Submission on the Patents Amendment Bill [B 17 – 2005]
The AIDS Law Project (ALP) and the Treatment Action Campaign (TAC) welcome this opportunity to make written submissions on the Patents Amendment Bill [B 17 – 2005] (“the Bill”). As two organisations that have consistently advocated for the development of our patent system into one that considers South Africa’s competitive advantage and takes into account the specific needs of its people, we support what the Bill aims to achieve and, in general terms, how it goes about accomplishing its stated objective. In our view, the Bill is a necessary and constitutionally required legislative measure that complements the National Environmental Management: Biodiversity Act, 10 of 2004 (“the Biodiversity Act”).
Over the past few years, the ALP and TAC have sought to use and develop the law to ensure that all people in South Africa have access to a sustainable supply of affordable medicines for preventing and treating HIV infection and AIDS-related illnesses. In particular, we have taken direct action to remove some of the many barriers that currently limit access to all essential medicines. Part of this work has included a focus on ensuring that the Patents Act, 57 of 1978, is amended to ensure a suitable balance between creating incentives for innovation and ensuring access to the benefits of scientific developments. This submission is made infurtherance of this body of work.
We support the Bill in general and in principle. However, we submit that if it is to play its rightful role in striking a balance between incentives for innovation and access to the benefits of scientific developments, it needs to be strengthened by:
- Requiring the applicant for a patent to submit proof of his or her title or authority to make use of the identified indigenous biological resource, genetic resource, traditional knowledge and/or traditional use. In our view, the mandatory submission of proof is preferable to the current formulationin the Bill that simply empowers the registrar to request such proof.Without the obligation on the applicant to submit proof, a patent could be granted in the absence of title or authority, amounting to classic biopiracy.
- Introducing a system of pre-grant opposition by interested parties, which is especially relevant in a country that does require (and may not have the capacity to conduct) full patent examinations.
- Ensuring that applicants for patents take all reasonable steps to ensure that they have title or authority to engage in bioprospecting, being research and development (“R&D”) based on indigenous biological resource, genetic resource, traditional knowledge and/or traditional use. The Bill merely proposes that a patent can be revoked if the declaration regarding bioprospecting is materially false and the applicant had knowledge of the falseness. In our view, this should be expanded to include cases where the applicant ought reasonably to have known that the declaration was materially false and would have known had he or she taken reasonable steps.
- Expanding the grounds of patent revocation to include revocation on the basis of a lack of valid legal title or authority.