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. Without any agreement to assign his right, the joint owners 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 patent owners 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 the partial right of the patent 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, 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. If 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 vary their rights by contract. The statutory default rule under the Korean patent law controls unless there is an agreement to the contrary.
Requirements and Procedures when a foreign applicant claims 12-months Grace Period in Korea
Based on 12 months grace period under the Korean patent law, an inventor or his assignee may obtain a patent through filing an application for any already disclosed invention within 12 months from the date of novelty destroying event. The disclosure of an invention as novelty destroying event might be done by an inventor, his assignee or a 3rd party. In order obtain such benefit of grace period under the Korean patent law, a foreign applicant must meet substantive and procedural requirements as follows:
1. Priority claim under the Paris Convention or PCT may not apply beyond 12 months from the first disclosure.
For example, an inventor disclosed his invention on October 1, 2013 and filed a patent application with claiming benefit of grace period on December 1, 2013 at USPTO. Later, the applicant filed a Korean patent application based on the US patent application with priority claim under the Paris Convention on December 1, 2014. The applicant may not obtain a patent in Korea because the disclosure of the invention on October 1, 2013 shall destroy the novelty of the invention filed at KIPO. Because an applicant did not file the application within 12 months from the first event of invention disclosure, he may not claim benefit of 12 months grace period. Accordingly the priority claim under the Paris Convention cannot save the lost of novelty.
Therefore, a foreign applicant must file a Korean patent application at KIPO with 12 months from the first disclosure event regardless of claiming priority under the Paris Convention or PCT. Otherwise, a foreign applicant will lose an chance to obtain a patent in Korea under 12 months grace period.
When an inventor had disclosed his invention several times before he has filed a patent application before KIPO, the applicant must disclose all of them and request benefits of 12 months grace period for all and each events of invention disclosures. Otherwise, the unreported event may be a basis to deny the novelty of the filed invention.
For example, (1) an inventor disclosed an abstract about his invention in a brochure of a conference on October 1, 2013 and (2) gave a detailed presentation about his invention before audience in the conference on October 10, 2013 and then (3) published his article about the invention on November 1, 2013 and further (4) the organizer of the conference uploaded the inventor's presentation at an official website of the conference on November 10, 2013.
In order to be safe based on benefits of grace period under the Korean patent law, an inventor must disclose all of the above 4 events and claims benefits of 12 months grace period for all of them when he files a patent application at KIPO within October 1, 2014. For example, if an applicant did not report No. 4 event of posting his presentation at the conference website, it may be a basis for denying novelty of the invention. However, in my view, it may be possible to argue that the inventor could not know the event and did not have any intent to deceive KIPO. Accordingly an applicant may probably overcome such a hurdle but it is better to check all possible events of disclosures and report all and each of them to KIPO. On the other hand, in case an applicant did not disclose No. 2 event or No. 3 event, he cannot save his application from loss of novelty by his disclosing the invention before the filing date.
Therefore, a foreign applicant must file a Korean patent application at KIPO with 12 months from the first disclosure event regardless of claiming priority under the Paris Convention or PCT. Otherwise, a foreign applicant will lose an chance to obtain a patent in Korea under 12 months grace period.
2. An applicant must disclose all and each event of invention disclosures when files a patent application at KIPO
When an inventor had disclosed his invention several times before he has filed a patent application before KIPO, the applicant must disclose all of them and request benefits of 12 months grace period for all and each events of invention disclosures. Otherwise, the unreported event may be a basis to deny the novelty of the filed invention.
For example, (1) an inventor disclosed an abstract about his invention in a brochure of a conference on October 1, 2013 and (2) gave a detailed presentation about his invention before audience in the conference on October 10, 2013 and then (3) published his article about the invention on November 1, 2013 and further (4) the organizer of the conference uploaded the inventor's presentation at an official website of the conference on November 10, 2013.
In order to be safe based on benefits of grace period under the Korean patent law, an inventor must disclose all of the above 4 events and claims benefits of 12 months grace period for all of them when he files a patent application at KIPO within October 1, 2014. For example, if an applicant did not report No. 4 event of posting his presentation at the conference website, it may be a basis for denying novelty of the invention. However, in my view, it may be possible to argue that the inventor could not know the event and did not have any intent to deceive KIPO. Accordingly an applicant may probably overcome such a hurdle but it is better to check all possible events of disclosures and report all and each of them to KIPO. On the other hand, in case an applicant did not disclose No. 2 event or No. 3 event, he cannot save his application from loss of novelty by his disclosing the invention before the filing date.
Steady Increase of Patent Applications to KIPO from Foreign Applicants
The number of patent applications in Korea has steadily increased in 5 recent years. According to statistics from KIPO, the number of patent applications in 2013 was 204,589 that was 8.6% increase compared to that of 2012. 44,894 new patent applications among them were filed by foreign applicants. It has increased by 11.7% compared with the numbers during the same period in 2012. We could observe the steady increases in the numbers of patent applications from foreign applicants by in recent 5 years that ranges from 5.8% to 11.7%.
