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SOUTHNEWS

 
No. 427, 18 November 2022

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Addressing the public health implications of patent policies for biologicals: patent offices share their perspectives at the South Centre



Participants during the South Centre Workshop
Photo Credit: Yiduo He
 
On 21 September 2022, the South Centre organized a workshop with nine patent offices from developing countries (Argentina, Brazil, Colombia, Cuba, Ecuador, Egypt, Morocco, Peru, South Africa) to share experiences and exchange offices’ practices relating to the examination of patent claims relating to biological medical products, including monoclonal antibodies and vaccines, and CRISPR gene editing technology and the use of CAR-T. The workshop also discussed the main training and capacity-building needs of the respective offices in this area and how to capacitate trainers in this field.
 
Biological medical products are more difficult to manufacture than chemical pharmaceutical products and many are among the most expensive drugs sold worldwide.[1] The rigorous application of patentability criteria to biologicals prevents unmerited applications from obtaining patents and ensures that only real innovations will be granted patents while enabling generic competition. As such, rigorous examination is critical for access and affordability of such products, especially in developing countries.
 
The technical characteristics of biologicals pose challenges to patent examiners and many offices face problems of lack of information/expertise. The purpose of this workshop by the South Centre was to facilitate the identification and resolution of existing gaps through cooperation and exchange between patent examiners from developing countries. This activity aims at advancing recommendations for the development of guidelines relating to the examination of patent applications on biologicals, having in view typical claims made in relation to products, manufacturing processes and uses as well as the special problems raised by compliance with the written description requirement.
 
The workshop was opened by Dr. Viviana Muñoz-Tellez, Coordinator of the Health, Intellectual Property and Biodiversity Programme (HIPB) of the South Centre. Remarks about the importance of the subject and the need to cooperate to improve examination practices were provided by Dr. Carlos Correa, Executive Director of the South Centre. The workshop was facilitated by Ms. Srividya Ravi, patent expert from India, and Dr. Gabriela Costa Chaves, an independent consultant from Brazil, with additional comments and remarks by Mr. Nirmalya Syam, Senior Programme Officer, and Dr. Vitor Ido, Programme Officer, HIPB.
 
The following were the main findings of the workshop:
  • There is wide recognition that there is a growing number of patent applications on biologicals;
  • The vast majority of claims on biologicals in the participating offices relate to antibodies (including monoclonal antibodies);
  • Divisional patents, patent applications with broad claims and insufficient disclosure, how to determine the inventive step are common issues to be addressed;
  • There is a need to get access to databases not available now to carry out appropriate searches;
  • Some offices have developed specific guidelines and put in place teams to address biologicals, while others rely on prior internal practices – in both cases, constant update of the practices and trainings are required as the technology is evolving rapidly;
  • There are differences in terms of the patentability standards applied in the countries participating in the workshop; some also apply exclusions from patentability (established in their national laws or developed through patent offices’ practices and guidelines) relating to certain biological claims.
 
In addition to antibodies and vaccines, the workshop also discussed recombinant proteins, blood and blood products. The analysis included mutations, modifications and changes in the complementarity directing regions of the antibodies, shortcomings in prior arts – i.e., data on IC50 or binding affinity not being available, claims pertaining to second medical uses and combinations, totipotent and pluripotent cells, essentially biological process and combination with biotechnology-based processes, crystalline structures, multiple claims binding the aspects of the invention-vector, host cells, vector-host cell systems and emerging technologies such as those relating to the use of T cells. The participants also discussed policy issues raised by regional and national regulations, and how to foster South-South cooperation and further dialogue between patent offices.
 
For more information on the workshop, please see the following website: https://ipaccessmeds.southcentre.int/event/workshop-on-patent-examination-practices-relating-to-biologics/. The South Centre warmly thanks all patent offices for their participation and the rich exchange.
 
The South Centre continues to provide no-cost technical assistance on intellectual property (IP) and public health to developing countries’ officials, including IP offices, judicial authorities, policymakers of different agencies and ministries. More information can be obtained from the dedicated website: https://ipaccessmeds.southcentre.int/services/ or through email to munoz@southcentre.int.
 
[1] See: https://www.i-mak.org/wp-content/uploads/2022/09/Overpatented-Overpriced-2022-FINAL.pdf

Author: Vitor Ido is Programme Officer of the Health, Intellectual Property and Biodiversity Programme of the South Centre.

 

SOUTHNEWS is an e-newsletter service of the South Centre providing information and news on topical issues from a South perspective.

To view other articles in SouthNews, please click here.

For more information, please contact Anna Bernardo of the South Centre: Email abernardo@southcentre.int, or telephone +41 22 791 80 50.
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