Sweden's life sciences sector has a strong international position, with a history of world-class research and development in both pharmaceuticals and medical technology. Several vital innovations originate from Sweden, and Sweden has long focused on investment in frontline medical research and innovation, while simultaneously giving all citizens affordable access to high-quality health care.

Sweden is one of the countries in the world that invest most in R&D per capita. Swedish universities are at the forefront of medical research, and there is generally a comparatively large proportion of researchers in relation to the total population in Sweden.

The Swedish model is built on and has a long tradition of strong collaboration and interaction between academia, industry, government, and civil society. This is one of the main underlying factors for Sweden's success as a life sciences nation. Another important factor for Sweden's success is that it has made significant investments in life sciences research infrastructure, such as national quality registers.

Sweden has a relatively large and growing number of life sciences companies in the early development phase. The number of IPOs, especially on active small company exchanges, reaches internationally uniquely high levels. At the same time, the number of venture capitalists currently specialising in life sciences in Sweden has decreased since the turn of the millennium. Private and public venture capital is of great importance as a source of financing since, for example, the IPO climate and stock markets can change rapidly. Early investments with high or difficult-to-asses risk and/or long lead times to return (which characterises the life sciences sector) generally have difficulty attracting private funding. In addition, the government's life sciences investments have increasingly come in later phases during the recent years, which creates challenges for the life sciences companies, especially in the early development phases.

Responsibility for health and medical care in the Swedish health care system is shared between the state, regions (formerly county councils) and municipalities. The state is responsible for the overall health and medical care policy, while the regions are responsible for providing health care. The municipalities are responsible for, among other things, elderly care and home care. Most hospitals and health service entities are public, although private health care exists.

Apoteket's (the state-owned pharmacy) monopoly on the sale of medicinal products to consumers was abolished in 2009. Since then, several new parties have entered the Swedish pharmacy market. The Swedish Medical Products Agency (Läkemedelsverket) (MPA) approves and monitors the establishment and operations of pharmacies under the Act on Trade in Medicinal Products (SFS 2009:366). Other types of retailers (for example, grocery stores and convenience shops) can sell non-prescription medicinal products, subject to regulations issued under the Act on Trade in Non-Prescription Medicinal Products (SFS 2009:730) (see Question 5).

At national level, the regions are responsible for providing adequate health and medical care to all citizens. The public health care system is mainly funded by:

In addition, the government can provide funding for certain specific health care projects, for example to improve accessibility to the health care system.

Like public health care, most private health care services are publicly funded through tax revenues. Private health care providers may enter into an agreement with regions or municipalities, or apply to provide services in a region that has introduced a system of choice giving patients the opportunity to choose health care providers based on their own requirements.

The pricing of prescription medicinal products included in the reimbursement system is regulated. The cost of medicinal products included in the reimbursement scheme dispensed in pharmacies to patients is to a large extent reimbursed by the state, and the patient only pays part of the costs.

The prices for in-patient care medicinal products are negotiated in public procurement processes regulated by the Public Procurement Act (SFS 2016:1145). The cost of medicinal products used in in-patient care is reimbursed by the state and the patient only pays the standard patient fee that applies for the in-patient treatment concerned.

See Question 4.

A pharmaceutical company marketing a medicinal product can apply for the product to be included in the national pharmaceutical benefits scheme under the Pharmaceutical Benefits Act (SFS 2002:160). The Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket) (DPBA) determines whether the medicinal product qualifies for the pharmaceutical benefits scheme and sets the price for the product (based on the price applied for by the pharmaceutical company). The DPBA's decision may be preceded by negotiations between the pharmaceutical company, the regions and the DPBA.

When assessing the pharmaceutical company's application, the DPBA makes an overall assessment, taking into account a number of principles in the health care system, including:

An application may be granted by the DPBA if the health economic analysis shows that the applied price is justified based on the value that the medicinal product provides in terms of improved health. The DPBA's decision can be appealed to the Administrative Court.

Under the system for generic substitution, pharmacies must substitute a medicinal product with the least expensive medicinal product available, provided that the following conditions are fulfilled:

The reimbursement system means that the cost of a medicinal product is gradually reduced for the individual patient over a period of 12 months. The patient pays the full cost of a medicinal product up to a maximum price. The cost is then gradually reduced step by step over the 12-month period. The maximum aggregated amount an individual will pay during this period is currently SEK2,600. All children under the age of 18 years are offered prescription medicinal products included in the pharmaceutical benefits scheme for free.

Pharmacies are mainly compensated through the retail margin for selling medicinal products. This is the difference between the purchase price paid by pharmacies and the sales price they charge to their customers. The retail margin is set by the DPBA under its Regulation on the Retail Margin for Medicinal Products and Other Products Included in the Pharmaceutical Benefits Scheme (TLVFS 2009:3).

