As of March 15, 2015, the new Pharmaceutical Act was implemented for the Korean version of HWA of patent drug market approval (MA) linkage. The key features are summarized below.
1. Listing Drug patents in Green List – the Korean version of Orange Book
When an drug application 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. Submitting a Certification of ANDA Applicant 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 20 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. 9-Months 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 9 months from the receipt date of the notice from an ANDA applicant. Such stay shall apply only once to each generic applicant.
5. First Generic's 9-Month Marketing Exclusivity
The first applicant may obtain first generic marketing exclusivity for 9 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; (b) to be the first filer of patent invalidity petition or non-infringement declaration action before the IPT, and (c) 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 9-Month Marketing Exclusivity
The first generic's marketing exclusivity shall be forfeited if the ANDA applicant failed to obtain MA within 9 months from the filing date; or failed to launch generic within 2 months from the date that the generic may be marketed.
Showing posts with label invalidity. Show all posts
Showing posts with label invalidity. Show all posts
The Korean Supreme Court sided with Canon in Patent Infringement Lawsuits
Canon brought many legal actions against several Korean companies. Recently the Korean Supreme Court affirmed lower court decisions for the patentee Canon in printer cartridges patents. In other hand, accused infringers challenged validities of Canon’s patents but the Korean Supreme Court affirmed validity of challenged claims, too. Canon has successfully enforced his patent against local competitors.
As for damages, the Seoul Central District awarded Canon about US$14 million to an infringer company among several other infringers. The court used an interesting method to calculate the amount of Canon's damage. The patentee used an official statistic number of the government; the tax authority of the Korean government published an official data regarding an average profit ratio per each business area every year.
According to the official notices, average profits for periods of infringements were 10% for computer printer fields. Under the Korean patent law, courts have discretion to determine a moderate amount of damage to prevent non-compensation to a patentee even though the infringement is found but no sufficient evidence to prove an amount of damage exists. It eases the patentee’s burden of proof. Based on the provision, the district court computed damage of Canon’s patent infringement through the total sales of infringement x 10%. The total amount of US$14 million is a quite big number in the history of patent infringement litigation in Korea.
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.
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.
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
Basics on Preliminary Injunction Lawsuits in Korea
Preliminary actions to preserve rights are designed to either temporarily preserve the current state or to form a preliminary state. The purpose of the preliminary actions is to avoid undue losses until the final decision is reached or executed.
A party who seeks a preliminary injunction must prove that the party is the owner of the right and that there is an urgent necessity to preserve the right. For the case involving a preliminary injunction of IP infringement, the right to be preserved is easily recognized provided that the IP right is valid and that it was infringed. However, there are several obstacles in recognizing the necessity to preserve the right. For example, even if there is evidence of infringement, if the foreign patent owner has not practiced his patent in Korea, the necessity for preliminary injunction will be a subject of debate. This issue is important when it comes to a preliminary injunction of IP infringement.
In most cases, preliminary injunction against IP users usually endows IP owners with a satisfactory remedy before the main suit, while it may afflict the other party rather severely. Therefore, courts should carefully consider all aspects regarding the necessity to preserve the right immediately. Furthermore, a higher standard of proof is required to prove the necessity because a preliminary injunction in IP infringement action may come to the same satisfaction as the main lawsuit.
When determining the necessity to preserve a right, the validity of the right and the anticipated outcome of the main suit are important factors. Since validity is a prerequisite, courts often face difficulties in recognizing the necessity to preserve the right immediately if there is a probability of invalidating the patent.
In sum, courts must give a consideration of balances between all interests of parties and anticipate a possible outcome of the main suit. And courts will recognize the necessity to preserve a right if the damage caused by IP infringement is not expected to be fully compensated with only the main lawsuit. Preliminary injunctions are not granted when the right holder’s damage is small compared to the infringer’s damage. For example, the necessity to preserve is more readily accepted if the right holder invests a large amount of money in R&D, or if the technology related to IP is developing rapidly and instigating fierce competition between the parties. The infringer’s intent or negligence is certainly an important factor here as well.
Meanwhile, if the right holder remains indifferent and does not take measures for a considerable period of time despite his awareness of the infringement, it will be difficult to persuade the need to preserve the right. And even more so if the right holder is a foreign national who has not exercised his IP right in Korea.
