Life Sciences & Pharma IP Litigation 2024 Comparisons

Patent infringements typically grant the patent owner the right to initiate legal proceedings. Where a patent has multiple owners, unless an additional agreement has been reached among the co-owners, they are obliged to exercise their rights collectively. This affects, for instance, the issuance of licences, as the consent of each co-owner is required. Regarding patent infringements, however, the Swiss Federal Patent Act (PA) enables each owner to initiate legal proceedings autonomously (Article 33 et seq PA).

If the licensor grants an exclusive licence to the licensee, solely the licensee is entitled to exploit the patent within the designated territory for the duration of the agreement. Consequently, patent infringement actions can only be filed by the licensee, unless expressly excluded in the licence agreement (Article 75 PA). Litigation does not necessarily require the patent owner’s participation and a licence registration in the patent registry is not required for this purpose. Although non-exclusive licensees have no standing to sue on their own, in accordance with the PA, licensees may participate in litigation initiated by patent right holders to receive compensation for their own damages. This rule is of a dispositive nature, meaning that the parties may contractually agree otherwise. The above legislation was introduced in 2008. Hence, the right of licensees to sue infringers requires particular attention in older licence agreements.

The objective of a nullity action is the judicial declaration that the patent has never existed. It is accessible to any person and/or entity which demonstrates an interest in a nullity action. There are no specific requirements regarding proof of interest. In most cases, it is sufficient if the parties compete for the same goods, and such goods fall within the patent’s scope of protection.

Numerous activities, including the import, temporary storage, transit, and resale of goods abroad, may constitute infringements. In the pharmaceutical sector, suppliers, manufacturers and regional distributors are typical defendants. Specific actions performed by medical doctors, pharmacists or similar professionals in connection with medicinal products are deemed outside the patent’s scope (Article 9 PA). Health authorities and similar entities are not required to participate in infringement or nullity proceedings.

Preliminary injunctions (both ex parte and inter partes) are of decisive importance because infringing products may have been commercially available for a significant period prior to a final judgment in the main proceedings. Furthermore, during this period, the patented technology may have become outdated or the patent itself may have expired. Proceedings in Switzerland are, in principle, adversarial – that is, the opposing party is given an opportunity to present its case prior to the handing down of a preliminary injunction. To streamline the preliminary injunction proceedings, a mere exchange of writs is conducted followed by an oral hearing. Ex parte injunctions may be granted in circumstances of extraordinary urgency.

Requirements for a Preliminary Injunction

The following requirements must be credibly demonstrated for a preliminary injunction:

• The plaintiff must demonstrate either ownership or the status of exclusive licensee of a patent that is officially recognised in Switzerland (see 1.1 Claimants/Plaintiffs to an Action), as well as that the defendant is interfering, or threatening to interfere, with the scope of protection of this patent.
• The infringement may have caused the plaintiff to suffer irreparable harm, including due to market confusion, protection by the patent owner’s licensing agreement system, or difficulty in re-establishing a connection with customers who have migrated to another product.
• The plaintiff must have a sense of urgency in initiating proceedings. Absence of urgency is evident when the initiation of main proceedings could have been achieved earlier. Preliminary injunction proceedings before the Federal Patent Court last approximately ten months, while main proceedings last 24 months. The plaintiff forfeits the right to a preliminary injunction when the delay in filing for such an injunction exceeds 14 months from the date of learning of the infringement. Ex parte injunctions require an even higher degree of urgency. Generally, decisions regarding ex parte injunctions are rendered quickly. When necessity dictates, the Federal Patent Court has the authority to render a decision regarding an application on the day it is served.
• Additionally, the extent of the likely damage must be reflected in the measure.

A fact is considered credibly demonstrated when the judge finds the presentation to be “predominantly true”, notwithstanding the absence of complete elimination of doubt. Document-based evidence is required. Other types of evidence are deemed admissible only if they can be presented without delay or if they are required for the purpose of the proceedings.

Amendments to Preliminary Injunctions

Preliminary injunction proceedings are independent proceedings that may be initiated either prior or subsequent to the initiation of the main proceedings. They only offer interim legal protection and are of a provisional nature. Therefore, they are subject to amendment if there is a change in the circumstances on which the preliminary injunction is based. If preliminary injunctions have been applied for prior to the commencement of the main proceedings, the interim judgment must be confirmed in the main proceedings. The court that handed down the preliminary injunctions must set a deadline for filing such confirmation. If this deadline is missed, the injunctions will lapse.

