Infringement Actions

In an action for patent infringement in Saudi Arabia, the primary parties involved are:

• the patentee: the owner of the patent who holds the exclusive rights to the invention; and
• the alleged infringer: the party accused of infringing the patent rights.

If a patent is co-owned, each co-owner has the right to use the patent independently. However, co-owners must agree to bring an infringement action jointly.

An exclusive licensee, who has been granted the exclusive rights to use the patent within a specific territory or field, can bring an infringement action. The licence must be registered with the Saudi Arabian Authority for Intellectual Property (the “SAIP”) to be enforceable.

Generally speaking, non-exclusive licensees do not have the standing to bring an infringement action unless explicitly granted this right in the licence agreement.

If the patentee does not consent to being a claimant/plaintiff, they must be joined as a defendant in the action brought by an exclusive licensee.

Nullity/Revocation Actions

To file a nullity/revocation action, the plaintiff must have legitimate interest. This typically applies to:

• alleged infringers: parties accused of infringement who seek to invalidate the patent as a defence; and
• other interested parties: any party that can demonstrate a direct and legitimate interest in the invalidation of the patent.

The SAIP can provide opinions on infringement. However, these opinions are not binding and serve as guidance. Actions for revocation can be brought before the Committee for Reviewing Patent Disputes, which has the authority to issue binding decisions.

The parties who are usually sued in infringement actions are:

• manufacturers: they are often the primary target in infringement cases due to their role in producing the patented product;
• suppliers and importers: they can be sued for distributing or importing infringing products; and
• local distributors/wholesalers: they are frequently involved in the supply chain and can be held liable for selling infringing products.

Revocation actions are usually filed against patentees.

In Saudi Arabia, healthcare regulatory authorities and intellectual property offices are not required to be notified of or given an option to join infringement and nullity proceedings. However the SAIP will be notified with the final decisions issued by the Committee for Reviewing Patent Disputes.

Preliminary Injunctions

Key details

In Saudi Arabia, preliminary injunctions (PIs), including ex parte injunctions, are available under the Law of Commercial Courts. The key details are as follows.

PIs

Both ex parte and inter partes PIs are available. Ex parte injunctions can be granted without notifying the opposing party, typically in urgent situations where immediate action is necessary to prevent irreparable harm.

A PI is to be decided on by the court within three working days as from the date it was filed.

Practical considerations

When deciding whether to grant a PI, Saudi Arabian courts consider:

• balance of convenience: the court assesses whether the benefits to the plaintiff outweigh the potential harm to the defendant;
• adequacy of damages: the court evaluates whether monetary compensation would be sufficient to remedy the plaintiff’s harm. If not, an injunction is more likely to be granted;
• validity: the court considers the likelihood of the plaintiff’s success on the merits of the case; and
• urgency: the plaintiff must demonstrate that there is an urgent need for the injunction to prevent irreparable harm.

There are special requirements for an applicant to file a PI. Practically speaking, a quia timet relief is available in Saudi Arabia. For example, it might apply to acts that amount to a threat to infringe, including any preparatory steps that indicate an imminent infringement, such as manufacturing or marketing preparations.

There is no consideration specific to patent litigation in life sciences cases in Saudi Arabia.

Court notifications are sent by the court via SMS to the mobile phone of the addressee. The alleged infringer is given an opportunity to file evidence and submissions in defence of a PI. In ex parte requests the right of the defence will be considered at the appeal stage.

Protective letters are not recognised in Saudi Arabian law.

Practically speaking, infringement and validity proceedings are to be bifurcated. An infringement proceeding will usually be stayed until a validity proceeding is concluded.

Filing Nullity Proceedings

It is possible to file nullity proceedings while there are ongoing patent office opposition proceedings in Saudi Arabia. The legal framework allows for both types of actions to be pursued simultaneously. This means that a party can challenge the validity of a patent through opposition proceedings at the SAIP while also initiating nullity proceedings in court.

Article 7 of the Patent Law

Under Article 7 of the Saudi Arabian Law of Patents, Layout Designs of Integrated Circuits, Plant Varieties, and Industrial Designs (the “Patent Law”): “If the subject matter claimed in the application or in the protection document is derived from a subject matter owned by a person other than the applicant or the owner of the protection document, then this person may request the Committee to transfer the ownership of the application or protection document to him. The case for the transfer application shall not be heard after the lapse of five years of granting the protection unless bad faith on the part of the applicant is established.”

