Kasan Insight :: Korea IP Law Blog

Expert Witnesses

The Guideline of the Patent Court may be summarized as follows:

If a party files a request for an expert witness, the party shall attach a declaration that can confirm the expertise and objectivity of the witness.

The Court may issue a preparatory order for examination of an expert witness (e.g. deadlines for submission of a statement of the expert witness and a questionnaire for the direct examination, limitation of the time for examination, and deadlines for submission of arguments and evidence for impeaching the credibility of the expert witness testimony).

The direct examination by the party who requests for the witness shall be made within the scope of the statement of the expert witness. All materials presented or cited in the direct examination shall be submitted as evidence before the date designated for examining the witness.

If an expert witness is a foreigner, the parties may be respectively accompanied by an interpreter for the direct and cross examinations. If a party cannot be accompanied by an interpreter, the party shall notify the Court of the same 4 weeks before the witness examination date and file a request for designation of an interpreter.

Technical Advisors called by the Court

If deemed necessary, the Court may hear opinions of the parties and designate one or more technical advisors.

A preparatory hearing may be held if it is deemed necessary for the technical advisors to understand the case. In the preparatory hearing, the technical advisors may directly question the parties with approval of the presiding judge. If it is necessary for a party to supplement its answer to a question from the technical advisors, the party shall submit its supplemental answer in writing to the Court by a deadline designated by the presiding judge.

Pre-Hearing Procedures in the Patent Court : Preparatory Hearing or Video Conference for Case Management

Before oral hearings, the court may have a preparatory hearing to submit a summary of arguments and evidence; to summarize disputed issues; and to submit petitions for evidence such as expert witnesses, etc.

The court may hold video conference for case management to discuss the procedural matters of the case with the parties.

In a video conference for case management, the following matters may be handled.

l The dates of hearings, and matters to be addressed for each hearing;

l Deadlines for submission of arguments and evidence (including deadlines for submission of summary briefs and expert statements, and the number or volume of briefs to be submitted);

l Whether to request for evidence requiring a substantial amount of time such as verification, appraisal, and expert witness, and the deadline for such request;

l Whether to designate a technical advisor;

l Whether to hold a special hearing session for technical explanation;

l Whether to hold a claim construction hearing; and

l Summary of undisputed facts and disputed issues.

Patent and Drug Marketing Approval (MA) linkage in Korea

It has been more than 2 years to implement the Korean version of HWA of patent drug market approval (MA) linkage. The key features are as bellows:

1. Listing Drug patents in Green List – the Korean version of Orange Book

When a 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.