Enforcement Regulations of the Pharmaceutical Affairs Law The Enforcement Regulations of the Pharmaceutical Affairs Law ( PAL ) shall be amended, in part, as follows: Article 24 (Product approval application for manufacturing/marketing and importation) A party who intends to obtain product approval according to PAL Article 31 - or 42 shall submit an application (including electronic copies) using attached Form 13 with the following documents (including electronic copies): 1-9. (omitted) 10. If a party files a product approval application for manufacturing, selling or importing a pharmaceutical product relying on the safety or efficacy information of the pharmaceutical product listed on the Patent List (hereinafter referred to as "Listed Pharmaceuticals") pursuant to PAL Article 31-3, paragraph 2 (including such cases as applied mutatis mutandis under Article 42-4), the Confirmation of Patent Relationship according to attached Form No. 13-2 and a document explaining the grounds with supporting materials shall be submitted. Article 30-2 (Listing on the Pharmaceutical Patent List, etc.) 1 If a party who intends to list the patent information of approved pharmaceutical products (hereinafter referred to as "Patent Information") on the Pharmaceutical Patent List (hereinafter referred to as "Patent List") pursuant to PAL Article 31-3, paragraph 1 (including such cases as applied mutatis mutandis under Article 42-4), that party must submit to the Commissioner of the Korea Food and Drug Administration (hereinafter "KFDA") an Application for Listing on the Patent List using attached Form No. 21-2 with a document specifying the following items within thirty (30) days from the date of product approval. 1. Copy of patent registry 2. Copy of patent publication gazette 3. Document providing a detailed explanation of the subject matter of the patent claims 2 Matters which are determined by a Decree of the Ministry of Health and Welfare (hereinafter "MOHW") in PAL Article 31-3, paragraph 1 are as follows: 1. Basic information including the commercial name of the approved pharmaceutical product and the party who obtained product approval, etc. 2. Information on the patent owner (including information on the representative having an address and a place of business in the Republic of Korea when no address or a place of business is available for the patent owner); 3. Patent registration date and expiration date; - 1 -
4. Patent number; 5. Information regarding the subject matter of the patent claims (the contents are limited to those satisfying the subject and standards specified in Paragraph 3) 3 The Commissioner of the KFDA must list the Patent Information of the pharmaceutical product on the Patent List if the patent of the pharmaceutical product applied for listing pursuant to Paragraph 1 satisfies the subject and standards specified under the following items: 1. A patent related to any one of the following; (1) substance (2) formulation (3) composition (4) medical use 2. A patent that is directly relevant to the active ingredient and its standard, a pharmaceutical raw material and its quantity, dosage form, efficacy/effectiveness and usage/dosage among the approved items of the pharmaceutical product; 3. A patent that is directly relevant to the safety, efficacy and quality approved by the Commissioner of the KFDA based on documents submitted when filing the product approval application; 4. A patent that is recognized as having a difference in terms of safety, efficacy and quality from an already listed patent on the Patent List; 5. A patent that has not expired and is valid; and 6. A patent related to a pharmaceutical product whose product approval is valid. 4 5 If the party who obtained product approval of the Listed Pharmaceuticals intends to list a change in the Patent Information, where the change in the Patent Information (excluding the basic information of Paragraph 2, item 1) is to additionally register a patent relevant to the Listed Pharmaceuticals, the party must submit to the Commissioner of the KFDA within thirty (30) days from the date of the occurrence of the change an Application for Listing Change on the Pharmaceutical Patent List using attached Form No. 21-3 with documents verifying the changed items. The Commissioner of the KFDA may, at its discretion, change or delete the Patent Information on the Listed Pharmaceutical from the Patent List in any of the following cases: 1. when Paragraph 3, Item 5 is not satisfied due to the loss of the patent right by expiry, abandonment, withdrawal, cancellation, invalidation, etc. of the patent right; 2. when Paragraph 3, Item 6 is not satisfied due to the loss of product approval by - 2 -
revocation of the product approval of the Listed Pharmaceutical; 3. when the subject and standards under Paragraph 3 are not satisfied or when the Patent Information is changed, due to other cases stipulated in Items 1 and 2. Article 30-3 (Notification of Filing Application for Product Approval) 1 A party who files a product approval application of a pharmaceutical pursuant to Article 31-4, Paragraph 1 (including those applied mutatis mutandis under Article 42, Paragraph 4 of the PAL) relying on the safety or efficacy information of a Listed Pharmaceutical shall notify the following items to the party who obtained the product approval for the Listed Pharmaceutical and the patent owner within seven (7) days from the filing date: 1. filing date of the application for product approval; 2. the fact that an [application for product approval] has been filed by submitting bioequivalence test data, etc. and relying on the safety or efficacy data of the Listed Pharmaceutical for the purpose of commercial manufacture or importation, use, or sale before the expiry of the patent term of the Listed Pharmaceutical; and 3. grounds demonstrating that the patent right regarding the Listed Pharmaceutical is invalid or that the pharmaceutical product whose product approval application is filed does not infringe the patent right. 