Notification of Main Action

The notification process for the alleged infringer (in the case of an infringement action) or the patentee (in the case of a nullity action) is as follows.

• The notification is typically carried by the court through SMS (if the defendant is located in Saudi Arabia).
• The service takes place once the first hearing is scheduled.
• The location of the infringing entity can impact the service process. If the entity is located outside Saudi Arabia, international service procedures may apply, potentially causing delays.

Usual Time to a First Instance Hearing and Decision

The time to a first instance hearing and decision can vary, but it generally takes several months from the filing of the action.

Although the Patent Law doesn’t explicitly specify when an infringement action can first be filed, in practice, a main infringement action can only be filed once the patent has been granted. The patent must be validated, and any necessary translations must be filed before it can be asserted.

Important Factors/Difficulties with Asserting Different Types of Patents

Process patents

Asserting process patents can be particularly challenging due to the difficulty in proving that the infringing party is using the patented process. This often requires detailed technical evidence and expert testimony to establish infringement.

Product patents

These are generally easier to enforce as the infringing product can be directly compared to the patented invention.

Biotechnology and pharmaceutical patents

These patents often involve complex scientific data and regulatory considerations, making enforcement more complicated.

Reversal of Burden of Proof for Certain Types of Patents

In Saudi Arabia, there is a reversal of the burden of proof for process patents. According to Article 48 of the Patent Law, if the subject matter of a patent is a process for obtaining a product, the defendant must prove that the identical product was not manufactured by this process without the consent of the owner of the patent, under two specific conditions:

• when the product obtained through a patented industrial process is a new product; or
• when there is a substantial probability that the identical product was manufactured through the patented industrial process and the owner of the patent was unable to determine the method actually used despite reasonable efforts.

This provision is designed to address the inherent difficulties in proving infringement of process patents.

The Saudi Arabian legal system lacks a formal process for pre-action discovery similar to those found in common law jurisdictions. Instead, the focus remains on the claimant proving their case without obliging the defendant to disclose or build evidence before the commencement of formal proceedings.

It is possible to use materials obtained in other jurisdictions in Saudi Arabian legal proceedings. However, there are procedural requirements to ensure the admissibility of such evidence.

Authentication and Translation

Documents obtained from other jurisdictions must be attested and translated into Arabic to be admissible in Saudi Arabian courts.

Seizure orders are available in Saudi Arabia as a form of interim/summary measures under the Law of Commercial Courts.

The main requirements for seeking the issuance of a seizure order is to prove to the court the urgency for issuing the order and specify the items that need to be seized.

The main action needs to be filed within seven days as from the date of issuing the seizure order.

Saudi Arabian courts are willing to grant declaratory relief. Declaratory relief can be sought to clarify the legal rights and obligations of the parties without necessarily seeking coercive enforcement.

Declaratory Relief Requirements

To obtain declaratory relief, the following requirements must be met.

• Existence of a legal dispute: there must be a genuine legal dispute between the parties that requires clarification.
• Legal interest: the party seeking declaratory relief must have a legitimate legal interest in obtaining the declaration.
• Specificity: the request for declaratory relief must be specific and clearly define the legal rights or obligations in question.

Types of Declaratory Relief Available in Life Sciences Patent Proceedings

In life sciences patent proceedings, the types of declaratory relief that may be available include the following.

• Declarations of non-infringement: a declaration that a particular product or process does not infringe on the patent in question.
• Validity declarations: a declaration regarding the validity of a patent.

Parties’ Burden

The party seeking the declaration must demonstrate:

• direct and personal interest: the party must have a direct and personal interest in the outcome of the declaration; and
• potential impact: the declaration must have a potential impact on the legal rights or obligations of the party seeking relief.

The Patent Law implicitly supports the application of the Doctrine of Equivalents (DoE) by allowing for the protection of the essential elements of a patented invention. This doctrine allows for a finding of infringement even when the accused product or process does not literally infringe the express terms of a patent claim, provided that the differences are insubstantial.

The relevant legal test for determining equivalence in Saudi Arabia involves assessing whether the accused product or process performs substantially the same function in substantially the same way to achieve substantially the same result as the patented invention. This is similar to the function-way-result test used in other jurisdictions.

In Saudi Arabia, there is no legal obligation to “clear the way” ahead of a new product launch. However, it is a prudent practice for companies to conduct thorough due diligence to ensure that their new products do not infringe on existing patents or other intellectual property rights. This practice helps to mitigate the risk of legal disputes and potential infringement claims.

