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.

From Obamacare to trade, superversion not subversion is the new and very real threat to the state

Rightwing politicians and their press use talk of patriotism to disguise where their true loyalty lies: the wealthy elite

BETA

• 
• • George Monbiot
  • The Guardian, Monday 14 October 2013 20.31 BST

Daily Mail editor Paul Dacre. 'Strangely, this suspicion of the state and the People Who Know Best does not appear to extend to the security services, whose assault on our ­freedoms Dacre was defending'. Photograph: Suzanne Plunkett/Reuters

Subversion ain't what it used to be. Today it scarcely figures as a significant force. Nation states are threatened by something else.  Superversion: an attack from above.

It takes several forms. One is familiar, but greatly enhanced by new technology: the tendency of spooks and politicians to use the instruments of state to amplify undemocratic powers. We've now learnt that even members of the cabinet and the National Security Council had no idea what GCHQ was up to. No one told them that it was developing the capacity to watch, if it chooses, everything we do online. The real enemies of state (if by state we mean the compact between citizens and those they elect) are people like the head of MI5, and the home secretary, who seem to have failed to inform cabinet colleagues about these programmes.

Allied to the old abuses is a newer kind of superversion: the attempts by billionaires and their lieutenants to destroy the functions of the state. Note the current shutdown – and the debt-ceiling confrontation scheduled for Thursday – in the United States. The Republicans, propelled by a Tea Party movement created by the Koch brothers and financed by a gruesome collection of multimillionaires, have engineered what in other circumstances would be called a general strike. The difference is that the withdrawal of their labour has been imposed on the workers.

The narrow purpose of the strike is to prevent the distribution of wealth to poorer people, through the Affordable Care Act. The wider purpose (aside from a refusal to accept the legitimacy of a black president) is to topple the state as an effective instrument of taxation, regulation and social protection. The Koch shock troops in the Republican party seem prepared to inflict almost any damage in pursuit of this insurgency, including – if they hold out on Thursday – a US government default, which could trigger a new global financial crisis.

They do so on behalf of a class which has, in effect, seceded. It floats free of tax and the usual bonds of citizenship, jetting from one jurisdiction to another as it seeks the most favourable havens for its wealth. It removes itself so thoroughly from the life of the nation that it scarcely uses even the roads. Yet, through privatisation and outsourcing, it is capturing the public services on which the rest of us depend.

Using an unreformed political funding system to devastating effect, this superversive class demands that the state stop regulating, stop protecting, stop intervening. When this abandonment causes financial crisis, the remaining taxpayers are forced to bail out the authors of the disaster, who then stash their bonuses offshore.

One result is that those who call themselves conservatives and patriots appear to be deeply confused about what they are defending. In his article last week attacking the Guardian for revealing GCHQ's secret surveillance programmes, Paul Dacre, the editor of the Daily Mail, characterised his readers as possessing an "over-riding suspicion of the state and the People Who Know Best". Strangely, this suspicion of the state and the People Who Know Best does not appear to extend to the security services, whose assault on our freedoms Dacre was defending.

To the rightwing press and the Conservative party, patriotism means standing up to the European Union. But it also means capitulating to the United States. It's an obvious and glaring contradiction, which is almost never acknowledged, let alone explained. In reality the EU and the US have become proxies for something which transcends national boundaries. The EU stands for state control and regulation while the US represents deregulation and atomisation.

In truth, this distinction is outdated, as the handful of people who have heard of the Transatlantic Trade and Investment Partnership (TTIP) will appreciate. The European commission calls it "the biggest trade deal in the world". Its purpose is to create a single transatlantic market, in which all regulatory differences between the US and the EU are gradually removed.

It has been negotiated largely in secret. This time, they're not just trying to bring down international trade barriers, but, as the commission boasts, "to tackle barriers behind the customs border – such as differences in technical regulations, standards and approval procedures". In other words, our own laws, affecting our own people.

A document published last year by two huge industrial lobby groups – the US Chamber of Commerce and BusinessEurope – explains the partnership's aims. It will have a "proactive requirement", directing governments to change their laws. The partnership should "put stakeholders at the table with regulators to essentially co-write regulation". Stakeholder is a euphemism for corporation.

They want it; they're getting it. New intellectual property laws that they have long demanded, but which sovereign governments have so far resisted – not least because of the mass mobilisation against the Stop Online Piracy Act and Protect IP Act in the US – are back on the table, but this time largely inaccessible to public protest.

So are data protection, public procurement and financial services. You think that getting your own government to regulate bankers is hard enough? Try appealing to a transnational agreement brokered by corporations and justified by the deemed consent of citizens who have been neither informed nor consulted.

This deal is a direct assault on sovereignty and democracy. So where are the Daily Mail and the Telegraph and the other papers which have campaigned so hard against all transfers of power to the European Union? Where are the Conservative MPs who have fought for an EU referendum? Eerie silence descends. They do not oppose the TTIP because their allegiance lies not with the nation but with the offshored corporate elite.

These fake patriots proclaim a love for their country, while ensuring that there is nothing left to love. They are loyal to the pageantry – the flags, the coinage, the military parades – but intensely disloyal to the nation these symbols are supposed to represent. The greater the dissonance becomes, the louder the national anthem plays.

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.