Life Sciences & Pharma IP Litigation 2024 Comparisons

Revocation Actions

Subject to the exclusive jurisdiction of the Unified Patent Court in revocation actions relating to European patents that have not been opted out, European patents (except Unitary Patents) and Danish patents and utility models can be made subject to administrative re-examination proceedings or revocation actions before the Danish courts. There is no requirement for standing. Thus, any person is entitled at any time after grant to file a request for re-examination with the Danish Patent and Trademark Office (DKPTO) or to initiate a revocation action before the Danish courts.

Infringement Actions

The typical scenario in infringement actions before the Danish courts is that the registered rights holder is included as a plaintiff. Co-ownership of rights is not addressed in the Danish Patent Act or the Danish Utility Model Act. Presumably, each of the co-owners can instigate an infringement action, with or without the consent of other co-owners.

The Danish Patent Act is based on an assumption that an infringement action can be brought by a licensee, but an exclusive or non-exclusive licensee should be able to prove that it has been licensed by the registered rights holder to take enforcement action. It is possible to register a licence, but it is not a requirement for a licensee to bring an infringement action. Moreover, it is not a requirement for the registered rights holder to be joined in an infringement action. However, in the event of a counterclaim for revocation, the defendant must join the registered rights holder to the proceedings.

In infringement actions, the defendants will typically be the local distributors of the allegedly infringing products, eg, local subsidiaries of manufacturers and/or the registered national representative pursuant to a marketing authorisation (MA). In some cases, wholesalers or pharmacies may also become involved as defendants. Public bodies are generally not involved, but the DKPTO must be notified in writing about any action for the revocation of a patent or utility model.

PI Proceedings

Preliminary injunction (PI) proceedings are available and common in Denmark.

In theory, PI proceedings can be conducted ex parte, but there have only been a very limited number of examples of that, and it is highly unlikely to happen in practice within Life Sciences and Pharma cases. For that reason, it is of limited practical significance that it is further not possible to file protective letters with Danish courts.

Filing an application for a PI against infringement of patent rights requires that a patent with effect in Denmark has been granted. In relation to European patents, a translation of the claims into Danish must have been filed and validated.

Requirements for Grant of a PI

Under the relevant provisions of the Danish Administration of Justice Act, the applicant must prove or render it probable that:

• the applicant has the right that it seeks to have protected by a PI;
• the defendant’s behaviour makes it necessary to grant a PI; and
• that the purpose would be defeated if the applicant had to await the courts’ decision in an action on the merits (periculum in mora).

There is also a general requirement that other remedies are not adequate, including in light of a bond offered by the defendant, and that the grant of a PI must be a proportional remedy, but none of these conditions generally give rise to much consideration in PI proceedings relating to intellectual property (IP) rights. As such, a PI is considered the primary legal remedy and does not amount to a test for balance of convenience.

An application for a PI can be based on the threat of an infringement, provided that the applicant can prove or render it probable that the defendant’s behaviour makes it necessary to grant a PI. Applying for and obtaining the grant of a MA has been held to not be sufficient for the grant of a PI, whereas participating in a tender for the supply of a medicinal product should be sufficient. In most circumstances, registering a price in the official Danish medical product price register should also be sufficient to render it probable that the defendant’s behaviour makes it necessary to grant a PI.

There is no requirement of urgency as such, and the timeframe within which PI proceedings have to be initiated in the face of actual or threatened infringement depends on the specific circumstances. It has been held to imply that the condition for periculum in mora was not satisfied where the rights holder had initiated an infringement action before making an application for a PI.

Process

An application for a PI will be served on the defendant, generally by digital notification, or if that fails through the assistance of a summoner, in case of a domestic defendant. In the case of a foreign defendant, service will generally be done in accordance with the rules of the EU Service Regulation or the Hague Convention. The timing for service is generally only a few weeks for domestic defendants, whereas it is difficult to predict in case of foreign defendants. Only upon service of the application will the defendant be given a deadline for filing a Statement of Defence, generally within 4–6 weeks. Further exchange of written pleadings is the rule, and all parties can file any manner of evidence, including expert reports.