Frequency

It is common for Saudi Arabian courts to use evidence from experts to determine issues of infringement and validity in patent cases. Expert evidence is crucial in providing technical insights that the court may not possess.

Forms

Experts typically submit detailed written reports outlining their findings and opinions. Experts also often prepare reply reports to address points raised by either party. Additionally, experts may be called to testify in court and answer questions raised by the court or either party.

Significance

Expert evidence is highly significant in the decision-making process, especially in complex technical cases.

Court-Appointed Experts

The court appointing the expert will specify the time limit for the expert to prepare its report while allowing both parties to submit their comments, which is then followed by a final version of the report. After filing the final version of the report, the court can ask the expert to submit oral testimony or address any other points the court sees fit.

Court-appointed experts owe a duty to the court to provide impartial and unbiased opinions.

Party-Appointed Experts

It is not common for both sides to have their own experts as the court will eventually appoint its own expert when needed. However, in very complex technical issues, parties appoint experts independently so that they can have a reference when they are working with the court-appointed experts.

Khibra Portal

Courts appoint experts through the Khibra portal, which is a portal operated by the Saudi Arabian government and includes a list of registered experts in different fields. Whenever the court decides to appoint an expert in a specific case, it electronically refers the decision to appoint the expert to the Khibra portal while specifying the scope of the expert mission. The Khibra portal will then refer the scope to relevant registered experts while asking them to submit their technical and financial proposals to complete the mission. Once the Khibra portal receives the technical and financial proposals they will send them over to the parties to the case who will be granted the opportunity to exclude one of the proposals. The Khibra portal will then automatically choose one of the experts to complete the mission.

Technical or Scientific Advisors

Courts in Saudi Arabia do not appoint technical or scientific advisors and only appoint experts when needed.

PIs

Practically speaking, PI proceedings do not involve the appointment of court experts.

There is no mechanism to adduce results from experiments in order to prove or disprove infringement or validity. Additionally, using experiments is not common in Saudi Arabian courts.

There is no specific discovery and disclosure process for patent litigation in Saudi Arabia. Discovery and disclosure are not actually specifically addressed in Saudi Arabian law. However, parties are required to prove their cases by submitting the evidence they have in their possession either in the form of documents or submitting dispositions (as to be accepted by the court). Additionally, a party can ask the court to order the counterparty to submit documents proving evidence in their possession in certain circumstances.

Defences and Exceptions

In Saudi Arabian law, several defences and exceptions are available in infringement actions. Some of the key defences and exceptions are as follows.

• Invalidity: a common defence where the defendant argues that the patent or intellectual property right in question is invalid. Article 32 of the Patent Law provides that any party with an interest may challenge the decision granting a protection document before the Committee for Reviewing Patent Disputes, and seek total or partial revocation, relying upon the violation of the stipulated conditions for granting the protection document.
• Consent/licence: if the alleged infringer has obtained permission or a licence from the rights holder, this can serve as a defence against infringement claims under Article 21 of the Patent Law.
• Exhaustion: once a patented product is sold by or with the consent of the patent owner, the patent owner’s control over the product is exhausted, and the buyer is free to use or resell the product.
• Compulsory licence: under certain conditions, the government can grant a compulsory licence to use a patented invention without the consent of the patent owner, typically to address public health needs under Article 24 of the Patent Law.

Special Considerations for Life Sciences Cases

Life sciences products, including pharmaceuticals and medical devices, must comply with regulations set by the Saudi Arabian Food and Drug Authority (the “SFDA”). This includes obtaining necessary approvals and adhering to guidelines for clinical trials.

All clinical studies must be registered with the SFDA and comply with guidelines for good clinical practice and ethical standards. The SFDA has provisions for the emergency or compassionate use of unapproved medical products, which can be a critical factor in infringement cases.

Other Relevant Proceedings

Infringement and validity proceedings can be stayed pending the outcomes of other proceedings. If there are ongoing opposition or intellectual property rights proceedings, the court may decide to stay the infringement or validity proceedings until the outcome of these proceedings is determined.

Local nullity proceedings, where the validity of a patent or intellectual property right is challenged, can also form a basis for a stay. The court handling the infringement case may wait for the nullity proceedings to conclude before making a decision.

Recognition of Foreign Court Orders

Saudi Arabian courts can recognise foreign court orders or judgments when the conditions under the Saudi Arabian Enforcement Law are met.

