Plaintiffs to an Infringement Action

According to Article 126 of the Korean Patent Act, the parties that may file a patent infringement action are limited to the patent holder or a registered exclusive licensee that has completed the registration of the exclusive licence at the Korean Intellectual Property Office. A registered exclusive licensee may initiate an infringement action independently without the consent or involvement of the patent holder.

Non-exclusive licensees, as well as exclusive licensees that have not completed the registration of the exclusive licence, are not entitled to file a patent infringement lawsuit as plaintiffs.

If a patent is jointly owned by multiple parties, each co-owner of the patent has the right to independently file a patent infringement lawsuit as a plaintiff without the consent of the other co-owners.

Standing Requirement to File a Nullity/Revocation Action

According to Article 133 of the Korean Patent Act, an interested party may file a nullity/revocation action with the Korean Intellectual Property Trial and Appeal Board (IPTAB). An interested party refers to anyone that has a legitimate interest in the patent, including a potential defendant in a patent infringement suit.

Whether the IPTAB’s Opinion is Binding

The IPTAB may issue opinions on patent infringement and validity. However, Korean courts are not bound by the IPTAB’s opinion in patent infringement proceedings and may independently evaluate and determine matters of patent infringement and validity, regardless of the IPTAB’s decision.

In Korea, defendants in life sciences and pharmaceutical cases involving patent infringement are usually suppliers, importers, manufacturers or distributors of the generic drug. Patent infringement lawsuits against pharmacists, doctors, hospitals or healthcare regulatory authorities (HRAs) in Korea are highly unlikely. Infringement and nullity proceedings do not require notification to, or involvement of, HRAs in Korea or the Korean Intellectual Property Office.

PIs Are Available in Korea

Preliminary injunctions (PIs) are generally available in Korea as part of patent infringement proceedings. A PI against patent infringement is a proceeding between the parties, and both parties are given the opportunity to be present for the hearing. Ex parte PI proceedings and protective letters are not available in Korea.

Both injunctive relief, which seeks to enjoin current patent infringement, and quia timet relief, which seeks to prevent future patent infringement, can be sought.

Requirements for Filing PIs

A patentee or registered exclusive licensee of a granted patent may file a PI, and there are no other special requirements for filing a PI.

Procedures and Timeline

PI proceedings typically take about six to 12 months, where one to three hearing sessions can be held. Briefing is allowed prior to each oral hearing. These oral hearings often include technical explanations to clarify issues for the court. Korean law does not provide a process for filing protective letters.

Notification of PI

Once a petition for PI is filed, the Korean court serves the petition for PI on the alleged infringer by registered mail. The hearing will not proceed until the alleged infringer has been served. After the alleged infringer has been served with the PI petition by registered mail, the case is usually managed via the court’s e-filing system.

Evidence and Defence in PIs

For a PI to be granted, both the right to be preserved and the necessity of preservation must be established. The patent holder must demonstrate that the patent is valid and is being infringed or will be infringed in the near future, ie, establish urgency.

The alleged infringer may submit evidence and arguments in defence against PIs. PIs may be denied under the following circumstances:

• the patent is likely to be invalidated in an invalidation trial or a revocation action of administrative decision;
• a favourable declaratory judgment regarding the scope of the patent to the generic manufacturer; or
• the remaining patent term is too short (indicating a lack of necessity for preservation).

Life Sciences Cases

The filing of a marketing authorisation (MA) application typically serves as the trigger point for seeking a PI against a generic or biosimilar manufacturer. Under Korean law (Art. 96(1)1 of the Patent Act), the use of a patented invention for the purpose of research and testing to obtain MA approval is excluded from acts of infringement. Consequently, similar to the US Hatch-Waxman Act, an originator cannot initiate a patent infringement lawsuit prior to the filing of the MA application.

When submitting an MA application, a generic/biosimilar company is required to provide a patent certification to the originator of the MA application under the regulatory approval-patent linkage system. This certification process usually prompts the originator to file a patent infringement lawsuit, typically shortly after the generic/biosimilar company submits its MA application.

PIs are not granted based solely on the filing of MA applications. The patentee must demonstrate that the generic/biosimilar manufacturer is actually producing, selling or importing the drug in a manner that infringes the patent, or that there is a substantial likelihood that it will infringe the patent in the future.