Preliminary Injunction Action to IP infringement is handled by a panel of three judges. In general, the right holder has to file a suit with the court that has jurisdiction over infringer’s residence. The court must give a chance for oral hearing in the case of preliminary injunction of IP infringement. As a standard of proof, it requires lower burden of proof than the main civil suit; i.e., it is enough for parties to prove to the extent that the judge may guess it would be certain. Evidence for preliminary actions should be confined within the scope where they can be examined by the court immediately. For example, they can be in the form of documents, samples or witnesses that are readily available for examination at the court. However, for a patent infringement case, courts will usually allow parties to submit experts’ testimonies and presentation of technical matters.
The party that wins the preliminary action but loses the main suit is liable for the other party’s damages inflicted by exercising the right. The Supreme Court also applies this legal principle to IP cases.[1] Therefore, even if the patentee wins the preliminary action of a patent infringement and/or obtains an expert opinion from a patent attorney or other expert stating that the other party’s act constituted an infringement, the patentee must be liable for the other party’s damage inflicted by exercising the patent right if he loses the main suit.
Furthermore, according to the Supreme Court, an IP owner is liable for compensating other party’s damage if the right holder loses the main suit, if the other party had suffered losses from the cancellation of a contract with his buyer and if the lost was caused by IP owner’s warning to the buyer for criminal liability. In other words, it makes no difference whether or not the IP owner obtains a favorable expert opinion from the Korean Patent Attorney Association (KPAA) before his warning.
A party who seeks a preliminary injunction must prove that the party is the owner of the right and that there is an urgent necessity to preserve the right. For the case involving a preliminary injunction of IP infringement, the right to be preserved is easily recognized provided that the IP right is valid and that it was infringed. However, there are several obstacles in recognizing the necessity to preserve the right. For example, even if there is evidence of infringement, if the foreign patent owner has not practiced his patent in Korea, the necessity for preliminary injunction will be a subject of debate. This issue is important when it comes to a preliminary injunction of IP infringement.
1. The Urgent Necessity to Preserve a Right
In most cases, preliminary injunction against IP users usually endows IP owners with a satisfactory remedy before the main suit, while it may afflict the other party rather severely. Therefore, courts should carefully consider all aspects regarding the necessity to preserve the right immediately. Furthermore, a higher standard of proof is required to prove the necessity because a preliminary injunction in IP infringement action may come to the same satisfaction as the main lawsuit.
When determining the necessity to preserve a right, the validity of the right and the anticipated outcome of the main suit are important factors. Since validity is a prerequisite, courts often face difficulties in recognizing the necessity to preserve the right immediately if there is a probability of invalidating the patent.
In sum, courts must give a consideration of balances between all interests of parties and anticipate a possible outcome of the main suit. And courts will recognize the necessity to preserve a right if the damage caused by IP infringement is not expected to be fully compensated with only the main lawsuit. Preliminary injunctions are not granted when the right holder’s damage is small compared to the infringer’s damage. For example, the necessity to preserve is more readily accepted if the right holder invests a large amount of money in R&D, or if the technology related to IP is developing rapidly and instigating fierce competition between the parties. The infringer’s intent or negligence is certainly an important factor here as well.
Meanwhile, if the right holder remains indifferent and does not take measures for a considerable period of time despite his awareness of the infringement, it will be difficult to persuade the need to preserve the right. And even more so if the right holder is a foreign national who has not exercised his IP right in Korea.
2. Oral Hearing
Preliminary Injunction Action to IP infringement is handled by a panel of three judges. In general, the right holder has to file a suit with the court that has jurisdiction over infringer’s residence. The court must give a chance for oral hearing in the case of preliminary injunction of IP infringement. As a standard of proof, it requires lower burden of proof than the main civil suit; i.e., it is enough for parties to prove to the extent that the judge may guess it would be certain. Evidence for preliminary actions should be confined within the scope where they can be examined by the court immediately. For example, they can be in the form of documents, samples or witnesses that are readily available for examination at the court. However, for a patent infringement case, courts will usually allow parties to submit experts’ testimonies and presentation of technical matters.
3. IP Owner’s Liability
The party that wins the preliminary action but loses the main suit is liable for the other party’s damages inflicted by exercising the right. The Supreme Court also applies this legal principle to IP cases.[1] Therefore, even if the patentee wins the preliminary action of a patent infringement and/or obtains an expert opinion from a patent attorney or other expert stating that the other party’s act constituted an infringement, the patentee must be liable for the other party’s damage inflicted by exercising the patent right if he loses the main suit.