An authorisation from the MPA is required to distribute prescription medicinal products to consumers. Only dispensing pharmacies (regular pharmacies in Sweden) can obtain this authorisation. New actors can enter the Swedish pharmacy market (Apoteket's exclusive right to sell prescription and non-prescription medicinal products to Swedish consumers was abolished in 2009).

Under the Act on Trade in Non-Prescription Medicinal Products, non-prescription medicinal products can be distributed to consumers by dispensing pharmacies or other sales outlets. Retailers other than pharmacies (for example, grocery stores and convenience shops) can sell certain types of non-prescription medicinal products (such as painkillers of limited strength sold in small packages). The retail sale of non-prescription medicinal products in places other than pharmacies must be notified to the MPA.

Under the MPA Regulation on Import of Medicinal Products for Personal Use (LVFS 1996:5), a private individual can order medicinal products from outside Sweden by, for example, mail order or the internet, if the individual can prove that the product:

If the product is a prescription medicinal product, the individual must also prove that they received the prescription from a person authorised to issue prescriptions in the EEA.

The import of medicinal products from a non-EEA country requires a manufacturing authorisation or a specific import licence. It is illegal to order medicinal products from a non-EEA country through the internet or mail order without an import licence, regardless of whether the products are intended for personal consumption. The MPA can grant exemptions but in practice these are rarely given.

The Act on Trade in Medicinal Products defines "wholesale" as an activity including the purchase, possession, export, supply or sale of medicinal products that does not constitute retail trade. Retail trade is defined as the sale of medicinal products to consumers, regions, municipalities, hospitals or other health care facilities as well as to those that are authorised to prescribe medicinal products. A licence is required to engage in wholesale distribution activities. A holder of a Swedish wholesale licence can also engage in some retail trade, such as with hospitals.

An application for a wholesale licence must be submitted to the MPA. The application must be in writing and contain certain information and documentation, including information on the:

A wholesale licence can only be granted to wholesale distributors that have proven capable of meeting certain specific requirements in the Act on Trade in Medicinal Products, such as requirements regarding the suitability of the facilities used and the appointment of a qualified person. In addition, a wholesaler must, among other things:

A wholesale licence allows the holder to engage in the export of medicinal products to countries outside the EU/EEA as well as the bringing in of medicinal products from another country within the EU/EEA. The import of medicinal products from countries outside the EU/EEA requires a manufacturing licence issued by the MPA.

The MPA monitors compliance with wholesale licences as well as with the laws and regulations applicable to the distribution of medicinal products by, for example:

The licence holder must provide necessary assistance in connection with MPA inspections.

The MPA can issue injunctions and prohibitions, sometimes under the penalty of a fine, to ensure compliance with, for example, the Act on Trade in Medicinal Products. A wholesale licence can be revoked by the MPA due to non-compliance with applicable laws and regulations and the requirements for the licence. A decision by the MPA can be appealed to the Administrative Court.

The import of medicinal products from countries outside the EU/EEA requires a manufacturing licence or a specific import licence issued by the MPA.

For a licence for the import of medicinal products to be granted by the MPA, the applicant must, among other things, comply with good manufacturing practice (GMP). In addition, all importers acting under a manufacturing licence must have a qualified person to be responsible for, among other things, verifying that each batch of medicinal products coming from a third country:

The sale of parallel imported medicinal products requires a licence from the MPA. Under the MPA Regulation on Parallel Imported Medicinal Products for Human Use (HSLF-FS 2022:8), a licence is granted if the following conditions are fulfilled:

A licence for a parallel imported medicinal product is granted for five years and can be extended for an indefinite period.

The repackaging or re-labelling of parallel imported medicinal products requires a manufacturing licence issued in an EEA member state. The labelling and package leaflet must be designed in accordance with the MPA Regulation on Packaging and Labelling of Medicinal Products for Human Use (HSLF-FS 2021:96), which requires information to be written in Swedish. Foreign text on packages may be accepted if it does not conflict with the Swedish text.

The Swedish licence for the parallel imported product expires if, for example:

Under the Trade Marks Act, the trade mark holder can impede parallel import if the condition of the products has changed, deteriorated or there are other reasonable grounds to do so.

As a main rule, repackaging of products is not allowed without the trade mark holder's permission. However, there is an exception that allows repackaging under the following conditions:

Issues have arisen relating to parallel imports of medicinal products and IP law, especially in relation to repackaging and trade marks. In 2013, the Stockholm District Court rejected the respondent's claim that repackaging was objectively necessary, and found that the respondent had violated the claimant's trade mark (Decision T 13704-11).

In another dispute, the Supreme Court found that alteration of a trade mark by the parallel importer on sticky labels was objectively motivated and did not violate the trade mark owner's right (NJA 2006 s. 380)).