Key conditions for recognition include:

• non-contradiction with Saudi Arabian public policy; and
• reciprocity between Saudi Arabia and the foreign country regarding recognition and enforcement of court orders.

Staying Local Proceedings Pending Foreign Proceedings

Saudi Arabian courts have discretionary power to stay the local proceedings if they conclude that deciding on the local proceedings is dependent on the outcome of the foreign proceedings.

Legal Basis for Granting a Stay

Under Article 87 of the Saudi Arabian Law of Civil Procedure, a stay may be granted if the requested proceedings will resolve an issue that will significantly impact the decision in the case sought to be stayed.

Permissibility of Amendments

Patents can be amended during litigation in Saudi Arabia.

Legal Framework

The Patent Law allows for amendments to be made to the claims of a patent, provided that the amendments do not extend the scope of the protection conferred by the patent.

Frequency

These types of applications are not uncommon.

Reasons for Amendments

Patent holders may seek to amend their patents to clarify claims or address issues raised during litigation.

Court Approach

Courts in Saudi Arabia are generally receptive to amendment applications, especially if the amendments are made to address specific issues raised during the litigation process.

Legal Requirements

The amendments must comply with the legal requirements and should not extend the scope of the original claims.

Conditional Amendments

Amendments can be conditional, meaning that they may be subject to certain requirements or limitations imposed by the court. For example, the court may allow amendments on the condition that they do not introduce a new matter or broaden the scope of the original claims.

In Saudi Arabia, there are no specialised judges for pharma/life sciences cases. All Saudi Arabian judges have the same background. That being said, actions for patent revocation are to be brought before the Committee for Reviewing Patent Disputes which includes two technical members.

Forum shopping is not permitted in Saudi Arabia. The principle of avoiding forum shopping is upheld to ensure judicial efficiency and consistency in rulings.

The Patent Law and its implementing regulations do not contain specific provisions regarding patented pharmaceutical products. In addition, there are no published Saudi Arabian court decisions addressing when infringement rights crystallise, what constitutes infringing, special considerations for second medical use patents and skinny labelling, or rules governing parallel imports.

In Saudi Arabia, tender submissions for pharmaceuticals are accessible to the public. The Government Tenders and Procurement Law requires all public tenders, including those from the Ministry of Health and other governmental agencies, to follow principles of publicity (Article 6) and be published through a designated unified electronic portal (Article 16).

Data and Market Exclusivity

The Patent Law does not contain specific provisions regarding data and market exclusivity periods for pharmaceutical products, including orphan drugs, paediatric formulations, new indications, combinations, or reclassifications. However, under Article 19 of the Patent Law, patents receive 20 years of protection from the filing date.

Challenges and Frequency

Frequency of challenges cannot be reliably assessed due to the lack of a specific legal framework for data/market exclusivity, limited publicly available records, and no dedicated challenge process in the Patent Law.

Regulatory Authority

The SFDA serves as the regulatory authority for pharmaceuticals and health-related products.

Forum and Timeframes

The Patent Law doesn’t provide for a specific forum regarding data and market exclusivity. However, in general, commercial courts have jurisdiction over intellectual property law claims and violations according to Article 16(3) of the Law of Commercial Courts.

Article 47 of the Patent Law only mentions a limited exemption for “non-commercial activities relating to scientific research”, but does not explicitly address Bolar-type exemptions for generic manufacturers’ pre-launch activities. The regulatory framework does not provide clear guidance on what preparatory acts are permitted before patent expiry.

Saudi Arabia does not have an Orange Book equivalent system. The SFDA maintains a public list of the approved drugs and those awaiting approval.

While the SFDA issued a Regulatory Framework for Drugs Approval (the “Regulatory Framework”), it does not include a system for notifying marketing authorisation (MA) reference product holders about generic/biosimilar applications. Monitoring is probably needed as there is no sufficient data on the existence of an automatic notification system.

There is no formal patent linkage system in Saudi Arabia that connects MA or pricing/reimbursement decisions to patent status. However, the SFDA’s Pricing Rules for Pharmaceutical Products (the “Pricing Rules”) provide some relevant guidelines.

Patent Status Considerations

For innovative and biological products manufactured locally under licence from international companies during the patent term, they must be priced at the same price as the innovative product (Article 3(D) and 3(E) of the Pricing Rules).

Once patents expire, products are treated as generics for pricing purposes.

Pricing Process

The pricing process is handled by the Registration Committee for Pharmaceutical Companies, Manufacturers and their Products.

