News Link n. 54

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 54

2013 progress report on the global plan towards the elimination of new HIV infections among  children by 2015 and keeping their mothers alive

WHO governance reform: Report by the Secretariat

Medical R&D Convention Derailed: Implications for the Global Health System 

Miracle In Marrakesh: “Historic” Treaty For Visually Impaired Agreed

Obama’s Africa Trip: Expectations and the Unexpected

The G8 Verdicts: Devils, Details, Geeks and Whimpers

Antitrust: Commission fines Lundbeck and other pharma companies for delaying market entry of generic medicines 

US Supreme Court Rules On Pharma Payments To Delay Generic Drugs On Market 

Industrial policies for development: It’s more than you think

QUAMED Newsletter June 2013

FAO conference: 7 takeaways 

Eve Crowley: How FAO can adapt to the post-2015 development agenda

Demand Forecasting Takes Off 

Health financing for universal coverage and health system performance: concepts and implications for policy

L’ITALIA DONA 1,5 MILIONI PER GRUPPI VULNERABILI

Harvard Professor A Flag Bearer For Agricultural Innovation, Biotechnologies In Africa 

The World Bank and the Green Climate Fund: “an ironic contradiction”?

What Climate Change Means for Africa, Asia and the Coastal Poor

170 Members Of US Congress Pressure India On IP Rights 

US Businesses Launch Coalition For Fair Trade With India 

Aurobindo Signs Licence to Make HIV Medicines for Children

 

 

 

 

 

News Link n. 53

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 53

Three organizations to hold joint symposium on ‘Medical Innovation — Changing Business Models’

International consultation focuses on access to HIV medicines for middle-income countries

UNITED NATIONS Human Rights: Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health 

Obama administration blocking consensus at Human Rights Council on access to medicines resolution 

Ambassador Eileen Donahoe explains why United States will not vote for UN resolution on access to medicine 

UNITAID TO PROVIDE USD 77 MILLION FOR BETTER HIV MEDICINES

Myriad Case Decided: Natural Human Genes Not Patentable In US

Can Global IP Rules Be Responsive To Public Interest Demands? The Case Of The Treaty For The Visually Impaired 

Developing Countries Lead Global Shift to Green Energy

Pandemic Influenza Risk Management: 2013 WHO Interim Guidance

UN: Children Victimized in World Conflicts

Child Labor Robbing Millions of Health, Education and Growth, UNICEF Says 

Global Fund: More value for money

Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

IP Trends in African LDCs and the LDC TRIPS Transition Extension

New funds and science back drive to fight malnutrition

Big commitments made at London nutrition summit

The BRICS Bank gathers momentum: another sign of the world’s shifting power balance 

Is the Price Right? Evaluating Advanced Market Commitments for Vaccines 

Despite decade of innovation, much left to do on neglected tropical diseases 

 

 

 

 

Indian Patent Law TRIPS Compliant: Novartis judgment shows the way

While patients groups around the world have expressed joy over the Novartis decision of the Supreme Court of India, western Multi National Companies (MNCs) and their governments have expressed extreme displeasure over it. Some in the US have even urged their Administration to take India to the Dispute Panel under the WTO, as according to them, Indian patent law is not compliant. They have even found supporters in the business community in India. Unfortunately these kinds of criticisms reflect either ignorance at worst or poor understanding of the debate at the best. Worse still criticism appears to be motivated. So what is the Novartis case all about?

Indian Patent Law TRIPS Compliant: Novartis judgment shows the way

 

By Anand Grover*

Senior Advocate practicing in the Supreme Court of India and the Director of the Lawyers Collective HIV/AIDS Unit

 

While patients groups around the world have expressed joy over the Novartis decision of the Supreme Court of India, western Multi National Companies (MNCs) and their governments have expressed extreme displeasure over it. Some in the US have even urged their Administration to take India to the Dispute Panel under the WTO, as according to them, Indian patent law is not compliant. They have even found supporters in the business community in India. Unfortunately these kinds of criticisms reflect either ignorance at worst or poor understanding of the debate at the best. Worse still criticism appears to be motivated. So what is the Novartis case all about?