Considering the background of such steady increases, we could observe that many Korean companies became key players in the world's major manufacturers and sellers of smartphones, semiconductors, display panels, TVs, etc. Accordingly manufacturers of parts and raw materials have critical interests in Korean market, too. Naturally they need IP protection about their businesses in Korea and have filed more patent applications in Korea.
Considering the background of such steady increases, we could observe that many Korean companies became key players in the world's major manufacturers and sellers of smartphones, semiconductors, display panels, TVs, etc. Accordingly manufacturers of parts and raw materials have critical interests in Korean market, too. Naturally they need IP protection about their businesses in Korea and have filed more patent applications in Korea.
Amendments to the Korean Patent Act from January 1, 2015
1. An applicant may file an English specification without the Korean translation
An applicant may file a provisional application in English without the Korean translation in order to obtain a patent filing number and date in Korea. The description of an invention in English does not have to be a formal patent specification. A simple literature about an invention should be sufficient if it describe all elements of an invention clearly. Under the current law, an applicant may file a provisional application in Korean without claims. Furthermore, an applicant may file a formal application in English without the Korean translation in order to obtain a patent filing number and date in Korea. Within 14 months from the earliest priority date, an applicant must file the Korean translation and claims.
2. 32 months deadline for submitting the Korean translation for national entry of PCT application
Under the current Korean law, a PCT applicant must enter a Korean national phase of a PCT application through filing documents for entering a Korean national phase of a PCT application that includes the Korean translation of a PCT specification. However, under the new law, a PCT applicant may request a one-month extension of time for submitting the Korean translation and thus may submit the Korean translation within 32 months from the earliest priority date. But, an applicant may not extend the 31 months deadline for national entry of a PCT application in Korea.
3. An applicant may correct Korean translation errors based on an original foreign language specification
Under the current Korean law, any amendment beyond the scope of the Korean translation filed shall be regarded as new matter even though the amendment has been based in the original specification in foreign language. Accordingly it is critical once there is any translational error in the Korean translation. The revised new law allows that an applicant may correct any translational errors based on the original foreign language specification and the PCT specification in foreign language.
Criminal Sanctions on Trade Secret Infringements in Korea
Trade secret Infringers may be prosecuted as criminals in addition to civil litigations. The Korean UCPA stipulates that anyone who illegally acquires trade secret of others or uses or discloses to a third party a misappropriated trade secret may be imprisoned up to ten (10) years or fined in an amount of KRW50,000,000 (approximately US$50,000) or two (2) to ten (10) times of the monetary gains. The fine may amount to the 10 times of the value of the stolen trade secret. In Hyundai Motors case, two former engineers were punished to 3.5 years imprison and US$3 million fines respectively.
Further, the Korean Supreme Court held that the act of divulging trade secret to the competitor for the purpose of gaining economic benefit by former employees shall be punished as criminal violation of the fiduciary duty under the Criminal Code. Besides UCPA, trade secrets misappropriations may be prosecuted under the criminal code, too.
In addition to criminal sanction on individuals, companies may be punished by fine that is KRW50,000,000 (approximately US$50,000) or two (2) to ten (10) times of the value of the stolen trade secrets or monetary gains of infringers.
Further, the Korean Supreme Court held that the act of divulging trade secret to the competitor for the purpose of gaining economic benefit by former employees shall be punished as criminal violation of the fiduciary duty under the Criminal Code. Besides UCPA, trade secrets misappropriations may be prosecuted under the criminal code, too.
In addition to criminal sanction on individuals, companies may be punished by fine that is KRW50,000,000 (approximately US$50,000) or two (2) to ten (10) times of the value of the stolen trade secrets or monetary gains of infringers.
Criminal Procedure of South Korea
1. Initiation of Investigation
Investigation is initiated upon discovery of the possibility that a crime may have been committed. The ultimate responsibility in all investigative procedures is in the hands of the prosecutor. Based on collected evidences, the prosecutor assess the validity of the judgment that a crime has occurred, and take appropriate measures upon this ascertainment.
2. Booking, Arrest & Detention
Booking denotes the formation of a criminal case after initiation. An individual subject to investigation becomes a criminal suspect once a criminal charge has been determined by the investigation agency. In principle, prosecutors or police officers must obtain a warrant issued by a judge to arrest a suspect; however, there exist certain exceptions to these warrant requirements in cases that necessitate "Emergency Arrest" and "Arrest of Flagrant Offender". The prosecutor may detain the arrested suspect with a warrant of detention issued by the judge upon request by the prosecutor within 48 hours from the time of arrest. A suspect may request a preliminary hearing prior to detention, and an arrested or detained suspect may request a review of legality to the court. Through such process, the suspect may be released.
3. Prosecution
4. Trial and Sentencing
A judge hears trial upon motions filed by prosecutors. Sentencing occurs when defendants are found guilty of their charges. The punishment may include death penalty, imprisonment and fine, etc.
