Trade Secret Protection in South Korea

1. What is Trade Secret under Korean law?

“Trade secret” under Article 2.2 of the UCPA of Korea means technical or business information that: (i) has not been publicly disclosed, (ii) has an independent economic value, and (iii) has been maintained as secret with substantial effort. The clause of article 2.2 of the UCPA is : "trade secret" means information, including a production method, sale method, useful technical or business information for business activity, that is not known publicly, is the subject of considerable effort to maintain its secrecy and has independent economic value.
 
2. What is misappropriation or infringement of trade secret under Korean law? 

Article 2.3 of the UCPA further stipulates that any of the following acts shall constitute an act of trade secret misappropriation:
(i) acquisition of a trade secret through theft, deception, coercion or other improper means (hereinafter referred to as “act of improper acquisition”), use or disclosure, to a third party, of the acquired trade secret (including disclosure thereof to a third party while maintaining its secrecy);
(ii) acquisition of a trade secret, with the knowledge that an act of improper acquisition was involved with respect to the trade secret or failing to know thereof due to gross negligence, use or disclosure thereof to a third party;
(iii) use or disclosure, to a third party, of a trade secret, with the knowledge gained subsequent to its acquisition that an act of improper acquisition was involved with respect to the trade secret or failing to know thereof due to gross negligence;
(iv) use or disclosure, to a third party, of a trade secret by a person who has a fiduciary duty not to use or divulge the trade secret under a contractual relationship and the like;
(v) acquisition, use or disclosure, to a third party, of a trade secret with the knowledge that the trade secret was disclosed in violation of the fiduciary duty referred to in item (iv) above or failing to know thereof due to gross negligence; and
(vi) use or disclosure, to a third party, of an acquired trade secret with the knowledge gained subsequent to its acquisition that the trade secret was disclosed in violation of the fiduciary duty referred to in item (iv) above or failing to know thereof due to gross negligence.
 
We can assume that the meaning or scope of misappropriation under Korean law is almost the same as those of misappropriation under American UTSA. Namely, the key points of misappropriation under Korean law include (1) acquisition of a trade secret of another by a person who knows or has reason to know that the trade secret was acquired by improper means; or (2) disclosure or use of a trade secret of another Without express or implied consent by a person who used improper means to acquire Knowledge of the trade secret; or (3) at the time of disclosure or use, knew or had reason to know that his knowledge of the trade secret was (i) derived from a person who had utilized improper means to acquire it; (ii) acquired under circumstances giving rise to a duty to maintain its secrecy or limit its use; or (iii) derived from a person who owed a duty to the person seeking relief to maintain its secrecy or limit its use; or (4) before a material change of his position, knew or had reason to know that it was a trade secret and that knowledge of it had been acquired by accident or mistake.
 
3. Remedies for Trade Secret Misappropriatio

(1) Injunctive Relief -
(2) Damages
A. Actual loss (including lost profits where applicable),
B. Unjust enrichment, and/or
C. Reasonable royalties.
(3) Criminal Sanctions
 

[Patent Infringement Litigation in Korea - 6] Litigation Costs and Attorney Fees



Official fees for a preliminary injunction action or a permanent injunction action would be small rather than significant. Those would be about US$500. A lawsuit to the Patent Court is an administrative lawsuit that seeks to review the decision of the IPTAB of KIPO. Official fee for such action to the Patent Court would small, too. That is about US$500.

As to a lawsuit for damage compensation, official fees are correlated with the amount of claims. For the first instance lawsuit, a plaintiff must pay 0.5% of claimed amount as official fee. Accordingly, it could be considerable amount.

In terms of attorney fees, two options are usually used in Korea; Flat fee in lump sum or hourly charge based on actually spent time. Considering the unpredictable nature and complexity of patent infringement litigation, it is difficult to estimate the total cost of litigation. Just as a rough estimate, it would be approximately US$200,000 ~ 500,000 for a district court action for a straightforward litigation case. In a big case with complex and difficult technology issues, it may cost much more. In addition, translation of court documents into English will increase costs accordingly.

