A Q&A guide to pharmaceutical IP and competition law in Egypt. The Q&A gives a high-level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance, and parallel imports. To compare answers across multiple jurisdictions, visit the Pharmaceutical IP and competition law Country Q&A tool. For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labeling, and product recall and liability, visit Medicinal product regulation and product liability in Egypt. The Q&A is part of the global guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Patents

1. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?

 

Conditions and legislation

Law No. 82 of 2002 Relating to the Protection of Intellectual Property Rights and its Executive Regulations, as amended (IP Law), governs patents in Egypt.

Patents are granted for inventions that are industrially applicable, novel and involve an innovative element, concerning new industrial products, innovative industrial methods, or a new application of known industrial methods (Article 1, IP Law).

A patent can be separately granted for an amendment, modification or addition to an invention already granted a patent, provided that the conditions of novelty, innovation and industrial applicability are met.

 

Scope of protection

Patents are not granted for the following (Article 2, IP Law):

• Inventions the exploitation of which may prejudice national security, breach public order or morality or seriously damage the environment or life or health of a human, animal or plant.
• Scientific theories and discoveries, mathematical methods, programs and layouts.
• Diagnosis, therapeutic and surgical methods for humans or animals.
• Plants and animals, whatever their rareness or strangeness, and biological processes for the production of plants or animals, except for micro-organisms and non-biological and non-microbiological processes for the production of plants or animals.
• Living organisms, tissues, cells, natural biological materials, deoxyribonucleic acid (DNA) and genomes.

 

2. How is a patent obtained?

Application and guidance

The Patent Office, at the Academy of Scientific Research and Technology in the Ministry of Scientific Research, registers and issues patents. Its website (www.egypo.gov.eg/) provides guidance on the application procedure and fees.

Under Ministerial Decree 370/2017, the fee for examining a patent application is EGP17,000. Annual maintenance fees must also be paid every year from the application filing date, even before the patent is granted.

 

Process and timing

The inventor or the inventor’s successor in title can apply for a patent from the Patent Office. An application cannot include more than one invention. A group of inventions forming an integrated innovative idea are deemed one invention.

The Patent Office will examine the application and the required supporting documents, to verify that the invention is novel, involves an inventive step and is industrially applicable. If relevant, the applicant must provide information about applications previously submitted abroad for the same invention or in relation to its subject, and the outcome of the examination of these applications.

If the invention meets the above conditions, the Patent Office will publish the application in the Patents Gazette.

In practice, it takes about three years from the filing date for a patent to be granted.

 

3. How long does patent protection typically last? Can monopoly rights be extended by other means?

Duration and renewal

Under the IP Law, a patent is valid for 20 years from the application filing date. Annual maintenance fees must be paid until expiry of the patent protection period. Patent protection cannot be renewed.

 

Extending protection

The IP Law does not allow extension of patent protection by any other means.

 

4. How can a patent be revoked?

 

A patent will be subject to compulsory licensing under the IP Law if either:

• The owner does not exploit the patent in Egypt, it is not exploited with his/her approval, or it is not sufficiently exploited, for a period of at least four years from the date of submitting the patent application or three years from the date of grant (whichever is longer).
• The owner ceases exploitation of the patent without an acceptable reason for a period exceeding one year.

The IP Law stipulates that the rights conferred by a patent will lapse and the patent fall into the public domain in the following cases:

• Expiry of the 20-year protection period.
• Relinquishing by the owner of the owner’s rights, without prejudice to the rights of third parties.
• A final court decision revoking the patent.
• Failure to pay, within one year from the due date, the annual maintenance fee or late payment penalty of 7% of the annual maintenance fee.
• The invention is not exploited in Egypt within two years following the grant of a compulsory licence and on request by an interested party to the Patent Office.
• Abuse by the owner of the owner’s rights, where a compulsory licence is insufficient to remedy that abuse.

Any termination of patent owners’ rights in the above cases is published in the Patent Gazette.

 

5. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?

 

Conditions for infringement

 

Under the IP Law, there is patent infringement in the following cases:

• Counterfeits with the aim of commercial circulation of the patented products or a utility model granted a patent.
• Selling, offering for sale or circulation, importing or possessing with the aim of trading counterfeit products, while knowing that they are counterfeit.
• Unlawfully placing on products, adverts, trade marks, packaging materials or other materials information leading to the belief that the party has registered an invention patent or a utility model patent.

