As long as a patent is in force, any party may initiate an action to have the patent revoked, including individual co-owners and third parties such as licensees.
The patentee and an exclusive licensee – ie, a licensee that has the exclusive right to make, sell and/or put the invention on the market ‒ has standing to commence an action for patent infringement. Registration or recording of an exclusive licensee is not required in order for it to bring an action.
The patentee does not need to be joined as a party to the infringement action. However, if infringement proceedings are commenced by a licensee, the patentee must be notified. The same applies if the patentee brings an action – licensees registered in the official patent register must be notified.
The parties in life sciences/pharma actions in Norway are, almost without exception, manufacturers of pharmaceuticals. The Norwegian Industrial Property Office (NIPO) is required to be notified if a revocation action is initiated, but they have no role in revocation or infringement actions between pharmaceutical manufacturers.
Preliminary injunctions (PIs) are available in Norway, including ex parte PIs. A PI is available on the condition that the claimant establishes as probable that there is either:
Moreover, the claimant must establish that an injunction is necessary, as pursuing the claim would otherwise be substantially more difficult or cause substantial harm or inconvenience. Additionally, the court must find that an injunction is justified when taking into account the interests of both parties. Upon granting a PI, the court may order the claimant to provide a guarantee for compensation to the defendant in the event that it is later established that the injunction was unjustified.
A patentee should not delay in commencing the PI action once they become aware of potential imminent infringement or actual infringement. A warning letter with a short deadline (normally two weeks, or shorter if there is urgency) should be issued first, followed by filing a request for a PI fairly soon thereafter ‒ normally within two to four weeks. Note that protective letters are not available in Norway.
Inter Partes PIs
The timeline in inter partes PI proceedings is typically as follows.
The verdict may be appealed within a month to the court of appeal, which normally will assess the matter based on the written pleading and evidence.
Ex Parte PIs
The criteria for obtaining an ex parte PI are based on extreme urgency and the threat of substantial harm to the patentee’s interest if inter partes proceedings are allowed. The threshold for the grant of an ex parte injunction in Norway is high in pharma patent cases. In complex patent cases, they are rarely granted.
In Norway, revocation claims and infringement claims are dealt with in the same proceedings.
A typical timeline for a revocation and/or infringement action in Norway is as follows.
Infringement actions are normally brought on the basis of a granted patent. In theory, an infringement action can be filed before the grant or validation of a patent, but there are very few examples of this in practice.
There is no pre-action discovery/disclosure as such in Norway.
One may, however, initiate measures for securing of evidence prior to proceedings. This is relevant if the evidence is at risk of being lost otherwise. Additionally, securing of evidence prior to proceedings is possible if done in order to provide an opportunity to assess a claim and possibly reach an amicable settlement.
The securing of evidence ‒ specifically, information related to patent infringement – can under certain conditions be obtained prior to an action for infringement. The securing of evidence does not necessarily imply that the claimant may obtain access to the evidence, especially if the evidence is confidential. As mentioned earlier, the claimant must show that:
A request for such evidence may also be made ex parte if there is reason to fear that notice to the opposite party could lead to obstruction of the securing of evidence. If granted, the opposite party will be allowed an oral hearing. The petitioner shall, in that case, not be allowed access to the evidence until the ruling is final.
The issue of confidentiality may be resolved by the court appointing an expert to look into the material and give the court advice concerning the relevance of the material and its suitability as evidence in the case at hand. The petitioner pays all costs ‒ including those of the defendant ‒ in this kind of procedure, which is very rarely used in patent matters. The authors are not aware of examples where it has been used in pharma patent litigation.
Note that materials obtained by discovery or disclosure requests in other jurisdictions can be used in Norwegian proceedings.
Norway has implemented quite a similar customs regime to Customs Regulation (EC) No 1383/2003, under which the court can issue a PI ordering the custom authorities to seize products if importation of the products will constitute infringement of IP rights. An injunction can be issued even where the recipient of the products is unknown. If necessary, a PI can be issued without an oral hearing of the evidence.
The customs authorities can also, ex officio, decide to withhold goods for up to ten days if they have reasonable grounds to suspect that the goods will constitute infringement of IP rights. If the goods are withheld, notice shall be given to the recipient of the goods and the patent owner. To prevent further release of the goods, the patent owner must obtain a preliminary injunction.