Korean laws allow the prevailing party to claim court costs and legal fees from the losing party. Official fees and legal costs paid to a court are usually reimbursed in full to the prevailing party. As to attorney fees, however, the Supreme Court has a regulation that limits the reimbursement of actual attorney fees. For instance, for a PI case, a prevailing party may recover about US$5000 per instance from a losing party; not more than US$10,000 in total. However, the amount for damage lawsuit is correlated with the amount of claim and ration of winning. That may be quite different. At any way, it is safe to assume that the amount as a reimbursement of legal fees could be substantially less than the actual cost.


[Patent Infringement Litigation in Korea - 5] Injunction


Permanent Injunction

An IP right owner will seek to enjoin an infringer at the beginning of a lawsuit through preliminary injunction. The nature of a patent right is the right to exclude others. Once the patent has been held valid and infringed, the patentee is entitled to the full enjoyment and protection of the patent right. The infringer shall not be allowed to continue his infringement.


Under Korean patent law, when the infringement of a patent is found, a permanent injunction shall be automatically granted. Only in extraordinary circumstances like patent misuse or substantial injury to the public interest may a court deny a permanent injunction.


Preliminary Injunction (PI)


Preliminary injunction is drastic and extraordinary remedy. Thus, a court allows preliminary injunction only in extraordinary circumstances. PI may be allowed when the circumstances are met by showing a reasonable likelihood of success on the merits, the existence of irreparable harm to the patent owner if a PI is not granted; the balance of hardship between the patent owner and the infringer. Further, a PI should not be against the public interest.


PI is often granted to a patentee in Korea. Under Korean patent law, the validity of a patent and its enforceability are presumed and further irreparable harm is presumed where there is reasonable likelihood of success. Therefore, preliminary injunction shall be granted when the accuser’s infringement is proved.


In contrast, in case a patentee has not practiced the patented invention within Korea, preliminary injunction will not be allowed because no irreparable harm is presumed. Further, in case it is probable that the subject patent will be invalid through invalidation proceeding, it will be hard for the patentee to obtain PI. Preliminary injunction may give full and final satisfactory remedy in advance before a main lawsuit, and can cause significant suffering to the other party. Accordingly, a PI case shall be carefully decided by a panel of three judges.

 

[Patent Infringement Litigation in Korea - 4] Patent Infringement Litigation Procedures

 1. Complaint and Answer


A patentee may initiate a lawsuit by filing a complaint that includes the parties’ information, prayer of remedy and grounds why the defendant is liable to the plaintiff. The plaintiff may seek a court granting an order of barring the opposing party’s infringing manufacturing, marketing and selling activities; the seizure or destruction of all finished or half-finished infringing products in the opposing party’s possession and compensation for damages.

 
The defendant may submit a written answer to deny or accept the complaint within 30 days of being served the complaint. Furthermore, the defendant may file a counterclaim. But, due to bifurcated system about independent invalidity action, the defendant may not file a counterclaim to invalidate the subject patent.

 
2. No Discovery like the US type is available.

 
3. Briefs and Evidence as Exhibits

 
After the court has served the answer to the plaintiff, the parties are required to exchange briefs and exhibits. Each party may object to those exhibits that are irrelevant or inappropriate. The plaintiff ordinarily files his briefs at first, and then the defendant files his briefs in turn. A court may allow the parties having another opportunity to exchange briefs before a preparatory oral hearing which is a kind of scheduling meeting. The court usually permits a 3~4 weeks period for each brief filing. The court usually rules on the admissibility of the objected exhibits in the oral hearing.

 
4. Oral Hearing

 
In the first oral hearing, the court will allow parties submitting their arguments and evidence and then will arrange the disputed facts and issues between parties. Through briefs, parties will provide the court with the nature of the controversy, evidence, legal contentions that the parties believe support their positions. The court will decide what issues are presented by both parties and how the case will proceed. It is likely for parties to have two or more oral hearings in patent infringement case.

 
5. Evidence

 
Korea does not have discovery procedures and jury trials. All lawsuits are tried by judges. Because judges are skilled in the rules of evidence, judges are usually lenient in allowing evidence to be introduced.

