The opening speech was delivered by Mrs. Hoda A.Serageldine, President of the Egyptian Association for the Protection of Intellectual Property (AEPPI); General Haytham Hamouda, Vice President of the Internal Trade Development Authority; Mrs. Eng. Esmat Abdel Latif, President of the Patent Office; H.E. Ambassador Amgad Abdel Ghaffar, Regional Manager for the Arab Countries at WIPO.

Mrs. Serageldine pointed out the importance of reviewing the Intellectual Property Law No. 82 of 2002 in light of the results of its application over the past years specially in the fields of patents and trademarks. Regarding the development in the judicial field, Mrs. Serageldine praised Dubai’s leading experience in establishing special courts for intellectual property rights disputes and stressed the importance of benefiting from this experience. Gen. Hamouda emphasized the fact that Egypt was one of the leaders among Arab nations to issue a legislation for protecting intellectual property rights by issuing the law No. 57 of 1939 for the trademarks in addition to the adaptation of the Egyptian legislature to international developments eventually resulting in the issuance the law No. 82 of 2002 as a unified law for protecting the intellectual property rights. Further, Egypt joined most of the international treaties on intellectual property.

Mrs. Eng. Esmat Abdel Latif said that the legal protection encourages the development of human innovations, protects innovators and creators and contributes to the wheel of progress and development. She said the Egyptian Patent Office, in performing its duties and increasing its efficiency, concludes cooperation and training agreements with international organizations and advanced research centers. Consequently, the Egyptian Patent Office has become one of fourteen offices worldwide to carry out preliminary examination and international research for applications submitted in the Arabic language.

Ambassador Abdel Ghaffar discussed the role of the WIPO’s Regional Office for Arab Countries in the cooperation with the Arab Countries for identifying their needs in the field of intellectual property and developing the legal systems and execution departments therein. He emphasized the importance of the effective participation of Egypt and the Arab Countries in international forums in order to protect their interests and the importance of establishing technology transfer centers in cooperation with WIPO following the Tunisian experience.
 

FIRST SESSION:
SPEECH OF DR. SAMIR MANSOUR: REGIONAL REPRESENTATIVE OF THE PHARMACEUTICALS RESEARCH AND MANUFACTURE ASSOCIATION (PHRMA)

(1)    Introduction to PhRMA

PhRMA is an American association for the producers of pharmaceuticals and pharmaceutical researches representing the largest research and production companies in the world. The member companies lead the way to new medical discoveries whereas the PhRMA members invested around USD 45.8 billion in researches in 2009 which constitutes a large portion of the pharmaceuticals industry investments which has invested about USD 65.3 billion on 2009. The main mission of PhRMA is to generate general policies that encourages discovery of disease treatments.

(2)   Stages of a Pharmaceutical

Dr. Samir Mansour presented the stages which a pharmaceutical goes through and explained that a small percentage of the discovered pharmaceuticals proceeds to be marketed after their discovery whereas only 2.5% of the latent compounds persist until the registration of patents and stages before the medical experiments, and only 0.5% of the latent compounds persist to reach the stages 1,2 and 3 of the medical and bed experiments. Development stages last from 10 to 12 years until registering the drug which is almost half the term of protection granted to patents before offering the pharmaceutical in the market.

(3)   Benefits of Research & Development

During the phase of medical experiments, research and development have several benefits as they participate in increasing the investments, labor, skills and knowledge, the competitiveness capabilities, and in addressing the needs of the medical care sector. After registration, benefits include the capability of manufacturing and packaging, employment of new manpower, training and education regarding new pharmaceuticals and disease management. After the expiry of the patent, benefits include commencing the production of generic drugs, technology transfer and improvement of the local industry.

