1. If the holder of a new drug permit deems it necessary to submit the patent information regarding such drug, such holder shall submit relevant documents and information to the Central Competent Health Authority within 45 days after the next day to the receipt of the drug permit. If the holder fails to file such submission within the stipulated period, the regulations under this Chapter do not apply.
2. The drug patent stipulated under Paragraph 1 hereof shall be limited to the following:
(1) Substance.
(2) Composition or Formulation.
(3) Medical use.

1. The "patent information" stipulated in Article 48-3 shall include the following items:
(1) Certification number of the invention patent(s); if the invention patent refers to medical use, the number of claims shall be concurrently provided.
(2) The expiration date of the patent(s).
(3) The patentee's name, nationality, place of domicile or business office; for a patentee having a legal representative, the name of the legal representative shall be listed. If said patent has been exclusively licensed and has been recorded in accordance with the Patent Act, the aforementioned information of the exclusive licensee shall be listed.
(4) If the patentee or the exclusive licensee in Item (3) hereunder does not have a domicile or a business office in the R.O.C., an agent thereof shall be appointed. The appointed agent's name, place of domicile or business office shall be submitted.
2. If the holder of a new drug permit is different from the patentee, the patentee’s consent shall be obtained when submitting the patent information; if the patent has been exclusively licensed and has been recorded in accordance with the Patent Act, it is only required to obtain the exclusive licensee's consent.

If the holder of a new drug permit obtains the approval of an application for an invention patent(s) from the Competent Patent Authority after the approval of said new drug permit from the Central Competent Health Authority, and such patent(s) is subject to the scope of drug patent set forth in Paragraph 2 of Article 48-3, the patent information thereof shall be submitted within 45 days after the next day to the patent issuance in accordance with Article 48-4. If the holder fails to file such submission within the stipulated period, the regulations under this Chapter do not apply.

1. The holder of a new drug permit shall amend or delete the listed patent information within 45 days after the next day to the occurrence of any matter set forth below:
(1) The patent term extension is approved and issued by the Competent Patent Authority.
(2) The post-grant amendment to patent claim(s) is approved and issued by the Competent Patent Authority.
(3) The patent has been revoked finally and bindingly.
(4) The patent has become extinguished.
(5) The patent information set forth in Items 3 and 4, Paragraph 1 of Article 48-4 has been amended.
2. If the holder of a new drug permit is different from the patentee or the exclusive licensee, Paragraph 2 of Article 48-4 shall apply hereto mutatis mutandis when dealing with the matters stipulated in Paragraph 1 of this Article.

1. Anyone may notify any of the following items to the Central Competent Health Authority with written explanations and evidence attached:
(1) The invention listed in the patent information is irrelevant to the approved drug.
(2) The invention listed in the patent information does not comply with Paragraph 2 of Article 48-3.
(3) The patent information listed is incorrect.
(4) No amendment or deletion has been made for any of the occurrences stipulated in Article 48-6.
2. The Central Competent Health Authority shall, within 20 days after the next day to its receipt of the notification under Paragraph 1 hereof, forward said notification to the holder of the new drug permit.
3. The holder of a new drug permit shall, within 45 days of the next day to its receipt of said notification, respond to the Central Competent Health Authority with written explanations, and may amend or delete the patent information as the case may be.

1. The Central Competent Health Authority shall establish a Registration System for Patent Linkage of Drugs to list and publish the patent information submitted by the holder of a new drug permit. The aforementioned shall also apply to the amendment and deletion of the patent information.
2. Upon the occurrence of the matters stipulated in Article 48-7 for the listed patent information, the Central Competent Health Authority shall publish the third party's allegations and the written responses made by the holder of the new drug permit.

The applicant for a generic drug permit shall, with respect to the patent(s) of the approved new drug listed by the holder of said new drug permit, declare one of the following item(s) when applying for a generic drug permit:
(1) No patent information of said new drug has been listed.
(2) The patent(s) corresponding to said new drug has extinguished.
(3) The Central Competent Health Authority will issue the generic drug permit after the patent(s) corresponding to said new drug extinguishes.
(4) The patent(s) corresponding to said new drugs shall be revoked, or the patent(s) corresponding to said new drugs will not be infringed by the generic drug subject to the application for drug permit.

For the application for a generic drug permit that only involves a declaration based on Item 1 or 2 of Article 48-9, if in compliance with the regulations under this Act after examination, the Central Competent Health Authority shall issue the drug permit thereof.