Earlier, like a number of countries, India did not provide patent protection for products in the field of foods and medicines. This was because after India gained independence, it found that the medicines were mostly imported, they were amongst the highest priced in the world, the pharmaceutical industry in India was dominated foreign Multi National Companies, the Indian generic industry was practically non-existent. In response the Patent Act was amended and patent protection for products was removed and patent protection for processes was kept intact. The period for protection was limited to 7 years. In this India was simply following a number of other countries in Europe, notably Germany.

As a result of this apparently very minor change, the Indian generic industry flourished, competition increased, prices of medicines in India plummeted and became affordable. By 1988 India became a next exporter of drugs and by the middle of 1990s it was delivering over 90% of the Anti- Retrovirals for HIV in the developing world. These were safe efficacious quality drugs at affordable prices. India became the pharmacy of the developing world.

In the meantime under the pressure of western MNCs and their governments, which wanted that the world should have intellectual property (IPR)  laws like the US, TRIPS Agreement was entered into. It was brought into force on 1 January 1995. Under the TRIPS Agreement, different countries, had to make their laws TRIPS compliant at different times. India had to finally comply with its TRIPS obligations by 1 January 2005.

Importantly, the western MNCs and their Governments did not get what they wanted in the TRIPS Agreement.  The TRIPS Agreement only provides for the minimum standards and leaves the precise working to be left to the member countries. The TRIPS Agreement sets out only the mandatory minimum standards of IPR protection and enforcement measures that WTO member countries have to provide. Thus, in terms of patent law, the TRIPS Agreement mandates that member countries have to provide patent protection for products and processes for a period of twenty years, for products and process which are novel, not obvious and are industrially applicable. However it does not stipulate what is “€œnew”€ or “inventive step”€. These are known as flexibilities, which the developing countries were able to extract as a major concession. Thus they have the flexibility to define for themselves these terms in their patent laws.

When India had to finally comply with its TRIPS obligations by the 1st January 2005, that is it had to have protection for product and process patents for 20 years.

But there was a problem. It was noted that in the developed countries, US, Europe and Japan, patents were being granted not only for the New Molecular (or Chemical) Entities [NME or NCE] but also new forms of the same. For instance if a base of a compound is the NCE or NME, had been granted a patent, then even a salt or crystalline form of that compound was also being granted patents, even though it may not have any additional therapeutic benefit, provided of course it satisfied the criteria of novelty, inventive step and industrial applicability. In fact over 75% of the patented drugs were such forms of known substances.This allowed what is known as ever greening, patent term being extended for new forms without any real therapeutic benefit. This eliminated competition, extended monopolies, making drugs unaffordable and inaccessible, adversely impacting the Right to Health.

Addtionally the world had seen a crisis in the access to medicines over AIDS epidemic, when drugs were being sold at the rate of USD 10,000 per patient per annum, leaving huge populations to die. Because of the Indian generic competition, available at that time at USD 350 per patient per annum, it was possible to launch a huge global effort of providing ARVs across the world to the people who needed them, saving millions of lives. This had led the WTO, which oversees the TRIPS Agreement, to pass the famous DOHA Declaration, highlighting the member countries right and need to protect public health while implementing the TRIPS Agreement.

The Indian Parliament had a challenge. The challenge was to strike a balance to, on the one hand, comply with the obligations under the TRIPS Agreement and provide for patent protection for both product and processes for 20 years; and on the other hand substantially limit ever greening, promote generic competition and thereby protect the Right to Health. In so doing it enacted section 3(d) of the Indian Patents Act. Simply it states that a new form of a known substances would not be patented unless it has enhanced efficacy over the known substance. Section 3(d) is perfectly compliant with TRIPS when one takes into account the flexibilities available to member states.

It is section 3(d) has been under challenge by Novartis and the foreign MNCs and their governments, who have been carrying on a relentless campaign against it.

When the Novartis application for patent for its drug was published by the Patent Controller, 5 entities filed oppositions against it, the Cancer Patient Aid Association (CPAA) and 4 Indian generic companies. Novartis argued before the Patent Controller that its drug, Gleevec, the beta crystalline form of imatinib mesylate salt, was new (or novel), not obvious and industrially applicable. The Oppositionists contended otherwise and also that it was hit by section 3(d). The Patent Controller in his decision agreed with the Oppositionists and held that claimed invention was not novel, it was obvious and it was hit by 3(d). There was no dispute it was industrially applicable.

