Patent Litigation 2023

Last Updated January 04, 2023

Switzerland

Law and Practice

Authors



Pestalozzi is a multicultural Swiss business law firm that has focused on high-end work for domestic and international clients since 1911. Pestalozzi’s lawyers are strong and empathic personalities, known for their truly independent approach to advising and representing their clients. The firm guides and supports its clients in their strategic business decisions, anticipates their future challenges and helps them solve their critical issues. Being fully integrated, Pestalozzi encounters no internal limits in shaping the most competent and efficient teams for clients’ needs. With over 100 professionals in Zurich and Geneva, the firm is at home in Switzerland’s two main commercial hubs. While being locally embedded, Pestalozzi has also developed a sought-after expertise in dealing with multi-jurisdictional transactions and disputes. Pestalozzi has a long tradition in providing intellectual property services. Its IP practice group is known to provide results-oriented, effective and pragmatic solutions for the protection and commercialisation of intangible assets, including representing clients from all industry sectors in enforcing and defending their intellectual property rights.

In Switzerland, inventions are primarily protected by patents. A patent with effect for the territory of Switzerland can either be applied for and granted as a Swiss national patent under the Swiss Patents Act (PatA) or as a European patent under the European Patent Convention (EPC) with the designation of Switzerland. According to the PatA and Swiss judicial practice, certain inventions are excluded from patentability, such as gene sequences, methods of medical treatment or mere computer programs.

Under Swiss law, protection of an invention as a utility model is not available and the Federal Council (the Swiss government) recently abandoned its plan to introduce a utility model as part of the partial revision of the PatA that is currently underway. See 1.2 Grant Procedure and 1.7 Third-Party Rights to Participate in Grant Proceedings for details of this revision.

Undisclosed inventions may qualify as trade secrets and are then protected by law against unlawful use and disclosure, which may qualify as an act of unfair competition (Article 6, Act against Unfair Competition) or a criminal act (Article 162, Penal Code). In addition, trade secrets can be protected through contractual means. The Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) is not directly applicable in Switzerland, which is not an EU country, nor has any analogous law been adopted in Switzerland. Overall, the Swiss provisions on trade secret protection are less detailed than the legal framework in the European Union, but they provide effective protection that meets the requirements of Article 39, paragraph 2 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

A Swiss national patent is granted pursuant to the PatA upon application to the Swiss Federal Institute of Intellectual Property (Institut Fédéral de la Propriété Intellectuelle, or IPI). European patent applications with protection for Switzerland may be filed with the European Patent Office (EPO) pursuant to the EPC.

European patent applications have the same effect in Switzerland as national patent applications filed with the IPI (Article 110, PatA) and are recorded in the Swiss register once granted by the EPO.

The IPI currently examines national patent applications only with respect to formal requirements and selected legal requirements, such as the technical nature of the invention, whether the invention is contrary to public policy or morality, the clarity and uniformity of the claims and added matter. In contrast to the examination procedure of European patents by the EPO, the IPI does not examine the material requirements of novelty and non-obviousness before granting the patent (Article 59 paragraph 4, PatA).

However, it should be noted that the PatA is currently undergoing a partial revision, which aims at introducing the option of requesting a full examination of a patent application, including with respect to novelty and inventive step. As a result, inventors should soon have the choice between applying for an “unexamined” or a “fully examined” national patent with the IPI. Pursuant to the proposed bill, the examination for novelty and inventive step can not only be requested by the applicant, but also by third parties. As an additional innovation, in each case a public state of the art search report would be prepared, which is intended to give at least preliminary indications as to the novelty and inventive step of the claimed invention. The new law will be debated in parliament this year and it is not expected to enter into force before mid-2024 or even 2025.

Trade secret protection is granted by law, without any examination or registration by any authority, provided that the undisclosed invention meets the conditions for protection, such as confidentiality and an interest in such confidentiality.

Currently, patent examination by the IPI for granting a national patent may last between one and two years or even longer, depending on whether the IPI is asked to provide a report on the state of the art or arrange an international-type search (Article 59 paragraph 5, PatA). Patent granting proceedings by the EPO usually take longer, as the examination of the novelty and obviousness requirements takes time. The European patent grant procedure generally takes about three to five years from the date the application is filed, but in certain cases it can last considerably longer depending on the complexity of the file.

The average costs for the grant of a patent by the IPI amount to approximately EUR700 (without any fees for optional searches). To take a patent application through to the grant stage before the EPO, one may expect costs of around EUR5,000. These costs do not include the fees for consultancy services of a patent attorney.

Swiss residents do not need to be represented by a patent attorney before the IPI, but applicants (natural or legal persons) who have neither residence nor a place of business in Switzerland are obliged to be represented by a local professional representative. Similar rules apply for residents of non-contracting states in front of the EPO.

For both Swiss national patents and European patents with protection for Switzerland, the term of protection is 20 years from the filing date of the patent application (Article 14, PatA).

Inventions that qualify as trade secrets are protected by law as long as the invention meets the conditions for protection – ie, as long as the invention remains confidential and the inventor has an interest in its confidentiality.

Obligations

In order to maintain both Swiss national patents and Swiss parts of European patents, once granted, the patent owner’s primary obligation is to timely pay the registration and annual renewal fees. The amount of the renewal fees is progressive based on the years of protection.

Rights

Both Swiss national patents and European patents with protection for Switzerland, confer on their owners the right to prohibit others from commercially using the invention (Article 8, PatA). It is the responsibility of the patent owner to enforce their exclusivity rights. Possible civil legal actions include:

  • an action for permanent injunction or remedy of the unlawful situation (Article 72, PatA);
  • an action for monetary relief, including damages such as lost profits, accounts of the infringer’s profits and surrender of the unjust enrichment in the form of a reasonable licence fee (Article 73, PatA); and
  • an action for declaratory judgment on the existence or non-existence of a circumstance or right governed by the PatA (Article 74, PatA).

Actions for injunction or remedy can also be requested as preliminary measures (Article 77, PatA). Moreover, in order to establish infringements, patent owners may request as a preliminary measure that the court carries out a so-called precise description of the allegedly unlawful process or product (Article 77, PatA).

Besides the initiation of civil actions, the patent owner may file a complaint in order to start criminal proceedings against the infringer of their patent rights (Articles 81 et seq, PatA). The PatA also provides for custom measures (Articles 86a et seq, PatA). If the patent owner has clear indications that goods infringing their patent may imminently be imported into or exported out of Swiss customs territory, they may request the Customs Administration to refuse the release of the goods. The Customs Administration may withhold the goods for a maximum period of ten working days, so that the applicant may obtain preliminary measures.

Inventions that are only protected as trade secrets enjoy protection either under Swiss criminal law (Article 162, Penal Code), under unfair competition law (Article 6, Act against Unfair Competition) or by contractual means. Unfair competition law provides for civil injunctions, remedies and monetary relief actions as well as for criminal sanctions.

Upon an application by the owner of a Swiss national patent or a European patent with protection for Switzerland, the IPI may grant a supplementary protection certificate (SPC) for the active ingredients or a combination of the active ingredients of medicinal products or plant protection products (Articles 140a et seq, PatA). An SPC can only be granted on the basis of a valid patent and a granted marketing authorisation for the medicinal product.

The period of protection for the SPC begins as soon as patent protection expires and is valid for a maximum period of five years. This term may be extended for a further six months if paediatric studies have been carried out and the results are reflected in the product information of the respective medicinal product (paediatric extension).

For situations where the patent owner is not eligible to apply for an ordinary SPC, which could be prolonged through a paediatric extension, the PatA also provides the possibility of a paediatric SPC that is directly linked to the patent and not to the ordinary SPC.