The defendant can make all defences generally available under Danish law, including invalidity and non-infringement defences. Defendants should be aware that the Danish courts operate a presumption in favour of the validity of rights registered after examination, and that non-infringement defences therefore generally have a better chance of carrying through in PI proceedings.

An oral hearing will be conducted, which can take several days. Evidence will be taken, including cross-examination of witnesses and experts, and the parties will make oral arguments.

Timelines

The oral hearing usually takes place 4–5 months after the application for a PI has been served on the defendant, although the timelines may be longer in extraordinarily complex cases. It takes an additional 6–8 weeks for the court to render a decision.

Validity and infringement are dealt with in the same proceedings in actions before a court. It is possible to file a revocation action before the courts even though patent office opposition or re-examination proceedings are ongoing, but the revocation action may be stayed pending the outcome of opposition proceedings. However, re-examination proceedings will be stayed if a revocation action is initiated.

Revocation Actions

A revocation action can only be initiated when the patent or utility model has been granted. In relation to European patents, it is probably a requirement that a translation of the claims into Danish must have been filed and validated.

In principle, a revocation action can be initiated even after expiry of the patent or utility model.

Infringement Actions

There are no deadlines for filing an infringement action as such, but generally applicable rules in Danish law on a right holder’s failure to act (passivity) as well as the Statute of Limitations may become available as defences to a defendant in the event of a delay. Claims for damages arising out of IP infringement become statute-barred three years after the plaintiff knew or ought to have known about the factual circumstances upon which the claim is based, and in no event later than ten years after the act of infringement.

Process

The complaint that initiates a revocation or infringement action will be served on the defendant in accordance with the procedure and timelines outlined in 1.3 Preliminary Injunction Proceedings.

An exchange of pleadings and filing of evidence generally follows, with the defendant typically being given 6–8 weeks from service of the complaint to file a Statement of Defence. The number of pleadings and the time between them will vary depending on the nature of the action, including whether any formal objections are being made.

A characteristic feature of Danish actions on the merits is the use of court-appointed technical experts, which it will generally be necessary to make use of in any revocation or infringement action. That part of the process, involving the submission of questions to, and the procurement of, written answers from the expert(s), will generally follow an initial exchange of a set of pleadings and a case management conference conducted by the court. Upon receipt of answers from the experts, a further exchange of written pleadings generally occurs, and the experts give testimony at the oral hearing.

Thus, the process concludes with an oral hearing of up to several days. The court will not issue a preliminary opinion before the oral hearing.

Timelines

A timeline for revocation or infringement actions in Denmark can vary, based on factors such as complexity of the case, including whether a counterclaim for revocation is made in an infringement action, the court’s dockets, and any potential appeals of decisions on formal questions along the way.

It should be expected for it to take around 1½ years before the oral hearing, with an extension of up to one year in the event of the appointment of court-appointed experts. It will take an additional 1–2 months for the court to render a decision.

See 1.3 Preliminary Injunction Proceedings.

The rights holder will have the burden of proving the alleged infringement, except that the burden is reversed in the case of a process patent claim relating to a novel product.

Denmark does not have a formal pre-action discovery process like that of other jurisdictions, such as the US. In Denmark, the filing of evidence generally takes place after an action has been initiated. However, it is possible to formally take evidence prior to lodging a revocation or infringement action by means of a special mechanism. The evidence thus taken can be relied upon in a subsequent action.

Under Danish law, search and seizure orders are applied for in proceedings separate from a main action. The main requirement is that the applicant must render it probable that the defendant has infringed, or will infringe, a particular IP right and that there is evidence of the infringement and its scope at the premises to be searched. Taking, inter alia, the need to protect trade secrets into account, the court must also consider whether it will be a proportionate remedy to conduct the search. After the conduct of a search, the court will release a report detailing the findings of the search to the applicant. As a general rule, there will be no restrictions attached to the use of the information of that report. Within four weeks from having received formal notice from the court that the search and seizure is completed, the applicant must initiate a main action.

