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South Africa National Policy on Intellectual Property: Inconsistent with Biotech Development Goals

October 18, 2013
BIO submitted comments this week to the government of South Africa on their proposed “Draft National Policy on Intellectual Property.”  Below are some highlights.
“BIO and its member companies are aware of the South African government’s aspirations to develop its life sciences industry, a message that South African officials communicated clearly at the recent BIO International Conference in Chicago, USA, in April 2013. At that conference and in subsequent discussions, South African officials have sent strong signals that they intend to develop the Life Sciences sector, including biotechnology, to emerge as a global top 20 country by 2020.

BIO welcomes discussion of South Africa’s proposal to transition from a patent registration system to a system that would search and substantively examine patent applications from all fields of technology. The establishment of a new cross-disciplinary corps of hundreds of patent examiners could be an important step in building regulatory and technological capacity to promote industrial and agricultural innovation through the issuance of strong patents.

If building a South African substantive examination capacity is deemed a proper use of budgetary resources, not unnecessarily duplicative of work done by other patent offices (in the case of applications that were also filed in other jurisdictions), with searching and examination done in a timely manner and according to international best practices, this endeavor may result in stronger patents and more certainty for innovators in all technology areas.

The South African government should carefully consider the negative consequences of introducing new mechanisms that are likely to delay access to essential new technology for South Africans. For example, duplicative mechanisms (e.g. pre-grant oppositions or multiple agencies reviewing patent applications) can significantly delay patent grant and may not comport with the principles of justice and due process for innovators. In addition, these mechanisms may violate international treaty obligations, and delay market entry of the life-changing products biotechnology creates. We note that recently in Brazil, courts have held that a system involving the health regulatory authority is onerous to innovators and unnecessarily duplicative because applications are reviewed by the patent authority in that country.

Patentability restrictions and exclusions designed to benefit one industrial non-innovative sector also undermine innovation. All science occurs incrementally. Restrictions against “new uses of known products” remove necessary commercial incentives for innovators to conduct further research on breakthrough products. Such research could include testing proven cancer medications for other potential cancer targets, transferring drought tolerant genetic traits from one type of grain to another, and other areas of incremental innovation where South Africa may command a competitive advantage.

Likewise, exclusions for plant breeders and seed-saving exclusions undermine incentives to commercialize plant biotechnology innovation. Investors will not provide the necessary capital to test and seek regulatory approval of new ideas and educate customers when others can easily copy and resell their technologies without taking risks or investing their own capital. The South African government should carefully consider patentability restrictions and exclusions that retard the commercialization of innovation.

Finally, BIO believes that measures aimed at increasing access through the use of compulsory licenses and parallel importation are misguided and will not solve South Africa’s healthcare access problems. Incidentally, such measures would also have the effect of reducing incentives from global researchers and innovators to partner with companies or other parties in South Africa.

Indeed such measures often have the precise opposite effect… BIO’s members believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are not mutually exclusive-- rather they are mutually supportive.”

Read the full comments.