In the pharmaceutical sector, there is frequent patent infringement by generic products. Since patent registration is lengthy (about three years), pharmaceutical companies do not wait for patent registration to start commercialising their products. Some companies register their products with the Ministry of Health before even applying for patent registration. Such practices allow for the registration of generic products and their market entry almost at the same time as the new product.

 

Claim and remedies

The IP Law stipulates that patent infringement is a criminal offence punishable by a fine of at least EGP20,000 up to EGP100,000. In case of a recurring offence, imprisonment of no more than two years and a fine of at least EGP40,000 up to EGP200,000 will apply.

In all cases, the court can order confiscation of the counterfeit products and tools used. The court judgment in the case of patent infringement is published in one or more daily newspapers.

The owner can also claim damages or seizure of infringing products through a claim in the civil courts. The Economic Court has jurisdiction over IP matters. Further, Article 33 of the IP Law provides that the owner can request from a court a precautionary measure against products or goods suspected to infringe a patent, to preserve the patent owner’s rights. In that case, the court can issue a preliminary injunction before the main proceedings. The preliminary injunction will expire if the main proceedings are not brought within eight days from the date of the injunction.

 

6. Are there non-patent barriers to competition to protect medicinal products?

 

There are no specific data and marketing exclusivity protection periods for medicinal products in Egypt.

Currently, registration of pharmaceuticals is lengthy. A decree was issued in 2016 creating a fast-track one-month registration for medicinal products already approved by foreign authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This would effectively give pharmaceuticals a marketing exclusivity period against generic products not approved by the FDA or EMA that go through the normal lengthy registration process. The decree has not been applied yet by the relevant authorities. There is no visibility on when the decree will be applied.

Pharmaceutical registration is only possible when there is availability in the relevant box of pharmaceuticals with similar specifications. Ministry of Health Decree 425/2015 stipulates that the maximum number of pharmaceuticals with similar active ingredients and specifications is 12, including the original (innovator) pharmaceutical.

There is no extension of the patent term for new therapeutic indications. If a new therapeutic indication satisfies the conditions of patentability, it can be registered as a new patent.

 

Trade marks

7. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?

 

Conditions and legislation

Article 63 of the IP Law defines a trade mark as a sign distinguishing goods or services of a particular industry, agricultural, forest or mining venture, or to indicate either:

• The origin of products or goods, or their quality, category, guarantee, or preparation process.
• The provision of a service.

In all cases, a trade mark must be a sign that is recognisable by sight.

Trade marks can include names represented in a distinctive manner, signatures, words, letters, numerals, designs, symbols, signposts, stamps, seals, drawings, engravings, a combination of distinct colours and any combination of these elements.

Part 1 of Book II of the IP Law and related executive regulations regulate marks, trade names and geographical indications.

 

Scope of protection

The following, among others, cannot be registered as trade marks:

• Marks without any distinctive character, or composed of signs or statements that are simply the name called by custom for a product, or which is the normal picture or image of it.
• Marks contrary to public order or morality.
• Public armorial bearings, flags and other emblems relating to the state or another state, regional or international organisation, and any imitations of them.
• Marks identical or similar to symbols of religious character.
• Marks and geographical indications likely to mislead or confuse the public or containing false descriptions of the origin of goods or services, or their other qualities, and signs indicating a fictitious, imitated or forged trade name.

A medicinal brand can be registered as a trade mark if it complies with the above definitions and requirements of the IP Law.

 

8. How is a trade mark registered?

 

Application and guidance

The General Authority for Trade marks and Industrial Designs at the Trade Registry Department of the Ministry of Trade and Industry registers trade marks in its trade mark register. It does not have a website.

The fees for trade mark registration are set out in the executive regulations of the IP Law. The fees for a request to register a trade mark under one category are EGP50 and EGP25 for any additional categories in the same request. The fees for registration of a trade mark under one category is EGP60 and EGP50 for any additional category in the same request. The fees for an international registration request of a local trade mark is EGP100 per country.

