Experts Debate Medicines Access In South Africa And Beyond

CAPE TOWN – Pharmaceutical patents and access to medicines was the focus of an animated panel discussion by experts offering divergent views on the topic at intellectual property group FICPI’s 2015 World Congress, currently underway in Cape Town, South Africa.

The 2015 FICPI World Congress is taking place from 13-17 April.

Yesterday’s panel of experts was made up of a range of players, including: Ellen ’t Hoen, the founder of the Medicines Patent Pool; Fiona Bor, vice president and director of IP, Mylan; Jürgen Dressel, head, Global Patent Litigation Strategy, Novartis Pharma AG, Louis Harms, Hon Justice (former deputy president of the Supreme Court of Appeal) and professor in IP at the University of Pretoria in South Africa.

Dressel kicked off the discussion by seeking to debunk the term “ever-greening.” The term is used to describe the ways pharmaceutical companies use the law to extend intellectual property rights over drugs by obtaining new patents on variations of existing products.

Dressel argued that the term implies that by employing “artificial procedure,” pharmaceutical companies are able to extend a patent on a drug forever, which he says in reality, is not the case.

He warned against governments prohibiting secondary patents, arguing that it would inhibit further innovation especially in developing pharmaceutical industries. Dressel proposed globalised and harmonised patentability standards, strong and efficient examination and fair balance of technical contribution and exclusivity.

“There needs to be business certainty, otherwise there will be no innovation from originators, he emphasised.

Bor said that ever-greening is “not a simple innovator versus generic” debate and that the generic industry depends on big pharma.

“It is vital for the innovators to be successful at what they do and continue to innovate but this does not mean that all incremental innovation warrants a 20 year term of patent protection,” Bor said.

‘t Hoen said she believes the function of patents is to encourage inventors to make an investment in time and money in research and development by providing exclusive rights. But ’t Hoen added that patents have an effect on the prices of drugs which in turn influences R&D agendas.

She provided some suggestions to avoid ever-greening which included allowing pre-grant opposition for patents as well as post-grant measures such as exceptions and limitations.

Also on the panel, Harms brought the issue of pharmaceutical patents and access to medicines back to South Africa.

Harms, a South African, argued that misconceptions about what a patent is abound. He cited an example of an (unnamed) local politician who had said that big pharma stands guilty of “tweaking a molecule” thus allowing for a new patent to be registered.

“If you can simply tweak a molecule, then it is obvious, it can’t be patented,” he said.

Harms also took on the Treatment Action Campaign’s “Fix the Patent Laws” campaign which seeks to amend South Africa’s Patents Act 57 of 1978 to “reduce the cost of medicines.”

Harms said that the TAC’s campaign wants the law fixed “but they don’t say how.”

He said that he didn’t think that amendments to the act in line with India or Brazil would change incremental or adaptive innovations.

Harms also spoke of contradictory standpoints on intellectual property laws within the South African government.

“The Department of Trade and Industry have a different view to patents than the Department of Science and Technology.”

The Department of Science and Technology encourages research and patents, he said, while prima facie evidence in the form of the draft national IP policy (drafted by the Department of Trade and Industry) suggests that the Department of Trade and Industry (DTI) is anti-patents.

Harms said that the policy document points to DTI not conferring with the Department of Science and Technology in putting together the draft policy. “So within one government we have a conflict,” he asserted.

Meanwhile, ’t Hoen noted that to allow for more access to drugs, use of compulsory licences is not a “silver bullet,” given that they are territorial. She posed the question to delegates to consider “other ways to finance R&D.”

“Where we delink the cost of R&D from the cost of medicines …are there alternatives to patent systems?” she asked, encouraging delegates to further that train of thought and to explore it at the next FICPI conference.