http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
Jae-Deuk Kim(김재득),JooYong Cheon(천주용),JaeHun Kim(김재훈),JaeWon kim(김재원),Junsoo Kim(김준수),Hyunwook Jun(전현욱),Wonho Kim(김원호),Changwook Ji(지창욱) 대한용접·접합학회 2021 대한용접학회 특별강연 및 학술발표대회 개요집 Vol.2021 No.5
Recently, global environmental regulations getting more strict, and hence it is increasing that the interest and investment of automobile companies on the aluminum die casting parts to make light-weight vehicles. Die casting molds are fabricated by the machining of billets of tool steels such as AISI 4140 or H13, in general. But, it has disadvantages like a large material loss and long lead time. Meanwhile, a Wire Arc Additive Manufacturing (WAAM) process could be an alternative fabrication method of the die casting mold. It has advantages such as less material loss, short lead time, easy repair and modification, the chance to make a reinforced mold using dissimilar materials, etc. The 5 Cr - 4 Mo tool steel wire is a commercial tool steel solid wire which designed for the repair and modification of tools and molds. It has superior hot wear resistance and toughness as well as the high strength, thus has high potential to produce die casting molds via the WAAM process. On the other hand, the WAAM process is basically the process that stacking the layers repetitively using a conventional arc welding process based on the designed tool paths by CAD/CAM. Thus, the predictability and the reproducibility of every single layer are the most important core factor to obtain the advantages of the automated WAAM process. Due to its nature, a new process parameter whose named an interpass distance should be considered as well as the conventional process parameters such as current, voltage, travel speed, etc. However, there are lack of researches on the interpass distance of WAAM process. In this research, it was found that the interpass distance greatly affect the arc stability due to arc interference induced by the variation of distance from the prior deposited pass. That is to say that the more arc interference was observed as the less interpass distance was given. This phenomenon had been proven through the analysis of high-speed camera results and the variation in the amount of spatter. Further, it was observed that the interpass distance affects the dimension precision and predictability of automated WAAM process of the 5 Cr - 4 Mo tool steel. And it was found the critical interpass distance that could be utilized in the automated WAAM process of the 5 Cr - 4 Mo tool steel. The effect of the interpass distance on the arc interference would exist unless the interpass distance would be given over 100 %, thus, it is important to find out a point of compromise based on the arc stability, dimension predictability, and reproducibility.
‘Product Hopping’의 특허남용과 경쟁제한성
김재득 ( Jae Deuk Kim ) 법과사회이론학회 2021 법과 사회 Vol.- No.68
‘product hopping’이란 의약품 특허권자가 자신이 보유하고 있는 특허권을 남용하여 특허만료가 임박한 시기에 브랜드 의약품을 시장에서 철수시키고 제네릭 대체가 불가능한 개량신약, 즉 유사 의약품을 출시하는 행위를 말한다. 이는 합법적인 사업 정당화 없이 환자가 값비싼 새로운 제형으로 전환하도록 강제하여 소비자의 선택권을 침해하고 후생을 저해한다. 또한 이러한 행위는 특허권의 범위를 넘어 제네릭 진입을 방해하고 경쟁을 제한하는 이중효과를 발생시키는 행위이기도 하다. 이러한 이유로 product hopping은 최근 미국과 EU를 비롯하여 우리나라에서도 경쟁 제한성 측면과 특허권 남용의 법리에서 관심의 대상으로 부상하고 있다. product hopping에는 연성전환과 경성전환 방식이 있다. 경성전환은 2006년 트리콜(Tricor) 사건이 대표적이며, 브랜드사가 사소하게 개량된 새로운 의약품을 출시하면서 시장에서 구 버전 의약품을 철수 또는 제거하는 전략을 사용하여 소비자에게 신제품에 대한 선택을 강제하는 방식이다. 한편 연성전환은 2008년 프릴로섹(Prilosec) 사건이 대표적인데 구 버전 의약품에 대하여 마케팅과 홍보만 중단할뿐 생산과 공급은 계속하는 방식이다. 브랜드사가 시장에서 구 버전을 철수하는 방식 등을 사용하여 소비자에게 개량된 제품으로의 전환을 강제한 경우에는 경쟁제한성과 반독점법 위반이 있을 수 있다. 미국의 법원은 product hopping의 경쟁제한성을 판단할 때에는 ‘합리의 원칙(rule of reason)’을 따르며, 복잡하고 고도로 규제된 제약산업의 특이한 시장 특성에 대한 이해뿐만 아니라 해당 질환 치료의 특유한 특성이 요구된다고 보았다. 