Need for new IP approaches to facilitate collaborative (academic-industrial) drug development.

• Author: FitzGerald, Garret A.
• Position: Intellectual property

The relative strengths and weakness of academia and industry in the skills necessary to bring a molecule forward to an approved drug are widely appreciated. Indeed, the efficiency of moving to a modular approach to drug discovery and development--with modules drawn at different stages from diverse sectors and geographies--has been realized in the altruistic sector. However, conversion of this approach to the for-profit sector requires a revision of our thinking on intellectual property (IP).

The potential value of too many molecules remains locked in company freezers, while exploitation of biological insights in academia is classically limited by the lack of tool compounds and of translational infrastructure to convert such leads into approved drugs. Segregating these opportunities from each other are unrealistic expectations of IP rewards by both academia and industry, and an outmoded and inefficient approach to IP by both parties. While some progress has been made with respect to academic infrastructure via clinical and translational science awards; and, industry has begun to make widespread but essentially limited deals with universities, it is worth considering the fundamentals of IP.

Despite the odds of a new molecular entity becoming an approved drug being extremely long, the dominant IP is vested in chemical composition of matter. In the era of large vertically integrated companies--now on the wane--this did not really matter. The chemist, the expert in model systems and the clinical trialist all worked for the sponsoring company and all would profit via its stock shares if the drug was approved. In an era of modular drug discovery and development, the trick will be to engage the best investigators at various stages in the process, despite them working in a different public or private entity than the originator of the chemical matter in question. Provision of the funds to do their bit of the research will be insufficient; if they are best in brand they will...