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 Misappropriation
(1) Injunctive Relief
(2) Damages
A. Actual loss (including lost profits where applicable),
B. Unjust enrichment, and/or
C. Reasonable royalties.
(3) Criminal Sanctions
(2) Damages
A. Actual loss (including lost profits where applicable),
B. Unjust enrichment, and/or
C. Reasonable royalties.
(3) Criminal Sanctions
Statistics of KIPO - IP Applications Trend Over Three Years in Korea
Statistics of KIPO - IP Applications Trend Over Three Years in Korea
12 Months Grace Period in Korea
Article 30 of the Korean Patent Act provides 12 months grace period for disclosed inventions. In inventor or his assignee may obtain a patent through filing an application for the disclosed invention within 12 months from the date of novelty destroying event.
The disclosure of an invention as novelty destroying event might be done by an inventor, his assignee or a 3rd party. If an inventor or his assignee disclosed the invention, they may obtain a patent under the grace period scheme. However, in case the invention was disclosed through patent publications such as A1 publication or B1 publication in any country which was filed by an inventor or his assignee, the grace period may not be applied and thus the applicant finally lost an opportunity to obtain a patent in Korea. Therefore, patent specification publications are critical exceptions to grace period under then Korean patent law.
In other hand, where a 3rd party disclosed the invention without permission of an inventor or his assignee, an inventor or his assignee may file an application for the disclosed invention within 12 months from the date of disclosure. An applicant must prove that the invention was disclosed by a 3rd party against his intention.
An applicant must submit a written document claiming grace period benefit to KIPO when filing a patent application. Further, within 30 days from the filing date, an applicant must submit evidence supporting his claims to the novelty destroying event.
BMS sued Korean pharmaceutical companies alleging patent infringement of entecavir compound patent and low dose formulation patent
Baraclude tablets are a blockbuster drug of BMS that has
been sold for the treatment of chronic hepatitis B virus infection in Korea.
BMS listed 2 patents in Green List of KFDA that is a local version of the
Orange Book of US FDA. Entecavir compound is the active ingredient of
Baraclude.
Korean generic companies obtained MA for generic
versions to Baraclude and are ready to launch their generic products to the local
market. BMS filed patent infringement lawsuits against Korean pharmaceutical
companies recently.
Before BMS patent infringement lawsuits,
local companies filed invalidity trials to challenge the validity of the
corresponding Korean entecavir compound patent. Also, they filed trials to
confirm the scope of patent right about the corresponding Korean low dose
formulation patent. The invalidity case of the compound patent is pending in
the IPT of KIPO. But the IPT decided that generic products do not infringe the
scope of the low dose formulation patent. In appeal, the Patent Court upheld the
IPT decision that low dose entecavir formulations of 0.5mg or 1.0 mg should be
regarded being obvious over the prior art and that generic drug do not infringe
the subject patent.
Korea has the bifurcated system that allocates
decision power to separate authorities. Patent infringement issue and patent invalidity
issue must be decided by two separate and independent courts. Patent infringement
and invalidity challenge may occur simultaneously but two proceedings are
correlated.
In the patent infringement lawsuits,
defendants Korean companies will raise an affirmative defense about invalidity of
entecavir compound patent. Such invalidity defense is allowed and the court may
stay the infringement lawsuit proceeding on its discretion until the IPT of
KIPO decides validity issue.
On the other hand, defendants are quite
safe from patent infringement liability of low dose formulation patent because
they had prior decisions from the IPT and the Patent Court that their products
are out of the scope of the patent claims in issue.
IPT Decided One of 2 Patents on Herceptin (trastuzumab) Listed in Green List of KFDA as being Invalid
Roche launched Herceptin for the treatment
of HER2-positive metastatic breast cancer in Korea. And Celltrion, a Korean Pharmaceutical
company, developed a biosimilar Herzuma to Herceptin (trastuzumab) and obtained
marketing approval (MA) for a biosimilar Herzuma (trastuzumab) from KFDA on
January 16, 2014. It has been approved for treatment of early and advanced
(metastatic) HER2-positive metastatic breast cancer as well as advanced
(metastatic) stomach cancer. Roche filed a patent infringement lawsuit against
Celltrion.
Under the bifurcated system about patent
invalidity challenge and patent infringement litigation, an invalidation trial
against one of 2 listed Herceptin patents was filed to the IPT in KIPO rather
than a court. On May 28, 2014, the IPT
decided that Korean Patent No. 1,261,749 on Herceptin is invalid due to
obviousness. Korean Patent No. 1,261,749 with the expiry date of August 25, 2020
is based on PCT/US2000/023391 claiming the priority on US60/151,018
application.
The losing party, patentee, appealed the
IPT decision to the Patent Court.
Remicade v. Remsima - Trademark Dispute between J&J and Celltrion
Remicade is a monoclonal antibody to treat
RA. This blockbuster biopharmaceutical product was developed and has been sold
by Centocor that is one of J&J groups.
A Korean company Celltrion developed a
biosimilar product to Remicade and obtained a Market Approval (MA) from KFDA in
2013. Further Celltrion filed an application on their biosimilar product to EMA
and has been trying to obtain MA, too.
On the other hand, Celltrion filed Remsima
as their trademark with KIPO. J&J opposed to the TM application but failed
in opposition. And Celltrion succeeded to register Remsima as their trademark
for their new biosimilar products.
J&J filed an invalidation trial to
Remsima TM registration before the IPT within KIPO. But Celltrion prevailed on
the IPT proceeding. The losing party J&J appealed against the IPT decision to
the Korean Patent Court. The two subject trademarks in dispute are shown below.
