News Link n. 88

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


News Link 88

Environmental Justice Atlas   

South Africans urge Trade Minister to finalise IP policy before elections and open up access to medicines  

Changing mind-sets, transforming research   

Building Research Capacity in Africa: Equity and Global Health Collaborations

US Defends Investor-State Provisions; EU Promotes TTIP Consultation

US companies fret over selling TTIP  

Alleged Leaked EU Analysis Sheds Light On TTIP Negotiations On IP

Scare Tactics Over Foreign Drugs 

Sunshine Act. La trasparenza nelle transazioni tra medici e Big Pharma

Alternative Therapies, Incentive Models Eyed For Antibiotic Resistance

New Business Models  for Sustainable Antibiotics

Pneumonia vaccine shows promise in Kenya   

How She builds……  

The 1000 Day Investment for Our Future 

Farm Subsidies: Cairns Group Paper Riles India, China 

UN human rights experts denounce land-grabbing case in Viet Nam 

What do farmers really know about climate change? 

Five tips for producing more food, saving the planet and making more money   

We are at war with climate change and hunger: Yeb Saño   

A Cassava Revolution Could Feed the World’s Hungry

The Cost of Corruption  

Papa Francesco e la dimensione sociale della salute 

Muhammad Yunus reaveals Social Business as Powerful Weapon Against poverty  

Somaliland: Nine Problems That Hinder Partnership in Africa

West African states close to trade deal with EU 




Whither the Endgame of the Anti-Vaccination Movement?

Effective immunization programs protect our communities and our way of life from innumerable communicable diseases, while encouraging development efforts abroad. Eradication is a laudable goal that can only mean better health for all. Thus, it matters not if anti-vaccinators are radical militants or Hollywood celebrities; they stand with each other, and with these preventable diseases

Whither the Endgame of the Anti-Vaccination Movement?


By Lawrence C. Loh, MD, MPH, CCFP, FRCPC*

Adjunct lecturer at the University of Toronto’s School of Public Health, co-founder and Director of Operations at The 53rd Week



A roadside bomb detonates in northwest Pakistan, and militants open fire on a convoy in an hour-long attack that kills 12 and wounds dozens more.  This attack successfully disrupts the delivery of polio vaccine to a remote area of the subcontinent, delaying and hampering ongoing efforts to eradicate poliovirus from the face of the earth. Meanwhile, across the world, in a boardroom meeting in Canada, a group of public health professionals fall silent at news that containment of a measles outbreak has failed. Despite their best efforts, what started as a few cases in a school with poor vaccination coverage has now exposed people in retail settings, transport terminals, universities, and healthcare facilities. These widespread community exposures are compounded with declining rates of vaccine coverage, which all but assure ongoing spread. Measles remains as infectious at it has ever been.

These professionals are fighting the same war that humanity has waged against disease and contagion for millennia.  These scenes are battles, repeated all over the world, to that cause; battles of recent times that have not gone well. Increasingly, public health encounters opposition from the very people who they are trying to protect from these diseases. Be it allegations that vaccination is a Western plot to sterilise Muslims, or misguided beliefs based on spurious or fully retracted research, a small but vocal minority in populations cling to their beliefs, spread misinformation, and make it easier for the diseases to spread and win battles. A decision to not vaccinate threatens overall community immunity, allows the re-establishment of disease transmission in the public, and threatens to undo the work of decades of battles won against vaccine-preventable diseases.

As with any conflict, there are sides, each with their own resources and special weapons. In the fog of war it is often difficult to determine which side will be victorious, and sometimes difficult to see which side is the “€œright side”€. To make this analogy easy, let us define the “€œright side”€ as the side you’€™re meant to cheer for when you’€™re watching the hindsight Hollywood depiction years later. In this sense, public health professionals and advocates will argue that they make a compelling case for being that side. Their weapons and tools are immunisation, surveillance, and isolation, all backed by research and evidence that prove their effectiveness in turning the tide.

Deploying these resources has brought about measured successes, including the eradication of smallpox and the bringing of polio to the brink. Immunisation and related efforts have prevented innumerable cases of diseases worldwide, directly alleviating human suffering and protecting healthcare resources while indirectly driving the educational, social, and economic development of nations.

So who is on the other side? For centuries, the diseases that plagued society stood alone on the other end. As outbreak after outbreak crippled children, scientists raced to discover an effective way to treat or prevent disease while societies stood together to support these efforts. The discovery of vaccination meant that slowly, one by one, former scourges fell to the ingenuity of science and innovation.  Diseases like diphtheria, measles, and mumps, all became far less commonplace. As communicable disease rates plummeted, civilisations flourished. Quality of life improved, economies thrived, and non-communicable diseases began to replace vaccine-preventable diseases as contemporary concerns.

In their near defeat, the vaccine preventable diseases found an unlikely ally. Their virtual disappearance made them less of a threat to human society. Through success, though, vaccination turned out to be its own worst enemy perhaps; by removing these diseases from public consciousness, vaccines themselves have come under scrutiny. The spectre of crippling polio was replaced by pointed questions about vaccines. A spectrum of reasons -€””€œconscientious”€ objection, anti-establishment views, religious re-interpretation -€”brought together with junk science and double-agents – €”has succeeded in giving vaccine preventable diseases a breakthrough in areas which have not seen battle for many years.

Celebrities make spurious claims about long-disproved, barely rational linkages between immunisations and any number of diseases. Healthcare workers taking care of vulnerable populations still continue to resist policies that make immunisation with flu vaccine mandatory. And as they do, the diseases return with a vengeance. Measles, once nearly eliminated in North America, now leaves communities all over the continent stricken. Public health departments struggle with limited resources to control outbreaks of pertussis.

Thus, to return to the analogy: the war yet rages on, but today, the sides and their resources are far more complex. Public health and their allies continue with their tools of immunisation, surveillance, isolation, prophylaxis, and prevention, while anti-vaccination folks have aligned with these preventable diseases, spreading their opinion and sharing misinformation that leads people to opt-out of vaccination. That much is clear.

As with any war, there is also strategy involved. And for at least one of these sides, the endgame is absolutely clear. Those that stand on the side of immunisation are looking to defeat these diseases. After the success of smallpox, with polio on the brink, these groups would imagine a world where the threat of many of these communicable diseases is eliminated or minimised as much as possible. Their endgame is the safeguarding of health through prevention, and through the eradication, of vaccine preventable diseases.


The polio endgame

The polio campaign is one of the most demonstrable examples of the strategic goal of those who support immunization. Polio, once an endemic virus spread by fecal-oral transmission, once darkened many families’€™ hopes with paralysis and iron lungs. Today, it is endemic in three final countries in the world: Pakistan, Afghanistan, and Nigeria. The formerly perceived impossibility of interrupting poliovirus transmission in India came to pass in January 2014, with endemic transmission of polio not seen in this populous nation for 3 full years.

Driven by the World Health Organization (WHO), Rotary International, the United States Centers for Disease Control (CDC) and the United Nations International Children’s Emergency Fund (UNICEF), the Global Polio Eradication Initiative oversees ongoing programs in polio endemic areas, research, and fundraising worldwide. An ambitious goal of no wild-type transmission of polio by 2014 has been set. There are detailed, outlined plans to strengthen surveillance systems and secure polio vaccine stocks and certify regions as polio-free while synchronising an eventual change from oral polio vaccine to inactivated polio vaccine.

Efforts to eradicate polio drew their inspiration from smallpox eradication efforts. To date, smallpox remains the only such disease eradicated. It had the benefit of a very effective, heat-stable vaccine that could be transported to myriad far-flung locations and administered with a bifurcated needle that was readily available in remote outposts and could be readily re-sterilised. Trained local staff, together with international experts, would quickly identify outbreaks of smallpox and deploy the vaccine to prevent its spread. In the last days of smallpox, efforts intensified; cases were actively sought out and their close contacts vaccinated. Hard work paid off when the last case of smallpox was reported in 1977 in Somalia.

Polio eradication efforts stand on the cusp of a similar victory. It has been a far more challenging road, but the endgame and strategy remains the same -€”use vaccination to wipe an otherwise incurable disease off the face of the earth. Provided diseases meet certain criteria, they could all theoretically be a candidate for eradication. And the optimists in the public health field often highlight that a world without vaccine-preventable diseases would be a wonderful world indeed.

As Poonam Singh, the South-East Asian Regional Director for the World Health Organization, stated on India’€™s being certified polio-free: “Such an achievement can also be reached for diseases such as measles and rubella […] eradication helps to reduce poverty and give children and families a greater chance of leading healthy and productive lives.”€

In the ongoing struggle against communicable disease, those who would vaccinate espouse a clearly defined strategy with unequivocal goals.


The rise of the anti-vaccinators

One wonders what vision those who are against vaccines hold. Much vaccine refusal is rooted in fear: fears that certain vaccines are linked to autism (a research finding since retracted and heavily discredited); fears of the contents of vaccines; fears of societal medicalisation; moral fears of promiscuity in adolescents. Despite the disease-free modern world we live in today as a tribute to earlier immunisation programs, vaccines have become the enemy, and are feared.

Many famous anti-vaccine activists are successful because they appeal to base human fears of the unknown. In a world where measles or mumps no longer causes encephalitis (brain inflammation), they become an unknown. “€œWhat is this vaccine really doing to our kids? How can we know it is preventing what it claims to be preventing? How do we know it isn’€™t necessarily causing something worse? “€œ

Anti-vaccinators trot out stories of their children. Their stories tug at heartstrings, and they support their views with whatever “€œevidence”€ they can find, rather than let evidence dictate their views. And in doing so, they influence a too-often persuadable public to not vaccinate. Other members of the public find other reasons to not vaccinate: “€œbig pharma is screwing us”€, “€œit’€™s not the natural solution I ascribe to”€, or “€œI’€™m simply just scared of needles”€.

The end result is still the same. The collective immunity that protected our communities from these diseases and drove the prosperity of the 1960s-2000s is now dropping across continents. Measles outbreaks from the Netherlands get imported into our backyard here in North America. Pertussis has returned with a big whoop and cry. Public health departments, struggling to cope with rising obesity, cardiovascular disease, cancer and diabetes (the other by-products of affluence: chronic disease) now contend with re-established transmission of diseases once thought eliminated.