By demonstrating an exceptionally high level of urgency, the court may grant an ex parte injunction without hearing the counterparty in the first step. Concurrent with granting an ex parte injunction, the court either invites the counterparty to a hearing or sets a deadline for the submission of a written statement. After the hearing, or having read the counterparty’s statement, the court decides (again) on the preliminary injunctions.

Typically, the defendant becomes aware of the preliminary injunction through either the court order requiring the submission of a statement or the invitation to the hearing. Court orders and summons are delivered by registered mail. If delivery is not possible, the defendant is obliged to retrieve the court documents from the post office. Seven days after an unsuccessful delivery attempt, service is considered to have been effected even if the documents remain uncollected.

Any presumable defendant may file a caveat to the Federal Patent Court if such defendant expects a counterparty to request an ex parte injunction. The caveat will only be notified to the counterparty if it initiates an ex parte proceeding. It expires six months after submission, although an additional six-month renewal is possible.

It is not mandatory to initiate nullity and infringement proceedings concurrently in the form of a main action and counterclaim. Even if the actions are brought at long intervals, a suspension of one of the proceedings is unusual. Validity is often challenged as a means of defence in infringement proceedings. An initial action brought by the infringer for nullity is rare.

The defence of nullity is examined on a preliminary basis and is inextricably linked to the main proceedings – if the claim in the main proceedings is withdrawn, the defence automatically falls away. Upon confirmation, the defence of nullity enters into force among the disputing parties regarding the ongoing lawsuit. The judgment merely declares the preliminary nullity and does not factor into the judgment dispositive. The patent entry in the register remains intact. Additionally, nullity may be claimed by a counterclaim. Such judgment, if successful, has an erga omnes effect. Consequently, the patent will be revoked.

It should be noted that Swiss patent law provides for a suspension of proceedings under certain conditions for European patents (Article 128 PA; see 1.16 Stays and Relevance of Parallel Proceedings).

An Action for Nullity

In principle, an action for nullity can be initiated at any time. In Swiss civil proceedings, the principle applies that two unrestricted statements may be made on the matter. This necessitates that the defendant raises the nullity defence no later than in the second exchange of writs. An instruction hearing is often scheduled prior to the main hearing. Should this occur prior to the second exchange of writs, then the nullity defence should have been raised during the instruction hearing.

Infringement Claims

In the case of infringement claims, it should be noted that claims for damages or for the disgorgement of profits may be subject to defence of the statute of limitations. A relative three-year statute of limitations applies to unauthorised acts, commencing on the date of identification of the infringer and knowledge of the damaging act or actual damage. An absolute statute of limitations of ten years applies, commencing from the damaging event.

Injunctive Relief, Removal and Declaratory Judgment

Claims for injunctive relief, removal and declaratory judgment are not subject to a limitation period.

Timeline of Lawsuits and Hearings

The Federal Patent Court generally sets a deadline of six weeks for a written response to the lawsuit (see 1.3 Preliminary Injunction Proceedings). Upon reasoned request before expiry of the deadline, an extension of two weeks may be granted. Additional extensions are typically permissible solely with the opposing party’s consent.

An instruction hearing usually takes place before subsequent exchanges of writs. In around 50% of the cases, a settlement is reached at (or before) the instruction hearing. If no such settlement can be achieved, an additional exchange of writs occurs. Typically, a four-week timeframe is allocated for the reply and the rejoinder. In this situation, a two-week extension is permissible, provided a valid request is made prior to the deadline’s expiration.

Panel of Specialists

The Federal Patent Court relies on a panel of specialists as judges. The parties are given the opportunity to provide written comments on the expert judges’ opinions once they become available during the main proceedings.

The plaintiff may file a complaint once the patent has been validly granted and the plaintiff has established the validity of the claims. The patent owner has the burden of proof regarding the alleged infringement. In the absence of such proof, the action for infringement is dismissed.

An exception applies regarding specific process patents. Until proved otherwise, any product that is identical in nature is presumed to have been produced using the patented process, provided that the invention pertains to a process for the manufacturing of a new product (Article 67 PA). This is especially pertinent in the context of pharmaceutical or chemical process patents.