Declaratory relief is, in principle, available in Norway, both in the form of declarations of non-infringement as well as in the form of “arrow declarations”.
Norwegian courts recognise a Doctrine of Equivalents (DoE). The legal test follows from the Norwegian Supreme Court decision in the “Donepezil” matter (Rt-2009-1055).
The three questions to be answered in the DoE are:
If these three questions are answered affirmatively, infringement of the original patent can be established. The Norwegian DoE is, however, rather narrow in scope. According to the Supreme Court in the above-mentioned decision, protection by equivalence is a matter of claim construction and can only encompass modifications that are “fairly identical” to the features set out in the patent claim.
Filing a claim for revocation and/or a non-infringement declaration is often used as a strategy to “clear the way” before the launch of a new product. However, there is no legal obligation for a potential competitor to clear the way ahead of product launches.
In matters where complex scientific issues are involved in terms of validity and/or infringement, the party-appointed experts will normally submit reports and provide testimony during the proceedings.
In a PI action, the court will normally appoint independent expert witnesses with particular expertise in the relevant field. Typically, two court-appointed experts will attend the hearing including the evidence; at the end of evidence, they will deliver a report and also expand their view by oral testimony to the judge. Thereafter, it will be for the counsel to put further questions to the court-appointed experts – following which, the experts will leave the courtroom and not take any more part in the proceedings.
In an action on the merits, with infringement and/or validity issues at hand, there will be no court-appointed experts as per PI proceedings; instead, expert lay judges will be appointed by the court. They will typically have technical expertise in the relevant field. In some pharma patent litigation cases, the expert lay judges have comprised one technical expert (eg, a professor in biochemistry) and a patent attorney working within life sciences.
The expert lay judges participate during the hearing as members of a panel of three, including the patent judge. In the court of appeal, this will be a panel of five (including three legal judges).
Results from experiments may be filed as evidence in order to prove/disprove infringement/validity of patents and Norwegian courts allow experiments in patent cases. There are no specific procedures that must be followed in order for the experimental results to be admissible; however, the courts will assess the relevance of the experiments based on the protocols of the experiment(s).
In response to an infringement claim, the defendant will normally provide evidence in the form of a product or process description. Confidential information in such descriptions may be redacted.
The most relied-upon defence against an infringement claim is a counterclaim for invalidity. A separate claim for revocation must be filed, leading to the validity and infringement being assessed in the same case before the Oslo District Court.
Another ground for defence is that the defendant is entitled to a compulsory licence. Other available defences include the defendant being entitled to a prior use right on the basis that they were already using the invention before the priority date, experimental use and exhaustion. For life sciences cases, the Norwegian “Bolar” exemption is particularly relevant (see 2.4 Publicly Available Drug and Patent Information).
As the Oslo District Court is the mandatory venue both for infringement cases and revocation actions, infringement and revocation actions will be joined and heard together in most cases. Thus, the infringement proceeding will normally not be stayed.
When Norway acceded to the European Patent Convention (EPC) on 1 January 2008, the Patents Act was amended with a provision stating that a court may decide to stay a trial until a final decision concerning the same patent is delivered by the European Patent Office (EPO). In practice, this also applies to Norwegian patents granted nationally, but the court will normally only stay the proceedings if a decision from the EPO can be expected within a few months. The fact that the validity of a corresponding patent is disputed in another country is normally not considered directly relevant for proceedings in Norway.
If invalidity or revocation proceedings are pending before both the NIPO and a court at the same time, one of the actions will be stayed. In most cases, this will be the proceedings before the NIPO.
A patent can be amended in administrative proceedings before the NIPO or in a trial before the court. After the opposition period, a patent may also be amended upon request by the patent owner. Amendments can be made to the claims or the description.
Furthermore, the patent holder may file auxiliary requests to the court in revocation/cancellation proceedings. The amendments made in the auxiliary requests must not extend the scope of the patent as granted.
The Oslo District Court has a panel of judges with particular experience in patent matters, who will hear all cases brought before the court. However, requests for PIs must be initiated in accordance with the general law on civil procedure ‒ meaning that the venue will normally be either the district court where the alleged infringer has its headquarters or, alternatively, the court at the place of infringement. If an infringement action or revocation action is already pending, the venue for the request for a PI must be filed to the Oslo District Court.