Against the decision of the Patent Controller the Novartis not only filed appeals but also challenged the validity of section 3(d). It argued that 3(d) was arbitrary and violated the Constitutional provision in this behalf as also that it did not comply with TRIPS. The Madras High Court rejected both the challenges. Pertinently it held that it is not for an Indian court to decide about TRIPS compliance. For that the remedy is provided under TRIPS. Significantly no member State has thought it fit to take the issue of 3(d) to the Dispute Panel under the TRIPS agreement. Obviously because it is TRIPS compliant.

The Appeals were heard by the Intellectual Appellate Board, which held that though the claimed invention was novel and not obvious it was hit by section 3(d) and thus not patentable. It is against this decision that Novartis went to the Supreme Court.

Novartis had argued that the beta crystalline form of imatinib mesylate salt was a two fold step invention over the free base of imatinib disclosed in the Zimmerman patent, firstly from imatinib to non-crystalline form of imatinib mesylate and thereon to the beta crystalline form of imatinib mesylate salt. They argued that the steps were novel and non-obvious. The Court disagreed with Novartis and held that the non-crystalline form of imatinib mesylate salt was disclosed and anticipated in the Zimmerman patent.

However on the beta crystalline form of imatinib mesylate salt, the court assumed that it was novel and not obvious and decided the fate of the claimed invention on the basis of section 3(d).

For the purpose of satisfying the requirement of 3(d), that is the new form being significantly more efficacious over the known substance, Novartis had filed affidavits to show that the beta crystalline form of imatinib mesylate salt was 30% more bioavailable than the imatinib free base as according to them that was the known substance. They also contended that its three additional properties, namely more beneficial flow properties, better thermodynamic stability, and lower hygroscopicity, were properties with regard to efficacy.

The Court held that for the purpose of section 3(d) imatinib free base could not be taken to be the known substance and the comparison with that the claimed invention was not correct. The non-crystalline form of imatinib mesylate salt was the known substance and comparison should have been made with it. It was also because the claimed invention was derived from it. The court further opined that increased bioavailability was on account of the salt and the crystalline form.

Secondly the Court held that efficacy in section 3(d) is therapeutic efficacy. In that context the physio-chemical properties, namely beneficial flow properties, better thermodynamic stability, and lower hygroscopicity, may have advantages but were not properties with regard to efficacy.

On the question of bioavailability, the Court held that bioavailability by itself cannot determine efficacy. In each case the applicant has to determine, through animal in vivo models, how therapeutic efficacy is effected. As Novartis had not done that, it had not satisfied the test of section 3(d) of the Indian Patent Act.

The Novartis decision has enormous significance. The relentless by western pharma MNC to whittle down section 3(d) has been repelled. The case has also made clear what is the meaning of efficacy in section 3(d). Mere advantages is not sufficient. The Applicant has to show by animal in vivo models how therapeutic efficacy is significantly enhanced.

———————————————–

* Anand Grover is a Senior Advocate practicing in the Supreme Court of India and the Director of the Lawyers Collective HIV/AIDS in India.

Mr Grover is a pioneer in the field of HIV and has handled several hundred HIV/AIDS related litigations in India. He appeared in the first HIV case relating to the HIV activist, Dominic D Souza, The Lucy D€™ Souza case, challenging the isolationist Goa Public Health Amendment Act. He also fought the first case on blood transfusion in the Calcutta High Court, P v. Uol as well as successfully arguing against the patenting of anti-AIDS drug Nevirapine Hemi-hydrate. He and his team in the Lawyers Collective represented the Cancer Patients Aid Association in the Novartis case from the Patent Controller to the Supreme Court.

The United Nations Human Right Council appointed Mr Anand Grover as Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health at its eighth session held in June 2008. 

