An enormous amount of intellectual energy has gone into the global response to HIV & AIDS over the past 30 years. The results have been visible in local, national, and international spheres at community and governance levels. These results have included awareness campaigns and advocacy; increasingly tailored and effective policies from prevention to treatment to care; and research and medical developments, from diagnostic tests to treatments for opportunistic infections (most notably tuberculosis) in addition to anti-retroviral therapy to stop HIV reproduction and stave off the onset of AIDS. Despite the progress, the fight to counter the spread of HIV has been mired in controversies over intellectual property rights, which stymie further progress.

This CAI discussion paper delves briefly into the definition and importance of intellectual property rights and the role that they play in the response to the HIV & AIDS pandemic. Furthermore, it identifies how intellectual property rights may be employed to maximum benefit. It analyses and offers an update on the erstwhile intellectual property right stalemate with regard to the pandemic. Finally, it proffers some recommendations on the way forward – for intellectual property rights to benefit all.

Progress

Intellectual property is a heady subject. According to the most common definition, it is a “property right” applied to “works, ideas, discoveries, and interventions.”⁽²⁾ It relates to “intangible property such as patents, trademarks, copyrights, and trade secrets.” A patent, furthermore, “is the right to exclude others from making, using or selling the invention… without the authorisation of the patent owner.⁽³⁾ In other words, “it is a limited monopoly granted by the government for the term period of the patent; after the patent expires, anyone may make, use or sell the invention.”⁽⁴⁾ In the context of HIV & AIDS, it is intellectual property rights, and more visibly, patents, that form the core of the matter, as patents protect the production, sale and resale of the life-saving anti-retroviral drugs and medicines upon which HIV-infected persons rely to survive.

Patents are generally issued for a period of 20 years and are subject to extension due to upgrades in the original design and content of the patented intervention, i.e. a medical drug or combination pill. Patents have ruled the HIV & AIDS response for decades. First they served as an impetus for the development of initial treatments before the enormity of the crisis and potential profits were evidenced. Later they served to secure research progress and reap profits, as it became clear that the majority of those requiring patented treatments were unable to pay, relying instead on donor programmes, such as the US President’s Emergency Fund to Fight AIDS (PEPFAR), which exclusively purchased patented drugs under its first authorisation in 2003.

The provisions of the World Trade Organisation’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) legislation, first adopted in 1995, require all countries to recognise and protect intellectual property rights and patents. With specific regard to pharmaceuticals, developing countries were allowed to delay the adoption of TRIPS until 1 January 2005, e.g. India, which became the world’s main developer and manufacturer of generic drugs. Ministers at WTO have extended the TRIPS adoption in least developed countries until 1 January 2016.⁽⁵⁾ Technically TRIPS offers countries the possibility of invoking voluntary and compulsory licenses in order to access the trade secrets involved in manufacturing patented medicines, in the case of national emergencies. These provisions, though, were often challenged in court, notably in cases in Brazil and South Africa.

However, the era of the monopoly of patents, and even of the relatively inflexible application of the TRIPS’ provisions might be nearing an end. This is attributable to two factors: a rising sense of the need for collaboration in order to continue the fight against HIV & AIDS – in all areas, including advocacy, policy, research and development and delivery; and a change in India’s role from generic producer of patented medications to a cutting-edge innovator in its own right. Evidence of the former is the re-organisation of PEPFAR, UNAIDS and the World Health Organisation’s aid efforts to support and shore up national HIV & AIDS and health programmes and the decrease in the availability of domestic funding sources in the wake of the 2007-2008 global financial crisis. Signifying the latter is India’s adoption of TRIPS and its signalled intention to move up the value-chain of pharmaceutical invention, creating, for example, a combination pill consisting of numerous – usually four – antiretrovirals; or developing heat-resistant pills stable in the absence of refrigeration.

The result is two-fold. First, greater collaboration breeds greater cooperation, as seen in recent efforts to create (imperfect) patent pools. Second, out of this collaboration and coordination a new interpretation of intellectual property appears to be emerging: a notion of intellectual property for all.

Patent pools

Medical advances that could benefit the developing world are a foremost inspiration for patent pools. These are innovations that address diseases that primarily affect the poor, including but not limited to HIV & AIDS. The notion is that new technologies work and so should be made widely available. After all, in an ever more globally connected world HIV & AIDS potentially affects all people so efforts to combat and eradicate it should be available to all including those who are unable to pay. Anti-retroviral drug technology is the most hopeful effort to combat HIV & AIDS, and it has been argued that “people with H.I.V who start their antiretroviral therapy as soon as they are diagnosed, instead of waiting for their immune systems to degrade, have a near-zero chance of passing the virus on to their sexual partners…a 96 percent drop in infection rates is far better protection than any currently conceived AIDS vaccine could provide. It has also now been shown that giving one antiretroviral pill a day to people who don’t have HIV but are at very high risk for catching it can reduce their risk by two-thirds or more.”⁽⁶⁾ Of course to make ARV therapy widely available, this means coordinating policy and making provision for providing the necessary drugs – first-line, second-line and eventually third-line (at least) – to all those who need them. Produced by different companies, the only way this might be feasible is for the companies to join forces, share innovative insights, and enable the joint production and distribution of medical prowess.

