South Africa: Patients' Rights: The Achilles Heel Of The Patient System? An Indian Perspective For South Africa

Currently there is litigation between a numbers of parties concerning the application of a patent in respect of a cancer medicine in South Africa. The parties concerned include Sanofi Aventis SA (Proprietary) Limited and Cipla Medpro (Proprietary) Limited ("Cipla"). The particular medicine concerned is a generic medicine currently being made available by Cipla and referred to as Cipla Docetaxel. The appellants, amongst them Sanofi Aventis SA (Proprietary) Limited, are endeavouring to obtain interim interdicts against the respondents preventing the respondents from making available and selling the medicine concerned in so far as the generic medicine infringes a patent held by the appellants under South African patent number 93/8936 and entitled "New Taxoid-Based Compositions.

The litigation is based primarily, if not exclusively, on the provisions of the Patents Act No. 57 of 1978. One of the aspects that has been raised within the context of the litigation, now before the Supreme Court of Appeal, is whether or not patients' rights have a role to play in determining whether or not patents should be protected. It is the issue of patients' rights that may bring into sharp focus the balancing act that a court will ultimately have to strike between the property rights contained in section 25 of the Constitution of the Republic of South Africa, 1996 ("the Constitution") and the right to access healthcare in section 27(1)(a) of the Constitution.

The current debate before the Supreme Court of Appeal follows debates in developing countries such as India and Brazil about the rights of patent holders of medicines, on the one hand, and the rights of generic manufacturers to sell medicines notwithstanding certain patent protections, on the other hand. The debates are premised on the rights of the Governments of developing countries to alter property regimes in order to facilitate, it is argued, the provision of medicine to and increase access to healthcare services for their populations.

The decisions of courts in other jurisdictions are also central to the issue of formulating the particular public interest arguments in the matter before the Supreme Court of Appeal, more particularly, the decision of Roche vs Cipla 159 (2009) DLT 243, MIPR 2009 (2) 1 ("the Indian decision"). The Indian decision is of great interest in relation to the stance that it intends to take on matters of access to cancer medicine for people living with HIV.

The Indian decision concerns the granting of an interdict in respect of the availability of a generic medicine in India pending the determination of a patent dispute. The Indian decision is a decision of the High Court of Delhi held at New Delhi and is an appeal decision. The Indian decision concerns a number of aspects concerning Indian patent law that are unique to this system of law based on the legislation applicable to patents in India. However, the Indian decision does deal with the issue of patients' rights in the context of the principles of "public interest.

The public interest is defined principally with reference to the harm that would ultimately be visited upon patients should a particular medicine become unavailable due to, in the Indian decision, a court granting an interdict. This harm is based on very particular evidence.

The evidence, in turn, is based on two primary premises: the first is how unique the medicine is in a particular market and the second is how successful the medicine is in treating a particular condition, which must ultimately be a medicine of a life-saving nature. The Indian decision summarises the decision of the first court before which the matter served in respect of the public interest as follows:–

What emerges from the Indian decision are the criteria to be used to address issues concerning public interest in the context of patients' rights. In this regard, the criteria need to be considered carefully in relation to how these criteria relate to the provisions of section 27(1)(a) of the Constitution. These criteria are the following: –

• the medicine in question must be a lifesaving medicine and used for a medical condition that has serious medical and social implications, such as cancer or HIV;
• the unavailability of the medicine, due to the granting of an interdict or similar court action, would cause such harm to patients so as to result in harm that could never be remedied in any manner by an alternative medicinal substance or treatment;
• the cost at which the medicine is being made available to the public and whether or not, based on the economic realities of the population that uses the medicine, that medicine is affordable. This is an important aspect of the matter as this is the counter argument to the argument that was raised in the Indian decision that "if the rights of a patentee are not respected then it would be contrary to the public interest of encouraging further research. Further it would discourage the requirement of disclosure which inheres in patent regime thereby creating a situation where opportunity of further innovation based on fundamental research on an existing patent product/process would be lost or unduly deferred." (See paragraph 72 on page 21 of the Indian decision). The High Court of Delhi rejected this as a basis for granting the interdict or dealing with the issue of public interest on the basis that "[t]his court is unable to accept the submissions of the plaintiffs on this aspect. The amendment to the Patents Act 1970 in 2005 introduced Section 83(e) which states that among the general principles applicable to the working of patented inventions regard shall be had 'that patents granted do not in any way prohibit Central Government in taking measures to promote public health' and under Section 83(g) 'that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.' Under Section 84 among the grounds on which a person can seek a compulsory license on a patent is that 'the patented invention is not available to the public at reasonably affordable price.' The element of public interest is therefore not alien to the scheme of the Patents Act 1970." One aspect that one needs to consider in South Africa is that our patent legislation may not contain similar provisions to that of the Indian statute;
• the demand for the medicine in a particular jurisdiction, which is a reference to epidemiological data;
• the consequences of depriving members of the public of the benefit of the medicine (see paragraph 79 of page 23 of the Indian decision). This onus is borne by the patent holder and must take into account the following –
  
