제약분야 기술거래의 로열티 결정구조와 요인

Structure and Determinants of Royalty in Pharmaceutical Licensing

본고는 제약분야 라이센싱 거래의 기초가 되는 주요 경제적 조건에 근거한 분석적 접근방법을 검토하기 위한 것이다. 그 목적은 관련된 주요 요인들 간의 관계에 대한 이해를 높이는 것이다. 여기에서 제기되는 몇 가지 논점은 다음과 같다. 즉, 신약개발의 특징인 대규모 투자, 고위험 및 긴 개발기간 등의 수익에 대한 효과, 최종 매출수준과 영업이익이 적정 로열티율에 미치는 효과, 선불금 및 신약개발 단계별로 지불될 마일스톤 기술료와 약품이 시장에 진입된 후에 지불될 기술료간의 관계 등이 그것이다. 본고에서는 먼저 제약분야 기술이전 거래의 로열티 결정을 위한 사전 단계로서, 기술가치평가의 주요 방법과 특징을 살펴보고, 다음으로 로열티 결정을 위한 주요요소인 기대이익, 매출액, 각종 비용, 투자 등의 측정방법을 검토한다. 그리고 이러한 주요 요소의 측정에 기초하여 로열티와 이윤율, 기술제공자와 기술도입자 간의 이익배분, 로열티의 산출과 결정방식에 대해 고찰하고자 한다.

Most pharmaceutical licensing deals are made in the early stage of drug development. While this development process is not unique for complicated technology, a special feature of drug development is that it is highly regulated and a well-defined process. Its statistics in terms of costs and chances of technical success have been researched extensively. This enables relatively detailed calculations as benchmarks for actual deals to be made. Based on such calculations and on the analysis of licensing terms in published agreements, various companies offer quite expensive information, databases, software programs and consultation services to help establish what might be reasonable economic terms in a licensing deal. Over the years, pharmaceutical royalties have been the subject of various articles in journals. Most specific on this subject was the article on determining pharmaceutical royalties. Many other articles are about a more general nature deal with determining reasonable royalty rates, evaluating and underpinning the empirical value and usefulness of the 25% rule. The object of this article is to provide a relatively simple analytical approach based on the major economic terms underlying pharmaceutical licensing deals. The aim is to enhance the understanding of the relations between the major factors involved. Details are disregarded, as generally, where the terms of licensing deals depend on predictions over a considerable length of time, the value of detail is limited. Some specific issues addressed by the approach are the impact on profits of large investments, high risks and long development times characteristic of drug development, the consequent strong impact that the ultimate sales levels and operating margins may have on what might be considered a reasonable royalty rate, and the relationship between upfront payments and milestone payments to be paid during pharmaceutical development and the royalties due once the drug enters the market.