 
A. Document Request

 
Each party can request the court to order the other party to submit relevant documents in issues. The party having the document must submit the document to the court. The court can enforce this order by monetary sanctions and evidentiary sanctions. Evidentiary sanctions include not allowing responding party’s submission of the evidence for his benefits, and more importantly may regard the requesting party’s assertion as true. The document request is not applicable to attorney client privilege documents, attorney work products and confidential information.

 
B. Protective Order

 
In case a party insists the document is private, trade secret, or others, the court may order the party to submit the document and then examine without the other party’s participation. Hence it is not permitted for a respondent to refuse document submission for trade secret reasons. Only the party may seek court’s protective order on his information.

 
C. Expert Opinion

 
The parties can retain experts to testify on their behalf. The party applying for expert opinion should submit expert candidates and manner of expert opinion, and further should pre-pay the cost. If the party applying for expert opinion wins the case, the prevailing party will recover the cost from the losing party. Patent cases need prudent expert opinions that usually need considerable time and cost.

 
D. Court Inspection

 
Court inspection is adopted for judges to examine and analyze actual objects using the five senses of judges. The court inspection can be the most powerful means for proof if judges recognize the nature and contents of the subject evidence adequately. For example, judges may compare patent’s product with infringer’s product through watching experimentations or seeing or touching by themselves. Though ordinarily it is not easy for judges to comprehend the technical peculiarity through court inspection, the court often allows parties court inspection.

 
E. Special Hearing for Technical Issues (Markman Hearing)

 
A court usually set an oral hearing for examining technical features. Both parties may present technical issues including background technology, claimed inventions, elements of the invention and comparison of elements between the patented invention and the accused product or process. Parties are permitted to use drawings, documents, power point presentations, models, real products, demonstrations, and others. It is one of the most important proceedings for parties to be able to have an influence on judge’s decision.

 
F. Witness Examination

 
The party who calls a witness will conduct the first examination of the witness. The direct examination shall be done by using open-ended questions. For instance, any leading questions, which allow only for a “yes” or “no” answer, are not allowed. The opposing attorney has a chance to cross examine the witness and he is allowed to use leading questions: cross examination. But the cross examination shall be limited to the subject matter raised during the direct examination. When the opposing attorney has finished his cross examination, the attorney who did direct examination has an opportunity to conduct redirect examination. The attorney again cannot use leading questions.

 
Parties may submit an affidavit as documentary evidence for direct examination of a witness. In the oral hearing, only crucial points of the affidavit are examined and other details can be omitted in that direct examination. Accordingly, sufficient time is allotted for cross-examination. When a witness is hostile and is not under the influence of the requesting party, the party may file a motion that the witness must be summoned and when the motion is accepted the party must submit main contents for direct examination in advance.

[Patent Infringement Litigation in Korea - 3] Check Points & Actions Must Be Considered Before Enforcement Actions



Patented claims must be valid and infringed in theory. However such claims are not common in reality. Accordingly a patentee must check strength of his patent before enforcing his patent against accused infringers. To be a valid patent claim, it should be strong enough to sustain invalidity challenges. The scope of the claim must be narrow enough to be novel and non-obvious over the prior art. On the other hand, a claim should be infringed by the competitor’s product or process. For this purpose, the scope of a claim must be broad enough to cover competitor’s product or process. These are contradictory and it is really hard to achieve desirable balance between two opposites.

 
Before filing a patent infringement lawsuit, it is desirable for a patentee to check strength of each patented claim based on thorough prior art search. Usually, it is necessary to fix any errors in issued patents, protect claims from possible invalidity challenges through amending claims to be novel and non-obvious over the prior art; and further pursue claims directed to competitor’s products or process if possible.

 
Two ways are available to amend patented claims after granting a patent in Korea. Before a patent infringement action, a patentee may amend claims as precautionary measure through ex parte proceeding at the IPT of KIPO. Namely, the first way is an independent petition to request amendment as like re-issue request in the U.S. Actually, Korea use a different terminology of “correct” for granted patents rather than “amend” for pending application before grant. It is to differentiate from each other because two terms do not have the same meaning.



