Defending India’s patent law

Prabha Sridevan in The Hindu

No one can attack India’s well-founded Intellectual Property regime as being weak merely because a drug that is claimed to be an invention fails the test of law

India and its intellectual property (IP) laws have been the subject of sharp criticism recently. Now, there is talk of the government invoking emergency provisions with regard to Dasatinib, a cancer drug. The decibel level may go up several notches.

Let us look at our law. The sovereignty of a country includes its power to make laws. Any person who pursues commercial interests in another country must submit himself/herself to the laws of the country. No one can attack our regime as being weak only because his/her invention did not stand up to the test of our legislation. Nor can India be accused of robbing Peter to pay Paul. It sounds romantic, but it is still robbery.

The Novartis case and the Nexavar case of compulsory licence (CL) are what have impelled this attack. Innovation and invention have speeded up in myriad ways in the last few decades and our country had committed itself to the obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights. Therefore, it was necessary for India to revisit its patent law; in 2005, the Indian Patents Act was amended, Section 3(d) being one of the amendments. It was the basis of the Novartis case.

TRIPS recognises that members have the right to use/adopt measures to protect public health so long as they are consistent with TRIPS. A recent study notes: “Policy makers in developing and developed countries need to base their implementation of intellectual policy rules on these pro-public health and pro-access principles.” The Doha Declaration is an affirmation of the right to use the flexibilities in TRIPS, especially by developing and less developed countries, regarding access to medicine. The language of the Doha Declaration emphasises the importance of implementing and interpreting the TRIPS Agreement in a way that supports public health.

“The TRIPS agreement does not limit the grounds on which compulsory licences can be granted, and does not prevent patent applicants from having to demonstrate enhanced efficacy for their allegedly new and useful inventions. There are many problems affecting access to and rational use of medicines in India but the provisions within the country’s patent laws, if more extensively and properly applied, should help rather than hinder such access. India’s laws and experiences could provide a useful example for low-income and middle-income countries worldwide.”

About patentability, not price

In Novartis, the Supreme Court said that while harmonising the patent law in the country with the provisions of the TRIPS Agreement, India had attempted to balance its obligations under the international treaty and its commitment to protect and promote the public health considerations of people in the country and elsewhere. The ‘thorn in the flesh’ Section 3(d) had been challenged by Novartis before the Madras High Court earlier. But the court upheld its constitutionality and rejected the attack on the grounds of vagueness and arbitrariness. Novartis did not file an appeal against that judgment. Novartis claimed a patent for Gleevec, a cancer drug which was refused. Novartis then appealed to the Supreme Court.

The intellectual property of the inventor lies in the invention which is claimed to be novel, inventive and patentable. The patent is a creature of law by which the state bars public access to that invention for a fixed period. The economic reward from the invention is earned during this time after which it goes to the public domain. Section 3(d) is a test of patentability. With reference to Gleevec, it is enough to know that 3(d) inter alia says that in the absence of evidence of enhancement of known efficacy, the mere discovery of a new form of a new substance is not an invention deserving the grant of patent. Imatinib Mesylate was the known substance and Novartis claimed a patent for its (the substance) beta-crystalline form.

The Supreme Court asked: “Now, when all the pharmacological properties of beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt, where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form?” If an invention fails the 3(d) test, it means there was no inventive step. There was no intellectual property in the alleged invention, and nothing that could be stolen. Our lawmakers meant to check any attempt at repetitive patenting or extension of the patent term on spurious grounds, and blocked attempts to keep an invention “evergreen.” If those who attack the Indian patent regime claim that a minor tweaking of chemicals is a giant step forward for an invention, then our legislators begged to differ. The Supreme Court said that it was not ruling that all incremental innovations were non-patentable and that every case would be examined. Our law says that new forms of known substances which do not have enhanced efficacy are in effect advances without real innovation. Therefore, Section 3(d) is actually a catalyst for genuine inventions.

The Supreme Court said that Novartis had attempted to get a patent for a drug which would otherwise not be permissible under our law. Filtering doubtful patents is the strength of our law and not its weakness. The Novartis judgment was not about price but about patentability.

Let us look at the compulsory licence (CL) case, i.e. Bayer vs. NATCO. The mechanism of CL is essentially about balancing patent rights with access to medicine. The words “social and economic welfare,” “public health,” “national emergency” and “public health problems/crises” used in the Act are all pointers to the CL provisions being centred around access to medicine.

A CL is granted subject to three conditions; one of them is about price. The reasonable requirement of the public with regard to the invention should be satisfied. The price at which it is made available should be reasonably affordable. It should be worked in India. A CL may be granted if the answer is a “no” to any of the three conditions. The interpretation of the word “working” by the Controller-General was criticised. It is incorrectly projected that the CL was granted on this score alone. Bayer failed in the other two tests. As far as working is concerned, the question is this: should the inventor manufacture the invention locally or is it sufficient to import it? The Controller held that “working” meant local manufacture to a reasonable extent. The Intellectual Property Appellate Board (IPAB) said that “working” could in some cases mean local manufacture entirely, while in others, only importation, and that it would depend on the facts and evidence of each case. “Working” is not defined in the Act. This issue will be settled by the superior courts on review. The power of review by the superior courts is sufficient to show that our law provides for safeguards.

Compulsory licence

Even in the U.S., it is believed that CL would be a beneficial addition to its patent system, would not significantly impact the incentives for innovations, and that, “a compulsory licensing provision would ensure that the American public is adequately supplied with a product. If the patentee is unable to produce enough supply to meet the demand for the product, another producer should be able to license the product to meet the demand.” This is precisely what our law says!