Infringement and validity proceedings are bifurcated. However, an infringement court can hear and determine the validity of a patent without regard to the validity proceedings, and infringement proceedings do not need to be stayed until the validity proceedings are completed. Although it is up to the infringement court’s discretion, most infringement courts typically stay the infringement case upon the filing of a strong invalidation or revocation case.

Statute of Limitations

Pursuant to Article 766 of the Korean Civil Code, a patentee’s right to claim damages is time-barred after three years from the date the patentee became aware of the infringement or ten years from the date the infringement occurred.

Notification of Infringement/Validity Proceedings

Once a complaint for infringement is filed with a Korean court, the Korean court notifies the defendant by registered mail. If the defendant is a foreign entity, the plaintiff must provide a translated version of the complaint, which will be served under the applicable treaty, eg, the Hague Convention, and the notice period is approximately three months to one year, depending on the country in which the defendant is located and any applicable treaties. If the defendant does not receive the complaint for infringement, the case will not proceed. Once the defendant is served with a complaint for infringement by registered mail, the case is usually managed through the court’s e-filing system.

A petition for invalidity proceedings before the IPTAB should also be served on the patentee under similar procedures. However, under the Korean Patent Act, a foreign patentee is required to appoint a Korean counsel, and the petition for invalidity proceedings against the foreign patentee is served on the patentee’s Korean counsel.

Procedure and Timeline of Infringement/Validity Proceedings

The defendant in an infringement case must file a response within 30 days of service of the complaint. Typically, the defendant will submit a short formal response denying the claim, followed by a detailed response within two to four weeks, as directed by the court. The court will then schedule a first hearing. Depending on the complexity of the case, multiple hearings may be held. The duration of infringement proceedings varies significantly based on the circumstances of the case. Generally, it takes between six months and two years for the court to render a decision.

The duration for a patent invalidity review proceeding filed with the IPTAB also varies depending on the case, but on average, it takes approximately 12 to 18 months for the IPTAB to render a decision. A patent invalidity review request filed by a defendant in a patent infringement action may be subject to expedited review, in which case the review process is accelerated, and a decision may be issued in approximately six to eight months.

A patent must be granted and registered before an infringement action can be initiated. There are no additional requirements such as validation or translation. The type of patent is irrelevant to the requirements for filing an infringement action.

Korea does not have a pre-action discovery/disclosure process. Instead, the Korean Civil Procedure Act provides a general procedure for preserving evidence, but it is rarely used in patent infringement cases due to its strict requirement that the requesting party must demonstrate that the evidence would likely become unavailable or unusable if it is not preserved in advance.

Search and seizure orders are not available in patent cases in Korea.

Under Korean patent law, a plaintiff may ask the court to order the defendant to produce specific evidence to prove patent infringement and damages. However, unlike the US discovery system, Korea does not allow the plaintiff to undertake broad access to the defendant’s documents. The defendant is only required to produce the documents ordered by the court.

Korean courts generally accept evidence lawfully obtained in other jurisdictions without restrictions. Discovery under 28 USC Section 1782 is often used to gather evidence in Korean infringement cases.

Courts in Korea do not grant declaratory relief for patent infringement cases. Instead, they provide remedies such as injunctive relief, preventative relief and damages if infringement is established. In other words, it is not possible for a plaintiff in a patent infringement case to seek declaratory relief from the court. However, it is possible to obtain confirmation from the IPTAB as to whether the infringing product falls within the scope of the patent (Positive Patent Scope Trials if filed by the patent owner or Negative Patent Scope Trials if filed by the potential infringer), but these scope trial decisions are only binding on the parties and not binding on the infringement courts.

In Korea, an accused product that contains a modified element compared to a patented invention may still be infringing under the doctrine of equivalents (DoE) if it satisfies the following criteria:

(1) The accused product operates based on a solution principle that is a substantially identical to that of the patented invention;

(2) The accused product achieves substantially the same effect as the patented invention, although some elements are different; and

(3) The modifications made to the accused products would have been obvious to a POSITA (person of ordinary skill in the art).

However, DoE infringement may not be found if (4) an accused product incorporates technology that was publicly disclosed prior to the filing of the patented invention, or that a POSITA could readily conceive of from the publicly known technology, or (5) the prosecution history of the patented invention indicates that the modified element of the invention under consideration was deliberately excluded from the claims of the patented invention.