Applying for declaratory relief is not commonly used in practice under Danish law, but it would in principle be possible to apply for a declaration of non-infringement. The party seeking declaratory relief would have the burden of proving non-infringement, which could cause issues in relation to the need to disclose specifics about the product- or process-in-suit that it would otherwise be the rights holder’s burden to prove. The general requirements for standing under Danish law would apply, meaning that there must be a current and specific dispute. This entails that an application for declaratory relief should not be brought prematurely before the courts.

The Danish courts apply a doctrine of equivalents, but there is no fixed formula for establishing infringement by equivalence. Weight has been attached to:

• whether the essential feature(s) of the invention are manifested in the product-in-suit;
• whether the differences over the claim are immaterial; and
• whether the differences are obvious to the person skilled in the art.

It is generally considered that the doctrine of equivalents cannot extend so far as the patent claim covering the prior art, but the extent to which a Formstein Defence would apply under Danish law is not clear.

There is no obligation under Danish law to “clear the way” ahead of a new product launch.

Experts are almost always involved in patent litigation in Denmark, where they provide opinions on questions related to validity as well as to infringement. There is a distinction between PI proceedings and main actions as the parties can involve their own experts in PI proceedings, whereas the court will appoint experts for a main action. For an outline of the relevant processes, see 1.3 Preliminary Injunction Proceedings and 1.5 Timing for Main Proceedings on Infringement/Validity. For a party’s own experts, there is no duty owed to the other party or the court as such, and there are no specific procedures for instructing those experts. However, there are certain customs for dealing with expert evidence, and the expert must answer all questions, including in cross-examination, truthfully.

Overall, it is not common to file results from experiments as such and there are no specific procedures for doing so. However, it would be possible to do so, and it would need to be taken into consideration whether, in the specific circumstances, it would be relevant or necessary to have an experiment conducted by, or be subject to, the involvement of a court-appointed expert.

With respect to discovery and disclosure given by the claimant and defendant, the starting point is that each party is free to determine which evidence to file and which information to give, and the decision is generally very fact-specific. Usually, the plaintiff in an infringement action will be able to provide, to some degree, evidence of the composition of the product-in-suit or process-in-suit, but the defendant may equally wish to provide evidence of that in support of a non-infringement argument.

There is a range of statutory defences and exceptions to patent infringement of which the most frequently relied upon are consent/licence, invalidity/counterclaim for revocation, non-commercial use, exhaustion, experimental use/Bolar exemption and prior use. Compulsory licences are available but would have to be applied for and would accordingly not be dealt with as a defence to infringement.

A main action can, and often will, be stayed pending the outcome of opposition proceedings, most notably before the EPO.

Foreign case law, in particular relating to parallel proceedings, may be taken into consideration by the Danish courts, but it is rare for decisions to expressly refer to the findings in such foreign case law. Based on the relatively high degree of harmonisation between the patent laws of these countries and Danish patent law, there is a tendency to consider case law from the other Nordic jurisdictions to be the more persuasive.

There have been only a few examples of attempts to amend patent claims during litigation. In a recent case before the Eastern High Court, it was held not to be allowable to amend the claims of a utility model during litigation. The effect of Article 128(3) of the EPC, does not appear to have been settled in Danish law.

The Maritime and Commercial High Court is the first instance patent court in Denmark, and it hears applications for PIs as well as main actions. The court is composed of three judges out of which one is a legally qualified judge while the rest are technically qualified judges, often European Patent Attorneys. In precedential cases, the bench may be increased to three legally qualified judges.

With regards to infringement in respect of small molecule pharmaceutical products, the relevant question will generally be whether there has been an offer for sale of the medicinal products. In relation to acts constituting infringement in that regard, see 1.3 Preliminary Injunction Proceedings.

For second medical use claim patents, it is possible and necessary to skinny-label the generic medicinal product. The rules in Danish law on generic substitution provide a robust framework for mitigating against infringement in relation to medicinal products that are dispensed from pharmacies, which will generally be small molecule medicinal products.

