Over the past several years, almost every country in the MENA region has updated, revamped or introduced new patent laws in regards to pharma; with many adopting internationally accepted practices. While in the past only pharmaceutical processes were patentable, it is now possible to patent pharmaceutical products or substances. In most cases, only new chemical entities are patentable, while in others, second medical use or Swiss-type claims are allowed. In some countries, patent term extension is possible if certain conditions are met. Morocco is an example where a supplementary protection certificate is issued for a period covering the number of days of delay in the event of unjustified delays by the authorities in awarding the authorization for marketing approval.

The number of MENA countries with PCT membership is increasing, alongside trade agreements between those countries and the US or Europe. These afford prospects for businesses looking to penetrate new markets with growth opportunities.

Procedures at different patent offices vary substantially. In many countries, substantive examination as to novelty, inventiveness, and applicability is performed locally. In some countries, the same is outsourced to foreign patent offices. What is allowed under each local patent law also varies. In Egypt, it is not allowed to claim method of treating or use of a product, be it to diagnose, treat, or prevent. The Egyptian Patent Office does not even allow Swiss-type claims. Such is not the case in Saudi Arabia where medical use and Swiss-type claims are allowed, while methods of treatment are not.

The overall trend in the legal environment in the MENA has been dealing with the ubiquitous problem of counterfeiting and imitators, such as generic brands. Porous borders, as well as inadequate border control, lead to substantial losses in sales and profits. Patent owners may be resistant to registering and penetrating a market where legal recourse against imitators is ineffective or unavailable. If we were to extrapolate on the evolution of the legal enforcement as it applies to trademarks, it is to be expected that the legal environment surrounding patents will follow suit in providing the adequate protection.

Customs in various MENA countries have become very active when it comes to trademarks. In Saudi Arabia, for example, it has become increasingly difficult for an infringer to import counterfeit goods. Customs check the Trademark Office records if they suspect counterfeit consignments. In 2012, concerted efforts and joint planning by the Commercial Anti-Fraud Department and the Customs Authorities led to a successful year in fighting piracy and suspending a considerable amount of counterfeit imported into the country, including pharmaceutical products.

Other countries have updated their laws to better protect the consumer as well as enable rights holders to take actionable measures. In Egypt, for instance, IP Law no. 82 for the year 2002 introduced new provisions on enforcement against counterfeiting. In these provisions the judges have the competence to issue provisional measures such as seizure of goods to determine infringement and preserve evidence. With regards to sanctions, this IP law increased the amount of fines and imposed new remedies. Some of these remedies include confiscation and destruction of infringing goods and the tools or equipment used in the infringement. Enforcement in Egypt was taken further by providing an IP unit in the police force, as well as teams of civil inspectors who are authorized to seize infringing goods from the market.

In short, protection 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 well-established protection strategy.

Should you have any questions, or require any additional information, please contact us at news@sabaip.com