South Africa writes IP policy making it harder to get drug patents

Big Pharma has fought bruising battles in India over intellectual property. China has added compulsory licensing to its bag of tricks for dealing with costly drugs. Now drugmakers can add South Africa to the list of countries that are looking askance at unimpeded patents.

The South African government is asking for comments by Oct. 4 on a proposed National Policy on Intellectual Property, PharmaTimes reports. It would raise the bar on innovation, striking a blow at what critics consider "evergreening" by drug companies to extend patent protection.

The problem, critics contend, is that South Africa currently doesn't even examine patent applications. It just hands them out, allowing drugmakers to get a number of patents on the same drug. Often the patents are for items that don't qualify under the country's definition of innovation. Health groups that work with the poor, like Medecins Sans Frontieres (MSF), point out that in 2008, South Africa granted 2,442 pharmaceutical patents, while a country like Brazil approved only 278 in the 5 years between 2003 and 2008.

The result for South Africans, they contend, is that it keeps cheaper generics from getting on the market. For example, Novartis' ($NVS) patent on leukemia drug Glivec, first granted in 1993, was set to expire in April. Instead, MSF says a secondary patent will protect it until 2022. India, by comparison, recently denied Novartis a patent on the drug.

South Africa is not a huge market, but it is one of those emerging markets that Big Pharma has been turning to as growth in developed markets has slowed. But the governments of some emerging markets like China, South Africa and Brazil are learning from the battles fought over patents in India. China last month yanked the patent on Gilead Sciences' ($GILD) popular HIV and hepatitis B drug Viread (tenofovir) on a challenge from a generic drugmaker there. The move is expected to cut the price of the drug in half.

Of course, the comments are only the first step toward a potentially tougher IP market in South Africa. The government would have to create and fund a much more sophisticated process for evaluating and granting patents. As the health groups noted, "the principles in the document set the stage for changes that promise to increase competition in the pharmaceutical sector and lower the price of medicines in the sector."

- read the PharmaTimes story