01 Aug 2024
Navigating Pharmaceutical Intellectual Property Developments
The Arabian Peninsula had adopted limited provisions on the protection of Intellectual Property (IP) rights before the 1970s except for Saudi Arabia, which already had trademark laws in the 1930s. Kuwait initiated the protection standards creating a regional benchmark in addressing patent and industrial design statutes within its civil, commercial, and penal laws in the early 1960s and by the mid-1970s Kuwait and Bahrain introduced and progressed trademark protection laws while Qatar was in motion to enact such laws. However, Oman and the United Arab Emirates (UAE) were still lagging behind in providing specific laws for IP protection. Further, none of them were able to protect copyright until then. The Gulf Cooperation Council (GCC) countries, however, have delayed in adopting international instruments and their legal frameworks, all of them are currently member states of international organizations such as the World Intellectual Property Organization (WIPO) and are parties to international treaties and conventions enacted to govern IP rights in the member states. Protection of IP Rights in the GCC region does not have an extensive history since the development and growth of the countries in this region are heavily accredited by the revenues generated by oil and gas. However, in recent times the practice of innovation has been observed radically in this region consequently UAE is paving the way on the Global Innovation Index Score. In Europe, the pharmaceutical industry is identified as the most IP-intensive industry contributing to its Gross Domestic Product and employment as per the European Centre for International Political Economy. Similarly, the Pharmaceutical Research and Manufacturers of America stated in the 2021 Special 301 Report that the United States of America has surpassed other countries in the research and development of new medicines and vaccines. The protection of pharmaceutical IP rights ensures innovation in the medicinal sector while encouraging research on unachieved pharmaceutical needs. The exclusive rights over the new innovation provide a temporary monopoly to the innovator helping to reimburse the expenses of research, innovation, and experiment through revenue and profit. Similarly, the cheaper counterfeit copies of pharmaceutical products can be controlled to a significant extent.
GCC has not only been speeding its development in the medicinal sector and undergoing a broad transformation but it is also expecting to increase at a Compound Annual Growth Rate of 4.9 % to USD 99.6 Billion in 2023 from USD 86.2 Billion in 2020. The patented drugs dominate the GCC pharmaceutical market and account for 58% of the overall market. The enhanced preference for branded and foreign medicines of the nationals of GCC countries has led to a significant rise in the average drug price in the countries of this region.
Comparative Analysis of IP Protection in GCC
Generally, pharmaceutical innovations are protected under various IP rights like patents, regulatory data exclusivity, trademarks, and trade secrets. These rights do not only secure your innovation but also provide incentives for such innovation, research, and development. The IP rights may vary according to country-specific criteria, scope, and duration. However, being member states of WIPO, the GCC countries have enacted legal provisions on the protection of pharmaceutical products in line with international treaties and conventions. This article will give an insight into a comparative analysis of how the GCC countries have provisioned the legal and institutional arrangements in order to govern pharmaceutical IP rights.
Institutional and Legal Framework
A GCC Patent Office (GCCPO) is established to govern the protection of Intellectual Property rights in GCC countries. Such regional patent office based in Riyadh, Saudi Arabia grants patents in all its six (6) member-states. Applicants seeking protection of patents within GCC countries shall make an application directly within the Patent Office of each state. Since all member states are parties to the Paris Convention and Patent Cooperation Treaty (PCT), the priority may be claimed within 12 months of an application being filed in the national patent office or entering PCT applications into the national phase in each member state before the 30th month. As of November 2023, the GCCPO has granted 1373 Patents for the sector of pharmaceutical and biotechnology. Pharmaceutical patents are protected for a period of twenty (20) years from the date of filing with the exception of some countries providing an extension of the protection period.
Likewise, GCC has a unified trademark law to govern the registration of trademarks including pharmaceutical trademarks however it does not provide a cohesive filing system hence the applicants have to make an independent trademark application in the concerned trademark offices of each GCC country. The registration of pharmaceutical trademarks falls under Class Five (5) of the NICE Classification and the protection period is Ten (10) years from the date of application.
