The role of governments, both in South Africa and elsewhere in the world, in

finding cures for dread diseases such as AIDS and cancer is important but the impact is minimal. The main player in this regard is the private sector in gen-eral, and the pharmaceutical industry specifically.

“The truth is that our human hope for a cure for cancer, AIDS and other illnesses should not depend on the government’s will to pick the right research group to give money to,” said Chief judge Randall Rader US court of Appeals for the federal circuit in Washington DC.

“Research for cures is predominantly privately funded, and patents play an important role in this,” he added.

Before Rader became a judge, he worked for the American legislature and sat on the United States Appropriation committee a committee that deter-mines which organisation or research group would get federal funding for continuing research.

“Giving federal funding for health research was a significant responsibility of ours,” he recalled. “We would decide We were basically the ones who would decide who would get money for health research, and how much. For example, what breast cancer researchers would get and much the govern-ment would give to prostate cancer.”

“I felt very important in those days,” Rader pointed out. “We were talking about millions of dol-lars. I felt it was a very important duty, and of course it was. I then how-ever learned that the US government was responsible for less than 5% of the research funding for dread diseases in-

cluding cancer and AIDS. The rest came and still comes from the private sector.”

According to Rader, this particular set up is not confined to the United States alone and is appli-cable to other parts of the world, South Africa in-cluded.

He added that patents play a crucial role in the funding of healthcare research. “The patent system is our best hope of finding cures for various diseas-es,” Rader said, adding that it is a misconception that too many drugs are patented.

“A recent study of 350 medicines shows that less than 20 of these drugs were patented,” he noted. “Most of the patented medicines that were sur-veyed, with an exception of one of two, did not strike me as essen-tial. This tells me that the issue of patenting in the health sector is often over-em-phasised.”

Patents crucial in dread disease research

Judge Randall Rader

Judge Randall Rader addresses the delegates

The non-examining patents system in operation in South

Africa is detrimental to innova-tion in the country.

This was the view put forward by Professor Anastassios Pouris of the Institute for Technological Innovation, University of Pretoria during the panel discussion on Implications of Govern-mental Policies on the Rate of Innova-tion and Investment.

Professor Pouris said the existing pat-ent system is beneficial to certain indus-tries but ambivalent to others and that it creates substantial social costs.

“The South African authorities should aim to create an examining system of the same standard as the rest of the world,” Professor Pouris said.

The system excludes an official search by the Companies and Intellectual Prop-erty Commission (CIPC) in Pretoria which is the Patent Office for South Africa. The substantive examiniation process is used to determine whether the patent sought meets the strict requirements of section 25 of the Patents Acts – which sets out the requiremenets for eligibility for pat-ent protection.

“We are clever. We don’t need to have ex-aminers in the patents office. It’s too much trouble,” Professor Pouris joked. “You pay the two hundred bucks and get your pat-ents. It results in frivolous applications.”

He said in Australia only 20 percent of patents applied for are granted. In China the figure is six percent and in Finland two percent. “In South Africa, we award

100 percent of applications.Morné Barradas, Chief IP Legal Advisor,

Sasol Ltd, said a key lesson her organisa-tion has learnt is the importance of high-lighting Intellectual Property education throughout the organisation.

“This education starts with your in-novators, scientists and engineers. They must understand the full IP toolbox and how it should be utilised. This knowledge must be pulled through all managers and processes.”

She said Sasol, a petro-chemical com-pany, regularly monitors the global IP environment for risks, opportunities and other developments.

“How you position your IP assets gives you a clear direction on the best way to commercialise your technology.”

Lessons learnt by Sasol were: Protect proprietary technology at all costs and select appropriate IP strategies to best position the company.

Germǻn Velǻsquez, Special Advisor for Health and Development, South Cen-tre, Geneva said while patents might be important for economic growth in many different fields, it is a different matter in the pharmaceutical sector, where access is vital. “You will not die if you don’t have the latest version of the Apple Ipod, but you can die if you don’t have the medi-cines you need.”

He said globally, only 20 percent of people needing Antiretroviral treatment are receiving it and a third of the world’s population do not have regular access to essential medicines, with the WHO say-

ing that 30 000 children die every day from diseases that could be easily treated with access to medicines.

Velasquez concluded there is a need for a rethink on global public health gov-ernance. Binding health laws and norms should be adopted. International nego-tiations should begin towards a binding global instrument for research and de-velopment and innovation for health, as recommended by the WHO’s Consulta-tive Expert Working Group (CEWG), set up to find ways to finance research and development into diseases afflicting de-veloping countries.