As mentioned, in proceedings on the merits there will be two appointed expert lay judges in both the first and second instance. These expert lay judges will be accompanied by one legal judge in the first instance and three legal judges in the second instance. The expert lay judges are normally appointed upon (often joint) proposal from the parties and have their background within the technical field to which the case relates.
Expert lay judges cannot be appointed in PI proceedings, but it is common to use court-appointed experts in such proceedings. These experts are not associated with any of the parties and will be appointed to assist the legal judge in their assessment of the case. They are not part of the panel of judges, but will hear the trial and deliver an opinion on the matter in open court. Often, they also deliver a written opinion.
An application for a marketing authorisation (MA) is not an infringing act, and will not in itself be considered sufficient for the grant of a PI. However, the court will consider if there are additional circumstances that ‒ together with the grant of an MA ‒ constitute sufficient evidence that infringement is either imminent or likely in the near future.
A communication to customers of the intended launch date after patent term expiry will normally be viewed as an offer to deliver after expiry; this is generally considered an infringing act in Norway. Responding to a request for tender, where supply would take place after expiry of the relevant rights, may equally be classed as an act of patent infringement. In theory, a PI application could be made on such basis, but the authors are not aware of any such PI being granted in Norway.
EU legislation on data and market exclusivity is included in the EEA Agreement and implemented in Norwegian law under the Norwegian Medicine Regulation of 18 December 2009 No 1839 (NMR).
Chapter 3 of the NMR, as a main rule, distinguishes between an eight-year period of data protection (Section 3-10(c) and 3-10a(b)) and a ten-year period of market protection (Section 3-11(b) and 3-11a (b)) (the “8+2 system”). During the two-year period after expiration of the data protection, the market protection prohibits the placing on the market of a generic medicinal product but does not prohibit preparatory actions prior to putting the product on the market.
In addition, under Chapter 3, Sections 3-11b and 3-11d, the MA holder of the reference product may qualify for another year of market exclusivity if the MA holder is granted further marketing authorisation for a significant new indication for the relevant medicinal product (the “8+2+1 system”).
However, Chapter 3 of the NMR does not distinguish between the data and market protection where the reference product application was filed prior to:
NP applications filed in the period between 1 November 2005 and 12 January 2010, and CP applications filed prior to 1 November 2005, enjoy a ten-year period of data protection with no additional market protection period (Sections 3-10(b), 3-10a(a), 3-11(a) and 3-11a(a)). NP applications filed prior to 1 November 2005 enjoy a six-year data protection period with no additional market protection period (Sections 3-10(a) and 3-11(a)).
The Bolar exemption introduced in Directive 2001/83/EC Article 10(6) has been implemented in the Norwegian Patent Act Section 3(3) No 5. The Bolar exemption applies to patents and Supplementary Protection Certificates (SPCs) covering pharmaceuticals, and allows the undertaking of “tests, trials and similar” of pharmaceuticals that are necessary for obtaining market authorisation. Furthermore, the Bolar exemption is applicable for obtaining marketing approvals in all WTO-signatory countries ‒ ie, the Bolar exemption is not limited to EU/EEA countries.
As mentioned previously, applying for an MA or a pricing and reimbursement (P&R) decision is not an infringing act and will not in itself be considered sufficient for the grant of a PI. See 2.1 Infringing Acts for exceptions.
Publicly Available Information
The Norwegian Medicines Agency (NOMA), which is the authority responsible for granting MAs and P&R decisions, publishes updates to the following different lists on their website.
In addition, information about granted MAs, P&R decisions, and substitution status is made available in NOMA’s public database (Legemiddelsøk). The database is updated shortly after NOMA has granted the MA. Hence, information may be published in NOMA’s database before the aforementioned lists and databases are updated.
Moreover, the product must be listed in the database of the Association of Pharmacies (Farmalogg). In practice, a product is available on the market when it is included in Farmalogg. This register is also updated on the first and 15th day of each month.