The specific legislation enacted by the GCC countries and their institutional arrangements for governing pharmaceutical IP rights are briefly described.
OMAN
Royal Decree 67/2008 Promulgating the Law on Industrial Property Rights governs the registration and enforcement of industrial property rights in Oman. It is governed by the IP Department under the Ministry of Commerce and Industry. The right of the patent belongs to the inventor which may be assigned or transferred by succession. The joint invention provides joint rights of patent. The employer gets the right of the patent in the invention created by the employee while executing the employment contract. The exploitation of pharmaceutical innovations is generally assigned to a government agency or third party principally for the export of the product or to supply in the market in Oman or to a foreign territory having inadequate capacity for such pharmaceutical products for a limited period of the license providing adequate remuneration paid to the patent owner. A pharmaceutical product is considered a novel product if the chemical entity used therein has not been previously approved by the concerned regulatory authority of Oman.
The Ministry of Health of Oman limits the use of marks with the purpose of facilitating the prescription of and access to generic pharmaceutical products and medical devices not impairing the efficiency of the trademarks used in relation to pharmaceutical innovation. In granting the marketing approval for a pharmaceutical product that includes a chemical entity that has been previously approved for marketing of another pharmaceutical product, the new clinical information shall be submitted which can be authorized only after the consent of the innovator.
SAUDI ARABIA
The Kingdom of Saudi Arabia is one of the first countries in the GCC to introduce laws on the protection of IP. The Saudi Authority for Intellectual Property governs the protection, regulation, and enforcement of IP rights. For pharmaceutical products, the kingdom has adhered to compulsory licensing aligning with the provisions of international instruments. The pharmaceutical product must be protected by a local patent prior to the marketing of the product. If marketing approval for a pharmaceutical product is sought in the Saudi Food and Drug Authority which is not protected by a local patent then the innovator company must submit a statement confirming that there is no local patent protecting the said pharmaceutical product in Saudi Arabia or the GCC. Similarly, the Department of Trademark provides a grace period of Six (6) months for renewal with a fine pursuant to the Hijri Calendar in case of protected pharmaceutical trademarks.
UAE
In comparison to other GCC countries, the UAE excels in the innovation of pharmaceutical products. To regulate such innovation, the Ministry of Economy enacted Federal Law number 11 of 2021 on the Regulation and Protection of Industrial Property Rights and the Ministry of Health and Prevention has issued a Ministerial Decree 321 of 2020 to regulate the use of data and information related to innovative pharmaceutical products registered in the UAE. The inventing pharmaceutical companies should use patent protection in order to strengthen and extend their protection against generic products within the UAE and should not rely on patents of origin which are not recognized in relation to any future products. UAE has revised its regulations with respect to innovating pharmaceutical companies and generic drugs. This helps to cordially manage their wider innovation and economic diversification ambitions and visions which is essential for other countries to learn from the UAE. The rights granted by the patent or utility certificate do not apply to the mixture of two (2) or more medications for the purpose of medical treatment by a licensed pharmacist. The protection of industrial property is extended to undisclosed information including pharmaceutical products. Government authorities receiving such undisclosed information shall protect such from disclosure and unlawful commercial use from the date of submission of information to declassification or for the period not exceeding five (5) years, whichever is shorter. The right holder of the pharmaceutical property holds the liability of limiting the circulation of the information in order to protect the information and prevent the leakage to any non-concerned third parties. The Ministry of Economy receives international applications under the PCT.
QATAR
The IP Protection Department at the Ministry of Commerce and Industry administers the registration and regulation of IP rights in the state of Qatar. It has adopted Decree Law no. 30 of 2006 Issuing Patents Law which governs patents in Qatar. It has also issued an implementing regulation for it. Qatar still does not have any specific national provisions for pharmaceutical IP protection and regulation.