Third parties currently do not have any right to participate in the grant proceedings for a Swiss national patent or an SPC – eg, by filing third party observations. However, any person may file an opposition against a Swiss national patent once it is granted by the IPI. Due to the currently limited scope of the examination by the IPI, the national opposition proceedings system was never used. Hence, with the current revision of the PatA, which aims at introducing the option to request a full examination of the patent application (see 1.2 Grant Procedure), opposition proceedings will be abolished. Instead, third parties will have the possibility to file an appeal to the Federal Patent Court (and subsequently to the Federal Supreme Court), whose specialised judges will also be competent to review the patent for novelty and inventive step, if a full examination had been requested. The current opposition deadline of nine months will be shortened to an appeal deadline of four months for third parties.

The grant of an SPC can be challenged by appeal if the appealing party can show a legal interest in the outcome of the proceedings.

In proceedings before the EPO, third parties can file observations concerning the patentability of the invention (third-party observations) in order to try to prevent a patent from being granted. However, third parties cannot take part in the grant proceedings as a formal party. Any person may, however, file an opposition against a European patent once it is granted by the EPO.

Against a refusal to grant patent protection or an SPC by the IPI, an appeal can be filed with the Swiss Federal Administrative Court and thereafter to the Swiss Federal Supreme Court.

A decision of the EPO refusing to grant a European patent may be appealed with the EPO’s Boards of Appeal.

A patent registered in the Swiss patent register is cancelled (and the patent protection terminates with effect ex nunc) if the annual renewal fees are not paid on time.

Where the patent owner provides prima facie evidence of having been prevented, through no fault on their part, from observing a time limit, the IPI may grant, on request, the re-establishment of their rights (Article 47, PatA). Acceptance of the request has the effect of restoring the situation that would have resulted from carrying out the act in good time. However, due to the quite strict practice on the no-fault requirement, Article 47 of the PatA is often not applicable.

Alternatively, the patent owner may file a request for further processing with the IPI (Article 46a, PatA). The request must be made within two months after receiving notification of the missed time limit or within six months after the time limit has expired. Within this time, the action that has been omitted must be executed. If the request for further processing is approved, the situation that would have resulted from executing the act on time will be restored.

Once the patent has been granted (and the opposition period has expired), the patent owner may file with the IPI a request for a declaration of partial surrender of a Swiss national patent or the Swiss part of a European patent in order to:

  • surrender a patent claim;
  • limit an independent claim by combining one or more patent claims, which are dependent on it; or
  • limit an independent claim in some other way – in such cases, the limited claim must refer to the same invention and define an embodiment that is included in the specification of the published patent and in the version of the patent application that determined the date of filing.

The partial surrender may not be used to file new patent claims or to make up for something else that was overlooked in the granting procedure.

On the occasion of registration of a partial surrender, the patent owner may, within a three-month period, file an application for the establishment of one or more new patents to cover the dropped patent claims; such new patents are given the filing date of the original patent.

Under Swiss law, civil legal actions include:

  • actions for permanent injunction or remedy of the unlawful situation (which may also be requested as preliminary measures);
  • actions for monetary relief; and
  • declaratory judgment actions.

Moreover, the patent owner may also initiate criminal proceedings or apply for customs measures.

Please see 1.5 Rights and Obligations of Owners of Intellectual Property Rights for more detail.

Opposition Proceedings

Pursuant to the current law, within nine months of publication, any third party, without the need to demonstrate a proven interest, may file an opposition against a Swiss national patent granted by the IPI or against a European patent granted by the EPO.

Grounds for opposition against a Swiss national patent are rather limited. The opposing party may claim that the patent contains inventions that are excluded from patentability because:

  • the invention relates to the human body or its elements;
  • the invention relates to naturally occurring sequences or partial sequences of genes; or
  • the invention’s exploitation is contrary to human dignity or disregards the integrity of living organisms, or is in any other way contrary to public policy or morality according to Article 2 of the PatA.

It should be noted that the ongoing revision of the PatA will abolish this opposition system and replace it with an appeal option to the Federal Patent Court with a four-month appeal deadline for third parties. The grounds for appeal will be expanded to include a review for novelty and inventive step. See 1.2 Grant Procedure and 1.7 Third-Party Rights to Participate in Grant Proceedings for details of this revision.

The EPC allows for more grounds for opposition. In addition to similar opposition grounds allowed under Swiss law, a third party may also claim that:

  • the invention is not new;
  • the invention does not involve an inventive step;
  • the invention is not susceptible to industrial application;
  • the invention is not disclosed clearly and completely enough for a person skilled in the art to carry it out; or
  • the patent’s subject-matter extends beyond the content of the application as filed.

Civil Proceedings

Third parties, with a proven interest, may also initiate civil proceedings in order to claim the invalidity or partial invalidity of a Swiss national patent or of the Swiss part of a European patent if the invention is excluded from patentability, is obvious, not novel or not disclosed in a way that a person skilled in the art could carry it out, or if matter was added after the filing date (Articles 26 et seq, PatA).

In addition, when the patent has been filed by an applicant who was not entitled to that patent, the entitled person may apply for assignment of the patent application or, if the patent has already been granted, of the patent itself (Article 29, PatA).

Compulsory Licensing

Under Swiss law, third parties with a legitimate interest may, under certain conditions, also initiate actions for the grant of compulsory licences (Articles 36 et seq, PatA), if:

  • a patent cannot be used without infringing a prior patent, provided that the invention represents an important technical advance of considerable economic significance in relation to the invention that is the subject matter of the prior patent;
  • a patent is not sufficiently exploited in Switzerland, and where such a failure to exploit cannot be justified;
  • the public interest so requires;
  • a licence to patents in the field of semiconductor technology is required to remedy a practice held to be anti-competitive; or
  • a licence to use a patented biotechnological invention is required for research purposes.

Requests for the grant of compulsory licences are rare and to date no compulsory licence appears to have ever been granted by a court in Switzerland.

The Swiss Federal Patent Court rules on civil actions concerning patents at first instance. Pursuant to Article 26 of the Patent Court Act (PCA), it has exclusive jurisdiction over civil patent litigation concerning patent validity as well as patent infringement, compulsory licence actions, requests for preliminary measures and enforcement of judgments made under its exclusive jurisdiction.

The Federal Patent Court also has jurisdiction in other civil actions that have a connection to patents, in particular those concerning contractual rights to patents (ownership and licensing) or their assignment. In such cases, the jurisdiction of the Federal Patent Court does not preclude the jurisdiction of the cantonal courts. For such disputes, the claimant may choose whether to bring an action before the Federal Patent Court or the relevant cantonal court.

An appeal against the decision of the Federal Patent Court or of a cantonal court can only be lodged with the Federal Supreme Court directly as second instance. The decision of the Federal Supreme Court is final. The Federal Supreme Court can, however, remand the case back to the Federal Patent Court for new consideration of certain aspects. In such event, the Federal Patent Court’s second decision can again be appealed to the Federal Supreme Court.

The Federal Patent Court is a specialised court for patent matters. It comprises judges with legal training and judges with a technical qualification.

Besides the Federal Patent Court and cantonal courts, arbitral tribunals may also be competent to resolve disputes related to patents. According to Swiss case law, all aspects of intellectual property disputes are arbitrable, including contractual issues related to patents as well as disputes over the validity of patents. Although arbitral awards on the validity of patents are recognised and enforced in Switzerland, arbitration proceedings related to mere validity disputes are rather rare, because of the multi-jurisdictional nature of most arbitral proceedings and hence possible enforcement issues with respect to certain jurisdictions. However, contractual disputes in connection with patents, such as licensing disputes, are often submitted to arbitral tribunals.