And through it all, anti-vaccinators get what they wanted; they did not need to take a vaccine. In many ways, this reflects the “€œme-first”€ nature of today’€™s society. They get what they wanted. Never mind that with the return of these diseases, the weak and infirm are more vulnerable to being exposed, infected, and dying. Never mind the economic impact that new measles outbreaks will cause as tourists flee and business close to prevent spread. And of course, as diseases re-establish transmission in communities, at least their kid didn’t have to get vaccinated, never mind that someone else’s kid manages to contract meningitis.


A story of two endgames

Thus, returning to the initial premise that there are two sides, we can see that each side’€™s strategies and resources drive towards very different ends.

Those who would vaccinate propose an endgame where collective health is a target to be aimed towards. They recognize the importance of collective immunity in interrupting disease transmission, and are acutely aware that public health departments need to be able to focus on the challenges of our time. Health needs to be able to turn back obesity, chronic disease, and mental health issues without also worrying about preventable communicable diseases.

Those who would vaccinate believe the world would be a better place without polio, mumps, measles, meningitis, whooping cough, Hepatitis B, cervical cancer, and any other number of diseases. These are the people who are putting themselves out there every day; working tirelessly to deliver immunisations, educate the public, and in some cases, putting themselves in harm’s way for the cause of polio eradication.

They recognize that the modern societies we live in today have enjoyed economic prosperity and development owing to the immensely effective control of communicable disease through hygiene and vaccination. They want to address communicable disease because today’€™s challenges are increasingly non-communicable: over a quarter of most adults in the industrialised world are obese, while depression and injuries take their toll on the younger, more productive members of our society. Tobacco and unsafe alcohol use continue to take lives every year and years off of lives.

They also recognise that in the developing world, immunisation remains one tool in an arsenal against poverty; it guarantees a modicum of health for those who live in indigent settings; it allows healthy children and youth to make use of education and social services to become productive members of a growing nation and economy.

On the other side, what precisely is the anti-vaccination endgame?

In a world where vaccinations are shunned, we have the return of outbreaks that bring fear and hamper efforts on other critical public health issues of our time. Massive recurring measles outbreaks become de rigueur; when one pops up, isolation protocols disrupt daily life, bankrupting small businesses while turning schools and community centres into ghost towns. Public health efforts to address other issues (chronic disease, or mental health) go by the wayside as outbreak after outbreak calls for containment.

People remember the halcyon days where adequate population coverage meant that they could travel without having to regularly check their immunity at their physician’€™s office. Influenza strikes more people harder due to more frequent transmission and mutation. Eventually, driven by a massive swing in popular opinion, governments de-list immunizations from public insurance plans. Some individuals pay for immunizations privately and benefit, but society as a whole does not reap the benefits of collective immunity because there simply aren’t enough people vaccinated.

This dystopian future serves to illustrate a simple point: ask an anti-vaccinator what their endgame is. We need to challenge their assertions beyond the surface answer. Dig deeper, and genuinely explore how they see the future. No matter how much one believes in celebrity star power, natural solutions, or even the non sequitur “€œbecause I believe in being healthy”€, the fallacy of an anti-vaccine argument unravels very quickly when taken to its logical question of “€œBut what if we as a society chose not to vaccinate? What then?”

Effective immunization programs protect our communities and our way of life from innumerable communicable diseases, while encouraging development efforts abroad. Eradication of polio and other vaccine preventable diseases is a laudable goal that can only mean better health for all.

Thus, it matters not if anti-vaccinators are radical militants or Hollywood celebrities. By refusing to vaccinate, they stand with each other, and with these ancient, preventable diseases.

Seen in the stark light of the endgame and goals, “€œthe right side”€ in the vaccination debate becomes quickly obvious.



*Dr. Lawrence Loh is a global public health and family physician based in Vancouver. He serves as a Medical Health Officer at Fraser Health Authority and as an adjunct lecturer at the School of Public Health at the University of Toronto. A proud alumni of the Schulich School of Medicine at the University of Western Ontario, he completed his residency at the University of Toronto and obtained his Master of Public Health from the Johns Hopkins Bloomberg School of Public Health. He serves as co-founder and Director of Operations for The 53rd Week and is committed to reducing the harms and maximising the outcomes of short-term global health experiences through awareness advocacy, innovation, and research.

To learn more about what The 53rd Week is doing to improve short-term volunteerism abroad, visit

The High Price of Drug Patents: Australia, Patent Law, Pharmaceutical Drugs and the Trans-Pacific Partnership

 Published by the Australian Government on the 20th March 2014, the independent "Pharmaceutical Patents Review Report" recommends to shorten and reduce patent term extensions, to address the problems of evergreening and data protection, and to reverse Australia's passive approach to the negotiation of intellectual property and international trade. The report emphasizes the need for Australia to protect its public health interests in the negotiation of the "Trans-Pacific Partnership"

The High Price of Drug Patents: Australia, Patent Law, Pharmaceutical Drugs and the Trans-Pacific Partnership

by Matthew Rimmer*

Associate professor, Australian National University College of Law, Canberra

This week, the secrecy surrounding an independent Australian report on patent law and pharmaceutical drugs has been lifted, and the work has been published to great acclaim.

On the 20th March 2014, the Australian Government published the final version of an independent policy report, the Pharmaceutical Patents Review Report, after much public pressure.1 The report has significant implications in respect of patent law, pharmaceutical drugs, the Pharmaceutical Benefits Scheme, and trade policy -€“ particularly in respect of the Trans-Pacific Partnership. The independent report has also highlighted the opportunity of great savings for the Australian health-care system through shortening patent term extensions. The economist Peter Martin has warned: ‘€˜Australia’s enthusiastic approach to extending the life of pharmaceutical patents has cost the economy “€œbillions of dollars”€ an independent review has found.’€™2

This paper provides a short review of the Pharmaceutical Patents Review Report, and highlights key recommendations. In particular, it looks at the call by the review for a frugal, parsimonious approach to the granting of patent rights in respect of pharmaceutical drugs in Australia. The paper considers the recommendations of the Pharmaceutical Patents Review Report to shorten and reduce patent term extensions. It examines the proposed recommendations to address the problem of evergreening. This paper also considers the debate over data protection. Finally, the Pharmaceutical Patents Review Report is critical of Australia’€™s passive approach to the negotiation of intellectual property and international trade. The findings of the report emphasize the need for Australia to protect its public health interests in the negotiation of the Trans-Pacific Partnership.

The Pharmaceutical Patents Review Report

Under the leadership of Julia Gillard, the Australian Labor Party took a keen interest in the impact of patent law upon research, patient care, and the provision of health-care.3 Indeed, Gillard had taken a particular interest in patent owners engaging in the nefarious practice of ‘€˜evergreening’€™ -€“ extending the life of patents beyond their natural term by making minor changes.

The report had been commissioned by Mark Dreyfus QC MP, a Parliamentary Secretary for Innovation in the former Australian Labor Party Government. The review was designed to examine whether Australia’€™s patent system was ‘€˜effective in securing timely access to competitively priced pharmaceuticals and in supporting innovation and employment in the industry.’€™ The report was undertaken by three well-respected experts -€“ Tony Harris; intellectual property academic Professor Dianne Nicol, and economist Dr Nicholas Gruen.

Initially, the Minister for Industry Ian McFarlane for the new Coalition Government was reluctant to release the final report. Melissa Parke MP -€“ the member for Fremantle -€“ asked in the Australian Parliament: ‘€˜By what date will he release the final report of the 2012 Pharmaceutical Patents Review, and is he considering the draft recommendations released in April 2013?.’€™4 Ian McFarlane responded that ‘€˜the Government has no plans to release the final report at this stage’€™ and ‘€˜the Government is not considering the recommendations made by the panel in the draft report.’€™ Ian McFarlane maintained: ‘€˜As the Pharmaceutical Patents Review was commissioned by the previous government and conducted by an independent panel, the government is not obliged to release the report.’

Dr Deborah Gleeson from LaTrobe University highlighted the failure of the Coalition Government to publish the report.5 She noted: ‘€˜While Treasurer Joe Hockey is complaining that Australia is running out of money to fund the health system, the Coalition Government has buried a report with recommendations for large-scale savings on drug costs.’€™ But the burial of the final report, the submissions made to the review and the economic estimates of the costs of patent term extension is particularly concerning in the light of the current Government’s search for cost-cutting measures.’€™ Gleeson lamented: ‘€˜It will be a shame if we end up with knee-jerk policies like $6 GP co-payments in an attempt to cut health system costs when sensible reforms to patent law could generate hundreds of millions of dollars of savings through the Pharmaceutical Benefits Scheme’€™. She warned that ‘€˜an even worse prospect would be the further extension of patent monopolies through our international trade agreements, adding hundreds more millions to the health budget.’ 

Information activist Brendan Molloy -€“ a member of Pirate Party Australia, and Electronic Frontiers Australia – sought to reveal the report through freedom of information requests.6 

In the end, the Australian Government relented, and published the Pharmaceutical Patents Review Report. The Australian Government was non-committal about the recommendations of the report:

Government statement on the Pharmaceutical Patent Review final report. The Pharmaceutical Patent Review was commissioned by the previous government and conducted by an independent panel. The review panel provided its final report to the previous government in May 2013, which did not release the report. The government notes that the report is one of a number of reviews of the pharmaceutical system conducted during the term of the previous government. The government has no plans to respond to the report at this stage but may take information in the report into account when considering future policy. The views expressed and recommendations made in the report are those of the review panel and do not necessarily reflect government policy.

It is a credit to the Minister Ian MacFarlane to release the report, so that there could be a full and frank public discussion in respect of patent law and pharmaceutical drugs.

A Frugal Approach to Patent Rights

The final 233-page report – Pharmaceutical Patents Review Report – is essential reading for those interested in intellectual property and public health. The combination of Tony Harris, Dianne Nicol, and Nicholas Gruen has ensured that the work is a multi-disciplinary investigation into patent law and pharmaceutical drugs. The report is a thorough, systematic, and balanced piece of work. The report is informed wide-ranging consultations and interactions with industry, government, academia, and consumers.

The Pharmaceutical Patents Review Report emphasizes that ‘€˜the question of how much patent protection to offer is crucial.’€™ The study noted:

Pharmaceutical patent rights that run for too long or that are defined too expansively will deprive people of drugs because purchasers, including Governments, cannot afford them. They can also constrain follow on innovation: too weak a patent system means patients will suffer because the industry has inadequate incentives to develop new drugs. 