News Link n. 52

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 52

A NEW GLOBAL PARTNERSHIP: ERADICATE POVERTY AND TRANSFORM ECONOMIES THROUGH SUSTAINABLE DEVELOPMENT. The Report of the High-Level Panel of Eminent Persons on the Post-2015 Development Agenda 

UN Panel’s Post-MDG Agenda: a Coherent Vision for a Better Future

Two topics: Non-Voluntary uses of medical patents, and delinkage of R&D costs from drug prices

WTO Members Agree On Draft Extension Of TRIPS Transition For LDCs

EU Court Backs Secrecy, Privileged Industry Access In Trade Talks

Fact Sheet: White House Task Force on High-Tech Patent Issues

The White House: PATENT ASSERTION AND U.S. INNOVATION

US Businesses Urge Obama To Stoke Trade War With India 

New vaccine drives Africa meningitis cases to lowest in decade

Polio is back in the horn of Africa

Shortages of Drugs Threaten TB Fight

UN: Global Malnutrition Costs Are Unacceptable

Developing countries see hidden cost in food price hikes

Bill Gates Leads $35 Million Investment In Global Disease Research

Use of data from registered clinical trials to identify gaps in health research and development 

Green Growth should be at the heart of development policies, new OECD report says 

Aid agencies of the future: Poverty, geography and the double dilemma

We’re not there yet – why we must keep current MDGs in sight

Protection Of Local GI Products Can Benefit Women, Speakers Say

Chi paga le multe di Big Pharma?

Public sector services for the prevention of mother-to-child transmission of HIV infection: a micro-costing survey in Namibia and Rwanda

The cost of type 1 diabetes: a nationwide multicentre study in Brazil

 

Medicines for the World

While research and development (R&D) of new medical treatments has greatly improved health around the world, there is widespread agreement that poor populations could and should benefit much more. Clearly identified in a report by a WHO Consultative Expert Group (www.who.int/phi/cewg/), the key obstacles are two: pharmaceutical research tends to bypass health problems concentrated among the poor, and newer medicines tend to be sold with very large patent-protected mark-ups that effectively price them beyond the reach of poor patients.

A sophisticated joint solution is the Health Impact Fund (HIF) which would offer to reward the development of any new medicine according to its measured actual health impact on condition that it is sold at no more than the lowest feasible cost of manufacture and distribution

Medicines for the World

 

by  Thomas Pogge*

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

 

While research and development (R&D) of new medical treatments has greatly improved health around the world, there is widespread agreement that poor populations could and should benefit much more. Clearly identified in a report by a WHO Consultative Expert Group (www.who.int/phi/cewg/), the key obstacles are two: pharmaceutical research tends to bypass health problems concentrated among the poor, and newer medicines tend to be sold with very large patent-protected mark-ups that effectively price them beyond the reach of poor patients.

There are obvious solutions to both problems. Public or private donors can fund new R&D into neglected diseases -€” either by awarding grants to promising research outfits (push funding) or by offering prizes for the development of a medicine that meets certain pre-set specifications (pull funding). And pharmaceutical firms can be given special incentives to sell specific products to poor patients at much lower prices. There are also joint solutions that reward innovation in a way that guarantees affordability. An example is an advance market commitment which is an offer to reward development of a new medicine that meets certain pre-set specifications by subsidizing its sale at a low price.

A sophisticated joint solution is the Health Impact Fund (HIF) which would offer to reward the development of any new medicine according to its measured actual health impact on condition that it is sold at no more than the lowest feasible cost of manufacture and distribution. Uniquely, the HIF avoids having to specify the medicine to be developed or even the disease to be targeted, leaving innovators themselves (who are best informed about their own capacities) to work out how their R&D investments can yield the greatest health impact.

The HIF also avoids the problem of wastefully excessive rewards by paying out a fixed stream of rewards to be divided among registered products according to their respective therapeutic benefits.  An overly lucrative reward rate (dollars per unit of health impact) would attract additional product registrations that would reduce this reward rate; and an unattractive reward rate would discourage registrations, thereby raising the reward rate. Each product would share in eight or ten annual HIF pay-outs and then go generic. With total annual pay-outs of $6 billion, about 20-30 products can be expected to be HIF-supported at any given time, with about 2-4 products joining and exiting each year. Most new medicines registered with the HIF would likely be for diseases that disproportionately affect poor people — products whose potential profits from patent-protected mark-ups are limited.

