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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
A new Trade Secrets Act, which implements the EU Trade Secrets Directive, recently entered into force. Even if the strengthened position for trade secret owners is welcome, discrepancies remain between trade secrets and other IP rights. Further, any dispute on trade secrets will not be subject to the jurisdiction of Sweden's specialised IP courts – jurisdiction will remain vested in the courts of general jurisdiction and often subject to labour dispute rules.
The Supreme Court has rendered its judgment in a long-running dispute concerning private copying levies on mobile phones with an external memory device. The court found that the right to collect private copying levies extends to devices which consist of two technically independent devices, even if the independent devices are not "especially suited for the production of copies of works for private use" and would thus not be subject to private copying levies if sold individually.
The Supreme Court has confirmed that domain names are property which can be forfeited to the state, providing rights holders with another measure in their fight against online infringement. The court noted that the concept of 'property' is central for the rules on forfeiture. It concluded that a person who registers a domain name is granted an exclusive right to that domain name and the right to a domain name may be subject to dispute resolution and entitlement claims.
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.
The Supreme Court recently clarified that copyright infringement is not a crime where the presumed penalty is imprisonment. This decision marks a change in relation to previous case law regarding the penalty for copyright infringement through illegal file sharing. The Supreme Court has now aligned the view on the severity of IP infringements. This is a welcome development, although rights holders may have benefited from a stricter view and a development in the opposite direction.
The holder of an IP right which considers that right to be infringed will often seek a preliminary injunction. If the injunction is wrongfully granted and then overturned, the plaintiff is liable to pay damages to the defendant. A recent Supreme Court case discussed several issues relevant to proceedings concerning such damages and damages in general and is likely to be a leading case for years to come.
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.