Under Korea’s approval-patent linkage system, generic/biosimilar manufacturers cannot obtain marketing approval for the duration of a patent, unless they successfully challenge a Green-Listed patent (the Green List is similar to the Orange Book in the USA) or obtain a licence from the patent holder. Korea also provides a generic exclusivity incentive of nine months granted to the first generic manufacturer that successfully challenges a patent under the approval-patent linkage system. For example, a generic manufacturer must be the first to submit an MA application and to file either a patent invalidation trial or a negative patent scope action in order to secure first generic exclusivity (Art. 50(7) of the Pharmaceutical Affairs Act). Thus, this generic exclusivity incentive encourages generic manufacturers to challenge patents.

In Korean patent litigation, expert evidence is often presented by the parties. Each party may request testimony or submit opinions from a qualified expert they select. Oral testimony is not always required, as expert statements may also be submitted in written form.

In addition to party-appointed experts, a Korean court can separately appoint a neutral expert at an early stage of the proceeding to assist the judge in understanding the technical aspects of the case. Please also note that specialised IP courts typically have technical advisers on secondment from the Korean Intellectual Property Office.

Expert Evidence in PI Proceedings

Expert evidence can be used in PI proceedings, but due to procedural restrictions under the Korean Civil Procedure Act, oral testimony in court is generally not allowed in PI proceedings. As a result, expert evidence is usually submitted in written form.

Expert Evidence in Main Proceedings

In the main proceeding, unlike the PI proceeding, expert evidence can be presented through both oral testimony in court and written statements.

Under Korean law, there is no specific procedure or requirement for the submission of experimental results, but parties to a litigation may submit experimental results as evidence to support their claims. Such experimental results are typically conducted by technical experts and submitted in written expert statements.

In addition to submitting the results of experiments conducted by the parties themselves as evidence, if the parties wish to have the experiments conducted by a court-appointed expert, they must file an application for an expert with the court under the Korean Civil Procedure Act. Such application for court-appointed experiments is not available in PI proceedings, but only in the main proceedings.

Korea does not have a discovery/disclosure process similar to that of the USA. Instead, under Korean patent law, the plaintiff may request the court to order the defendant to produce evidence to prove patent infringement and damages. However, unlike the broad scope of discovery in the USA, Korea does not allow the plaintiff access to all of the defendant’s documents, and the defendant is only required to produce the specific documents ordered by the court.

Common defences raised by generic/biosimilar manufacturers in patent infringement cases include non-infringement, invalidity, and practising the invention before the filing of the patent. The court will consider both non-infringement and invalidity arguments. If it is clear that no infringement occurred, the case may be dismissed solely on the basis of non-infringement, without addressing the validity of the patent. If the patent is found to be invalid in an invalidity action before the IPTAB, there is a high likelihood that the action will be dismissed by the civil infringement court.

Korea does not have a formal system for staying litigation due to parallel proceedings. However, judges have discretion in managing such situations. Some judges may choose to delay a case while awaiting the results of an invalidity proceeding before the IPTAB if a decision is expected within a few months, while others may proceed without waiting for the IPTAB’s ruling. Korean courts typically do not pause cases based on foreign proceedings.

If a parallel proceeding is concluded or a foreign court has rendered a decision before the Korean court’s ruling, the outcome of those proceedings may be considered as persuasive but non-binding evidence.

Under Korean patent law, patent correction (also known as patent amendment) is an IPTAB process that allows a patent holder to amend the claims, description or drawings of a granted patent. This process is designed to correct errors or clarify ambiguities in the patent.

Corrections can also be requested during patent infringement litigation or invalidation trials to strengthen the patent’s enforceability. For clarity, a patent correction must be requested through the IPTAB under a separate proceeding and cannot be directly filed with the court during an infringement lawsuit. As a result, claim correction cannot be conditionally presented at the infringement court.

If an IPTAB trial decision on a correction (amendment) of a patent specification or other relevant documents becomes final and binding after the conclusion of fact-finding hearings in an invalidation action or a civil patent infringement lawsuit, the correction shall be deemed retroactively effective pursuant to Article 136(10) of the Korean Patent Act. As a result, the invalidation IPTAB court or the civil patent infringement court will decide the case based on the corrected version of the claims and/or specification.

The first instances of patent infringement lawsuits are handled by five courts, which have IP specialised courts: the Seoul Central District Court, as well as the Daejeon, Daegu, Busan and Gwangju District Courts. Appeals in patent infringement cases and IPTAB actions (eg, cancellation of trial decisions for invalidity or scope confirmation) fall under the exclusive jurisdiction of the Intellectual Property High Court.