On August 18, 2014, the Patent Court
rejected J&J's appeal finally. The Patent Court held that Remsima TM registration
shall be valid because Remsima is not similar to Remicade in their sounds,
shapes and meanings. The losing party J&J may appeal to the Supreme Court
again.
Statistics on New IP Applications Filed to KIPO in 2013
KIPO published the annual report of 2013 that includes statistics of filing numbers.
In 2013, KIPO received 204,589 new patent applications that is 8.3% increase to 2012 year; 10,968 new utility model applications that is 11.7% decrease to 2012; 66,940 new design applications that is 6.0% increase; and 147,667 new trademark applications that is 11.4% increase to 2012.
In total, KIPO received 430,164 new applications with an 8.4% growth compared to the total number of 2012.
Reverse Payment Agreement violates Antitrust Law in Korea: the First case decision by the Korean Supreme Court for GSK v. KFTC case on Feb. 27, 2014
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.
Korea is scheduled to implement 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 12-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, accordingly, it is recommendable to closely review the first decision of the Supreme Court on the reverse payment case.
Patent Marketing Approval Linkage
The FTA between Korea and USA includes provisions regarding the patent drug market approval (MA) linkage. Pursuant to the KORUS FTA, Korea has to fully implement patent drug market approval linkage from March 15, 2015. The key changes are summarized below.
When a company of a new drug application (NDA) has obtained a drug market approval (MA) from KFDA, the NDA holder must list patent information in the patent list (“Green List”) of KFDA. The Green List is similar to the Orange Book in the U.S., but is not the same. The deadline to list is 30 days from the receipt date of MA.
Unlike the Orange Book in the U.S., a NDA holder must list patents with the claim-by-claim basis in the Green List. Therefore, an applicant must specify every claim that covers the approved drug product and further an applicant must submit detailed explanation between each claim and the approved drug to KFDA.
Like the HWA, an applicant of a generic drug application (ANDA) must submit a certification regarding listed patents of Green List to KFDA. The patent certification is similar to those of HWA. For example, an ANDA applicant must file a Para. IV certification if he wants to launch a generic drug before the expiry date of listed patents. In such a certification, the generic drug applicant must provide a detailed statement demonstrating that the listed patent is invalid or that the generic drug does not infringe the listed patent.
Like the HWA, an ANDA applicant with Para. IV certification must notify the fact that an application for generic drug approval has been filed and the filing date of the application to the product approval holder and patent owner within 7 days of the application filing date. The obligation to notice will apply to an ANDA applicant who will launch their product before the expiry date of term of the listed patent. Otherwise, this provision does not apply to generic applicants who intend to launch their drug after the expiration of the listed patent.
Within 45 days from the receipt date of the notice, the Patentee may file: a patent infringement action or a scope confirmation trial before the Korea Intellectual Property Tribunal (KIPT) against the generic drug. Further, the patentee/NDA holder may request KFDA to take an action stay generic drug entry for 12 months from the receipt date of the notice from an ANDA applicant. Such stay shall y apply only once to each generic applicant.
The first applicant may obtain first generic marketing exclusivity for 12 months over other generics. The first applicant for this marketing exclusivity means : (a) to be the first filer of ANDA application or skinny (paper) NDA applications that are similar to 505(b)(2) applications in USA; and (b) to be successful in obtaining an IPT decision or a court decision from challenging actions against listed patents including a scope confirmation trial or invalidation action. The actions must be filed before filing a generic approval application.
The first generic's marketing exclusivity shall be forfeited if the ANDA applicant failed to obtain MA within 12 months from the filing date; or failed to launch generic within 2 months from the date that the generic may be marketed.
The patent MA linkage system in Korea may share basic principle with the HWA system of the U.S. Upon reviewing the Bill to the Drug Act and the draft of KFDA regulations, however, we can find that many details will be quite different from those of HWA. In order to grasp practical implications, it is better to compare two systems in detail after the Korean version has been fixed. The FTA of Korea and U.S. set the deadline to implement a full system of patent MA linkage in Korea: March 15, 2015. Therefore, we will certainly have final versions of law provisions and regulations within this year. We will provide you with them when they are available.
1. Green List – the Korean version of Orange Book
When a company of a new drug application (NDA) has obtained a drug market approval (MA) from KFDA, the NDA holder must list patent information in the patent list (“Green List”) of KFDA. The Green List is similar to the Orange Book in the U.S., but is not the same. The deadline to list is 30 days from the receipt date of MA.
Unlike the Orange Book in the U.S., a NDA holder must list patents with the claim-by-claim basis in the Green List. Therefore, an applicant must specify every claim that covers the approved drug product and further an applicant must submit detailed explanation between each claim and the approved drug to KFDA.
2. ANDA Applicant’s Certification regarding Listed Patents
Like the HWA, an applicant of a generic drug application (ANDA) must submit a certification regarding listed patents of Green List to KFDA. The patent certification is similar to those of HWA. For example, an ANDA applicant must file a Para. IV certification if he wants to launch a generic drug before the expiry date of listed patents. In such a certification, the generic drug applicant must provide a detailed statement demonstrating that the listed patent is invalid or that the generic drug does not infringe the listed patent.