No other (non-statutory) specialised organisations exist in Switzerland to rule on patent disputes.

There are no special prerequisites for filing a patent action in Switzerland. Civil actions relating to intellectual property rights can be filed with the competent court without any need to attempt conciliation in front of a conciliation authority.

The issuance of warning letters is also not required, although mostly recommended to consolidate the legitimate interest of the claimant and to support the attribution of the procedural costs to the defendant. Sometimes litigation costs can even be avoided following settlement discussions or voluntary undertakings triggered by warning letters.

If patent infringement proceedings are commenced by an entitled licensee (see 3.1 Necessary Parties to an Action for Infringement), it is not required that the licence is registered in the patent register.

Parties may decide, but do not have any obligation, to be represented by an attorney at law in intellectual property matters. If a party decides to be represented in front of a Swiss court, the representative must be a qualified attorney at law. In proceedings concerning the validity of a patent in front of the Federal Patent Court, the parties may also be represented by a qualified and admitted patent attorney (Article 29, PCA).

Measures for interim relief are available under Swiss law if the applicant can provide prima facie evidence that the following requirements are met:

  • the right to which they are entitled has been infringed or an infringement is imminent;
  • such infringement threatens to cause not easily reparable harm;
  • the requested relief is relatively urgent; and
  • the requested relief is proportionate to the harm caused by the alleged infringement (Articles 261 et seq, Civil Procedure Code, CPC).

Note that urgency is not a strict requirement for granting interim relief. However, interim relief will not be granted if the applicant has waited for a substantial period of time (according to current practice, for more than 14 months) before requesting measures for interim relief.

In cases of special urgency, and in particular where there is a risk that the enforcement of the measure will be frustrated, the court may order the interim measure immediately and without hearing the opposing party (ex parte interim measures) (Article 265, CPC). The ex parte interim measures must subsequently be confirmed in inter partes proceedings granting the opposing party its right to be heard.

In addition, all interim relief proceedings require confirmation in main proceedings. In an interim judgment, the Federal Patent Court will set a deadline for the commencement of main proceedings, whereby the injunction lapses if the applicant does not initiate main proceedings, in which case the applicant is liable for any damages caused to the defendant.

In interim relief proceedings the applicant can request:

  • an injunction;
  • an order to remedy an unlawful situation;
  • an order to a registering authority or to a third party; or
  • performance in kind.

Any person who has reason to believe that an ex parte interim measure will be applied against them, may set out their position in advance by filing a protective letter (Article 270, CPC).

Protective letters must be filed with the Federal Patent Court and/or the cantonal courts that are likely to have jurisdiction for ordering the ex parte interim measures in the case at hand. The other party will be served with the protective letter only if they actually initiate the respective proceedings. The protective letter becomes ineffective six months after it was filed.

Statute of Limitation

Monetary claims in patent infringement proceedings are time-barred after three years from the date on which the injured party became aware of the loss or damage and of the identity of the person liable for them, but in any event ten years after the date on which the loss or damage was caused. If the action for damages is derived from an offence for which criminal law envisages a longer limitation period, that longer period also applies to the civil claim.

Claims for injunctive and declaratory relief are in principle not time-barred, but rather remain available as long as there is a legitimate interest in obtaining such a relief.

Forfeiture

The enforcement of rights might be limited due to their forfeiture based on Article 2 of the Swiss Civil Code, which requires every person to act in good faith in the exercise of their rights. If a person waits too long before initiating enforcement proceedings, their rights may be forfeited if the court determines, taking into account all relevant circumstances, that the claimant acted against good faith. As an example, the right to apply for interim measures is considered forfeited 14 months after the patent owner actually learned, or should have learned, of the infringement unless there are special circumstances (see 2.7 Interim Injunctions). With regard to main proceedings, forfeiture is likely to occur after approximately eight years. Based on Swiss case law, urgent status will not be granted by the courts if the patent owner has waited so long.

Swiss procedural law does not provide any procedural mechanisms for far reaching US-style fishing expeditions in order to obtain all evidence from the opposing party that might be relevant. However, there exist certain mechanisms allowing a party to obtain specific evidence.

Swiss Patents Act

Based on the Swiss Patents Act, a patent owner with a legitimate interest – ie, providing prima facie evidence that their patent has been infringed or an infringement is suspected – may request that the Federal Patent Court order as an interim measure:

  • the securing of evidence; and/or
  • a precise description to be made of the allegedly unlawful processes used and/or of the allegedly unlawful products manufactured, as well as the means used to manufacture them (Article 77, PatA).

The procedure for making the description is typically carried out by a technically trained judge and a clerk at the location where the alleged infringement takes place. Upon the request of an opposing party, the court will take necessary measures to safeguard business and trade secrets and might exclude the applicant (but not its representatives) from taking part in the inspection. The court will draft a written report describing the product or process and before the applicant receives the report, the opposing party is given the opportunity to comment (Article 77, PatA).

Under Swiss law there is no limitation as to how the evidence obtained through a description can be used, which means that a Swiss description can also be used to support proceedings abroad.

Swiss Civil Procedure Code

The Swiss Civil Procedure Code also allows a more general right to ensure preliminary taking of evidence without any need to start civil litigation (Article 158, CPC). Similar evidence as during a pending litigation on the merits can be the subject of such a preliminary taking of evidence – ie, the party may request witness hearings, the production of specifically identified documents, the inspection of goods or places or the drafting of a court-appointed expert’s report. The questioning of the parties, however, can only be part of the proceedings on the merits.

In general, the parties to the case, and third parties, have a duty to co-operate in the taking of evidence (Article 160, CPC). However, the court cannot enforce its order, if a party to the proceedings does not produce the required evidence. But the court will take such conduct into account when assessing the evidence and the facts of the dispute.

Under Swiss procedural law, the statement of claim must contain:

  • the prayers for relief;
  • a statement of the value in dispute;
  • the allegations of fact;
  • a notice of the evidence offered for each allegation of fact; and
  • the date and signature.

It is not required by law to state the legal arguments (since the court must know the law), but it is common practice to do so and some courts expressly expect the parties to briefly state on which grounds their actions are based.

In general, in main proceedings, each party is entitled to two submissions during which it may provide new facts and evidence, amend its prayers for relief and limit the patent claims at stake; either inter partes or through a limitation request at the IPI. After the second submission, new facts and new evidence are admissible only if presented immediately after they become known and (i) if they occurred after the second submission (proper nova), or (ii) if they existed before but could not have been submitted despite reasonable diligence (improper nova). At such stage, a limitation of the patent claims at stake will only be considered if it were triggered by new arguments or evidence brought forward in the rejoinder. In any case, new facts and new evidence are admitted only until the court begins its deliberations.

Under Swiss law, no class actions or other collective actions are permitted. However, joinder of parties in civil proceedings is admissible.

Restrictions on the assertion of patent rights may apply from the law against unfair competition and antitrust law, in particular with respect to restrictions against parallel imports which are not justified (Article 9a, PatA and Article 5, Swiss Cartel Act) and unlawful practices by market-dominant undertakings or undertakings with relative market power (Article 7, Swiss Cartel Act).

Furthermore, a patent owner might be restricted in the enforcement of their rights due to their forfeiture based on Article 2 of the Swiss Civil Code (acting in good faith), in particular if they were to wait too long before initiating enforcement proceedings (see 2.9 Special Limitation Provisions).