Freedom of Information Requests
Freedom of information requests to NOMA are available under the Freedom of Information Act. Usually, when requests under the Norwegian Freedom of Information Act are made to NOMA, a reference will be made to the published lists and databases without giving any additional information. Additional information about pending applications is generally classed as trade secrets, and therefore excluded from the right to information (see Section 13 of the Norwegian Freedom of Information Act and Section 30 of the Norwegian Medicine Act). NOMA will not notify the generic MA applicant/holder if someone (eg, the MA holder of the reference product) requests information under the Norwegian Freedom of Information Act.
Generally, NOMA will neither consider the patent situation on its own, nor act upon notifications from the patent holder covering an innovative product, when it comes to marketing authorisation, pricing and reimbursement, and generic substitution.
There is one exception, however. According to Section 2.3 of NOMA’s guidelines regarding the substitution list, generic drugs covered by a second indication patent are still added to the substitution list ‒ albeit with the instruction that the drug is not to be substituted if the pharmacy is aware that the drug is prescribed for the patented use. Hence, the holder of a second indication patent will regularly notify NOMA following the grant of an MA to a generic product for which the originator holds a second indication patent.
The holder of the MA for the reference product is not notified of any MA, P&R or listing applications made by a generic or biosimilar, nor of the grant of such applications. Information may be obtained through freedom of information requests or, alternatively, by monitoring publicly available lists and databases (see 2.4 Publicly Available Drug and Patent Information).
See 2.1 Infringing Acts.
See 2.2 Regulatory Data and Market Exclusivity.
See 2.3 Acceptable Pre-launch Preparations.
See 2.4 Publicly Available Drug and Patent Information.
See 2.5 Reimbursement and Pricing/Linkage Markets.
SPC protection is available in Norway. This is regulated by the relevant EU regulations and these have been implemented into Norwegian law by application of the EEA agreement. SPCs are therefore available for patents that cover an authorised medicinal or plant pharmaceutical product.
The relevant law is Regulation 469/2009 concerning the supplementary protection certificate for medicinal products; however, this has been amended at EU level through Regulation 2019/933 implementing the SPC manufacturing waiver. The waiver enables manufacturers of generics and biosimilars to manufacture such medicines for the purpose of exporting them outside the EU during the SPC protection term. After a lengthy process, the waiver entered into force in Norway on 1 February 2023 by amendment of the Norwegian Patents Act Section 62a.
Paediatric extensions are available in Norway and regulated by EU law. The Paediatric Regulation was introduced into Norwegian law and entered into force on 1 September 2017, bringing some statutory amendments that make it possible to apply for a six-month extension to the period of validity of SPCs.
The court may provide for when the PI should be enforced and how long it should last. Enforcement of a PI shall take place as soon as requested by the claimant, and must follow the rules of the Enforcement Act of 1992.
If the court has required a bond in relation to a PI, the PI will not take effect before a bond is in place. The value of the bond is normally calculated on the basis of the potential damage the defendant could suffer in the period before delivery of judgment in the first instance (after which the PI will be lifted, if the defendant is successful).
For a PI to be enforced, the patentee is not required to have commenced a main action; however, the claim in question must normally be established as probable. If a PI is granted, the courts will normally set a deadline for the patentee to initiate main proceedings.
Final injunctions are granted if the claimant is successful at proving at trial that infringement or significant preparatory acts with the aim of carrying out an infringing act took place. Such injunction will normally not be enforceable pending an appeal.
The court will assess the proportionality of a PI in PI proceedings. In such assessment, the court may also take public interest arguments into account.
If requested by the defendant, a court may ‒ in lieu of a final injunction – award a licence against reasonable compensation to the patentee. However, the defendant must establish that there are some special circumstances in order for such a licence to be awarded. To date, this narrow exception has not been used by a Norwegian court.
Damages are calculated on the basis of lost profits. In order to estimate the potential damages exposure, one would need to provide proof of the suffered damages (eg, loss of sales of a generic or biosimilar). The time period for claiming damages based on a patent infringement is three years from when the cause of action accrued. This period will commence at the time of infringement; however, if the infringement has been concealed during this three-year period, the damage claim is not time-barred until the expiration of a one-year period from the time when the claimant should – with reasonable diligence – have discovered the infringement.
Damages are normally assessed as part of the infringement action – ie, there is no separate procedure for establishing the quantum of damages. The infringer is liable for damages in the form of remuneration for the exploitation of the invention and, if applicable, compensation for any further economic loss to the claimant caused by the infringement. The patentee can also choose to claim the infringer’s profits. Thus, the patent owner can either claim their own lost profits, reasonable royalties on sales by the defendant, or the defendant’s profits.