3. Notice to an NDA holder and a Patentee
Like the HWA, an ANDA applicant with Para. IV certification must notify the fact that an application for generic drug approval has been filed and the filing date of the application to the product approval holder and patent owner within 7 days of the application filing date. The obligation to notice will apply to an ANDA applicant who will launch their product before the expiry date of term of the listed patent. Otherwise, this provision does not apply to generic applicants who intend to launch their drug after the expiration of the listed patent.
4. 12-Month Stay on Generic Drug Entry
Within 45 days from the receipt date of the notice, the Patentee may file: a patent infringement action or a scope confirmation trial before the Korea Intellectual Property Tribunal (KIPT) against the generic drug. Further, the patentee/NDA holder may request KFDA to take an action stay generic drug entry for 12 months from the receipt date of the notice from an ANDA applicant. Such stay shall y apply only once to each generic applicant.
5. First Generic's 12-Month Marketing Exclusivity
The first applicant may obtain first generic marketing exclusivity for 12 months over other generics. The first applicant for this marketing exclusivity means : (a) to be the first filer of ANDA application or skinny (paper) NDA applications that are similar to 505(b)(2) applications in USA; and (b) to be successful in obtaining an IPT decision or a court decision from challenging actions against listed patents including a scope confirmation trial or invalidation action. The actions must be filed before filing a generic approval application.
6. Forfeiture of 12-Month Marketing Exclusivity
The first generic's marketing exclusivity shall be forfeited if the ANDA applicant failed to obtain MA within 12 months from the filing date; or failed to launch generic within 2 months from the date that the generic may be marketed.
7. Substantial Differences from the HWA system of USA
The patent MA linkage system in Korea may share basic principle with the HWA system of the U.S. Upon reviewing the Bill to the Drug Act and the draft of KFDA regulations, however, we can find that many details will be quite different from those of HWA. In order to grasp practical implications, it is better to compare two systems in detail after the Korean version has been fixed. The FTA of Korea and U.S. set the deadline to implement a full system of patent MA linkage in Korea: March 15, 2015. Therefore, we will certainly have final versions of law provisions and regulations within this year. We will provide you with them when they are available.
Benefits on Prior Art Search to Korean Language Documents in ICT Fields
Korea becomes one of the largest pools of patent publications in the world. In every year, KIPO receives over 350,000 domestic patent applications with specifications written in Korean. Furthermore, Korea already had the largest number of patent applications per year in the world in several technology fields.
1. Market Trend
a. Mobile Phone
Samsung extended its lead in the overall mobile phone market as well, selling more than one in four phones worldwide in the third quarter of this year. While Apple’s market share in the worldwide mobile phone market increased slightly, the pricing of the new iPhone 5s and iPhone 5c in both mature and emerging markets failed to entice consumers as hoped. The table shows a recent market trend of smartphone sales.
b. Embedded OS
In the smartphone operating-system market, Android continued to dominate the industry with more than 80 percent of the market's share in the third quarter of 2013. And, while Apple's iOS and BlackBerry suffered a drop in their worldwide market shares, Microsoft’s Windows Phone showed significant growth, albeit from a low base.
c. Digital / Smart TV
Samsung’s nearest competitor, LG, registered a 14.4 percent market share of Smart TV shipments. Although Sony ships fewer Flat Panel TV (FPTV) units than LG, it has been aggressive in its efforts to add Smart TV capabilities to nearly all models it currently offers, which helped Sony capture another 14.3 percent of the Smart TV market.
Samsung and LG have done well in growing their overall FPTV market shares while also refreshing their line-ups with more high value-added products like Smart TVs that have slowed ASP decline at these two companies. Not coincidentally, both companies witnessed a surge in Smart TV market share in the same period.
2. Patent Applications Trend in Recent 5 Years
a. Mobile Phone/Embedded OS Fields
b. Digital TV Field (excluding display panel technology)
3. Korean Patent Documents as Prior Art Pool
Accordingly, it is certainly necessary to search and review patent publications in Korean for prior art searches. Nonetheless, it is really difficult to fully understand Korean texts because Korean is a language far remote from English. Usually it has been our experience that we can often find a critical prior art written in Korean that was never considered during patent examination in EPO or USPTO.
Search is not simple. Rather it requires expertise in strategy and deep understanding of technology. We have been entrusted for prior art search by large companies who have multinational patent litigations. Our experienced experts can provide high value-added search strategy and results for analyzing and compiling of patent database information. We have a lot of search and analysis experiences in smart phones, digital TV, video data processing, etc.