Infringing Acts

In Korea, there are no specific rules governing the infringement of pharmaceutical products. Thus, as with general patent infringement, the sale, manufacture, use, export, import or offering for sale of generic drugs constitutes patent infringement.

In practice, pharmaceutical patent infringement lawsuits are typically filed after the MA application. When submitting an MA application, a generic/biosimilar company is required to provide a patent certification to the originator of the MA application under the regulatory approval-patent linkage system, similar to Paragraph IV certification under the Hatch-Waxman Act. Consequently, the originator often files a patent infringement lawsuit after receiving the patent certification, eg, shortly after the time the generic/biosimilar company’s MA application is filed.

Skinny Labelling

In Korea, the issue regarding skinny labelling is whether the extended term of a pharmaceutical patent applies not only to the indications approved at the time of the initial MA of the drug but also to the indications added through subsequent approvals. Generic manufacturers have argued that the extended term of the pharmaceutical patent only applies to the indications approved at the time of the initial MA of the drug and does not apply to the indications added later; thus, their use does not constitute infringement of the patent. In recent Intellectual Property High Court decision 2024Heo13541, the Intellectual Property High Court rejected the arguments of the generic manufacturers and determined that the indications added through subsequent approvals are substantially the same therapeutic effects as the indications approved at the time of the initial authorisation, and therefore, the extended term of the pharmaceutical patent also applies to the indications added through subsequent approvals; thus, generic manufacturers’ use constitutes patent infringement.

Parallel Imports

Under the Korean Pharmaceutical Affairs Act, only entities that have obtained import approval for pharmaceuticals are permitted to sell them. As a result, there are no known court precedents in Korea where patent infringement issues have arisen due to parallel imports, as such an act would be illegal.

On 20 February 2024, an amendment to the Korean Pharmaceutical Affairs Act (the “Amendment”) was promulgated, which abolished the current drug review system and established a new system explicitly protecting drug data for the MA. The Amendment took effect on 21 February 2025, one year after its promulgation.

Under the Amendment, the periods of data exclusivity are as follows:

• Orphan drug: ten years from the date of MA (with an additional one-year extension if a paediatric indication is added).
• New drug: six years from the date of MA.
• Drug requiring submission of new clinical trial data due to a material change to a drug already approved (eg, modifications to improve safety, efficacy or usefulness): six years from the date of MA.
• Other drugs requiring submission of new clinical trial data and for which the need for data protection is acknowledged: four years from the date of updated MA.

The Korean Patent Act allows the production of pharmaceutical products for research and experimental purposes, even if not conducted specifically for obtaining MA (Article 96(1) of the Patent Act). Korean case law has established that the Bolar exemption applies to the manufacture and storage of pharmaceutical products for bioequivalence testing.

The Ministry of Food and Drug Safety (MFDS) provides information on registered patents for each product called the “Green List”, which is equivalent to the Orange Book. This information is publicly accessible at nedrug.mfds.go.kr/searchBioeq. Under the approval-patent linkage system, when a generic manufacturer submits an MA application, the generic manufacturer must notify the patent holder of the MA applicant’s information within 20 days of the MA application submission.

Under Korea’s approval-patent linkage system, generic/biosimilar manufacturers cannot obtain MA while a relevant patent remains in force, unless it successfully challenges a Green-Listed patent or obtains a licence from the patent holder. Any patent that is recognised as relevant to an eligible original medicinal product may be Green-Listed, and different criteria are not applied depending on the category of the patent.

The pricing and reimbursement process takes place after MA and, unlike the MA process, is not specifically tied to the patent status. In Korea, the pricing and reimbursement process is done by drug, but not by indication.

2.1 Infringing Acts applies equally to biologics or biosimilar patents; there are no differences.

2.2 Regulatory Data and Market Exclusivity applies equally to biologics or biosimilar patents; there are no differences.

2.3 Acceptable Pre-Launch Preparations applies equally to biologics or biosimilar patents; there are no differences.

2.4 Publicly Available Drug and Patent Information applies equally to biologics or biosimilar patents; there are no differences.

2.5 Reimbursement and Pricing/Linkage Markets applies equally to biologics or biosimilar patents; there are no differences.

Korean Patent Term Extension

According to Article 95 of the Korean Patent Act, a patent term extension (PTE) allows for extension of a patent term by a maximum of five years if a delay in obtaining regulatory approval for a pharmaceutical or agrochemical product has significantly impacted the time for commercial sale, essentially providing additional protection for the time spent waiting for MA. The PTE can only be applied once per patent and is subject to certain conditions regarding the “new substance” requirement of the product involved.