Pricing decisions are based on multiple factors outlined in Article 2 of the Pricing Rules, including therapeutic value, prices of alternatives, and economic studies.

There is insufficient data on the existence of an automatic notification system to originators about generic pricing applications.

Second Medical Use Patents

The Pricing Rules do not contain specific provisions on indication-specific pricing. All concentrations and pack sizes of the same product are subject to unified pricing rules.

Administrative Appeals

According to the Policy of Appeal to Drug Sector Decisions, a first appeal to pricing decisions can be submitted within 60 days from notification, with a 60-day review period.

A second appeal to pricing decisions can be filed within 30 days of the first appeal decision, with a 30-day review period.

Appeals must follow the procedures outlined in the Policy of Appeal to Drug Sector Decisions.

There is insufficient data as to how common appeals are.

Monitoring Requirements

Monitoring is probably needed as there is no sufficient data as to the existence of a notification system. Pricing information for registered drugs is publicly available through the SFDA’s website.

There are no differences in how infringing acts are treated between biologics or biosimilars and small molecule pharmaceuticals in Saudi Arabia. The Patent Law does not make any specific distinctions regarding infringement rights between biologics and small molecules.

The key differences for biologics and biosimilars compared to small molecules are as follows.

Price Impact

According to Article 6 of the Pricing Rules, when the first biosimilar enters the market, the price of the reference biological product is reduced by 20% (compared to a 25% reduction for small molecule generics under Article 4).

Pricing Structure

According to Article 7 of the Pricing Rules, the pricing structure is as follows.

• First biosimilar: maximum 75% of the reference biological product’s pre-reduction price.
• Second biosimilar: maximum 65% of the reference biological product’s pre-reduction price.
• Third and subsequent biosimilars: maximum 55% of the reference biological product’s pre-reduction price.

There are no specific differences in pre-launch preparation exemptions between biologics or biosimilars and generics. Article 47 of the Patent Law provides the same limited “non-commercial activities relating to scientific research” exemption without distinguishing between product types.

There are no differences. Saudi Arabia does not have an Orange Book equivalent system. The SFDA maintains public lists of approved drugs and products pending approval.

The key difference is in the pricing rules, as outlined in Article 15 of the Pricing Rules. The price of biological products manufactured locally under licence from foreign companies can be fixed for up to seven years if all manufacturing phases are transferred to Saudi Arabia. Beyond the pricing differences noted in 3.2 Data and Regulatory Exclusivity, the same basic reimbursement and pricing procedures apply to both biologics or biosimilars and small molecules.

Availability and Legal Framework

In Saudi Arabia, supplementary protection certificates (SPCs) or similar patent term extension instruments are available. These are governed by the Patent Law and its implementing regulations, which aim to extend the protection of patents beyond their standard term to compensate for the time taken to obtain regulatory approval.

Applicable Laws and Main Provisions

The main provisions related to SPCs in Saudi Arabia are found in the Patent Law. This law provides the framework for extending the patent term for pharmaceuticals and other regulated products to account for the time required for regulatory approval.

Patents Eligible for SPCs

Patents that can form the basis of an SPC include those covering:

• active pharmaceutical ingredients (APIs);
• medicinal products;
• processes for manufacturing medicinal products; and
• medical devices.

Identity of the Applicant

The identity of the applicant for an SPC matters. Typically, the originator or the patent holder is the one who applies for the SPC. However, third parties can also apply for an SPC if they have obtained the necessary rights from the patent holder.

The originator can be denied an SPC if a third party has already obtained an SPC based on the originator’s basic patent, provided the third party has the legal rights to do so.

Rules for Different Products and Same Patent

In terms of different products and same patent, an SPC can be granted for each product covered by the same patent, provided each product meets the criteria for SPC eligibility.

In terms of one product, multiple patents, if a single product is protected by multiple patents, an SPC can be granted for each patent, but the total duration of the SPCs cannot exceed the maximum extension period allowed.

Rules for Combination Products

For combination products, the SPC can be granted if the combination is covered by the basic patent and meets the regulatory approval requirements. The combination must be specifically claimed in the patent or be clearly derivable from the patent claims.

Specific Considerations and Jurisdictional Nuances

Saudi Arabia does not currently have specific provisions for SPC manufacturing waivers. However, the general principles of patent law and regulatory approval processes apply.

The time taken for regulatory approval by the SFDA is a critical factor in determining the duration of the SPC.

Availability

In Saudi Arabia, paediatric extensions are available as part of the broader framework for patent term extensions. These extensions are designed to encourage the development of medicines specifically for paediatric use by providing additional market exclusivity.