The second option to amend a patented claim is correlated with an invalidity proceeding. During invalidity proceeding, a patentee may request to amend granted claims as a defense. It is very common to file a motion to correct patents during invalidity proceeding. This is inter partes proceedings between a patentee and a challenger and consolidated in invalidity proceeding. Both parties may argue whether or not such amendment to be allowed.

 
A patentee may amend granted claims of a patent within the scope of original disclosure and within the scope of protection of the patent as granted. In reality, post grant corrections of claims are allowed within a very limited scope. The correction must be made to (1) narrow a claim, (2) correct typological errors, or (3) clarify ambiguous description. The correction must not broaden or alter the scope of the patent right.

[Patent Infringement Litigation in Korea - 2] Claim Interpretation under Korean Patent Law



1. All Elements Rule

The scope of a patent is defined by the elements of a claim. It is well settled that each element in a claim is deemed material to defining the scope of the patented invention. Therefore, only when every element defined in a claim is found in an accused product or process, the accused product or process literally infringes the patent right.

2. Doctrine of Equivalents

 
It has been long time for the Patent Court and the Supreme Court to adopt the doctrine of equivalents as a part of Korean patent law for interpreting claims.

 
The rationales of the doctrine of equivalents in Korea are similar to those of the U.S. Thus, it is true that if the accused product or process performs substantially the same function in substantially the same way to obtain the substantially same result of the patented invention, the accused infringes the patent in Korea.

 
In particular, the Supreme Court held that the accused product or process infringes a patent where an element of the patented invention is substituted with another element and, if (i) the technical concepts or principle to solve the objective of the patented invention and the accused invention are the same or common; (ii) the substituted element in the accused invention performs substantially the same function in substantially the same way to obtain the substantially same result of the patented invention; (iii) such substitution is obvious to an ordinarily skilled person in the art. However, the doctrine of equivalents shall not be applicable to the circumstances that (iv) the accused substitution was already known to skilled persons in the art at the time of filing an application and (v) the accused element was excluded from the claimed invention during prosecution.

 3. Prosecution History Estoppel


Based on the doctrine of equivalents, a patentee cannot regain his rights to any elements that were abandoned through an amendment or a response during prosecution. For example, when an element is excluded through an amendment in order to secure novelty and non-obviousness in response to the examiner’s rejection, an invention with an equivalent element is outside the scope of the patent.


The Supreme Court held that prosecution history estoppel should be applied in view of specification, opinions of an examiner from filing of the application to issuance of a patent and the intent of an applicant as indicated in the amendments and arguments during prosecution. Furthermore, in a patent containing more than one claim, the prosecution history of each claim should be independently reviewed to decide whether certain subject matter was intentionally excluded from the scope of the claim.

 

[Patent Infringement Litigation in Korea - 1] Cease and Desist Letter – Warning Letter


When a patentee finds his patent right being infringed by a third party, he may send an alleged infringer a cease and desist letter. It is to warn the infringer of legal responsibilities and demand the cessation of infringement activities. Furthermore, the accused infringer, at least from the day of receiving the warning letter, will not be able to deny his intent or negligence in the infringement activities.
 
This warning letter plays an important role in proving the claim of damage compensation as well as the criminal liability for infringement. For criminal action, it is required to prove the intent of an infringer regarding infringing acts of a patent without doubt. In particularly, infringer’s intent in the infringement shall not be presumed even if a patent marking is present on the patented product. With a warning letter, it is easy and convenient to prove the infringer’s intent beyond reasonable doubt. Therefore, a patentee has often sent warning letters to infringers to point out the ownership of the patent and their infringing activities.

The Doctrine of Equivalents (DOE) in Korea


The rationales of the doctrine of equivalents in Korea are basically similar to those of the U.S. Namely, when an accused product or process performs substantially the same function in substantially the same way to obtain the substantially same result of the patented invention, the accused product or process infringes the patent right. 