Even prior to the commencement of the main proceedings, the Swiss Civil Procedure Code permits the court to admit evidence on a precautionary basis, provided a credible interest of protection can be demonstrated, which is typically the case if evidence is in jeopardy of being destroyed, lost or altered. In such proceedings, the court also evaluates the likelihood of success in a legal proceeding.

The expenses associated with the precautionary collection of evidence, which may include compensation for the opposing party, are typically borne by the requesting party. If the requesting party subsequently initiates main proceedings and succeeds, the court may order that the expenses associated with the precautionary collection of evidence have to be borne by the losing counterparty.

There is no discovery/disclosure available that is comparable, for example, with such remedies under US law.

The information in 1.7 Pre-action Discovery/Disclosure also applies in general during the proceedings.

Patent law does not require a party to hand over evidence in its possession. Nevertheless, a party can request the disclosure of evidence held by the other party. If the opposing party is unwilling or unable to disclose such evidence, it will only have an impact on the evaluation of the evidence by the court. Search orders are not available under Swiss Civil Procedure law. Preliminary injunctions, however, can lead to the seizure of infringing goods, for example.

The seizure of, for example, infringing products may be achieved by means of a (preliminary) injunction. The requirements are the same as for other (preliminary) injunctions. The destruction of seized infringing goods can only be awarded in the main proceedings.

In Switzerland, actions for a declaratory judgment are typically subordinate to actions for performance. The prerequisite for an immediate declaratory judgment is that the plaintiff can establish a substantial legal interest in receiving a declaratory judgment. This requirement is met if the legal relationship between the parties is ambiguous but can be resolved by means of a judgment. Such ambiguity must, however, be so severe that the plaintiff cannot reasonably be expected to endure its continuation.

For instance, the required interest of a plaintiff for a declaratory (negative) judgment regarding an alleged patent infringement was upheld by the Federal Supreme Court (FSC) in a case where the defendant had issued a cease-and-desist letter to prevent the plaintiff from conducting business with an allegedly infringing product (FSC 129 III 295, E 2.4).

It is worth mentioning that in the context of international relations, a party’s desire to secure a favourable place of jurisdiction for an upcoming court case may qualify as a sufficient interest in a declaratory judgment (FSC 144 III 175).

The doctrine of equivalents is used in Switzerland. According to Swiss court practice, the following three questions must be answered in the affirmative to demonstrate an equivalent infringement:

• Do the features of the possible infringing product have – from an objective point of view – the same function as the features of the original product although they have been replaced (same effect)?
• Is the replaced feature and its equal objective function obvious to a hypothetical specialist (accessibility)?
• Is the patent specification drafted in a manner that a hypothetical specialist would consider the modified features as a solution of equal value (equal value)?

In Switzerland, there is no legal obligation to “clear the way” prior to the introduction of a new product. There is no obligation to challenge another patent in court prior to marketing a pharmaceutical product.

Court expert opinions are considered as evidence, whereas private expert opinions are merely considered as party statements. The parties’ joint commissioning of the expert opinion and the assurance of the expert’s independence are irrelevant. However, a party’s expert opinion can be useful when assessing the chances of winning a legal dispute, attempting to reach a settlement with the opposing party, or initiating a lawsuit that is well founded.

Since the Federal Patent Court employs specialised judges (see 1.5 Timing for Main Proceedings on Infringement/Validity), expert opinions are of lesser significance in patent proceedings. Instances where technical expert opinions are requested are exceedingly rare and occur only when the court is unable to decide the case with its own technically proficient judges. After a court has ordered an expert opinion, all parties involved must be given the opportunity to provide their comments on the expert opinion.

The Swiss Civil Procedure Code exhaustively lists the methods of establishing evidence (testimony, document, inspection, expert opinion, written information, party questioning). An experiment might be requested as part of an “inspection”.

In principle, no evidence is collected ex officio in Swiss civil proceedings. It is the responsibility of the parties to introduce facts and evidence into the proceedings in due time. There are two unrestricted statements on the matter for each party, in which the presentation of new facts and evidence is allowed. Hence, the parties must introduce all new facts and associated evidence in the second exchange of written submissions at the latest, or at the instruction hearing if applicable. Thereafter, the presentation of amendments (new facts and evidence) is only possible in limited circumstances, for example, when new facts have arisen, or the evidence has surfaced after the submission of the second writ. 