Civil Actions

The patent owner who has their rights infringed, or is threatened with an infringement, may initiate a civil action. The exclusive licensee, irrespective of the registration of the licence in the patent register, may also bring an infringement action independently, provided this is not expressly excluded by the licence agreement (Article 75, PatA). Non-exclusive licensees, however, may only join the infringement proceedings filed by the patent owner or the exclusive licensee in order to claim their own losses or damages.

An infringement action can be raised against any person:

  • who uses a patented invention unlawfully;
  • who refuses to notify the authority concerned of the origin and quantity of products in their possession which are unlawfully manufactured or placed on the market, and to name the recipients and disclose the extent of any distribution to commercial and industrial customers;
  • who removes the patent mark from products or their packaging without authorisation from the proprietor of the patent or the licensees; and
  • who abets any of the said offences, participates in them, or aids or facilitates the performance of any of these acts (Article 66, PatA).

If there are several infringers, the claimant is not obliged to initiate the infringement action against all potential infringers.

Criminal Proceedings

Criminal proceedings can be initiated against the same persons provided that they wilfully committed the patent infringement, on complaint by the patent owner or ex officio if the infringer acts for commercial gain (Article 81, PatA).

Swiss law does not explicitly know a doctrine distinguishing between direct and indirect patent infringement. Whoever commits an infringement act as described in Article 66 of the PatA may be held liable under Swiss civil and criminal law.

However, the PatA implicitly distinguishes between direct infringement (Article 66 litterae a, b and c, PatA) and contributory infringement (Article 66 littera d, PatA), according to which any person who abets, participates in, aids or facilitates the performance of any (direct) infringement may also be held liable under civil and criminal law. According to case law of the Swiss Federal Supreme Court, a contributory infringement is accessory to a direct infringement, meaning that an unlawful principal act is required for a contributor infringement, whereby it is sufficient for a claim for injunctive relief against the contributory infringer that a direct infringement is imminent.

With regard to its application in an international context, the “accessoriness” has the effect that the contributory infringer, acting in Switzerland but contributing to a direct infringement abroad, cannot be held liable under Swiss law. On the other hand, if the direct infringement takes place in Switzerland, a contributory infringer contributing to that infringement may be liable irrespective of whether the contributory acts are performed in Switzerland or abroad.

Regarding the supply of (non-infringing) materials or parts to a customer who uses these parts or materials for the manufacture of goods infringing a patent, the Swiss Federal Supreme Court has clarified that the supplier is liable as contributory infringer if they knew or should have known that the means supplied were suitable for, and intended to be used by the customer for use in the infringing goods.

The most important particularity of process patent infringement proceedings concerns the burden of proof. In general, the claimant carries the burden of proof in infringement proceedings. However, the burden of proof may be reversed if the patent in question is a process patent. If an invention concerns a process for the manufacture of a new product, every product of the same composition is presumed to have been made by the patented process until proof to the contrary has been provided (Article 67 paragraph 1, PatA). The same applies by analogy to a process for the manufacture of a known product if the patent owner provides prima facie evidence of an infringement of the patent (Article 67 paragraph 2, PatA).

Regarding the territorial scope of a process patent infringement, the general rules apply, meaning that a direct infringement must occur in Switzerland in order for Swiss law to apply. Accordingly, the Swiss Federal Supreme Court held in a case that if a device intended for carrying out a patented process is manufactured in Switzerland, but the process itself is only carried out abroad, the process patent is not infringed in Switzerland.

Literal Infringements

The patent claims determine the scope of protection of a patent (Article 51 paragraph 2, PatA). According to established practice, the patent claims must be interpreted from the viewpoint of a skilled person, starting with the claim language but also taking into account the description and the drawings. General technical knowledge is also accepted as a means of interpretation.

The Swiss Federal Supreme Court held that the prosecution history of a patent is, in general, not decisive for the interpretation of the patent claims. Waivers and limitations made by the patent applicant during prosecution are to be taken into account only to the extent that they are ultimately reflected in the patent claims and/or the description.

Equivalent Infringements

The PatA explicitly holds that an imitation is also deemed to constitute a use (Article 66 littera e, PatA) and, hence, not only literal infringements but also equivalent infringements are known under Swiss law. The Swiss Federal Supreme Court and the Federal Patent Court have elaborated in several decisions, taking into account other European courts’ practice, a standard test for the assessment of an equivalent infringement based on three main steps.

  • Equal effect – the modified feature must objectively fulfil the same technical function as the corresponding feature of the patent claim.
  • Accessibility – the modified feature must be obvious to the skilled person in light of the teaching of the patent; the Federal Patent Court has clarified that the starting point for the assessment of accessibility is not the general prior art, but the patent at issue, as this step should not be confused with the assessment of the inventive step.
  • Equality – the skilled person must consider the modified feature as an equivalent solution taking into account the claim language and the description.

If all three requirements are fulfilled, an equivalent patent infringement exists according to Swiss practice.

Within Swiss patent infringement proceedings, the defendant may attack the validity of the claimant’s patent or raise non-infringement arguments.

Validity Defences

The defendant may plead the invalidity of the patent as a defence in the form of an objection or as a formal counterclaim. If the defendant raises the invalidity as an objection and the court determines that the patent is in fact invalid, that decision has only a direct effect between the parties – ie, the infringement action is rejected but the patent is not revoked from the patent register. If the defendant decides to file a counterclaim, this has the same effect as a standalone invalidity action – ie, if the invalidity of the patent is confirmed by the court, the infringement action is rejected and the patent is also declared invalid and formally revoked.

Lawful Use Defences

Alternatively, or additionally, defendants may also claim to have lawfully used the allegedly infringed patent. Defendants may argue the following.

  • That they have been granted a valid licence right.
  • That they can rely on a statutory exception as per Article 9 of the PatA, including the exceptions of:
    1. private use for non-commercial purpose;
    2. use for research or experimental purposes (in order to obtain knowledge about the subject-matter of the invention);
    3. use for teaching purposes, use for obtaining marketing authorisation for a medicinal product (Bolar-type exemption);
    4. use by a medicinal professional for an individual person (medical prescription exemption); or
    5. use for a direct individual preparation of a medicinal product in a pharmacy (pharmacists’ exemption).
  • That the patent owner’s rights were exhausted (Article 9a paragraph 1, PatA); whereas in general EEA-wide exhaustion applies, but if the patent is of subordinate importance for the functional characteristics of the goods, global exhaustion applies, and if the price of the patented goods is fixed by the state (such as with medicinal products), national exhaustion applies.
  • That they have a prior use right (ie, have commercially used the invention in good faith in Switzerland or have made special preparations for that purpose prior to the filing or priority date of the patent application (Article 35, PatA)); in this case, the defendant might have to pay the patent owner appropriate compensation (Article 48, PatA).
  • That the patent in question is a standard essential patent and defendants rely on a FRAND (fair, reasonable and non-discriminatory) licence; so far, no case law in this respect has been established in Switzerland since all FRAND cases in front of the Federal Patent Court have been settled.

As a general rule, the Federal Patent Court makes its decisions as a three or five-member body (panel), of whom at least one member must possess technical training. One of the technically trained judges will issue a written opinion (the “Technical Opinion”) covering all technical aspects of the case and the parties are given the opportunity to comment. Such Technical Opinions do not bind the other judges, although in many instances they will be largely followed in the judgment.

Additional technical know-how, at the request of a party or ex officio, may be obtained by an opinion from one or more external experts appointed by the court ad hoc (Article 183, CPC). However, external expert opinions basically do not play a role in patent proceedings, since the Federal Patent Court has technically trained judges with expertise in all relevant fields of science.

The parties may submit written expert statements. However, these are considered as assertions of the parties only.