Subject to authorisation from the Danish Medicines Agency (DKMA), parallel imports from EU and EEA countries are allowed. The originator must be informed of any contemplated parallel import.

In terms of IP rights, it would be the parallel importer/distributor’s burden to prove that relevant IP rights have been exhausted.

Data and market exclusivity is provided for by virtue of the relevant EU Regulations and the transposition into Danish law of the provisions of Directive (EC) No 2001/83, including by virtue of an Administrative Order on Marketing Authorisation for Medicinal Products.

Danish law is in line with applicable EU law. Thus, data submitted in support of an application for a MA is subject to eight years of data exclusivity from the first MA and an additional two years of marketing exclusivity. The period of exclusivity may be prolonged/extended by an additional period of one year if, during the first 8 years, the MA holder obtains an authorisation for one or more additional therapeutic indications, which brings a significant clinical benefit in comparison with existing therapies.

Orphan medicinal products benefit from ten years of market exclusivity once they receive a MA. During this period, member states must not accept another application for a MA or grant a MA or accept an application to extend an existing MA, for the same therapeutic indication, in respect of a similar medicinal product. The period may, however, be reduced to six years, if at the end of the fifth year, it is established that the criteria for designation as an orphan medicine are no longer met. For paediatric medicines, the period may be extended to 12 years.

Challenges to data and market exclusivity are not common in Denmark, but there have been a few examples of an action being filed to enforce data and market exclusivity.

A broad version of the Bolar exemption has been implemented in the Danish Patent Act, which allows any act necessary to obtain a MA for a medicinal product for human use or a veterinary medicinal product. Thus, the exception applies regardless of whether the medicinal product is a generic, and regardless of whether the MA is applied for in Denmark, the EU or a third country. No Bolar exemption has been provided for in the Danish Utility Model Act, but that might be of limited practical consequence as the maximum term of a registered utility model is ten years. Moreover, a general experimental use exception has been provided for under the Danish Patent Act as well as the Danish Utility Model Act.

A list of medicinal products and plant medicinal products with MAs granted by the DKMA is available via the website of the Medicines Agency, with the possibility of retrieving the associated Supplementary Protection Certificates (SPCs). This service does not give access to the MA as such, and it does not provide any information on related patents. It is possible to make freedom of information requests for access to a MA or a pending application, but those are rarely successful. The holder of a MA for a reference medicinal product will not be notified of the filing of an application for a generic or biosimilar MA.

There is no patent linkage in relation to the rules on pricing and reimbursement for expenses for medicinal products in Danish law.

The rules on generic substitution in Danish law allow the holder of a MA to notify the DKMA about a patented indication for a medicinal product, which will enable the DKMA to not make an approved generic or biosimilar substitutable within the patented indication. However, these rules affect only the dispensation of medicinal products at pharmacies. Purchases through tenders organised by the central purchasing entity of the Danish hospital operator, Amgros I/S, generally will not be indication specific, and this can give rise to complications in relation to second medical use claim patents. There have been no examples of an enforcement action being taken against Amgros I/S.

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. The tendering practices of Amgros I/S may be said to have particular significance for biologics and biosimilars, as large molecule medicinal products are generally only dispensed through hospital pharmacies in the Danish healthcare system.

SPCs are granted by the DKPTO in accordance with the applicable EU Regulations relating to medicinal products and plant protection products as supplemented by provisions in the Danish Patent Act and an Administrative Order on Patents and Supplementary Protection Certificates. In both cases, the patent term can be extended for up to a maximum of five years for the product and protected use in question, provided that the MA for the product is the first authorisation of that product as a medicinal product or plant protection product and that no SPC for the product has previously been granted. The basic patent must protect the product in question and be in force with effect for Denmark at the time the application for a SPC is filed. The applicant must be the registered holder of the basic patent. If several basic patents protect the product, several applicants can obtain a SPC for that product. If a basic patent protects several products, a SPC for each product can be granted. The DKPTO will treat an application relating to a combination product in accordance with the same rules and administrative practice as is applied to products with only a single active ingredient.