Frank Grassler, Vice President, Intellec-tual Property, Gilead Sciences Inc, New York cited a case study of a small group of scientists in Czechoslovakia who came up with a key compound which was adapted and used in AIDS treatments.

“The invention of the drug VIREAD and its subsequent success, resulted in a flow of sizeable royalties from sales back to the institute in Prague.

“The same thing can happen in SA if you can establish a climate for gifted scientists and engineers to protect their inventions by patents throughout the world markets.

“Your future minds are going to come from all sections of the country as the spread of intellect is equal. The kids in the shanty towns will produce as many new drugs or rechargeable batteries as kids from all over the country. So give them the educational opportunities to benefit your country,” he added.

sa’s Patent system is ‘detrimental’

German Velasquez Morne’ Barradas

Professor Anastassios Pouris

resPonsible iP use can lead to further develoPment of hiv drugs

Eight years after launching its international HIV access

programme, pharmaceutical company Gilead Science will be reaching 1.6 million HIV patients living in developing countries by the end of this year.

“Today, over two thirds of the 2.3 million people that are taking our antiretroviral drugs (ARVs), live in developing countries,” said Clifford Samuel, vice president of Gilead In-ternational Access Operations, this afternoon.

The objective of Gilead’s 2003 initia-tive was to make its various ARVs - drugs that are crucial in prolonging the lives of those living with HIV - accessible to all patients who needed them.

“Especially in developing countries. It is here where 95% of the world’s HIV pa-tients – over 34 million – live,” he pointed out, adding that Gilead currently delivers ARVs to 132 developing countries around the world.

“We use a two-tracked system to achieve this. Our branded distribution track comprises 11 regional partners which supply steeply discounted brand-ed products,” he pointed out.

“The generic licensing track comprises 13 licensing partners in India, which are producing low cost but quality generic versions of our ARVs.”

“We chose India because that particu-lar country is renowned for being able to manufacture cheap but high quality ge-neric medications,” Samuel emphasised.

Over the past few years, HIV drugs and other medications have become more and more sophisticated and innovative, Samuel pointed out.

“We have seen some major innova-tions in therapies for infectious diseases such as HIV. In 1996, someone living with the virus needed a cocktail of quite a few different drugs,” he explained while showing a photograph of a hand holding up over a dozen of pills and tablets. “In 2006, the same treatment is contained in one tablet.”

Despite the scientific progress of the past decades, the world continues to face

challenges when it comes to delivering treatment for infectious diseases, Samuel said. Funding is one of them.

He emphasised that the responsible use of IP can ensure investment and thus innovation when it comes to treatment for infectious diseases.

“IP stimulates private investment, which is one of the drivers of research,” he said.

“For instance, we see that licensing and the transfer of technology allows for roy-alty payments,” Samuel continued, add-ing that at Gilead “royalty payments – 5% on sales of the finished product – are used to support the registration of new drugs, for further medical education and research, safety monitoring and drawing up demand forecasts.”

Dr Frank Litvack gives his address over Skype

Clifford Samuel & Gordon Myers Ambassador Dr Konji Sebati

In South Africa, the Big Five re-fer to the trophies sought by

hunters and photographers: li-ons, leopards, elephants, buffalo and rhinoceros.

In the intellectual property ecosystem, the Big Five are rather different:: Europe, the USA, China, Korea and Japan.

The IP Big Five deal with just under 75 per-cent of all the world’s patent applications.

Teresa Stanek Rea, the deputy director of the US Patent and Trademark Office in Washington, DC, was pleased that efforts to create ‘‘work-sharing’’ were underway in order to combat the US backlog, cur-rently standing at two years until the first action is filed.

‘‘If we can trust the work of the exam-iner in Europe and then do a tiny supple-mental search, we can leverage our work product,’’ Rea told delegates at a session on creating a model patent office in de-

veloping countries.Rea listed ten joint projects for the IP

Big Five, including common classifica-tion, search protocol, information tech-nology systems and software.

In the ideal world of patent harmoni-sation, she foresaw ‘‘a one portal dossier where the examiner in the USA can get online and get access to the Korean and European decisions.’’

Later, in the question and answer ses-sion, Rea – who filed her first patent in 1980 – urged developing nations not to institute a costly and detailed examiner system until the Big 5 had made progress on harmonisation.