All arguments against the infringement of patent claims must be raised within the same proceedings. There is no separate procedure for construing patent claims.

Swiss law does not provide for a mechanism where a third party that is not a party to the patent proceedings may file, on its own, any kind of amicus brief to the court.

There are several reasons for a revocation or cancellation of a patent.

Often, a patent registered in the Swiss patent register is cancelled because the renewal fees are not paid on time.

Swiss national patents or Swiss parts of European patents are also cancelled, and removed from the Swiss patent register, if an action for invalidity of the patent has been successful. The cancellation is done by the IPI upon the provision of full official copies of the final judgments. Any person with a proven interest may bring an invalidity action if the invention is excluded from patentability (eg, human body), is obvious, not novel, not disclosed in a way that a person skilled in the art could carry it out or if the application has been unduly amended (Articles 26 et seq, PatA). The requirements for the interest to be demonstrated by the claimant are rather low. The only exception is an invalidity action based on the allegation that the patent owner has no right to the grant of the patent. This particular ground for invalidity can only be asserted by the person claiming to actually be entitled to the patent.

An action for the cancellation of a patent could also be brought by a person with a demonstrated interest if the grant of licences does not suffice to meet the demand of the domestic market after a period of two years from the grant of the first compulsory licence (Article 38, PatA). Such actions are very rare and to date no patent appears to have ever been cancelled based on such action in Switzerland.

Finally, based on the prohibition against double patenting, a Swiss patent is revoked in favour of a European patent for one and the same invention with effect in Switzerland and granted to the same inventor or to their successor in title with the same filing or priority date (Article 125 paragraph 1, PatA).

Partial cancellation is possible if the successful invalidity action relates to certain patent claims only (Article 27, PatA).

A patent owner may amend a patent by surrendering a patent claim, limiting an independent claim by combining one or more patent claims which are dependent on it or limiting an independent claim in some other way (see 1.10 Post-grant Proceedings Available to Owners of Intellectual Property Rights).

A patent may also be amended during invalidity or infringement proceedings. However, the patent owner is only able to rely on the amended patent up to a certain stage of the proceedings.

The Swiss Federal Supreme Court has clarified that if the patent owner amends the patent through the IPI during pending infringement proceedings, this has an ex tunc effect and thus the original patent that is the subject of the infringement proceedings no longer exists. If the introduction of new facts (ie, the amended patent) is no longer admissible at the stage of the proceedings in question, the infringement proceedings must be dismissed. This is generally the case if the patent is limited after the second pleading, at which stage new facts and new evidence are admissible only under very strict circumstances (see 2.11 Initial Pleading Standards). Hence, if the patent owner wants to proceed against the alleged infringer based on the amended version of the patent, they must commence new infringement proceedings.

The Swiss patent litigation system is not bifurcated. Where an invalidity claim is raised as a defence within patent infringement proceedings, that invalidity claim is heard at the same time and within the same proceedings.

Procedural Provisions

The Swiss Federal Patent Court has exclusive jurisdiction in certain civil patent litigations. However, the proceedings before the Federal Patent Court are primarily based on the ordinary Swiss Civil Procedure Code, which applies to all civil proceedings. The Patent Court Act only contains a few provisions relating to the proceedings (eg, composition of the panel, jurisdiction and legal representatives).

Typical Steps of Infringement Proceedings

Ordinary infringement proceedings are initiated by filing a written statement of claim, followed by a written statement of defence in which the defendant usually asserts invalidity of the patent; either by way of a defence or by filing a counterclaim.

After the exchange of the first briefs, the parties are summoned to an instruction hearing in front of a delegation of the court, normally consisting of the court president, the leading technical judge and a court clerk. The instruction hearing consists of two parts. In a first part that is minuted, the court delegation can pose questions to the parties to seek specific clarifications or to get information with respect to parallel proceedings. The delegation will also mention if further substantiation is required. This part is normally quite short. The second, informal part of the instruction hearing is not minuted. The delegation of the court will present a confidential preliminary assessment of the case and the parties may then engage in court-mediated settlement negotiations.

If no settlement is found, the proceedings continue and the parties will exchange their second briefs (ie, reply, rejoinder and comments on new invalidity arguments and evidence in the rejoinder). Thereafter, the technical judge will issue their written expert opinion, on which the parties may comment in writing. As a final step, the parties are summoned to the main hearing. After the parties’ pleadings, the court can decide whether a court expert will be appointed, witnesses will be heard, or other evidence will be taken. In most cases the court closes the proceedings after the main hearing and renders its judgment in writing within four to six weeks.

Ordinary proceedings on the merits concerning infringement or the nullity of a patent generally take about 18 to 24 months.

Action by Stages

An infringement action is typically initiated as a so-called action by stages (Stufenklage). In the first stage, the Federal Patent Court renders a partial judgment on the validity of the patent (if contested), the infringement, injunctive relief and the disclosure of information for the calculation of monetary relief. In the second stage, the patent owner asserts the amount of its monetary relief claim based on the information received and the Federal Patent Court decides on the monetary relief.

The Federal Patent Court makes its decisions as a three-member (or occasionally a five-member) body (panel), of whom at least one member must possess technical training.

In the rare proceedings concerning patent matters that are ruled before civil cantonal courts (see 5.4 Other Court Proceedings), external technical experts may be appointed to submit an expert opinion ex officio or at the request of a party (Article 183, CPC). However, the final decision remains with the judges also with regard to technical questions.

Settlements may be agreed at any stage of civil proceedings. They may be discussed with the mediation of the court or upon separate negotiations among the parties only. Swiss courts often actively support the parties in order to find a settlement.

In front of the Swiss Federal Patent Court, the parties are summoned to an instruction hearing after the exchange of the first briefs (see 5.1 Special Procedural Provisions for Intellectual Property Rights). During this hearing, the court will present a confidential preliminary assessment of the case, which should serve as a basis for settlement discussions. A considerable number of disputes are settled at this stage.

In respect of contractual rights related to patents, such as ownership and licence rights, legal actions may not only be filed with the Federal Patent Court but also with the cantonal courts (Article 26 paragraph 2, PCA). Where the invalidity or infringement of a patent is to be adjudicated in such proceedings as a preliminary question or on a defence basis, the cantonal court grants the parties a reasonable period of time for filing the validity or infringement action before the Federal Patent Court, which has exclusive jurisdiction over this subject matter (see 2.3 Courts with Jurisdiction). The cantonal court must then stay the proceedings until a final decision has been made by the Federal Patent Court. However, considering that actions before cantonal courts with regard to patents have become very rare since the establishment of the Federal Patent Court, the influence of cantonal proceedings on the others are, in practice, very limited.

If infringement proceedings before the Federal Patent Court relate to a European patent which is the subject of pending opposition or appeal proceedings before the EPO, the Federal Patent Court may stay its proceedings. In practice, however, this plays only a very limited role, since the Federal Patent Court emphasises that it only suspends its proceedings if a decision by the EPO can be expected in a short time. Instead, it is the Federal Patent Court’s standard practice to submit an acceleration request to the EPO.

Parallel infringement proceedings in front of other European courts do not have a direct influence on proceedings before the Federal Patent Court. The Federal Patent Court, however, is generally interested in judgments of other European courts when parallel parts of European patents are involved, although such judgments do not bind the Swiss courts in any way.

Anti-suit injunctions of foreign courts are generally considered as inadmissible under Swiss law.

Civil remedies for patent owners include injunctions or reparatory remedies, damages (including legal costs), declaratory judgments, delivery up or destruction of infringing goods, a recall order and publication of the judgment. See 1.5 Rights and Obligations of Owners of Intellectual Property Rights for further detail.