On 18 February 2022, the Patent and Market Court of Appeal confirmed that parallel importers, despite the new rules on medicinal products in Directive 2011/62 on the prevention of the entry into the legal supply chain of falsified medicinal products and Commission Delegated Regulation (EU) 2016/161 laying down detailed rules for the safety features appearing on the packaging of medicinal products (together, the Safety Rules), must still prove that it is objectively necessary to replace the original package of medicinal products (case PMT 8284-20). The parallel importer was not able to show that statements made by the MPA entailed that the MPA's interpretation of the Safety Rules implied a general requirement for parallel importers to repackage medicinal products. Consequently, the parallel importer had not proven that it was objectively necessary to replace the original packages and was therefore considered to have committed trade mark infringement.

The Medicinal Products Act contains specific rules on the advertising of medicinal products. In addition, the MPA has issued a regulation clarifying and specifying the rules on advertising of medicinal products for human use in Sweden (LVFS 2009:6) (Advertising Regulation 2009). The responsibility for supervision and enforcement of the Medicinal Products Act and the Advertising Regulation 2009 lies with the MPA as the supervisory authority.

In addition, the general provisions of the Market Practices Act (SFS 2008:486) apply to advertising of all kinds of products and services, including medicinal products. The Act imposes a general requirement that all marketing must be compatible with good marketing practices and fair to consumers and the industry. The Swedish Consumer Agency and/or Consumer Ombudsman supervise the marketing of medicinal products under the Market Practices Act.

The Radio and Television Act (SFS 2010:696) also applies to the advertising of medicinal products, among others, in television broadcasts, radio broadcasts and so on.

Detailed rules on the advertising of medicinal products can also be found in the LER Rules issued by the Swedish Association of the Pharmaceutical Industry (LIF). Although not legally-binding, the LER Rules are widely recognised by the pharmaceutical industry and applied by courts as an expression of fair and ethical marketing. Members of LIF are contractually bound by the industry code. The LER Rules cover a range of issues related to marketing directed at health care professionals (HCPs) or the general public, including:

Compliance with the LER Rules is monitored by the LIF Information Examiner Committee (IGN). The IGN is responsible for investigating cases and imposing sanctions, both on its own initiative and in response to complaints. IGN decisions can be appealed to the Information Practices Committee (NBL).

The Market Practices Act defines marketing as "commercial advertising and other business measures intended to promote the disposal of and access to products, including a business proprietor's acts, omissions or other measure or behaviour before, during or after the sale or delivery of products to consumers or business proprietors".

The Medicinal Products Act does not contain any definition of "advertising" in the context of medicinal products. However, the legislative bill preceding the Act refers to the definition provided in Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive). The Medicinal Products Act explicitly provides that vaccination campaigns against infectious diseases are exempted from the general prohibition on the advertising of prescription medicinal products to the general public.

The LER Rules apply to any information, regardless of medium, provided by the pharmaceutical industry in connection with marketing operations directed at HCPs or the general public. Generally, what constitutes "advertising" or "marketing" is very broad in Sweden, and most information on medicinal products emanating from a pharmaceutical company is considered to be marketing material. Therefore, not only do traditional commercials or brochures fall within this definition, but also for example the unsolicited distribution by a pharmaceutical company of a scientific article mentioning a company's products.

Information on medicinal products that is non-promotional (and that is protected by the constitutional right of freedom of speech) is not covered by the LER Rules. Information that is generally considered to be non-promotional includes information on human health, health care or diseases, such as disease awareness campaigns, as well as general company information.

Under the Medicinal Products Act, the MA holder of a medicinal product must have a specific division in place with scientific competence to supervise the information on the product.

Under the LER Rules, pharmaceutical companies must appoint a competent person among the executive staff to be responsible for ensuring compliance with regulatory requirements and for supervising the company's external information and marketing practices.

The appointed person must:

The LIF secretariat must be annually informed of appointed persons and of any changes in responsibilities. These rules apply to medicinal product information aimed both at HCPs and the general public.

Pharmaceutical advertising does not have to be approved by a regulator, as requiring a general pre-approval of this kind by a Swedish authority would be contrary to the Swedish Freedom of the Press Act (SFS 1949:105).

However, the LER Rules allow pharmaceutical companies to provide public access on demand to easily understood information on prescription medicinal products through websites. Such information must be pre-approved by the IGN and have as its factual basis what is stated on Fass.se and the SPC, as approved by the MPA. The pre-approved website must contain patient-appropriate information on the correct use of the medicinal product in question. To enable the IGN to carry out its task of monitoring product information provided online by pharmaceutical companies, the LER Rules require such companies to send new, up-to-date medicinal product information to the IGN (such as publications, advertisements, invitations, or information on websites) within a reasonable period after the medicinal product information was put in use or in any case within three months.

The Medicinal Products Act does not cover the issue of comparative advertising, but the Market Practices Act contains some general provisions in this regard. Among other things, a comparison must not discredit or denigrate a competitor or take unfair advantage of the reputation of a competitor's trade mark, trade name or other distinguishing symbol.