However, if one party submits new facts or evidence in its second and final writ, the other party is entitled to provide a response to the newly introduced facts and evidence. Nevertheless, the unrestricted right of reply must be exercised within a reasonable period of time, generally within five to ten days.

Typically, the assertion that a product or process does not infringe the patent is put forward as a defence. Certain acts are excluded by law from obtaining patent protection (Article 9 PA). Examples include actions performed in the personal sphere for non-commercial objectives, actions performed at educational institutions for educational purposes, actions performed as part of a medical activity concerning medicinal products and an individual, or the direct preparation of medicinal products in pharmacies to fulfil a prescription (see also 2. Generic Market Entry).

Swiss patent law grants rights to compulsory licences under specific conditions (Article 36 et seq PA). In all cases involving compulsory licences, it is essential that the applicant has been unable to secure a contractual licence on reasonable market terms within a reasonable timeframe. A compulsory licence may be granted for the manufacture and export of certain patented products. This includes pharmaceuticals, active ingredients, diagnostic kits, and vaccines required in underdeveloped countries to combat health issues such as HIV/AIDS, tuberculosis, malaria, COVID-19, and other epidemics and pandemics. Many of the common defences are available under the PA: nullity of the plaintiff’s patent, consent and licences granted to the “infringer”, exhaustion, experimental use, Formstein defence, etc. Swiss courts have not yet expressly ruled on the Gillette defence, but it is probable that the Gillette defence would be applicable in Switzerland. In general terms, Swiss case law has for years accepted the state-of-the-art defence. Swiss law has not expressly included the Bolar exemption, but it provides a similar research exemption (see 2.1 Infringing Acts).

Since the Federal Patent Court has exclusive jurisdiction in the first instance for infringement and validity issues, there cannot be any parallel proceedings at different courts in Switzerland. As already mentioned above, preliminary injunctions and ex parte injunctions can also be asserted before the lis pendens in the main proceedings (see 1.3 Preliminary Injunction Proceedings).

Switzerland’s non-membership of the EU precludes the application of the Brussels Ia Regulation (Regulation (EU) 1215/2012), which governs the recognition and enforcement of judgments in civil and commercial affairs. This fact must be considered in an international context. However, Switzerland is a signatory to the Lugano Convention, which was established in accordance with the Brussels Ia Regulation. Swiss courts therefore generally adhere to the case law of the European Court of Justice (ECJ) or at least consider it diligently.

If the same parties bring actions before the courts in different countries bound by the Lugano Convention regarding the same claim, the Lugano Convention stipulates that the court second seized shall stay the proceedings until the court first seized has decided on its jurisdiction. In the absence of the Lugano Convention, Swiss international procedural law states that the subsequently seized Swiss court shall stay the proceedings if a foreign court is expected to render a recognisable decision within a reasonable period of time.

Swiss patent law provides that the Federal Patent Court may stay the proceedings in certain circumstances, for example, if the European Patent Office has not yet rendered a decision on the limitation of a European patent or if an opposition is pending at the European Patent Office (Article 128 PA). Such a stay has so far played a minor role in court practice. If the Federal Patent Court is aware of a pending opposition, it will make an ex officio request to speed up the proceedings before the European Patent Office.

An amendment to the action is admissible if the amended or new claim is factually related to the previous claim or if the opposing party agrees. During the main hearing, an amendment to the claim is only admissible if it is founded upon newly discovered facts and evidence that did not previously exist.

An amendment to the claim is generally admissible if it is directed against the same object of infringement and is founded on the same, potentially restricted patent.

In Switzerland, patent disputes are decided in the first instance before the Federal Patent Court only. The Federal Supreme Court serves as the appellate court. Therefore, forum shopping only occurs in non-patent-related IP litigation. 

In ordinary proceedings, cases are dealt with by panels of three, five or seven judges. Each panel includes both jurists and technicians (see 1.5 Timing for Main Proceedings on Infringement/Validity). Preliminary injunctions are dealt with by a single judge. When legal or factual considerations so require, a panel of three judges may render decisions. There are no juries in Switzerland.