Permanent injunctions are the most common remedy sought in infringement proceedings and are generally granted if an infringement is affirmed. In order to enforce the injunction, the judgment provides for administrative fines (per day of violation) if the infringer does not comply with the injunction, and for criminal sanctions.

For past infringements, the patent owner may claim monetary remedies in the form of damages such as lost profits or, if the infringer acted in bad faith, account of the infringer’s profit. Alternatively, the patent owner can choose to ask for surrender of the unjust enrichment in the form of a reasonable royalty rate. Swiss law does not provide for punitive or exemplary damages or the like.

Since the patent owner usually does not have all the necessary information to prove the amount of damages or the profit to be surrendered, Swiss law grants the patent owner a claim for the necessary information and the infringer may be ordered to render account on the sales and gross turnover made from the infringing activities. Such a claim is usually asserted in a so-called action by stages. See 5.1 Special Procedural Provisions for Intellectual Property Rights.

The court is bound by the available civil remedies and the parties’ prayers for relief and has no discretion in ordering other remedies.

According to Swiss civil procedure law, the losing party must bear the court costs and has to reimburse the prevailing party for its legal costs and expenses, including the costs for assisting patent attorneys. The compensation for legal costs is calculated based on tariffs depending on the value of the dispute. Such compensation will often not cover all the fees actually incurred.

If the defendant has incurred damages as a consequence of the proceedings, they may claim compensation for such damages. Within proceedings for interim measures, the court may make the interim measure conditional on the payment of a security deposit by the applicant, if it is anticipated that the measures may cause damage to the opposing party. An applicant for interim relief is liable for any damages caused in the event such measures are later found to be unjustified. If the applicant proves, however, that they applied for the measures in good faith, the court may reduce the damages or entirely release the applicant from liability (Article 264, CPC).

The same types of remedies are available for infringements relating to Swiss national patents and Swiss parts of European patents. Essentially, also the same types of remedies are available for civil proceedings involving inventions protected as trade secrets. See 1.5 Rights and Obligations of Owners of Intellectual Property Rights for further detail.

An appeal to the Swiss Federal Supreme Court does not have suspensive effect and, accordingly, injunctions granted at first instance are enforceable during the appeal proceedings. Upon request, the Federal Supreme Court may grant suspensive effect, but this is quite rare.

Appeals to the Swiss Federal Supreme Court against decisions of the Federal Patent Court or the civil cantonal courts as sole instance follow the same rules as appeals in civil matters.

The Swiss Federal Supreme Court’s discretion when reviewing final decisions of prior instances on the merits is limited to legal questions. In a recent judgment the Swiss Federal Supreme Court decided that the construction of patent claims is a legal question. In addition, the assessment of invalidity grounds is also a legal question. In contrast, a review of the facts is only possible in a very limited manner by ascertaining an abuse of law by the prior instance in arbitrarily determining the facts (Article 97, Supreme Court Act, SCA).

With regard to decisions on interim measures, the discretion of the Swiss Federal Supreme Court is narrower and limited to a review of a violation of constitutional rights (Article 98, SCA).

Prior to filing a patent lawsuit, there may be significant costs associated with the technical assessment of a patent’s validity (as the defendant’s usual defence will be to bring an invalidity action against the patent) and the assessment of the potential infringement of said patent by the allegedly violating goods of the counterparty. Additional costs may arise for the issuance of warning letters or the preparation and filling of protective briefs.

Upon filing an action, the claimant is requested to advance part of the court costs. In proceedings before the Federal Patent Court, the advance payment is usually half of the expected court costs, which corresponds to the expected court costs up to and including the instruction hearing.

As a principle, the losing party must bear the court costs and has to reimburse the prevailing party for its legal costs. A proportionate allocation in relation to the outcome is also possible. Both, court costs and the compensation for legal costs, are calculated based on tariffs depending on the value of the dispute.

In Switzerland, alternative dispute resolution (ADR), or more specifically arbitration, is an important means of resolving intellectual property disputes, particularly in international cases where a single decision is advantageous.

ADR in Switzerland is attractive for patent disputes as Switzerland provides for arbitration experts in most fields of technology and Switzerland has a liberal regime regarding the recognition and enforcement of arbitral awards.

According to Swiss case law, all aspects of intellectual property disputes are arbitrable, including contractual issues related to patents as well as disputes over the validity of patents. Whereas arbitration proceedings related to mere validity disputes are rather rare, contractual disputes are often the subject of arbitration proceedings (see 2.4 Specialised Bodies/Organisations for the Resolution of Disputes).

Under Swiss law, the assignment of intellectual property rights consists of the undertaking to assign the right and the actual disposition of the right. While the undertaking to assign the right is not required to fulfil specific formal requirements, the actual transfer of the patent or patent application rights must be made in writing (Article 33 paragraph 2bis, PatA).

In order to validly assign and transfer the patent or patent application rights neither the approval of the IPI nor its recording in the Swiss patent register is required. However, if the assignment is not recorded, it is invalid against persons who have acquired in good faith rights to the patent from the registered patent owner.

For the recording of the assignment of the patent or patent application rights, the IPI requests the written consent of both the assignor and the assignee.

See 10.1 Requirements or Restrictions for Assignment of Intellectual Property Rights.

Under Swiss law, there are no specific formal requirements for licence agreements. Licence agreements can even be concluded orally and no approval of the IPI is required. However, where the patent application or the patent is owned by two or more persons, a licence grant requires the consent of all co-owners.

Licences may be recorded in the Swiss patent register, but this is not required for their validity between the contractual parties. However, if the licence is not recorded, it is invalid against persons who have acquired the patent in good faith (Article 34 paragraph 4, PatA).

For the recording of the licence rights, the IPI requests the written consent of the licensor.

See 10.3 Requirements or Restrictions to License an Intellectual Property Right.

Pestalozzi

Loewenstrasse 1
8001 Zurich
Switzerland
Cours de Rive 13
1204 Geneva
Switzerland

+41 44 217 91 11

+41 44 217 92 17

zrh@pestalozzilaw.com www.pestalozzilaw.com
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Trends and Developments


Authors



MLL Legal has an IP team that unites Switzerland’s leading consultants and representatives for patent law. Led by Simon Holzer, MLL’s patent team includes four partners and four associates. The firm handles an impressive amount of litigation in the Swiss life sciences and hi-tech areas and it is many global pharmaceutical originators’ first choice. The team covers a wide range of industries, including pharmaceuticals, medical devices, software, telecommunications, and foodstuffs. It has also taken centre stage in Switzerland’s first FRAND battle. MLL’s patent team has particular expertise in the field of supplementary protection certificates and achieved two landmark Swiss Federal Supreme Court decisions on behalf of Gilead Sciences Inc. (Gilead v Mepha Pharma AG), which affirmed the validity and infringement of Gilead’s SPC for the combination product Truvada. Measured by published decisions, there is no other firm that has represented as many clients before the Swiss Federal Patent Court as the MLL Legal patent team.

The Next Ten Years for the Swiss Federal Patent Court

On 1 January 2022, the Swiss Federal Patent Court had its tenth anniversary! In the Swiss Trends & Developments chapter of the 2022 Patent Litigation Global Practice Guide, we took this as an opportunity to look back and reflect upon the last ten years for a moment – and this year we want to give an outlook on how the Swiss Federal Patent Court could further establish and position itself in the second decade after its foundation. If one looks at the most recent case law of the past year, one clearly notices that the Swiss Federal Patent Court renders its judgments with both the necessary pragmatism and a sense of proportion, making it an increasingly attractive forum for any patent owner to enforce their patent rights.