The SPC manufacturing waiver introduced in the EU Regulation on SPCs for medicinal products applies to SPCs granted by the DKPTO.

Paediatric extensions of six months of the term of a SPC for a medicinal product are available in accordance with the provisions of the applicable EU Regulation.

The concept of an undertaking for damages is not used in Danish law, but the grant of a PI will typically be conditional upon the applicant posting a bond. The quantum is fixed at the discretion of the court but is intended to be in reasonable proportion to the likely damage that the defendant can be caused by the PI. Actual amounts are somewhat modest.

The court will hand down a written decision on an application for a PI. A PI will enter into force and be enforceable upon posting of the bond, and there is no requirement for service of the decision on the defendant.

If a PI is granted, the applicant will have to initiate an action on the merits within two weeks after the decision to grant the PI becomes final, ie, after expiry of the term for filing an appeal (four weeks) or after a decision on an appeal.

An appeal against a decision to grant a PI will not have suspensive effect.

A PI may be enforced by the Enforcement Courts, assisted by the Danish Police, upon application from the PI applicant. Such enforcement action is rare in practice but must be expected to be executed relatively swiftly.

Final injunctions typically become enforceable 14 days after the court hands down a written decision in the infringement action and would not be conditional upon the posting of a bond. There is no requirement for service of the decision on the defendant.

A decision to grant a final injunction can be appealed against within a term of four weeks. An appeal against a decision granting a final injunction made within two weeks will have suspensive effect.

There is no basis in statute law or case law for a Danish court to have discretion to award damages in lieu of a final injunction. It may be that proportionality arguments can play a role in limiting the scope of preliminary injunctive relief, but there are no examples of this in Danish case law.

Claims From the Rights Holder

Under the Danish Patent Act, the rights holder is entitled to claim an amount in compensation for infringement corresponding to (i) equitable remuneration and (ii) damages for any additional damage caused by the infringement. The rights holder is always (ie, regardless of whether the rights holder has suffered a loss in the specific circumstances) entitled to claim equitable remuneration. If the rights holder can prove to have suffered damage in the form of a loss in excess of what constitutes equitable remuneration, it is entitled to damages for the balance.

The amount of any equitable remuneration is to be determined on the basis of what the rights holder would have demanded in remuneration for granting a licence. In the absence of any evidence of the specific rights holder’s past practice, there is a tendency in case law to consider standards within the industry/technical field in question. With the caveat that cases about compensation for IP rights infringement turn very much on the specific facts of the case and the arguments made by the parties, case law suggests that the default rule could be a royalty rate of around 5% of the sales price of an infringing product. Damages will typically be calculated on the basis of lost sales, and case law suggests that the rights holder has a claim for damages corresponding to lost gross profits. In theory, it is possible to take account of the infringer’s profit, but that has rarely been a decisive factor in Danish case law. The rights holder may also claim damages for other types of losses that have been caused by an infringement. Punitive damages or other special damages awards are not available.

Damages accrue as of the time of the infringement, but interest, fixed in accordance with the Danish Act on Interests, will not be payable as of a date prior to when a claim for compensation has been made.

A claim for damages can be heard together with the hearing on infringement or in a separate hearing following that, depending on the specific circumstances.

A decision on an award of damages can be enforced after two weeks if an appeal against it has not been lodged by then.

Claims From the Alleged Infringer

An applicant for a PI is strictly liable for damages caused by a PI, which is subsequently held to have been wrongfully granted. Awards on this basis have been rare in practice but would typically be determined in the main action that has to be initiated on the back of a PI. A specific consideration in these cases is the possible presence of several generic or biosimilar players on the market.

Claims From Third Parties

Provided that negligence can be proven, claims for damages from third parties, including public healthcare payers, are in principle possible, but there have been no examples of such claims being made.

