ENSafrica updates

Draft IP Policy Phase 1 – part two: access to medicines, state 'walk-in' rights and parallel import
ENSafrica
  • Healthcare & Life Sciences
  • South Africa
  • December 06 2017

The recently published Draft IP Policy Phase 1 2017 includes a number of provisions relating to parallel import and state 'walk-in' rights for access to affordable medicines. Although there are complex issues surrounding access to affordable medicines, the inclusive process that the government has used in the implementation of the new policy is encouraging.

Draft IP Policy Phase 1: access to medicines and compulsory licensing
ENSafrica
  • Healthcare & Life Sciences
  • South Africa
  • October 11 2017

The keenly anticipated draft IP Policy Phase 1 (2017) was recently published for public comment. It constitutes the first phase in the implementation of a comprehensive IP policy for South Africa. One of the key issues to be addressed is the interplay between the constitutional rights relating to property and access to healthcare. According to the policy, the scope of compulsory licences will be strengthened and clarified in an effort to facilitate the process of exporting IP goods, such as medicines.

Doctrine of equivalents and pharmaceutical patent infringement
ENSafrica
  • Healthcare & Life Sciences
  • South Africa
  • August 09 2017

South African pharmaceutical product litigation case law provides no particular test that refers to the doctrine of equivalents. However, when interpreting the scope of patent claims, the courts may hold that a claim extends to obviously substituted equivalents in the infringing product or process that are not literally provided for in the specification and claims. As such, a pharmaceutical product or process with chemical equivalents may also be considered to constitute infringement.

Human genome editing with CRISPR-Cas9: South African legal perspective
ENSafrica
  • Healthcare & Life Sciences
  • South Africa
  • May 17 2017

In South Africa, gene editing techniques have and are being used in research studies for therapy with adult human cells. However, the ethical concerns around somatic gene editing therapy are less controversial than with germline therapy. At present, the modification of a human embryo's germline for therapeutic purposes culminating in the reproduction of a human being is prohibited. Germline editing for research purposes might be permitted, but would require conditional ministerial approval.

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