The redraft of South Africa’s intellectual property (IP) policy could have significant ramifications for the pharmaceutical industry, says specialist IP law firm Spoor & Fisher partner David Cochrane.
He suggests that the redraft was partially prompted by the concerns of pharmaceutical companies over the current IP policy’s lack of clarity, stating that this was caused, in part, by a lack of input from IP experts when the document was originally drafted in 2013.
The most significant concern for pharmaceutical companies is if the redrafted policy suggests amendments to the patentability requirements, which could make it increasingly difficult to patent pharmaceutical technology, Cochrane says.
However, he points out that this will not improve access to medicine in South Africa, as there are already mechanisms to ensure pharmaceutical companies make patented drugs available in the event of a legitimate public health concern.
This has already taken place in South Africa with the granting of licences for patented antiretroviral (ARV) drugs to treat the human immunodeficiency virus (HIV), enabling those infected with HIV access to significantly cheaper generic ARV medication, Cochrane notes.
Further, pharmaceutical companies have also expressed concern over the IP policy lacking an extension-of-term clause, which is used to extend the timeframe of a patent, should a product launch into a country be delayed, owing to regulatory requirements, such as human trials.
“A significant amount of work and time goes into the research and development of pharmaceuticals, including human trials and applying for regulatory approval in various countries such as the Medicines Control Council in South Africa. This process can take up to 15 years, while a patent is valid only for 20 years,” Cochrane highlights, adding that it is unlikely that South Africa will include an extension-of-term clause in the redrafted IP policy.
Meanwhile, activists have expressed concern over pharmaceutical companies’ ‘evergreening’ patents, a practice whereby a patent that is not legitimately new and inventive is used to extend the term of patent protection over a product.
Cochrane points out that although South Africa, which lacks a patent examination office, has a registration system in place for patents, the court system will not allow a patent that is not new and inventive to be enforced. This ensures that only valid patents are enforced and evergreening is prevented, however, the problem with the court procedure is that it is expensive to challenge the validity of a patent.
He adds that the South African government has indicated that it is proceeding with the development of a local patent examination office, which he suspects will be established within the next three to four years, provided the necessary skills and resources are available to successfully examine patentability requirements. The establishment of a patent examination office can help to prevent invalid patents from being granted in the first place.
However, the draft local IP policy suggests the formation of an IP tribunal, which would handle matters concerning IP before an IP dispute is heard in court, making it less expensive for third parties to challenge the validity of a patent.
In view of the draft IP policy, Cochrane suggests that local IP laws may be amended in the future to be more in line with the flexibilities allowed in the Trade-related Aspects of Intellectual Property Rights (Trips) agreement and the Doha Declaration, particularly in the areas of compulsory licensing and parallel importation.
“The Trips agreement refers particularly to public health, and I believe that our laws could be amended in the future to refer in particular to the granting of compulsory licences for public health, which is not explicitly mentioned in the law at this time,” he concludes.