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 Drinking Water Inquiry recently submitted its final report to the government. The aim of the report was to identify challenges to a secure drinking water supply from raw water sources to delivery, and to suggest relevant actions. The inquiry contains good proposals to improve planning and management of drinking water from source to tap. However, its future success relies heavily on the work of authorities within their appointed areas of responsibility.
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 new Ordinance on Traffic Noise Levels in Housing Construction contains provisions on noise from rail, road and airport traffic. The main purposes of the ordinance are to harmonise the legal framework for construction and promote the construction of residential buildings in urban areas. The ordinance sends a clear signal that the legislature intends to fulfil the goals set out to promote housing construction in urban areas.
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 Land and Environment Court of Appeal recently tried two cases concerning the interpretation of the EU Directive on the Conservation of Wild Birds. Both cases concerned the construction of wind turbines in areas where birds protected under the directive live and breed. The central question was whether the construction of the wind turbines should be considered to be the deliberate killing of these birds, and therefore prohibited.
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.
Whether a crime should be considered as punishable by imprisonment is based on the general penal value of the crime. In a recent case the Supreme Court considered whether a prison sentence is the presumed penalty in counterfeiting cases based on trademark rights. If the penal value is less than one year, it held, prison should be the last resort.
The Chemicals Agency has published new guidelines for suppliers of articles concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals duties to inform about candidate list substances. The new guidelines underline the importance for Swedish suppliers to comply with the Swedish interpretation of how to calculate the level of substances in an article.
The government and the Left Party recently reached agreement on initiatives aimed at restricting private companies from engaging in certain publicly funded healthcare, care and educational services and, as part of that limit, their right to distribute profits. Much of the criticisms leading up to the suggested initiatives may be addressed by stricter tender procedures.
One of the largest science infrastructure projects in Europe, the European Spallation Source (ESS), has been given the formal go-ahead to start construction on the outskirts of Lund, Sweden. The groundbreaking took place after permission from the Swedish Land and Environmental Court and the Swedish Radiation Safety Authority. The environmental licensing of the ESS has given rise to a wide array of complex assessments.