In 2010, in a show of support from the Obama administration, the U.S. National Institutes of Health (NIH) became the first entity to donate intellectual property to a patent pool – The Medicines Patent Pool. The Medicines Patent Pool is “a two-year-old organisation that was established by UNITAID, an international body dedicated to buying AIDS drugs. The US NIH gave the pool, rights to an AIDS drug developed in NIH labs. Then in early July 2011, Gilead Sciences, one of the most important manufacturers of AIDS drugs, became the first drug maker to join. In joining the patent pool, Gilead agrees to let generic pharmaceutical companies copy four of its drugs for sale at very low prices in poor countries. Gilead will get a small royalty for every copy sold.”⁽⁷⁾ Significantly, “the licence agreement with Gilead Sciences will help make medicines available at a lower cost and in easier-to-use formulations without delays,”⁽⁸⁾ eliminating the usual years-long way for access to life-saving drugs.

Most recently, in October 2011, Aurobindo Pharma and MedChem became the first producers of generic antiretroviral medicines to join the Medicines Patent Pool, through which they can take advantage of the agreement signed between Gilead Sciences and the Medicines Patent Pool in July. Under the provisions of the Patent Pool, all participating companies gain access to the necessary information to manufacture various individual antiretrovirals, as well as the combination pill called the ‘Quad’, which contains tenofovir, emtricitabine, cobistat and elvitegravir. In addition, generics manufacturer MedChem has also chosen to produce tenofovir.⁽⁹⁾

“Generic manufacturers can also improve on the drugs in other ways — by inventing formulations that are heat-stable, for example, or made for children. (To encourage the development of paediatric formulations, which are in very short supply, Gilead says it will waive its royalties on these drugs.)”⁽¹⁰⁾ Similarly, the Medicines Patent Pool could become a force to drive drug prices down - on the one hand, by licensing various generic manufacturers to make them, thereby creating competition, and on the other, by selling these generic medicines in middle-income countries, creating larger markets which will bring down prices.

However, these benefits of competition and of bringing generic medicines into the middle-income countries that need them have not as yet been fully realised. In fact, they are currently still considerably curtailed. At present, the Medicines Patent Pool only allows for Indian generic manufacturers. Furthermore, “the agreement Gilead negotiated only covers very poor countries. It leaves out Egypt, China, Brazil, plus dozens of other developing countries;”⁽¹¹⁾ as well as Russia, where an epidemic is burgeoning.

Intellectual property

The collaboration and cooperation on display in the patent pool are also impacting the deployment of intellectual property rights, which have undergone various metamorphoses over the past 15-20 years especially. At the outset, TRIPS stipulated intellectual property (IP) protections with limited exemptions to lower- and least- income countries, a tendency currently being reinforced by the so-called TRIPS-Plus provisions, which further extend such safeguards.⁽¹²⁾ However, although intellectual property rights have been, and still are, couched as a trade off between protecting and thereby enabling (expensive) innovation and inventions versus offering inexpensive access to the final product, particularly life-saving medications, this need not the be case.

Just as patent pools might offer a win-win scenario for both companies and patients, so, too can collective intellectual property ownership. This is evidenced by the emergence of “public-private product development partnerships (PDPs).”⁽¹³⁾ PDPs assume much of the early-stage risk of investing in research and development, including scientific contribution, and technical and clinical assets, thus engaging the private sector into what would ordinarily be prohibitively costly and risky product development projects. PDPs have so far brought more than a dozen new products to market — including malaria drugs and vaccines against cholera and meningococcal disease. The latter also affects the weakened immune systems of HIV-infected individuals, and collectively account for at least 150 biomedical products under development.

The International AIDS Vaccine Initiative (IAVI) is an example of a PDP. Applying the PDP model, IAVI files patents to “ensure its freedom to operate and the ability to guarantee that products developed through IAVI funding (and by extension, donors) are brought to market”⁽¹⁴⁾ in accordance with its stated public health imperative.

In order to operate according to the model, IAVI might retain rights to a potential product in the initial phase of the development, while planning to transfer development rights to a partner once a product reaches its proof of concept. This transfer provides the partner with the rights to manufacture and distribute a potential product in developed countries, for instance, while IAVI retains these rights for developing countries. Or, “a partner might be granted exclusive or non-exclusive rights to manufacture and develop for a specific region or worldwide, provided they commit to distribute the vaccine at accessible prices in developing countries.”⁽¹⁵⁾ The aim is the same as that of the patent pool, underscored by the new wave of public policies brought to the table: collective and collaborative action to address HIV & AIDS around the globe.

