Originals versus generics


Oon Yen Yen

The battle between original pharmaceuticals and their generic counterparts has always been about balancing public interest with a rigorous national intellectual property regime.

This balancing act is particularly important but difficult for developing countries, such as Malaysia.

Original pharmaceutical drugs are generally protected by patents, which are essential to ensure a return on investment (in research and development, clinical studies, clinical trials), through a fixed-term market monopoly. On average, it can take between seven and 10 years for original drugs to get from the laboratory to the market. By comparison, a granted Malaysian patent confers a non-extendable 20-year monopoly, calculated from the filing date of the patent application.

Patent owners argue that, due to delays in patent prosecution and the process of regulatory approvals, this 20-year monopoly is insufficient compensation for the substantial investment committed to bring original drugs to the market. Unlike in the US or Europe, there are no provisions in Malaysian patent law for the grant of either supplementary protection certificates (SPC) or patent term extensions (PTE) to patents.

pharmaceuticals, generic drugs, Malaysia Patent Act