Patent Enforcement In The Life Sciences Sector In South Africa – Quo Vadis?

The dynamics of the pharmaceutical market in South Africa and the pharmaceutical patent enforcement landscape is changing rapidly, especially in the light of recent developments towards the end of 2013 with a new Draft National Intellectual Property Policy.
 
Some of the reasons for the change stems from a greater need to provide access to medicine, often times blaming the patent system for the hold up, the successful amendment to Indian patent law and the successful attacks on patents relating to new crystalline forms or polymorphs, new formulations, new uses and the like in India; the introduction of authorised generics into the market by originator research and development entities prior to patent expiry and the launch of generic products by generic manufacturers, at risk, during the pendency of a patent.
 
From an enforcement point of view, the judicial enforcement of patents relating to pharmaceutical products is alive and well, a landmark case having taken place mid-2012.  In Cipla Medpro (Pty) Ltd v Aventis Pharma SA, Aventis Pharma SA and Others v Cipla Life Sciences (Pty) Ltd and Others (139/2012, 138/2012) [2012] ZASCA 108; 2013 (4) SA 579 (SCA) (26 July 2012), the issue of public interest was added to South African jurisprudence as a factor to be considered when looking at the balance of convenience in granting an interim injunction.
 
In 2010, the Sanofi-Aventis group sought to enforce a patent for its oncology drug Taxotere® (and its authorised generic, Docetere),against Cipla-Medpro (the local distributor of Cipla India’s products in South Africa).  In an appeal against the denial of an interim injunction by the court a quo, the Treatment Action Campaign (an activist group promoting access to medicine, amongst other things, hereinafter referred to as the TAC) unexpectedly sought to intervene as an amicus curiae.
 
In short the TAC argued that the rights under the Patents Act should be viewed through “the prism” of the Constitution of South Africa, especially with reference to Section 27 of the Constitution which provides that everyone has the right to have access to healthcare services, which includes the right to have access to medicines. 
 
For the purposes of argument before the Supreme Court of Appeal, Sanofi-Aventis accepted that the issue of public interest could indeed play a role in a court exercising its discretion in the grant or refusal of a preliminary injunction.  On the facts of the case, the court nevertheless overturned the lower court decision by granting the preliminary injunction in favour of Sanofi-Aventis.  It was clear from the facts of the case that there was no prejudice to patients in either the private or public sector, being adequately served by the originator and the authorised generic and thus the issue of “public interest” was not adversely affected. 
 
The outcome was seen as a significant victory for innovator pharmaceutical companies as is perhaps best illustrated by the following extracts from the judgment:
 
“Bearing in mind the commercial advantage of first-entry to the generics market, it is common for a patentee of a pharmaceutical product to enter the market shortly before its patent expires with an alternative product that will compete with anticipated generics.”
 
“The TAC’s opposition to the grant of the interdict (injunction) really comes down to no more than opposition to the monopoly that the law confers upon a patentee.  It submits that those who cannot afford Taxotere, but are able to afford the price of Cipla docetaxel, will be prejudiced if distribution of the latter were to be prohibited.  Where the public is denied access to a generic during the lifetime of a patent that is the ordinary consequence of patent protection and it applies as much in all cases.  To refuse an interdict only so as to frustrate the patentee’s lawful monopoly seems to me to be an abuse of the discretionary powers of a court.”
 
More recently, in the case of ASTRAZENECA AB & ASTRAZENECA PHARMACEUTRICALS (PTY) LTD V SANDOZ SA (PTY) LTD, September 2013 (unreported at the time of drafting this article), Astrazeneca successfully obtained an interim injunction against Sandoz in respect of Nexiam®.  The judgement is particularly instructive insofar as the question of urgency in injunction proceedings is concerned and in terms of launching at risk while a patent is in force, the court stated that any loss of reputation occasioned by the withdrawal of the generic product from the market would be of the generic manufacturer’s own making for launching at risk.  The case is however currently being appealed. 
 
Finally, and insofar as the future of patent protection and enforcement in the pharmaceutical sector is concerned note must be taken of the DRAFT NATIONAL POLICY ON INTELLECTUAL PROPERTY, 2013, General Notice 918 of 2013 GG 36816 of 4 September 2013(the policy), which at this point is merely in draft form, and does not have the force of law.  The policy also comes amidst much activism to promote access to medicines and to reduce patent protection for inventions relating to pharmaceutical products.
 
The policy, inter alia, deals with the need for amendment of the South African Patents Act so as to be amenable to public health, and to facilitate entry of generic medicines.  Reference is also made to the use of pre- and post-grant opposition proceedings in India to prevent the granting of ‘weak’ patents and that similar provisions should apply in South Africa.  Although there is no specific reference to such weak patents as relating to patents going beyond a basic pharmaceutical compound (e.g. different crystalline forms etc) the intention, the author believes, is clearly there and the policy has already been cited in litigation proceedings. 
 
The policy has attracted much criticism both locally and internationally, by various industry sectors and the legal fraternity.  The South African Health Minister, Aaron Motsoaledi, has, very recently, in response to a draft document entitled “Campaign to Prevent Damage to Innovation from the Proposed Draft National IP Policy (Mail & Guardian, 17 to 22 January 2014, Vol 30, No 3) accused a group of multinational pharmaceutical companies of conspiring against the state, labelling the plan as a conspiracy of “satanic proportions”. 
 
Unfortunately there is a lot of misinformation on the current South African patent law and its effect on access to medicines and any campaign which would result in an honest, open, informed and rational discussion on these aspects should be encouraged.  The policy however has a very long road to travel and thereafter legislation would have to be amended to be in line with the policy.  In this process the author believes that there will be much consultation and that an objective and fair policy will result which will hold approval both locally and internationally.