Where different products are covered by a single patent, the patent term may be extended based on the longest regulatory approval period among the products. In the past, it was possible to extend the term for multiple patents covering the same drug product, but recent amendments to the Korean Patent Act now allow only one patent to be extended per product.

SPC Waiver

Korean law does not currently provide a Supplementary Protection Certificate (SPC) manufacturing waiver or an equivalent legal mechanism.

Korea does not provide PTEs specifically for paediatric drugs, nor does it grant a paediatric-specific data exclusivity period under current law.

In Korea, MAs are not available for already authorised medicines that have no remaining patent or SPC (or equivalent PTE) but are developed specifically for paediatric use.

Korea gives a ten-year data exclusivity for orphan medicines.

Under Korean law, it is not possible for a patent holder (or exclusive licensee) to request an undertaking from the alleged infringer to pay damages in exchange for a PI.

In order to obtain a PI, a security deposit is typically required to cover any damages that may be incurred by an alleged infringer. The PI becomes enforceable upon submission of proof of the bond deposit.

Once the PI is granted, a court-appointed enforcement officer will take custody of the defendant’s infringing products in accordance with the terms of the PI.

In Korea, the mere filing of an objection by the defendant against a PI does not automatically suspend the execution of the PI. Unless the court accepts the defendant’s objection to the PI, the execution of the PI cannot be suspended, even if the defendant provides a security deposit.

Final injunctions issued by the first-instance court can be provisionally enforced even before the judgment becomes final on appeal, ie, enforcement is possible after conclusion of the first instance. However, the defendant may file an appeal and request a stay of execution upon submitting a bond covering the potential damages until the appellate court renders its decision.

In the pharmaceutical sector, generic manufacturers typically comply with the first-instance court’s final injunction and voluntarily cease production and sales. If a generic manufacturer were to violate the final injunction and continue manufacturing and selling the product, the patent holder could seek enforcement through a court bailiff to seize the stock of pharmaceutical products.

Under Korean law, when patent infringement is recognised and the patent holder requests an injunction, the court is required to grant the injunction as a matter of principle. Once the court upholds the injunction request, it has no discretion to impose restrictions or conditions on the injunction or to substitute it with damages.

Damages Calculation Methods

Under the Korean Patent Act, the damages for patent infringement are calculated or estimated as follows:

• The quantity sold by the generic/biosimilar company multiplied by the patent holder’s profit per unit. For quantities exceeding the patent holder’s production capacity, a reasonable amount the patent holder could have received is applied;
• The profit gained by the generic/biosimilar company from the infringing activity;
• A reasonable amount the patent holder could have received for licensing the patented invention. Seeking claims for additional damages beyond this amount is also permissible; or
• An appropriate amount determined by the court based on the entirety of the arguments.

In practice, courts typically recognise a percentage of the generic manufacturer’s sales revenue as the basis for calculating damages.

Punitive Damages

The punitive damages system has been strengthened to allow compensation of up to five times the actual damages for wilful patent infringement (Art. 128(8) of the Patent Act, effective 21 August 2024).

Damages in Pharmaceutical Cases

In Korea, there are no special damages provisions applicable exclusively to pharmaceutical cases.

Interest on Damages

Generally, interest accrues at 12% per annum from the day after the date of judgment in the patent infringement action until the date of payment.

When Are Damages Considered?

At the patentee’s option, the patentee may choose to pursue both infringement and damages claims separately or in a single action. The court will first address infringement and validity. If the court finds that the defendant is infringing a valid patent, it will then consider the calculation of damages.

Damages for a Wrongful Injunction

If a PI is enforced but ultimately dismissed on appeal, the alleged infringer may be entitled to seek damages for wrongful enforcement of the PI. However, to date, there have been very few such cases in the pharmaceutical sector.

Third-Party Claim

No person other than the patentee and exclusive licensee may claim damages for patent infringement.

Court fees are relatively low; for example, the court fee for filing a patent infringement suit against a single company without a damages claim is approximately KRW1 million. In cases involving a damages claim, the court fee varies based on the claimed amount. Korean courts will decide how litigation costs (including attorneys’ fees) are to be divided, at the time of judgment in patent infringement cases. Generally, the losing party is required to bear the statutory litigation costs, which are different from the actual litigation costs.