All actions aimed at obtaining marketing authorisation for a medicinal product (not only for a generic product), including but not limited to acts of scientific research, clinical trials, and the application for reimbursement or engagement in activities related to price fixing, are excluded from the validity of a patent (Article 9(1)(b)(c) PA). Swiss law does not contain any explicit provisions that implement or reference the Bolar exception; however, these provisions function as analogous specific exceptions. Thus, in cases involving generic entry, the aforementioned activities do not generally enable a party to bring an action for infringement.

This exception to the patent’s effect is restricted to circumstances where the quantity produced or imported does not exceed the quantity necessary for the marketing authorisation process. Purposeful stockpiling for future market supply is not encompassed within the scope of the privilege. Production is restricted to the quantity specified by the authorisation authority (ie, validation batches). Situations not encompassed by this exception render actions for infringement conceivable. This also pertains to preliminary injunctions in cases where an imminent infringement has not yet commenced (see 1.3 Preliminary Injunction Proceedings).

For medicinal products, the Swiss Agency for Therapeutic Products (“Swissmedic”) grants the following data exclusivity periods:

• ten years for a medicinal product that includes a novel active substance;
• three years for a modified dosage or route of administration;
• three years for a new indication; however, Swissmedic may grant a period of ten years if the new indication is anticipated to yield a substantial clinical advantage over established treatments;
• ten years for a fixed combination of medicinal products if at least one new active substance is prevalent;
• ten years for medicinal products intended exclusively and specifically for paediatric use, provided that pertinent clinical data substantiates the indication; and
• 15 years for essential medicinal products for orphan diseases.

Swissmedic’s decisions regarding data exclusivity are susceptible to appeal to both the Federal Administrative Court and, ultimately, the Federal Supreme Court. Appeals to the Federal Administrative Court can take 12–18 months, although the duration may be extended in cases involving high complexities. In general, decisions regarding appeals to the Federal Supreme Court are rendered within six to 12 months.

See 2.1 infringing Acts.

In Switzerland, no equivalent exists to the Orange Book. Patent rights are neither verified nor considered by Swissmedic prior to the issuance of marketing authorisations. Swissmedic publishes all granted marketing authorisations in its monthly Official Journal. To obtain access to the contents of the marketing authorisations, a Freedom of Information request must be submitted to Swissmedic. However, Swissmedic will refrain from disclosing any personal data, confidential information, or data protected by data exclusivity regulations. Swissmedic does not proactively notify product marketing authorisation holders of any generic or biosimilar marketing authorisations.

The Federal Office of Public Health (FOPH) is the competent authority by default in Switzerland regarding all public health matters concerning the pricing and reimbursement of medicinal products. Pricing and reimbursement, in addition to the issuance of marketing authorisations, are not contingent upon patent status. Thus, in their regulatory supervisory activities, neither Swissmedic nor the FOPH consider patent status. In general, pricing approvals and issuances of marketing authorisations are determined irrespective of the existence of patents. Nevertheless, the patent status could potentially be considered by the FOPH in the determination of the reimbursement amount.

In contrast to other countries, the utilisation of biosimilars in Switzerland has thus far been limited. However, since costly biological active ingredients contribute significantly to increasing expenses in Swiss healthcare, the potential savings from increased use of more cost-effective biosimilars will be significant. Generally, the provisions elucidated in 2.1 Infringing Acts with respect to generics, possess a broad applicability to biologics and biosimilars as well.

Biosimilars may only be authorised with reference to a fully documented biological medicinal product. Consequently, biosimilars cannot be granted marketing authorisation as reference products. First-time-approved biosimilars are not classified as new active substances; thus, they do not receive data exclusivity, apart from in special cases, as outlined in 2.2 Regulatory Data and Market Exclusivity.

The provisions outlined in 2.3 Acceptable Pre-launch Preparations with respect to generics are also broadly applicable to biologics and biosimilars.

The provisions commented on in 2.4 Publicly Available Drug and Patent Information with respect to generics are also broadly applicable to biologics and biosimilars.

The provisions elucidated in 2.5 Reimbursement and Pricing/Linkage Markets with respect to generics are also broadly applicable to biologics and biosimilars.

