October 2021
Egypt has introduced a new customs system pursuant to the new Executive Regulations of the Egyptian Customs Law number 207/2020, hereinafter referred to as “the Executive Regulations”. The new executive regulations were issued by the Ministry of Finance and published in the official gazette (issue 193 continued) on 31 August 2021. The Executive Regulations developed procedures for IPR protection, which was not envisaged in the previous Executive Regulations No. 10/2006). The new Executive Regulations has set out new procedures in Articles 2 to 13. These advanced procedures have been introduced to enhance Intellectual Property Rights (IPR) protection in Egypt and to prevent IPR infringement, criminal offences relating to IPR, and the remedies available to an IPR proprietor.
Primarily, the Customs Authority (“CA”) undertakes customs control duties, particularly in relation to the protection of IPRs related to goods throughout the Egyptian territory. The Egyptian CA shall enforce all measures it deems necessary to secure and facilitate international trade. In parallel, the Regulation has expanded the role of the IPR holder regarding seizing the counterfeited products prior to their entry into the Egyptian market.
On one hand, the Customs Regulation grants powers to Customs Authorities to seize products which are found to infringe certain IP rights, including – but not limited to – trademarks, patents, copyrights, geographical indications, industrial designs, etc., on the contrary the previous Executive Regulations which did not explicitly set forth the extent to which the CA can undertake to enforce measures on the products that are found to infringe IP rights that previously led to failure of exercising Customs control over counterfeited products.
On the other hand, the IPR holder or its legal representative is granted the right to file a complaint before the Department for the Protection of Intellectual Property Rights of the CA to prevent the release of goods that have not been released or are on their course to reach the Egyptian borders once the IPR holder or its representative submits a complaint along with proof of infringement of an Intellectual Property Right.
Not only did the new regulation mitigate the procedures to deter the entry of the counterfeited products to Egypt, but it has also highlighted the significance of having an IP right duly protected i.e., through registration. Since the regulation has relied solely on filing a complaint to prevent the release of the counterfeited products following the provision of proof of both the legal capacity and the infringement.
However, the Regulation was silent on the CA’s mechanism of detecting the counterfeited products upon their arrival to the Egyptian borders. Consequently, this promotes the importance of trusting an active legal representative with the company’s Intellectual Property Rights; whereas an effective beneficial application of this Executive Regulation comes with constant monitoring with the CA and most substantially, ensuring the proper methods to protect the IP right have been implemented.
In summary, the basic principles of the newly issued Executive Regulations of Customs Law may remain the same in terms of the required grounds and mechanism for the CA to take ex officio actions to detain, seize, and destroy counterfeited products upon their arrival at the Egyptian borders, it has also offered effective interim measures against counterfeited products to an IPR proprietor instead of pursuing lengthy court proceedings to protect their IP right.
IPR Enforcement under the New Egyptian Customs System.
To Egyptian patients with affordable prices and to open more doors for export opportunities . Therefore, it is crucial that local companies recognize the value of biotechnology and be courageous to invest in this field. Recently, several Egyptian pharmaceutical companies in Egypt are daring to start several massive biotechnological projects:
EIPICO (Egyptian International Pharmaceutical Industries Company):
Furthermore, to meet the company’s strategic development plans, establish itself as the manufacturer of the first biosimilar, and reinforce its leading position in the region, EIPICO is planning to build a new factory, “EIPICO 3” with investments of more than EGP 1.4 bn. The new manufacturing facility, a green-field establishment next to the current site in the 10th of Ramadan City, Egypt, will be designated for biosimilar products and the first of its kind in Egypt and the MENA region. A significant milestone for EIPICO and the supply of biopharmaceutical products to the region, EIPICO will produce several biosimilar monoclonal antibodies and small protein products in the new facility. These products are manufactured from basic raw materials, including drug substance production and formulation, filling, inspection, and packing. EIPICO also plans to formulate, fill, inspect, and pack other products, such as insulin, in vials, and syringes. In addition, EIPICO is collaborating with Reliance Life Sciences, which is an Indian research-driven organization developing business opportunities in bio-therapeutics (plasma proteins, biosimilars, and novel proteins), pharmaceuticals (later-generation, oncology generics), clinical research services, regenerative medicine (stem cells therapies) and molecular medicine. Also, EIPICO cooperates with the multinational company Pharmadule (part of Morimatsu Industry Group), aworldwide international manufacturer of industrial modules and systems with its head office located in Stockholm and its branches in New Jersey, Shanghai, and Mumbai. EIPICO also has ambitious plans to start at the Suez Canal Free Zone a new active ingredient (API) Manufacturing facility “ARABAPI”, which is the first of its kind in Egypt.
