News & insights
IP HIGHLIGHTS: Expanding Medical Devices Patent Protection to the Growing Middle East Market
June 9, 2014
Pharmaceutical companies have become aware of the importance of extending their patent portfolios to the rapidly growing Middle Eastern market. The region witnessed a remarkable development of the generic pharmaceutical industry in several countries, including Jordan, Saudi Arabia and Egypt in the past decade. Generic players from outside the region began to exhibit increased interest as they investigated gaps in patent protection. They include major generic pharmaceutical companies from India, as well as generic businesses or subsidiaries of innovator pharmaceutical companies.
In many cases, the New Chemical Entity (NCE) or Active Pharmaceutical Ingredient (API) patents had not been filed in the region. Only follow-on applications, such as method of treatment, formulations, including others have been filed. Such patents are not as easily upheld in court against infringement as NCE or API patents. Local and regional legal experience remains unequipped to accurately predict how an infringement case will play out.
This is not a major area of concern regarding newer products, as innovator pharmaceutical companies shifted to filing NCE type patent applications. The rise of the medical tourism industry in the UAE, Egypt, and Jordan necessitates a need to evaluate the risks associated with the lack of an adequate IP protection in these countries as well as the region.
“The Saudi Arabian medical devices market is estimated at around US$ 1.1 Billion in 2013 and is expected to surpass US$ 1.6 Billion by 2018, by registering a growth of 9% CAGR,” states the KuriK Research report . This favorable growth is spearheaded by public spending, in which nearly a third can be attributed to the Ministry of Health.
An increase in the budget allocation and expansion of healthcare facilities like hospitals and clinics, coupled with an increase in the number of new health projects in the public sector is attributed as the causal factor of this growth. Similar patterns are taking place in the UAE and Qatar.
The public spending has led to the creation of miriad collaborations with both local and foreign leaders in the health industry. These include but are not limited to the Weill Cornell Medical College and the Mayo Clinic. The collaborations aim to create hubs of medical excellence in both managed healthcare and biomedical research.
Medical devices incur immense investments on the long run and might not be readily imitated. The local or regional industry might not pose a threat for those requiring larger investments but could constitute as such for the more accessible, smaller investment ones. Unlike NCE patents, device patents cannot be further protected by follow-on inventions such as formulations or second medical use. Extending the patent term of an invention is more limited when it comes to medical devices, hence the need to consider a timely entry prior to any deadlines.
Emerging markets may constitute a real threat in the Middle East for innovator medical device manufacturers. Growth and expansion into new lucrative markets would be their natural next step of action. The BRIC (Brazil, Russia, India and China) countries, as an example, have developed and advanced industries which would seek new markets and become a threat in growing markets such as the UAE, Saudi Arabia, and Egypt.
The Arab Health Exhibition and Congress has been attracting an increased number of exhibitors and speakers in recent years. Innovators and imitators head to Dubai to market their products in the booming health care sector in the Emirates, as well as in neighboring countries in the region. In 2014, the Exhibition attracted over 500 Chinese companies and about 120 Indian companies out of a total of over 3,700 exhibitors .
The threat to innovator products and inventions in the region remains to be assessed. The patent laws in the region are partly based on internationally accepted laws; however the application of these laws remains uncertain due to the lack of precedence. Despite the presence of the laws, the lack of a patent means that a case cannot be made against an alleged infringer.