The LER Rules also provide detailed guidance regarding comparative advertising, under which:

A fair comparison requires, among other things, that the:

The main rule under the Medicinal Products Act and the LER Rules is that the advertising of medicinal products that are not authorised for sale in Sweden is prohibited. Equally, it is prohibited to advertise indications or dosages or other variations that are not approved in Sweden. The MPA and the IGN/NBL strictly monitor the market to ensure compliance with these prohibitions.

As an exception to the main rule, information on an unauthorised medicinal product or indication can be sent to an HCP in response to a specific request and only to the extent required to meet the request. Any other dispatch of such information to HCPs is normally regarded as unlawful pre-launch marketing. However, information on medicinal products that does not qualify as marketing and that is protected by the constitutional right of freedom of speech can be distributed to and discussed with HCPs before the MA. Information on unauthorised medicinal products can be made available at, among other things, scientific meetings, provided that it does not constitute disguised advertising. Sponsorship of the meeting by the company manufacturing the medicinal product in question will increase the risk of the information being considered unlawful marketing.

Provided that it is not disguised advertising, information on an unauthorised medicinal product or indication and the off-label use of medicinal products can be published in scientific journals and in articles written by independent journalists.

Swedish case law has regarded press releases about medicinal products as unlawful marketing based on the purpose of the information, linkage to an upcoming authorisation and the availability of the information. In 2013, the Administrative Court of Appeal upheld the lower instance's judgment that altered the (until then) longstanding view that press releases aimed at journalists and news editors did not constitute marketing and were protected by the constitutional right of freedom of speech. Instead, the Administrative Court applied a wide definition of marketing, held that journalists belonged to the general public and found that a press release about a prescription medicinal product constituted unlawful marketing. The Court also considered it relevant that information published online was technically available to anyone, even if it had to be actively sought and could not be obtained by accident. In a more recent case, the NBL did not consider a press release regarding clinical trial results to constitute marketing (and therefore not did constitute prohibited marketing of an unauthorised medicinal product), concluding that an assessment had to be made of the overall content and purpose of the press release.

Internet advertising of medicinal products is subject to the same rules as advertising in any other Swedish media, that is, primarily the:

The NBL has taken the view that a website falls within its jurisdiction if the website is aimed at the Swedish market (under the country of destination principle).

According to IGN/NBL case law, no particular website security is required, provided that it is clearly stated on the website whether it is aimed at HCPs or at the general public. A common solution is to ask visitors entering the website to answer whether they are HCPs, and to thereafter present different medicinal product information on the site depending on the answer.

A company providing access to information through a link from a website it sponsors is responsible for the content of the information and its compliance with the LER Rules. However, a company is not liable for any reverse linking undertaken independently by another party.

In addition, the LER Rules include specific guidelines on the marketing of non-prescription medicinal products on mobile phones and tablets, that is, digital platforms where the viewers' field of vision is limited. According to the guidelines:

The LIF has also adopted special guidelines on compliance with the LER Rules in the use of digital channels.

The MPA is responsible for supervision and enforcement of the rules on advertising under the Medicinal Products Act. The MPA primarily seeks voluntary corrections in cases of non-compliance, but if the result is not satisfactory, the MPA may issue a prohibitive injunction subject to fines or refer the case to the NBL. The MPA may also notify the Consumer Ombudsman, who may issue a prohibitive injunction subject to fines for non-compliance or, depending on the sanctions sought, initiate action under the Market Practices Act.

The Market Practices Act provides for several remedies or sanctions depending on the nature of the violation. Available sanctions include:

An action relating to advertising in breach of the Market Practices Act can be brought before the Patent and Market Court by the Consumer Ombudsman or by a trader.

Although many cases on the advertising of medicinal products are regularly handled by courts and the MPA, a great number of these matters are handled by the two self-regulatory bodies IGN and NBL. The IGN monitors the market and can open or refer a case to the NBL without a formal complaint. Private persons and companies (including competitors) can bring actions on advertising transgressions before the IGN. The IGN and the NBL also have contractual authority to fine LIF members for violating the LER Rules (up to a maximum of SEK500,000). If a violation is serious, the IGN or NBL can also instruct the pharmaceutical company to make a corrective statement.

The advertising of prescription medicinal products as well as of unauthorised medicinal products or indications to the general public is explicitly prohibited under the Medicinal Products Act and the LER Rules (with the exception for vaccination campaigns against human infection diseases). However, advertising of non-prescription medicinal products to the general public is permitted (except to children under the age of 18 years).

The Medicinal Products Act states that all advertising of medicinal products must encourage the rational use of the medicinal product by presenting it in a way that is up-to-date, factual and balanced. The advertising must not be misleading and must otherwise be in accordance with good marketing practice.

The Medicinal Products Act requires the advertising of medicinal products to the general public to:

The Advertising Regulation 2009 also sets out restrictions on information included in the advertising of a medicinal product to the general public. For example, such advertising must not include any material that:

The general provisions of the Market Practices Act (see Question 9) impose a general requirement that all marketing must be compatible with good marketing practice and fair to consumers and the industry. The Market Practices Act also sets out specific rules on, among other things, misleading advertising, comparative advertising and special offers.

