The battle for African generics

South African patents

There has been controversy in South Africa over access to a wide range of drugs. Campaigners argue that new patents are handed out too readily to pharmaceutical companies, preventing more competition in the sector and blocking access to badly needed generics. The main problem appears to be that patent applications are not properly checked to see that sufficient new research and development has actually taken place to justify extending or granting a patent. A study by researchers at the University of Pretoria found that four out of every five patents that were granted should have been rejected.

At the same time, some drugs are just not available to most people because of their cost. One example cited by critics is Pfizer’s tuberculosis drug linezolid, which costs R12,000 ($1,000) a month and funding is only available under medical cover in unusual circumstances, while no generic option is yet available because of patent protection.

New patent legislation is being prepared that could improve access to generics but its passage has been repeatedly delayed. The government has promised to introduce a patent regime in line with international standards that includes the option to grant compulsory licences when ‘a public health rationale exists’. This means that regulators can sanction the production of generics if the medical condition in question is having a really big impact on public health.

However, the big pharmaceutical companies have fought to protect their current strong position in the market. Pharmaceutical companies planned a campaign against the new legislation that the Minister of Health, Aaron Motsoaledi, described as “a genocide” and on a “satanic magnitude”.

Regulators need to prove that the public health rationale exists and this requires clinical trials. In the case of linezolid, Pfizer has greatly reduced its investment in infectious diseases research and so is unlikely to generate the kind of evidence that the regulator requires. In this way, drug companies can actually protect their revenues by reducing R&D spending, which is the opposite of what is intended by the patent system.

Ilne Grobler of South Africa intellectual property attorneys Von Seidels explains: “The secondary patents often prevent generic products being registered and the practice of filing these has been termed patent ‘evergreening’.

“Numerous patent cases have been fought over the patentability of new crystalline forms of APIs. A different arrangement of molecules in a single crystal, which is obtained when different processing or crystallisation methods are used, can result in a new crystalline form.

“A new crystalline form of an API may be superior to existing or ‘prior art’ crystalline forms by virtue of it having enhanced solubility, ease of formulation or stability. In some cases, its therapeutic efficacy may also be enhanced. Patentability disputes generally revolve around the novelty and inventiveness of a new crystalline form. However, what is considered inventive may vary from country to country.”

The chief director of policy and legislation at the Department of Trade and Industry (DTI) , Macdonald Netshitenzhe, comments “We are dealing with pharma companies many of which are multinationals. They are eating well under the system, therefore we are under extreme pressure to not come with substantive search and examination by the multinationals.” However, the Department of Trade and Industry has promised to complete the new regulations by the end of this year with a view to submitting the law to parliament.

If the new legislation is passed on time, patent applications should face a full search and examination process from the second half of next year. Speaking at a Treatment Action Campaign summit in October, Elena Zdravkova, the senior manager for patents and design at the Companies and Intellectual Property Commission, said: that new pharmaceutical applications would be given the highest priority, above that given to patent applications in almost every other industry, with the possible exception of mining.