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한국의 의약품 허가-특허연계제도에서 제네릭 시장독점제도의 도입 필요성에 관한 연구
정용익 한국지식재산연구원 2014 지식재산연구 Vol.9 No.4
As the grace period of three years is over, Approval-PatentLinkage System based on Korea-US FTA will be implemented inearnest from 2015. The generic marketing exclusivity will be alsoimplemented. This paper studied the grounds for promotions ofgenerics' release by the generic marketing exclusivity and possibility ofside effect derived from the generic marketing exclusivity. As theresults, the generic marketing exclusivity is not only means foractivation of the generics’ release and the generics will be released bysomeone without the generic marketing exclusivity, however, it is clearthat the generic marketing exclusivity will be strong inducement for thegenerics’ development. The generic marketing exclusivity can promotegenerics’ release through the expanding of the target for patentchallenge and advancing the date for patent challenge. Also, it isexpected that our pharmaceutical industry’s practice focused on themarketing will be innovated. However, there is concern about thenegative factors, such as increasement of the reverse paymentagreement according to collusion the patent holder and the genericdeveloper that can occur because of the introduction of genericexclusivity system, delay of generic entry. But, it is thought to be solvedby providing a method introduced by considering the characteristics ofKorean patent system that patent challenge is possible before the marketing authorization application and the pharmaceutical industry ofwhich the majority are generic companies. When a new system is introduced, there are always the positiveand the negative sides, and it is not shown the same effect. Under theintroduction of generic exclusivity system, it is should be provided theway that the positive aspects are maximized and the negativeminimized. Therefore, by facilitating market entry of generics and making adevelopement of pharmaceutical industry, it should be provided thesystem which can further increase the accessibility on pharmaceuticalproduct by people. 2012년 발효된 한·미 FTA가 3년이 경과함에 따라, 그동안 유예되었던 의약품 허가-특허연계제도가 2015년부터 본격 시행될 예정이며, 이와 동시에 제네릭 시장독점제도도 그 시행을 준비하고 있다. 본 연구에서는 제네릭 시장독점제도가 특허도전 활성화를 통한 제네릭 진입을 촉진한다는 근거와 함께 제도 도입에따른 부작용 발생 가능성도 동시에 검토하였다. 그 결과 제네릭 시장독점제도가제네릭 진입 활성화의 유일한 방법도 아니고, 독점권이 없더라도 제네릭이 개발이중단되는 것은 아니지만, 독점권의 부여가 제네릭 개발을 촉진하기 위한 강력한유인으로 작용한다는 점을 보다 명확히 확인할 수 있었다. 제네릭 시장독점제도가도입됨에 따라 특허도전 대상을 확대하고 그 시기를 앞당겨 제네릭 진입이 촉진되며, 영업 위주의 우리나라 제약산업의 경영관행을 혁신할 수 있는 변화를 가져올수 있다. 다만, 제네릭 독점제도 도입 시 발생할 수 있는 제네릭 개발자와 특허권자의 담합에 따른 역지불 합의의 증가 가능성, 제네릭 진입의 지연 등 문제 발생에 대한 우려의 목소리도 있으나, 품목허가 신청 전에 특허도전이 가능한 우리나라 특허제도의 특성과 제네릭 제약기업이 다수를 차지하는 제약산업의 특성을 고려할 때, 이에 대한 방지책 마련을 통해 문제해결이 가능할 것이다. 하나의 제도는 새로 도입됨에 따라 항상 긍정과 부정의 양측면을 가지게 되며, 그 효과도 항상 같은 것은 아니다. 제네릭 시장독점제도의 도입에 있어서도 긍정적 측면은 최대화하고 부정적 요인은 최소화할 수 있는 방안을 마련함으로써, 제네릭의 시장진입 촉진과 국내 제약산업의 한 단계 도약을 통해 국민들의 의약품에 대한 접근성을 더욱 높일 수 있는 성과를 이루어내야 할 것이다.