The LER Rules contain detailed provisions on advertising of medicinal products to the general public, including rules about, for example, comparative advertising, misleading, incomplete or unsubstantiated information, and disguised promotion. The LER Rules also set out minimum requirements as to the information to be included in advertising of medicinal products to the general public, such as the name of the medicinal product and necessary warnings or limitations to its use.

Under the MPA's Advertising Regulation 2009, free samples of medicinal products authorised for sale in Sweden can be provided to:

The promotional supply of samples of medicinal products to any other recipient is explicitly prohibited.

In addition, medicinal product samples can only be supplied in a very restrictive manner and if the following conditions are met:

Under the LER Rules, a maximum of one sample per year can be provided to the same person. Samples of prescription medicinal products can only be provided if they are of new medicinal products that have been publicly available for less than two years (a new strength or a new pharmaceutical form without a new indication is not considered to be a new product). Medicinal product samples must not constitute an incentive to recommend, prescribe, purchase, supply, sell or administer specific medicinal products.

Interactions with and support of patient organisations are governed by a specific chapter in the LER Rules. The following fundamental principles serve as guidance for all collaboration between pharmaceutical companies and organisations:

The LER Rules contain basic rules that always apply to the collaboration, including restrictions in relation to meetings, collaboration projects and sponsorships. For example, pharmaceutical companies must not provide gifts to organisations and their representatives or to patients, with the exception of product-neutral information and educational material and items of medical utility where the material both:

The Medicinal Products Act, the MPA's Advertising Regulation 2009 and the LER Rules do not contain any explicit definition of "health care professionals" or "health care organisation" in the context of advertising of medicinal products. However, the MPA's Advertising Regulation 2009 contains specific rules on marketing directed towards persons qualified to prescribe or dispense medicinal products.

Similarly, the LER Rules contain rules governing information that, in connection with marketing of medicinal products, is targeted at physicians, dentists, pharmacists or other personnel within Swedish health care or distribution of medicinal products. According to the LER Rules, an advertisement for a medicinal product for which the relevant SPC is available at any time via Fass.se must, if the SPC is not reproduced, include at least the below information if sent to these medical professionals:

The information must always be correct, up-to-date, verifiable, and detailed enough for the recipient to be able to assess the medicinal product's value as a treatment. If the advertisement contains quotes, numerical data or diagrams from a scientific study, or a comparison of medicinal products based on such a study, reference must be made to the source.

Great care must be taken when gifts or other benefits are offered to public or private medical practitioners, as what can be received is strictly regulated.

Any individual who gives, promises, or offers improper remuneration to an employee in relation to their work duties may be guilty of bribery under the Criminal Code (SFS 1962:700). Bribery is broadly interpreted, and cash benefits are generally considered improper, including, for example:

Benefits directly related to and constituting a natural and useful part of the employee's work duties are normally not considered improper, provided they fulfil the applicable requirements. Such benefits include:

Under the LER Rules:

The LER Rules directly ratify the 2013 EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Health Care Professionals and Health Care Organisations and apply to all companies within the pharmaceutical sector that target or are active on the Swedish market.

A "transfer of value" is defined as any direct or indirect transfer or value, in cash or in kind, in connection with the development or sale of medicinal products irrespective of whether for promotional purposes. Direct transfers of value are those made directly by a pharmaceutical company to or for the benefit of a recipient. Indirect transfers of value are those made on behalf of a pharmaceutical company by a third party (such as a subcontractor, a co-operation partner or affiliate) to or for the benefit of a recipient, provided that the company knows or can identify the recipient.

Transfers of value made during each calendar year must be disclosed annually in Swedish (and preferably also in English) in the form provided in Appendix 1 of the LER Rules in a designated section of LIF's online co-operation database or on the company's own website. Transfers of value that must be disclosed include:

As a main rule, the transfers of value made per year must be disclosed on an individual basis for each identifiable recipient where reasonably allocable to one of the above categories.

In addition, the LER Rules provide that, for example, collaborations between pharmaceutical companies and organisations or individual patients as well as development projects between pharmaceutical companies and health care must be published in LIF's online co-operation database.

See Question 16.

For an invention, including a medicinal product, to be patentable, it must be all of the following:

There is an exception to the novelty condition relevant for medicinal products. An invention having to be novel does not prevent granting a patent for a known substance or known composition of substances for use in a method for surgical or therapeutic treatment or a diagnostic method, provided that the substance or composition is not known for the method.

The Patents Act (SFS 1967:837) and the Patents Regulation (SFS 1967:838) apply.

There are three types of patents:

The following cannot be patented:

The Patents Act includes the following provisions specifically relating to the life sciences industry:

Patents of new uses of known substances are available under Swedish regulation (second medical uses). A patent can be granted on a known substance or mixture of substances for use in a procedure for surgical or therapeutic treatment or for diagnostic purposes, if the use of the substance or mixture of substances is not known in any such procedure. A patent can also be granted for a known substance or mixture of substances for a specific use in a procedure for surgical or therapeutic treatment or for diagnostic purposes, if such use is not known.