The Pharmaceutical Patents Review proposed a frugal approach to the grant of patent rights. The Review recommended that ‘the Government should expeditiously seek a situation where Australia has strong yet parsimonious IP rights – that is, rights that are strongly enforced and that provide the incentive necessary to underpin an appropriate level of investment in innovation – but that are not defined so broadly as to impose costs on innovation or other activity without commensurate benefits.‘  The report suggested: Australia should take a leadership role in seeking consensus with jurisdictions with similar interests to identify and pursue a range of changes in international patent law and practice along these lines.‘  The report observed: ‘€˜While the patent system must be strong to be effective, it should also be parsimonious, avoiding restrictions on trade and innovation that are not necessary for it to deliver incentives to innovate.’€™

Patent Term Extensions

The Pharmaceutical Patents Review Report makes a number of important recommendations relating to patent term extensions. Under Australia law, the patent term lasts for twenty years. Since 1998, pharmaceutical drug patents can obtain additional term extensions for up to a further years. The inquiry noted:

An important part of the terms of reference of this inquiry is to evaluate the extension of term (EOT) that the Australian patent system allows. It applies to some pharmaceuticals for which patentees have taken at least five years from the effective patent filing date to obtain regulatory approval for the pharmaceutical’s use. The current scheme dates from 1998. It aims to attract investment in pharmaceutical R&D in Australia, as well as providing an effective patent term for pharmaceuticals more in line with that available to other technologies. The scheme currently provides an effective patent term of up to 15 years. 

The report noted that patent term extensions were expensive for the Australian Government: ‘€˜The estimate for 2012-13 is around $240 million in the medium term and, in today’€™s dollars, around $480 million in the longer term’€™. The report stressed: ‘€˜The total cost of the EOT to Australia is actually about 20 per cent more than this, because the PBS** is only one source of revenue for the industry.’€™ The report emphasized: ‘€˜Using the patent scheme to preferentially support one industry is inconsistent with the TRIPS rationale that patent schemes be technologically neutral.’€™

**acronym for Pharmaceutical Benefits Scheme

The inquiry canvassed a number of policy options to address patent term extensions:

Australia is required by AUSFTA to provide some form of pharmaceutical EOT but its scope and length are not specified. Actual savings obtained from reducing the term of the extension would be affected by many factors, including price changes caused by increasing sales volumes, the 16 per cent mandated price reduction following the entry of a second drug, the influence of competing generic manufacturers and reductions from price disclosure mechanisms. But there are timing issues in reducing the EOT provisions immediately without compensation. Savings from the options considered in this report, including the recommendation to reduce the effective life of extended Australian pharmaceutical patents, would take several years to reach full effect.

The inquiry recommended: ‘€˜The Government should change the current EOT to reduce the maximum effective patent life provided from 15 years.’€™ There was a difference of opinion between the members of the review: ‘€˜Harris and Gruen support reducing the effective life to 10 years, whereas Nicol supports reducing the effective life to 12 years.’€™ The report advised: ‘€˜The length of the extension should be calculated as being equal the number of days between the patent date and the date of first inclusion on the Australian Register of Therapeutic Goods minus 20 years less the maximum effect patent life.’€™ The report noted: ‘€˜The current 5 year cap on extensions should remain, providing a maximum of 25 years patent term for extended patents.’

The Pharmaceutical Patents Review Report emphasized that there could be significant savings to Australian tax-payers from the reform of Australian patent term extensions. The recommendation by Harris and Gruen was predicted to provide for massive savings:

Mr Harris and Dr Gruen recommend reducing the effective patent life from 15 to 10 years. Over time this would save the PBS approximately $200 million a year. in today’€™s dollars, based on current pricing arrangements (that the entry of generics will lead to price falls of 35 per cent) which the Government has agreed with Medicines Australia. The savings would grow in line with PBS costs which are growing at 4.5% per annum, substantially faster than real GDP. If the Government secured all of the pricing benefits allowed by the entry of generics, annual savings in today’€™s dollars could amount to around $400 million which would similarly be expected to grow with PBS costs. This is calculated on data that generics have led to a 70% price reduction in the United States. This is consistent with recent findings by the Grattan Institute that the price of generics paid by the PBS is several times the price secured by relevant Australasian Governments.

It is calculated that Professor Nicol’€™s recommendation to shorten the effective patent life would result in significant savings: ‘€˜The estimated savings resulting from this reduction would be approximately $130 million a year.’€™ Moreover, it was noted: ‘€˜If a 70% price reduction from generic entry was achieved as discussed above, the savings would be approximately $260 million a year.’€™

Patent Standards and the Problem of Evergreening

The former High Court of Australia Justice Michael Kirby observed in a case that patent law ‘€˜should avoid creating fail-safe opportunities for unwarranted extensions of monopoly protection that are not clearly  sustained by law.’€™

The Pharmaceutical Patents Review Report also addressed the pernicious problem of evergreeening -€“ where patent owners seek to indirectly extend the life of patent protection, beyond its natural monopoly. The report noted:

In most developed countries, including the United States and Europe, there are concerns about pharmaceutical manufacturers using patents and other management approaches to obtain advantages that impose large costs on the general community. The cost arises because these actions impede the entry of generic drugs to the market. Although some find the term to be a pejorative, relevant literature has dubbed such actions ‘€˜evergreening’: steps taken to maintain the market place of a drug whose patent is about to expire.

The report noted: ‘€˜It is probable that less than rigorous patent standards have in the past helped evergreening through the grant of follow-on patents that are not sufficiently inventive.’€™ The report called for improvements in the oversight of patent quality standards: ‘€˜The Panel sees a need for an external body, the Patent Oversight Committee, to audit the patent grant processes to help ensure these new standards are achieved, and to monitor whether they inhibit the patenting of follow-on pharmaceuticals which promote evergreening with no material therapeutic benefit.’

Data Protection

The inquiry also considered the vexed question of data protection for pharmaceutical drugs. The report noted: 

When an originator seeks regulatory approval for a drug, it must provide data to the TGA*** demonstrating the drug’€™s safety and efficacy. Although these data remain confidential to the TGA, it may use them after a five year period to approve a generic or equivalent drug. This saves the pointless replication of tests to show safety and efficacy.

***acronym for Therapeutic Goods Administration 

The pharmaceutical drugs industry argued that the five-year period of data exclusivity in Australia was too short. The Pharmaceutical Patents Review Report found that there was no need to extend data protection in respect of pharmaceutical drugs: 

It is conceivable that drugs might not be brought to Australia, for example, because regulatory and marketing costs cannot be recouped within five years. Medicines Australia submits that some of its members chose not to supply a total of 13 drugs to the Australian market because of the inadequacy of the data exclusivity period. However, they are only able to identify three of these, and the Panel’€™s analysis – shown in chapter 8 – suggests they are not convincing. AbbVie offers a more compelling example, but even there the Panel believes that expanding data exclusivity for all or for a wide class of drugs is a poorly targeted response to issues affecting a small number of pharmaceuticals. A policy of subsidising drug development discussed above seems more appropriate.

The report noted: ‘€˜The Government should actively contribute to the development of an internationally coordinated and harmonised system where data protection is provided in exchange for the publication of clinical trial data.’

Such a finding has a broader significance, given the push by the United States for stronger data protection in the Trans-Pacific Partnership.

Trade and the Trans-Pacific Partnership

The Pharmaceutical Patents Review Report observed that ‘€˜Larger developed countries that are major net IP exporters have tended to seek longer and stronger patents, not always to the global good.’€™ The report warned: ‘€˜The acquiescence of Australia and other countries to that agenda means that some features of Australia’s patent law are of little or no benefit to patentees but impose significant costs on users of patented technologies.’

The Pharmaceutical Patents Review Report was highly critical of Australia’€™s passivity in international negotiations over intellectual property and trade. The report found:

In their negotiation of international agreements, Australian Governments have lacked strategic intent, been too passive in their IP negotiations, and given insufficient attention to domestic IP interests. For example, preventing MFE**** appears to have deprived the Australian economy of billions of dollars of export revenue from Australian based generic manufactures. Yet allowing this to occur would have generated negligible costs for Australian patentees. The Government does not appear to have a positive agenda regarding the IP chapters of the TPP Agreement.

****acronym for Manufacturing for Export

The report noted: ‘€˜The Government has rightly agreed to only include IP provisions in bilateral and regional trade agreements where economic analysis has demonstrated net benefits, however this policy does not appear to be being followed.’€™

The Pharmaceutical Patents Review Report recommended that ‘€˜the Government should ensure that future trade negotiations are based on a sound and strategic economic understanding of the costs and benefits to Australia and the world and of the impacts of current and proposed IP provisions, both for Australia and other parties to the negotiations.’€™  The Pharmaceutical Patents Review Report stressed that ‘€˜the Government should strongly resist changes -€“ such as retrospective extensions of IP rights -€“ which are likely to reduce world economic and social welfare and it should lead other countries in opposing such measures as a matter of principle.’€™

Furthermore, the Pharmaceutical Patents Review Report recommended: ‘€˜Given the current constraints placed on Australia by its international obligations, as an interim measure the Government should actively seek the cooperation of the owners of Australian pharmaceutical patents to voluntarily agree to enter into non-assertion covenants with manufacturers of generic pharmaceuticals seeking to manufacture patented drugs for export’€™. In its view, ‘€˜This would help them avoid the embarrassment of Australia’€™s trade and investment performance being penalised by its previous agreement to strengthen IP rights.’

The Pharmaceutical Patents Review Report warned: ‘€˜There are signs that these past failures are being replicated in the current Trans-Pacific Partnership (TPP) negotiations because small, net importers of intellectual property, including Australia, have not developed a reform agenda for the patent system that reflects their own economic interests – and those of the world.’ 

WikiLeaks has published a draft text of the Intellectual Property Chapter of the Trans-Pacific Partnership.7  The Intellectual Property Chapter contains a number of measures, which support the position of pharmaceutical drug companies and the biotechnology industry.8 Notably, the United States has pushed for extensions of the patent term in respect of pharmaceutical drugs, including where there have been regulatory delays. There has been a concern that the Trans-Pacific Partnership will impose lower thresholds for patent standards, and result in a proliferation of evergreening. There has also been a concern about patent-registration linking to marketing regimes. The United States has also pushed for the protection of undisclosed data for regulatory purposes. There has been wide concern that the Trans-Pacific Partnership will result in skyrocketing costs for health-care systems in the Pacific Rim.

