Introduction to Algerian Patent Law
Algeria's patent law is governed by the Patents Ordinance No 03-07, dated July 19, 2003. This ordinance sets the framework for what can be patented, the process of patent application, and the rights and obligations associated with patent ownership.
Patentability of Biopharmaceutical Inventions
In Algeria, inventions related to products or processes that are new, result from an inventive step, and are susceptible to industrial application can be protected by a patent. This includes biopharmaceutical inventions.
- Novelty: An invention is considered new if it is not included in the state of the art, which encompasses everything made accessible to the public by any means before the day of filing the application or the priority date validly claimed[4].
- Inventive Step: The invention must result from an inventive step, meaning it must not be obvious to a person skilled in the art.
- Industrial Application: The invention must be capable of industrial application, which means it can be used in any kind of industry[4].
Biologics and Biosimilars
Algerian law distinguishes between biologic medicines and biosimilar medicines.
- Biologic Medicines: All reference biotherapeutic products are patentable in Algeria. This includes new manufacturing processes for these products[4].
- Biosimilar Medicines: Biosimilar medicines are not considered the same as generic medicines. The Health Law No 18-11 of 2018 introduced specific regulations for biosimilars, making a clear distinction between similar biotherapeutic products and generic products[4].
Regulatory Framework for Biosimilars
As of the latest updates, there are no specific regulations for the marketing authorization of biosimilar medicines in Algeria, apart from the provisions introduced by the Health Law No 18-11 of 2018.
- Marketing Authorization: The law does not use the term "biosimilar" in legal provisions prior to Article 210 of the Health Law No 18-11. However, this law has laid the groundwork for future regulations specific to biosimilars[4].
Enforceability of Biopharmaceutical Patents
Enforcing biopharmaceutical patents in Algeria remains a challenge due to several factors.
- Coordination Between Authorities: There is a lack of effective coordination between Algeria’s health and patent authorities, which can lead to the issuance of marketing approvals for unauthorized copies of patented pharmaceutical products[1].
- Judicial Remedies: The judicial system in Algeria lacks effective remedies for right holders to challenge the granting of marketing approvals for generic pharmaceutical products that infringe Algerian patents[1].
- Piracy and Counterfeiting: Algeria has weak enforcement against piracy and counterfeiting, which further complicates the enforcement of biopharmaceutical patents[1].
Scope of Claims
The scope of claims for biopharmaceutical patents in Algeria is defined by the Patents Ordinance No 03-07.
- Claim Definition: Claims must be clear and concise, defining the matter for which protection is sought. The scope of protection is determined by the claims, and any ambiguity can lead to challenges in enforcement[5].
- Experimental Use: Experimentation and/or research aimed at determining how the patented invention works, the scope of the patented invention, or the validity of the patented invention are allowed under certain conditions[2].
Registration and Protection
To protect biopharmaceutical patents, registration is crucial.
- First-in-Time, First-in-Right Basis: Registration of patents is on a first-in-time, first-in-right basis. Companies should consider applying for patent protection before selling products or services in Algeria[5].
- Local Laws: U.S. trademark and patent registrations are not immediately recognized in Algeria. IP rights holders must register and seek enforcement of their rights under local laws[5].
Recent Improvements and Challenges
In recent years, Algeria has taken steps to improve the intellectual property (IP) protection environment.
- Upgraded Ranking: The U.S. Trade Representative upgraded Algeria from the Priority Watch List to the Watch List in its May 2021 report, reflecting positive steps in IP enforcement[5].
- Capacity Building: Algerian authorities have increased efforts at IP enforcement, including disbanding informal markets selling counterfeit merchandise and conducting capacity-building and training efforts for law enforcement and IP protection agencies[5].
Challenges in Enforcement
Despite improvements, several challenges remain.
- Weak Enforcement: Weak enforcement against piracy and counterfeiting continues to be a significant issue in Algeria[1].
- Judicial Efficiency: The court system in Algeria needs improvement in terms of efficiency and transparency, and judges need to impose deterrent-level sentences in IP infringement cases[1].
International Cooperation
Algeria is working with international bodies and other countries to address IP concerns.
- WTO Accession: Algeria’s bid for accession to the WTO and the bilateral Trade and Investment Framework Agreement with the U.S. are part of efforts to address IP concerns[1].
- U.S. Cooperation: The U.S. is working with Algeria to strengthen its IP regime and enhance enforcement efforts[1].
Key Takeaways
- Patentability: Biopharmaceutical inventions are patentable if they are new, result from an inventive step, and are susceptible to industrial application.
- Regulatory Framework: Biosimilars are distinguished from generic medicines, but specific regulations for their marketing authorization are still evolving.
- Enforceability: Enforcement remains challenging due to lack of coordination between health and patent authorities and weak judicial remedies.
- Registration: Registration of patents is on a first-in-time, first-in-right basis, and must be done under local laws.
- Improvements and Challenges: Algeria has made positive steps in IP enforcement but still faces significant challenges.
FAQs
Q: Are biosimilar medicines considered the same as generic medicines in Algeria?
A: No, biosimilar medicines are not considered the same as generic medicines in Algeria. The Health Law No 18-11 of 2018 made a clear distinction between them[4].
Q: Can biologic medicines be patented in Algeria?
A: Yes, all reference biotherapeutic products are patentable in Algeria, including new manufacturing processes[4].
Q: What are the main challenges in enforcing biopharmaceutical patents in Algeria?
A: The main challenges include lack of coordination between health and patent authorities, weak judicial remedies, and weak enforcement against piracy and counterfeiting[1].
Q: How does Algeria protect intellectual property rights?
A: Algeria protects IP rights through registration under local laws, increased coordination between customs authorities and law enforcement, and capacity-building efforts for law enforcement and IP protection agencies[5].
Q: Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in Algeria?
A: As of now, there are no specific regulations for the marketing authorization of biosimilar medicines in Algeria, apart from the general provisions introduced by the Health Law No 18-11 of 2018[4].
Cited Sources
- United States Trade Representative. Watch List ALGERIA. [PDF]
- World Intellectual Property Organization. Algeria - Exceptions. [PDF]
- PharmaBoardroom. The Pharma Legal Handbook: Algeria.
- PhRMA. 2025 National Trade Estimate Report on Foreign Trade Barriers (NTE). [PDF]
- U.S. Department of Commerce. Algeria - Protecting Intellectual Property.
