Pharmaceuticals

From Malta Enterprise:
Malta’s Patents legislation dates back to the 1960’s and protects the interests of proprietors of a patent against third parties. (CAP. 417 of the Laws of Malta). The insignificant size of the domestic market, however has resulted in the registration of comparably few patents.

Generic pharmaceutical manufacturers may therefore develop and produce in Malta a large number of medicines for launch on EU and other markets upon expiry of the patent protecting the innovative drug elsewhere. Since the novelty criteria allows no more than one year from the date of first filing to protect an innovation, the vast majority of patented medicines, medicinal ingredients and production processes will not have had their patents registered in Malta. T

he prohibition of retroactive patent registration provides a long-term window of opportunity benefiting generic pharmaceutical manufacturing companies locating in Malta. In this highly competitive industry, timing bestows a crucial advantage. Malta’s Patents and Designs legislation also incorporates the “Bolar” provisions which clearly define the circumstances in which the proprietors of a patent still have no right to prevent third parties from performing those acts which are otherwise protected under the Patent legislation. The Malta Medicines Act of 2003 stipulates only a six-year data protection period from the date that the originator drug is first marketed.  

European Union entry has served to further consolidate Malta’s position by enabling generic pharmaceutical manufacturers operating on the island to easily promote their medicines on North African markets where there are established trading routes for onward delivery particularly to the Sub-Sahara region. Market authorisation granted by a regulatory authority in a EU member state should suffice to ensure market penetration to this continent, and to the fast growing markets in South America.

 

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