バイオ・医薬業界における特許ライセンスの実状と課題(<特集>知的財産戦略とイノベーション)

抄録

The drug market is oligopolistic owing to the governmental approval system and the patent system. Manufacturers have to allow a period of about ten years and an amount of 20-30 billion yen for the development of a new drug until its approval. Recovery of this investment within about ten years after launching is a prerequisite for continuing growth of the industry. Many "bioventures" resulting from biotechnology research, lacking resources for producing and marketing final products, usually depend on licensing big manufacturers to use their R&D outcomes. This situation presents various problems for universities and bioventures experience to obtain and exploit patents on genes and research tools. The licensing issue on Housey's assay procedure and the conflict involving Myriad Genetics about a patent for the BRCA genes for breast and ovarian cancers are commented as examples of those problems. Related issues include the deviation of bioventures' strategy on licensing of patents on genes and research tools from common-sense practice, public arbitration of licensing conflicts, reach-through loyalty, and excessive increase in cumulative loyalties. It is proposed to solve these problems, after an American model, by interventions of public agencies based on both pharmaceutical and industrial property administration policies. A public sector-based alternative would be a collective patent management system, in which patent proprietors agree upon common use of pooled patents under certain licensing conditions.