The pharmaceutical sector has long been a strong point of the Maltese economy. The presence of a number of companies active in the industry is large and healthy, and there has always been Government commitment – first by enacting favourable legislation, then by providing incentives and most recently by dedicating space and resources to a Life Sciences Park.


Roche Bolar and Data Exclusivity


Patent protection in any given jurisdiction means that within that territory the subject matter of the patent cannot be produced, offered or put on the market, used, imported or stocked except by the patent holder or with his authorisation.


One rule which created an exception to this rule has been developed in the US following a famous case which resulted in a new legislative Act. This is the Roche Bolar provision, named after the case, and is a provision which Malta has incorporated into the Patents and Designs Act of the Laws of Malta.


In line with the TRIPS Agreement, the Roche Bolar exemption is a derogation negotiated specifically with the European Union during Malta’s accession.


The Roche Bolar rule effectively bars patent holders from stopping third parties who are using the product for purely experimental or scientific research, or when the act is done for purposes related to the development and presentation of information regarding the production, use or sale of medicinal or pharmaceutical products. Therefore this rule applies only to working scenarios and not scenarios such as pure stockpiling.


In practice, this means that pharmaceutical companies, such as generic companies, can establish themselves in Malta to conduct development work, testing and go through the administrative applications phase while the primary patented subject matter is enjoying the last years of patent protection.


The Medicines Act regulates, amongst other things, the period of data exclusivity. The provision contained in the Medicines Act regarding data protection and exclusivity is the fruit of the derogation from Art 10 of Directive 2004/27/EC.


At Fenech & Fenech Advocates our team is active in assisting all industries active in research, technological development and innovation, such as the pharmaceutical industry and the life sciences industry. Our team is made up of experts knowledgeable on patent and design law, and the rules and exceptions contained therein; incentives related to protecting your intellectual property and related to research and innovation; parallel importation; and product marketing. We have helped a number of clients apply for an obtain patents in Malta as well as in foreign jurisdictions. As a full service law firm, this is complemented by professionals active in tax, company structures, real estate, foundations, funds, litigation and all other matters which may be ancillary to the main pharmaceutical matters.


Members of our team are frequent speakers and examiners at the University of Malta on matters concerning patents and members of the Chamber of Commerce, Industry and Enterprise special Committee on Research, Technological Development and Innovation.