Intellectual Property Policy Reform in South Africa
Part II
In the previous edition of this series, we discussed South Africa’s current patent position and this edition we will tackle the non-examination practice and evergreening in South Africa.
Non-examination practice and evergreening
South Africa uses a depository system for patent applications this means applications are examined if they meet the formalities with no substantive search and examination required. Any complete patent application that is filed and meets with the formal requirements (fees and correct forms) of the Patents Act will therefore be granted.
It’s interesting to note that section 34 of the Patents Act states that there should be an examination of patent applications, however, the patent regulations state that the “examination” is limited to whether the application meets the procedural requirements.
South Africa’s approach of not examining patent claims creates undesirable consequences, for example, the patent office grants applications that meet the procedural requirements and in doing so it may grant patents that fall into excluded categories like software code or grant patents that have a very wide breadth of patent claims in turn creating obstacles for further research and development in certain fields.
The act of applying for patents with wide claims is known as Markush claims. A Markush claim is a patent claim that lists alternative species or elements that can be viewed as being part of the claimed invention. Markush claims theoretically impede research and development and the commercialization of medicines. This is further exacerbated by the patent’s office lack of a comprehensive search portal, which makes it more difficult and expensive for new or small companies to do validity searches. A potential patentee could abandon his/her research and development under a threat of a potentially expensive litigious patent infringement suit.
Pharmaceutical companies tend to file several patent applications for the same drug, and in such applications, different features would be subject to patent applications i.e. the process used to manufacture the molecule, the form the medicine would take e.g. powder, tablet etc, the dosage, derivative forms of medicine. This would result in one drug being subject to separate multiple patent applications. By filing these multiple applications pharmaceutical companies can extend their monopoly on a certain drug for longer than the intended period by the Patents Act, this act is often referred to as “evergreening”. The act of evergreening prevents a drug from going into the public domain, which results in the delay or blockage of generic versions of that drug, which limits the access to pharmaceutical medicine. Pharmaceutical companies get away with such practices such as evergreening due to the non-examination of patent claims.[1] Vastly put, evergreening undermines the country’s ability to provide affordable access to medication and the growth of the generic medicine industry.
It has been said that the Patents Act has checks and balances in place in the form of Section 68[2] to make sure that a patentee of an invalid patent cannot enforce their rights. The provision aims to make sure that the patent applicant ensures that their claims are valid. However, I am of the view that section 68 is not enough and more proactive approach has to be taken i.e. having patent examiners for starters. Some practitioners/academics have also said that in practice other legislations also serve as a check and balance to curb the abuse of the patent system such as the Competition Act, and the Medicines and Related Substances Act. Section 15C of Medicines and Related Substances Act allows parallel importation of drugs, which itself goes against the Patents Act.
Section 45 (1) of the Patents Act states “that the effect of the patent shall be to grant the patentee the right to exclude other persons from making, using, exercising, disposing or offering to dispose of, or importing the invention so that the patentee shall have and enjoy the whole profit and advantage accruing by reason of the invention.” Parallel importation occurs when a genuine good is bought from another country and imported to South Africa without the consent of the intellectual property rights owner in this instance a patent holder. I am of the view that the Patents Act should sufficiently deal with its shortfalls and interested parties should not rely on other legislation to circumvent the shortfalls of the Patents Act that could be fixed.
Having patent examiners would be beneficial as they would play an important role in safeguarding the quality by:
1. Reviewing the patent application to determine whether it complies with the requirements.
2. “Devising and performing a search of previously issued patents and other published literature to determine whether the claimed invention is both novel and not an obvious extension or variation of what is already known.
Patent and non-patent literature (e.g. scientific, technical, business or other published literature) that is relevant to defining the claims or defeating the patent altogether is known as prior art. Patent applicants may submit prior art for consideration by the examiner or the examiner may be aware of pertinent prior art or discover it during the search. Applicants are required to disclose prior art known to them that may be material to the examination of their applications.”[3]
3. Determine the scope of protection for the claims made by the patentee.
4. “Examining the application to determine that the claimed invention was not known and would not have been obvious to a person of ordinary skill in the art at the time of invention based on the prior art found during the search, that the invention has utility and that the invention is described in such full, clear and concise terms as to enable a person of ordinary skills in the art to make and use it.”[4]
The advantages of examining patent applications may include but are not limited to:
I. Only valid patents will be licensed
II. Expensive IP Litigations can be avoided
III. Parties can avoid paying royalties for invalid patents
IV. Prior art in search reports can be used for reverse engineering, patent information & IP exploitation
The disadvantages of examining patents:
I. Potential high costs for the patent application.
II. Longer periods for patent applications to be granted
The examination of the patent application would curb the practice of evergreening amongst other things. I am of the view that the advantages of examining patent applications far outweigh the disadvantages.
— — — — — — — — — — — — — — — — — — — — — — — — — — — — —
[1] Why South Africa should Examine Pharmaceutical Patents, MEDICINS SANS FRONTIERES ACCESS CAMPAIGN 11–12 (2013), http://www.msfaccess.org/content/why-south-africashould-examine-pharmaceutical-patents (05 May 2020)
[2] Patents Act section 68; Relief for infringement of partially valid specification. Where in any proceedings for infringement of a patent, the commissioner finds that any claim in the complete specification in respect of which infringement is alleged, is valid, but that any other claim therein is invalid, the following provisions shall, notwithstanding anything contained in section 66 (5), apply, namely —
(a) If a counterclaim for the revocation of the patent has been made in the proceedings on the ground of the invalidity of any claim in the specification, the commissioner may postpone the operation of any order issued thereon for such time as may be required to enable the patentee to effect any amendment of the specification pursuant to the conditions imposed by the commissioner, who may attach such other condition to any order to be issued on the counterclaim as he may deem fit; and
(b) when the specification has been amended in terms of paragraph (a), the commissioner may, subject to such order as to costs as he may issue and as to the date from which damages shall be calculated, grant relief in respect of any claim which had, before the amendment, been found to be valid and infringed, and in exercising his discretion he may take into consideration the conduct of the patentee in inserting in the specification those claims which had been found, before amendment, to be invalid or permitting such claims to remain there.
[3] Pouris A, Pouris A. Patents and economic development in South Africa: Managing intellectual property rights. South African Journal of Science. 2011 Jan, 107(11–12) 01–10 on page 5.
[4] Above.