With many governments joining hands, $6 billion per annum is not a lot on money. It is, for example, less than 1 percent of worldwide spending on medicines. Depending on participation, countries might contribute some 0.03 percent of their GNI (Gross National Income), and their inhabitants would in return receive offsetting savings from much lower prices on HIF-supported medicines (affluent countries declining to join the HIF partnership would be excluded from the price ceiling; their inhabitants would continue to pay high patent-protected mark-ups). The HIF would also drastically reduce the burdens of waste now plaguing the pharmaceutical industry: patenting costs, competitive marketing, patent litigation and deadweight losses.

Innovators would pay much more attention, beyond sales, to the actual use of any products they choose to register for HIF rewards. Sales resulting in no therapeutic benefit are worthless to the innovator whose earnings depend on health gain to the patient. Innovators would therefore try to reach the patients who can benefit the most, often selling to poor patients even below the price ceiling (if the expected health impact reward exceeds the loss on the sale). An innovator would also try to ensure that patients are properly instructed in the optimal use of the drug and adhere to the proper regimen. These efforts to optimize a medicine’€™s benefits to its users would benefit poor and rich patients alike. Patients would furthermore benefit from a sharp decline in counterfeiting, which is quite common in many developing countries: little profit can be made from the sale of counterfeit medicines when the genuine article is on sale at a very low price.

The two great obstacles to establishing the HIF are lack of political will in a period of austerity and skepticism about the reliable measurement of a drug’€™s health impact. If the skepticism can be shown to be unwarranted, perhaps the political will can be mobilized. In the next few years, we plan to conduct several pilot projects that would monitor the introduction of a new medical treatment into a country or other jurisdiction. Some such pilots might be purely passive, just measuring the health impact of a product introduction, others might also pay rewards to the relevant innovator or distributing agent, thus also exploring how such an agent may introduce a new product differently if it is rewarded according to health impact rather than through high mark-ups. Even the latter kind of pilot could not show how the HIF would encourage the R&D of new medicines. But it could greatly expand access to an existing new drug; and it would cost money only if and insofar as it actually achieved this objective.

 

*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 (http://www.healthimpactfund.org) and toward developing better indices of poverty and gender equity.

News Link n. 51

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 51

66th World Health Assembly: 5 takeaways

World Health Assembly: IP Considerations Play Key Role In Final Outcomes 

U.N. High-Level Panel Releases Final Report On Post-2015 Development Agenda, Calls For Ending Extreme Poverty By 2030 

Assessing Population Aging and Disability in Sub-Saharan Africa: Lessons from Malawi?

Science should focus on ‘new’ environmental health risks, EU report says 

MDG Report 2013: Assessing progress in Africa toward the Millennium Development Goals  

PEPFAR: Drug supply chains are stronger, but more steps are needed to reduce risks 

Health groups dismayed by news ‘big tobacco’ funded rightwing thinktanks 

Is there a role for the G8 in helping developing countries raise tax revenues?  

Technical Note: The LDC TRIPS Transition Extension and the Question of Rollback 

The UN and the World Bank: Rare co-operation

Global Fund: New Approach to Funding – a “Striking Change”

HIV laws in Asia-Pacific lack teeth – UNDP

Food Culture Clash: EU, US Conflicting Concepts For GIs; Both Covet Asian Market 

Civil Society Observer At UPOV Gets A Public Face 

Bill Gates urges more aid from China

Asian Development Blog: What comes after the MDGs?

100 years on, Rockefeller Foundation still promotes ‘the well-being of mankind’ 

Generation MDGs: How Youth are Pushing to Reach the MDGs and Shaping the Post-2015 

Diabetes in India rising, with women at a particular disadvantage

The global impact of indian generics on access to health

India has developed a low-cost rotavirus diarrhea virus vaccine that could save lives of lakh of children 

Bringing Health to World’s Poor Goes Beyond Drug Price

Reshaping the fight against poverty  

UNITAID LAUNCHES CALL FOR SUBMISSIONS FOR NEXT ROUND OF FUNDING