In all these years, there has been only one instance of the grant of compulsory licence. In fact it was refused recently for Dasatinib, the drug that is now in the news. And Section 3(d) has been invoked by our patent office only rarely. If Gleevec was refused a patent, it is only because it failed the test of Indian law. Refusal is not an act of robbery, for it means there was no invention and hence no property in the first place. There is really no case made out for there being a weakness in Indian law. The pharmaceutical industry’s anxiety behind the clamour against Indian law cannot be on account of any inherent weakness in our law, but only because other countries will follow it.

(Prabha Sridevan is a former judge, Madras High Court.)

India's activist role in breaking the pharmaceutical patent monopolies

Ritu Kumar in The Indian Express 4 March 2014

Recently, there were rumours that the United States Trade Representative (USTR) was getting ready to announce “trade enforcement actions” or sanctions against India over its intellectual property rights regime. The Obama administration has been under pressure from the US Chamber of Commerce and lobby groups, like the Pharmaceutical Research and Manufacturers of America, to take a tough stance against Indian rulings that have vetoed several multinational pharmaceutical company patents.

The lobbyists are pushing for India to be classified as a “priority foreign country”, a label associated with the worst offenders of patent law. The row blew over, but not before the USTR had filed a case at the World Trade Organisation (WTO) against India’s domestic content requirements for its solar programme.

In the last few years, the Indian government and judiciary have taken up major cases on patent protection for life-saving cancer drugs. Novartis’s drug Glivec was denied patent protection by the Supreme Court and India granted a compulsory licence to Bayer’s drug Nexavar, which treats kidney and liver cancer.

Compulsory licences are a provision in international patent norms, including the WTO’s TRIPS agreement, under which a government permits someone else to manufacture the patented product without the consent of the patent owner, usually to lower prices of life-saving drugs and increase access to them.

This is not the first time that India has taken a strong stance in the pharmaceutical patent wars. In 2001, Indian generic manufacturers played a crucial role in slashing prices of anti-retroviral (ARV) drugs used against HIV, bringing down the cost of the drugs per patient per year from around $15,000 to about $300. Today, the cost of ARV drugs is as low as $60 per patient per year. This remarkable achievement was only possible because at the time, India was not party to WTO agreements on patent protection.

Indian generic manufacturers were able to disregard patents, and ended up supplying over 80 per cent of all ARV drugs purchased in the world. India was recognised as playing a leading role in providing quality healthcare to people in developing countries.

It is evident that India’s role in the pharmaceutical patent wars has great implications for poor people’s access to healthcare, not just at home but around the world. Emerging economies like Brazil and South Africa follow the Indian model when they modify their intellectual property laws in order to bar awards to frivolous and obvious patents, and to allow pre-and post-grant challenges. For instance, Brazil’s proposed changes to its patent policy quote provisions in India’s Patents (Amendment) Act, 2005. Doctors Without Borders, meanwhile, has publicly encouraged South Africa to borrow from India when drafting its new patent policy.

With markets in the developed world becoming saturated, multinational drug companies are increasingly looking to emerging economies with large populations for sales expansion and growth. However, their model of intellectual property protection as an incentive for innovation is running into obstacles in low- and middle-income countries. Supporters of the pharmaceutical industry believe that without patent protections, there will be no breakthrough innovations and no new life-saving technologies.

They argue that the high costs of research and development for new drugs can only be compensated by patent monopolies that allow expensive drug prices. Yet, developing economies are keen on providing affordable healthcare products for their citizens. The developed world itself is beset with unsustainable rising healthcare costs and is looking for cost-effective innovation. A reassessment of patent monopolies, especially in the case of life-saving products, is essential if healthcare access is to be broadened beyond wealthy patients.

Some new models of incentivising medical research are being proposed. Since large funds are required for the development of new medical technologies, scholars have proposed the creation of attractive prizes, along the lines of the XPrize, which was instituted to encourage space exploration by giving successful teams up to $10 million in awards. The idea behind prizes is that the winning team receives a large one-time payment, but it cannot patent the solution, which ensures that the technology remains in the public domain.

Other models of funding innovation have already seen success in the marketplace, such as the public-private partnership that created a new rotavirus vaccine. This vaccine, called Rotavac, is now sold in India and other developing countries by Bharat Biotech, at profit, for about $1 per dose.

Millions of patients are suffering from many other poorly managed or untreatable diseases, such as diabetes or dengue fever. They would greatly benefit if companies were incentivised to create therapies at affordable prices that were widely accessible. India must not slow the pace of developing new therapies, nor shy away from the difficult work of making healthcare available to all. The rest of the world is watching.

Why do private-sector zealots choose to ignore the countless ways public money underpins daily life?

OWEN JONES 

Wednesday 13 November 2013

Free market capitalism is a con. The state is the backbone of modern British capitalism

 

 

Clutch your mobile phone close to your bosom, stroke it tenderly, and praise the Fairy Godmother of Free Market Capitalism that you’re not walking around with an obscene brick stuck to your ear, a breadstick aerial reaching towards the heavens. “Imagine what telephones would look like if the public sector had been entrusted with designing and making them,” as an opinion piece in theTelegraph had it this week, reflecting views widely held on the Right. “The smartphone revolution would probably be at least another couple of decades away.”

One tiny little flaw with this dystopic piece of counter-factualism: er, the public sector was entrusted with doing just that. Economics professor Mariana Mazzucato’s The Entrepreneurial State shows how – to take just one example – the Apple iPhone brings together a dazzling array of state-funded innovations: like the touchscreen display, microelectronics, and the global positioning system.

The governing ideology of this country is that it is the entrepreneurial private sector that drives human progress. The state is a bureaucratic mess of red tape that just gets in the way. But free market capitalism is a con, a myth. The state is the very backbone of modern British capitalism.

