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A. The scope of patentability requirements

The TRIPS Agreement allows the members to define the scope

patentability requirements, which are, novelty, inventive step involvement
and industrial capability; nonetheless, excessively permissive standards on

patentability are specifically troublesome in the area of pharmaceuticals due

to their effects on the accessibility to medicines. As the worldwide drug
(8)
industry has become less improving over years, some drug enterprises have
increasingly sought to applied for secondary patents, for instance, patents on

novel ways of utilization of drugs, or novel forms of known pharmaceutical
(9)
compositions, such as enantiomers, esters, polymorphs, prodrugs or salts. The

secondary patents are generally regarded less innovative than patents on novel
active pharmaceutical substances (primary patent), and are often utilized by
(10)
industry to extend the period of patent protection. The case of anti-HIV

medicine efavirenz can be raised as an example. This medicine was granted
five patents in China, but only one of those patents claims the novel

(8)
For example, the Report of the Commission on Intellectual Property Rights, Innovation and
Public Health of the WHO (2006) mentions about the evidence that many newly patented

pharmaceuticals offer slight innovative characteristics over existing ones. For example, in
British Columbia, the research shows that 80 percent of the rise in pharmaceutical
expenditure during 1996-2003 was generated by the utilization of patented medicines which
did not provide significant enhancements over cheaper options available.
(9)
Monika Sawicka and Ron A. Bouchard, çEmpirical Analysis of Canadian Drug Approval Data
2001-2008: Are Pharmaceutical Players ùDoing More with Lessû?é†MCGILL JOURNAL OF
LAW AND HEALTH / REVUE DE DROIT ET SANT? DE MCGILL†3 (2009): 85.
(10)
European Commission (2009), European Commission, Pharmaceutical Sector Inquiry: Final
Report, (2009): 189; M. Burdon and K. Sloper, çThe Art of Using Secondary Patents to

Improve Protection,é†Journal of Medical Marketing†(2003) 226-228.

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