If the infringement has been committed intentionally or through gross negligence, the patentee can claim compensation corresponding to 200% of a reasonable royalty.
With the exception of the option of claiming 200% of a reasonable royalty when the patent infringement was wilful or grossly negligent, punitive damages are not an option under Norwegian law.
Legal costs are normally recoverable from the losing party unless the court decides to reduce the amount, owing to it being unreasonably high. Hence the losing party will typically be required to pay all costs to the party that prevails in a litigation.
The court may decide that the winning party should bear its own costs partially or in full – for example, if the winning party is to blame for the matter coming before a court or has declined a reasonable settlement offer. The Norwegian Dispute Act further provides that a party may recover costs that arise from the counterparty’s conduct, such as censurable actions or omissions that make the procedure more complex than it already is. The parties’ conduct prior to the proceedings is also relevant ‒ for example, if the claimant fails to notify or inform about the existence of relevant evidence.
Trade mark disputes within the life sciences and pharma sector are not very common in Norway. The few cases that have been tried before the courts concern medical devices and repacking issues related to parallel import of pharmaceuticals.
Copyright issues may also arise in the life sciences and pharma sector, but are very seldom litigated before the courts.
Trade secrets disputes have been seen within the life sciences and pharma sector, particularly in relation to a company’s former consultants or employees. The relevant sources of law are the Norwegian Trade Secrets Act of 2021 and the Norwegian Marketing Act of 2009.
A PI decision may be handled in the second instance if appealed. An appeal may be filed within a limited one-month time period. The appellate court will normally only review the case based on the written submissions and evidence.
A judgment in infringement (and/or revocation) proceedings from the Oslo District Court may be appealed to the “Borgarting” Court of Appeal. A court of appeal hearing in Norway implies hearing the case all over again with evidence, expert witnesses and legal arguments; also, new evidence and arguments are allowed. The appeal hearing in the appellate court will normally take place about a year after an appeal was made. A judgment is normally expected within four to ten weeks of the hearing, depending on the complexity of the case.
A further appeal is possible to the Supreme Court; however, leave for appeal is only granted if the appeal raises principal points of law for which guidance from the Supreme Court would be deemed useful. The appeal hearing in the Supreme Court will normally take place within three to five months of an appeal being made to the Supreme Court. A judgment is normally expected two to four weeks after the Supreme Court hearing.
The “Borgarting” Court of Appeal decides patent litigation appeals from the Oslo District Court in the first instance. The appeal is heard by three legal judges and there is no specialisation in patent matters; however, the appellate court will be assisted by two appointed expert lay judges.
An appeal to the Supreme Court is heard by five legal judges and, as in the Court of Appeal, there is no specialisation in patent matters.
The Oslo District Court is the mandatory venue for design, trade mark and patent cases. IP proceedings are, however, dealt with in accordance with the general procedural rules set out in the Norwegian Dispute Act.
The holder of the relevant right may request that the Customs Authority retains goods that are in the authority’s control if there is reasonable suspicion that the importation of said goods will constitute:
This may be done if the infringement consists of an imitation of someone else’s product, characteristic, advertising material or other similar material.
The holder of the right must send an application to the Customs Authority containing, among other things:
The parties are not required to undertake mediation before commencing court proceedings. Nevertheless, according to Section 5-4 of the Norwegian Dispute Act, the parties shall consider whether it is possible to reach an amicable settlement of the dispute before action is brought and shall make an attempt at settlement.
According to Section 8-1 of the same Act, the court shall also ‒ at each stage of the case – consider the possibility of a full or partial amicable settlement of the legal dispute through mediation or judicial mediation, unless the nature of the case or other circumstances suggest otherwise. Mediation or arbitration is, however, not commonly used in patent disputes.
The parties cannot agree upon terms prohibited by Norwegian competition law or EEA/EU competition law. Terms that restrict competition in the relevant market and extend the monopoly conferred by the patent – for example, by restricting the licensee’s use of its own technology – might be unlawful under competition law.
