On December 29, 2017, upon the third read, the Legislative Yuan passed –and the President announced on January 31, 2018- Chapter 4-1 of the Pharmaceutical Affairs Act (Patent Linkage of Drugs), which relates to the patent linkage system of drug registration and patent information.  The Taiwan Food and Drug Administration (hereinafter “TFDA”) expects to initiate the patent linkage system next year.  Upon its initiation, brand pharmaceutical companies applying to the system must disclose patent information of related substances, compositions or formulas, and medical uses, of any new drugs to be sold.  

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Generic pharmaceutical companies, at the time of application for approval, must provide certifications against the patent information of the brand-name drug.  If a patent invalidity and/or non-infringement claim is made, the generic pharmaceutical company must notify the brand-name drug’s pharmaceutical company.  The first generic pharmaceutical company to file the invalidity and/or non-infringement claim against the brand name pharmaceutical company will enjoy a 12-month marketing exclusivity period.  On the other hand, a brand pharmaceutical company can file a patent infringement action against the generic pharmaceutical company; the TFDA will then suspend issuance of approval of the generic drug for a reasonable amount of time (not to exceed 12 months).  This allows the parties to resolve the infringement dispute.

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As to the procedural and logistical issues of the patent linkage system, the TFDA announced the promulgation of proposed regulations “Enforcement Rules of Western Pharmaceuticals Patent Linkage” (hereinafter “Enforcement Rules”) and the “Reporting Rules of Western Pharmaceuticals Patent Linkage Agreement” (hereinafter “Reporting Rules”), respectively on September 11 and October 12 of 2018.  The Enforcement Rules proscribe regulations in the following: 1) filing, amendment, and deletion of patent information, 2) publication and disclosure of patent information, 3) generic pharmaceutical company’s patent certifications and written notice requirements, 4) the notices related to initiations of patent infringement actions by brand pharmaceutical companies and obtaining the final and binding judgments confirming infringement, 5) completion notice from the TFDA of generic drug approval, 6) specific durations of marketing exclusivity periods, 7) the applicability of mutatis mutandis to the new drugs not having new ingredients, and 8) indication carve out and its certification.  The Reporting Rules regulate procedural and substantive reporting duties on the agreements relating to patent linkage and/or reverse payments between brand and generic pharmaceutical companies, to the relevant authorities.

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Both proposed regulations are currently undergoing a 60-day period for referendum; interested parties from all industries are encouraged to provide their input.  The public’s response and reaction to these two proposed regulations, and any potential impact on the patent linkage system, remains to be seen.

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If you have any question, please feel free to contact us. (+886-2-27058086)

Yow-Lun (Albert) Su, Partner/Patent Attorney   yowlunsu@mail.fblaw.com.tw

Brian P.H Chang, Senior Associate/M.D.   brianchang@mail.fblaw.com.tw

Yun-Ting (Tim) Tsai, Associate   timtsai@mail.fblaw.com.tw

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