Pharmaceutical Patent Loophole to Close

South Africa is looking to close a loophole in its patent law which allows drug companies to extend their patent protection through “ever-greening”. By slightly modifying an existing drug and passing it off as new, or “ever-greening” the drug, pharmaceutical companies extend their patent protection and continue to profit at the expense of the poorer population who is unable to afford the brand-name drugs.

This overhaul to South Africa’s intellectual property law is intended to make it much more difficult for drug companies to rollover patents on their medicines. In turn, the market for generic and cheaper versions of important cancer and HIV/AID drugs would improve, making these vital medicines accessible to a population that has one of the highest HIV infection rates in the world.

The Department of Trade and Industry’s Head of Policy, MacDonald Netshitenzhe, explained: "We have a policy position that says 'Let us have a strong system that will not grant easy patents.’”

Many organisations and lobby groups stand by the proposed changes. Doctors Without Borders (MSF) spokesperson, Julia Hill, agrees that “South Africans are missing out on affordable versions of life-saving medicines because generic competition is blocked by frivolous patents that prevent or delay generic competition.” In fact, MSF is urging the South African government to follow India’s lead in their approach to patent drug law.

As stated in section 3(d) of the Indian Patents Act, no patents will be granted for new versions of known drug molecules, unless they make the medicine significantly more effective than before. MSF wants South Africa to enact a similar clause into their patent law reform, in turn giving the government more power over “ever-greening.” It could also pave the way for challenging money-hungry pharmaceutical companies in court, which is something the Supreme Court of India recently did.

In a landmark decision by the Supreme Court of India, a patent application for a slightly altered version of the Glivec cancer medicine created by Swiss drug maker Novartis AG was dismissed. Despite Novartis’ efforts to prove increased efficacy of its altered drug, the court believed their application to be purely an attempt at “ever-greening.” The impact of this court ruling is far reaching.

Currently, Novartis’ monopoly on its cancer drug in South Africa, as a result of the patent loophole, prices the drug at 259 times more expensive than the cheapest generic alternative available in India. Should South Africa’s parliament agree to the patent reforms, the impact could be equally beneficial as it was for India. The price of the drug will plummet, cheaper alternatives could enter the market and access to drugs will improve significantly.