It begins with the state’s protection of property rights, which needs a costly legal system to protect. Patent law prevents companies having their products ripped off by rivals, and limited liability and insolvency law encourages investment by preventing shareholders being made personally liable for debts. As the economist Ha-Joon Chang has pointed out, in the early days of capitalism a businessperson would have to sell all their earthly possessions if they fell into ruinous debt, even facing the prospect of the debtors’ prison.

The state spends billions of pounds a year on research and development that directly benefits business: no wonder the CBI applauds “additional spending on research and innovation” that attracts business investment. Businesses depend on the billions the state lavishes on infrastructure, too. The CBI routinely demands more and more public dosh is thrown at roads and airport expansion. Our taxpayer-subsidised privatised railway network is a classic example of how our modern economic system works. The government splashes out several times more money than in the days of British Rail.

Recently, the House of Commons’ Public Accounts Committee denounced the Government for throwing a £1.2bn subsidy at British Telecom for building rural broadband. Fossil-fuel industries are granted effective subsidies, too, with generous tax allowances, and by leaving the state to deal with the costly environmental damage they inflict. A recent environmental committee of MPs found that nuclear power gets an annual subsidy worth £2.3bn, and arms exports benefit from government subsidies worth £890m a year.

Who do businesses depend on to train their workers? State-funded education, of course, and indeed there are those who advocate letting for-profit companies take over schools, which would mean taxpayers’ money subsidising shareholders rather than looking after children.

Many companies pay poverty wages, leaving the state to subsidise them with billions of pounds of tax credits, housing benefits and other in-work benefits. Businesses are even increasingly benefiting from free labour with the rise of so-called workfare, where they pay nothing to shelf-stackers and other workers, leaving the taxpayer to pay out derisory benefits instead.

Privatisation has proved a generous subsidy of the private sector, too, with £1 in every £3 of government spending on public spending going straight to profiteers. Like G4S, for example, which failed to provide the security personnel for the Olympics, leaving the state to come to the rescue. Or take PFI, where private contractors are paid to build schools and hospitals and lease them back to the state. The actual worth of the completed projects was £54.7 billion, but the taxpayer is projected to pay them £310 billion when it finally pays them off. And then there’s the financial system that all businesses depend on. It wasn’t free-market dogma that saved the banks: it was, of course, the state.

Free-market triumphalism is endemic among the British elite, but rarely challenged. It’s time to start exposing it for the sham it is. They demonise the state, but they are dependent on it. Perhaps they should be a bit more grateful.  

WikiLeaks publishes secret draft chapter of Trans-Pacific Partnership

Treaty negotiated in secret between 12 nations 'would trample over individual rights and free expression', says Julian Assange

• Alex Hern and Dominic Rushe
• theguardian.com, Wednesday 13 November 2013 18.12 GMT

Demonstrators protest against the Trans-Pacific Partnership (TPP) after the May Day rally in Tokyo, Japan. Photograph: EPA/Kimimasa Mayama

WikiLeaks has released the draft text of a chapter of the Trans-Pacific Partnership (TPP) agreement, a multilateral free-trade treaty currently being negotiated in secret by 12 Pacific Rim nations.

The full agreement covers a number of areas, but the chapter published by WikiLeaks focuses on intellectual property rights, an area of law which has effects in areas as diverse as pharmaceuticals and civil liberties.

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Also Read

Transatlantic Trade and Investment Partnership: Wake up people, we’re being shafted

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Negotiations for the TPP have included representatives from the United States, Canada, Australia, New Zealand, Japan, Mexico, Malaysia, Chile, Singapore, Peru, Vietnam, and Brunei, but have been conducted behind closed doors. Even members of the US Congress were only allowed to view selected portions of the documents under supervision.

"We're really worried about a process which is so difficult for those who take an interest in these agreements to deal with. We rely on leaks like these to know what people are talking about," says Peter Bradwell, policy director of the London-based Open Rights Group.

"Lots of people in civil society have stressed that being more transparent, and talking about the text on the table, is crucial to give treaties like this any legitimacy. We shouldn't have to rely on leaks to start a debate about what's in then."

The 30,000 word intellectual property chapter contains proposals to increase the term of patents, including medical patents, beyond 20 years, and lower global standards for patentability. It also pushes for aggressive measures to prevent hackers breaking copyright protection, although that comes with some exceptions: protection can be broken in the course of "lawfully authorised activities carried out by government employees, agents, or contractors for the purpose of law enforcement, intelligence, essential security, or similar governmental purposes".

WikiLeaks claims that the text shows America attempting to enforce its highly restrictive vision of intellectual property on the world – and on itself. "The US administration is aggressively pushing the TPP through the US legislative process on the sly," says Julian Assange, the founder and editor-in-chief of WikiLeaks, who is living in the Ecuadorean embassy in London following an extradition dispute with Sweden, where he faces allegations of rape.

"If instituted," Assange continues, "the TPP’s intellectual property regime would trample over individual rights and free expression, as well as ride roughshod over the intellectual and creative commons. If you read, write, publish, think, listen, dance, sing or invent; if you farm or consume food; if you’re ill now or might one day be ill, the TPP has you in its crosshairs."

Just Foreign Policy, a group dedicated to reforming US foreign policy, managed to crowdfund a $70,000 (£43,700) bounty for Wikileaks if the organisation managed to leak the TPP text. "Our pledge, as individuals, is to donate this money to WikiLeaks should it leak the document we seek." The conditions the group set have not yet been met, however, because it required the full text, not individual chapters.