Statistics re Korean Patent Applications from WIPO world IP indicators 2012
Patent
Office
|
Non-Resident
Filing
|
Total
Filing
|
Percentage
|
KR
|
40,890
|
178,924
|
23%
|
Japan
|
55,030
|
342,610
|
16%
|
China
|
110,583
|
526,422
|
21%
|
Germany
|
12,458
|
85,674
|
14%
|
<Data Source: WIPO, World IP Indicators, 2012>
Origin
|
Office
|
||||
US
|
EP
|
CN
|
JP
|
KR
|
|
US
|
-
|
34,987
|
28,457
|
23,414
|
12,139
|
CN
|
10,545
|
2,548
|
-
|
1,401
|
752
|
JP
|
85,184
|
20,568
|
39,231
|
-
|
15,234
|
KR
|
27,289
|
4,889
|
8,129
|
5,007
|
-
|
Year
|
2007
|
2008
|
2009
|
2010
|
2011
|
PCT
applications in USA
|
54,042
|
51,642
|
45,627
|
45,008
|
48,596
|
PCT
International Search by KIPO
|
2,735
|
11,371
|
13,356
|
13,319
|
15,168
|
For example, Major US companies who appointed KIPO as their PCT International Searches in 2012 include Intel, MS, HP, Google, 3M, Hughes, Applied Materials, Caterpillar, Kimberly-Clark.
Functional Language in Claim
In general, a claim with functional language is very often objected by the Examiner in Korean patent practice. Examiners usually consider functional wordings or expressions used in claims rendering the scope or constitution of the claimed invention unclear and indefinite. Further, they seem to surely have the opinion that such functional expressions make the scope of the functional language claim to be unduly broader than the subject matter supported by the specification.
However, functional wordings or functional expressions are surely allowed under Korean patent practice when no alternative and effective expressions that can clearly and definitely describe the claimed subject matter; the meanings of the functional expressions are fully supported by the detailed description of the invention; and the functional expressions do not pose any problems in defining the scope of the claimed invention. For example, for the specifications of electronic technology field, functional wordings are usually and often allowed in claims. An examiner who is in charge of examinations for chemistry, biotechnology or pharmaceutical patent applications, has relatively high tendency to reject functional language claims.
Recently the Supreme Court held that the scope of protection for an invention is limited to the embodiments clearly specified in the detailed description and drawings when means-plus-function features are exceptionally allowed. The detailed descriptions and drawings of the invention are critical factors to be considered in narrowly interpreting functional claims for purposes of determining the scope of protection. Therefore, it is advisable to keep in mind that many examples should be described in the detailed description when the applicant files an application for a functional claim.
Denied Patent Term Extension for Novartis' Exelon® Patch in Korea
Novartis' Exelon® Patch has been used to treat mild to moderate dementia of the Alzheimer's type and mild to moderate dementia associated with Parkinson's disease. The active ingredient is rivastigmine.
Novartis obtained the first MA for Exelon® Capsule and the second MA for Exelon® Patch in Korea. Exelon® Patch uses a new formulation that allows rivastigmine to be administered in a transdermal therapeutic system (TTS).
Novartis listed two patents in the Green List (http://medipatent.kfda.go.kr) of KFDA pursuant to the linkage system of patent and market approval. The first patent is Korean Patent No. 133,686 that claims chemical compounds including rivastigmine, its pharmaceutical use. The term of the compound patent expired on December 23, 2012. The second patent is Korean Patent No. 569,051 that claims inventions of TTS formulation. The second patent will expire on January 8, 2019.
Novartis obtained the first MA for Exelon® Capsule and the second MA for Exelon® Patch in Korea. Exelon® Patch uses a new formulation that allows rivastigmine to be administered in a transdermal therapeutic system (TTS).
Novartis listed two patents in the Green List (http://medipatent.kfda.go.kr) of KFDA pursuant to the linkage system of patent and market approval. The first patent is Korean Patent No. 133,686 that claims chemical compounds including rivastigmine, its pharmaceutical use. The term of the compound patent expired on December 23, 2012. The second patent is Korean Patent No. 569,051 that claims inventions of TTS formulation. The second patent will expire on January 8, 2019.
Novartis has another patent in issue that claims rivastigmine compound for transdermal administration and compositions for them. The patent in issue is Korean Patent No. 121,596 that has actually lmost the same scope of protection that of the basic compound patent of Korean Patent No. 133,686. The background between two patents is somewhat complicated because Korean Patent No. 121,596 stems from transient measure in 1987.
The Patentee and NDA holder, Novartis filed a petition for patent term extension of the basic compound patent on April 23, 2012. In Korea, the patent term extension system was first introduced on July 1, 1987. Under the 1987 Act that applied to the patent in issue, a petition for patent term extension may be filed only during the last three (3) years of the original term of the patent. Upon filing a PTE request, the term of the subject patent shall be extended automatically and shall be terminated on the expiry date retroactively in case the petition has been denied.
KIPO denied Novartis’ petition. Novartis appealed to the Seoul Administrative Court. On September 26, 2013, the court rejected Novartis’ arguments and denied PTE for Exelon Patch patent. The Patentee and NDA holder, Novartis appealed the lower court decision to the Seoul High Court again. The current PTE system has been based on 1990 amendment and the first PTE regulations of 1987 are quite different from those of the current PTE regulations. The PTE regulations of 1987 that must applied to Exelon Patch case had much more narrow scope than those of the current regulations in subject patents and gourds for PTE. Exelon Patch falls in such unfortunate cases during transient period between 1987 and 1990.