Furthermore, according to the Supreme Court, an IP owner is liable for compensating other party’s damage if the right holder loses the main suit, if the other party had suffered losses from the cancellation of a contract with his buyer and if the lost was caused by IP owner’s warning to the buyer for criminal liability. In other words, it makes no difference whether or not the IP owner obtains a favorable expert opinion from the Korean Patent Attorney Association (KPAA) before his warning.
[1] Supreme Court case No. 79Da2138, rendered Feb. 26, 1980. In this decision, the Supreme Court ruled that there is no reason to differentiate IP cases from other cases.
POSCO v. Nippon Steel re: Patent Disputes and Invalidity Proceedings in Korea
In 2012, Nippon Steel & Sumitomo Metal (NSSMC) sued POSCO at the Tokyo District Court alleging patent infringements on technology for grain oriented (GO) electrical steel sheets of NSSMC. In the complaint, Nippon Steel also alleged that POSCO infringed trade secrets about GO electrical steel sheets of NSSMC.
Nippon Steel seeks 100 billion yen (approx. US$1 billion) compensation for damages and injunction against manufacture and sale of POSCO’s GO electrical steel sheets. The lawsuit is still pending in the first instance stage.
On the other hand, Nippon Steel filed another complaint to the State Court of New Jersey in April, 2012, too. This case is still pending, too.
Responding the patent infringement lawsuits, POSCO filed invalidity trials challenging validity of 4 patents of Nippon Steel at the Korean Patent Office (IPT of KIPO). Last week, the IPT of KIPO rendered the decision that all claims of one basic patent among the challenged 4 patents should be invalid because those are obvious over the prior art.
Upon receiving the losing decision, Nippon Steel announced by press release that they will immediately appeal the invalidity decision by the IPT of KIPO to the Patent Court.
Menarini’s Priligy (Dapoxetine HCl) Use Patent held Not Valid as being Obvious
Menarini launched Priligy in Korea. Dapoxetine HCl is the active ingredient in Priligy tablets. Korean patent No. 719, 977 covers the branded products and is listed in Green List of KFDA. The patented invention is “Methods of Using Rapid-Onset Selective Serotonin Reuptake Inhibitors for Treating Sexual Dysfunction.” The patent at issue is not for a compound invention but for the second use invention. The Korean patent for the second use invention will expire on June 5, 2021. Several Korean generic companies filed invalidity proceedings to challenge the second use patent. Menarini will face generic companies’ challenges soon.
On August 23, 2013, the IPT of KIPO held that the patent in issue is not valid because the compound and its use have been disclosed in the prior art. There has been no challenge to the compound patent so far. The key issue for the second use patent was a new limitation of “on as as-needed basis” in claim language. The patentee argued that such a new limitation was not found in the prior art and made the claimed use invention being novel and nonobvious over the prior art. However, the IPT rejected the argument on the ground that such limitation is related to a method of administering a drug and thus such limitation may not be regarded as an element for a patent claim under Korean patent law.
The patentee appealed the IPT decision to the Patent Court and the case is pending.
Low Dose Entecavir Formulation in Korean Patent held as being Obvious by the IPT of KIPO
Entecavir is the active ingredient in Baraclude tablets of BMS. The drug has been sold for the treatment of chronic hepatitis B virus infection in Korea. When Korean generic companies noticed that a US district court found that entecavir would have been obvious in light of the prior art, they filed an invalidity trial to challenge the validity of the corresponding Korean compound patent, too. The invalidity case is pending in the IPT of KIPO.
On the other hand, Baraclude is covered by another patent for low dose formulation of entecavir. Several companies including those want to launch generic versions of Baraclude after expiry of extecavir compound patent, filed separate proceedings to challenge non-obviousness of law dose formulation over the prior art. The subject Korean patent is No. 757,155 that claims low dose entecavir formulations of 0.5mg or 1.0 mg for the treatment of chronic hepatitis B virus infection. The prior art discloses enetcavir compound, its use, a range of doses and animal test data, but did not disclose claimed doses.
On April 30, 2013, the IPT held that low dose entecavir formulations of 0.5mg or 1.0 mg should be regarded being obvious over the prior art. To the IPT decision, the patentee BMS appealed to the Patent Court and argued that a person of ordinary skill could have neither anticipated nor determined the claimed low dose formulations of 0.5mg or 1.0 mg entecavir from the prior art. Oral hearings were held two days for expert witness examination and BMS’s expert argued at the Patent Court that determining specific doses for human required numerous trials. The panel of 3 judges in the Patent Court will decide the case on March 14, 2014.
