Tips for Saving Cost in Korea

There are several ways to save the cost of prosecuting a patent application and maintaining once it has been granted. And the key to considerably lowering the expense is to reduce the number of claims by incorporating multiple claims.

There are three ways in which reducing the number of claims can help save cost. First, an applicant can save cost during substantive examination, where the applicant must pay the total amount of US$37 multiplied by the number of claims in addition to the official fee of US$121. Second, once the patent has been granted, the applicant can reduce the amount of annuities, where they are charged based on the basic fee of US$36 multiplied by the number of granted claims in addition to the official fee of US$42. Lastly, the applicant can save the cost of translating the claims and the costs of prosecution and maintenance.

Much like EPO and JPO, multiple dependent sub-claims are permissible under Korean patent law. And for PCT route applications, it is recommendable to redraft claims to reduce the number of claims by using multiple dependent claims before starting the international phase.

But the Korean Rule of claim dependency is different from that of the EPO and the USPTO. According to the Korean Regulation, “No claim referring to two or more claims shall refer to another dependent claim to which two or more claims are referred.” This is to avoid high complexity caused by limitless dependent sub-claims. Therefore, the number of claims must be reduced within the limitation of the Rule in Korea.

In closing, an applicant can effectively reduce the number of claims without altering the scope of claims, and accordingly is able substantially to cut the cost of prosecuting an application and maintaining the granted patent.

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.

Recent Developments of KIPO Examination Capability

According to WIPO statistics, Korea has been ranked No. 4 in the number of patent filings with KIPO, and No. 5 in the number of PCT application filings in the recent several years. KIPO announced that they achieved one of the fastest examinations in the world. KIPO has over 1,000 members including about 700 patent examiners. Among the patent examiners, nearly 40% of the examiners have doctorate degrees and the others are well qualified as they passed a high standard national examination.

KIPO has been serving as both an international search authority and an international preliminary examination authority for international applications under the PCT since January 1, 2006. The USPTO, which files the largest number of PCT applications in the world, has designated KIPO as a competent international searching and examination authority for international applications filed at the USPTO under the PCT. The USPTO decision can be interpreted as recognition that KIPO’s examination capabilities meet world standards. According to KIPO, their fees are much less than those of the USPTO and the EPO.

Applicants can compare the quality of examination, costs and conveniences of each patent office to conduct international searches and preliminary examinations of PCT applications. According to KIPO, Microsoft, Intel, Hewlett-Packard, Google, 3M and Kimberly-Clark have used KIPO as their PCT International Search Agency.

Under the circumstances, foreign applicants may obtain a search or examination report within ten months after filing a patent application in Korea. We believe that the applicant, like Microsoft Corporation, might benefit from KIPO’s highly qualified and speedy examination capabilities.

Data Exclusivity (DE) in Korea

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

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

Two categories of DE exist as follows:

1. New Drug – 6 years from marketing

    A. New Chemical Entity (NCE)
    B. Ethical Drugs different from already licensed drugs in terms of active ingredients or mixture ratios
    C. Ethical Drugs different from already licensed ones in the route of administration, while containing the same active ingredients

2. Improvement Drug – 4 years from marketing

    A. Ethical drugs which are identical to already licensed drugs in terms of active ingredients and route of administration but distinctively different in added indications.
    B. Ethical drugs which are modification of the structure, formulation, or indication of existing drugs. It is generally an improved version of the original drug in terms of safety, efficacy or convenience.

KFDA Guidance on Mobile App for Medical Use

KFDA* announced that the Safety Guidelines for Mobile Medical Applications should be applied on December 31, 2013. The gist of guideline is summarized as follows:

1. Subject App

All mobile platforms including smartphone, tablet PC and smart watch for the medical use may be subject to the guidelines. But the scope shall be limited to the Apps whose use meets the definition of a medical device under Article 2 of the Medical Device Act.

According to KFDA, the guidelines would be applied to the apps below:

   A. Apps that remotely control medical devices
   B. Apps that display, store or analyze data acquired from medical devices
   C. Apps that transform the mobile platform into a medical device by using attachments such as electrodes or sensors
   D. Apps that act as a medical device by using sensors within the mobile platform
   E. Apps that perform patient-specific analysis and provide diagnosis or treatment recommendations.

2. Required Marketing Approval

Before launching a mobile medical app, the publisher shall obtain market approval from KFDA. It is required as like a medical device. It must meet the safety requirements of KFDA guidelines; i.e., Criteria and Standards for the Electrical and Mechanical Safety of Medical Devices, Criteria and Standards for Electromagnetic Safety of Medical Devices, Standard of Medical Device Software Validation, etc.

Furthermore, the applicant must meet the guidelines about the activities to collect, store and process personal medical information. He or she must protect personal information properly pursuant to the KFDA Guidelines of Approval and Examination of U-Healthcare Medical Devices.

* KFDA officially changed its name to the Ministry of Food and Drug Safety (MFDS) in March 2013.