Supplementary protection certificates (SPC) may be granted for active ingredients or for the combination of active ingredients in medicinal products (Article 140a(1) PA). However, this requires that the product (ie, the active ingredients or combination of active ingredients) is protected “as such” and that a medicinal product containing the product is authorised in Switzerland at the time of the application (Article 140b(1) PA). The SPC is granted to the owner of the patent (Article 140c(1) PA) and is valid for no more than five years (Article 140e(2) PA). Under specific conditions, an SPC may be extended once for an additional six months (Article 140n PA). In general, only one SPC will be granted for each product (Article 140c(2) PA). If several patent owners submit an application for the same product on the basis of different patents and no SPC has yet been granted, each applicant may be granted an SPC (Article 140c(3) PA).

The Swiss Patent Act draws inspiration from the EU Regulation on SPCs for medicinal products (Regulation (EC) No 469/2009). Thus, the FSC generally follows the ECJ case law. However, there are exceptional circumstances where the Swiss legislator may have intended to establish a different set of rules, which would be the only exception to this rule. As an illustration, the FSC ruled unequivocally, based on the ECJ case C-322/10 Medeva, that if the basic patent designates only one of two active substances, a product cannot be granted an SPC after marketing authorisation if it is composed of two active substances (FSC 144 III 285).

It is worth mentioning that an application must be submitted within six months of the initial authorisation of a medicinal product containing the product in Switzerland, or within six months of the patent grant if the patent was granted subsequent to the market authorisation to obtain an SPC (Article 140f(1) PA). However, despite adherence to these time limits, an SPC will not be granted (Article 140f(2) PA). The aim of this process is to establish legal certainty by informing the public and competitors in advance that a medicinal product will not be released at the end of the patent term, but at a later date. In addition, Switzerland has yet to implement a manufacturing waiver for SPCs, which is contrary to EU policy.

Swiss patent law offers both independent paediatric SPCs (Article 140t et seq PA) and paediatric extensions of SPCs (Article 140n(1) PA). Both can be granted for a period of six months. A paediatric SPC may only be issued in the absence of an “ordinary” SPC (Article 140t(2) PA). Consequently, ordinary SPCs and paediatric SPCs are mutually exclusive.

Should the ordered preliminary injunction be deemed unjustified, the plaintiff may be held liable for the payment of damages. The defendant must prove the damage, which is a challenging task, particularly in cases where the defendant was not even selling the product at the time the preliminary injunction was issued. It is difficult and hence rare in Switzerland to claim damages based on unjustified preliminary injunctions. In addition, if the requesting party can prove that it made its request in good faith, the court can reduce or completely release it from its obligation to pay compensation.

The opposing party may request that the ordering of preliminary injunctions is made dependent on the provision of a surety by the plaintiff that potential danger of harm exists. To obtain a surety during the preliminary injunction proceedings, the opposing party must file an application with the court. In ex parte proceedings, the court has the authority to order on the provision of security ex officio.

Preliminary injunctions in patent law focus on injunctive or removal claims. This prohibits the defendant from committing imminent or actual patent infringing acts for the duration of the main proceedings. At the plaintiff’s request, the injunction may be accompanied by a penalty or threat of a fine if the injunction is disregarded. In exceptional circumstances, the judge may also seize existing infringing products, or the equipment, devices and other components used in their production.

If a preliminary injunction is ordered, the court will require the plaintiff to file an action. Generally, the deadline for bringing such an action is one month. This deadline is extendable upon reasoned request to the court. Damages may be assessed against the plaintiff if the claim is not brought forth in a timely manner (see 1.3 Preliminary Injunction Proceedings).

Preliminary injunctions are generally enforceable upon receipt by the defendant, unless otherwise stated in the judgment. Service of legal documents is                                                                                                                                                                                effectuated by the court itself via Swiss post. The court is also responsible for carrying out all measures to fulfil its judgment (eg, seizing orders). In the latter case, the court can entrust national or cantonal police forces to carry out the necessary acts by issuing a corresponding order.

As appeals to the FSC regarding infringement actions typically lack suspensive effect, decisions rendered thereunder are typically enforceable promptly upon issuance. The FSC may, however, issue a different ruling on the suspensive effect ex officio or at the request of a party. In principle, the Federal Patent Court is responsible for enforcing its own judgments using the means outlined in 5.1 Preliminary Injunctive Relief.

