The novelty criterion is aimed at ensuring that only inventions, which do not form part of the state of the art, before the priority date, are entitled to benefit from patent protection. In fact, the monopoly granted by a patent can only be justified if the invention is not in the public domain, meaning that it has not been previously disclosed. There are two definitions of novelty, “relative novelty”, which considers an invention to be new only in relation to the state of the art in the country in which the patent protection is requested; and “absolute novelty”, which takes into account all prior disclosures globally.
Under the South African law, “an invention shall be deemed to be new if it does not form part of the state of the art immediately before the priority date of that invention” (Section 25(5)). The following Section 25(6), further explains the meaning of “state of art” affirming that it “shall comprise all matter (whether a product, a process, information about either, or anything else) which has been made available to the public (whether in the Republic or elsewhere) by written or oral description, by use or in any other way”. This provision makes clear that South Africa adheres
to an absolute definition of novelty. Thus, also a matter disclosed outside the country will nullify the novelty of the invention.
Yet, the South African jurisprudence has often broadly interpreted the novelty principle, holding that little differences between the prior art and the claimed invention are able to satisfy the novelty requirement. In the case Schlumberger Logelco Inc. v. Coflexip SA, the Supreme Court of Appeal stated that an invention is not anticipated “if the description in the prior document differs, even in a small respect”120. Thus, according to South African courts even a small difference between what exists in the prior art and what is claimed in the patent application, can be considered new and therefore meritorious of patent protection.
In addition, Section 25(9) of the South African Patents Act expressly recognises the patenting of new uses of already-known substances, which is an exception that goes beyond the patentability requirements set by the TRIPS Agreement. According to this provision: “In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art immediately before the priority date of the invention shall not prevent a patent being granted for the invention if the use of the substance or composition in any such method does not form part of the state of the art at that date”.121
Indeed, Section 25(9) manifestly brings into the South African system the so-called problem of
“patent evergreening”, that “is a patenting strategy consisting of acquiring patents on minor, often trivial, modifications of existing pharmaceutical products or processes in order to indirectly extend the period of patent protection over previously patented compounds”.122 Consequently, the
“evergreening” phenomenon allows pharmaceutical companies to maintain their control over a drug through issuance of a new patent for the small change they have made to the expired patent, which is an obvious obstacle to the manufacturing of the generic drug equivalents, and ultimately
120 See Schlumberger Logelco Inc. v. Coflexip SA, 2003 (1) SA 16 (SCA).
121 See Section 25(9) of the South African Patents Act.
122 C. Correa, “Pharmaceutical inventions: when is the granting of a patent justified?”, in Int. J. Intellectual Property Management, Vol. 1, Nos. 1/2 (2006) 20.
to access to medicine.123 In this way, a medicine already used for the treatment of a particular disease can be claimed as new, and therefore obtain patent protection, for the new use of the same invention. For example, as pointed out in the United Nations’ report of 2013, which investigated the condition of accessing essential medicines in South Africa, the ARV zidovudine (AZT), was developed in the 1960s as a cancer treatment. Subsequently, it was found that AZT could be used in the treatment of HIV. The existence of Section 25(9) of the South African Patents Act allowed the pharmaceutical company Burroughs Wellcome, now GlaxoSmithKline, to obtain patent protection for AZT as a “method of treating” HIV and AIDS. In light of the above, a stricter interpretation of the novelty principle would have nullified the novelty and impeded the grant of the patent.124
Despite the wording of South African Patents Act, the TRIPS Agreement contains no provision requiring an interpretation of the novelty criteria in the manner adopted by Section 25(9). In light of this consideration, the South African legislative authority could amend or delete the provision set by Section 25(9) so as to exclude a patent evergreening phenomenon consisting of granting a new patent for new uses of already-know substances.
Another aspect that should be taken into consideration when assessing the issue of access to medicine in South Africa, is the recognition and application in the country of the so-called mechanism of “selection patent”125. Even though a selection patent, which is a second patent granted for a selection of compounds from a broad range of compounds described in a prior patent, is acceptable in principle, it must strictly satisfy the requirements of novelty and non- obviousness.126 In practice, generic companies would not be able to produce generic equivalents after the initial patent had expired, where the monopoly of 20 years is extended beyond its natural
123 Interestingly, although the TRIPS Agreement does not impose WTO States to grant patents on new uses of already known substance, United States signed three bilateral FTAs with Morocco, Australia, and Bahrain, that extend the patentability to new uses of a known product (AFTA, art. 17.9.1; MFTA, art. 15.9.2; BFTA, art 14.8.2).
124 C. Park, A. Prabhala & J. Berger (note above) 29.
125 See C. Correa, (note above) 12, in which the author clarifies that “a ‘selection patent’ is a patent under which a single element or a small segment within a large known group is ‘selected’ and independently claimed based on a particular feature not mentioned in the large group”.
126 See B-M Group Ltd. v. Beecham Group Ltd. (note above) according to which “selection patents” is valid when
“the selected members” have some substantial, special, peculiar advantage over the other, unselected members.
term, by granting a new patent upon the selection of one or more elements already disclosed in the original patent.
Many legislations have a different approach regarding the acceptance of “selection patent”. In the UK, for instance, selection patents are subject to some restrictions: it is accepted only if it is based on some substantial advantage gained or disadvantage avoided.127 However, the selection is not valid, and therefore not patentable, when the quality of the selected group is not of special character, but it is common to the quality of the larger group for which the previous patent exists.
The European Patent Office (EPO) approach is stricter than the one followed by the UK.128 According to the EPO, when the subject matter of a new invention is the selected group of a larger class of compounds contained in a earlier patented invention, the selection is considered novel only if “(a) the selected sub-range is narrow compared to the known range; (b) the selected sub- range is sufficiently far removed from any specific examples disclosed in the prior art and from the end-points of the known range; (c) the selected range is not an arbitrary specimen of the prior art, i.e. not a mere embodiment of the prior art, but another invention (purposive selection, new technical teaching)”.129
Recently, the Argentinian Government in cooperation with the National Institute of Intellectual Property issued new guidelines regarding the patent applications, which specifically reject applications deemed as selection patents.130
Thus, as pointed out by a relevant scholar, “selection patents should not be admitted if the selected components have already been disclosed and, hence, lack novelty”.131
127 See the UK Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the UK Patent Office (May 2005), para 24 and Section 3 of the Manual of Patent Practice, para 3.27.
128 See the Technical Board of Appeal’s decisions in T12/81 (BAYER/Diastereoisomers) OJ 8/1982, 296 and in T 198/84 (Hoechst) OJ 1985, 209.
129 EPO, Guidelines for Examination, Part G - Patentability, Chapter VI - Novelty, Sect. 8(ii).
130 Joint Resolution No. 118/20012, 546/2012 and 107/2012 of May 2, 2012, of the Ministry of Industry, Ministry of Health and the National Industrial Property Institute, approving the Guidelines for the Examination of Patent Applications of Pharmaceutical and Chemical Inventions, Date of Entry into Force: 16 May 2012, available at http://
www.wipo.int/wipolex/en/details.jsp?id=13007, accessed in February 2015.
131 See C. Correa, (note above) 12.
In light of the above, it can be stated that a narrower interpretation of novelty which will expedite access to medicine in South Africa, is not only possible, as demonstrated by the approach taken by the EPO and Argentina, and importantly, is in line with the TRIPS Agreement provisions.