In particular, the Korean Supreme Court held that the accused product or process infringes a patent where an element of the patented invention is substituted with another element and, if (i) the technical concepts or principle to solve the objective of the patented invention and the accused invention are the same or common; (ii) the substituted element in the accused invention performs substantially the same function in substantially the same way to obtain the substantially same result of the patented invention; (iii) such substitution is obvious to an ordinarily skilled person in the art. However, the doctrine of equivalents shall not be applicable to the circumstances that (iv) the accused substitution was already known to skilled persons in the art at the time of filing an application and (v) the accused element was excluded from the claimed invention during prosecution. 

On July 24, 2014, the Supreme Court further clarified the scope and meaning of the above (1) requirement of DOE; the technical concepts or principle to solve the objective of the patented invention and the accused invention must be the same or common. 

The patent claimed a cutter for dry seaweed. The seaweed cutter has cutting blades laid out in a grid pattern. Seaweed is placed on top of the cutting blades and pressed from top to down and then sliding down into a container through a grid-patterned box attached to the bottom of the cutting blades. The patented invention can achieve a cutting and storing of seaweed in a single process.

The accused cutter is different from the patented cutter in which the accused cutter has moving blades that move from top to down and cut seaweed. Instead, the patented invention does not have moving blades. Except the position of blades, other technical features of the two devices are the same. Two cutters perform the same function in the substantially same way and achieve the same result. 

However, the Seoul High Court denied patent infringement under DOE because the accused cutter did not meet the (1) requirement of DOE. The accused cutter cut seaweed in a different way from the patent technology; there is no the same technical principle of resolving the technical problem. 

The Supreme Court vacated the lower court decision. The Court held that the "essence or core of the technical idea" must be determined between two cutters in order to apply DOE and then found that two cutters used the same technical idea because it should be the incline of the grid patterned box that allowed seaweed to be automatically stored after being cut and it is found in two cutters although two cutters employed different embodiments. The Court found that the change to position of the cutting blades was obvious. The Supreme Court decision clarified (1) requirements of DOE under the Korean patent law. In practice, patentees may have higher chance to apply DOE under the recent decision.

Practical Points Under Korean Patent law on Joint Ownership of Patent in Korea


Under the Korean patent law, when there are joint inventors of a single invention, each inventor is entitled to be a joint owner in the right to obtain a patent of the invention. Or anyone may obtain the joint ownership through buying a portion of a patent ownership.

The joint owners of an invention before a registered patent must file an application for a patent together. Otherwise, the application shall be rejected or the granted patent shall be invalid.

In the absence of an agreement to the contrary, each joint owner has an equal partial interest in the invention as a whole. When a company is an employer of an employee inventor and the employee is a co-inventor, the company shall be a joint owner of the invention through assignment.

The Korean patent law provides that joint owners of a patent may freely make, use and practice the patented invention without consent to the other joint owners. In this regard, each co-owner does not have the duty to account profits to the others.

However, each co-owner may not assign his right of the patent in part to a 3rd party without consent of the other co-owners. Namely a joint owner may sell his own interest in the paten only when the other joint owners consent such an assignment.

Furthermore, under Korean patent law, a joint owner may not license the patented technology to a third party based on his co-ownership of the patented invention unless he has obtained consent of the other joint owners about the license.

The Korean Patent Act has specific provisions for such restrictions of joint ownership. This principle of the Korean patent law is to protect each co-owner from an unreasonable change of co-ownership.

For example, in case a joint owner may freely assign or license the jointly owned patent, other co-owners may be at the mercy of the co-owner. For example, in case a co-owner assigned his co-ownership to a large company and the other co-owner is a very small company and then a new co-owner large company may use and practice the patented technology as a whole independently without any duty of account profits to the other co-owners, the new joint may have the whole value of the patent and the small company does not have any profit.
 
However, joint owners may determine and vary their rights by contract. The statutory default rule under the Korean patent law controls unless there is an agreement to the contrary.
 

Reverse Payment Agreement between patentee and generic company violates Korean Antitrust Law



Recently KFTC announced to watch license agreements between patentees and generic companies under the patent and drug MA linkage system. That is a Korean version of the Hatch-Waxman Act system from March 15, 2015.