 

Process and timing

The applicant must submit the required documents within six months from the date of submitting the application.

The Ministry of Trade and Industry will then inspect the mark to ensure that it is not the same or similar to a registered trade mark or to a mark for which an application has been already submitted. The application will then be approved, approved subject to conditions or rejected. The applicant can appeal a rejection or an approval subject to conditions.

After registration is accepted, the trade mark is published in the Gazette of Trade marks and Industrial Designs issued monthly by the General Authority for Trade marks and Industrial Designs.

Anyone with an objection must notify the Ministry of Trade and Industry within 60 days from the date of publication of the registration. The applicant then has 30 days from the date of being notified of the objection to respond. If the applicant does not respond during the 30 days, it will be deemed to forfeit the application. On the request of any of the parties, the head of the Trade Registry Department can hold a hearing for the parties to present their arguments.

The Trade Registry Department will notify the parties of its decision, by registered mail with acknowledgement of receipt, within ten days from the date of the decision. If the objection is rejected, the applicant has 90 days from notification of the decision to complete the registration. If not, it will be deemed to forfeit the application.

If there are no objections, the trade mark will be registered and the registration certificate issued.

The time frame to complete registration is usually around 12 to 24 months.

 

9. How long does trade mark protection typically last?

 

The protection period for a registered trade mark is ten years, renewable for an identical period or periods on request of its owner. A renewal request must be submitted within the last year of the protection period, subject to paying the fees for the initial registration.

If the protection period expires, the owner can request renewal of the protection period within six months of its expiry, subject to paying the prescribed fees and additional fees. Otherwise, the trade mark will be cancelled.

 

10. How can a trade mark be revoked?

 

The trade mark owner or other person authorised by power of attorney must submit to the Head of the Trade Registry Department a written request to cancel a trade mark registration. The Trade Registry Department will decide that request within 30 days of its submission. A decision to cancel the registration is effective as of the date of submission of the request.

A trade mark can be revoked by a court order, on the request of an interested party, if the owner does not seriously use it without a valid reason for a period of five consecutive years (Article 91, IP Law).

 

11. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?

 

Conditions

Trade mark infringement occurs in the following cases (IP Law):

• Counterfeiting a trade mark registered under the IP Law, or imitating it in a way likely to mislead the public.
• Fraudulently using counterfeit or imitated trade marks.
• Fraudulently affixing to products a trade mark belonging to a third party.
• Knowingly selling, offering for sale or distributing, or acquiring to sell, products bearing a counterfeit or imitated mark, or on which the mark was unlawfully affixed.
• Affixing a false trade mark to products, on or inside shops or warehouses, signboards, packaging, invoices, correspondence, adverts or other means used to offer the products to the public.
• Fraudulently placing on marks or commercial documents an indication suggesting that the mark has been registered.

 

Claim and remedies

Trade mark infringement is a criminal offence punishable by imprisonment for at least two months and/or a fine of at least EGP5,000 up to EGP20,000 (IP Law). The owner can file a complaint of trade mark infringement before a public prosecutor. A warrant for arrest and inspection can be issued. If sufficient evidence of infringement is collected, the case will be referred to the criminal courts, which will impose the penalties and order destruction of the counterfeit products.

Trade mark owners can also claim damages or seizure of counterfeit/infringing products in the civil courts. The Economic Court has jurisdiction over IP matters.

In case of imported products, trade mark owners can stop counterfeit/infringing products through filing a complaint with the Ministry of Supply or the Customs Authority.

The Ministry of Supply can conduct raids and seize products. If they are counterfeit, the case will be transferred to the public prosecutor who will continue the investigation and transfer the case to the criminal courts.

Following any civil or criminal actions, the trade mark owner can still bring a civil action to claim compensation for loss of profit and reputational damage.

 

12. Outline the regulatory powers and enforcement action against counterfeiting in the pharmaceutical sector.

 

A pharmaceutical trade mark owner, as well as pharmacies and patients, can report counterfeit products to the Central Administration of Pharmaceutical Affairs at the Ministry of Health (CAPA). CAPA can seize and inspect the products. If they are counterfeit, CAPA will transfer the case to the public prosecutor to take the necessary action (see Claim and remedies).