Life sciences related provisions in the Patents Act are often a result of specific EU legislation. As a member of the EU, Sweden is obligated to transpose EU directives in the patent field. Directive 98/44/EC on the legal protection of biotechnological inventions (Biotech Directive) is an example of a directive that has been incorporated into Swedish law.

At national level, the Swedish Intellectual Property Office (SIPO) (Patent- och registreringsverket) administers patent applications and maintains the official patent register.

The SIPO website contains information about the requirements and the application process. It also contains application forms and access to an electronic application service.

Patent applications must, among other things, include information about the inventor. If the applicant is not the inventor, it must clarify how it obtained the rights to the invention.

The application must also include a detailed description of the invention, stating its area of use and presenting the problem to be solved and the solution. The description must be comprehensive enough for a person skilled in the relevant technical area to be able to apply the invention. As there is limited scope to change or supplement the description after submission, the application should include all information necessary to explain the invention.

The applicant must pay a filing fee and supplementary fees for, among other things, each patent claim in addition to the first ten. If the patent is granted, a granting fee and annual fees must be paid. Current fees are available on the SIPO website.

The inventor or its successor-in-title can apply for a patent with the SIPO. The claims, description and abstract can be in English, although a translation into Swedish of the patent claims must be submitted within two months of a notice of intention to grant. In addition, the patent holder can in certain circumstances also be requested to provide translations into Swedish of the description and abstract.

After a patent application is filed, the SIPO performs an initial check to see whether the application meets certain formal requirements. Certain information in the application, such as the applicant's name and address, is published as of the filing date. However, the content of the application is kept confidential for up to 18 months from the filing date or priority date. Unless the application is rejected or dismissed, it is published 18 months after the filing date or priority date.

The SIPO carries out a substantive search and technical examination, during which it:

The SIPO aims to process applications within seven months and render a final decision within two years from the filing date, although the time period can vary significantly.

If the applicant has filed a patent application in another country that is a signatory to the Paris Convention for the Protection of Industrial Property 1883 (Paris Convention), the WTO, or another country with corresponding legislation, it has the right to, within 12 months, file an identical application in Sweden and claim priority from the first application. An applicant wishing to claim priority based on a previous application must do so within 16 months of the priority date, or within four months of the filing date of the new application, whichever is later.

If a patent application is rejected, the decision can be appealed to the Patent and Market Court (Patent- och Marknadsdomstolen) within two months.

Objections to patent applications can be submitted by anyone during the application process. The SIPO will take any objections into account when assessing applications. An objection cannot be based solely on the invention not being new on the filing date because it was practised publicly. Such cases can only be examined by the SIPO if presented in oppositions.

Claims of "better rights to the invention" can be submitted to the SIPO by anyone who believes it has ownership rights to an invention that someone has submitted a patent application for. On request, the SIPO can transfer the patent application in its entirety to the claiming party. If the SIPO is not able to decide who has the rights to the invention, it can serve the claiming party with a notice to bring court proceedings within two months.

Oppositions to the patent can be filed within the nine-month period after the patent is granted. The applicant is immediately notified if an opposition is filed. When the nine-month period is over, the SIPO reviews the oppositions and decides if the patent can be upheld, either as granted or in amended form.

The existence of a patent dispute does not prevent regulatory review of an application for a pharmaceutical's approval. The MPA does not take IP issues into account in its assessment.

A patent is effective for 20 years from the day the patent application was filed.

An annual fee must be paid after filing the patent application, otherwise the application will be dismissed or, following grant, the patent will lapse. Details of current fees are on the SIPO website.

A patent cannot be renewed.

Supplementary protection for a period of up to five years can be granted for:

Medicinal products that have been authorised for the paediatric population and that have been granted supplementary protection can enjoy an additional six months of protection under Regulation (EC) 1901/2006 on medicinal products for paediatric use.

It is possible to intervene in the regulatory proceedings of a generic product, and possible to appeal a decision made by the MPA to an Administrative Court, such as a decision by the MPA to grant an MA for a specific medicinal product or a decision on substitutional products under the Medicinal Products Act (SFS 2015:315).

In addition, it is possible to oppose a MPA decision on the substitutability of a generic product before a final decision is made. Before making the final decision, the MPA will send a referral for consideration to all concerned MA holders on the proposed decision, giving the MA holders an opportunity to express their opinion on the parts of the proposal that concerns them.

A patent safeguards the exclusive right to commercial exploitation of the patented invention. The exclusive right conferred by a patent implies that the patent holder has an exclusive right to:

A patent is infringed when a person without the patent holder's consent takes any of the actions described above.

A patent holder claiming patent infringement can submit an application for summons to the Patent and Market Court.