Disturbingly, Australia has been quite passive in the debate over intellectual property and public health in the Trans-Pacific Partnership negotiations. Other countries -€“ such as Canada, New Zealand, and Malaysia -€“ have argued, more passionately, that there is a need for the patent system to protect public health.

Moreover, the Trans-Pacific Partnership also contains an investment chapter, with investor-state dispute settlement. The brand name pharmaceutical drug company Eli Lilly have deployed an investor clause under the North American Free Trade Agreement to challenge Canada’€™s drug patent laws. There is a concern that the investor-state dispute settlement regime in the Trans-Pacific Partnership could be deployed to challenge public health measures, and reforms to the patent system designed to combat problems such as evergreening.

Professor Joseph Stiglitz has been concerned about the impact of the Trans-Pacific Partnership upon equality and human rights.9 He observed that ‘€˜Agreements like the TPP have contributed in important ways to this inequality’€™. Stiglitz warned: ‘€˜Corporations may profit, and it is even possible, though far from assured, that gross domestic product as conventionally measured will increase’€™. He feared that ‘€˜the well-being of ordinary citizens is likely to take a hit.’€™ The Nobel Laureate warned that ‘€˜Trickle-down economics is a myth’€™. Stiglitz concluded that ‘€˜enriching corporations -€” as the TPP would -€” will not necessarily help those in the middle, let alone those at the bottom.’


The Pharmaceutical Patents Review Report is a landmark report, which should receive serious consideration by policy-makers in Australia, and throughout the Pacific Rim. The study deserves a wide readership amongst intellectual property academics, economists, and health experts. The Pharmaceutical Patents Review Report provides a cautionary warning of the need to design a patent regime, which is appropriate and well-adapted to Australia’s economy, research and development system, and public health-care regime:

The Report shows that the Australian patent system has worked against Australia’€™s best interests. Patents are clearly necessary and important for the development of and access to needed drugs. But Australia’€™s patent system has allowed and will continue for some time to allow patents to be granted which would not be granted elsewhere; it has awarded a longer effective patent life than is provided in the United States or than seems necessary to underpin drug development in Australia; it has allowed patents to expire later in Australia than in its major trading partners. All of this has limited the generic manufacturing base, employment and exports and it has increased Australia’€™s pharmaceutical costs. The Raising the Bar Act which recently came into force may moderate this, but its efficacy will not be evident for some years, and there is the prospect that, even with the changes introduced by Raising the Bar, patent standards are still insufficient to moderate evergreening in the pharmaceutical industry. The Panel’€™s recommendations, if adopted, would only start the next phase of the repair work.

The report also highlights the problem of patent owners seeking corporate welfare in domestic patent law reform and international negotiations. There is a need to guard the integrity of the patent system against being co-opted by brand-name pharmaceutical companies and biotechnology companies. Patent term extensions and evergreening undermine the public bargain of patent law to promote the progress of science and the useful arts. There is a need to ensure that the public domain is not captured by private companies. The report should be a guide in Australia’€™s future approach to domestic patent law reform, and international negotiations over intellectual property and trade. The study highlights the need for greater consideration of the economic impact of legal revisions -€“ particularly in the area of patent law and pharmaceutical drugs. Australia’€™s patent regime should protect the public health of its citizens.


1          Tony Harris, Dianne Nicol, and Nicholas Gruen, Pharmaceutical Patents Review Report, Canberra, 2013,

2          Peter Martin, ‘€˜Drug Patents Costing Billions’€™, The Sydney Morning Herald, 2 April 2013,

3          Matthew Rimmer, ‘Julia Gillard, Big Pharma, Patent Law, and Public Health’, The Conversation, 27 November 2012, 

4          Melissa Parke MP, ‘€˜Pharmaceutical Patents Review’€™, House of Representatives, Australian Parliament, 11 February 2014,;query=Id%3A%22chamber%2Fhansardr%2F55d46158-f865-4a9f-9015-36543a3b6b7b%2F0183%22

5          Deborah Gleeson, ‘€˜Cost-Cutting Crusade Ignores Health Savings’€™, ABC, The Drum, 6 March 2014, 

6          Brendan Molloy, ‘€˜Pharmaceutical Patents Review’€™, Right to Know, 28 February 2014, 

7          WikiLeaks, ‘€˜Advanced Intellectual Property Chapter for All 12 Nations with Negotiating Positions (30 August 2013 consolidated bracketed negotiating text)’€™ 

8          Alexandra Phelan and Matthew Rimmer, ‘Trans-Pacific Partnership #TPP #TPPA Drafts Reveal a Surgical Strike against Public Health’, East Asia Forum, 2 December 2013, 

9          Joseph Stiglitz, ‘€˜On the Wrong Side of Globalization’€™, The New York Times, 15 March 2014,  


*Dr. Matthew Rimmer is an Australian Research Council Future Fellow working on Intellectual Property and Climate Change. He is an associate professor at the ANU College of Law and an associate director of the Australian Centre for Intellectual Property in Agriculture (ACIPA). He holds a BA (Hons) and a University Medal in literature, and a LLB (Hons) from the Australian National University. Rimmer received a PhD in law from the University of New South Wales for his dissertation on The Pirate Bazaar: The Social Life of Copyright Law. He is a member of the ANU Climate Change Institute. Rimmer is the author of Digital Copyright and the Consumer Revolution: Hands off my iPod, Intellectual Property and Biotechnology: Biological Inventions, and Intellectual Property and Climate Change: Inventing Clean Technologies. He has co-edited Incentives for Global Public Health: Patent Law and Access to Essential Medicines, and Intellectual Property and Emerging Technologies: The New Biology. Rimmer has published widely on copyright law and information technology, patent law and biotechnology, access to medicines, clean technologies, and traditional knowledge. His work is available here. 

News Link n. 87

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


News Link 87

On the Wrong Side of Globalization

Global Health Best Buys  

Interview With Hans Hogerzeil: Recognising Good Practices Of Pharma

EU Parliament To Vote On Compulsory Publishing Of Clinical Trial Data 

Medicines Made in India Set Off Safety Worries

Let’s go the distance: Investing in partnerships for a healthier future

Devex Reporters Discuss Public-Private Partnerships In U.S. Foreign Aid

Does health aid reach the poor? 

Will It Be Famine or Feast for Africa As Big Food Retailers Look to the Continent? 

If China Sneezes, Africa Can Now Catch a Cold


Addressing Violence Against Women and Children Is Critical to Achieving an AIDS-Free Generation and the Millennium Development Goals  

Moment ‘ripe’ for improving women’s access to finance

MakaPads Helping Disadvantaged Girls And Women In Uganda

African women and girls at the grassroots – Their say on their world post 2015  

Promozione della salute o profitto a ogni costo: una terza via è possibile? 

What nonprofits can learn from Coca-Cola

The Gates Foundation’s Hypocritical Investments

IMF: To solve inequality, tax food, books and funerals

Beginning of the end of the neoliberal approach to development 

Global health philanthropy and institutional relationships: how should conflicts of interest be addressed?

Forests crucial to green growth

Breeders’ Group CIOPORA Redefining Its Position On IP  

WHO and regional malaria experts reiterate warning about drug resistance 





The Health Impact Fund: a Mechanism to Improve Access, Innovation and Delivery of Medicines

Problems of innovation, access and delivery in the domain of pharmaceuticals still exclude billions of people from the health benefits that advanced medicines can provide. This article turns the spotlight on the Health Impact Fund as an initiative that could systematically and sustainably address these problems

The Health Impact Fund: a Mechanism to Improve Access, Innovation and Delivery of Medicines 

by  Thomas Pogge* 

Director of the Global Justice Program and the Leitner Professor of Philosophy and International Affairs at Yale University


Despite much heralded advances in health and well-being over the past twenty years, there remain significant disparities in access to lifesaving medicines globally. About 30 percent of the world’€™s population still lack access to essential medicines.  In addition, no adequate and effective treatments exist for the numerous neglected diseases that disproportionately affect the poor. Indeed, only 1% of therapies introduced between 1975 and 1999 targeted these diseases, despite the fact that they affect over one billion people globally.

Such gaps are a direct result of the misaligned incentives present in the current pharmaceutical innovation system. Drug development is currently incentivized and rewarded through the exorbitant mark-ups that innovators, protected by patents from market competition, can charge for their products during their early years on the market. Given very high economic inequality globally and increasingly also within countries, innovators find that the profit-maximizing prices for their pharmaceuticals make these products unaffordable to a substantial majority of the world’€™s population. As a result, many poor people, even in the more affluent countries, suffer or die because they cannot afford medicines whose marginal cost of production and distribution is quite low. Moreover, innovators shun research on diseases concentrated among the poor because they will not be able to recover their R&D costs from mark-ups on new products in such an area.

The existing system presents three major problems. First, R&D is focused on drugs that are conceived to be the most profitable, rather than on those that would lead to the most cost-effective improvements in health.  Second, profit-maximizing prices prevent much of the world’€™s poor from purchasing even the medicines medicines we have available so long as they are still under patent. Third, even when a treatment is priced affordably, there remain gaps in access due to the “€œlast mile”€ problem – that is, the challenge of ensuring that available medicines are of good quality as well as accessible to and correctly used by the people who need them. These three problems exclude billions of people from the health benefits that advanced medicines can provide.

Incomplete Solutions to An Access to Medicines Crisis

Two decades ago, lawyers in Geneva included in an international trade treaty an agreement on intellectual property (IP) rights that has had a massive impact on medical treatment for individuals suffering from many of the world’s deadliest diseases. One effect of this Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was to apply standards for patents developed in the world’s most industrialized countries to any country intent on joining the World Trade Organization (WTO). Member countries must grant 20-year product patents on pharmaceuticals, for instance, and must ensure that corporations owning such patents can price their products without fear of competition.

Before TRIPS, IP rights were only enforced domestically. Many industrialized countries were members of international organizations and signatories of agreements that required a specific level of IP protection. Yet, none of these organizations had enforcement mechanisms and the consequences of not respecting these IP norms rarely affected other aspects of international commerce. Further, many least developed countries had only weak IP protections, or none at all. India, for example, had seven-year process patents that generic firms there were typically able to circumvent by finding a different process for manufacturing the drug.