  
  "A life-saving drug is in an exceptional position. There are often cases where a number of drugs exist alongside each other and are in general all equally efficacious for a particular ailment of disease. If the evidence shows it to be the fact that there may well be cases where it would make little, if any, difference to the public, apart from satisfying personal preference, whether a particular drug was no longer available or not, then in such a case it may well be proper to grant an injunction. At the other end of the scale, however, there is the unique life-saving drug where, in my judgment, it is at least very doubtful if the court in its discretion ever ought to grant an injunction and I cannot at present think of any circumstances where it should." (See paragraph 79 at page 23of the Indian decision);
  
  
• evidence concerning the views of patients in relation to whether they are peculiarly sensitive to and fearful of changes in medicine regimes (see paragraph 79 on page 23 of the Indian decision);
• evidence of what would occur if greater availability of the particular medicine in a particular country were to occur i.e. the relief imposed upon the disease burden of a particular country;
• the availability and success rate of the medicine in a population; and
• based on all that is set out above, whether or not the granting of an interdict or the refusal to grant an interdict would cause a disservice to the public, which is a blending of the position under Indian law with a decision of the United States Supreme Court in the matter of eBay Incorporated v MercExchange 547 US 288 [2006].

The conclusion of the Indian decision, in respect of the public interest, was that "[t]he question of general public access in [India] to life-saving drugs assumes great significance and the adverse impact on such access which the grant of injunction in a case like the instant one is likely to have, would have to be accounted for. This Court finds no ground to differ with the reasoning or the conclusions arrived at by the learned Single Judge on this aspect." (See paragraph 85 on page 25 of the Indian decision).

A number of points are highlighted by this action and deserve consideration –

• the issue of patients' rights may very well change the parameters of the debate about patents in South Africa as it has done in India;
• whether or not one is comfortable that patients' rights should trump property rights and how one would balance the rights of patients with the rights of pharmaceutical manufacturers to protect their proprietary interests;
• whether or not patients' rights always trumping proprietary interests is in the interests of future patients. Patient protection does facilitate and encourage further investment, research and development into new medicines, improvement in overall treatment regimens and facilitates access to aspects of treatment other than simply medicines such as medical devices, clinics, hospitals and similar centres of excellence.

The outcome of the matter before the Supreme Court of Appeal may very well influence political decision-making in so far as the power is already afforded to the Minister of Health ("the Minister"), in terms of section 15c(a) of the Medicines and Related Substances Act No. 101 of 1965, as amended, to take measures to ensure the supply of more affordable medicines. In terms of section 15c(a) the Minister is afforded the power to "prescribe conditions for the supply of more affordable medicines in certain circumstances so as to protect the health of the public, and in particular may ... may notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act No. 57 of 1978), determine that the rights with regards to any medicine under a patent granted in the Republic shall not extend to acts in respect of such medicine which is being put into the market by the owner of the medicine, or with his or her consent." In so far as such a remedy is already available within the confines of South African law, it may be argued that the necessity for the Supreme Court of Appeal to deal with issues concerning patent rights, within the context of medicines available within the Republic, is unnecessary as with proper motivation, the Minister may be in a position to deal more appropriately with proprietary rights in the interests of the health of the public.

What does remain evident is that the issue of patients' rights is securely on the healthcare agenda of developing countries. The potential clash in South Africa between patients' rights and property rights is now inevitable within a context of the Constitution and the manner in which that document, as the supreme law of the Republic, endeavours to balance the rights of property holders and cancer patients.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.