최근에는 전 세계적으로 COVID-19로 인한 글로벌적인 팬데믹이 발생하고 있고, 새로운 질병과 희귀질환 환자가 증가하는 추세이기 때문에 혁신의약품에 대한 요구가 그 어느 때보다 커지고 있는 상황이다. 따라서 product hopping에 대한 ‘혁신’과 ‘특허권 남용 또는 독점연장’에 대한 논의, 이로 인해 경쟁법을 적극적으로 적용해야 하는지 아니면 제한적으로 접근해야 하는지에 대한 논쟁은 더욱 첨예해질 것으로 예상된다. product hopping의 경쟁제한성을 판단함에 있어서는 경쟁법 적용을 무리하게 하여 오히려 인류의 건강과 생명에 도움이 될 수 있는 ‘혁신’을 저해하지 않도록 최소한의 범위 내에서 객관적인 요건을 명백히 만족하는 경우에만 규제를 해야 할 것이다. 즉, 브랜드사의 product hopping 행위가 언제 발생했는지(시기, timing), ‘진정한 혁신’에 해당하는지, 친경쟁적 정당화 사유가 있는지, 정당한 사유없이 독점을 연장 내지 확장하고자 하는 의도가 있었는지, 소비자의 선택권을 침해하거나 소비자 후생이 저해되지는 않았는지에 대한 면밀한 분석이 필요하다. 이에 경쟁당국은 경쟁보호를 위해 의약품의 연구개발·생산·판매·특허권 만료 및 제네릭 진입단계에서부터 반경쟁적 행위를 지속적으로 감시해야 한다고 본다. ‘product hopping’ refers to the act of the drug patent holders abusing patent right he owns, withdrawing the brand name drug from the market when the patent is nearing expiry, and launching an improved new drug, i.e., a similar drug, that cannot be replaced with a generic. This infringes on consumer choice and significantly decreasing consumer welfare by forcing patients to switch to expensive new formulations without legitimate business justification. In addition, such an act is an act that has the dual-effect of hindering the entry of generics beyond the scope of patent rights and restricting competition. For this reason, product hopping has recently emerged as an subject of interest in the US and EU as well as in Korea in terms of competition restrictions and the legal principles of patent abuse. There are soft switch and hard switch methods for product hopping. The most representative case of hard switch is the Tricor case in 2006, a brand company use a strategy of withdrawing or removing older versions of drugs from the market as they launched new drugs with a slight improvement, to coerce consumers to switch new products. On the other hand, the most representative case of soft switch is the Prilosec case in 2008, which is a method of continuing production and supply while only stopping marketing and promotion of the old version of the drug. If a brand coerces consumers to switch to an improved product, such as by withdrawing an older version from the market, there may be anti-competition and antitrust violations. When judging product hopping’s Restraint of Competition, the U.S. court followed the ‘rule of reason’ and saw that not only understanding the unique market characteristics of the complex and highly regulated pharmaceutical industry, but also unique characteristics of treating the disease were required. Recently, global pandemics due to COVID-19 have occurred worldwide, and the demand for innovative drugs has never been greater as the number of patients with new and rare diseases has been on the rise. Consequently, discussions on ‘Innovation’ and ‘Patent abuse or Monopoly Extension’ of product hopping are expected to further sharpen the debate over whether competition laws should be actively applied or approached in a limited manner. In determining the competitive restraints of product hopping, regulations should be made only when the objective requirements are clearly met to the minimum extent so as not to overdo the application of competition laws to hinder ‘Innovation’ that could benefit human health and life. In other words, it is necessary to closely analyze when the brand company's product hopping behavior occurred (timing), whether it corresponds to ‘real innovation’, whether there is a reason for pro-competitive justification, whether there was an intention to extend or expand monopoly without justifiable reasons, or whether it violates consumer choice or hinders consumer welfare. In addition, competition authorities must anti-competitive behavior monitor continuously to protect competition from the R&D, production, sales, patent expiry, and generic entry stages of pharmaceuticals.