Sweden, Westerberg & Partners Advokatbyrå Ab updates

Healthcare & Life Sciences

Contributed by Westerberg & Partners Advokatbyrå Ab
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.

Judgment on public procurement puts parallel importers at a disadvantage
  • Sweden
  • 17 October 2018

The Stockholm Administrative Court recently ruled that the obligation on tenderers of public procurements of medicinal products to have routines which ensure that the use and handling of active ingredients would have as little effect on the environment as possible, as well as the obligation that they routinely survey and have dialogue with their subcontractors, were permissible. The decision has been appealed to the Administrative Court of Appeal in Stockholm, which has yet to make a decision.

Pharmaceutical companies request Patent and Registration Office to reassess decisions
  • Sweden
  • 22 November 2017

In eight landmark decisions, the Patent and Market Court of Appeal decided that the terms for already granted supplementary protection certificates (SPCs) should be recalculated in order to reflect a 2015 European Court of Justice decision regarding the method for calculating SPC terms under EU Regulation 469/2009. Several pharmaceutical companies that had been granted SPCs noted that the Patent and Registration Office's method of calculating SPC terms was not in line with EU law.

New pricing principles applied in decision on orphan drugs
  • Sweden
  • 12 April 2017

The Dental and Pharmaceutical Benefits Agency recently reassessed the reimbursement status of Cerezyme and VPRIV – two products indicated against Gaucher's disease – and decided to decrease the products' prices. This caused the marketing authorisation holders behind the products to withdraw them from the reimbursement system. Consequently, there is no longer a product against Gaucher's disease that is nationally reimbursed in Sweden.


Intellectual Property

Contributed by Westerberg & Partners Advokatbyrå Ab
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.

Calculating copyright infringement damages using hypothetical licence fees
  • Sweden
  • 11 February 2019

The Supreme Court recently rejected the application of a hypothetical licence fee to calculate reasonable compensation for massive copyright infringement through the operation of an illegal streaming site. This decision raises several interesting questions, including to what extent an infringer's illegal business model should be taken into account when calculating reasonable compensation.

No infringement where software backups are passively stored
  • Sweden
  • 24 December 2018

The Supreme Court recently declared that the mere passive storage of backups of copyrighted software with expired licences does not constitute copyright infringement. The judgment is significant as it clarifies which actions constitute copyright infringement and, from a practical perspective, relieves licensees from having to mine their backup servers in pursuit of potential 'sleeper' infringements.

Patent and Market Court rules on global retransmissions of TV broadcasts
  • Sweden
  • 22 October 2018

On the ever-growing market for streaming services and online access to TV broadcasts, illegal services are common and sometimes difficult to shut down due to their technical complexity and the multi-jurisdictional scope of the infringing activities. The Patent and Market Court recently held three persons liable for global retransmissions of TV broadcasts, sentencing them to prison and awarding rights holders significant compensation for damages.


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