Related to the TPP is a second secret trade agreement, the Transatlantic Trade and Investment Partnership (TTIP), which ties together regulatory practices in the US and EU. George Monbiot, writing in this paper, referred to the treaty as a "monstrous assault on democracy". Ken Clarke, the minister without portfolio, replied that it "would see our economy grow by an extra £10bn per annum".

Campaign group Fight for the Future has already collected over 100,000 signatures in an online petition against what it calls the “extreme Internet censorship plan: contained in the TPP.

Evan Greer, campaign manager for Fight for the Future, said: "The documents revealed by WikiLeaks make it clear why the US government has worked so hard to keep the TPP negotiatons secret. While claiming to champion an open Internet, the Obama administration is quietly pushing for extreme, SOPA-like copyright policies that benefit Hollywood and giant pharmaceutical companies at the expense of our most basic rights to freedom of expression online."

Transatlantic Trade and Investment Partnership: Wake up people, we’re being shafted

A global ban on left wing politics

George Monbiot

Remember that referendum about whether we should create a single market with the United States? You know, the one that asked whether corporations should have the power to strike down our laws? No, I don’t either. Mind you, I spent ten minutes looking for my watch the other day, before I realised I was wearing it. Forgetting about the referendum is another sign of ageing. Because there must have been one, mustn’t there? After all that agonising over whether or not we should stay in the European Union(1), the government wouldn’t cede our sovereignty to some shadowy, undemocratic body without consulting us. Would it?

The purpose of the Transatlantic Trade and Investment Partnership is to remove the regulatory differences between the US and European nations. I mentioned it a couple of weeks ago(2). But I left out the most important issue: the remarkable ability it would grant big business to sue the living daylights out of governments which try to defend their citizens. It would allow a secretive panel of corporate lawyers to overrule the will of parliament and destroy our legal protections. Yet the defenders of our sovereignty say nothing.

The mechanism is called investor-state dispute settlement. It’s already being used in many parts of the world to kill regulations protecting people and the living planet.

The Australian government, after massive debates in and out of parliament, decided that cigarettes should be sold in plain packets, marked only with shocking health warnings. The decision was validated by the Australian supreme court. But, using a trade agreement Australia struck with Hong Kong, the tobacco company Philip Morris has asked an offshore tribunal to award it a vast sum in compensation for the loss of what it calls its intellectual property(3).

During its financial crisis, and in response to public anger over rocketing charges, Argentina imposed a freeze on people’s energy and water bills (does this sound familiar?). It was sued by the international utility companies whose vast bills had prompted the government to act. For this and other such crimes, it has been forced to pay out over a billion dollars in compensation(4).

In El Salvador, local communities managed at great cost (three campaigners were murdered) to persuade the government to refuse permission for a vast gold mine which threatened to contaminate their water supplies. A victory for democracy? Not for long perhaps. The Canadian company which sought to dig the mine is now suing El Salvador for $315m – for the loss of its anticipated future profits(5).

In Canada, the courts revoked two patents owned by the US drugs firm Eli Lilly, on the grounds that the company had not produced enough evidence that they had the beneficial effects it claimed. Eli Lilly is now suing the Canadian government for $500m, and demanding that Canada’s patent laws are changed(6).

These companies (and hundreds of others) are using the investor-state dispute rules embedded in trade treaties signed by the countries they are suing. The rules are enforced by panels which have none of the safeguards we expect in our own courts(7,8). The hearings are held in secret. The judges are corporate lawyers, many of whom work for corporations of the kind whose cases they hear. Citizens and communities affected by their decisions have no legal standing. There is no right of appeal on the merits of the case. Yet they can overthrow the sovereignty of parliaments and the rulings of supreme courts.

You don’t believe it? Here’s what one of the judges on these tribunals says about his work. “When I wake up at night and think about arbitration, it never ceases to amaze me that sovereign states have agreed to investment arbitration at all … Three private individuals are entrusted with the power to review, without any restriction or appeal procedure, all actions of the government, all decisions of the courts, and all laws and regulations emanating from parliament.”(9)

There are no corresponding rights for citizens. We can’t use these tribunals to demand better protections from corporate greed. As the Democracy Centre says, this is “a privatised justice system for global corporations.”(10)

Even if these suits don’t succeed, they can exert a powerful chilling effect on legislation. One Canadian government official, speaking about the rules introduced by the North American Free Trade Agreement, remarked, “I’ve seen the letters from the New York and DC law firms coming up to the Canadian government on virtually every new environmental regulation and proposition in the last five years. They involved dry-cleaning chemicals, pharmaceuticals, pesticides, patent law. Virtually all of the new initiatives were targeted and most of them never saw the light of day.”(11) Democracy, as a meaningful proposition, is impossible under these circumstances.
This is the system to which we will be subject if the transatlantic treaty goes ahead. The US and the European Commission, both of which have been captured by the corporations they are supposed to regulate, are pressing for investor-state dispute resolution to be included in the agreement.

The Commission justifies this policy by claiming that domestic courts don’t offer corporations sufficient protection because they “might be biased or lack independence.”(12) Which courts is it talking about? Those of the US? Its own member states? It doesn’t say. In fact it fails to produce a single concrete example demonstrating the need for a new, extra-judicial system. It is precisely because our courts are generally not biased or lacking independence that the corporations want to bypass them. The EC seeks to replace open, accountable, sovereign courts with a closed, corrupt system riddled with conflicts of interest and arbitrary powers.
Investor-state rules could be used to smash any attempt to save the NHS from corporate control, to re-regulate the banks, to curb the greed of the energy companies, to renationalise the railways, to leave fossil fuels in the ground. These rules shut down democratic alternatives. They outlaw left-wing politics.

