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.
In a recent case, the claimants brought forward other circumstances to demonstrate that a preparatory patent infringement had occurred. The Stockholm District Court was clear that it must be demonstrated that preparatory acts are undertaken with the intent to commit or promote patent infringement. The decision appears to indicate that stating in general terms that valid patent rights will be respected is sufficient to oppose claims of preparatory infringement.
The government recently issued new directives to review the pricing and reimbursement system and the national financing system for medicinal products. The government declared that the existing system is complex and complicated and must be improved in order to operate a modern healthcare system. The review seeks to find a clear division of responsibilities between the national government and local county councils and regions and to establish foreseeable processes for stakeholders.
The Svea Court of Appeal recently shed much-needed light on whether a right to digital use can be established through the interpretation of recording contracts from a time when such use did not even exist. The case shows how a party to a contract can be found to have consented to new terms regarding digital use through passivity and confirms that a recording artist has standing to seek an injunction on his or her own without the co-creators.
The Stockholm Patent and Market Court recently sentenced four company executives to up to 18 months in prison and ordered them to pay fines and damages amounting to several million Swedish kronor for copyright and trademark infringement through the online sale of counterfeit furniture. In light of the considerable damages, forfeiture of illegal gains and criminal liability, the story is likely to continue with an appeal.
The Supreme Court recently ruled on whether linking to live broadcasts of hockey games was communication to the public, and whether the live broadcasts met the requirements for copyright protection. The court made clear that the EU standard of copyright fully applies in Swedish law. Following this judgment, it would appear that these types of broadcast can rely only on the protection of related rights.
The Dental and Pharmaceutical Benefits Agency (TLV) recently denied reimbursement for an orphan drug for the treatment of chronic thromboembolic pulmonary hypertension based on a health technology assessment which took into account off-label use of treatments for pulmonary arterial hypertension (PAH). The Stockholm Administrative Court has since upheld the TLV decision, agreeing with the TLV's reasoning that the orphan drug should be compared with available PAH treatments.
In the first decision of its kind from a Swedish appellate court, a Svea Court of Appeal panel recently found that car rims do not constitute spare parts and thus enjoy the protections offered by the EU Community Designs Regulation. The court's findings give the spare parts exemption a fittingly narrow and functional interpretation in line with the regulation.
The Supreme Administrative Court recently ruled that e-cigarettes not marketed for smoking cessation purposes should not be classified as medicinal products. The court stated that in order to be classified as a medicinal product, the product, if used as intended, must be capable of appreciably restoring, correcting or modifying physiological functions in human beings. It is not sufficient that the product has a pharmacological effect on the body's functions.
The Supreme Administrative Court recently handed down a long-awaited judgment in the case between the Dental and Pharmaceutical Benefits Agency and the Skane Region. The court departed from earlier judgments and stated that county councils and regions are permitted to enter into discount agreements with pharmaceutical companies for medicinal products which are included in the reimbursement scheme.
The Supreme Court recently clarified the scope of jurisdiction of the Swedish courts in infringement actions involving Swedish trademarks where the infringer is domiciled outside the European Union or European Economic Area. Due to the territorial character of nationally registered trademarks, there is a legal interest for the country of registration to hear cases where a national trademark right has been invoked.
The Supreme Court has strengthened the position of copyright holders in enforcing their rights against companies trying to circumvent court-ordered injunctions. Companies are generally not responsible for the actions of third parties. However, the company can be held responsible if it fails to prove that it has taken reasonable measures to prevent the third party from violating the injunction.
The Stockholm Administrative Court of Appeal recently clarified the possibility to consider financial aspects when determining whether there are special requirements for granting a named patient permission. The court dismissed arguments that high prices and limited availability of an authorised medicinal product could constitute special requirements for a named patient permission for an unauthorised medicinal product.
The Supreme Court recently confirmed that the Swedish implementation of the EU IP Rights Enforcement Directive goes further than the directive in relation to the information on infringing goods that a party can be ordered to provide. Under Swedish law, an information order can relate not only to goods which have been established to be infringing, but also to other specimens of the goods sold before and after the infringing goods.
A pharmaceutical company's recent application to the Dental and Pharmaceutical Benefits Agency (TLV) for a pricing and reimbursement decision regarding a medicinal product with orphan drug status was rejected. The decision appears to be the first in which a product under off-label use has been used as a comparator in the TLV's health technology assessment.
The Uppsala Administrative Court has upheld a Medical Products Agency decision that a generic inhaler was not considered substitutable within the substitutability groups for which the generic company had applied. The court denied substitutability based on the generic inhaler's incompatibility with a spacer mentioned in the original inhaler's summary of product characteristics.
The Svea Court of Appeal recently clarified the method used by the courts to determine whether a trademark should be cancelled due to lack of distinctive character or degeneration. The court also provided guidelines on the importance of rights holders enforcing their rights and the value of well-conducted market surveys at the time of registering a trademark.
The Administrative Court of Appeal recently issued a judgment on the pricing of orphan drugs in the reimbursement system. The court considered whether a maximum price cap exists with regard to the cost-effectiveness calculation within the health technology assessment. The outcome is unsatisfactory for pharmaceutical companies, particularly those with orphan drugs or innovative new drugs in their product portfolio.
In certain situations the use of a third party's trademark is allowed – for example, to show that services for another business's products are offered. The Stockholm District Court recently clarified the distinction between the use of logos and word marks for such purposes, confirming that while the former create the impression of a commercial connection between two undertakings, the latter do not.