The Latest in Norwegian Life Sciences and Pharmaceutical Intellectual Property Litigation
In the life science industry, where expensive innovation projects, research and development hold the key to advancing healthcare and improving lives, the protection of intellectual property rights, especially patent rights, becomes paramount.
Generally, Norwegian law provides for a strong legal system, including robust protection of patents and other intellectual property rights. The Norwegian court system offers effective and relatively quick case handling in intellectual property litigations.
Norwegian law on intellectual property rights is harmonised with the EU legislation through the EEA Agreement, and Norway is a party to all major multinational agreements relating to intellectual property rights. Furthermore, Norway is a member of the European Patent Office (EPO).
Market development – increased focus on developing the life science industry in Norway
The Norwegian national healthcare system is widely known for its universal healthcare, encompassing both public hospitals and private clinics.
In 2022, the total sales of pharmaceuticals for human use in Norway amounted to NOK25.6 billion corresponding to approximately EUR2.2 billion (calculated according to the pharmacies’ purchase price – AIP). The major part of this amount (NOK25.6 billion) is funded by the government/social security. The sales figures represent sales from wholesalers to pharmacies, hospitals/nursing homes, grocery retailers, and other entities authorised to distribute pharmaceuticals. This constitutes an increase of 2.8% from the previous year and continues the steady increase in total sales that Norway has experienced over time. The sales of veterinary pharmaceuticals amounted to NOK1.9 billion, corresponding to approximately EUR162 million.
Surprisingly, considering the extensive focus on the healthcare system, Norway has historically had little focus on the development of the life science industry and little activity within this sector. This is evident from the fact that, unlike its neighbouring countries, Denmark and Sweden, Norway has no national strategy for developing the life science sector.
However, market actors and lobby organisations are pushing heavily for development in the life science industry, driven in part by a stronger collaboration between the public sector and industry. Historically, there has been, and still is, limited collaboration between private companies, academia, and the health system, which should be strengthened. The physical scene has been set for such stronger collaboration as significant public investments have been made in hospital and R&D infrastructure over the past few years, creating a unique opportunity to generate a return on investment by using those facilities to strengthen such collaboration.
Following the pandemic, the Norwegian Minister of Health and Care Services said that “The COVID-19 pandemic has demonstrated the importance of close collaboration between the different stakeholders in the health and life science sector”. Thus, it appears to be a political will to follow up these investments and pave the way for development within the life science industry in Norway.
Some Norwegian companies have already achieved success in the development of pharmaceuticals for animal use, particularly within the aquaculture sector. While not directly transferable, the experience gained from developing this area of the pharmaceutical sector could serve as inspiration for development in other areas.
Within pharmaceuticals and medical devices for human use, Norway already hosts several growing niches of high-quality research. These niches particularly pertain to research within oncology, immunology, neuroscience and ultrasound. The conditions for strengthening these research fields are greatly supported by the general high levels of public trust, including the willingness to share health data and participate in clinical trials.
It appears that the development is heading in the right direction. The Life Science Cluster, a network for companies and organisations within the life science sector, reported in 2023 a promising pipeline of over 50 companies at an investable stage.
A positive development is anticipated to continue – and increase – in 2024 and the years to follow.
Government measures to keep pharmaceutical expenses down
Generic substitution expanded to biosimilars
In Norway, the practice of generic substitution, after patent (and SPC) expiry, of pharmaceuticals, where the active ingredient is a chemical compound, in pharmacies has been permitted since 2001. In the summer of 2021, the Norwegian parliament (Nw: Stortinget) passed a resolution to expand this system to also include pharmaceuticals where the active ingredient is derived from biological material or by biological processes (biosimilars). This expansion is now reflected in the Norwegian Pharmacy Act Section 6-6, second paragraph. The condition for an original biological pharmaceutical to be substituted with a biosimilar in the pharmacy is that the original and the biosimilar have been assessed by the Norwegian Medicines Agency (NoMA) as being equivalent and interchangeable. Biosimilar pharmaceuticals are biological pharmaceuticals that closely resemble already approved biological pharmaceuticals and are subject to the same requirements for quality, safety, and efficacy as other biological pharmaceuticals.