The remedies available under the Patents Act are:

The public prosecutor can bring criminal proceedings if the claimant has reported the crime and a prosecution is necessary in the public interest. To date, this has never been the case. Therefore, normally the claimant must bring proceedings itself.

Another effect that follows a successful infringement claim is the reimbursement of litigation costs. As a main rule, the losing party must reimburse the winning party for all its litigation costs (including, among others, costs for counsel, witnesses and experts, and the party's own costs).

Research exemption. Research and development work carried out in relation to a generic on third-party patented products is exempted from the patent holder's exclusive right under the Patents Act, if it is done with the object of obtaining an MA.

IP exhaustion. Under Swedish law, anyone who acquires a copy of a patented invention with the patent holder's permission can use, rent or resell the copy in the EEA. The same is provided for non-patented products under the Trade Marks Act. There is no exhaustion for copies placed on the market in countries outside the EEA. The patent or trade mark holder's permission is required to import such copies into the EEA.

Other exemptions. Further defences to a patent infringement action include:

Preparation in a pharmacy of a medicinal product in accordance with a physician's prescription in individual cases, or acts with the medicinal product so prepared, is not considered infringement.

During the period of an SPC, EU-based manufacturers of generic medicinal products and biosimilars are, under certain conditions, allowed to commence manufacturing and storing for either:

Sweden is a party to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Sweden is a party to the:

The case law of the European Patent Office (EPO) is considered by the Swedish Patent and Market Courts and has a considerable impact on their decisions in patent cases.

Sweden is a party to the:

The Trade Marks Act (SFS 2010:1877) and the Trade Marks Regulation (SFS 2011:594) apply. Sweden has implemented Directive (EU) 2015/2436 to approximate the laws of the member states relating to trade marks (New Trade Marks Directive).

Registering a trade mark provides exclusive rights to prevent third parties from using a mark in the course of trading that is either:

An unregistered trade mark can acquire the same protection as a registered trade mark if it is used in such a way that the mark becomes known as a sign for the goods or services provided under it. If the mark is only known as a sign for goods or services provided under it in a certain part of Sweden, it is only protected in that part of Sweden.

Company names are protected under the Company Names Act (SFS 2018:1653), under which registered or established company names enjoy protection against identical and confusingly similar trade names. A bearer of a characteristic surname is protected under the Name Act (SFS 1982:670) against third parties using their name as an indicator of trade origin, if such use would be disadvantageous to the bearer of the name.

To be eligible for registration, a trade mark must be:

The requirements to be distinctive and not descriptive do not apply where the mark has become distinctive through use.

A medicinal product brand can be registered as a trade mark under the Trade Mark Act in the same way as any other brand.

Registration is not allowed if, for example, the mark is intended to mislead the public or is contrary to law, regulations, principles of morality or public policy.

At national level, the SIPO administers trade mark applications and maintains the official trade mark register.

The applicant must pay a filing fee and a supplementary fee for, among other things, each class in addition to the first. Instructions, application forms and information on current fees can be found on the SIPO website.

The MPA also examines the name of a medicinal product in connection with MA approval.

The application must be written in Swedish, unless the SIPO in an individual case decides otherwise, and must include:

An applicant wishing to claim priority must do so before the trade mark is registered and must indicate the time, place, applicant and application number of the priority application. The SIPO may direct the applicant to prove its right to priority by filing:

If the formal requirements are fulfilled, the SIPO examines whether there are any grounds for refusing registration of the mark (for example, if the mark is confusingly similar to an earlier trade mark or business name). If no grounds are found, it takes about three months to obtain trade mark registration. However, the time period can vary significantly.

The registration is published in the Swedish Trade Mark Gazette (Svensk varumärkestidning). Oppositions can be filed within three months of registration. Examples of grounds for opposition include that the mark applied for:

If an application is rejected, the decision can be appealed to the Patent and Market Court.

As a general rule, Swedish competition law mirrors the EU competition framework, and the Swedish Competition Authority/courts must as far as possible ensure that Swedish competition law is interpreted and implemented consistently with EU competition law.

The key legislation is the Competition Act (SFS 2008:579), amended in 2021 to implement Directive (EU) 2019/1 to empower the competition authorities of the Member States (ECN+ Directive).

The Competition Act, as well as the EU competition rules, contain two main prohibitions against:

It also contains rules on anti-competitive sales activities by public entities and merger control.

The Competition Authority (Konkurrensverket) is the Swedish regulatory authority responsible for safeguarding competition and supervising public procurement in Sweden. It can initiate investigations of potential infringements of the Competition Act. If necessary, it can require companies to supply information and relevant persons to appear at a hearing. It can also carry out unannounced inspections (dawn raids).

If the Competition Authority finds that a company is infringing the prohibition against anti-competitive co-operation or the prohibition against abuse of a dominant position it can, for example:

The Competition Authority's recent activities include the following matters:

Commercial contracts and other business arrangements relating to pharma products can constitute anti-competitive co-operation if they restrict the parties' freedom in certain inappropriate ways. Issues in this respect are governed by the Competition Act, particularly the prohibition on anti-competitive co-operation. For example, similar to EU competition law, Swedish competition law generally prohibits resale price maintenance and passive sales restrictions.

