Achieving a Fair and Equitable Balance: The Role of Patents in the Governance and Oversight of Human Germline Genome Editing

Abstract

The patent system can assist with the governance and oversight of human germline genome editing but can also hinder that process if not deployed in a fair and equitable way. At the pre-grant phase, patent systems determine what constitutes patentable subject matter, often taking into account ordre public or morality exclusions to determine whether a patent can be granted at all. The patent examination procedure also determines the scope of patent claims, with the prospect that claims can be narrowed to exclude the use of an invention in ways which would otherwise contravene ordre public or morality exclusions. Post-grant, voluntary licensing strategies adopted by right holders can play an important role in determining how patented human germline genome editing technologies are used, who can afford to access the technologies and on what terms, but only to the extent that such uses are subject to granted patent claims. Achieving a fair and equitable balance in the governance and oversight of human germline genome editing, taking into account both pre-grant and post-grant issues, will be a key challenge for the patent system in the years ahead.

Keywords: patents, genome editing, morality, licensing, governance