Valentin Mir, the director of inter-national affairs for the European Pat-ent Office, also referred to the Big Five when warning developing nations that ‘‘it makes no sense to have IP just for the sake of IP.’’

Speaking via Skype from Germany, Mir urged delegates to ‘‘make use of other patent offices, not to repeat unnecessar-ily this work.’’

Agreement came from James Pooley, the American-born deputy director general for innovation and technology for the 144 countries which make up the World Intel-lectual Property Organization (WIPO).

Economists said that the examination system did not survive a costs-benefit analysis, Pooley said. In fact, fewer than five percent of patents that went through the system seemed to have any value at all – although often economists used litigation to demonstrate that the patent was currently significant enough to war-rant a battle!

He also identified the problematic op-portunity costs of an examiner system: ‘‘if you bring in hundreds of your highly trained engineers and scientists, these are people who are not working at the workbench or the lab, who are not in-venting themselves.’’

If South Africa was to adopt an ex-amination system, Pooley suggested, it might be worthwhile using it only in spe-cific contexts, such as software, health, or medical devices.

Pooley also urged South African del-egates to consider sharing the burden by using a regional rather than a national or-ganisation, such as the African Regional Intellectual Property Office (ARIPO), based in Zimbabwe.

John Kabare, the Kenya-born senior pat-ent examiner within the 18-country ARIPO, noted that the organisation was already handling the registration of marks on be-half of ten of its member states.

The Bulgarian-born Elena Zdravkova, now the registrar of patents at South Africa’s new Companies and Intellec-tual Property Commission, highlighted a number of concerns.

These included the fact that foreign ap-plications dominated domestic ones, in-dicating that ‘‘the ratio is not very good in terms of our technology development,’’ she said.

More alarmingly, ‘‘the registrar is not in a position to ensure compliance with the Patents Act,’’ Zdravkova said. ‘‘The lack of control by the government leads to grant-ing of patents invalid from the outset.’’

This resulted in a situation in which powerful companies could block the rel-evant market sector ‘‘to the disadvantage of local small and medium enterprises.’’

Overall, speakers at session seven agreed that there were many choices and routes for ideas en route to building something practical and substantial.

As Pooley noted, ideas ‘‘have to cross the valley of death before reaching com-mercialisation.’’

the big five of Patents

Elena Zdravkova

Teresa Stanek Rea and James Pooley

John Ndirangu Kabare

netWorKing time: a meeting of minds and a Place to forge ties

It takes about four years to li-cense and register a medicine

in South Africa because the coun-try has run into a serious capacity problem.

So said Rene Doms, a South African Fo-rensic and Regulatory Pharmacist, during the panel discussion on Regulatory Aspects of Product Development: Acceleration of Approvals in Developing Countries.

Doms said four years is “a very long time” – especially for a patent-protected medi-cine to be registered.

“It’s all about time to market and how quickly one can get out there and start sell-ing. Unfortunately it is very, very difficult for developing countries to find people with the knowledge to evaluate a medicine. Medicines are registered for quality, safety, efficacy and suitability. To find people with the right capacity is a very difficult task,” Doms said.

He said the another problem for the reg-ulatory authority is the “lengthy and com-plicated” guidelines and regulations.

Doms advised foreigners wishing to trade in South Africa to find a local consult-ant to help them work though “the maze of paperwork”.

“I have yet to find a country in the world that is totally compatible with the next. “Come into the country, get help and the consultants who operate in this area will be in position to walk you through whole process,” he said.

Murray M Lumpkin, Senior Advisor, Of-fice of the Commissioner in the US Food and Drug Administration in Washington, talked delegates through some of the ef-forts made in the USA to create incentives for needed products when the market does not create those incentives.

Among these was the Orphan Legislation, adopted in the mid-1980s which focused on trying to create incentives for compa-nies to develop products aimed at illnesses contracted by fewer than 200 000 patients a year. Incentives included market exclusiv-ity, tax breaks and initial research grants.

The result was that 350 drugs had been brought into the market since 1983, as op-posed to fewer than ten products before the legislation was introduced.

A similar incentive programme, intro-duced into the area of paediatric medicine in 1997 resulted in more than 420 new safe products for children.

Incentives had also been introduced into the issue of tropical medicines with the re-sults still remaining to be seen.

Lumpkin said their newest regulatory approach is the fast-track, rolling review for products for serious life threatening products.

