Strategic balance of drug lifecycle management options differs between domestic and foreign companies in Japan

ABSTRACT

Introduction: Drug approvals and patent protections are critical in drug lifecycle management (LCM) in order to maximize drug discovery investment returns.

Area covered: We analyzed drug LCM activities implemented by 10 top companies in Japan, focusing on drug approvals and patent term extensions.

Expert opinion: Foreign companies acquired numerous drug approvals primarily for new molecular entities (NMEs), while Japanese companies mainly obtained approvals for improved drugs including new indications, and intensively extended patent terms. Furthermore, we discovered three factors likely responsible for differences in drug LCM strategies of Japanese and foreign companies: research and development capacities for drugs, drug lags of foreign-origin NMEs, and cooperation between Research and Development Departments and Intellectual Property Departments.

KEYWORDS:

• Lifecycle management
• patent
• patent term extensions
• market exclusivity
• drug approval
• Japan

Article highlights

• Drug LCM approaches implemented by 10 top companies in Japan were divided into two clusters.

• Foreign companies conducted NME-oriented LCM with enhanced R&D capacities.

• Domestic companies intensively extended patent terms with additional drug approvals.

• Drug lags of foreign-origin NMEs might prevent patent term extensions.

• Lack of cooperation between R&D departments and intellectual property departments might cause opportunity loss.

This box summarizes key points contained in the article.

Declaration of Interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.