In the first years after its foundation, quite a number of cases dealt with procedural questions and were decided on the basis of Swiss procedural law. Depending on whether one sympathised more with the plaintiff or the defendant, one was happy or not with the result – but a true patent litigator is jubilant only when the case is argued and decided on the merits, not when a case is won because the filing of amended patent claims after having obtained the Court’s preliminary opinion is deemed too late (which is the case in Swiss proceedings and often a pain for patent owners). The possibility of still amending the patent in infringement proceedings has been unnecessarily limited in recent years by the Federal Supreme Court and should again be handled more pragmatically in the authors’ view.

Like other courts, the Swiss Federal Patent Court always tries to find a compromise between time, costs and quality. It is immediately clear that these aspects are contrary to each other and that, especially in patent litigation, the highest quality can hardly be achieved quickly and, at the same time, at low cost. But since the Swiss are well-known for reaching good compromises, it seems clear that the Swiss Federal Patent Court is on a very promising path. In particular, a look at some recent decisions in summary proceedings shows that the Federal Patent Court is taking a quick and pragmatic and, at the same time, well-founded approach, which – from a neutral and restrained perspective – could be called patentee-friendly. To illustrate this rather patentee-friendly approach, this article highlight three cases which the Swiss Federal Patent Court decided last year. Some of these judgments were made in awareness of – and in contrast to – rulings in parallel proceedings by well-established courts in the United Kingdom, Germany, or the Netherlands.

The “Fingolimod Case” (S2022_002)

In a dispute spreading across numerous European countries, Novartis sought to enforce its second medical use patent EP 2 959 894 (EP 894). The patent covers a 0.5mg per day dosage of active ingredient fingolimod, which forms the basis of Novartis’ drug Gilenya. The product is used to treat relapsing-remitting multiple sclerosis.

The dilemma Novartis faced was that the extended market exclusivity for Gilenya expired in March 2022, but EP 894 had not yet been officially granted by that time. However, the patent grant was imminent, as the European Patent Office (EPO), in the form of the Board of Appeal, had already given the green light to the granting of EP 894.

In light of Article 67 of the European Patent Convention (EPC), the EPC member states have different regimes as to what rights a patent application confers. In Switzerland, injunctive relief generally requires a granted patent. The same applies, for example, in Germany.

In the meantime, some generic manufacturers in Europe took advantage of the gap between the end of Novartis’s market exclusivity and the official granting of the patent to sell their own generic products in various markets. Therefore, Novartis initiated patent infringement proceedings against these generic manufacturers, including Mepha Pharma AG in Switzerland, even though Novartis did not yet have a granted patent.

Several courts, including the Düsseldorf Regional Court, dismissed Novartis’s application for preliminary injunctions on the grounds that injunctive relief is only available for a granted patent while financial compensation can also be claimed based on a published patent application.

So, what did the Swiss Federal Patent Court do?

The Swiss Federal Patent Court neither dismissed nor suspended the case.

It was undisputed between the parties and acknowledged by the Court that a published European patent application does not grant the applicant the protection provided for in Article 64 of the EPC in Switzerland and that preliminary injunctive relief requires a granted patent. However, in Switzerland, it is sufficient for the issuance of preliminary measures if, at the time of the judgment, the plaintiff is entitled to a claim that has been infringed or that is likely to be infringed. If an application for a preliminary injunction is filed while the application is still pending and the patent is granted only during the course of the proceedings, this defect is deemed to be “cured” because, according to general principles of Swiss civil procedure, the facts at the time of the judgment (rather than at the time of filing) are decisive. Therefore, a patentee can file a request for preliminary measures as soon as the grant of the patent is only a question of time and the claims have been established. In the present case, the fact that the defendant was not aware of the reasoning of the EPO Board of Appeal was not considered to cause any significant disadvantage. Firstly, the applicant was not aware of the reasoning either. Secondly, and crucially, the defendant must allege and establish the lack of validity in the present proceedings and respond to the relevant counterarguments of the applicant presented in those proceedings. The Board of Appeal’s reasoning is not binding on the Swiss Federal Patent Court in any case.

Likewise, the defendant’s request to suspend the preliminary injunction proceedings was dismissed immediately. The Court pointed out that summary proceedings serve the purpose of granting quick and provisional legal protection if the relevant prerequisites are met. Accordingly, preliminary injunction proceedings should be suspended only with extreme caution. In the present case, the grant of the patent was foreseeable and, according to general experience, would take place before the summary proceedings were ready for judgment. If this were not the case, the judgment would have to be suspended until the patent were granted. However, the proceedings should not be stayed immediately, as this would violate the applicant’s constitutional right to have its case decided within a reasonable time.

The “Sorafenib Tosylate Case” (S2021_006)

In this case, also spreading across Europe, Bayer HealthCare sought preliminary injunctive relief against the generic product Sorafenib Zentiva of Helvepharm, the Swiss branch of Zentiva. More specifically, Bayer HealthCare sought to enforce the compound claim 12 of EP 2 305 255 B1 (EP 255), claiming the tosylate salt of sorafenib as such. Sorafenib tosylate is the active ingredient in Bayer’s medicament Nexavar, which is, inter alia, authorised for the treatment of primary kidney cancer and advanced primary liver cancer.

This case has attracted attention because it was litigated simultaneously in a number of European countries. For example, EP 255 was held to be invalid in Germany, UK and in the Netherlands.

So, what did the Swiss Federal Patent Court decide?

While the Technical Judge in his written Preliminary Opinion provisionally regarded claim 12 of EP 255 as invalid due to lack of inventive step, similar to the positions taken, for example, in the UK and Germany; the applicant convinced the court to decide that claim 12 was valid and a preliminary injunction was granted accordingly.

Even though the defendant referred to the entire range of grounds for invalidity to defend itself, namely Article 123(2) of the EPC, invalid priority, lack of novelty and lack of inventive step, in the end, the case depended mainly on the assessment of inventive step.

With respect to the examination of priority, attention should be paid to one important aspect where Swiss case law might differ from the case law of other European jurisdiction. The Swiss Federal Patent Court pointed out that according to the case law of the Swiss Federal Patent Court, it was sufficient for a valid priority claim if at least one of the applicants of the earlier application and one of the applicants of the later application were identical. Since in the present case, the defendant did not dispute that at least the eight inventors/applicants for whom copies of the signed “Bayer Corporation Agreements” were filed were identical during the relevant period, the priority claim was considered valid. Thus, in a case where validity is dependent on the priority claim and where the priority claim might be disputed because not all applicants of the earlier application and the later application are identical, it could still be advisable for a patent owner to enforce the patent in Switzerland.

Regarding inventive step, the judgment discussed the questions as to whether the skilled person would have considered the tosylate salt at all as a target compound for the development of a sorafenib medicament and, if so, whether and at which stage the skilled person would have given up in view of discouraging results obtained in pre-formulation studies. The judgment of the Swiss Federal Patent Court came to the conclusion that the skilled person could not have determined promising properties of sorafenib tosylate – ie, by measuring the dissolution rate of sorafenib tosylate – with routine methods at the priority date. The Court concluded that the skilled person would not have realised that sorafenib tosylate had a surprisingly high dissolution rate, despite its low solubility.

As mentioned above, an inventive step was acknowledged by the Swiss Federal Patent Court, and a preliminary injunction was granted.

The “Deferasirox Case” (S2021_005)

In this case, Novartis and Mepha Pharma again faced each other, and Novartis AG sued Mepha Pharma AG for the alleged infringement of the Swiss parts of EP 2 964 202 (EP 202) and EP 3 124 018 (EP 018).