Regulation (EC) 316/2014 on the application of Article 101(3) of the TFEU to categories of technology transfer agreements (Technology Transfer Block Exemption Regulation) is also relevant to licensing technology or patenting, since it applies directly in Sweden.

There are no statutory restrictions on licensing or transferring patents to foreign parties, or on IP transfers for inventions funded or partially funded by public investment. There are certain restrictions on the disclosure of inventions relating to defence and munitions, but they are not relevant in this context.

There is no requirement for a patent or trade mark licence agreement and payment of royalties under it to a foreign licensor to be approved or accepted by a government or regulatory body.

A patent or trade mark licence can be registered with the SIPO but this has no effect against third parties. Generally, such agreements are considered enforceable against third parties from the date of the licence.

The Consumer Agency has overall responsibility for supervising manufacturers' compliance with the Product Liability Act (SFS 1992:18). The Consumer Agency shares this responsibility with other authorities, which are responsible for certain specific products or risks.

The MPA monitors the pharmaceutical market and is responsible for the regulation and surveillance of the development, manufacturing, and sale of medicinal products. The MPA can:

Decisions by the MPA can be appealed to the Administrative Court.

A patient who suffers personal injury from using a particular medicinal product can bring an action under the Product Liability Act (SFS 1992:18). Damages can be claimed for injuries caused by a product due to a safety deficiency (that is, the injuries were caused because the product was not as safe as could reasonably be expected). A patient can also bring a claim under the Tort Act (SFS 1972:207).

The Pharmaceutical Insurance Association (Läkemedelsförsäkringen) (LFF) provides a voluntary no-fault insurance scheme for its members through the insurance company LFF Service AB. The insurance covers personal injury caused by adverse reactions to a medicinal product that a member company has provided for use on the Swedish market.

A large majority of the pharmaceutical companies conducting business in Sweden are members of the LFF.

The Pharmaceutical Injury Panel issues advisory opinions on matters concerning compensation from the LFF insurance scheme (available at http://yttrande.lakemedelsskadenamnden.se/).

To be entitled to compensation under the Product Liability Act, the claimant must prove that:

Under the Tort Act, the claimant must prove that there was a causal link between the injury and the use of the medicinal product. No-fault liability does not apply (as it does under the Product Liability Act), so the claimant must usually prove negligence.

Product liability claims under the Product Liability Act and the Tort Act are generally brought before a Swedish district court. Such a judgment from a district court is made public.

The LFF insurance scheme covers personal injuries that are likely to have been caused by adverse reactions of medicinal products that could not have been expected. The injury must be more severe than the underlying disease. However, there are exemptions from the coverage, such as injuries caused by misuse or incorrect administration of the medicinal product.

The following can be held liable for damages:

The Patient Safety Act (SFS 2010:659) provides that HCPs must perform their work in accordance with medical findings and well-established practices. The Health and Social Care Inspectorate (Inspektionen för vård och omsorg) (IVO) supervises HCPs. If an HCP is considered not to have performed their duties in accordance with the requirements of the Patient Safety Act, the IVO can report the HCP to the Health Care and Medical Services Disciplinary Board (Hälso och sjukvårdens ansvarsnämnd) (HSAN), which has the authority to revoke an HCP's licence. A decision of the HSAN can be appealed to the Administrative Court.

Due to the difficulties of receiving compensation under the Tort Act there are very few cases where patients claim damages directly from the hospital or physician. Patients usually turn to patient insurance (which hospitals must take out under the Patient Injury Act) or the LFF insurance scheme to receive compensation for injuries caused by treatment or medicinal products.

The defendant can avoid liability under the Product Liability Act if it can prove any one of the following:

In tort, the defendant can avoid liability if it can prove that, for example:

The limitation period for a claim based on the Product Liability Act is three years after the party suffering the damage became aware of, or should reasonably have become aware of, the damage and the identity of the person liable. This claim cannot be made ten years after the product was put into circulation, regardless of the injured or damaged party's state of awareness.

Claims based on the Tort Act have a limitation period of ten years.

Claims based on the LFF insurance scheme have a limitation period of ten years from the day the individual stopped using the medicinal product.

Natural or legal persons, certain non-profit organisations and certain authorities can initiate a group claim under the Group Claims Act (SFS 2002:599) if, among other things:

The group claim covers group members who declare within a certain period that they want to be included in the claim. The judgment is binding on all group members.

A company held liable under the Product Liability Act or in tort must pay damages for injury caused. Generally, the injured party can claim compensation for:

There is no upper limit on the amount of damages. The damages depend on the injury in question. However, damages paid due to a court action in Sweden are generally low compared to those in other jurisdictions.

Punitive damages are not allowed for product liability claims.