- Keywords > compulsory licences
- Keywords > intellectual property laws
- Keywords > intellectual property protection (IPP)
- Keywords > parallel importation
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > pharmaceutical legislation
- Keywords > public health
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
(2000; 140 pages) [French] [Spanish]
Claims are sometimes directed to a pharmaceutical composition, that is, to a formulated product containing an active ingredient and appropriate additives106. For instance, patents have been granted separately with regard to the injectable and oral forms of ofloxacin, a drug of relevance to the treatment of HIV patients. There is also a patent for the eye topical use107. Another example is a patent on a formulation form of “ddl” (another drug of importance to HIV patients) granted in Thailand, which may deter the entry of a generic version of the product in that country.
106 For instance, patent US 4,188,395 contains the following claims on compositions:
“A pharmaceutical composition containing as an active ingredient an effective amount for combating circulatory diseases relating to heart action and blood pressure of a compound according to claim 1 in admixture with a solid or liquefied gaseous diluent or in admixture with a liquid diluent other than a solvent of a molecular weight less than 200 except in the presence of a surface-active agent”.
107 Chirac, 1999, p. 24.
Compositions may refer to combinations of previously known products. For instance, patents on the combination of the following formulations were granted in the USA: Aspirin 325 mg. + Carisoprodol 200 mg. + Codeine Phosphate 16 mg. with the expiry date 13/08/2002108.
108 Source: Keayla, 1999, p. 18
If composition claims are accepted subsequent to a patent on the relevant active ingredient, the patent owner may be able to artificially extend the term of protection granted under the basic patent109. Unless the composition (which often consists of the simple mixture of components) includes additives that generate a truly new and inventive product, a pharmaceutical composition should generally be deemed anticipated by the effective ingredient that it contains, and not patentable.
109 See, e.g. Cook, Boyle and Jabbari, 1991, p. 91.
Another means to address the problem is to limit the scope of composition claims so that composition claims holders cannot prevent commercialization of other compositions containing the same active ingredient or of the active ingredient in bulk, after the basic patent has expired.