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정용익 원광대학교 법학연구소 2011 法學硏究 Vol.27 No.3
Procuration system is defined to be an institution that another person presents or accepts an expression for the principal so that the effect of law happens on the principal. In addition, in the case of representation of mandate, it is an expansion of private autonomy in the sense that one, with own intention, lets the third person commit a legal act and receives an effect. In the case of legal representation, the legal incompetent commits a valid legal act through a legal representative, and it has a function of supplementing private autonomy. However, it can be considered as an expansion of private autonomy in the respect that it creates a legal effect to the principal, for the principal on the premise of the intention of the principal. Merely, in the case of legal representation, it is considered to be different because the right of representation is granted under the law. All procuration system should not deviate from this original and characteristic. It is called an abuse of the right of representation when a representative works for himself or the third person, not for the principal who entrusts the right of representation. A number of theories exist for the case that the representative's action which corresponds to this happens. On the other hand, it causes another problem if procuration system, which is administered within a certain system, is able to fail to speak for the principal's opinion and profit. Procuration system is not always such in charter procedure, but it is considered somewhat meaningful because there exists a very unique phase, which is hardly found in general administration of procuration system. Charter procedure is commonly the most complicated among the administrative procedures, so the procuration system upon it seems to have a very peculiar characteristic. Other than the basic point that procuration system is managed for the principal himself, there might be various purposes such as stabilization of foreign relationship, effective management of related procedures, and etc. On charter procedure, procuration procedure seems to excessively emphasize the effectiveness of administrative procedure, among those several purposes. It is seen from the considerable amount of contents managed in charter procedure, other than the same points with civil law and the Civil Proceedings Act.Especially, about the management of comprehensive mandate system and appointment of sub-agent, the system is thought to be working for the comfort of representative more than for the effectiveness of procedure.Also, not a few of the contents, which regulate the unique produration system about charter procedure, are managed only with the basis related to the enforcement regulation format. Although it does not mean that these respect aught to be prescribed under the law, it needs a change, considering the fact that the recent tendency of legislation is trying to arrange legal basis as much as possible. Also, a problem of interpretation occurred while trying to include excessively complicated procedural term as a regulation.Though this originates in the complexity that the charter procedure carries, it is also a problem of legislation technology. Due to this kind of vagueness on regulations, the guidelines, which are only internal manuals, are sometimes understood as a bible. It needs to be stipulated more clearly.A national recognition of charter procedure is that it is difficult and complicated. Of course it is to create a new right by a certain procedure; therefore, it might be more complicated than other administrative procedures. However, it needs to be considered that the complexity originates from the systematic defect under management. About the charter procedure, procuration system is administered uniquely, and at some point, it needs to grope for more constructive plan for people. Further details are to be examined and learned, but some issues can be discussed as indications. First, it needs an improvement of unnecessary regulations whose meanings are hazy. They are the warrant of attorney and the assignment report that are provided under patent law enforcement regulation article 5 and the terms, related to the representative of multiple parties, provided under the patent law article 11.The former is judged to cause unnecessary administrative procedures without a distinguished actual profit, and the latter is capable of inducing confusion due to the vagueness of its contents; therefore, there needs to be a revision of text. Second, the articles, which are managed with excessive focus on the representative, needs to be improved to focus on the principal. Of course, although the representative is too big and his comfort can result in the benefit of principal due to the characteristics of administrative procedure, it needs to be improved because, eventually, the most important term is the intention of the principal in procuration system. The comprehensive mandate system is the typical term, and it is necessary to arrange a procedure to check the principal's intention even in simple format.On the other hand, the matters, related to the appointment of sub-agent about the corporate which himself belongs to, must be improved in the respect that certain matters might occur, inharmonious with or violating the patent law or patent attorney act. It should be solved with the replacement of representative, like a commonsense case. Third, there needs a legal basis about some subjects related to the procuration system. Especially, comprehensive mandate system, related to the appointment of sub-agent about the corporate which himself belongs to, needs a legal basis about the contents including the least definition of concepts. As consistently mentioned, procuration system is managed for the principal; at the same time, it is also a problem that the credit and control over the representative comes together. That is the reason why there exist regulations under the law so that the system can be administered, corresponding with the original purpose. In this sense, procuration system suggests many issues about the patent law. Even though this is an insufficient paper, I hope that the procuration system would approach to the original function and purpose in the patent system.
