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.

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

Patent and Drug Market Approval Linkage in Korea

The FTA between Korea and USA includes provisions regarding the patent drug market approval (MA) linkage. Pursuant to the KORUS FTA, Korea already amended the Drug Act and is preparing enactments of further necessary provisions in the Drug Act and the Patent Act in order to fully implement the FTA. The full system for patent drug market approval linkage will be implemented on March 15, 2015.

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 on 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 the NDA holder and the 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. Others to be Decided this year

The patent MA linkage system in Korea may be similar to the HWA system of the U.S. We envision that details will be quite different from those of HWA. However, we don’t have concrete information yet because the current law just has portions of necessary provisions. The FTA of Korea and U.S. set the deadline to implement a whole system of patent MA linkage in Korea: March 15, 2015. Therefore, with certainty, we will have details for remaining items within this year. We will immediately post them when they are available.