This is why there has been no attempt by our government to inform us about this monstrous assault on democracy, let alone consult us. This is why the Conservatives who huff and puff about sovereignty are silent. Wake up people, we’re being shafted.

Keep the pause button on GM pressed

JACK A. HEINEMANN in The hindu

  

 

Questioning a technology, especially of the kind that has serious unknowns and lacks clear social benefits, is not an attack on science

Jairam Ramesh, former Environment Minister for India, made the brave decision in 2010 to tell his then apex regulator of genetically modified organisms (GEAC) that it had failed to properly use available science to determine the safety — to human health and the environment — of Bt brinjal, created using genetic modification (GM). His decision followed careful evaluation of the science.

I was involved in Ramesh’s review. I read first hand the scientific evidence in my area of expertise provided to the GEAC and its responses. I was heartened to see that his decision was validated by the esteemed scientists that made up the Supreme Court Technical Expert Committee who have advised the Court on the need for better research and better process before continuing to release GM crops into the environment or using them as food.

Creating confusion

G. Padmanaban (“Sow the wind, reap a storm,” The Hindu, September 2) believes that the events surrounding the evaluation of Bt brinjal and now extending to other kinds of GM plants is an assault on science. He confuses science with technology. Science is the process of knowledge creation (or discovery) whereas technology is the means of knowledge application. This confusion causes some scientists to defend technologies that are questioned because they perceive questions on the technology as an attack on science. It is not.

There is much knowledge discovered or to be discovered that cannot be applied wisely — at least not now. GM plants are among the technologies that have both serious scientific unknowns and lack a clear social benefit — at least for now.

For over 30 years, GM has been promised to produce plants that will resist the stresses of drought, heavy metals and salt, that will increase yield, reduce the use of toxic pesticides and even fix their own nitrogen. To be fair, some GM crops have reduced the use of some toxic insecticides for a brief period. To be precise, though, none of these promises has been sustainably delivered to farmers.

Why not? Well, it isn’t complex regulation holding them back. By the year 2005, over 1,000 applications were approved to field trial stress-tolerant GM plants in the United States alone. None ever progressed out of the testing phase. The explanation for this is likely because stress tolerance is not a solution to the causes of stress. No matter how tolerant you make the plant to drought, using it in soil low in organic matter and unable to hold water will eventually further deplete the soil of moisture and the plant will struggle or die. GM is an attempt to use genetics to overcome the environment. This never works for long. That is why some call GM a distraction from investing in real solutions to the problems faced by real farmers.

A symptom

Herbicide use is increasing in the U.S. since it adopted GM maize (corn), soybeans and cotton. Insecticide use is down by a small bit, but extremely high compared to countries such as France which do not use GM crops. Western Europe’s maize yields match or exceed the U.S.’ yields using less pesticide. The yields in wheat and oilseed rape are increasing at an even faster rate in Western Europe than in the U.S. and Canada. This indicates a dangerous trend: those countries choosing to innovate in agriculture using GM are demonstrating lower productivity increases and greater dependence on chemical inputs in all crops compared to economically and environmentally comparable countries choosing to not use GM crops.

What is it about investing in GM products that seems to undermine other technologies in agriculture? GM products attract the strictest intellectual property (IP) rights instruments possible in agriculture (e.g., process patents). The use of those instruments concentrates investment and drives out simple but even more effective technologies.

Now every government research centre and public university seeks to compensate for the fall in direct public investment through licensing royalties from IP and the creation of partnerships with the private sector. This necessarily changes the kinds of questions they favour being asked by their researchers, the kind that will be supported by institutional resources or rewarded with promotion. With these policies in place we shouldn’t be surprised that every problem looks like it has a GM solution even to researchers who claim to have no entrepreneurial motivations.

Prof. Padmanaban’s ambition for a crop that provides all nutritional needs and grows everywhere demonstrates the poverty of the GM approach to hunger and malnourishment. Such a crop would quickly become obsolete as it would also serve as a wonderful meal for every conceivable form of pest. Meanwhile, it would undermine both biological and agricultural diversity as it became a weed in its own right.

Instead of that approach, supporting communities with education on nutrition and farmers with technologies that build up their soils, manage pests with little or no application of pesticide and manufactured fertilizers gives them the means and independence to grow a variety of crops and livestock to meet their dietary needs and sell their surplus in local markets.

This investment in agriculture is not as good at making intellectual property, but better for growing food. To properly support India’s mainly small holder farming requires removing the penalties and incentives on the public scientist to develop primarily technologies that bring direct revenue to their institutions. Instead, invest in them with public money and measure their success by the yields of farmers, the reduction of pesticides and fertilizer they use, and the increase in their wealth and health.

No missed opportunities

India is not missing out on the benefits of GM. So far, there haven’t been any proven to exist, or proven to be sustainable. GM crops are not designed to increase intrinsic yield and the largest scale and longest term studies bear out that they don’t yield more. Meanwhile, the cost of GM seeds is the fastest growing expense for U.S. farmers who are simultaneously suffering from weeds resistant to the herbicides excessively used on GM crops and pests resistant to the insecticides over-used in Bt crops. That likely would be India’s experience had it commercialised Bt brinjal which was developed with the least effective form of Bt for the target pest.

In addition, the safety issue still lingers over these products. It shouldn’t. The science needed to establish their safety exists and is affordable but it must be applied dispassionately and transparently. That is all Jairam Ramesh asked.

Claiming that GM crops are demonstrated safe by the absence of specific health claims from Americans is glib. There are no validated health surveillance programmes in the U.S. which could both detect and diagnose the cause of the most likely manifestations of harm if they do exist.