Realizing the impact the TRIPS agreement was having on access to medicines, the World Trade Organization in 2001 issued the Doha Declaration, which provided flexibility for member states to rescind the patent protection guaranteed by TRIPS when needed to protect public health. However, patent owners simultaneously lobbied their governments to increase the legal protection for their proprietary rights in the drugs used to treat these diseases. They did so through agreements now often referred to a TRIPS-plus. Pressure continues to mount on many countries to extend patent terms, agree to data exclusivity, or agree to other measures that indirectly increase the cost of pharmaceuticals. This has had a disastrous impact on access to essential medicines.

A number of initiatives have responded to the global health crisis resulting in part from a lack of access to medicines caused by the TRIPS and TRIPS-plus agreements. Beyond the usual declarations, working papers, conferences, summits, and working groups, these initiatives include inter-governmental initiatives such as UNITAID; governmental programs such as the US President’€™s Emergency Plan for AIDS Relief; and public-€“private partnerships such as the Global Alliance for Vaccines and Immunization and the Global Fund to Fight AIDS, Tuberculosis and Malaria. They also include attempts to foster new drug development such as the Drugs for Neglected Diseases Initiative, the Institute for One World Health, and the Novartis Institute for Tropical Diseases; and various prizes and advance market commitments (AMCs).

While improving the situation relative to what it would otherwise be, these efforts are not sufficient to secure access to medicines for the poor. Few expect that sufficient resources will be devoted to neutralizing the cost imposed on the world’s poor by the globalization of 20-year patents and none anticipate that such billions will reliably and efficiently be spent year after year. As a result we turn to a more systemic solution to address the global health crisis. Involving institutional reform, such a systemic solution is politically more difficult to achieve but also politically much easier to sustain once achieved. It also preempts the huge and collectively inefficient mobilizations required to fund the many stopgap measures listed above, which can at best only mitigate the effects of structural problems they leave untouched.

A Market Solution for Market Problems

The Health Impact Fund (HIF) is an initiative that could systematically and sustainably address the three problems of innovation, access and delivery in the domain of pharmaceuticals. Using a pay-for-performance mechanism, the HIF would align the incentives of pharmaceutical firms with the needs of public health, while also allowing these firms to fulfil their responsibility to investors to maximize profit.  Pharmaceutical firms would be given the option to register new medicines with the HIF.  By registering, a firm would agree to provide the drug at cost price worldwide. In exchange, the firm would be rewarded, during the first eight or ten years that its new product is on the market, according to the actual measured health impact of the drug. As all registered products would be competing for a fixed pool of annual funding, the greater the health impact created by a firm’€™s product, the greater would be its share of the reward pool that year. Since registration with the HIF would be optional, firms would be able to decide for each product whether the current patent system or the HIF would be more profitable. Firms would be more likely to register products that have relatively low profitability in the current system, but that would potentially have a high health impact (e.g. effective treatments for neglected diseases). As a complement to the current patent regime, the HIF would thus help lower prices, increase access to medicines, and enable pharmaceutical firms to bring significant benefits to patients while earning a profit.

 The Health Impact Fund (HIF) offers pharmaceutical firms an opportunity to register any of their products for a share of fixed annual reward pools for each of the first eight or ten years on the market. Each pool will be divided according to the health impact that the various registered products have achieved during the year. To exemplify, if all registered products saved twenty million “€œQuality-Adjusted Life Years”€ (QALYs) in a given year, then a registered product that had saved two million of these QALYs would receive ten percent of this year’s reward pool. In exchange, firms would have to sell their registered products at the lowest feasible cost of manufacture and distribution and to offer royalty-free open licenses for generic production following the reward period. In its mission to encourage the development of new medicines for the poor, the HIF depends on funding commitments from countries and other partners

  Since firms will be rewarded based on health impact assessment, it is important to discuss how health impact will be measured. The most important characteristic for measurement of health impact is that it must be consistent across countries and diseases in order to accurately compare and reward drugs. Furthermore, there must be some way of calculating the difference in health benefit between the new drug and the status quo. While the merits of several measurement metrics can be debated, it is important to realize that an ideal metric does not exist and that any payment based on measurement and therefore performance is better than the present system in which reward and health impact are barely correlated. It is crucial for the success of the HIF that the measurement system be designed to ensure that firms are incentivized to deliver health improvements and not game the system (i.e. capture rewards without producing outcomes). If there is margin for gaming, firms may be tempted to manipulate the process by exaggerating the benefit of the product. Doing so would stray from the end goal of increasing overall health benefit.

It is important to realize that the HIF will measure real world outcomes. Both the current system and the HIF use health outcome measurement to determine drug revenue. The current system (exemplified by NICE) uses data from clinical trials to estimate the health benefits of a drug. However, health benefits determined in clinical trials often do not reflect real health impact. There are many reasons for this. For example, patients included in a study have to meet certain characteristics that may not represent the entire population. Furthermore, patients in clinical trials are more closely monitored than they would be in the real world. Most importantly, a pharmaceutical innovator has conflicting incentives with regard to patients likely to derive little or no benefit from some product: incentives to exclude such patients from its clinical trials and yet to include them in its marketing efforts. These differences will lead to differences in outcomes. The HIF model addresses this concern by allowing for adjustments based on evidence of how the drug is used in practice and what the outcomes are.

A Solution for Innovation, Access, and Delivery

As mentioned before, there are three major problems with the current system: innovation, access, and delivery. The HIF addresses all three of these problems. Through the HIF model, firms will find it profitable to develop medicines to treat even the poor because reward will be based on health impact and marginalized populations are where the greatest health impact is waiting to be realized. The HIF will thus incentivize development of medicines for previously neglected diseases which, despite their large disease burden, have received little investment due to their unprofitability in the current innovation system.  The HIF will also ensure that, when beneficial drugs are developed, they are made widely accessible to patients.  The HIF would facilitate increased access to drugs by requiring that they be sold globally at cost price. The HIF would also create incentives for manufacturers to engage in facilitating the appropriate distribution of their products, as well as reducing other non-price barriers to access and rational use, since improved (appropriate) use will increase the rewards they earn. Thus, firms would be incentivized to ensure that drugs actually reach patients and are effectively used, thereby tackling the last mile problem. Thus the HIF will address the three biggest challenges of the pharmaceutical industry 1) incentivizing innovation for currently neglected diseases 2) improving access to life saving and life improving medications 3) addressing the last mile problem.


Importantly, the HIF does not act as a charity for the developing world but rather a system that benefits patients, pharmaceutical firms, and citizens on a global scale. In a time when we have seen significantly reduced global health spending due to the Great Recession and other economic setbacks, it is important to look for sustainable solutions that use the current resources more efficiently. The HIF is one such solution. The HIF would direct research towards the medicines that promise the greatest health gains and would offer those products at the same low cost to all patients. This would benefit patients regardless of their location and wealth. Firms would benefit financially from doing social good through a financing scheme that makes developing high-impact medicines profitable. Citizens, who support governments through tax payments, would benefit from the HIF because it supports efficient spending and results in lower costs for registered products. Ultimately the HIF is a market solution for market problems.


World Health Organization. 2004. The World Medicines Situation. Geneva: World Health Organization.

Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R & Ford N. 2002. Drug development for neglected diseases: a deficient market and a public-health policy failure. The Lancet, 359(9324)

Agreement on Trade-Related Aspects of Intellectual Property Rights (Marrakesh, Morocco, 15 April 1994), Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 321 (1999), 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [TRIPS]

World Trade Organization, Declaration on the TRIPS Agreement and Public Health of 14 November 2001, WT/MIN(01)/DEC/2, 41 I.L.M. 755 (2002) [Doha Declaration], at para 7.

Frederick M. Abbott, “The Doha Declaration on the TRIPS Agreement and Public Health: Lighting A Dark Corner at the WTO”, Journal of International Economic Law (2002) 469-505, at 470.

J.F. Morin, “€œMultilateralising Bilateral TRIPS-Plus Agreements: Is the US Strategy a Failure?”€ 2008, unpublished, quoting GRAIN (2001) TRIPS-plus through the back door [online]. GRAIN publications.  Available at: [accessed on September 2008],

F. Abbott (2006) Intellectual Property Provisions of Bilateral and Regional Trade Agreements in Light of US Federal Law. ICTSD-UNCTAD, Geneva; Fink, C. and Reichenmiller, P. (2005) Tightening TRIpharmaceuticals: The Intellectual Property Provisions of Recent US Free Trade Agreements. The World Bank, Washington, DC;

Krikorian, G. P. and Szymkowiak, D. (2007) ‘€˜Intellectual Property Rights in the Making: The Evolution of Intellectual Property Provisions in US Free Trade Agreements and Access to Medicine’€™, The Journal of World Intellectual Property, 10(5), pp. 388-418, among others.


* This piece received substantial research support from Narmeen Haider, Jake Hirsch-Allen and Zain Rizvi.

Thomas Pogge is the Director of the Global Justice Program and the Leitner Professor of Philosophy and International Affairs at Yale University. Having received his Ph.D. in philosophy from Harvard, Thomas Pogge has published widely on Kant and in moral and political philosophy, including various books on Rawls and global justice. In addition to his Yale appointment, he is the Research Director of the Centre for the Study of the Mind in Nature at the University of Oslo and a Professorial Research Fellow at the Centre for Applied Philosophy and Public Ethics. Pogge is also editor for social and political philosophy for the Stanford Encyclopedia of Philosophy and a member of the Norwegian Academy of Science. With support from the Australian Research Council, the UK-based BUPA Foundation and the European Commission (7th Framework) he currently heads a team effort towards developing a complement to the pharmaceutical patent regime that would improve access to advanced medicines for the poor worldwide ( and toward developing better indices of poverty and gender equity.

News Link n. 86


The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


News Link 86

United Nations: Report of the Special Rapporteur on the right to food

Negotiators meet for the fourth round of Transatlantic Trade and Investment Partnership (TTIP) talks

U.S. Objectives, U.S. Benefits In the Transatlantic Trade and Investment Partnership: A Detailed View 

The Transatlantic Economy 2014 

Green party leaks confidential TTIP paper

EU Needs Greater TTIP Transparency 

Report: Investor-state lawsuits worth €1.7 billion rage across Europe 

Open Letter to Vince Cable

EU-USA: e’ finita la luna di miele? 

