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in monopolistic environment under this program. Originally, the period of

monopoly marketing rights was 2 years with the possibility of extension for
(47)
two consecutive terms. Afterwards, they had approximately half a year to

analyze the information concerning safety and the FDA had another half a year
(48)
to make its decision on approval. Even though, at that time, the criteria of
patentability and opposition procedures had already been established in

Thailand, the Patent Act did not allow for Bolar provision; therefore, the

generic producers could not commence bioequivalence research and seek

marketing approval before the SMP being expired. In other words, the copy

could not be published at once when the premarketing protocol expired. Since

generic producers generally required around 6-12 months to carry out
bioequivalence research, then file the application for marketing approval to

Thai FDA, the SMP could create exclusivity for a total of around 6 years.

Through the SMP, Thai government awarded indirect market monopoly to

medicines which do not genuinely satisfy patentability criteria owing to the

absence of novelty.

Fortunately, owing to the healthcare policy of Thai government which

attempts to enhance pharmaceutical accessibility, the FDA presently allows

the approval of generic medicine during the period of SMP. At present, Bolar

exemption is available in Thai Patent Act. According to Section 36(4) of the

Act, Thailand only restricts this exemption to pharmaceuticals.

(47)
Kenneth C. Shadlen and S. Guennif,†Intellectual Property, Pharmaceuticals and Public Health:
Access to Drugs in Developing Countries†(Edward Elgar Publishing, 2011), 290-291.
(48)
Ibid.

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