Meanwhile, more research studies accumulate with evidence of adverse effects, some quite serious. These studies require replication, but they run into roadblocks or fail to find new funding. Most often these studies report low level health effects using animal feeding studies, so it is not clear whether the effect would be the same, more or less in humans and more or less likely to be caused using GM plants cooked and processed, as humans eat them, rather than raw or processed the way they are provided to test animals.

Hunger, pestilence, and economic failure are the images of fear increasingly being used to drive acceptance of GM crops. Ignorance, anti-science, ideology and hypocrisy are the insults used to counter questions about the safety of GM crops coming from scientists and the public. What is right for India’s agriculture is too important a question to leave to fear and insult to decide. I think that both Ramesh and the scientists of the Technical Expert 

Committee knew this when they asked India to pause on the use of GM products. Pause so that all voices can be heard. Reflect on what the problems are and whether technologies solve them or mask them for a time, or even make them worse later.

Coming soon: invasion of the marauding nymphomaniacs

Thanks to 'female Viagra' and government regulation, we women can enjoy sex again – just hopefully not too much

• 
• • Naomi McAuliffe
  • guardian.co.uk, Monday 27 May 2013 17.18 BST

'People like sex. Sex is sexy.' Photograph: Jennifer Szymaszek/AP

We are standing on the brink of the breakdown of society. A world in which the economy grinds to a halt. Schools stand empty; there are no teachers left and the dinner ladies have found something better to do. Hospitals career towards crisis point as nurses become the uniformed sex-crazed bunnies that porn has long suspected them to be. This is the land of the marauding nymphomaniacs – hypersexed women who are hardly able to walk straight, never mind function as citizens.

This is the risk potentially posed by Lybrido, the female arousal drug (or "female Viagra"), according to some "experts" who are worried that this drug won't get past the regulators unless there are assurances that it won't lead to women becoming raptorial sex beasts. Women should like more sex, but not too much.

Of course this is another pharmaceutical attempt to cure social ills with a pill. A lower libido in both men and women may well have more to do with that screaming baby in the next room or the pending redundancy at work than anything physiological. But dealing with individuals' psychology or social circumstances is boring and hard and complex while pharmaceutical marketing is fun and easy and quick.

And this involves SEX. People like sex. Sex is sexy. Diarrhoea isn't sexy, lung disease isn't sexy and things that aren't sexy get less of our attention and investment. Female sexuality is even more dark and mysterious and feeds those odd social constructs that say women don't like sex as much as men do and therefore have to be "fixed", unless they do like sex as much as men do and so must be broken and are either mad, bad or wanton. Maybe women need a recommended daily fornication allowance.

Interestingly, the inspiration for the lady-horn enhancer was not a desire to create a louche legion of loose women, but came from one tragic man's way of getting over a broken heart. Dr Adrian Tuiten, head of the Dutch firm Emotional Brain, which developed the drug, was trying to understand why his long-term girlfriend dumped him in his 20s. Apparently "the breakup inspired a lifelong quest to comprehend female emotion through biochemistry and led to his career as a psychopharmacologist." (I'd suggest the desire to comprehend female emotion through biochemistry might actually be part of the reason for the break-up). The developers of this drug actually want it to promote monogamy, not instigate indiscriminate sex mania.

The trials completed so far on this drug have been exclusively with women in long-term, monogamous relationships where simply the spark has gone. However, increasingly evidence shows that for many women the cause of their sexual malaise appears to be monogamy itself. Evolutionary psychologists (or as I like to call them, Just So Story tellers) claim that it is innate biology that gives men a naturally higher sex drive. But ameta-analysis of studies by psychologists in 2010 shows little sex differences in the sexuality of men and women and where there were differences – such as rates of masturbation or pornography use – they were heavily influenced by culture and the gender equity of the social group studied.

It is almost impossible to separate female sexuality from culture. Depending on a variety of factors from the number of sexual partners you have had, how much flesh you show, whether you use contraception, how much you masturbate (because women do masturbate!), whether or not you "use" pornography (read it, watch it, look at it) and what kind of pornography it is ("it's a book, therefore erotica!") all variously determine whether you are a slut, whore, slag, prude, lesbian, harlot, prig or the veritable Mrs Grundy.

Society is as concerned by women who like sex as those who don't. Nymphomania was a form of mental illness or disease in the Victorian era with seemingly endless symptoms; masturbation, homosexuality, sexual dreams, or in one case the "lascivious leer of her eye and lips, the contortions of her mouth and tongue, the insanity of lust which disfigured [her]". This disease was variously "cured" with abstinence, vegetarianism, cold douches or more viciously with confinement to an asylum or even a form of female genital mutilation where the clitoris was removed.

The modern version is seemingly to attain that perfect balance between women enjoying sex more in their long-term, increasingly loveless, monogamous relationship through some kind of love potion and also resisting the ever-present lure of the strumpet within us. Only a heady combination of drugs, government regulation (through marriage, adultery laws, access to contraception) and overwhelming social pressures seem to be able to regulate female sexuality around the world. Who knows what would happen if we could discover and develop our own sexuality and properly understand how that changes and fluctuates over time and circumstance? Who knows what might have been achieved had people spent their energy on things other than regulating female sexuality? Perhaps everyone might be happier and hornier.

Patent justice

SAKTHIVEL SELVARAJ  

The HinduThe Supreme Court’s patent denial to Novartis for its anti-cancer drug Gleevec leaves the door open for Indian pharmaceutical companies to produce their own versions of the drug.

Drug patents are designed to create profits that enable more research on diseases affecting millions. But in practice, they have often generated super profits for big pharma companies while erecting access barriers for the poor. The Novartis case spotlights much that is wrong with the system.