Prognoses and conclusion

The provisions of intellectual property are shifting. These include patent pools and PDPs, which are in turn influencing and changing the erstwhile discussion from a bionic one, pitting exclusive property rights and associated innovation against mass access of the ensuring products, to one of mutual benefit. This is further underscored by two additional trends.

The first is a renewed call, at international and national levels, for increased country-ownership of treatment and prevention for the entire approach to health – from recognising the right to health to the realisation thereof. This is leading nations to invest in their own responses and their own structures, and to increase their bargaining power vis-à-vis partner countries and (multinational) companies, most notably, African nations at the frontline of the fight against HIV & AIDS, faced with chronic health systems’ crises.

The second is India’s own transformation from a generic manufacturer and late-stage innovator to a research and development powerhouse initiating an innovation line, as discussed. On the one hand this threatens to limit the flow of life-saving generics (especially to Africa); on the other, it is expected to stimulate African nations (at present notably Mozambique, South Africa and Uganda) to experiment and produce their own medicines as well.

Given these new and emerging trends in intellectual property rights and their attendant applications, it can be concluded that IP can become a benefit for all.

NOTES:

(1) Contact Annamarie Bindenagel Šehović through Consultancy Africa Intelligence's HIV & AIDS Unit (hivaids@consultancyafrica.com).
(2) ‘Intellectual Property Law and Legal Definition’, USLegal, http://definitions.uslegal.com.
(3) Ibid.
(4) Ibid.
(5) ‘TRIPS: A More Detailed Overview of the TRIPS Agreement,’ http://www.wto.org.
(6) Tina Rosenberg, ‘Sharing Patents to Wipe Out AIDS’, The New York Times, 21 July 2011, http://opinionator.blogs.nytimes.com.
(7) Ibid.
(8) ‘Gilead first to join medicines patent pool’, PlusNews, 12 July 2011, http://www.plusnews.org.
(9) ‘Medicines Patent Pool helps make antiretroviral medicines more widely available’, 14 October 2011, http://www.unaids.org.
(10) Tina Rosenberg, ‘Sharing Patents to Wipe Out AIDS’, The New York Times, 21 July 2011, http://opinionator.blogs.nytimes.com.
(11) Countries excluded from the Patent Pool/Gilead deal for Gilead’s drugs already on the market: Asia: China, Malaysia, North Korea, Philippines; Latin America: Argentina, Brazil, Chile, Colombia, Paraguay, Peru, Uruguay, Venezuela; Central America: Costa Rica, Mexico, Panama; Middle East: Iran, Iraq, Jordan, Lebanon; Eastern Europe & Baltics: Albania, Azerbaijan, Belarus, Bulgaria, Croatia, Czech Rep, Estonia, Hungary, Latvia, Lithuania, Montenegro, Poland, Republic of Kosovo, Republic of Macedonia, Romania, Russia, Serbia, Slovak Rep, Turkey, Ukraine; Africa: Algeria, Egypt, Libya, Morocco, Tunisia; Island Nations: Marshall Islands, Micronesia. Countries that will be excluded from the Patent Pool for Gilead drugs still in trials: Asia: China, Indonesia, Kazakhstan, Malaysia, North Korea, Philippines, Sri Lanka, Thailand, Turkmenistan; Latin America: Argentina, Brazil, Chile, Colombia, Ecuador, El Salvador, Paraguay, Peru, Uruguay, Venezuela; Central America: Costa Rica, Mexico, Panama; Middle East: Iran, Iraq, Jordan, Lebanon; Eastern Europe & Baltics: Albania, Azerbaijan, Belarus, Bulgaria, Croatia, Czech Rep, Estonia, Hungary, Latvia, Lithuania, Montenegro, Poland, Republic of Kosovo, Republic of Macedonia, Romania, Russia, Serbia, Slovak Rep, Turkey, Ukraine; Africa: Algeria, Botswana, Egypt, Libya, Morocco, Namibia, Tunisia; Island Nations: Marshall Islands, Micronesia.
(12) ‘Using TRIPS flexibilities to improve access to HIV treatment’, UNAIDS Policy Brief, http://www.unaids.org.
(13) Margaret McGlynn, ‘Using IP to accelerate product development and ensure access’, Results for Development Institute, Centre for Global Health R&D, Policy Assessment, http://healthresearchpolicy.org.
(14) Ibid.
(15) Ibid.

Written by Annamarie Bindenagel Šehović ⁽¹⁾