Applicable Laws and Main Provisions

The primary legal framework governing paediatric extensions in Saudi Arabia includes the Patent Law and its implementing regulations. The main provisions are as follows.

Patent Law

The Patent Law provides the basis for extending the term of a patent to compensate for the time taken to obtain regulatory approval, including for paediatric medicines.

Implementing regulations

The implementing regulations to the Patent Law outline the specific procedures and requirements for obtaining a patent term extension, including paediatric extensions.

Regulatory approval

The extension is contingent upon obtaining regulatory approval from the SFDA. The SFDA evaluates the safety and efficacy of paediatric medicines and grants approval, which is a prerequisite for the extension.

Additional exclusivity

Paediatric extensions provide additional market exclusivity beyond the standard patent term. This is intended to incentivise pharmaceutical companies to invest in the development of paediatric formulations.

In Saudi Arabia, MAs are available for medicines that are already authorised but are developed specifically for children, even if they do not have a patent or SPC. The SFDA oversees the regulation and approval of these medicines.

Applicable Laws and Main Provisions

The SFDA is the primary regulatory body responsible for the approval of pharmaceuticals, including paediatric medicines. The SFDA’s regulations ensure that medicines are safe, effective, and of high quality.

Regulatory Framework

The SFDA has specific guidelines for the approval of paediatric medicines. These guidelines require that the medicines meet stringent safety and efficacy standards tailored to paediatric use.

Clinical Trials and Data Requirements

For a medicine to receive an MA for paediatric use, the applicant must provide clinical trial data demonstrating the safety and efficacy of the medicine in children. This data must comply with the SFDA’s requirements for clinical trials.

Labelling and Packaging

The SFDA also mandates specific labelling and packaging requirements for paediatric medicines to ensure proper usage and dosage.

Extensions for Orphan Medicines in Saudi Arabia

Availability of extensions

Extensions are available for orphan medicines in Saudi Arabia. The SFDA provides a framework for orphan drug designation and offers incentives, including potential extensions, to encourage the development of treatments for rare diseases.

Applicable laws and main provisions

The Saudi Arabian Patent Law and its implementing regulations provide the basis for patent term extensions, including those for orphan medicines. The extensions aim to compensate for the time taken to obtain regulatory approval.

The SFDA Guidance for Orphan Drug Designation outlines the criteria and procedures for obtaining orphan drug designation. It includes provisions for incentives to support the development and availability of orphan drugs.

The SFDA offers various incentives for orphan drugs, including regulatory support, fee reductions, and potential extensions of market exclusivity. These measures are designed to make it more feasible for companies to invest in the development of treatments for rare diseases.

Key provisions

To qualify for orphan drug designation, a medicine must be intended for the diagnosis, prevention, or treatment of a rare disease or condition. The disease must be life-threatening or seriously debilitating, and the prevalence must be low, or the development must not be financially viable without incentives.

Companies must submit an application to the SFDA, providing detailed information about the drug, its intended use, and evidence supporting its designation as an orphan drug. The SFDA reviews these applications and grants designation based on the criteria outlined.

Undertakings in the form of a financial guarantee can be requested by the court ahead of issuing a PI. This undertaking serves as a guarantee to compensate the defendant for any damages incurred if it is later determined that the injunction was wrongfully granted. The undertaking typically remains in force until the final resolution of the case.

PIs are enforced as per the terms of the Saudi Arabian Enforcement Law. Enforcement takes place through an application to be filed to the competent enforcement court and the method of actual enforcement will differ depending on the nature of the injunction. Once an enforcement application is accepted by the enforcement court, the respondent will be notified to voluntarily comply with the injunction within five days. If the five days lapse before the respondent voluntary complies with the injunction, the enforcement court will proceed with compulsory enforcement.

If a financial guarantee is required before the PI is issued, the court may decide the quantum of such guarantee. However, there are no guidelines on how this quantum will be determined. It will usually be an amount sufficient to compensate the defendant for the potential harm should the plaintiff lose the case.

If a PI is issued, the plaintiff will file the main claim within seven days as from the date of issuing the injunction.

Appealing the decision imposing the PI does not result in the PI enforcement being stayed.

There is no distinction in Saudi Arabian law between PIs and final injunctions as both are dealt with as per as a form of interim/summary relief. The same provisions which apply to PIs apply to final injunctions.