In patent infringement cases, the court may not withhold or reduce damages as a penalty for negative conduct by the plaintiff.

Trade mark disputes in the life sciences and pharmaceutical sectors are relatively common in Korea and are governed by the Korean Trademark Act. As with general trade mark cases, the main issue in a case is often whether the disputed trade mark is likely to cause consumer confusion as to the origin of the product.

Copyright disputes in the life sciences and pharmaceutical sectors are uncommon in Korea.

In Korea, there have been several large-scale trade secret disputes involving the strain that produces the botulinum toxin and the toxin manufacturing process. Other cases have involved trade secret leaks related to clinical trials and product development.

Appeal Against a PI

A plaintiff in a PI may file an appeal against the dismissal of PI within seven days of being notified of the decision. A defendant in a PI may file an appeal without limitation of time after the PI decision. If the plaintiff appeals the decision to dismiss the PI or the defendant appeals the granting of the PI, the appellate court will conduct a de novo review, reconsidering the same issues as addressed in the first instance. If the patent later becomes conclusively invalid after the PI is granted, the defendant can apply to have the PI cancelled.

Appeal Against a Main Action Decision

The plaintiff or the defendant may file an appeal against the decision of the first instance within 14 days of notification of the decision. The appeal is heard by the Intellectual Property High Court, which considers the case de novo, examining the same issues as in the first instance. If dissatisfied with the Intellectual Property High Court’s ruling, either the plaintiff or the defendant may appeal to the Supreme Court within 14 days of receipt of the decision of the Intellectual Property High Court. The Supreme Court does not review factual matters but limits its analysis to whether the decision of the Intellectual Property High Court was legally erroneous.

If the patent is invalidated during the main proceeding or on appeal, the court may decide to dismiss the plaintiff’s claims. However, if the patentee files a cancellation action in court against the IPTAB’s decision to invalidate the patent, the invalidity decision is not deemed final, and the court in the main proceeding may independently determine the validity of the patent.

A three-judge panel of the Intellectual Property High Court hears appeals.

Patent litigation is generally governed by the Korean Code of Civil Procedure. Specific provisions under the Korean Patent Act apply to patent litigation, including Article 128 of the Patent Act governing the calculation of damages and Article 132 of the Patent Act allowing the courts to issue orders for production of documents.

Under Article 128 of the Patent Act, courts can award up to five times the actual damages for wilful patent infringement, in addition to compensating for all profits derived from the sales of infringing products.

Under Article 132 of the Patent Act, the court may, at the request of the patent holder, order the defendant to submit documents necessary to prove patent infringement or calculate the amount of damages.

KTC Investigation

Any party that discovers unfair international trade practices with concrete evidence of infringement may file a complaint within one year from the date of the alleged infringement. The Korea Trade Commission (KTC) may undertake an ex officio investigation, if necessary, when there is a reasonable suspicion of unfair international trade practices. If the KTC determines that unfair international trade practices exist, it may issue enforcement measures against the relevant actors, including:

• Suspension of imports, exports, sales or manufacturing of infringing products;
• A ban on the landing and/or abandonment of the goods;
• Corrective advertising orders;
• Publication of violation of the Act, and other necessary measures.

Customs Suspension of Import and Export

Customs may, ex officio or at the request of the patent holder, suspend import and export procedures for products suspected of patent infringement to protect patent rights.

In the life sciences sector, dispute resolution through alternative dispute resolution is less common compared to court adjudication. In some cases, the parties may reach an agreement on the amount of damages during court proceedings following a court finding of patent infringement.

According to Supreme Court Decision 2012 Du 2449, a “reverse payment agreement”, whereby a patent holder agrees to pay a certain price to a generic drug developer with which it has a patent dispute to end the patent dispute and delay the generic drug developer’s entry into the market for a certain period of time, may constitute a violation of Korean antitrust law.

All settlement agreements of patent litigation between a patent holder and a generic drug developer must be submitted to the Korean Fair Trade Commission (KFTC) and the MFDS. The KFTC may also conduct investigations into patent licensing practices, including reverse payment agreements involving patent abuse, in co-operation with the MFDS on a regular or irregular basis.

There is no special system for group claims, such as class actions, in relation to allegedly defective medicines/medical devices. Korea does not yet have legal procedures for class action litigation. However, patients may initiate lawsuits as joint plaintiffs under the general civil litigation framework.