“We don’t wait till the end of develop-ment. We work with the company and the pieces of the marketing application are submitted sequentially.”

He said while countries all have domestic mandates, they are all intertwined in the regulatory enterprise.

Addressing the subject of how to register and license innovative pharmaceuticals, An-thony E Lockett, Medical Director, Biovaxp-harma in the United Kingdom said it is time to stop “re-inventing the wheel”.

“We need greater data sharing. We need to stop repeating trials in the US and Eu-rope purely because one doesn’t accept other data. We need openness to share data.”

It was crucial to educate the regulators of products in a wider field. “We need to have more regulatory understanding especially when dealing with oncology and HIV etc.”

He said with the increasing focus on meas-uring effectiveness, the phase four stage of trials is becoming more important.

Kelebohile Lekoape, Regulatory Affairs Manager, Bioscience, Bayer (Pty) Ltd dis-cussed the policy behind genetically modi-fied foods and crops and the regulatory ap-proval of those products.

She said challenges to plant biotech growth include the long and costly research and development timeline. “The cost to dis-cover and develop a new plant biotech trait is very high, and can it can take up to 15 years,” she said, adding that there is an even longer and costlier authorisation timeline.

Lekoape said her wish-list for improving the system was strong legislative protec-tion for innovations and products, as well as science-based risk assessments, harmo-nised policy-making, and transparency and predictability in decision making..

exPerts call for quicKer authorisations

Kelebohile Lekoape

Murray M Lumpkin through Skype

Rene Doms

innovation in the sPirit of ubuntu

Going beyond the conference theme of accelerating IP and

innovation, Deputy Minister for Science and Technology Derek Hanekom stated that the real challenge in South Africa is to find effective mechanisms to support and encourage more intellectual activity, invention and discovery leading to innovative solutions for the challenges our society faces and increasing innovation in our economy.

“An effective IP regime that encour-ages intellectual endeavour and crea-tivity offers a potentially powerful tool in the pursuit of innovation and competitiveness,” he suggested, while cautioning that excessive emphasis on the protection of knowledge could counteract the principles of collabora-tion and sharing of knowledge which we should be fostering. “The spirit of Ubuntu must never be discarded,” he declared emphatically.

September as Heritage Month cel-ebrates South Africans past and present and we have much of which to be proud. But despite the wealth of talent, creativ-ity and energy found in our country, we have not succeeded in reaching the re-quired sustained economic growth levels to create enough jobs and offer dignity to millions of unemployed in our country.

While the new IP Rights from Publicly Financed Research and Development Act ‘aims to identify, protect and utilise IP for the benefit of the people of the republic’, it should not be seen as an end in itself, said Hanekom. We need to achieve bet-ter alignment between development agendas and national imperatives. “Intel-

lectual property regimes in developing countries should be supportive of our de-velopment objectives,” he suggested. One of these objectives is to move from being a primarily resource-based economy to a knowledge-based economy.

“We cannot be a proudly self-sufficient economy if we continue to merely make use of the knowledge generated by other nations, without building capacity to gen-erate knowledge that is indeed Proudly South African.”

Hanekom noted the calibre of research conducted by South Africa’s various universities and science councils ranks among the best in the world. Where the focus has previously been on publica-tions and other academic indicators, “the major challenge lies in the translation of this research into tangible outcomes,” he said, highlighting the need to convert IP into products and services that have a positive impact on South Africans.

He said that the act is an attempt to correct this imbalance by ensuring that a proper management and legislative framework for publicly financed IP is in place. The new IP law should encourage local competition and innovation and the subsequent establishment of NIPMO will provide an instrument that monitors, fa-cilitates and aids a thriving national sys-tem of innovation.

The conference was closed with gener-ous compliments and promises of sup-port from stakeholders and a surprise appearance by Chief Judge Randall Rader in his role of singer and entertainer, tak-ing up the mic and singing The Rolling Stones’ Honky Tonk Women to delegates’ great delight. It proved an excellent close to a successful conference.

Ms Nombuyiselo Mokoena

Dr Michael Mol

Hon.Mr derek HanekomMcLean Sibanda leads the applause Judge Randall Rader entertaining the guests

Delegates looking fine at the gala dinner

This newsletter was produced by the team from hippocommunications.com. Stories by Miriam Mannak, Sue Segar, Jacqui Lund and Christina Scott. Design by Simon Wilson. Photographs by Andrew Swarts