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정용익(Jeong, Yong-Ik) 원광대학교 법학연구소 2011 圓光法學 Vol.27 No.3
Procuration system is defined to be an institution that another person presents or accepts an expression for the principal so that the effect of law happens on the principal. In addition, in the case of representation of mandate, it is an expansion of private autonomy in the sense that one, with own intention, lets the third person commit a legal act and receives an effect. In the case of legal representation, the legal incompetent commits a valid legal act through a legal representative, and it has a function of supplementing private autonomy. However, it can be considered as an expansion of private autonomy in the respect that it creates a legal effect to the principal, for the principal on the premise of the intention of the principal. Merely, in the case of legal representation, it is considered to be different because the right of representation is granted under the law. All procuration system should not deviate from this original and characteristic. It is called an abuse of the right of representation when a representative works for himself or the third person, not for the principal who entrusts the right of representation. A number of theories exist for the case that the representative's action which corresponds to this happens. On the other hand, it causes another problem if procuration system, which is administered within a certain system, is able to fail to speak for the principal's opinion and profit. Procuration system is not always such in charter procedure, but it is considered somewhat meaningful because there exists a very unique phase, which is hardly found in general administration of procuration system. Charter procedure is commonly the most complicated among the administrative procedures, so the procuration system upon it seems to have a very peculiar characteristic. Other than the basic point that procuration system is managed for the principal himself, there might be various purposes such as stabilization of foreign relationship, effective management of related procedures, and etc. On charter procedure, procuration procedure seems to excessively emphasize the effectiveness of administrative procedure, among those several purposes. It is seen from the considerable amount of contents managed in charter procedure, other than the same points with civil law and the Civil Proceedings Act.Especially, about the management of comprehensive mandate system and appointment of sub-agent, the system is thought to be working for the comfort of representative more than for the effectiveness of procedure.Also, not a few of the contents, which regulate the unique produration system about charter procedure, are managed only with the basis related to the enforcement regulation format. Although it does not mean that these respect aught to be prescribed under the law, it needs a change, considering the fact that the recent tendency of legislation is trying to arrange legal basis as much as possible. Also, a problem of interpretation occurred while trying to include excessively complicated procedural term as a regulation.Though this originates in the complexity that the charter procedure carries, it is also a problem of legislation technology. Due to this kind of vagueness on regulations, the guidelines, which are only internal manuals, are sometimes understood as a bible. It needs to be stipulated more clearly.A national recognition of charter procedure is that it is difficult and complicated. Of course it is to create a new right by a certain procedure; therefore, it might be more complicated than other administrative procedures. However, it needs to be considered that the complexity originates from the systematic defect under management. About the charter procedure, procuration system is administered uniquely, and at some point, it needs to grope for more constructive plan for people. Further details are to be examined and learned, but some issues can be discussed as indications. First, it needs an impro
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후발의약품 진입 후 신약 보험약가 인하와 손실 배분의 정의(正義)
박성민(Park, Sungmin),정용익(Jeong, Yongik),신혜은(Shin, Hyeeun) 한국정보법학회 2017 정보법학 Vol.20 No.3
현행 특허법, 약사법 그리고 국민건강보험법 하에서, 신약 제약회사는 특허도전에 성공한 후발의약품 진입으로 인한 신약 보험약가 인하에 관하여 (추후 그 특허가 무효가 아니라는 판단이 확정되더라도) 후발의약품 제약회사나 국가 등으로부터 손실 을 보전받기 어렵고, 신약 특허권자 등의 판매금지 신청에 따라 후발의약품이 판매금지를 당하였을 때 사후적으로 그 판매금지가 잘못된 것임이 확인되어도, 국민건강보험공단이 신약 제약회사에게서 손실을 회복할 수 없다는 결론에 도달하였다. 하지만해석론적으로 본고와 다른 해석이 불가능하지 않아서 법적 안정성과 예측가능성이 저해되는 상황이다. 이는 특허권의 유동적 권리성이라는 현실적인 한계 때문에 혁신에 대한 보상과 의약품 접근성 제고의 요구를 조화시키려는 특허법, 약사법, 국민건강보험법이 의도한배분적 정의가 왜곡된 것이다. 그러므로 후발의약품의 조기 진입 이후의 부당한 신약 보험약가 인하에 대하여는 국민건강보험공단이 신약 제약회사에게 손실보상을 하고 후발의약품 진입 지연으로 인한 신약 보험약가 인하 지체에 대하여는 신약 제약회사가 국민건강보험공단에게 그로 인하여 얻은 망외의 이익을 반환하도록 하는 입법적개선이 필요하다고 생각한다(제1안). 그러나 만약 그러한 입법적 개선을 통한 교정에행정비용이 과도하게 소요된다면 차선책으로서 법령에서 정한 절차에 따라 행한 행위에 대하여는 책임을 부담하지 않음을 명확히 하는 입법이 필요하다(제2안). We have studied and concluded that under the current patent act, pharmaceutical affairs act and national health insurance act, original pharmaceutical company is not able to receive the compensation for the loss of original medicine upper price limit lowering after the market entry of follow-on medicine which succeeded in patent challenge, from the follow-on pharmaceutical company or the state, and vice versa. That is to say, when follow-on medicine is prohibited to sell according to approval-patent linkage system, National Health Insurance Service(the insurer of Korean national health insurance) is not able to receive the compensation for the loss from the original pharmaceutical company. However the different interpretation from us is not impossible. There is the problem of legal stability and possibility of forecast. This issue is caused by the realistic limitation of probabilistic patent. It distorts the distribution justice under the patent act, pharmaceutical affairs act and national health insurance act. Therefore we suggest the legislative improvement that rectify the distortion through compensation from the one which gets benefit to the one which gets loss. However, if the correction by the legislative improvement requires too much administrative cost, then, as a second way, we suggest the legislation that clarifies original pharmaceutical company or follow-on pharmaceutical company which follows the process of the pharmaceutical affairs act is not responsible for the loss above.
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