As with preliminary injunctions, the plaintiff may request that the injunction be accompanied by the threat of a monetary penalty or other penalty should it be disregarded. The court may also seize infringing products, or the equipment, devices and similar materials utilised in their production.

In patent litigation as well as in most other civil proceedings, the principle of party disposition applies. This stipulates that the court is bound by the requests of the parties and must not award anything in excess of, or less or different to what the parties have applied for.

Consequently, the court is precluded from awarding damages in lieu of issuing an injunction. When an injunction is requested by the plaintiff due to infringement of a valid patent, the court is obliged to grant the injunction. This remains valid notwithstanding the absence of a public interest injunction.

Compulsory licences may be issued under extraordinary circumstances (see 1.15 Defences and Exceptions to Patent Infringement).

The injured party may seek either traditional damages or the disgorgement of the profits earned by the infringer.

Damage refers to an involuntary reduction of assets, which may consist of a reduction in assets, an increase in liabilities, or a loss of profit. The determining element is the disparity between the injured party’s present financial status and the assumed financial status of the injured party in the absence of the detrimental incident. In practice, establishing damages is difficult. The plaintiff could either prove that income generated by the infringer should have accrued to the patent owner, or the plaintiff could demonstrate that they could have generated a greater sales volume if the infringement had not occurred. Injured parties are obliged to furnish the most detailed evidence feasible pertaining to particular instances of harm, such as the quantification of transactions omitted as a consequence of the patent infringement.

In Switzerland, the issuance of preliminary injunctions is limited to the prevention of imminent harm; they cannot be utilised to seek compensation for harm that has already occurred. Consequently, the award of damages is limited to the main proceedings. According to established case law, damages encompass interest equal to 5% per annum commencing from the moment the damaging event had a financial impact.

The exclusive licensee and patent owner are the only parties permitted to file a claim for infringement (see 1.1 Claimants/Plaintiffs to an Action). Other licensees may, however, participate in an action (Article 75(2) PA). Therefore, it is essential for licensees to oblige the patent owner to take action against infringers in non-exclusive licence agreements.

Ordinary Costs

The parties typically request that the ordinary and extraordinary costs of the proceedings be borne by the other party. Court expenses are commonly referred to as “ordinary costs”. The court costs are proportional to the disputed amount. If the disputed amount does not exceed CHF50,000, a court fee of CHF12,000 may be assessed. If the disputed sum exceeds CHF5 million, the court may assess court costs of up to CHF150,000.

Extraordinary Costs

Attorney’s fees and the necessary expenses of the parties are examples of “extraordinary costs”. The attorney’s fee is also proportional to the disputed amount. The fee per attorney for resolving a dispute involving a maximum of CHF50,000 (disputed amount) is between CHF2,000 and CHF16,000. In cases where the disputed amount exceeds CHF5 million, attorney’s fees range from CHF100,000 to CHF300,000. This does not preclude the attorney from reaching an agreement with their client regarding a higher fee. The difference may then be borne by the client.

The Loser Pays

In principle, the losing party is obliged to reimburse the opposing party for all court costs, attorney’s fees and expenses, in addition to its own attorney’s fees and expenses. Court costs are typically payable in advance by the plaintiff. Payment of the advance on costs by the plaintiff is a condition of the proceedings. If a party succeeds only partially, the costs of the court and the attorney’s fees will be split between the parties proportionately.

The court may deviate from the principles outlined in 5.5 Legal Costs if, for instance, it finds the usual distribution to appear inequitable due to exceptional circumstances. This may be the case if the plaintiff has made no attempt to find an out-of-court solution with the defendant and the defendant is not resisting the action.

The regulations governing pharmaceutical trade marks consist of the overarching provisions outlined in the Federal Trademarks Act (“TmPA”) and are supplemented by the guidance documents “Medicinal Product Names” by Swissmedic. Trade mark disputes occur quite frequently in the pharmaceutical sector in Switzerland.

Pharmaceutical product trade marks are required to obtain Swissmedic approval. In its evaluation, Swissmedic does not consider the status of the trade mark. Swissmedic is solely responsible for ensuring that the nomenclature of a product does not evoke any confusion with another product, that the name does not convey any incorrect or misleading information concerning the product’s indications, quality, risks, or safety, and that it does not encourage improper usage or abuse.

