The African Regional Intellectual Property Organization’s (“ARIPO’s”) amended Harare Protocol on Patents and Industrial Designs (the “Protocol”), came into effect on 1 January 2017 and includes some important changes.
Most pertinent of these, for those who choose ARIPO as a filing vehicle in Africa, is that it is now compulsory to request substantive examination for ARIPO patent applications. A provision for restoration or re-establishment of rights has also been included. The introduction of new fees and the hiking of application and renewal fees, which, while perhaps necessary to ensure that ARIPO continues to develop systems and improve efficiencies, will not be popular with applicants. However, the amendments do clarify provisions on patentable inventions, restrictions on biotech inventions and multiple dependencies of claims, which are largely welcome. Below, we look at some of these amendments in more detail.
A request for substantive examination is now required to be filed for every ARIPO patent application, and patent applications will only undergo substantive examination once the examination fee has been paid and the request for examination has been lodged.
The deadline for filing the request for substantive examination is within three years of the earliest priority date, or of the filing date where no priority is claimed. Where no request and payment of the examination fee is made within the prescribed period, the application will lapse.
Reestablishment of rights
Another development is the inclusion of a provision relating to the reestablishment of rights or restoration. This provides for an applicant or proprietor of an ARIPO patent, utility model or industrial design, who, in spite of all due care required by the circumstances having been taken, was unable to observe a time limit set by the Protocol.
In such circumstances, the applicant or proprietor can file a request and pay the prescribed fee to have his/her rights re-established. Such a request must be filed in writing within two months of the removal of the cause of non-compliance and, at the latest, no more than one year from the expiry of the unobserved time limit. However, in the case of the deadlines for claiming priority specified in the Protocol, the request must be filed within two months of the expiry of that period.
An important condition for such a request to be granted is that the non-observance of the time limit must have a direct consequence of causing the refusal of the ARIPO application or of a request, or the deeming of the application to have been withdrawn, or the loss of any other right or means of redress. Once granted, the re-establishment of rights is to be published in the ARIPO Journal.
The Protocol also provides for the consequences, should such a restoration of rights be granted, for a third party who has, in good faith, used or made effective and serious preparations for using an invention or design in the period between the loss of rights and the publication in the ARIPO Journal of the mention of re-establishment of those rights. Such a person may, without payment, continue such use in the course of his/her business or for the needs thereof.
Limitation of an ARIPO patent, post grant (post-grant amendment)
A new section has been introduced into the Protocol that specifically regulates the amendment post-grant of an ARIPO patent. Such an amendment may be applied for from the ARIPO office in writing and on payment of the limitation fee. The amendment must fall wholly within the scope of the claims before amendment.
Claim drafting provisions
Rule 7 has been introduced to provide requirements for drafting method of treatment claims and multiple dependent claims:
(a) “Claims regarded as first medical indications
(i) Pharmaceutical composition for the prophylaxis/treatment of Y(=disease) comprising X(=a drug/medicament). (ii) Pharmaceutical composition comprising X. (iii) Compound X for use as a drug/medicament for the treatment of Y. (iv) Use of X for the manufacture of a pharmaceutical composition (Note that the disease indication is not mentioned in the claim). (v) Compound X for use as an analgesic. (vi) Compound X for use in treating disease Y. (vii) Compound A containing X for use in treating disease Y (composition A may be genetically defined). (viii) Medicament containing compound X. (ix) Use of X for preparing a medicament.
(b) Claims regarded as second medical indications
(i) Use of X for the manufacture/preparation of a medicament/pharmaceutical composition for the treatment of Y. (ii) Process for the preparation of a medicament for treating disease Y characterized in that compound X is used as the main active component of the medicament.”
In terms of multiple dependent claims, rule 7 states that:
“Any claim which includes all the features of one or more other claims (claim in dependent form, hereinafter referred to as ‘dependent claim’) shall do so by a reference, if possible at the beginning, to the other claim or claims and shall then state the additional features claimed. Any dependent claim which refers to more than one other claim (‘multiple dependent claim’) shall refer to such claims in the alternative only. Multiple dependent claims shall not serve as a basis for any other multiple dependent claims.”
Biotechnological inventions: guidelines on transgenic plants and animals
Rule 7 has also been amended to introduce guidelines on biotechnological inventions:
“For the purposes of these guidelines:
(a) ‘biological material’ means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system; (b) ‘microbiological process’ means any process involving or performed upon or resulting in microbiological material; (c) ‘biotechnological invention’ are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used; (d) ‘genetic engineering’ means the technology which manipulates gene recombination, cell fusion, etc. Inventions relating to genetic engineering include those of a gene or a DNA fragment, a vector, a recombinant vector, a transformant, a polypeptide or a protein, a fused cell, a monoclonal antibody, etc; (e) ‘plant variety’ means any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be –
(i) defined by the expression of the characteristics that result from a given genotype or combination of genotypes, (ii) distinguished from any other plant grouping by the expression of at least one of the said characteristics and, (iii) considered as a unit with regard to its suitability for being propagated and changed;
(f) a process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.
7bis. 2. Patentable Biotechnological Inventions
Biotechnological inventions shall be patentable if they concern –
(i) ‘biological material’ which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature, (ii) ‘plants or animals’ provided that the technical feasibility of the invention is not confined to a particular plant or animal variety, (iii)‘ a microbiological or other technical process’, or a product obtained by means of such a process other than a plant or animal variety,
7bis. 3. Exceptions to Patentability of Biotechnological Inventions
ARIPO patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:
(i) processes for cloning human beings, (ii) processes for modifying the germ line genetic identity of human beings, (iii) uses of human embryos for industrial or commercial purposes, (iv) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes, (v) an embryonic stem cell of an animal, an animal at the various stages of its formation and development such as a germ cell, a zoosperm, an embryo, etc., belong to the category of animal variety, (vi) a single plant and its reproductive material (such as seed, etc.) which maintains its life by synthesizing carbohydrates and protein from the inorganic substances such as water, carbon dioxide and mineral salts and so on through photosynthesis belong to the category of plant variety, (vii) inventions that do not possess practical applicability, i.e. cannot easily be reproduced, (viii) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.”
Extensions of time limits
Rule 15 has been amended to provide for extensions of time limits. Such requests for extension must be in writing and the applicable fee must be paid. Where such a request is granted, the period of extension will be three months.
Divisional patent application
A specific provision for divisional applications has been introduced in rule 18. Any divisional application relating to any pending earlier ARIPO patent application must be filed at the ARIPO office.
Publication of ARIPO patent applications
Rule 19 introduces a period for publication of ARIPO patent applications, which will be as soon as possible after the expiry of 18 months from the date of filing or, if priority has been claimed, from the earliest date of priority.
A number of new fees have been introduced into the ARIPO Official Fee Schedule and a number of amendments have been made to existing fees.