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Healthcare & Life Sciences
Marketing authorisation holder lacks standing to challenge off-label prescription for unlicensed productsSweden | 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.
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.
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 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.
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 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.
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 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.
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 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.
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 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.
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.
The Administrative Court of Appeal recently held that it is not possible for county councils and regions to acquire a discount on the price of medicinal products in the reimbursement system. The decision has been appealed to the Supreme Administrative Court. It remains to be seen what will happen to existing discount agreements within the reimbursement system should leave to appeal not be granted.
The Swedish Association of Local Authorities and Regions (SKL) represents the county councils which operate the majority of Swedish hospitals. The SKL has put in place a new cooperation framework for the introduction of new innovative medicinal products. The framework seeks to enable county councils to act as strong buyers of medicinal products, which would lead to, among other things, faster access to new treatments.
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.
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 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.
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.
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.
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 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.
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 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 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.
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.
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 Supreme Court recently considered Mon.Zon's use of Layher's trademark in its product catalogue. The court held that the product catalogues were directed only to prospective buyers and that the use of a photograph displaying Layher's trademark implied no connection between Layher and Mon.Zon. The court concluded that Mon.Zon had caused no damage to the trademark's indication of origin function.
Sweden has recently signed an agreement on the establishment of a Nordic-Baltic regional division of the Unified Patent Court. According to the agreement, English will be the only language of proceedings and the seat of the regional divisional will be in Stockholm. The Swedish national court structure for IP disputes is under revision.
HTC held a patent protecting the cleaning product Twister. HÅTE introduced a competing product and HTC instigated proceedings on the basis of patent infringement. The Gota Court of Appeal found that HÅTE's sales of the patented product should not be deducted from the compensation for lost profits, as HÅTE had already sold small quantities of Twister before the injunction.
In a landmark decision, the Supreme Court has held that the design of the Mini Maglite torch is sufficiently original and individual to enjoy copyright protection. In its reasoning the court thoroughly set forth the legal position and the threshold of originality required for copyright protection for applied art.
Sweden has now implemented the EU IP Rights Enforcement Directive. Some of the key changes relate to the right to information, publicity measures and corrective measures. Although the amendments have reinforced the penalties available within the IP field, there remain many unresolved issues to be determined by the courts.
The Stockholm District Court has rendered its judgment in the case against the operators of the Pirate Bay, considered to be the world's most visited file-sharing website. In a major victory for the entertainment industry, the defendants were each sentenced to one year's imprisonment and ordered to pay Skr30 million in damages to the rights holders concerned.
Product Regulation & Liability
The Patent and Market Court of Appeal recently assessed the use of quotations from wine reviews in ads and found the terms 'bargain' and 'recommended' and the phrase 'an excellent alternative for the big party' acceptable under the applicable Swedish and EU law. This ruling marks a small but significant shift in the strict Swedish jurisprudence on the subject and may give market actors a reason to pop a celebratory bottle.