BAHRAIN
The Foreign Trade and Industrial Property Directorate under the Ministry of Industry and Commerce regulates the registration and operation of IP protection within the Kingdom. The nation also has enacted special legislation named Law Number 1 of 2004 on Patents and Utility Models (as amended by Law Number 14 of 2006). The protection period for a patented pharmaceutical product can be extended to warrant the owner’s compensation for the period equivalent to the extent of time taken for marketing approval procedures concerning the first commercial usage of the product in the nation. Similarly, a protection period for a patent of a new pharmaceutical product approved to be marketed in another country can be extended with evidence of receipt of a previous marketing permit to warrant the compensation of the patent owner for the unreasonable reduction of the actual protection period owing to the marketing procedures approval whether in Bahrain or in another country. The pharmaceutical invention subject to patent used for an application to the marketing of such product is not to be manufactured, used, or sold within the Kingdom except if it has received approval for marketing only after the expiry of the patent protection period. In such a case, it is permissible to export such patented pharmaceutical products outside the nation if, it has received approval for marketing within the nation.
KUWAIT
Kuwait provides no effective legislation on protecting the IP rights of pharmaceuticals as of today through any specific laws. In 1998, the Ministry of Health approved MOH decision number 675 banning unauthorized copies of the products registered in Kuwait. And since, 1998 there has been no significant development in the patent law of the nation. Despite some worrisome regression in the sector can be felt when the parliament of Kuwait rejected the proposed amendments of the patent law. Though the validity of the patented product is for Twenty (20) years from the date of filing in the Kuwait Patent Office, the time period for examining and granting the patents has not been specified yet.
Data Exclusivity
Though the patent and data exclusivity seemingly work in a correlative way, they have distinctive mechanisms of protection. Data exclusivity protects the data submitted by the innovating company for their drug which cannot be used by the generic company for seeking approval of an equivalent generic drug during the protection period of data exclusivity which might be or not moving parallelly with the patent. It allows the originator company to enjoy the confidentiality of their pre-clinical and clinical trial data while seeking approval from regulatory authorities. It tries to ensure the balance in competition between novel drug innovation and generic drugs. The data exclusivity period is for Eight (8) years from the date of marketing approval. In UAE, a generic company can apply for marketing approval within the last two (2) years from the end of the data exclusivity period provided they produce evidence in the absence of a valid patent protection of the originator drug inside the country. Similarly, Saudi Arabia, Oman, and Bahrain have also provided data exclusivity provisions in their laws. Generic companies must ensure that no valid patent protection is registered for that specific drug prior to applying for marketing approvals from their concerned ministry.
Enforcement and Challenges Confronting Pharmaceutical IP
Despite various discussions and initiatives that have been taken with the goal of forming a patent tribunal or court system within the GCC, no unified patent judicial system has been established to govern patent disputes and infringements as of today. Such matters are currently handled by the court of jurisdiction of the concerned country under the applicable laws of that specific nation. The complex regulatory procedures of patents along with variations in judicial interpretation are the implication of the disparities in patent laws and data exclusivity provisions. Divergent patentability criteria impact innovation and market access for pharmaceutical companies that are functioning within multiple jurisdictions of the GCC. The prevalence of counterfeiting drugs has displayed a major challenge in the enforceability of pharmaceutical rights. Similarly, few GCC countries are not being able to move along with the evolving market dynamics where the competition between the rise of generic drugs has to be balanced with affordable Healthcare & Life Sciences. Similarly, no imperative and concrete understanding and awareness of the importance of IP protection in pharmaceutical sectors among GCC countries has posed another challenge.
Conclusion
At present, the GCC countries have been able to extend their commitment toward innovation and investment in Healthcare & Life Sciences and pharmaceutical sectors beyond oil and gas. However, significant progress can be achieved through homogenous and unified legal and institutional arrangements which bring pharmaceutical IP rights and their enforcement under a single umbrella of the GCC. By this, the existing challenges created by the ambiguous and variant procedural framework among the GCC nations will be radically mitigated. Similarly, the current scenario affirms the necessity of a conducive environment for safeguarding pharmaceutical IP. Once, the GCC is able to cope with all these challenges, it is certain that the GCC countries can be seen surpassing developed nations in innovation and safeguard of the pharmaceutical property.