The Norwegian system of generic substitution in pharmacies is comprehensive. Once pharmaceuticals are placed on the “substitution list” by the NoMA, pharmacies are required to dispense the most inexpensive that is available (ie, a generic product or a biosimilar), regardless of the brand name specified on the prescription by the doctor. However, doctors have the option to reserve against substitution if there are compelling medical reasons to do so. The primary objective of this system is to promote the use of more inexpensive generic and biosimilar medicines when original pharmaceuticals lose their patent protection, thereby reducing costs for both society and patients.
Proposed new tendering system for reimbursed pharmaceuticals from 2024
In the proposed state budget for the upcoming year, the government proposes a further measure to keep control over the government’s expenditure on pharmaceuticals by implementing a tendering system for reimbursed pharmaceuticals as a permanent arrangement starting from 2024. Under this system, pharmaceuticals funded through the National Insurance Scheme will be subject to competitive bidding. Consequently, patients will primarily receive the medicine offered by the winning bidder within each category of medicines. The Ministry of Health and Care Services has estimated that approximately 5% of the active substances covered by the reimbursed medicine scheme may be suitable for tendering.
The Norwegian Medicines Agency plans to put the following medicines out for tender.
The proposal has faced criticism from various stakeholders, including the industry association for the pharmaceutical industry in Norway. Concerns have been raised regarding potential limitations on treatment options, the impact on low-income patients, and the belief that alternative solutions could better achieve the desired cost reduction. To date, the proposal has not been approved by parliament.
Implementation of the SPC Manufacturing Waiver
The SPC Manufacturing Waiver was implemented in Norway with effect from 1 February 2023. It is set out in Regulation (EU) 2019/933, which amends Regulation (EU) 469/2009 on Supplementary Protection Certificates for Medicinal Products (SPC). Regulation (EU) 469/2009 is part of the EEA agreement, and is incorporated into Norwegian law through Section 62a of the Norwegian Patents Act. Regulation 2019/933 is implemented by an amendment to Section 62a.
Regulation (EU) 2019/933 introduced exceptions to the protection conferred by an SPC for products manufactured for export to third countries and for stockpiling purposes. This implies that generic and biosimilar manufacturers will be allowed to manufacture SPC-protected products within the EEA for the purposes of export to third countries outside of the EEA. Furthermore, they will be allowed to manufacture and stockpile such products within the EEA during the final six months of the protection period of the SPC for the purpose of placing the products on the EEA market after the expiry of the SPC. In Norway, these provisions concerning the manufacturing and stockpiling exceptions will only apply to SPCs granted on or after 1 February 2023.
Trends in life science patent litigation
Although the grounds for invalidity in the Norwegian Patents Act have remained unchanged for a long time, it was only common ten years ago and earlier to invoke lack of novelty and inventive step as grounds for invalidity.
However, in recent years, there has been an increasing trend of raising other grounds of invalidity in addition to novelty and inventive step. These grounds include insufficiency of disclosure, including lack of support (so-called Biogen insufficiency), added subject matter, and the argument that the technical effect substantiating an inventive step was not covered by the technical teaching in the patent application. This tendency is evidently inspired by the case law from the European Patent Office and other European jurisdictions, and a consequence of parallel patents being litigated in several European jurisdictions. Below, the authors will discuss some examples of this trend from recent years.
The first instance of this trend appearing in Norwegian patent litigation was in a case between Idenix Pharmaceuticals et al and Gilead, decided by the Court of Appeal in 2016. The case concerned the validity of two pharmaceutical patents, one with Idenix as the proprietor and one with Gilead as the proprietor.
Gilead claimed that Idenix’s patent NO 330 755 was invalid due to insufficiency of disclosure, lack of inventive step, lack of novelty, added subject matter, and that the technical effect of the invention was not made plausible at the filing date.
The Court of Appeal found that Idenix’s patent was invalid due to insufficiency of disclosure. The description in the patent was deemed not sufficiently clear for a skilled person to carry out the invention based on the description at the priority date. Additionally, in an obiter dictum, the Court of Appeal stated that the technical effect was not plausible. Thommessen represented Idenix Pharmaceuticals in the proceedings.
In the fall of 2022, Biogen International filed a request for a preliminary injunction against Sandoz and Laboratorios Lesvi/Neuraxpharm with the Oslo District Court. The requested preliminary injunction concerned the defendants’ generic versions of Biogen’s blockbuster drug Tecfidera® infringing Biogen’s European patent EP 2 653 873, which is validated in Norway.