The political origins of health inequity: prospects for change 

From public to planetary health: a manifesto   

Book Challenges ‘Neoliberal’ Approach In Global Public Health Policy 

WTO-WIPO IP Training Course For Governments Begins 

International Power Players Are Harming Global Health

Close the Gap: How to eliminate violence against women beyond 2015 

Foreign aid criticism from 2009 and a shift to 2014 evidence based foreign aid 

Health workforce shortages and international mobility in the EU: New HW4All report calls for action to address impending health workforce crisis in Europe

ANTIBIOTICS NO LONGER WORK, a global emergency:The need for an ecological response and intellectual property reform. Lunchtime seminar, Geneva 20 March  

Bevacizumab e DMLE: una decisione da rivedere 

Un farmaco utile, efficace  ed economico: non usiamolo  

La medicina diseguale. Come agire per la salute di tutti

La Copertura Sanitaria Universale: nuova frontiera della salute globale?         

A Gene Threat On Our Plate 




News Link n. 85

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries


News Link 85

3 easy ways to celebrate International Women’s Day

La Cooperazione italiana per i diritti delle donne 

L’aborto e la società americana

From concept to measurement: operationalizing WHO’s definition of unsafe abortion   

Aid freeze deepens after Uganda’s anti-gay bill   

Gurry Wins Committee Vote For Next Director General Of WIPO

With A “Clean Slate,” WIPO Director Nominee Gurry Looks Ahead

North and South sign commitment to family farming 

Intergovernmental South Centre Statement On “US Attacks On Indian IP Policy” 

US-India Trade Ties Worsen, Amid Claims of Protectionism  

Crisis Mismanagement in the United States and Europe: Impact on Developing Countries and Longer-Term Consequences 

Health in a time of “political plague”: Confronting the Clash of Ignorance!   

Health systems performance assessment in low-income countries: learning from international experiences 

Corporate influence in the Post-2015 process 

The U.S. Government Response to Global Neglected Tropical Diseases   

WIPO Exhibition for New Strategies Against Counterfeit, Pirated Goods   

UN Campaign To Engage Tourists In Fight Against Counterfeits

Why giving work is better than giving aid 

Why Bill Gates Can’t Solve Problems For The World’s Poor 

Reshaping African PhDs for development  

Most Southern African Countries to Miss 2015 MDG Water and Sanitation Targets

The difficulty of making healthy choices and “health in all policies” 

Water, Water, Everywhere: To Green our Deserts  

For Yunus, charity is not the only way  

Patents as Protection of Traditional Medical Knowledge?

WHO’s Draft Guideline: Sugars intake for adults and children 





Impact of the Amended Indian Patent Act (1970) on Access to Medicines in India

In the recent past, there have been several significant developments in India in the area of using TRIPS flexibilities for promoting access to health products. Several of these involve the Indian Patent Act (2005) especially Section 3(d) that defines the scope of patentability, limiting data protection, providing for government use and compulsory licenses to non-patentees etc. A major concern of several patent offices all over the world in respect of providing access is the growing prevalence of what are known as '€˜secondary'€™ patents i.e., patents covering various ancillary features of existing medicines. In addition, there are also attempts toward filing numerous patent applications for the same medicine (to create what are called as '€˜patent clusters' or '€˜patent thickets'€™, especially by global multinational companies (MNCs). The strategy called evergreening, that refers to patenting strategies to secure sequential and overlapping patents on a single object (qua invention) through trivial changes such as change in size, colour, dosage, delivery mechanism and composition of a patented drug. Broadly, there are two strategies to limit the scope of patentability: i) increase the threshold limit of patentability criteria by providing a definition of patentability criteria, viz. novelty, inventive step and industrial applications; and ii) exclude certain types of inventions, which do not satisfy any one of the patentability criteria, or those inventions which are in conflict with public morality, national security or affecting the health of humans, animals and plants. Section 3 of the Indian Patents Act (1970) lists 15 broad categories of knowledge as not inventions within the meaning of this Act. These include i) new uses of known substances [section 3(d)]; ii) new forms of known substances, without significant enhancement in efficacy [section 3(d)] providing for government use and compulsory licenses to non-patentees. This provision while excluding new forms of known substance, discovery of new property of known substance and new use of known substance, treats salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance as the same substance that do not confer significant enhancement in efficacy [section 3(d)]. The section 3(e) covers what are known as '€œmere admixtures'. Other safeguards include the pre-grant opposition where any person may file opposition by way of representation to the Controller against the grant of Patent, at the appropriate office, at any time after publication of patent application u/s 11A, but before the grant of Patent on any of the grounds mentioned in Section 25(1). The potential impact of effective implementation of these initiatives for promoting  access to health care with specific reference to India are discussed

 Impact of the Amended Indian Patent Act (1970) on Access to Medicines in India


 By Sadhana Srivastava* 

and Kanikaram Satyanarayana**

Indian Council od Medical Research, Department of Health Research
(Ministry of Health & Family Welfare), New Delhi



It is widely believed that pharmaceutical patents promote monopoly and thus significantly delay the entry of generics. Due to the lack of competition, the prices of medicines rise. The current system of product patent protection due to the harmonized global intellectual property rights laws  are widely considered to be a major barrier for the access to medicines, especially in the developing countries.1 [1] Until such a time the poor and middle income countries became signatories to the World Trade Organization’€™s 1995 Trade Related Intellectual Property Rights (TRIPS) agreement, they had the freedom and flexibility to design patent laws that prohibited product patents.   

With the enforcement of the TRIPS agreement in 2005, developing countries have been compelled to modify and introduce TRIPS-compliant national patent laws. The TRIPS Agreement harmonized the life of patent to a minimum of 20 years besides mandating the granting of patents in all fields of technology including food and drugs.  The potential adverse impact of the new patent legislation on global public health has been widely studied and reported although some observers feel that  the full impact is being felt only in recent years.1 [1]  Like, over the past decade, the global focus in this area is largely on India for at least two reasons. Firstly, India is considered to be global pharmacy for providing cheap drugs for diseases like the HIV/AIDS that brought a dramatic reduction of price from over US$ 10000 to about US$ 150. 2 [2] Also, close to 80 percent of drugs for HIV-AIDS to low income countries in Africa are sourced  from India 3 [3] Secondly, a new battle is being currently  fought  in the  Indian courts on issue of access to cancer medicines.

Given the legal complexities of the enforcement of the TRIPS agreement, especially in middle income countries, and the critical role countries as India and Brazil play in the manufacture and supply of cheap medicines for their own people and also the needy in other poor countries, legal interpretation of many clauses has been frustratingly slow. Public health and legal scholars have suggested that developing countries might ameliorate the potential negative effects of TRIPS on access to medicines by exploiting TRIPS “€˜flexibilities”€™3 [3] which provide some room for manoeuvre while  designing national patent laws. This is because the TRIPS Agreement provides for considerable discretion on how the obligations are interpreted and implemented by sovereign governments. Yet, several developing countries have faced obstacles when seeking to implement measures to promote access to affordable medicines in view of lack of clarity and/or willingness of developed countries and perhaps the lack of adequate expertise in the interpretation of international law. Thus, developing countries have been constantly seeking clarity about the provisions in the TRIPS Agreement that  provide sufficient flexibility and discretion to ensure access to medicines. And in the light of public health beginning with the Doha Declaration which affirmed  that the TRIPS agreement “€˜can and should be interpreted and implemented in a manner supportive of WTO Members’€™ right to protect public health and, in particular, to promote access to medicines for all”€. 4 [4] TRIPS flexibilities include, for example, the ability to delay entry into TRIPS (developing countries had until 2005, and least developed countries have until 2016) and to grant compulsory licenses, among other provisions. Another flexibility is the scope to define patentability standards. While countries cannot, under article 27.1 of TRIPS, exclude entire fields from patenting, they do have the right to determine standards of patentability.5 [5]  This is considered essential due to the continued attempts by multinational companies (MNCs) to seek IP protection and monopoly to prevent the entry of generics. One of the major concerns relates to filing of frivolous patents in developing countries on so-called incremental modifications to drugs. 5 6 [5][6] Such patenting is sometimes characterized as “€˜evergreening,”€™ since such patents are often filed late in the product life cycle and are used to temporally extend market exclusivity. 6 7 [6] [7]

Significantly, in the pre-TRIPS era due to absence of product patent protection, virtually all the HIV/AIDS programmes in countries like Brazil and Thailand were successfully run as several key pharmaceuticals could be produced locally at much lower costs. 8 [8]  These include the so called ‘€˜1st line’€™ drugs, that are used when patients first begin AIDS treatment. The production of anti HIV drugs (antiretrovirals-ARVs) in Brazil also created a large market for ARV active pharmaceutical ingredients (API), making it possible for the Indian pharma companies to produce ARVs in large volumes. 9 [9] The resulting scale of manufacture dramatically brought down the prices. In fact most of the currently affordable ARVs come from India. Like by 2008, an estimated 3 million people in low and middle income countries received ARV therapy for HIV/AIDS of which as much as 60% originated from India. 10 [10] What is more, 70% of the medicines for AIDS purchased by the United Nations Children’€™s Fund (UNICEF), International Dispensary Association (IDA), the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and the Clinton Foundation supplied to over 80 developing countries came from Indian suppliers. Similar is the case with purchases by the MSF and the US President’€™s Emergency Plan for AIDS Relief (PEPFAR).These efforts meant cost-savings of up to 90%. 11 [11] As many as 91% of all the generic ARVs manufactured in India were in US Food and Drug Administration (US FDA) approved facilities in India.12 [12] Significantly, as stated above these medicines could be brought in to the market in the pre-TRIPS era as they  were not under product patent regime.

While the developing world is grappling with the issue of access to Types II and III diseases, there is a steady rise of non-communicable diseases (NCDs) like heart disease, stroke, diabetes and cancers in the middle income and poor countries. 13 [13] 14 [14] In the next two decades a dramatic change on health needs of poor and middle income countries is anticipated. At present, lifestyle and behaviour are linked to 20-25% of the global burden of disease. In the developing countries, where four-fifths of the planet’s people live, NCDs such as cancers, heart disease, diabetes and mental health problems will  replace the traditional public health problems such as infectious diseases and malnutrition, as the leading causes of disability and premature death. Also, by 2020, NCDs are expected to account for seven out of every ten deaths in the developing regions, compared with less than half today. 14 [14] This is going to put the health care system of developing and least developed countries under more strain due to increased cost of medicines.

