Patent laws in practically all jurisdictions in the Middle East and North Africa clearly define what is considered to be an infringement act and from what date such acts may be considered infringing. As is the case in most countries outside the MENA region, there are many infringement exemptions that can be summarised in a brief statement: as long as the product and/or process is not being used for direct commercialisation and profits, then any related acts are not considered an infringement.
Essentially, the aforementioned statement is homologous to the more known Bolar Provision or the Hatch-Waxman Act. Indeed, as it is more and more apparent in the MENA, and primarily driven by the rapidly growing local generic industry, these exemptions stretch as far as submitting a marketing authorisation dossier for prompt approval following the expiry of any related patency.
As a result of international agreements, i.e. FTAs, TRIPS, and where regulatory data exclusivity (RDP) is enforced, it is conceivable that generic companies are unable to support their marketing authorisation dossiers with the requisite bioequivalence studies. This however may be overcome in certain cases by performing local clinical studies and submitting these in support of a marketing authorisation.
While an important driver is the local generic industry, the need for cheaper medicaments where social healthcare dominates has driven local authorities to introduce into law preferential pricing for local generics, as well as force dispensaries to supply generic substitutes when ones are available.
With an already well-established generic industry in the region, which is also rapidly growing in such countries such as Jordan, Lebanon, Saudi Arabia, Egypt, Morocco, Iran and, the United Arab Emirates, and the existing social healthcare system constantly demanding lower prices on drugs, local and regional generic companies have certain advantages over foreign generic companies.
Currently, none of the countries in the MENA maintain a patent listing system such as the Orange Book, which is maintained by the Food and Drug Administration in the United States. Between this shortcoming and the lack of an effective patent linkage system, the burden of preventing generics falls primarily and heavily on the patent owner. It is highly recommended that patent owners list any patents related to the chemical entity being registered with the health authorities. In case patency is obtained after a marketing authorisation, then it is also recommended that the health authorities be advised of this update.
In short, the assertion and enforcement of patents is a challenging and labor intensive process that requires special consideration and handling. Inventors and owners must be able and ready to adopt a model that incorporates both legal as well as regulatory approaches in order to arrive at a well-established protection strategy in the MENA.