Under the new system, the first generic company may obtain 9-month market exclusivity. Such exclusivity may cause motives or incentives for reverse payments between the patent owner and the first generic.

In order to avoid antitrust violation issue, it is recommendable to closely review the first decision of the Supreme Court on the reverse payment case in Korea that was rendered on February 27, 2015 by the Korean Supreme Court. For information, the GSK vs. KFTC case is summarized in the below.

1. Background

GSK owned a Korean patent for Ondansetron, antiemetic drug and sold with a tradename as Zofran. Dong-A Pharmaceutical Co. developed a generic version of ondansetron and received a cease and demand letter from GSK. Both parties started lawsuits but soon signed a settlement agreement and withdrew lawsuits.

2. Settlement of Patent Infringement Litigations

By a Sale & Supply Agreement for Ondansetron between both parties, GSK granted Dong-A to sell the product to large sized hospitals. Instead, Dong-A shall neither make nor sell any competing medications including ondansetron to Zofran. GSK agreed to pay large amount of money to Dong-A by cash every year for 5 years. Further GSK promised to offer additional significant amount as incentive for high sales performance.

3. KFTC investigation and lawsuits

KFTC investigated GSK/Dong-A patent settlement case and decided that the settlement was a reverse payment agreement that violated the Antitrust Act of Korea. In particular, KFTC found them violating Art. 19 of the Monopoly Regulation and Fair Trade Act (MRFTA) and fined GSK about US$2 million and Dong-A US$1.5 million.

4. The Supreme Court Decision

GSK raised an appeal to KFTC's decision to the Seoul High Court but the court confirmed the KFTC decision. And GSK further appealed the case to the Supreme Court.

GSK argued that the settlement was within the scope of his patent right. As they pointed out, Art.59 of MRFTA (Korean version of antitrust law) has provision that “This Act shall not apply to any act which is deemed as a justifiable exercise of the right under the Copyright Act, the Patent Act, the Utility Model Act, the Design Protection Act or the Trademark Act.”

However, the Supreme Court rejected GSK's argument. The court opined that a settlement with reverse payment violates antitrust law if a patentee may maintain his monopoly by the reverse payment and thus affects adverse effect on fair and free competition in the related market. In the decision, the court suggested several factors in finding any violation or liability. Those can include the amounts of reverse payment to the opposing party and anticipated profit of the patent owner, patent litigation cost, time span and period for non-compete, etc.

On the other hand, the Seoul High Court stated in their decision that when the subject patent is obviously invalid or the competing party has not infringed the patent, any settlement with reverse payment shall be regarded as being anticompetitive and shall be violation of antitrust law.


Patent Term Extension (PTE) Disputes on Period and the Scope of Protection in Korea



Many generic drug companies challenged the validity of PTEs on period and the protection scope of extended patent rights.

The first issue for PTE disputes in Korea is whether the extended period is valid or not because certain periods of time included within the PTE should not have been included under the relevant statutes. The second issue is on the scope of the patent right protection for an extended term after the expiry of an original term.

1. Recent Decisions of IPTAB and Patent Court on Period Issue  

In principle, the "time period during which the patented invention could not have been worked" of the Patent Act starts on the date on which the test for safety and efficacy is initiated or the date on which the patent is registered (whichever is later) and ends on the date on which the regulatory approval is reached to the MA applicant. It is not the date of MA issuance.

Under the Patent Act, the "time period of delay attributable to the patentee" must be deducted from the total delay period. The period is periods for which the patentee is responsible for delay in the regulatory approval.

The IPTAB of KIPO and the Patent Court affirmed the above principle. In practice, The IPTAB and The Patent Court appear to recognise and confirm the present status of the granted PTE periods according to KIPO's practice.

Because many cases are still pending, the issue has not been settled yet. The Supreme Court shall decide the issue in not too distant future.

2. Recent Decisions of IPTAB and Patent Court on the Scope of an Extended Patent Right

 The Korean Patent Act Article 95 (Effects of Patent Right with its Term Extended by Permit, etc) “The effects of a patent right, the term of which has been extended pursuant to Article 90 (4), shall not extend to any other acts except the working of the patented invention with respect to such products for which approval, etc. was the basis for registering the extension (or where approval, etc. was obtained for any specific use of the product, with respect to the product adapted for such specific use).”

