新药开发合作中的优先许可权机制研究：基于合同设计视角

In biopharmaceutical industry, new drug developments have been characterized with high R&D expenses, long development cycles, high technique and market risks, which facilitates the development partnerships between biotech companies with high R&D competence and pharmaceutical companies with manufacturing and commercialization capability. However, the partnership faces high uncertainties and information asymmetry, how to employ contract mechanisms to cope with the issues has attracted huge attention from both academic scholars and industry practitioners. This project will study two types of preemptive licensing rights: rights of first negotiation and rights of first refusal, which have often been observed in the industry but requires more academic analysis to achieve a better understanding on how to use them. The project will use contract design theory and econometric method to study the role of the two rights on coping with uncertainties and agency issues. First, the project will examine the values of the two rights, followed by demonstrating how to design the optimal contracts with the two rights in both symmetric and asymmetric information settings. Lastly, the project will conduct an empirical analysis to test the model results by collecting data from the biopharmaceutical industry. Our results will reveal the principles that how the two rights can be used to cope with uncertainties and information asymmetry and will offer an optimal strategy for firms to adopt the two rights, which provides theoretic supports for industry practices. Our results will also shed light on new product development partnerships in other high-tech industries and university-industry partnerships.

生物制药行业中，新药开发具有成本高、周期长、技术与市场风险高等特征，使得有研发能力的生物科技企业与有产业化能力的制药企业建立新药开发合作关系成为趋势。但合作过程面临高度不确定性和信息不对称，如何运用合同机制解决这些问题引起学术界与工业界的极大兴趣。本项目拟采用合同设计理论和计量方法，研究新药开发合作实践中常见但尚未在学术界得到充分研究的两种优先许可权机制：第一谈判权与第一拒绝权，探讨这两种权利在新药开发合作中的作用机理。首先研究两种优先权在不确定情境下的作用与价值，进而分析企业如何以两种权利为基础来设计信息对称与不对称情形下的最优合作契约，最后收集生物制药行业的合作协议数据验证理论模型的结论。研究将揭示两种权利应对合作过程中的不确定性和代理问题的原理，提出企业运用两类权利的最优策略，为企业实践提供理论依据。研究也将为高科技行业中新产品开发合作和我国科技成果转化机制提供参考。

高科技新产品的成功开发常常依赖于创新链和产业链的多方合作。当具有技术研发能力的企业和具有市场开发经验的企业合作开发新产品时，双方的比较优势可降低研发风险和成本，有效提高开发成功率。而当双方在新产品研发早期建立合作关系时，将面临较高的技术和市场价值不确定性，难以达成一个具体的利益分配合约。灵活的优先许可权机制不仅允许双方在早期建立合作关系，而且使得双方将具体的利益分配决策延迟到不确定性较低的时机。本项目主要通过建立博弈模型来研究新产品开发合作中的优先许可权机制作用机理。模型包含一个负责前期技术研发的技术发明者和一个负责后期生产推广的市场者。双方围绕一个处于早期技术研发阶段的新产品进行开发合作，仍面临技术和市场价值不确定性。项目采用合同理论框架讨论优先许可权的作用价值，并考虑技术发明者关于新产品的潜在平均市场价值的信息不对称情形。研究表明：当双方合作可以降低研发成本时，优先许可权可提升技术发明者的研发投入，并提升双方合作的总收益。进而，优先许可权的价值随着新产品的潜在平均价值、市场价值不确定性、以及市场竞争程度的增加而上升。在信息不对称情形下，技术发明者可以利用优先许可权建立一个筛选模型，使得高价值类型的市场者获得该产品。本项目的研究为理解优先许可权的价值作用提供了理论支撑，也为创新合作实践提供参考。