In terms of enforceability of final injunctions in Saudi Arabia, final injunctions in Saudi Arabia become enforceable upon the issuance of a written decision by the court. The enforcement process begins once the judgment is final and binding.

Courts in Saudi Arabia are granted the power to award damages in lieu of an injunction.

Damages are awarded according to the Civil Transactions Law to the extent required to remedy the sustained harm and compensate the aggrieved party for the lost profit. Saudi Arabian law does not recognise punitive damages or legal interest. There is no prescribed way to be followed by judges in awarding damages for patentee/exclusive licensees, and Saudi Arabian judges will apply the general rules prescribed in the Civil Transactions Law while calculating damages.

There is no typical court judgment for the pharma/biopharma/medical device industry, as courts are not bound by previous court decisions issued in similar cases.

Damages are awarded to remedy actual sustained harm or compensate lost profit from the date at which harm was sustained or the date at which the profit was lost. Damages are awarded by virtue of the court decision and there is no separate quantum hearing or proceedings. Damages are also not awarded via interim awards.

If an injunction was issued and the plaintiff lost the case, the defendant will be at liberty to claim damages for the harm it sustained as a result of the wrongful injunction. There are no special considerations to take into account in this respect and the general rules for awarding damages (wrongful act, harm and causal link) will apply.

The patentee is usually the only person to claim damages against an alleged infringer. It is not usual for national health services to claim damages in these cases.

Legal fees incurred by the winning party can be claimed in Saudi Arabia as per the principles of Islamic Sharia. However, as a matter of practice, legal fees are not usually awarded in full as a fraction of the incurred legal fees is usually awarded. There is no prescribed fraction to be decided by the Saudi Arabian courts as each judge will be able to exercise their discretion in this respect.

Court fees are prescribed by virtue of the Saudi Arabian Judicial Fees Law which imposes a maximum of 5% of the amount claimed as court fees (with a maximum amount of SAR1 million) on the losing party.

Saudi Arabian law does not recognise punitive damages, so the conduct of the parties is not usually considered when deciding on the relief to be granted by Saudi Arabian courts.

Commonality of Trade Mark Disputes

Trade mark disputes in the life sciences and pharmaceutical sectors are relatively common in Saudi Arabia.

Primary Sources of Law

The primary sources of law governing trade marks in Saudi Arabia include:

• the Trade Marks Law: this law provides the framework for the registration, protection, and enforcement of trade marks in Saudi Arabia;
• the GCC Trade Marks Law: this law was implemented in Saudi Arabia through Royal Decree No M/51. It harmonises trade mark regulations across the Gulf Cooperation Council (GCC) states; and
• the SFDA oversees the registration and regulation of pharmaceutical products, including trade mark considerations.

Additional Considerations for Pharma/Medical Devices Marks

Restrictions on naming

Pharmaceutical trade marks must not be misleading or suggest unapproved therapeutic claims. The SFDA has specific guidelines on the naming of pharmaceutical products to ensure they are not confusing or deceptive.

Issues around confusion

The likelihood of confusion is a significant factor in trade mark disputes. Courts consider the similarity of the marks, the similarity of the goods or services, and the likelihood of consumer confusion.

Anti-counterfeiting measures

The SFDA regulations include provisions to combat counterfeiting. These measures are critical in the pharmaceutical sector to ensure the safety and efficacy of medical products.

Copyright disputes in the life sciences and pharmaceutical sectors are not as common as trade mark or patent disputes, but they do occur. These disputes often involve issues related to the unauthorised use of copyrighted materials such as product labels, instructions for use, and other proprietary content.

Relevant Sources of Law

Saudi Arabian Copyright Law

The primary legislation governing copyright in Saudi Arabia is the Copyright Law. This law protects literary, scientific, and artistic works, including those in the life sciences and pharmaceutical sectors.

The SAIP

The SAIP oversees the enforcement of the Copyright Law and provides a framework for the registration and protection of copyrighted works.

Frequency

Trade secrets disputes in the life sciences and pharmaceutical sectors are relatively common in Saudi Arabia. These disputes often arise due to the high value of proprietary information and the competitive nature of the industry.

Common Issues

Employee mobility

One of the most common issues is the movement of employees between competing firms, which can lead to the unauthorised disclosure of trade secrets.

Cybersecurity threats

With the increasing reliance on digital data, cybersecurity breaches pose a significant risk to the protection of trade secrets.

Collaboration and partnerships

Joint ventures and collaborations in the pharmaceutical sector can lead to disputes over the ownership and use of shared proprietary information.