Pfizer’s Victory in Lyrica® Patent Infringement Lawsuit in Korea
Based on Pfizer’s Lyrica patent, Korean courts granted preliminary injunctions for patent infringement against two Korean pharmaceutical companies. The local companies launched a generic version of Lyrica last year. The active ingredient of Lyrica is pregabalin that is a known chemical compound and a derivative of GABA (gamma-aminobutyirc acid). Further, the pharmacological effect of pregabalin is known as a depressive neurotransmitter and has been sold as an anti-convulgent drug for a long time. Pfizer discovered a new medicinal use of pregabalin. The subject Korean Patent No. 491282 is directed to a new use of pregabalin for treating pain. It is a second use invention that is one of the main indications of Lyrica.
Korean companies challenged validity of the subject patent on the ground that the new use of pregabalin for treating pain can be anticipated or is obvious over the prior art. They alleged that the pain killing effect might be in the scope of anticipation of an ordinary skilled person because the prior art discloses the compound and its neurotransmitter depressing effect. Also, the blocking of certain neurotransmitter flow may be correlated with anti-pain effect. The IPT of KIPO and the Patent Court, however, maintained the patent by rejecting non-obviousness challenge. The invalidity proceeding has been reviewed by a separate authority rather than a civil court under bifurcation system and is pending before the Supreme Court as a final stage now.
In the meantime, the patentee brought lawsuit for seeking preliminary injunctions against generic companies before the Seoul Central District Court. Recently Pfizer won the cases and was successful in blocking selling generic version of Lyrica in Korea.
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.
Defenses of Defendant
Invalidity Defense
It is well settled that in case the patented invention lacks novelty over the prior art, the patent is unenforceable. Even before the patent has been invalidated through the separate invalidity proceeding, the patent shall be regarded as being void.
As for non-obviousness challenge within an infringement lawsuit under bifurcated system, the Supreme Court has maintained their firm position for a long time that the patent is enforceable before the invalidity based on the ground of being obvious over the prior art. However, the Supreme Court changed their position through en banc decision in 2012. Therefore, a defendant raise an affirmative defense based on obviousness of the patented invention.
The Korean Supreme Court en banc decision in 2012 is that in principle, (1) an issued patent is presumed to be valid; (2) an infringement court may not decide the validity of a patent; (3) arguing invalidity of a patent in suit shall not be a defense in an infringement action; but, as detour as a practical solution, (4) in case the patent in suit is clearly to be invalid due to lack of inventive step as well as lack of novelty, it is an abuse of patent right to seek the injunction and damages based on the patent. Therefore, in order to determine such abuse of a patent right, the infringement court may examine the validity of a patent due to lack of inventive step as well as lack of novelty.
As for standard of proof, presumption of validity is not strong. The challenger can meet his burden by preponderance of evidence, not by clear and convincing. For example, obviousness arguments will be in favor of invalidity where there is inevitable combination, no synergistic effect from combination, no unexpected result.
Other Affirmative Defense
Further, prosecution history estoppel, experimental use, pharmaceutical clinical test, prior user right, intervening right can be used as defense. For instance, the patent right does not extend to acts done for experimental purposes relating to the subject matter of the patented invention. Further, clinical tests for the purpose of KFDA approval of generics does not infringe a patent right. Unlike the U.S. patent law, a declaratory judgment or inequitable conduct before the PTO defense is not available.
Defendant’s Motion Practice: Deposit Cost in Advance
When a plaintiff is a foreigner having neither a residence nor a business office in Korea, a defendant can file a motion that the plaintiff has to deposit the cost of suit in advance. In this situation, a defendant is not required to respond to a plaintiff’s complaint until a plaintiff deposits the estimated cost of the lawsuit. If the foreign party does not deposit by the date the court specifies, the court may dismiss the suit. In the case where the plaintiff is a foreigner and the defendant is a Korean, the Korean defendant usually file this motion to obtain enough time for considering defense and counterclaim. The foreign party may deposit a bond.
Bifurcation – Separation of Infringement and Validity
Korea has 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 as shown below. Patent infringement and invalidity challenge may occur simultaneously but two proceedings are correlated. Invalidity defense is allowed in limited circumstances under patent Infringement lawsuits. A court may stay the infringement lawsuit proceeding on its discretion due to Invalidity proceeding.
