Introduction to Zambia's Patent System
Zambia's patent system is governed by the Patents Act No. 40 of 2016, which replaced the older Patents Act Cap 400. This new legislation aligns Zambia's patent laws more closely with international standards and introduces several key changes relevant to biopharmaceutical patents[2].
Patentability Requirements
Novelty
For a biopharmaceutical invention to be patentable in Zambia, it must meet the criterion of absolute novelty. This means the invention must not have been disclosed to the public anywhere in the world before the filing date of the patent application[2].
Utility and Industrial Applicability
The invention must be useful and have industrial applicability. This implies that the biopharmaceutical invention must have a practical application in any kind of industry[5].
Exclusions from Patentability
Certain inventions are excluded from patentability, including those related to the treatment of humans or animals or to pharmaceutical inventions that could restrict access to medical care and medicines. However, this exclusion does not apply to all pharmaceutical inventions, only those that would be contrary to public policy or morality[5].
Disclosure Requirements
Genetic Resources and Traditional Knowledge
The new Patents Act requires disclosure of information involving genetic resources and traditional knowledge. This is crucial for biopharmaceutical inventions that may utilize such resources[2].
Corresponding Foreign Applications
There is a duty of full disclosure of information involving corresponding foreign applications. This ensures transparency and prevents duplicate or misleading applications[2].
Enforceability of Biopharmaceutical Patents
Infringement and Validity
A patentee or exclusive licensee can commence court proceedings against a person alleged to have infringed or likely to infringe the patent. The defence of patent invalidity can be raised, and such issues are typically heard in the same proceedings as infringement[4].
Non-Literal Equivalents
Protection does not extend to non-literal equivalents in Zambia. This means that the scope of protection is strictly limited to the literal interpretation of the patent claims[4].
Public Interest Defence
In cases involving life-saving drugs or medical devices, a public interest defence can be invoked to prevent the grant of injunctions. This is provided under Section 99 of the Patents Act[4].
Scope of Claims
Types of Claims
The Patents Act does not specifically address the use of Swiss-type claims or purpose-limited product claims, but it adheres to international norms. For biopharmaceutical patents, claims must be clear and specific to ensure protection for the intended medical use[3].
Compulsory Licenses
A patent can be subject to a compulsory license if the patentee does not work the patented process in Zambia without reasonable cause. This provision ensures that essential medicines are accessible and can be manufactured locally if the patentee is not utilizing the patent effectively[4].
Registration and Examination Process
Filing Applications
Biopharmaceutical patent applications can be filed through the Patents and Companies Registration Agency (PACRA) or through the African Regional Intellectual Property Organization (ARIPO) for regional protection. International applications under the Patent Cooperation Treaty (PCT) are also recognized[5].
Substantive Examination
ARIPO provides technical support for substantive examination of patents and utility models, which can streamline the process for biopharmaceutical inventions[5].
Duration and Maintenance of Patents
Term of Protection
The term of protection for biopharmaceutical patents in Zambia is 20 years from the filing date, subject to the payment of annual maintenance fees. Renewal fees are payable from the 4th anniversary of the filing date up to the 16th year for national patents and up to the 19th year for ARIPO-route patents[5].
Regional and International Protection
ARIPO and PCT
Zambia is a member of ARIPO and the PCT system, allowing for regional and international protection of biopharmaceutical patents. This facilitates broader protection and simplifies the application process for inventors[5].
Representation and Fees
Representation
Non-citizens of Zambia or companies with their principal place of business outside Zambia must be represented by an agent when filing patent applications. Local applicants have the option to be represented by an agent[5].
Fees
The fees for patent applications include government (official) fees and professional fees. The fee schedule is published in a statutory instrument, and fees can be paid in the local currency (Zambia Kwacha)[5].
Key Takeaways
- Novelty and Utility: Biopharmaceutical inventions must be novel and have industrial applicability.
- Disclosure Requirements: Full disclosure of genetic resources, traditional knowledge, and corresponding foreign applications is mandatory.
- Enforceability: Infringement and validity issues are heard in the same proceedings, with no protection for non-literal equivalents.
- Compulsory Licenses: Patents can be subject to compulsory licenses if not worked in Zambia without reasonable cause.
- Registration and Examination: Applications can be filed through PACRA or ARIPO, with substantive examination supported by ARIPO.
- Duration and Maintenance: Patents are protected for 20 years, subject to annual maintenance fees.
- Regional and International Protection: Zambia is part of ARIPO and the PCT system, facilitating broader protection.
FAQs
Q: What are the key requirements for a biopharmaceutical invention to be patentable in Zambia?
A: The invention must be novel, useful, and have industrial applicability. It must also comply with disclosure requirements regarding genetic resources and traditional knowledge.
Q: Can a biopharmaceutical patent be subject to a compulsory license in Zambia?
A: Yes, a patent can be subject to a compulsory license if the patentee does not work the patented process in Zambia without reasonable cause.
Q: How long does the protection for a biopharmaceutical patent last in Zambia?
A: The protection lasts for 20 years from the filing date, subject to the payment of annual maintenance fees.
Q: Can non-citizens of Zambia file patent applications without an agent?
A: No, non-citizens of Zambia or companies with their principal place of business outside Zambia must be represented by an agent when filing patent applications.
Q: What is the role of ARIPO in the patent registration process in Zambia?
A: ARIPO provides technical support for substantive examination of patents and utility models, and it also offers a regional route for patent registration.
Sources
- WIPO - Questionnaire on exceptions and limitations to patent rights - Republic of Zambia.
- Spoor & Fisher - Zambia: New Patent Legislation.
- EPO - Purpose-limited product claims and Swiss-type claims.
- Dentons - Insights and Commentary from Dentons.
- Intellectual Property Helpdesk - ZAMBIA - Intellectual Property Helpdesk.