Pursuant to the Danish Administration of Justice Act, legal costs, which are deemed to have been reasonably necessary for the proper conduct of the case, are recoverable by the prevailing party. This will typically not amount to full recovery of all expenses actually incurred, as expenses for representation (ie, lawyers’ fees) are recoverable with an amount deemed suitable by the court (normally in the range of 60–80% of costs actually incurred) whereas costs for assistance from technical experts will normally be fully recoverable. In accordance with the Enforcement Directive, legal costs incurred before filing action can be recoverable. There will be no interim award, as the court makes a decision on legal costs in connection with its decision on the substantive issues. Costs awarded will generally be payable within 14 days of the decision, subject to the suspensive effect of an appeal in a main action.

Under Danish law, the courts have discretion to deviate from the main rule that the prevailing party is awarded legal costs in special circumstances, and it is possible that the conduct of the plaintiff could be a factor in making a decision to exercise this discretion.

Although cases have been seen in recent years, trade mark disputes within life sciences and pharma are not that common. The cases seen are primarily related to either parallel import or repackaging issues in general. However, it is of particular relevance that a number of cases concerning the interpretation of the Falsified Medical Products Directive (Directive 2011/62/EU) are pending before the Danish courts. The outcome of these cases will likely shape key practices for parallel importers for years to come.

Copyright disputes within life sciences and pharma are not commonly seen in Denmark, but could occur, eg, if the package insert instructions in a medicinal product are copied.

The Danish Trade Secrets Act and the Danish Marketing Practices Act are relevant for the protection of trade secrets under Danish law. Contractual obligations pursuant to, for example, an employment agreement, are also relevant in practice, and play a particular role in connection with churn of employees in R&D functions, etc. Recent years have seen an uptake in the number of disputes within life sciences and pharma relating to trade secrets.

PI Proceedings

See 5.1 Preliminary Injunctive Relief for deadlines for filing an appeal.

The subsequent timing of the appeal case depends largely on the court’s docket and the number of days required for an oral hearing, with up to one year until the oral hearing and a further 4–6 weeks for a written decision to be handed down not being an uncommon timeline.

Where a patent is overturned on appeal or is revoked, eg, by EPO, the PI is not automatically revoked but application to revoke the PI must be made.

Main Action

See 5.2 Final Injunctive Relief.

The subsequent timing of the appeal case again depends largely on the court’s docket and the number of days required for an oral hearing, and it should be expected for 1½–2 years to pass until the oral hearing and a further 4–6 weeks for a written decision.

De Novo Hearing

In all cases, an appeal is heard de novo and it may even be possible to introduce fresh arguments or evidence, but it will generally be necessary to consider how to concentrate the case.

Further Appeal

An appeal of a decision from the High Court is generally only available upon the grant of a leave to appeal from the Appeals Permission Board, subject to a requirement of the case being of a precedential nature.

Overturning an Injunction

An appeal case may lead to a preliminary or final injunction being lifted by the High Court. Injunctions are typically crafted in such a way as to enjoin an act only for as long as the patent is in force.

It will therefore generally not be necessary to apply for having an injunction lifted in the event of the patent being revoked in a revocation action. It is, however, possible to apply to have a PI lifted ahead of the decision in the main action that has to be initiated by the applicant for the PI.

An appeal against the decisions of the Maritime and Commercial High Court can be made to the High Court, where the general rule is that the appeal will be heard by three legally qualified judges with the possibility of including one or two technically qualified judges.

There are no special procedural rules applicable to proceedings relating to IP.

Denmark is a party to the UPC, but the effects of the advent of the UPC are still to be felt in Denmark.

An Application for Actions pursuant to the EU Customs Regulation can be filed with the Danish customs authorities and is generally quite an effective remedy.

It is possible under Danish law for parties to agree to arbitration proceedings, and there have been some examples of that being used as an alternative to court proceedings within life sciences and pharma. In addition, the Danish courts can facilitate mediation, but that mechanism is not commonly used.

It is not unusual for patent cases to be settled at some point during a main action. There are no competition law considerations arising specially out of Danish law to be made in that connection, but Danish competition authorities could apply particular scrutiny to settlements that are thought to be detrimental to public healthcare sector payers’ interests, such as innovations on “pay-for-delay” agreements.