What is the effective scope of an extended patent right through PTE registration? Article 95 of the Korean Patent Act specifically limits the scope of the extended patent right to be effective within working of the patented invention with respect to the 'approved product.'

Accordingly, there has been disputes over how the terms "product" and "usage" in the above clause should be interpreted. However, there are as yet no definitive criteria or court decisions issued as to the interpretation of this issue.

Before the IPTAB of KIPO and the Patent Court rendered their decisions, the IP Courts of Japan issued their decisions. Because the corresponding provisions on PTE of the Japanese Patent Act are really similar to those of the Korean Patent Act, the interpretations of IP courts of Japan were closely watched by Korean patent practitioners.

For information, Article 68bis (68-2) of the Japanese Patent Law is described as follows: “a patent right the term of which is extended via PTE registration "shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition designated by Regulation in Article 67, paragraph 2 of the Patent Law that constituted the reason for the PTE registration (when the specific usage of the product is prescribed in the disposition, the product used specifically for that usage)".

The Tokyo IP High Court stated in their opinion that "in light of the purpose of the PTE registration system and that of a patent infringement action, it is reasonable to understand that in the case of a patented invention relating to an ingredient of a medicine, a patent right whose duration was extended and by 'effectiveness/efficacy'and 'dosage/regimen' as the 'usage'." For example, the scope of an extended patent right based on a specific salt of API shall cover other salts of API.

Unlike the IP court’s decisions of Japan, the IPTAB of KIPO and the Patent Court of Korea held that the scope of an extended patent right based on a specific salt of API shall NOT cover other salts of API. Thus it was totally different interpretation. Namely, the scope of an extended patent right based on a specific salt of API only covers the approved Drug Product itself.

At present, the IPTAB of KIPO and the Patent Court maintain really strict interpretations on the scope of an extended patent right. Again, several cases are pending before the Supreme Court, this issue has not been settled yet. The Supreme Court shall decide the issue relating to the effective scope of a patent right extended via PTE registration in not too distant future, too.

 

Data Exclusivity (DE) Protection in Korea



In pharmaceutical industry, data exclusivity (DE) protection is an important IP right. DE is to protect the value of extensive pre-clinical and clinical data that establish a drug’s safety and efficacy, clinical indications and uses.

KFDA provides such DE through PMS (Post Marketing Surveillance) system. Before the expiry of PMS period, no generic drug is allowed to market. During PMS period, third parties cannot obtain approval for generic versions of the same product unless they can submit data that are (1) different from the data submitted for the first approval; and (2) equivalent to or exceeds the scope of data submitted for the first approval. There is no real case to obtain before expiry of PMS in Korea so far. Therefore, such PMS system has played an effective Data Exclusivity for drug developers.

Two categories of DE exist in Korea as follows:

  1. New Drug (NCE) – 6 years from marketing approval
    1. New Chemical Entity (NCE)
    2. Ethical Drugs different from already licensed drugs in terms of active ingredients or mixture ratios
    3. Ethical Drugs different from already licensed ones in the route of administration, while containing the same active ingredients
       
  2. Improvement Drug (NCI) – 4 years from marketing approval
    1. Ethical drugs which are identical to already licensed drugs in terms of active ingredients and route of administration but distinctively different in added indications.
    2. Ethical drugs which are modification of the structure, formulation, or indication of existing drugs. It is generally an improved version of the original drug in terms of safety, efficacy or convenience.

Patent Term Extension (PTE) in Korea


  1. Background
     
    The patent term extension system was first introduced in Korea on July 1, 1987. Under the 1987 Act, a petition for patent term extension may be filed only during the last three (3) years of the original term of the patent. Under the new 1990 Act, however, a petition for patent term extension may be filed within three (3) months from the date of the approval and six (6) months prior to the expiration date. The current law is basically the same as that of 1990.
     