Both patents concern formulations of deferasirox which is an active ingredient from the group of iron chelators and used to treat iron overload caused by frequent blood transfusions.

The patents require, according to the independent claims, that deferasirox or a pharmaceutically acceptable salt thereof is present in the claimed film-coated tablet for oral administration in an amount from 45% to 60% by weight based on the total weight of the tablet. The issue in dispute was, in particular, whether the alleged infringing product “Deferasirox Mepha® 90 mg, 180 mg and 360 mg” containing deferasirox in an amount of 64.3% by weight met this essential feature. Or, in other words, the Federal Patent Court considered the question whether a tablet with a higher amount of the active ingredient – ie, a tablet containing 64.3% by weight of that active ingredient – may fall within the protective scope of a patent wherein the weight range of the active ingredient is defined as 45% to 60% by weight.

Interestingly, in a parallel case, the High Court of England and Wales recently invalidated the two patents following revocation action proceedings brought by Teva. The presiding judge found that Novartis’ claim relating to the amount of deferasirox within the tablet was an obvious modification over the two previous examples of prior art. While the precise figures for Teva DFX were confidential in the UK proceedings, the judge also found that Teva did not infringe the claims of the patents.

So, what did the Swiss Federal Patent Court decide in this case?

The Swiss Federal Patent Court decided that Deferasirox Mepha® did not literally infringe the patents. So far so good. However, the Swiss Federal Patent Court also concluded that Deferasirox Mepha® 90 mg, 180 mg and 360 mg containing 64.3% Deferasirox by weight realised the feature “a Deferasirox content in the range of 45% and 60% by weight” by equivalent means.

In this case, the Court – for the first time, by the way – dealt with the question of how numerical ranges in a patent claim are to be construed, especially against the background of a product allegedly infringing the patent claim despite a feature deviating from this numerical range.

When assessing the question of infringement under the doctrine of equivalence, the Swiss Federal Patent Court basically applied the three-step-test known as “Schneidmesser’s” (cutting knife) questions, developed by the German Federal Supreme Court (BGH, judgment X ZR 168/00 dated 12 March 2003 “Schneidmesser I”; see the Swiss decision S2013_001 of 21 March 2013, cons. 17.2 “Drospirenon I”). However, the relevant questions are not formulated completely identically by the Swiss courts, as is shown below. According to Swiss practice, the first two questions must be answered in the affirmative and the last in the negative for a patent infringement to exist.

  • Does the modified feature, in combination with the other technical features of the patent claim, objectively perform the same function as the claimed feature? Known as “same effect.”
  • Is the equal effect obvious to the person skilled in the art when viewed objectively, considering the teaching of the patent, if the features are interchanged? Known as “accessibility.”
  • Does an objective reading of the patent specification lead the skilled person to the conclusion that the patent owner has formulated the claim – for whatever reasons – so narrowly that it does not claim protection for an accessible embodiment having the same effect?

In the case at hand, the Federal Patent Court affirmed the “same effect”, mainly because the tablet with 64.3% by weight of deferasirox was bioequivalent to Novartis’ tablet. The bioequivalence was confirmed by the fact that the generic tablet was approved by the Swiss Agency of Therapeutic Products (Swissmedic) in a drug application procedure to which bioequivalence is a prerequisite.

The second question – ie, “accessibility” – was also answered in the affirmative for the reason that the patents did not require explicit compliance with the upper limit of the claimed range. Rather, it was allegedly clear from the patents that the intention was to increase the proportion of active ingredient in the tablet. According to the Court, an increase of the portion of the active ingredient of up to 10% would still be considered safe and effective.

In a third step, the Federal Patent Court assessed whether the skilled person when reading the patent specification would conclude that the patentee had deliberately formulated the claim so narrowly that they thereby waived protection for an embodiment with an equal technical effect that would have been accessible to the skilled person. In assessing this question, the Court particularly considered accepted tolerances for pharmaceutical formulations. In doing so, the Court took into consideration both the accepted tolerance for active ingredient weight and for the total weight of the tablet. That, in practice, much smaller deviations from the target weight can actually be achieved today than are considered acceptable by the cited references, was not relevant. What was decisive, according to the Court, was that these generous tolerances are apparently accepted in the technical field in question. Therefore, the skilled person would assume that a drug which is within these tolerances is effective and safe.

With an active ingredient content of 64.3% by weight of deferasirox, the challenged embodiments were considered to be within the tolerance generally accepted in the relevant technical field, which is 66% for the upper value of the relative active ingredient content, based on the total weight of the tablet.

As a result, the Federal Patent Court considered that Deferasirox Mepha® 90 mg, 180 mg and 360 mg containing 64.3% Deferasirox by weight fulfil the feature “a Deferasirox content in the range of 45% and 60% by weight” by equivalent means.

This case shows that even numerical ranges in patent claims, the scope of protection of which is normally strictly determined by their literal sense, are certainly amenable to the doctrine of equivalence and that differences that are much more than mere rounding differences can still fall within the scope of protection under the doctrine of equivalence.

The latter two cases – ie, the Sorafenib Tosylate Case and the Deferasirox Case – are currently being litigated in ordinary proceedings on the merits and it remains exciting to see whether the Court will confirm the preliminary rulings.

***

In closing, with a look to the future, we would like to quote the President of the Federal Patent Court, Mark Schweizer. In a very recent interview, the President answered the question of where he sees the Federal Patent Court in 2032 as follows: “When I became president four years ago, I said that we wanted to become the best patent court in Europe. In ten years, that goal shall be realised.”

We think the Court is on its way to achieving this ambitious goal.

MLL Legal

Schiffbaustrasse 2
P.O. Box
8031 Zürich
Switzerland

+41 58 552 08 00

+41 58 552 08 01

zurich@mll-legal.com www.mll-legal.com
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Pestalozzi is a multicultural Swiss business law firm that has focused on high-end work for domestic and international clients since 1911. Pestalozzi’s lawyers are strong and empathic personalities, known for their truly independent approach to advising and representing their clients. The firm guides and supports its clients in their strategic business decisions, anticipates their future challenges and helps them solve their critical issues. Being fully integrated, Pestalozzi encounters no internal limits in shaping the most competent and efficient teams for clients’ needs. With over 100 professionals in Zurich and Geneva, the firm is at home in Switzerland’s two main commercial hubs. While being locally embedded, Pestalozzi has also developed a sought-after expertise in dealing with multi-jurisdictional transactions and disputes. Pestalozzi has a long tradition in providing intellectual property services. Its IP practice group is known to provide results-oriented, effective and pragmatic solutions for the protection and commercialisation of intangible assets, including representing clients from all industry sectors in enforcing and defending their intellectual property rights.

Trends and Development

Authors



MLL Legal has an IP team that unites Switzerland’s leading consultants and representatives for patent law. Led by Simon Holzer, MLL’s patent team includes four partners and four associates. The firm handles an impressive amount of litigation in the Swiss life sciences and hi-tech areas and it is many global pharmaceutical originators’ first choice. The team covers a wide range of industries, including pharmaceuticals, medical devices, software, telecommunications, and foodstuffs. It has also taken centre stage in Switzerland’s first FRAND battle. MLL’s patent team has particular expertise in the field of supplementary protection certificates and achieved two landmark Swiss Federal Supreme Court decisions on behalf of Gilead Sciences Inc. (Gilead v Mepha Pharma AG), which affirmed the validity and infringement of Gilead’s SPC for the combination product Truvada. Measured by published decisions, there is no other firm that has represented as many clients before the Swiss Federal Patent Court as the MLL Legal patent team.

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