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    의약발명에 있어서 특허법 제229조의 사문화와 입법적 개선방안 = The Obsolescence of Article 229 of the Korean Patent Act in Pharmaceutical Inventions and Legislative Measures for Its Reform

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    https://www.riss.kr/link?id=A110235093

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    Article 229 of the Korean Patent Act aims to preserve the integrity of the patent system by punishing those who acquire patents through false or fraudulent acts. However, in the field of pharmaceutical inventions, the provision has become virtually ineffective. Lengthy clinical trials, regulatory approvals, and data exclusivity under the Pharmaceutical Affairs Act often mean that several years pass between patent registration and market entry. By the time false data or manipulated experiments are discovered, the five-year statute of limitations has already expired, thereby making criminal prosecution impossible. This structural gap is exemplified by the Daewoong Pharmaceutical case exemplifies this structural gap: although the company obtained a patent based on falsified bioequivalence data, prosecutors could not apply Article 229 and instead relied on other statutes. This study argues that the provision fails precisely where it is most needed and proposes legislative reforms of resetting the limitation period, increasing penalties, adding administrative sanctions, and enhancing data verification during examination. These measures are essential not merely to strengthen punishment, but also to restore trust and fairness within the patent system and pharmaceutical industry.
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    Article 229 of the Korean Patent Act aims to preserve the integrity of the patent system by punishing those who acquire patents through false or fraudulent acts. However, in the field of pharmaceutical inventions, the provision has become virtually in...

    Article 229 of the Korean Patent Act aims to preserve the integrity of the patent system by punishing those who acquire patents through false or fraudulent acts. However, in the field of pharmaceutical inventions, the provision has become virtually ineffective. Lengthy clinical trials, regulatory approvals, and data exclusivity under the Pharmaceutical Affairs Act often mean that several years pass between patent registration and market entry. By the time false data or manipulated experiments are discovered, the five-year statute of limitations has already expired, thereby making criminal prosecution impossible. This structural gap is exemplified by the Daewoong Pharmaceutical case exemplifies this structural gap: although the company obtained a patent based on falsified bioequivalence data, prosecutors could not apply Article 229 and instead relied on other statutes. This study argues that the provision fails precisely where it is most needed and proposes legislative reforms of resetting the limitation period, increasing penalties, adding administrative sanctions, and enhancing data verification during examination. These measures are essential not merely to strengthen punishment, but also to restore trust and fairness within the patent system and pharmaceutical industry.

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