(4)   Importance of Intellectual Property in the Pharmaceutical Field

Intellectual property plays a significant role in the pharmaceutical industry, including: (i) motivating companies to more research to invent new medical products; (ii) assisting countries specifically developing ones in the technology transfer process to help treat diseases; (iii) developing and innovating more pharmaceuticals for treating incurable disease such as Aids, tuberculosis and else; and (iv) fighting counterfeited pharmaceuticals that have negative impacts on societies and decrease innovation and prevent societies from benefiting from new innovations.

(5)   Protecting Data Submitted to Health Authorities

During the process of issuing the required licenses for drugs circulation, companies have to submit detailed data to the competent health authorities. Such data are subject to the principal of data protection provided for in the third paragraph of article 39 of TRIPS. The purpose of such protection is to prevent the use of data submitted by the innovator to obtain a marketing license by a third party unless an approval is obtained from the innovator to protect the innovator from unfair competition which might negatively affect the innovation. Therefore, health authorities must prevent piracy by preventing unauthorized parties from relying on the data submitted from the innovators to register counterfeited drugs.

(6)   Counterfeiting Drugs and Effects on Patients and Other Entities

Doubtless, counterfeited drugs have negative effects on people that might reach death. They also have negative effects on innovative drugs manufacturers and countries. Counterfeited drugs are those substances designed and packed in a way which cannot be distinguished from original drugs available in the market. In most cases, they are not of the same quality and do not provide the safety provided by original drugs as they might contain wrong contents or might not contain the effective materials.

World Health Organization estimated that between 8% to 10% of the drugs in the world are counterfeited, a percentage that increases for some drugs in developing countries to reach 30%. The annual global sales of counterfeited drugs reach USD 40 billion.

In order to combat counterfeiting, governmental authorities and private entities should coordinate their efforts in all countries, internally and externally. The laws of intellectual property rights should be enforced strictly. In addition, awareness campaigns for the effects of using such drugs, educational and instructive programs for the customs employees and public order whereas most of the drugs enters through the borders, adopting deterrent laws against perpetrators of counterfeit and amending the current laws to meet the committed crime should be carried out.

Jordan is a role model in combating counterfeited drugs. It amended its laws to become deterrent, fully applied intellectual property laws, established specialized courts in this field, and provided specialized courses for judges on the dangers of counterfeiting.

 

OPEN DISCUSSION

(1)   Data Exclusivity

An open discussion was conducted regarding the protection of technical data submitted to the local authorities by applicants of licenses which enable the health authorities undertaking the required examination to ensure the licensing conditions are met.        Dr. Hossam Lotfy clarified the difference between the different types of data protected by the intellectual property legislations and international treaties as follows:

(a)  Undisclosed information: are secret information of a commercial nature, which owner or holder took reasonable steps for their protection. The protection is permanent as long as they are not disclosed.

(b)  Data Exclusivity: are granted to the applicant of a patent to him from any third party that might simultaneously apply for a license to market a pharmaceutical product. Protection apply only if the health authorities requested the data. The claimant bears the burden of proving the leak of date. The duration of protection is five years commencing from the date of submitting the data to the competent authorities.

(c)  Patents: are granted to new unprecedented inventions, at anytime and place, which are capable of industrial application, and conform to public order and morality. Usually, the protection term is 20 years.

There is no overlap between the two concepts because the applicant for detailed data protection does not cause any harm for the patent applicant, but protects a file in which great respectable efforts have been made.

In this context, it has been suggested to amend article 56 of the Law No. 82 of 2002 so that the Data Exclusivity protection term          (5 years) commences from the date of licensing the marketing of the pharmaceutical chemical product or agricultural product and not from the date of submitting the data to the competent authorities given that the average time for issuing the license is one year from the date of submitting the data, during which the applicant does not benefit from the granted protection.

(2)   Article 17 of Law 82 of 2002

The Symposium discussed the importance of reviewing article 17 of Law No. 82 of 2002, and discussed the feasibility of this article in light of the authorities’ right to object to the registration of a patent after its publication in addition to their right to issue compulsory licenses or dispossess the patent if its conditions are met.
 

