The patentability of genes and gene related inventions and its effects on the advancement of medical research in Malaysia / Farizah Mohamed Isa

The evolution of modern biotechnology in recent years, have made this industry a lucrative venture. Patents play a huge role in ensuring that the returns of investment for companies and investors are guaranteed. The issue of patenting of biotechnological inventions, particularly naturally occurring biological materials such as living organisms, particularly genetic sequences has spawned a number of endless debates and litigation across the globe. These conflicts have left legislators baffled as they struggle to strike a right balance between protecting public interests and private rights. Adversaries to patents of such nature argue that gene sequences are product of nature, not human inventions and as such their discoveries do not entitle anyone to the exclusive rights conferred by patents. Opponents of DNA patenting also contend that allowing such patents, does more public harm than good as it hinders medical breakthroughs which could save lives. They claim that instead of promoting innovations, it stifles scientific research and hurts patient care due to the exorbitant costs associated with using patented data. However, promoters of gene patents object the notion that gene sequences are mere discoveries. They assert that substantial time and efforts are expended in isolating and studying a particular gene sequence, to find its use and chemical make-up for the benefit of mankind, and such noble efforts merit reward and recognition in the form of patent rights. The Malaysian Patents Act 1983 as it stands now, does not provide clear guidance on the patenting of biotechnological inventions per se. Although there are some exclusions on the matter, the current position in Malaysia with regard to inventions in the field of biotechnology is still vague. This research explores the pertinent issues regarding gene patents and endevours to suggest changes to the Patents Act 1983 in order to strike a balance between the progress of medical science and the protection of investments and scientific efforts for the Malaysian researchers and industries in particular, and mankind in general.