2 3 A party who provides notification under Paragraph 1 shall immediately submit a document verifying the notification to the Commissioner of the KFDA. The term, "determined by the Decree of the Ministry of Health and Welfare," as set forth under Article 31-4, Paragraph 1, Item 5 of the PAL, shall refer to the case where the patent right regarding the Listed Pharmaceutical is not related to a pharmaceutical product approval application that has been filed. ADDENDUM Article 1 (Date of Entry into Force) The Regulations shall be enforced from the date when the Exchange of Letters concerning the Free Trade Agreement between the Republic of Korea and the United States of America becomes effective. Article 2 (Applying provision related to the submission of the Confirmation of Patent Relationship Form) Amended Article 24, Paragraph 1, Item 10 of the Regulations applies to a party that first files a product approval application after the enforcement of the Regulations. Article 3 (Applying special provision related to Listing on the Pharmaceutical Patent List) Notwithstanding Article 30-2, Paragraph 1, a party seeking to list the Patent Information concerning the pharmaceutical product whose product approval was obtained before the - 3 -
enforcement of the Regulations shall apply [for listing] within three (3) months from the enforcement date of the Regulations. Article 4 (Applying provision related to the Notification Application Filing for Product Approval) Amended Article 30-3 of the Regulations applies to a party that first files a product approval application after the enforcement of the Regulations. - 4 -
ㅎㄱ흐게흐 [Translation] Enforcement Regulations of the Pharmaceutical Affairs Law [Attached Form No. 13-2] Confirmation of Patent Relationship ( Manufacturing and Sales Importation) Product Applied for Product Approval Name of Product Dosage Form Administration Route Name of Active Ingredients and Content/Unit Efficacy/Effectiveness Directions for Use/Volume Listed Pharmaceutical Serving as Reference Name of Product Dosage Form Administration Route Name of Active Ingredients and Content/Unit Medical use Patent Owner Patent No. Related Patent Claims Party who obtained Product Approval Expiration Date Patent Relationship Please mark in the box, where appropriate with respect to the relationship between the Application for Pharmaceutical Product Approval and the patent of the Listed Pharmaceutical. 1. The patent term of the Listed Pharmaceutical has expired. 2. The product approval application is filed to market the products after expiration of the patent term of the Listed Pharmaceutical. 3. The Party who obtained product approval and the Patent Owner of the Listed Pharmaceuticals have consented that notification is not required. 4. The Intellectual Property Tribunal or a court has held that the patent of the Listed Pharmaceutical is invalid, or that the pharmaceutical for which product approval is sought does not fall within the scope of the patent of the Listed Pharmaceutical. 5. The Patent of the Listed Pharmaceutical is not related to the pharmaceutical for which product approval is sought. 6. It is believed that the patent of the Listed Pharmaceutical is invalid or [the product] does not infringe the patent right. This Confirmation of Patent Relationship is executed and submitted pursuant to Article 24, Paragraph 1, Item 10 of the Enforcement Regulations of the Pharmaceutical Affairs Law. Date: Applicant: Person in charge: Tel. No: FAX: (Signature or seal) To the Commissioner of the Korea Food & Drug Administration Attachments Document containing the reasons for marking the above identified relation and its supporting materials. * When marking Item 6, the applicant should describe the patent number and the claims of the patent believed to be invalid and not infringed when submitting attachments. - 5 -
Oath I hereby declare that in case of Item 6 above, I will submit without delay to the Commissioner of the KFDA the document confirming that I have notified to the party who obtained product approval of the Listed Pharmaceutical and the patent owner that a product approval application has been filed, etc, pursuant to Article 30-3, Paragraph 1 of Enforcement Regulations of the Pharmaceutical Affairs Law. Applicant (representative) (Signature or seal) - 6 -
Enforcement Regulation of Pharmaceutical Affairs Law [Attached Form 21-2] Pharmaceutical Patent Listing Application Filing No. Filing Date Date of Processing: 45 days 1 Product Product Name Product Approval No. Manufacture/Import Manufacture/Sale Date of Approval (Date of Approval of Change) Import Name of Representative Date of Birth 2 Applicant Name of Place of Manufacture(Marketing) Contact Information Address of Place of Manufacture(Marketing) Relation to Patent Owner 3 Origin of Manufacture Name Country of Origin/Location We apply for listing on the Pharmaceutical Patent List as above in accordance with Article 31-3, Paragraph 1 of the Pharmaceutical Affairs Act and Article 30-2, Paragraph 1 of the Enforcement Regulations to the Pharmaceutical Affairs Act. [Date ] Applicant (Signature or seal) Person in charge Tel. No. FAX To the Commissioner of Korea Food & Drug Administration Attached documents 1. Copy of patent registry 2. Copy of patent publication gazette 3. Document containing detailed description on the subject matter of the patent claims Procedure Preparation of application Filing Review Approval Listing on Pharmaceutical Patent List Applicant Korea Food & Drug Administration - 7 -
