The Place of Bolar Exception under Ethiopian Patent Law: The Need for Reform

Abstract

The basic principle of patent law is that once the term of a patent has expired, the protected subject matter becomes part of the public domain. This allows competitors to enter the market immediately after such term expiry, eventually lowering prices for consumers and increasing welfare gains. However, Pharmaceutical products cannot be marketed without the prior authorization of a competent regulatory agency. This would negatively affect the right to public health (access to medicine). In response to such problems, many countries have recognized the Bolar exception that endows the third party with the right to use the patented invention without the right holder's consent before the patent expiry to develop information to get market approval. The purpose of this article is to ascertain whether the Bolar exception is recognized under the Ethiopian patent regime or the research and experimentation exception under the Patent Proclamation can be broadly interpreted to justify the Bolar exception.
To meet this objective, the study employed doctrinal research methodology along with comparative exploratory tools. The research findings showed that Ethiopia recognizes neither the Bolar exception nor the research and experimentation exception envisaged under the national patent regimes justifies the exception through interpretation. The historical, theoretical, and empirical lessons from other countries show that most countries facilitate access to medicine by incorporating a Bolar exception into their domestic law. Ethiopia should, therefore, incorporate in its pertinent legislation an exception that allows the competitors to experiment with a patented invention to achieve market authorization on the day of or immediately after the expiry of the patent protection.