(2002; 67 pages)
What can be patented? TRIPS specifies that patents must be available for all discoveries which “...are new, involve an inventive step and are capable of industrial application” (Article 27).
The difference between the number of new drugs (“new chemical entities”) that are developed globally each year, and the number of patents awarded for new uses of a drug, processes, dosage forms, formulations and different forms of the same molecule, including patents on genes and genomic sequences is enormous. The latter is influenced by national legislation and practices
Yet because “new” and “inventive” are not defined, countries must establish their own criteria for these terms. They should remember that patentability standards which are too broad can contribute to “evergreening”. This means that the effective patent life for a new medicine is extended beyond the 20-year TRIPS minimum. Therefore, Ministries of Health must work closely with other ministries to formulate and/or revise national patent legislation to ensure that it takes public health needs into account.