In the light of the dual disease burden, one of the most pragmatic solutions available for developing countries, including India, is to make prudent use of the flexibilities available in TRIPS. But it is also equally important that these TRIPS flexibilities are incorporated into domestic patent laws. This requires clear understanding of the TRIPS obligations and the techno-legal expertise to translate the flexibilities into the domestic patent law. For India it is important that the vibrant and dynamic domestic generic industry built over the last three decades is  allowed to play its critical role for providing cheap medicines. 15 [15]

Important Sections of Amended Patent Act

India has modified its Patent Act (1970) through three amendments in the years 1999, 2002 and 2005. The main objectives of these amendments are to ensure that the changes made are TRIPS-complaint and at the same time as many safeguards as possible are built-in to protect the interest of public health. Some main components of modified Indian patent law that address the above include i) scope of patentability [Sections 3(d)] and 3[e], ii) limiting data protection, providing for government use; iii)  and compulsory licenses (Section 84) to non-patentees.

Section 3(d)

Section 3(d) of India’€™s Amended Patents Act of 2005 aims at reducing the scope of taking patent protection on grounds of new use of known compounds without establishment of significant enhanced efficacy: “€œthe mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”€ Section 3(d) specifically states that for the patenting purposes, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.16 [16]

Section 3 of the Indian Patents Act, 1970 lists 15 broad categories of knowledge as ‘€œnot inventions’ within the meaning of this Act particularly relevant in the pharmaceutical context.  The Section 3(d) also aims to address the issue of evergreening, a strategy through which companies aim at securing sequential and overlapping patents on a single invention through trivial changes or ‘€˜improvements’€™. It may involve changes in size, colour, dosage, delivery mechanism and composition. A particular salt form of a drug may establish improvements along a number of important parameters, including bioavailability, stability, ease of manufacture, and other solid-state properties.17 [17] While these improvements may be useful, they may not necessarily be particularly inventive falling short of the criteria of patenting. Like there are a limited number of known acids employed by pharma companies to produce pharmaceutically acceptable salts through well known processes. These therefore cannot fulfil the criteria of patentability. Some other common practices include the discovery that a previously known compound  in another stereoisomeric configuration (e.g., as enantiomers) may be more biologically active. Or it could even be a more pharmaceutically active metabolite of a known compound. There have been several cases where  applications have been filed with claimed improvement in physiochemical and pharmacokinetical properties like better solubility and improved plasma stability etc. Sometimes a claimed ‘€˜new drug’€™ may not be new at all like  the active substance in the ARV drug zidovudine (AZT) that is known since the 1960s investigated as an anti-cancer drug. 18 [18]  In fact over 75% of the patented drugs were reportedly modifications of known substances, with  a  study concluding that only 15% of drugs approved by the US Food and Drug Authority during 1989 and 2000 can be considered “highly innovative”. 19 [19] The Glivec case is a more recent and appropriate example on the issue of legal interpretation of  Section 3(d).


An Indian application “€œCrystal modification of A N-phenyl-2 Pyrimidineamine derivative, processes for its manufactures and its use”€ was filed by Novartis on July 17, 1998. (1602/MAS/1998). Glivec  (Imatinib mesylate) is a patented product by Novartis for Chronic Myeloid Leukemia in 35 countries. Various generic pharmaceutical companies including Ranbaxy, Cipla, Natco Pharma and one patients group -€“ the Cancer Patient Aid Association (CPAA) filed a pre-grant opposition to this Indian application under the provisions of section 25 (1) (e) & (g) of the Indian Patents (Amendment) Act 2005. The Chennai patent Office rejected the Glivec patent application in January 2006, on the grounds that the application claimed ‘€˜only a new form of a known substance’€™.  This Indian patent application is directed to the beta-crystal form of methanesulphonic acid salt, commercially called Imatinib Mesylate. Two polymorphs of imatinib mesylate are claimed: alpha and beta (Original molecule imatinib is disclosed in US 5521184 titled “€œPyrimidine derivatives and processes for the preparation thereof”€ in 1993). The patent office rejected patent application because the invention claimed only a new form of a known substance without making any significant improvements in efficacy, and hence constituted non-patentable subject matter.

Novartis appealed against the decision of the Chennai Patent Office before the Madras High Court. In addition to appealing against the rejection of the patent, Novartis also challenged the very validity of section 3(d), claiming that the provisions of the section are not consistent with India’€™s obligations under the TRIPS Agreement and therefore unconstitutional. The Madras High Court dismissed the appeal of Novartis challenge on all counts. The Court clearly distinguished between ‘€˜efficacy’€™ as ‘€˜therapeutic efficacy,’€™ and between drug’€™s ‘€˜potency,’€™ indicating that a very high threshold would have to met before the ‘€˜efficacy’€™ requirement is fulfilled under section 3(d). However, the Madras High Court decided only on the matter of section 3(d)’€™s validity and not the Chennai Patent Office’€™s rejection of its patent application. Subsequently, during the pendency of the appeal, the Indian Patent Appellate Board (IPAB) which has exclusive jurisdiction to hear appeals against decisions of all Indian patent office decisions was notified and created. The IPAB endorsed the Madras High Court’€™s interpretation of the meaning of ‘€˜efficacy,’€™ and made a clear distinction between “advantageous properties”€ and “€œtherapeutic efficacy”€. The IPAB specifically excluded improved bio-availability; better stability; improved flow properties; and lower hygroscopicity from the “€œadvantageous properties”€. In 2009, Novartis appealed to the Supreme Court. On 1st April, 2013, the Supreme Court rejected the Glivec patent. 20 [20]

 From the above it becomes clear that i) the legislative intent of Parliament in enacting section 3(d) was to protect public health and prevent ever-greening was recognized; ii) Indian patent offices must recognize that “€œpharmaceutical product [patents] in India should be granted with utmost care and should be granted only to very genuine cases;”€ iii) while interpreting the meaning of ‘€˜efficacy,’€™ extremely high standard have to be applied; iv) an ‘€˜advantageous property’€™ is not the same as efficacy in that ‘€˜new forms’€™ that result in advantageous properties with respect to bioavailability, stability, etc., are not patentable; and v) ‘€˜mere admixtures,’€™ compositions, dosage forms, formulations, and combinations are not patentable unless there is a demonstrable synergistic effect between the components. 21 [21]

Section 25(1)- Pre-Grant Opposition

Pre-grant opposition is another unique safeguard to promote accessibility and affordability through preventing of granting patents to inventions that do not fulfil the criteria of patenting by way of representation to the Controller at any time after publication of patent application but before the grant of patent. There are 11 grounds under Section 25(1) under which an application can be challenged. There are at least 10 instances where, using this provision, patents filed have been challenged in India.

Some of these include: 22 [22]

Darunavir (Tibotec v Cipla) Polymorph 3598/DELNP/2004 Section 3(d). In the matter of Application for patent no 3598/ DELNP/ 2004, Delhi Patent Office, 6 July 2009.

Adefovir dipivoxil (Gilead v Ranbaxy) Crystal Form 712/DEL/2002 on the basis of 3(d) In the matter of Patent application no. 712/del/2002 filed on 03/07/2002, Delhi Patent Office, 18 March 2009

Amlodipine-atorvastatin combination (Pfizer v Torrent) 2571/DEL/1998 Section (3d and 3e). In the matter of the application for Patent No. 2571/del/1998 filed on 28th Aug. 1998, Delhi Patent Office, 3 February 2009.

Rosiglitazone (Smithkline Beecham) Sulphonate Salt 295/DELNP/2003 on the basis of 3(d) Patent Application No.00295/DELNP/2003 -€” Hearing U/S 14 read with 15 of the Patents Act, 1970, Delhi Patent Office, 6 January 2009.

Erlotinib polymorph (OSI v Cipla) Crystal Form IN/PCT/2002/507/DEL. Section 3(d) In the matter the application for patent No. IN/PCT/2002/507/DEL filed on 14th May,2002, Delhi Patent Office, 15 December 2008.

Crystalline Macrolides (Novarts v Ranbaxy) Crystal Form 1440/MAS/1998. Section (3d) In the matter of Application for Patent bearing the number as 1440/MAS/1998 filed on 29th June 1998 by Novertis AG of Schwarzwaldallee 215, 4058 Basel, Switzerland,, A Swiss Company, Chennai Patent Office, 13 July 2007.

Atorvastatin (Warner-Lamber v Torrent) Crystal Form 1577/DEL/1996 Section (3d) In the matter of the Application for patent No.1577 /DEL/1996 filed on 19th April, 1998, Delhi Patent Office, 12 June 2007.

All these cases of pre-grant opposition were successful as the applicants failed to fulfil the conditions required under section 3(d), 3(e) and section 2(1.j) of the Patent Act. The main objective of such opposition is to improve the quality of patents or to prevent frivolous and unworthy patents from being granted. The rejection of these patent applications is considered a big step in towards ensuring access to cheap life-saving drugs.

Section 84(1) and 92 A (1)- Compulsory Licensing

Compulsory Licensing (CL) is a procedure whereby a Government can allow any company, agency or designated person the right to make a patented product, or use a patented process under licence, without the consent of the original patent holder.  CL is an important legal tool to promote competition to increase the affordability of drugs at once compensating the patent owner for the use of the invention. Section 84 of the Amended Indian Patents Act (2005) deals with compulsory licenses and allows any interested person to apply for a CL but only after the patentee rejects the request of applicant for issuance of a voluntary license. The Indian Patent Law provides sufficient powers to the Controller of Patents to issue compulsory licenses to deal situations that warrant intervention. Two sections directly address the requirement of essential drugs for domestic use and countries which do not have the manufacturing capacity for these drugs.  Section 84 mandates prevent the abuse of patent as a monopoly and facilitate manufacturing of invention by any interested person. Sections 92 (1) and 92 (3) lay down circumstances of national emergency or extreme urgency while Section 92(a) is meant for exporting pharmaceutical products to other countries that need such products for  public health purpose. The grounds broadly could be: i) reasonable requirements of the public with reference to patented invention are not met; ii) the patented invention was not available to public at an affordable price; and iii) patent is not worked in the territory of India to the fullest extent that is reasonably practicable.  Generally, such a license can be applied after three years of the grant of a patent: “€œAt any time after the expiration of three years from the date of the grant a patent, any person interested may make application to the Controller for grant of compulsory license.”€  In addition, a ‘€˜reasonable time period’€™ of up to six months has been introduced, before the Controller considers request for grant of a compulsory license in cases where the applicant fails to obtain a licence from the patentee on reasonable terms and conditions. 23[23]