    Some Changes to the current patent term extension system went into effect on April 3, 2013. The key change to the current system is limiting the number of PTE instances from multiple available chances to only one. Under the current PTE system in Korea, PTE may be available only to the "first" regulatory approval for "a new chemical entity."
     
  2. Subject Patent and Procedures for PTE
     
    A patent is eligible for term extension if the patent is related to an approved medicinal or agricultural product, if the patent was unable to be practiced after grant due to pharmaceutical or agricultural regulatory approval requirements. Such a patent should claim a compound, composition indicating use, formulation for (1) an invention relating to a drug which requires a product approval under the Pharmaceutical Affairs Act ("PAA"); or (2) an invention relating to an agrochemical which must be registered under the Agrochemical Management Act ("AMA").
     
    Only registered patentee may apply for patent term extension to KIPO. If the patent right is jointly owned, all the patentees must jointly apply for an extension of the term.
     
    An application for PTE must be submitted within three months from the date of the approval under the PAA or from the date of the registration under the AMA. The application, however, may not be submitted less than six months prior to the expiration of the original patent term. Also, a petition for patent term extension may not be filed after the expiration of the patent term. An application for patent term extension should be supported with evidence to show the reason for the extension.
     
  3. Period of Patent Term Extensions
     
    The term of a patent can be extended only once. In case a product approval (or registration) is sought for multiple patents, the term is extended for each patent. However, in case multiple product approvals (or registrations) are sought for a single patent, the term is extended only for the first approval (or registration).
     
    Under the old law, even an approval for a combination product whose components had been previously approved by KFDA could be the basis for PTE. In addition, the approval for a second use of an approved drug could also be the basis for PTE, since the approval was regarded as the "first" approval for the new use. Further, in some cases, even an approval for a new formulation comprising an approved active ingredient could be the basis for PTE, if the new formulation was not simply different in the dose of the active ingredient but was a different administration form compared to the previously approved drug (e.g., injection vs. tablet).
     
    However, under the current law and regulation, PTE may be available only once to the "first" regulatory approval for "a new chemical entity."
     
    The period of PTE shall be the total length of non-working time to obtain authorization or registration under provisions of the PAA or AMA to work a patented invention. For example, for drugs, the period commencing from either the approval of a protocol for clinical testing from the government authority after obtaining a conditional approval to manufacture for clinical testing or the date the patent is registered, whichever is later; to the date that the final approval to market.
     
    The maximum patent term extension obtainable is five (5) years regardless of whether the actual period of non-working caused by the statutory requirements under the relevant Act exceeds five years. 
     
  4. Appeal to the IPTAB and the Patent Court
     
    If an examiner of KIPO rejects the petition or application for patent term extension, the applicant or petitioner may appeal to the IPTAB of KIPO. The appeal must be filed within thirty days from the date a certified copy of the rejection is served to the applicant or his agent. On the other hand, a 3rd party may challenge PTE through Invalidation Trial at the IPT of KIPO. If a losing party in the IPT proceedings wants to appeal against the decision of IPT, the party may bring a lawsuit to revoke the IPT decision to the Patent Court within thirty days from the date of receiving the decision.
     

Appeal Procedure to KFTC’s Decision and Order to the Seoul High Court



KFTC’s decision or order does not become effective until the formal written decision and order has been issued. Following receipt of the KFTC’s written order, the respondent party may appeal as followings:

1. Filing an Request for re-hearing & suspension of enforcement

A respondent who is dissatisfied with the decision may file a request for re-hearing to the KFTC within 30 days from the receipt of the written decision.

The KFTC may hold a new hearing and make a decision within 60 days, but it can extend the decision-making period up to 30 days.

2. Filing a lawsuit for appeal to the Seoul High Court

The respondent party may appeal the KFTC’s decision to the Seoul High Court. In addition, the party may file a petition for a stay of the enforcement of order to the Seoul High Court, too.

The party shall file a lawsuit to the Seoul High Court within 30 days from the receipt of a written decision or re-hearing result.

3. Final Appeal to the Supreme Court

A losing party at the Seoul High Court may appeal to the Supreme Court within 14 days from the receipt of the decision.