SECOND SESSION:

SPEECH OF DR. HOSSAM LOTFY, FACULTY OF LAW DIRECTOR, BANI SWEIF UNIVERSITY

(1)  3-Dimensional Trademarks

Article 67 of Law No. 82 of 2002 does not require that the trademark subject of registration and protection be two-dimensional. In fact, most legislations allows the registration and protection of three-dimensional trademarks. Therefore, the Trademark Registration Office should accept applications submitted for the registration of three-dimensional trademarks.

(2)  Geographical Indications

Law No. 82 of 2002 does not stipulate a clear definition for geographic indications. Indeed, it mixes between three expressions that are widely used in intellectual property agreements and legislations in various countries: (a) indication of origin; (b) appellation of origin; and (c) indication of source/provenance.

Indications of source/provenance refer to the place of manufacturing or production and include the production, extraction, harvesting, packaging and distribution of the product. Such indications of source/provenance are two types as follows:

(a) Indication of Origin
Such indication of origin is connected with the actual process of production and includes the production, extraction, and harvesting of the product, and is therefore considered a part of the indication of source/provenance on a narrow basis.

(b) Appellation of Origin
Appellation of origin denotes the origin of the product, and depends on the climate, geography and skill that differentiate the product. Appellation of origin do not necessarily denote a certain quality of the product, however, they prescribe the characteristics of the products, either with respect to the climate and geography surrounding the product, or with respect to the skill in its production.

Law No. 82 of 2002 misused the term “Appellation of Origin” to describe the indication of source and the indication of origin besides the meaning of the appellation of origin set out above. This caused a serious problem in practice: Trademark Registration Office personnel could not differentiate between appellation of origin and the trademark.

It is worthy to mention that the Egyptian legislator violated the TRIPS Agreement by not conveying any additional protection to alcoholic drinks and wines as mentioned in Article 23 of the Agreement.

(3)  Collective Marks & Certification Marks

(a) Collective Marks
A collective mark is different from a trademark. While a trademark aims to determe the source of the product, a collective mark is not associated with a particular product, but may be used by any member belonging to a particular group, which is the owner of the collective mark.

(b) Certification Marks
The difference between collective marks and certification marks is that the latter may be used with permission from its owner after fulfilling the conditions set out by the owner of the certification mark. It is a common mistake to denote the certification mark as a quality mark, as it does not necessarily mean a certain quality, but only clarifies that its users have fulfilled the conditions set by its owner.

(4) Branding / Trade Dress

These are not legal terms. They are used to describe the form in which the product or service is presented to the public. It may be a patent, a trademark, an appelation of origin or an industrial design, or not. An example for a trade dress is the general appearance that McDonanlds is using all around the world.

(5)   Well-Known Marks

The legislator was inaccurate in the use of the term “well-known marks” in Article 68 of Law No. 82 of 2002, because the TRIPS agreement requires that that the mark be “very well-known”. It is therefore recommended to change the term used to become “very well-known marks”.

In order to benefit from the protection, even if not registered, well-known marks must be known both globally and in the Arab Republic of Egypt.

In practice, problems arise in proving the fame of the mark globally and in Egypt, whether before the Trademark Registration Office or before courts. The reason behind those problems is that the fame of a mark is based on relative standards. In all cases, the defendant must submit evidence of his mark’s fame, which is deemed a question of fact that may be proved by all means of proof, and is subject to the discretion of the court or the registering authority to protect such mark.

It was noted that WIPO has not set out a clear definition of a very well-known mark, and in practice it is almost impossible to develop a comprehensive definition of a very well-known marks as is evidenced by the TRIPS Agreement’s inability to do so.

At the end of the session it has been proposed to amend the terms contained in the law to conform with international conventions and their purposes. It was also proposed to issue different registration application forms for different types of marks that conform to the required conditions for the registration and protection of each type of mark.