The Patentee and NDA holder, Novartis filed a petition for patent term extension of the basic compound patent on April 23, 2012. In Korea, the patent term extension system was first introduced on July 1, 1987. Under the 1987 Act that applied to the patent in issue, a petition for patent term extension may be filed only during the last three (3) years of the original term of the patent. Upon filing a PTE request, the term of the subject patent shall be extended automatically and shall be terminated on the expiry date retroactively in case the petition has been denied.
KIPO denied Novartis’ petition. Novartis appealed to the Seoul Administrative Court. On September 26, 2013, the court rejected Novartis’ arguments and denied PTE for Exelon Patch patent. The Patentee and NDA holder, Novartis appealed the lower court decision to the Seoul High Court again. The current PTE system has been based on 1990 amendment and the first PTE regulations of 1987 are quite different from those of the current PTE regulations. The PTE regulations of 1987 that must applied to Exelon Patch case had much more narrow scope than those of the current regulations in subject patents and gourds for PTE. Exelon Patch falls in such unfortunate cases during transient period between 1987 and 1990.
Physicochemical Data Addition to the Specification during Prosecution
In general, the specification for a new chemical compound should describe physicochemical data of the claimed compound to such an extent that persons skilled in the art could clearly understand, recognize and reproduce the invention without any additional specific knowledge. However, as for addition of physicochemical data during prosecution, the Patent Court has somewhat differentiated a new compound invention from a new medicinal use invention. The Patent Court held that adding physicochemical data through an amendment does not constitute new matter if examples of a process for preparing claimed chemical compounds are described in detail in the specification. In principle, Korean patent practice requires that all patent applications for novel chemical compounds include physicochemical data in its original specification so as to confirm the production of the compounds. Physicochemical data refers to element analysis data, NMR data, melting point, boiling point, refraction rate, ultraviolet or infrared spectrum, viscosity, crystal type, color or the like. In case a specification fails to contain these data, the application was rejected on the grounds of (i) being an incomplete invention or (ii) failing to meet the description requirement.
The Patent Court decision is significant in that it somewhat relaxes the strict standard applied to all chemical compound inventions that are without physicochemical data. Here is an example. A patent application for novel chemical compounds was rejected by KIPO on the ground that the specification failed to meet the description requirement for a specification. In response, the applicant filed an amendment by incorporating physicochemical data on the claimed compounds, such as structural formulae, melting points and NMR data, into the specification. KIPO rejected the amendment on the ground that the incorporated physicochemical data constituted new matter. The issue was whether the physicochemical data later incorporated into the specification were essential to the confirmation of the production of the claimed compounds, in addition to the initial disclosure in the specification. The Patent Court found that the physicochemical data were not necessary since the production of the claimed compounds was confirmed from the initial disclosure based on the following: (1) chemical names and molecular formulae of substituents for the claimed compounds described in the specification can confirm structural formulae, molecular weights and chemical formulae of the claimed compounds; (2) the description "by crystallization" confirms that the compounds produced are in a solid state; and (3) reaction conditions and processes for preparing the claimed compounds are described in detail to be easily reproduced. The Patent Court has thus held that if the production of the claimed compounds can be adequately confirmed from the initial disclosure in the specification, adding such data to the specification does not constitute new matter.
Really Strict Description Requirement on Pharmacological Effect in Korea
In principle, the pharmacological effect should be described to such an extent that persons skilled in the art could clearly understand, recognize and reproduce the invention without any additional specific knowledge in the specification for a medicinal use invention at the filing stage. It is paramount to understand that under Korean patent practice the specification for pharmaceuticals or medicinal use inventions must quantitatively describe their pharmacological effects. The Korea Supreme Court specifically held that (1) if a pharmacological mechanism by which a certain pharmacological effect is provided has been clearly known, a simple description of the pharmacological effect would suffice; however, (2) in case such a pharmacological mechanism has not been known, the specification should include quantitative experimental data or the specific development of confirmation the pharmacological effect, i.e., when specific experiments were conducted, experimental methods, experimental results or the like, so that others could also confirm such a pharmacological effect.
For example, a new pharmaceutical composition with an enhanced anti-emetic effect in which the composition comprises two known anti-emetic agents, i.e., ondansetron and dexamethasone was claimed but the specification only described in connection with the pharmacological effect of the claimed composition that “the anti-emetic properties of one anti-emetic agent (i.e., ondansetron) are enhanced by administering with the second anti-emetic agent (i.e., dexamethasone).” No quantitative data supporting the enhanced effect was included in the original specification. The application was finally rejected on the ground that the specification violated the description requirement and that the claimed invention had not been completed.
Furthermore, it is not permitted to add quantitative pharmacological data to the specification through an amendment during prosecution. For example, there was a real case that an applicant submitted a declaration which was prepared before the application filing date, describing experimental data supporting the synergistic effect of the composition during the examination and trial proceedings. In that case, KIPO and the Patent Court did not allow the applicant to add data based on the ground that the addition of experimental data is new matter to the specification. Therefore, it is required to have such data or descriptions contained within the original specification at the filing stage.