For the application for a generic drug permit that involves a declaration based on Item 3 of Article 48-9, if in compliance with the regulations under this Act after examination, the Central Competent Health Authority shall issue the drug permit thereof after all of the listed patent(s) of said new drug extinguishes.

1. For the application for a generic drug permit that involves a declaration based on Item 4 of Article 48-9, the applicant shall, within 20 days after the next day to its receipt of the notification from the Central Competent Health Authority which indicates that all the documents required for an application of drug permit have been duly prepared, notify the holder of the new drug permit and the Central Competent Health Authority [of the declaration] in writing; if the holder of said new drug permit is different from the patentee or the exclusive licensee, the patentee and the exclusive licensee shall also be notified.
2. The applicant of a generic drug permit shall provide in the aforementioned notification an explanation and evidence regarding its allegation that that the patent shall be revoked or that there is no patent infringement.
3. The Central Competent Health Authority shall dismiss the application for generic drug permit if the applicant fails to issue the notification in accordance with Paragraphs 1 and 2 hereof.

1. If the patentee or the exclusive licensee intends to file a patent infringement complaint on the basis of the listed patent(s) after its receipt of the notification stipulated by Paragraph 1 of Article 48-12, it shall file the complaint within 45 days after the next day to its receipt of said notification and notify the Central Competent Health Authority.
2. The Central Competent Health Authority shall stay the issuance of the drug permit for twelve (12) months as of the next day to the new drug permit holder’s receipt of the notification stipulated in Paragraph 1 of Article 48-12. However, if there is any of the following matters, the Central Competent Health Authority may issue the drug permit if [said application is] is examined to be in compliance with the regulations under this Act:
(1) The patentee or the exclusive licensee, after its receipt of the notification stipulated by Paragraphs 1 of Article 48-12, fails to file an infringement complaint within the 45-day period.
(2) The patentee or the exclusive license files an infringement complaint based on the patents which are not those listed before the date of the application for the generic drug permit.
(3) The patent infringement complaint filed by the patentee or the exclusive licensee pursuant to Paragraph 1 hereof is overruled by the court according to Paragraph 1 or 2 of Article 249 of the Coded of Civil Procedure.
(4) The court has determined that all of the patents pending in the infringement lawsuit shall be revoked, or a non-infringement judgment is obtained by the applicant for the generic drug permit.
(5) All the patents under the declaration stipulated in Item 4 of Article 48-9 made by the applicant for the generic drug permit are determined as invalid by the Competent Patent Authority in a cancellation action.
(6) A settlement or a mediation has been reached by the parties.
(7) All the patents under the declaration stipulated in Item 4 of Article 48-9 made by the applicant for the generic drug permit have become extinguished.
3. The period [for notification] stipulated in Item 1, Paragraph 2 hereof shall be commenced upon the receipt of the notification by the patentee(s) or the exclusive licensee(s), whichever is later.
4. If the patentee or the exclusive licensee obtains a final and binding judgment confirming infringement of the listed patent(s) within the 12-month period stipulated in Paragraph 2 hereof, the Central Competent Health Authority shall issue the generic drug permit after said patent(s) extinguishes.
5. Where the patent infringement complaint filed by the patentee or the exclusive licensee pursuant to Paragraph 1 hereof, if by reason of being improper exercise of patent right ab initio, the stay of drug permit issuance has caused damages to the applicant of a generic drug permit, [such patentee or the exclusive licensee] shall be held liable for compensation.

For the applications for the generic drug permits filed by the same applicant for the same drug, the Central Competent Health Authority may only stay the issuance of the drug permit in accordance with Paragraph 2, Article 48-13 once.

1. During the period of stay of drug permit issuance stipulated in Paragraph 2 of Article 48-13, if the examination for the application for a generic drug permit has been completed, the Central Competent Health Authority shall inform the same to the applicant for said generic drug permit.
2. The applicant for a generic drug permit may apply for drug listing and reimbursement price with the National Health Insurance Administration after receiving the notification stipulated in Paragraph 1 hereof. However, no manufacture or importation [of the generic drug] is permitted before the Central Competent Health Authority’s issuance of the generic drug permit.