 

THIRD SESSION:

SPEECH OF DR. KHALED ATTIA, PARTNER AT SARIE EL DIN & PARTNERS LAW FIRM AND FORMER EXECUTIVE DIRECTOR OF THE EGYPTIAN COMPETITION AUTHORITY

Dr. Khaled started his speech with a brief account of the Egyptian transition to a market economy that necessitated the promulgation of modern economic legislations, specifically, the Intellectual Property Rights Law No. 82 of 2002 that regulates all matters relating to the protection of intellectual property rights in the context of the TRIPS Agreement, in addition to the Law on the Protection of Competition and Prevention of Monopolistic Practices No. 3 of 2005 (the “Competition Law”) that regulates the exercise of economic activity in a manner that does not prevent, restrict or harm free competition. The integration between the policies of the protection of intellectual properties on one side and the antitrust policies on the other side is important to achieve the common objectives of such laws, and would result in many benefits to the consumer and the market players, leading to the advancement of the Egyptian economy. There is an overlap between the two laws, since Law No. 82 of 2002 contains several provisions that relate to the protection of competition such as in the case of as patents, undisclosed information or other aspects of intellectual property rights.

The following are various aspects of the illegal practices identified by the Competition Law, which constitute a violation of free competition in the market:

1) Hardcore Cartels:
Agreements between persons competing in the market if they lead to the control of prices or market divisions or change in the manufacturing processes, distribution, marketing or coordination with regards to entering into tenders.

2) Vertical Agreements:
Agreements between a person and any of its suppliers or customers that would restrict competition. Upon examination of these cases, each case has to be examined seperatley in order to be able to determine whether the agreement or contract would restrict competition or not.

3) Abuse of Dominance:
The prohibited acts on each person with a dominant position in the market, including: acts that would lead to non-manufacturing, production or distribution of a certain product for a fixed period or periods, or that would lead to the exclusive distribution of a specific product, refraining from entering into sale or purchase deals, or refrain from producing or providing a product when its production is economically possible or available, and other forms of violations.

There are many practical applications of commercial exploitation of intellectual property rights that could constitute a violations of the Competition Law, such as the agreement between the owners of patents and the owners of trademarks, as an example of horizontal agreements, and agreements between the owner of a patent or trademark and the licensee as an example of vertical agreements, and the imposition of arbitrary conditions for granting a license to exploit a patent or trademark as a form of abuse of control.

Dr. Khaled presented the legal framework under the TRIPS Agreement and the supervision it imposes over non-competitive licenses in contractual licensing agreement (Article 40 of the TRIPS Agreement). He further presented procedures in other countries to face monopolistic practices in the commercial exploitation of intellectual property rights, such as the procedures set forth in the EU Regulation No. 240/96, and the competition regulations contained in the Sherman Act and Clayton Act and the Law of the Federal Trade Commission on Intellectual Property Rights in the United States.

One cannot only discuss commercial exploitation of intellectual property rights without giving attention to the property right in itself. The owner of the intellectual property right shall not be considered as a monopolizer or even in a dominant position unless such is proven through economic analysis and according to the provisions of the Competition Law.

In the session’s conclusion, Mr. Ahmed Abou Ali emphasized the importance of the cooperation and coordination between the authorities regulating competition and the protection of intellectual property rights, taking into account the common objectives of the laws. He further reiterated the importance of looking at the competition rules contained in both laws in a complementary way and to create a mechanism for joint cooperation in the examination of cases of commercial exploitation of intellectual property rights that result in monopolistic practices. He also pointed out the importance of considering the enforcement of the competition provisions contained in the Intellectual Property Law that relate to compulsory licensing, in addition to the importance of enhancing the cooperation between the relevant authorities to raise awareness of intellectual property rights and competition policies among dealers in the market. Finally, Mr. Abou Ali proposed to the audience to consider the possibility of issuing guidelines to clarify the difference between exploitation licenses that comply with the laws and those that are in violation thereto.

Seminar Reporters:
Ms. Farida Mortada – Helmy, Hamza & Partners
Mr. Gamal Abu Ali – Hassouna and Abou Ali Law Firm