The rejection of the Novartis petition challenging one of the most progressive tenets of the Indian Patents Act (1970), as amended in 2005 by the Supreme Court, is a landmark verdict for the public health community and the generic drugs industry, in particular, and for global health. Under the amended Indian Patents Act, Section 3(d) allows drug companies to obtain product patents for new salts or chemical ingredients. This is intended to encourage drug companies to protect their rights and prevent these from being copied by competitors, allowing for a 20-year protection period to recoup investments. However, Section 3 (d) does not encourage frivolous patents. It is intended to encourage only breakthrough innovations and discourage new use of known chemical substances or new delivery mechanisms of existing chemical compounds.

Transnational drug companies not only possess the first mover advantage, but owing to the high-voltage brand image they create, often extend their patents well beyond the already long period of protection. Drug companies are known for ‘evergreening’ patents by filing new patents, tweaking existing molecules to show novelty. Innovation is a red-herring, often used by multinational drug companies to make super-profits at the expense of social good and well-being. Under the mailbox agreement of Trade-Related Aspects of Intellectual Property Rights (TRIPS) provisions, India received over 9,000 mailbox applications as patent filings post-2000, while a major share of those were for pharmaceutical patents. Global evidence, on the other hand, shows that roughly 275 such patents were filed and granted for blockbuster drugs during this period. In order to pre-empt Indian generics companies from producing these drugs and to keep them away from the market, the big pharma companies have flooded the patent offices with frivolous patent applications, known to be existing molecules tweaked to appear as a novel product.

The R&D myth

The night before the apex court verdict, Novartis threatened to stop investing in research and development in India, if the verdict went against it. How serious is the threat and how realistic the scenario? In India’s drug production of over Rs. 100,000 crore, Novartis’ turnover is a little over Rs. 1,000 crore, constituting around one per cent. Out of the total expenditure of over Rs. 800 crores incurred by Novartis India in 2012, a paltry Rs. 29 lakhs was for R&D, constituting roughly 0.03 per cent of its entire expenditure in India.

Can such low spending can be considered R&D investment? In fact, Novartis R&D expenditure in India for the past five years has been in a similar range. On the other hand, Novartis consistently posted a profitability ratio (Profit After Tax as percentage of Total Income) of over 15 per cent in the last five years, something to envy for other sectors.

Big Pharma argues that if global R&D of innovator companies were to be considered, transnational drug corporations spend over US $ one billion to come up with a new drug. This includes cost of R&D incurred on failed drugs as well, as pharmaceutical companies take, on an average, roughly 12-13 years to get patents on new drugs. The magic one billion dollar figure is a gross overestimate. Even by conservative calculations, this figure would be one-fifth or one-fourth of the billion dollar estimate. But Big Pharma is quick to recoup its R&D spending from blockbuster drugs. Take the case of Gleevec (Imatinib Mesylate), sold in the US. Novartis raked in a total turnover of US $ 1.69 billion from the US alone in 2012 from the drug. The global turnover on Gleevec is anybody’s guess. It is also widely known that the cost of manufacturing drugs is only a fraction of the turnover.

Novartis currently sells Glivec (Gleevec) for Rs. 4,115 per tablet, while Resonance, an Indian generic drug company dispenses it at Rs. 30 per tablet. The annual cost of treatment per patient on Glivec would be in the range of Rs. 15 lakhs while Indian generic companies are offering it at Rs. 10,000. If Novartis were to get its patent on Glivec, Indian generic companies would have to stop their production, and therefore an unaffordable scenario would have prevailed for the common man in not only India but in other developing countries. Thankfully, the court ruled in favour of Section 3 (d) of the Patent Act.

Novartis claims that 95 per cent of cancer patients in India were provided the medicine free. This is patent untruth. Retail market sales in India for Glivec, sold by Indian generics producers are currently worth Rs. 20 crores. Novartis sells Glivec directly to patients and not through the usual retail chain, a system that is designed to make people believe that they offer the drug free.

After seven years of battle, the Supreme Court verdict seals this issue, facilitating Patent Controllers to strictly enforce Section 3 (d), thereby pre-empting pharmaceutical companies that seek to evergreen products. However, there are several other safeguards that are enshrined in the patent law that must be utilised to make life-saving and essential drugs affordable. And one such key safeguard is invoking compulsory licensing for blockbuster drugs, if the original manufacturer fails to sell it affordable rates.

Last year, India invoked the provision to license generic player Natco to produce Nexavar, after Bayer, the innovator failed to make it affordable. Such policy measures are critical, in order to improve access to life-saving medicines, as households in India are known to pay nearly 70 per cent of their health care spending on medicines.

(Dr. Sakthivel Selvaraj is Senior Health Economist, Public Health Foundation of India, New Delhi.)

Also read

Company profits depend on the 'welfare payments' they get from society

Novartis loses landmark patent case in India

Why Novartis case will help innovation

 

ACHAL PRABHALA

SUDHIR KRISHNASWAMY 

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The Supreme Court judgment on Glivec is a blow for a patent regime with a higher threshold of inventiveness

On April 1, 2013, the Supreme Court upheld the Intellectual Property Appellate Board’s decision to deny patent protection to Novartis’s application covering a beta crystalline form of imatinib —the medicine Novartis brands as Glivec, and which is very effective against the form of cancer known as chronic myeloid leukaemia (CML). The judgment marked a crucial conclusion to a saga that has been several decades in the making. The story could start in 1972, if you like, when the Indian Patents Act of 1970 — grounded in the findings of the Bakshi Tek Chand and Ayyangar Committee Reports — came into force, enabling the explosive growth of the Indian generics industry into the world’s largest exporter of bulk medicines. Or, it could start in 2005, when India amended its patent law to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), a trade rule at the World Trade Organisation (WTO) that established a new global regime of intellectual property.