* Please refer to a method for preparation on page 3 Information on Listing Application 1. Basic information Product Name Manufacture/Import [ ] Manufacture [ ] Import Classification No. Classification of Pharmaceutical Prescription Non-prescription Active Pharmaceutical Ingredient (API) Content and Formulation 2. Patent Information Patentee Name Date of Birth Location Telephone Agent Name Date of Birth Patent No. Location Date of Patent Registration Telephone Expiration Date of Patent Has the information above been submitted previously with an application for product approval or (an application for approval to change [the product approval information])? [ ] Yes [ ] No If so, has the expiration date of patent been changed? [ ] Yes [ ] No Substances Is there a substance patent for the API of the approved product? [ ] Yes [ ] No Please describe the patent claims related to the approval: Please describe in detail the relationship between the patent claims and the product approval information: Formulation Is there a formulation patent for the approved product? [ ] Yes [ ] No Please describe patent claims related to the approval: Please describe in detail the relationship between the patent claims and the product approval infomation: Composition Is there a composition patent for the approved product? [ ] Yes [ ] No Please describe the patent claims related to the approval: Please describe in detail the relationship between the patent claims and the product approval information: Medicinal Use Is there a medicinal use patent for the approved product? [ ] Yes [ ] No Please describe the patent claims related to the approval: Please describe in detail the relationship between the patent claims and the product approval information: We confirm that the information above is true. [Date] Applicant * This information is used only for the purpose of being included in the Pharmaceutical Patent List. - 8 -
<How to Prepare an Application for Listing on the Pharmaceutical Patent List> Product - Product Name: must be the same as described in the certificate of product approval. - Manufacture/Import: must indicate whether it is a manufactured or imported pharmaceutical product. - Approval No.: must be the same as that described in the certificate of product approval. - Date of Approval: must be the most recent date of approval or approval for change from the date of receipt of this application. Applicant: must be the person who obtained the product approval (such as the manufacturer or importer, etc.) Manufacturer: In case of an imported pharmaceutical, must describe importer s counter party in the import agreement. API, Content and Formulation: must be the same as those described in the certificate of the product approval. Agent: must indicate if the patentee has neither a residential nor business address in the Republic of Korea and has appointed an agent who has a residential or business address in the Republic of Korea. In this case, verifying documents must be submitted. Detailed explanation on the relationship between the patent claims and the product approval information : must describe how the claims embody the approved information using specific examples. - 9 -
Enforcement Regulation of Pharmaceutical Affairs Law [Attached Form 21-3] Application for Listing Change on Pharmaceutical Patent List Filing No. Filing Date Date of Processing 45 days Product Product Name Approval No. Manufacture/Import [ ]Manufacture/Sale [ ]Import Date of Approval (Approval for Change) Name of Representative Date of Birth Applicant Name of Manufacturer (Business Entity) Location of Manufacturer (Business Entity) Relation to Patentee Manufacturer Name Country of Origin/Location Changed Item Before Change After Change Reason for Change Matters of Application for Listing Change We submit this application for listing change on the pharmaceutical patent list in accordance with Article 24-3 of the Enforcement Regulations to the Pharmaceutical Affairs Act. [Date ] Applicant (Signature or seal) Person in charge Tel. No. FAX To the Commissioner of Korea Food & Drug Administration Attached documents Documents verifying the changed matters * copy of patent registry, copy of patent publication gazette, documents containing detailed explanation of the patent claims - 10 -
Product <How to Prepare an Application for Listing Change on the Pharmaceutical Patent List> - Product Name: must be the same as that described in the certificate of product approval. - Manufacture/Import:must indicate whether it is a manufactured or imported pharmaceutical product. - Approval No.:must describe the same as that described in the certificate of product approval. - Date of Approval: must describe the most recent date of approval or approval for change from the date of receipt of this application. Applicant: must describe the person who obtained the product approval (such as manufacturer or importer, etc.) Manufacturer: In case of an imported pharmaceutical product, must describe importer s counter party in the import agreement. Procedure Preparation of application Filing Review Approval Listing Change on Pharmaceutical Patent List Applicant Korea Food & Drug Administration - 11 -