Regulatory compliance

Ensuring compliance with local and international regulations while protecting trade secrets can be challenging, especially in a highly regulated sector like pharmaceuticals.

Relevant Sources of Law

Regulations for the Protection of Confidential Commercial Information

The primary regulation governing trade secrets in Saudi Arabia is the Regulations for the Protection of Confidential Commercial Information, which provides protection for confidential business information and outlines the legal remedies available in case of misappropriation.

The SAIP

The SAIP oversees the enforcement of intellectual property laws, including trade secrets, and provides a framework for the registration and protection of proprietary information.

In Saudi Arabia, the right to appeal is guaranteed. Parties have the right to appeal decisions from lower courts to higher courts, including decisions on injunctions and main actions.

Timing and Process for PI Appeals

Filing an appeal

The timing to file an appeal against a PI decision is typically within ten days from the date of receiving a copy of the decision.

PI appeal hearing and decision

The timing for a PI appeal hearing and decision can vary, but it is generally expedited due to the urgent nature of injunctions. The appeal court aims to resolve such matters promptly.

Considerations for an appeal

The appeal court considers whether the lower court correctly applied the law and whether the injunction was justified based on the facts presented. The matter is usually considered de novo.

Timing and Process for Main Action Appeals

Filing an appeal

The timing to file an appeal against a first instance main action decision is 30 days from receiving a copy of the decision.

Main action appeal hearing and decision

The timing for a main action appeal hearing and decision can vary depending on the complexity of the case. The appeal process can take several months.

Considerations for an appeal

Similar to PIs, the appeal court reviews the case de novo. The court considers whether the lower court correctly applied the law and whether the decision was supported by the evidence.

Further rights of appeal

Further appeals to the Supreme Court are possible if there are significant legal or procedural errors.

Bifurcated Proceedings (Infringement and Validity)

If proceedings are bifurcated:

• appeals related to infringement follow the same process and timing as outlined above; and
• appeals related to the validity of a patent also follow the same process and timing.

The appeal court reviews the validity of the patent de novo and considers whether the lower court correctly applied the law and whether the decision was supported by the evidence.

Overturning Preliminary or Final Injunctions

If an injunction is overturned on appeal or the patent is revoked, the court decision will be enforced through the competent enforcement court.

There are no specialised appeal judges to consider patent litigation appeals.

There are no special provisions for intellectual property proceedings in Saudi Arabia.

In Saudi Arabia, several forums and procedures are relevant to life sciences and pharmaceutical IP litigation beyond the traditional court system.

Customs Detention Applications

The Saudi Arabian Customs Authority plays a crucial role in preventing the importation of infringing or counterfeit products. Rights-holders can file applications with customs to detain suspected infringing goods at the border. This is particularly important for the pharmaceutical sector to prevent the entry of counterfeit medicines.

The SFDA

Any drugs imported to Saudi Arabia have to be registered with the SFDA.

The SAIP

The SAIP oversees the enforcement of IP rights and provides administrative procedures for resolving IP disputes. This includes handling complaints related to IP infringements and co-ordinating with other government agencies.

ADR is not commonly used in life sciences disputes as most of these disputes often arise between parties who are not connected through a binding agreement, so an agreement to resort to ADR does not usually exist. However, these kinds of disputes can still be resolved through an ADR method like arbitration, mediation or expert determination depending on the agreement between the relevant parties.

Court actions are commonly used in Saudi Arabia rather than ADR.

Specific Settlement/Antitrust Considerations

In Saudi Arabia, the General Authority for Competition (the “GAC”) oversees antitrust and competition matters. The Competition Law and its implementing regulations provide the legal framework for addressing anti-competitive practices and ensuring fair competition.

Settlement Procedures

The GAC allows for settlement procedures where parties can negotiate and settle disputes related to anti-competitive practices. This is becoming increasingly common as companies seek to avoid lengthy litigation. However, settlements data is not published.

Availability of Group Claims

Group claims are available in Saudi Arabia. These claims allow multiple plaintiffs with similar grievances to file a single lawsuit against a defendant if they agree to such arrangement. This mechanism is particularly useful in cases involving defective medicines or medical devices, where numerous individuals may be affected by the same issue.

Commonality in the Life Sciences/Pharma Sector

While group claims are available, they are not yet very common in the life sciences and pharmaceutical sectors in Saudi Arabia. The legal framework for class actions is still developing, and awareness among potential claimants is growing.