Copyright law in Switzerland is primarily regulated by the Federal Copyright Act (“CopA”). Copyright concerns are rare within the pharmaceutical sector in Switzerland.

Switzerland does not have specific legislation on trade secrets. Notwithstanding, numerous laws contain provisions in this regard, such as the:

• Federal Act Against Unfair Competition;
• Federal Criminal Code;
• Federal Data Protection Act;
• Code of Obligations (specifically its sections pertaining to corporate law, employment law, and agency law);
• Civil Procedure Code;
• Code of Penal Procedure; and
• Federal Therapeutic Act (“TPA”) (eg, Article 67(9) TPA).

Furthermore, contract parties (eg, in R&D and product development contracts) may design elaborate contractual clauses, including effective enforcement mechanisms, to protect trade secrets. Thus, depending on the specific situation, trade secrets may be protected in accordance with the principles of contract law, tort law, or criminal law.

Patent disputes are litigated in the first instance before the Federal Patent Court. Appeals from the Federal Patent Court to the FSC are possible. Additional legal conflicts pertaining to intellectual property rights are decided by the appropriate canton’s high court. An appeal of these decisions is also possible in the FSC.

The FSC is the highest court in Switzerland and its decisions cannot be appealed. In principle, appeals must be submitted to the FSC within 30 days of service of the reasoned decision of the lower court (Federal Patent Court or higher cantonal court). The appeal period is only ten days against judgments on the granting of a compulsory licence for the export of pharmaceutical products.

However, caution is required when it comes to preliminary injunctions ordered by the Federal Patent Court. In principle, only final decisions can be appealed to the FSC. Since preliminary injunctions must always be reviewed in the main proceedings, the Federal Patent Court’s order on preliminary injunctions is not a final decision. Such decisions can only be subject to appeal if they cause irreparable harm. If the Federal Patent Court rejects an application for provisional measures, and the rejection is considered a final decision, an appeal to the FSC within 30 days is possible. Appeals against decisions on preliminary injunctions can only be challenged on the grounds of a violation of constitutional rights.

In principle, there is only one exchange of writs before the FSC. Typically, the judges decide by way of circulation of the file and there is no hearing. If there is no consent among the judges, or if a judge requests it, the judges will hold an oral debate. The review of a lower court’s judgment by the FSC is limited to cases where the lower court has made blatantly erroneous factual findings, or national or international law has been improperly applied.

Intellectual property law-related appeals are decided by the First Civil Division of the FSC. Divisions typically reach decisions with the participation of three judges. In response to a judge’s request or on matters of fundamental importance, five judges render decisions. There are no specialist judges for intellectual property at the FSC.

Intellectual property law does not stipulate any procedural requirements for the FSC. Thus, the procedural provisions of the Federal Act on the FSC are applicable.

If the customs administration has reason to believe that the import, export or transit of goods may infringe on a valid Swiss patent, it may inform the patent owner (Article 86a ff PA). Such goods may be detained for three working days so that the patent owner can apply for measures. In the case of such an application, customs can block the goods for a maximum of 20 working days. Within this period, the patent owner must obtain a decision (ex parte, preliminary or by means of criminal proceedings) to prevent the goods from being put onto the market. If this is not achieved within this period, the customs administration must release the goods.

In principle, all civil disputes in the field of intellectual property law are arbitrable, even regarding validity claims. The Swiss Federal Institute of Intellectual Property (“IPI”) accepts arbitration awards on the validity of Swiss intellectual property rights for enforcement, provided they are accompanied by a certificate of enforcement issued by the state court at the seat of the arbitration court.

Since patent disputes are often based on non-contractual grounds and often require rapid initial intervention before the state courts, arbitration agreements prior to the outbreak of a dispute are rare.

Although mediation is available for all sorts of civil cases, including intellectual property matters, it is not commonly used.

The Swiss healthcare market is characterised by competition, which is why it is generally recognised that competition law applies to this sector, including the pharmaceutical markets (FSC 141 III 66). In recent times, the focus of the Swiss competition authorities and courts has mainly been on the pricing of prescription-only medicinal products. Nevertheless, it should be noted that scrutiny may extend to other domains as well, particularly in the context of preventing parallel imports of patented products, in situations involving the blocking of patents, or in cases involving patent trolls.