Key lesson

No matter where we start, the saga has come to a close, and the key lesson seeping through is that good sense won. Firstly, the Supreme Court decision was not about the patentability of the imatinib compound as such: that patent, having been instituted in 1993, is excluded from the purview of the Indian patent system, which is only obligated to consider patents filed in 1995 or after. The case the Supreme Court heard was whether Novartis’ beta crystalline form of imatinib was worthy of patent protection: its judgment was that this modification by Novartis did not satisfy the standard of inventiveness required under Indian patent law. Secondly, Indian patent law is as yet unchallenged at the WTO; Novartis’s earlier challenge to the constitutionality and TRIPs compatibility of Indian patent law was rebuffed by the Madras High Court in 2007 and no appeal was pursued. Thirdly, the Supreme Court judgment effectively recast Indian patent law as being nuanced and original in its meshing of domestic political economy concerns with the integrated global economy it participates in.

The outcome of this nuance and originality? Imatinib will continue to be 

available to patients in India from multiple suppliers at a price 10 times less than the current cost of Glivec; approximately 27,000 cancer patients in the country who pay for their imatinib will continue to have access to the medicine in the public and private sectors at the lowest cost possible; and should Novartis ever suspend its charitable programme, all 15,000 of the cancer patients who currently receive imatinib free from Novartis will have similarly equitable access to the medicine.

Hackneyed narrative

Despite substantial progress in the popular understanding of the place of patents in a developing country like India, a hackneyed narrative has emerged, especially in the pink press, warning us that this judgment will have a negative impact on innovation in the long run. As it happens, one of the most useful outcomes of the Supreme Court judgment is a renewed focus on what innovation is — and how it should be rewarded. Behind the headlines foretelling various levels of doom — the death of innovation in the country and the end of research for diseases which matter to us — is the popular idea that patents are a proxy for innovation. After all, patents are widely understood as short-term monopolies enshrined in the law and provided as incentive to inventors on the evaluation of publicly disclosed innovation. It would seem as if patents are synonymous with innovation. Except, this is not quite the case.

Minor variations

In the last three decades, the global gold rush for patents has been dominated by filings for minor and mostly inconsequential innovations — at the expense of breakthrough innovation. In large part, this is because weak standards in the patent laws of developed countries (led by the U.S. and Europe) have explicitly encouraged this shift. The whittled-down, lobbied-out, stretched-beyond-recognition patent regime that is characteristic of these countries — and other less-developed countries where they influence the polity — is unfortunately the ‘norm’ to which India now finds itself an ‘outlier.’ But the outlier is a solution: the norm is the problem. A British Medical Journal report from 2012 succinctly summarises the global research situation for new medicines: “This is the real innovation crisis: pharmaceutical research and development turns out mostly minor variations on existing drugs, and most new drugs are not superior on clinical measures.”

If the patent regimes of developed countries are dominated by minor patents, many or most of which have no demonstrable innovation to show, why are they so avidly pursued by global pharmaceutical companies? A Public Library of Science study from 2012 points to the answer: secondary patents extend the patent life (and thereby, the monopoly pricing) of pharmaceutical products long beyond their designated life span, adding, on average, between six and seven years to the patent life of the original compound. Any patent regime which incentivises secondary patents with weak laws will only serve to extend commercial monopolies at low levels of innovation — and will no longer provide the incentive for genuine innovation. The genius of the Supreme Court judgment on Novartis’s patent application lies in restoring the connection between patents and innovation by upholding and legitimising a regime with a higher threshold of inventiveness.

Will Indian patent law change the way the global pharmaceutical industry innovates? No; not immediately, at least. Could it positively affect pharmaceutical innovation in the long run? Absolutely. In the present day, India comprises 1.3 per cent of the global pharmaceutical market by value. That figure, in itself, is why changes to Indian patent law will not help global pharmaceutical giants break free from the incentive model they are prisoners of. At most, they might have to learn how to compete in a crowded market for some of their less original products. The symbolic opportunity presented by the Supreme Court’s backing of Indian patent law, however, is a real threat — and pharma CEOs in New York, London and Basel get it. In the long run, as more countries understand the Indian model, appreciate its legitimacy, and reflect on its benefits to both public health and innovation, they might want the same. And if that happens, when that happens, we may begin to see real, positive change in the way pharmaceutical innovation works.

Empowered scenario

The Indian Patents Act of 1970 was a game changer. From the perspective of 43 years of experience, we can safely say that it shook up the pharmaceutical industry and altered it irreversibly. The new, empowered scenario was most vividly illustrated during the peak of the HIV/AIDS treatment crisis in the first decade of the 21st century, when countries like Brazil, Thailand, South Africa and, of course, India, took health security into their own hands and legitimately moulded their domestic patent systems to respond to the crises within. The Indian Patents Amendment Act of 2005, which gave us the law we have today — a law which was ratified last week — has the potential to change the game once again. This time, however, the change might come more slowly; the hell the Indian government was dragged through has not been lost on anyone. The lengthy trials, the frequent challenges, the full-scale vilification, and every other scare tactic thrown our way by a public-relations juggernaut (along with the implicit support of many developed country governments) was not for nothing. And the Supreme Court judgment is all the more important as a result, for it shows a new way may be hard and tiresome, but is ultimately possible.

(Achal Prabhala works on access to medicines; Sudhir Krishnaswamy is on the faculty of Azim Premji University, and is the Dr. B.R. Ambedkar Visiting Professor of Indian Constitutional Law at Columbia Law School)