The defendants claimed that the patent is invalid and based their invalidity claim on various grounds. They invoked added subject matter and insufficiency of disclosure, arguing that the alleged technical effect of the compounds was not made credible in the patent application as filed (so-called Biogen insufficiency). Furthermore, the defendants claimed that Biogen could not rely on an alleged technical effect in the assessment of inventive step.
Oslo District Court found it likely that the patent would be invalidated due to added subject matter and lack of inventive step, and, therefore, the request for a preliminary injunction was dismissed. The Court’s decision to dismiss the request for a preliminary injunction is final. The main validity proceedings are stayed pending opposition proceedings at the EPO. Thommessen represented Neuraxpharm in the proceedings.
A similar argument regarding whether the patentee could rely on a technical effect in the assessment of inventive step was also raised in another Norwegian case this year. In 2022, Teva brought invalidity proceedings against Bristol-Myers Squibb and their Norwegian patent NO 328 558 covering apixaban, the active substance in Bristol-Myers’ blockbuster thrombosis drug Eliquis®. In this case, however, the argument that the technical effect could not be relied upon was invoked only in connection with inventive step.
After the oral proceedings, but before Oslo District Court issued its judgment, the European Patent Office’s Enlarged Board of Appeal issued its long-awaited decision in case G 0002/21, addressing the question of what requirements a patent application must meet for a claimed technical effect to be relied upon in the assessment of inventive step.
The District Court stated that the Enlarged Board of Appeal had abandoned the concept of “plausibility”, and that the decisive factor then becomes an assessment of what a skilled person, based on the patent application on the filing date and in light of common general knowledge in the field, would understand from the application as the technical teaching of the claimed invention.
The District Court concluded that the patent is valid. The judgment has been appealed, and Thommessen is representing Bristol-Myers Squibb in the appeal proceedings.
Finally, concluding the authors’ overview of untraditional grounds for invalidity invoked in Norwegian pharmaceutical patent cases, another patent related to the prevention of thrombosis has been brought before the Oslo District Court. Sandoz initiated invalidity proceedings against Bayer and their Norwegian patent NO 344 278, covering rivoraxaban, the active substance in Bayer’s thrombosis drug Xarelto.
Sandoz, among other arguments, invoked the “several obvious steps” approach as part of the problem and solution method, specifically in the assessment of what was obvious to the skilled person.
The District Court concluded that the patent is valid. The judgment has been appealed.
The Unified Patent Court – the impact of the new patent litigation regime in Norway
As of 1 June 2023, the European Union’s unitary patent and the establishment of the Unified Patent Court (UPC) have come into effect. While Norway is not part of this system, its implications could be significant for Norwegian businesses and foreign companies doing business in Norway.
UPC will now have the authority to decide all patent disputes concerning a unitary patent in the same legal proceeding, with implications for all EU countries participating in the system. Additionally, UPC will also be able to resolve disputes related to traditional European patents (EP patents), which many Norwegian businesses currently possess, unless the patent has been opted out of the system. UPC will serve as a relevant forum for parties seeking a unified enforcement decision across all participating member states, and decisions are expected to be rendered from the very first day of its operation.
What does it mean for Norwegian businesses?
Norway, along with the UK, Switzerland, and certain EU countries, stands outside the UPC system. As a result, unitary patents will not have any legal effect in Norway. Similarly, decisions rendered by the UPC will not have direct implications within the Norwegian jurisdiction. However, it is important to recognise that the UPC system can still have significant consequences for Norwegian businesses, including the following.
In essence, although Norway is not directly involved in the UPC system, Norwegian businesses must carefully consider the potential implications of the system on their patent-related activities, enforcement strategies and legal defences within the European context.
Patent holders have the ability to opt out of the UPC system by submitting a formal request through the opt-out regulations. Opting out maintains the existing situation, meaning that patent disputes will continue to be resolved by national courts as they have been in the past.
For existing European patents, the opt-out can be initiated within a seven-year transition period starting from 1 June 2023. However, opting out is not possible if an invalidity lawsuit has already been initiated against the patent under the jurisdiction of the UPC. For future European patents, patent holders can choose to opt out of the UPC system at the time of patent grant.