1. The application for a generic drug permit in accordance with Item 4 of Article 48-9 with application documents duly prepared at the earliest shall be granted a 12-month period of marketing exclusivity; the Central Competent Health Authority shall not issue other drug permits to other applicants for a generic drug permit before the expiration of the aforementioned period.
2. For the aforementioned application for a generic drug permit with documents duly prepared under Item 4 of Article 48-9, upon occurrence of [vacancy due to] any of the following matters, the vacancy will be fulfilled by the subsequent applicant with application documents duly prepared:
(1) During the period of drug permit examination, the declaration under Item 4 of Article 48-9 is amended.
(2) The earliest applicant fails to obtain from the Central Competent Health Authority the notification that the examination of the application for generic drug permit has completed within 12 months after the next day to the date that all the application documents are duly prepared.
(3) Any matter as stipulated in Paragraph 4 of Article 48-13 occurs.
3. If more than one application for a generic drug permit in compliance with the requirements regarding the earliest duly prepared application documents is filed on the same date, such applications are jointly subject to the 12-month period of marketing exclusivity.

1. The holder of a generic drug permit shall market the drug within 6 months after the next day to such holder’s obtaining of said drug permit, and shall, within 20 days after the next day to the earliest marketing date, provide the evidence of the actual marketing date to the Central Competent Health Authority for its determination of the marketing exclusivity period granted and the commencement date and end date thereof.
2. The marketing exclusivity period stipulated in Paragraph 1 hereof starts from the date of the actual marketing of the drug.
3. If more than one application for the generic drug permit is jointly subject to the marketing exclusivity period, the commencement date thereof shall be the date on which any of such drugs are actually first marketed.

If any of the following matters occur to the applicant for generic drug permit subject to the marketing exclusivity period, the Central Competent Health Authority may issue generic drug permits to other applicants without being restricted by Paragraph 1 of Article 48-16:
(1) Failure to collect the drug permit within the period prescribed by the Central Competent Health Authority.
(2) Failure to abide by Paragraph 1 of Article 48-17.
(3) All the patents declared under Item 4 of Article 48-9 have become extinguished.

1. For any settlement agreement or other agreement involving the manufacture, sales, and marketing exclusivity period of drug related to the regulations under this Chapter executed between the applicant for a new drug permit, the holder of a new drug permit, the applicant for a generic drug permit, the holder of a generic drug permit, and the patentee or exclusive licensee of a drug patent, within 20 days after the next day to the occurrence of such matter, both parties shall notify the Central Competent Health Authority, and if reverse payment interest agreement is involved, shall also notify the Fair Trade Commission.
2. The method and content of the notification stipulated in Paragraph 1 hereof, and other matters shall be abided by in this regard shall be promulgated by the Central Competent Health Authority jointly with the Fair Trade Commission.
3. If the Central Competent Health Authority considers that the agreement notified under Paragraph 1 hereof is likely to violate the Fair Trade Act, it may notify the Fair Trade Commission.

1. The provisions under Articles 48-9 through 48-15 hereof related to the application for a generic drug permit shall apply mutatis mutandis to the new drugs not having a new ingredient.
2. The provisions related to the stay of drug permit issuance and the marketing exclusivity period under Articles 48-13 to 48-18 are not applicable to the application for a generic drug permit set forth in Article 48-12 if the following circumstances are met:
(1) The patent(s) registered under an approved new drug is still valid, and is a patent for medical use under Item 3, Paragraph 2 of Article 48-3.
(2) The applicant of a generic drug permit excludes the indication corresponding to the patent for medical use referred to in Item (1) hereof, and declares that the generic drug does not infringe said patent.
3. The exclusion of indication, declaration, and other matters shall be abided by in this regard as stipulated in Paragraph 2 hereof shall be promulgated by the Central Competent Health Authority.

Before the enforcement of the provisions amended on [date], the holder of a new drug permit whose drug patent(s) is subject to the drug patent as stipulated in Paragraph 2, Article 48-3 and has not extinguished yet may submit patent information in accordance with Article 48-4 within 3 months after the enforcement of the amended provisions.

The details of the following should be promulgated by the Central Competent Health Authority: the method and content of submission of the patent information, the amendment and deletion thereof, the listing and publication of the patent information as stipulated in Articles 48-4 to 48-8; the declaration made by the applicant for a generic drug permit as stipulated in Article 48-9; the method and content of the written notification made by the applicant for the generic drug permit as stipulated in Article 48-12; the and content of the notification relating to completion of the examination procedures of an application for a generic drug permit by the Central Competent Health Authority as stipulated in Article 48-15; the commencement and termination of the marketing exclusivity period as stipulated in Articles 48-16 to 48-18; other matters that shall be abided by.