 

IP and competition law issues

13. Briefly outline the competition law framework in your jurisdiction and how it impacts on the pharmaceutical sector. In particular, the competition authorities and their regulatory powers, key legislation, whether pharmaceutical investigations are common, key recent activity and case law.

 

Competition is regulated under Law No. 3 of 2005 on the Protection of Competition and the Prohibition of Monopolistic Practices and its executive regulations (Competition Law). Article (5) provides that the Competition Law also applies to acts committed abroad if they result in the prevention, restriction or harm of/to freedom of competition in Egypt, and are offences under the Competition Law.

The Competition Authority enforces the Competition Law. It receives mergers and acquisitions notifications and reports of violations. Its board of directors can refer a case to prosecution on a written request of the chair if it obtains majority board approval. The Competition Authority can also opt for an out-of-court settlement.

Abuse of a dominant position is prohibited. The Competition Law considers an entity to be in a dominant market position if it holds over 25% of the relevant market share, can change the prices or volume of products offered in that market and competing parties cannot prevent this.

The Competition Law prohibits persons from entering into agreements that limit competition with their suppliers or clients. Competing persons in a relevant market cannot carry out price-fixing, market allocation, bid-rigging and output restrictions. However, there is an exception for horizontal agreements approved by the Competition Authority if the restrictive effect on competition is outweighed by the benefit to consumers.

The Competition Authority is very active. In 2016 it reviewed 28 complaints of anti-competitive practice, and issued a decision in 22 of them. However, there are not many cases concerning pharmaceuticals.

In 2015, the Competition Authority referred four drug distribution companies to prosecution for violating Article 6(a) and (d) of the Competition Law, by co-ordinating their marketing and selling terms for small and medium pharmacies and reducing the credits terms and cash discounts offered. In 2018, they were fined EGP500 million by the Egyptian courts. It is considered the largest fine in Egypt for competition violations.

In 2016, the Competition Authority challenged the Ministry of Health’s regulations on pricing and registration of drugs under Ministerial Decree 425 of 2016. The Competition Authority argued that this decree creates restrictions inhibiting the entry of new investors into the market, leading to a monopoly of big market player entities through their acquisition of other companies. The Competition Authority also challenged Decree 499 of 2012, arguing that the pricing mechanism breaches the principles of free competition and equal opportunities. These challenges did not lead to any changes in these laws.

 

14. Briefly outline the competition issues that can arise on the licensing of technology and patents in a pharmaceutical context.

 

There has been no precedent on competition issues arising from the licensing of technology or patents in Egypt.

 

15. Are there competition issues associated with the generic entry of pharmaceuticals in your jurisdiction?

 

There are no competition issues associated with the generic entry of pharmaceuticals in Egypt. The registration of pharmaceutical products in Egypt includes a compulsory pricing phase, in which the Ministry of Health intervenes to determine the price of the product regardless of it being innovative. The regulations also set the pricing of a registered generic product in relation to the innovative product. This compulsory pricing regime means that competition issues associated with the generic entry of pharmaceuticals do not arise.

 

16. Have abuse of dominance issues arisen in the pharmaceutical sector in your jurisdiction?

 

There is one recent competition law case relating to distribution companies in the pharmaceutical industry (see Question 13).

 

17. Have parallel imports of pharmaceuticals raised IP and competition law issues in your jurisdiction?

 

Parallel importation is not allowed in Egypt. An importer of a pharmaceutical must be registered in a special importers’ ledger at the Ministry of Health. Registration requires an appointment letter from the market authorisation holder.

However, there is unauthorised parallel importation of pharmaceuticals into Egypt, especially from gulf countries.

 

18. Does a patent or trade mark licence and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body? How is such a licence

made enforceable?

 

A licence is enforceable as from its registration and there is no nationality restriction or additional/ special approvals when granting a patent or trade mark licence and payment of royalties to foreign licensors.

Online resources

Egyptian Drug Authority

W www.eda.mohp.gov.eg

Description. This is the official website for the Egyptian Drug Authority. It includes several items of relevant legislation, announcements and application forms. The content is not regularly updated. The website includes a number of English translations, for guidance only. There is no free website with official and up-to-date Egyptian legislation.