Grifols Egypt for Plasma Derivatives: A joint venture company between the National Service Projects Organization (NSPO) and Grifols, a Spanish company established in 1909. By combining both organizations’ expertise, technology, and resources, this strategic partnership seeks to strengthen Egypt’s healthcare system by achieving self-sufficiency in plasma-derived medicines while reinforcing Grifols’ international expansion in the Middle East and Africa. The project’s scope entails initiating twenty plasma donor centres and establishing necessary manufacturing facilities to produce essential medicines. This includes testing and warehousing operations, a protein purification plant, and a plasma fractionation plant with a capacity of one million litres per year that is expected to double in the future.
Minapharm:
Launched in the late 1950s, Minapharm marked itself as Egypt’s first privately-owned pharmaceutical factory. This company already has several biotech products in the Egyptian market like Hirudin and Follitropin. Acknowledging the company’s development of sophisticated biotechnology platforms and its choice of strategic partnerships with Germany’s pharmaceutical sector, Minapharm is exceptionally well-placed to take advantage of an exponential increase in opportunities in Egyptian and other developing markets. Minapharm’s CEO considers the founding of tie-ups with German firms as a vital milestone. Minapharm got into a joint venture with Rhein-Biotech (now Dynavax Europe) as early as the 1990s, before the 2010 procurement of ProBioGen AG, a Berlin-based cellular engineering biotech expert. ProBioGen and Minapharm Pharmaceuticals announced the integration of ProBioGen’s subsidiary “MiGenTra” with its head office located in Berlin; while having access to the Cairo site, which will house the prime manufacturing plant. The formation of MiGenTra speeds up ProBioGen’s 2030 growth roadmap. It displays that further growth is not restricted to the ongoing capacity increase but reveals several significant steps in the variation of ProBioGen’s business.
SEDICO (South Egypt Drug Industries Company):
SEDICO is one of Egypt’s pioneer pharmaceutical drug industries that produce insulin and biotechnology products. Situated in 6th of October City and having several biotech products. The company manufactures biotechnology products including insulin, streptokinase, angikinase, Follicle Stimulating Hormone (FSH), somatropin, erythropoietin, and Trastuzumab that are produced under the BGP Pharma ULC/Mylan license in Canada -.
MUP (Medical Union Pharmaceuticals)
It was first established in 1984, owing to the cooperation of the Professional Syndicates Union. This company acquired the Eli Lilly insulin manufacturing facility in 6th of October City in 2016, which is considered the nucleus for starting a different line insulin product that it markets under the commercial name Insulinaegypt. In addition, the company has in its pipeline projects for enlarging the current manufacturing facility and adding more insulin dosage forms such as the cartridges and dispensing pens.
VACSERA /EGYVAC:
A producer of Vaccines and Sera in Egypt, being one of the leading blood banks in Egypt and the oldest manufacturer of vaccines in Africa and the Middle East. VACSERA’s mission is to produce, import, and market vaccines, sera, and biological products to secure society’s requirement of vaccines and sera with commitment to continuous development of all activities. More than one million doses of the VACSERA-Sinovac jab, the COVID-19 vaccine, had already been distributed within Egypt. VACSERA is also looking to expand and complete its unfinished projects; while taking into account that the most important is to provide a plan to produce retractable syringes.
EVA Pharma:
An Egyptian company that develops products that meet the health care needs of Egyptians. According to its CEO, their first introduction to biotech products will be the COVID-19 vaccine. According to EVA Pharma’s CEO, the ministries of higher education and agriculture will work on producing the viral antigen for the vaccine, which will be manufactured at Eva Pharma industrial complex following the standards of the Egyptian Drug Authority (EDA), the World Health Organization, and the US Food and Drug Administration.
Vaccine Valley:
It was established in 2006 as a dedicated facility for producing diverse types of veterinary vaccines. The factory is located in the sixth industrial zone and 6th of October city.
Dr. Gihan Taha
Scientific of Counsel, IP Department
+201223667746
gat@id.com.eg