Pfizer v. Hanmi re: Infringement Litigation on Viagra Trademark for Diamond Shape and Blue Color in Korea
Pfizer’s blockbuster drug, Viagra tablet has known worldwide for its blue color and diamond shape. Right after expiry of a compound patent in Korea, many Korean companies launched generic versions of Viagra in local market. Among them, in particular, Hanmi Pharmaceutical decided to adopt their product’s shape and color as similar as possible to the original drug Viagra. As a result, Hanmi’s generic pill has almost a carbon-copy design with blue color and diamond shape with round edges. Through such a good price and clever marketing strategy, Hanmi could take nearly half the market in about 5 months after Pfizer's patent lapsed.
As an anticipated course, Pfizer filed a trademark infringement lawsuit against Hanmi but lost the first instance case. Pfizer appealed to the Seoul High Court and won the second instance case. Hanmi appealed the case to the Supreme Court late last year.
Pfizer obtained a trademark registration for Viagra’s diamond shape with blue color on February 17, 2005. (Korean TM Reg. No. 608,773) Hanmi contended that any diamond shape and blue color for drug tablets is common or conventional and thus does not have distinctiveness. Also Hanmi’s products have their own Trademark on the surface of tablet and on their package. The package is totally different from Viagra’s.
Hanmi argued that there is no likelihood of confusion between Viagra and Hanmi’s generic drug because (1) two products have their own TMs respectively on product itself as well as its package; (2) the subject drug must be distributed through doctor’s careful prescription and pharmacist’s delivery; (3) Hanmi used the diamond shape and blue color as design elements for drug tablets; and (4) such a diamond shape with blue color has been applied to drug tablets conventionally.
The Seoul Central District Court agreed with Hanmi’s arguments. However, on October 17, 2013, the Seoul High Court reversed the lower court’s decision and held that Hanmi infringed Viagra’s registered TM in diamond shape and blue color. The High Court held that the diamond shape with blue color had become a famous TM and there is likelihood of confusion about source of products having the same shape and color even though they have further TM on their surfaces and packages.
Hanmi appealed the decision to the Supreme Court. The case is pending. Pfizer has not brought the second lawsuit for damage compensation yet.
Patent Term Extension (PTE) Based on MA for Drug Inventions in Korea
1. History of Changes
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
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, process of manufacturing, 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 patent term extension 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 and Number 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).
Prior to the current 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 PTE regulation, PTE may be available only 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 IPT 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 IPT 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.
Benefits on Prior Art Search to Korean Language Documents
Korea becomes one of the largest pools of patent publications in the world. In every year, KIPO receives over 350,000 domestic patent applications with specifications written in Korean. Furthermore, Korea already had the largest number of patent applications per year in the world in several technology fields. For example, Korea is the leading country in semiconductor chip area and LCD or OLED display panels. The table below shows the statistic of LCD panel market shares in 2012.
Accordingly, it is necessary to search and review patent materials in Korean for prior art searches. Nonetheless, it is really difficult to fully understand Korean texts because Korean is a language far remote from English. Usually it has been our experience that we can often find a critical prior art written in Korean that was never considered during patent examination in EPO or USPTO.
Search is not simple. Rather it requires expertise in strategy and deep understanding of technology. We have been entrusted for prior art search by large companies who have multinational patent litigations. Our experienced experts can provide high value-added search strategy and results for analyzing and compiling of patent database information.
While there are a lot of search and analysis experiences in smart phones, semiconductor, video data processing, auto parts, just as an example, we listed up technology areas in detail regarding Display technology.
Search is not simple. Rather it requires expertise in strategy and deep understanding of technology. We have been entrusted for prior art search by large companies who have multinational patent litigations. Our experienced experts can provide high value-added search strategy and results for analyzing and compiling of patent database information.
While there are a lot of search and analysis experiences in smart phones, semiconductor, video data processing, auto parts, just as an example, we listed up technology areas in detail regarding Display technology.
1) LCD
i) TFT: TFT structure, metal wiring, LTPS polysilicon semiconductor, Oxide semiconductor, Organic semiconductor,
ii) Pixel layout (patterned pixel)
iii) Organic/inorganic insulating layer, C/F, BM, column spacer, Color filter on array, Black matrix on array
iv) Liquid crystal mode: TN, VA, SVA, IPS, PLS, OCB, PDLC
v) Timing controller, Data/Gate Driving IC, COG, ASG, Backlight dimming
vi) LED, optical film (LGP, prism, diffuser, microlens), polarizer
vii) 5 mask/4 mask/3 mask process, nanoimprint, inkjet, Roll print
2) OLED
i) TFT: TFT structure, metal wiring, LTPS polysilicon semiconductor, Oxide semiconductor, Organic semiconductor, buffer layer
ii) Emitting material: EL, Quantum Dot, HITL, HIL, HTL, EITL, EIL, ETL
iii) PDL(pixel defined layer), Spacer, anode/cathode, Top/bottom emission display
iv) Encapsulation, polarizer
v) Fine metal mask, nanoimprint, inkjet, Roll print
vi) Protection Window
3) Miscellaneous
i) Touch screen panel
ii) Flexible display
iii) Digital Information Display
iv) Rounded display
v) 3D display
vi) Liquid crystal lens
vii) Smart watch