By Odireleng Keipopele, Patent Examiner, ARIPO
On 25 February 2021, ARIPO hosted a webinar on the use of ARIPO Form 22 by Rwanda and Uganda on the use of ARIPO FORM 22, in accordance with Section 3 (6) and Rule 18 (5) of the Harare Protocol in objecting to the protection of pharmaceutical product patents or utility models in their respective countries.
The webinar was officially opened by the ARIPO Director General, Mr. Bemanya Twebaze, who expressed his gratitude for the two Heads of IP offices’ commitment, Ms. Mercy Kainobwisho (URSB) and Mr. Richard Kayibanda (RDB) by their presence during the official opening.
What is ARIPO FORM 22?
ARIPO FORM 22 is one of the Harare Protocol forms, and member states use it to object to the grant of a specific patent in their respective territories.
When an ARIPO patent application satisfies all requirements of patentability, ARIPO Office issues Form 21 (Notification of Decision to Grant a Patent) and sends this to the applicant and designated State/s.
Why was the webinar hosted for Uganda and Rwanda?
Paragraph 7 of the 2001 Doha Declaration on TRIPS Agreement and Public Health provides that least developed country (LDC) Member States are not under the obligation to protect pharmaceutical product patents and undisclosed information. The transition period not to protect pharmaceutical product patents has been extended until 2033 in accordance with Article 66(1) of the TRIPs Agreement.
ARIPO hosted the webinar for Rwanda and Uganda because both countries have incorporated in their national legislation the TRIPS flexibilities specific for least developed countries, allowing them not to grant patent protection for pharmaceutical products in their respective territories.
According to the Uganda Industrial Property Act of 2014, Section 8(3)(f) excludes pharmaceutical products from patentable subject matter and Section 101(15) excludes pharmaceutical process as an enforceable patent right. For Rwanda’s case, article 18(8o) of law n° 31/2009 of 26/10/2009 on the protection of intellectual property excludes
Section 3 (6) and Rule 18 (5) of the Harare Protocol provide that before the expiration of 6 months from the date of the notification of the decision to grant a patent, a designated state may make written communication to the Office that if the Office grants a patent, that patent shall have no effect in its territory. Such communication is issued by the designated state on ARIPO Form 22.
The issue of communication by the designated States of their decision regarding applications involving pharmaceuticals has been raised during the 9th Session of the Working Group on the Improvement of ARIPO Protocols on Industrial Property held virtually on 15 July 2020.
According to the IP agents, challenges associated with the issuance of Form 22 by Rwanda and Uganda include, but are not limited to, issuing: of the Form 22’s outside the provided time limit, without identification of the claims for which the objection is based as well as un-dated and signed Forms.
Therefore, the purpose of the webinar was to discuss the procedures for issuance and processing of the communication by a designated State that a patent or utility model shall have no effect on its territory. Moreover, the aim of the webinar was to address the above-said challenges and at the same time offer
Topics covered during the webinar presentations included an overview of search and substantive examination at ARIPO, examples of pharmaceutical claims, national office processing of Form 21 and issuance of Form 22, and Member States Module (MS) transmission of Form 22. The presentations were followed by discussions that raised a number of issues and spelt some recommendations.
During the discussions, ARIPO emphasized the challenges confronting it and the applicants when there is no reply to an applicant’s response to the designated state issued Form 22. It urged RDB and URSB to ensure that such responses are replied to. ARIPO took advantage of the discussions and informed that designated states also hardly respond to issued ARIPO Form 37 (communication by designated state that registration of an industrial design shall have no effect in its territory).
The RDB thanked ARIPO for the presentations and the information provided. It raised the issue of notifications of decision to grant (Form 21) being sent to it via CD and to indicated that CDs are usually received late, resulting in some Form 22’s being issued after the 6 months period provided for in the Harare Protocol. It further indicated that its staff sometimes experience challenges in accessing notifications sent through the MS Module via the file transfer protocol (FTP).
The URSB also thanked ARIPO for the presentations and indicated that the issue focused webinar was a timely and very welcome initiative. It added that it had addressed most of the challenges associated with the issuance of Form 22 through regular engagement and consultation with ARIPO. URSB proposed that ARIPO designs a new Form to be used by clients when responding to an issued Form 22 instead of the current practice of using a letter and further proposed that a new Form be used by clients when responding to an issued Form 37 be designed.
In response to the issues raised by RDB, ARIPO highlighted that it had previously engaged its courier services providers, who advised that the CD’s would have arrived at the destination in time but would be ‘sitting’ in some office before being made available to the appropriate personnel. Regarding the challenge of accessing FTP delivered notifications, ARIPO reiterated the importance of an Office having a dedicated ICT person who would address such issues if and when they arise and liaise with ARIPO and WIPO where necessary.
ARIPO welcomed the URSB’s proposals to design new Forms for use in responding to Form 22 and Form 37 and advised Uganda to consider submitting such proposals to the 10th Session of the ARIPO Working Group on the Improvement of ARIPO Protocols on Industrial Property that will be held in May 2021.
At the end of the webinar all the parties expressed their sincere gratitude. They observed that the set objectives had been met and that going forward, the challenges identified by the IP agents would be overcome to the extent possible.