stockholm Administrative Court recently ruled that under the so-called 'trilogue negotiations' between pharmaceutical companies, the Dental and Pharmaceutical Benefits Agency and the Swedish regions could require an originator company to compensate them for products marketed by parallel importers.


Intellectual Property

Contributed by Westerberg & Partners Advokatbyrå Ab
Dynamic blocking injunction against ISPs
  • Sweden
  • 27 July 2020

In a groundbreaking case for copyright holders and internet service providers in Sweden, the Patent and Market Court of Appeal recently declared, for the first time, that dynamic blocking injunctions are in line with Swedish legislation. Unlike regular static blocking injunctions that cover only a specific infringement by a specific infringer, dynamic blocking injunctions also cover other infringements and possibly those by other infringers.

Supreme Court rules on balancing of copyright and fundamental rights
  • Sweden
  • 06 April 2020

A landmark Supreme Court judgment has closed the book on the widely known 'iron pipe scandal'. The court confirmed that fundamental rights such as freedom of the press, no matter how fundamental, do not justify the use of copyrighted materials outside the scope of the existing exceptions and limitations as set out in the Copyright Act and the EU InfoSoc Directive.

Blocking injunctions – proportionality and right of access to information
  • Sweden
  • 04 November 2019

The Patent and Market Court of Appeal recently ordered several internet service providers to take blocking measures against Sci-Hub and LibGen. The case is interesting in light of the court's 2019 decision in a similar case on interim blocking measures in which it denied blocking injunctions due to a lack of proportionality and issued stern words about the evidence invoked by the claimant and the risk of overblocking legitimate content.

Watch out! Patent and Market Court of Appeal finds watch protected by copyright
  • Sweden
  • 27 May 2019

For the first time, the Patent and Market Court of Appeal has confirmed that a watch can be protected by copyright as a work of applied art, even in a crowded design field. The decision enables rights holders to not only pursue counterfeits on the basis of trademark infringement, but also to prosecute copycat watch models on the basis of copyright protection in physical and digital environments.

Preliminary injunction denied in Swedish darunavir SPC proceedings
  • Sweden
  • 11 March 2019

The Patent and Market Court of Appeal recently handed down a preliminary injunction ruling in Sandoz v GD Searle LLC relating to the supplementary protection certificate (SPC) for darunavir. The ruling clarifies that SPCs enjoy a validity presumption for the purpose of a preliminary injunction ruling in the same way that patents do. However, in the instant proceedings, the court found that Sandoz, against which the lower court had issued a preliminary injunction, had managed to rebut the presumption.


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