First Compulsory License by the Indian Patent Office was granted for  Nexavar

‘Sorafenib Tosylate’ is a compound patented by Bayer Corporation, USA and marketed as Nexavar. The drug is life-€“extending drug used in the treatment of advanced stages of kidney cancer (Renal Cell Carcinoma) and liver cancer (Hepatocellular carcinoma). Sorafenib can extend the life of kidney cancer patients by 4-5 years and in liver cancer patients by 6-8 months. 24 [24] Bayer was granted a patent (No. 215758) as well as regulatory approval for importing and marketing the Drug in India in the year 2008. Bayer charges approximately US$66,812 per patient per year/ over US$5,500 per month in India for this drug.25 [25]

M/s Natco Pharma (Natco) tried for voluntary licence to manufacture and sell its generic version of drug in December 2010 for Nexavar from Bayer but the company rejected Natco’s proposal, saying it needed to reinvest its earnings from such patented products for future R&D. 26 [26] After the lapse of 3 years since the date of grant of patent to Bayer Corp. for Nexavar, Natco filed an application in July 2011 before the Controller of Patents for grant of Compulsory License under section 84 in respect of Sorafenib.25 [25]

 The grounds on which the appeal was made were: i) reasonable requirements of the public with reference to the  patented invention have not been met; ii)  patented invention was not available to public at an affordable price; and iii) patent has not been  worked in the territory of India to the fullest extent that is reasonably  practicable. Also M/s Bayer charged for Rs. 2.85 lakhs for a one month’€™s course of the medicine while Natco proposed to sell its generic version, sorafenib tosylate, for about Rs. 8,800, which is a about 3 percent of the cost of the innovator’s product. 27 [27]

In a landmark decision the Indian Patent office on 9th March 2012 granted the country’s first compulsory license. The CL allowed Natco Pharma Ltd, an Indian generic drug maker to make and sell generic version of liver/kidney cancer drug Nexavar patented by M/s Bayer Corporation. The order of patent controller is significant because this is the first time India had invoked the compulsory licensing provision  to increase citizens’ access to expensive, life-saving drugs. It’s also the first time that an Indian company has been granted compulsory license to market a generic version of a patented drug. 27 [27] 

The CL is valid till the expiry of the patent i.e. up to 2021. The company has to fulfil certain conditions like maintaining account of sales, and payment of royalty at 6% of the net sales on a quarterly basis. The order also makes it mandatory for Natco to supply the drug free of cost to at least 600 needy and deserving patients per year. 28 [28] Bayer appealed against this order to the Intellectual Property Appellate Board (“IPAB”). The IPAB held that the failure to meet the demand of the public on reasonable terms has to include both “quantity” and “price” i.e. the patentee has to work the invention in India on a commercial scale and the invention has to be available at a reasonably affordable price. 25 [25]

Concluding Notes

In the recent past, the Indian Patent Act  (2005), has been put to test with several sections challenged in the Indian Courts. The decisions of the courts have provided clarity on the interpretation in the decisions taken by the Patent Controller that comply with India’€™s obligations under the TRIPS agreements. This clarity should help India to make use of the safeguards available to limit the impact of the patent barriers towards promoting affordable health care. The uninterrupted supply of generic drugs from India has played a key role in lowering the price of essential drugs for poor both in India as well as many developing countries. It is also hoped that discussions as these will facilitate formulation of a cohesive policy. The significant participation of the civil society groups in the ongoing battle has been very important and such a pressure must be maintained. A robust legally enforceable mechanism is important as with time the effectiveness of CL is likely to be blunted and it is only competition among generic suppliers that would help India keep the supply channels of cheap medicines to poor countries open. 12 [12]


1.’€™t Hoen. Ellen F. M. TRIPS, Pharmaceutical Patents, and Access to Essential Medicines:Seattle, Doha, and Beyond. World Health Organization topic. 2003; 39-62. & ‘€™t Hoen. Ellen F. M. Drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and Public Health. The Global Politics of Pharmaceutical Monopoly Power 2009; 1-135

2. Running in Place: Too many patients still in urgent need of HIV/AIDS treatment. Briefing document on HIV/AIDS.XVII International AIDS Conference. Médecins Sans Frontières 2008  Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) – A Strategic Option for India Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) – A Strategic Option for India.

3. Correa, C, Matthews D. The Doha Declaration Ten Years On and Its Impact on Access to Medicines and the Right to Health. Discussion Paper, UNDP 2011. 1-31

4. Doha WTO Ministerial. Declaration on the TRIPS Agreement and Public Health.  WTO, 2001

5. Correa, CM. Pharmaceutical Innovation, Incremental Patenting, and Compulsory Licensing. South Centre Research Paper  no. 41. 2011; 1-22

6. Kapczynski, Amy and Park, Chan and Sampat, Bhaven N., Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of Secondary Pharmaceutical Patents. Yale Law School, Public Law Working Paper No. 271; Yale Law & Economics Research Paper No. 462. doi:10.1371/journal.pone.0049470. PLOS One  2012; 7:12

7. Hemphill, S, Bhaven Sampat B. When Do Generics Challenge Drug Patents? doi:10.1111/j.1740-1461.2011.01235.x. Journal of Empirical Legal Studies, 2011; 8: 4; 613-€“649

8. Satyanarayana K. TRIPS, patents and HIV/AIDS drugs. Indian J Med Res. 2005;121:211-214

9. Satyanarayana K, Srivastava S. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) -€“ A Strategic Option for India. The Open AIDS Journal 2010; 4: 41-53

10. Report of the Inquiry of The All Party Parliamentary Group on AIDS into long-term access to HIV medicines in the developing world. The treatment Timebomb 2009

11. Satyanarayana K, Srivastava S. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) -€“ A Strategic Option for India, The Open AIDS Journal 2010, 4, 41-53

12. Untangling the Web of Antiretroviral Price Reductions, 16th Edition. Médecins Sans Frontières, 2013

13. WHO. Defining Disease Types I, II And III, Background document provided by the WHO Secretariat, 2012: 1-3

14. Millennium Development Goal 8, The Global Partnership for Development: The Challenge We Face. United Nations, MDG Gap Task Force Report 2013

15. Chaudhuri S, Park. C, Gopakumar K M. Five Years into the Product Patent Regime: India’€™s Response. A study by United Nations Development, Programme Poverty reduction and HIV/AIDS 2010:73-105

16. Gopakumar K M. Product Patents and Access to Medicines in India: A Critical Review of the Implementation of TRIPS Patent Regime. The Law and Development Review 2010;3:2:Article11

17. Berge, et al. Pharmaceutical Salts. Journal of Pharmaceutical Sciences, 1977; 66:1:1-19

18. Horwitz, J., et al. The monomesylates of 1-(2’-deoxy-B-D-lyxofuranosyl) thymine, Journal of Organic Chemistry 1964: 29:7: 2076-2078 

19. Anand G. Analysing the Supreme Court Judgment.  Economic & Political  Weekly 2013. 48(32)

20. Kulkarni K, Mohanty S. (2013), Novartis loses landmark India patent case on Glivec. Reuters article 2013

21. Novartis case: background and update-€“Supreme Court of India to recommence hearing. Lawyers Collective HIV/AIDS Unit 2011

22. I-MAK. Initiative for Medicines, Access & Knowledge, Pharmaceutical Patent Case Law

23.  Indian Patents Act, 1970, s. 84 & s. 92

24. Background Information on India’s First Compulsory Licence. Médecins Sans Frontières 2012

25. Jha and Gokhle (2013), IPAB upholds the first compulsory license granted to generic drug company. Nishith Desai Associates 2013  

26. Natco Pharma bags licence to sell Bayer’s cancer drug Nexavar, ET Bureau The Economic Times 2012   

27. Vijayakumar S, Rajagopal D. Natco’s compulsory licence for selling generic copies of Bayer’€™s cancer drug Nexavar upheld by IPAB.  ET Bureau The Economic Times 2013

28. NATCO granted compulsory licence for Nexavar. Natco Pharma Ltd. News 2012


1.   &





























*Dr Sadhana Srivastava, a  qualified patent agent was an intern at the Cornell University and Office of Technology Transfer, NIH, Bethesda. She was a  Government delegate  in  the Inter-Governmental Working Group on Intellectual Property & Public Health, WHO, Geneva. Dr Srivastava is a senior scientist with the Indian Council of Medical Research, New Delhi looking after the IPR activities of the Indian Council of Medical Research.

**Dr Kanikaram Satyanarayana  has been instrumental in the formulation of the guidelines and policies for IPR and technology transfer of the Indian Council of Medical Research, Govt of India. He advises the Ministry of Health & Family Welfare, Government of India on IPR, health and trade issues and also served as a temporary adviser for the Inter-Governmental Working Group on Public Health and Innovation (IGWG) for the WHO,  Geneva and also the SEAR (WHO) for Consultative Expert Working Group (CEWG) meetings.  He was a member of the International Editorial Board for the Technology Transfer Manual on Agriculture and Health of the MIHR, UK and founder-Secretary of the Society for Technology Management (STEM), India. Dr Satyanarayana is currently Co-ordinator in the Department of Health Research, New Delhi. 


News Link n. 84

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 84

Uganda donors cut aid after president passes anti-gay law

Europe reconsiders Uganda aid following anti-gay law 

Uganda: The Politics of Uganda’s Anti-Homosexuality Legislation 

African farmers cut use of ‘toxic’ pesticides through EU-funded project

Land Grabs in Africa: Senegal Farmers and Herders Demand Shady Transnational Corporation to Get off their Land

How does crop biotechnology help food security

Big food companies improve policies in developing nations, Oxfam  

EU scientists’ biofuels warnings were ignored 

Parliament kicks off debate on the legal right to water 

EU, African science groups support biotech development 

The Trans-Pacific Partnership Agreement: Implications for Access to Medicines and Public Health

Evidence-based medicine vital for health and medical progress in China 

TRIPS Council: Discussion Of IP And Innovation Irritates India: Other Issues Unchanged 

The State Of Health Reform: A Health Affairs Conversation With James Capretta, Genevieve Kenney, and Larry Levitt 

Obamacare. Salute, lavoro, bugie 

The G-20′s Growing List of Unfinished Business 

Top 5 Lame Excuses Not to Support Extreme-Poverty Alleviation Work 

World Bank to help map Africa’s mineral resources 

More Than a Phone: Mobile Empowering Women 

Compulsory patent licensing and local drug manufacturing capacity in Africa  

Quanto costano i migranti in Europa