Access to Medicines in Rajasthan, after Novartis Ruling

In the backdrop of the Supreme Court judgment against Novartis trying to
seek patent on its anticancer drug Gleevec used for treatment of CML and
the granting of license to pharmaceutical company Natco by the Controller
General of Patents India to produce another anti cancer drug Sorafenib used
for treatment of liver and kidney cancers at 98% lesser cost than its
innovator company Bayer under the provisions of Compulsory Licensing, a
workshop for continuing medical education of the clinicians titled *”Making
Essential Medicines Available and Affordable to All Citizens” was jointly
organized by the SMS Medical College Jaipur, Rajasthan Medical Services
Corporation, Prayas and JSA Rajasthan on Saturday, 11th May 2013 in
Jaipur.*The key note address was delivered by Prof. Ranjit Roy
Chaudhury who
currently chairs the expert committee to formulate guidelines and SOPs for
approval of new drugs, clinical trials, banning of drugs and FDCs
constituted by the MOHFW, Govt. of India. Another speaker Mr. Anand Grover,
UN Special Rapporteur on Right to Health and intervening lawyer on behalf
of the Cancer Patients Aid Association in the famous Novartis V/s Union of
India case in the Supreme Court of India spoke about the history of patent
laws and its impact on access to essential medicines in India besides the
developments which led to the Supreme Court rejecting the appeal of
Novartis. Dr. Mira Shiva of AIDAN and IHES spoke on TRIPS, WTO and global
issues relating to access to medicines. Dr. Subhash Nepaliya, Principal SMS
Medical College, Jaipur welcomed the participants. Other speakers were Dr.
Samit Sharma, Managing Director Rajasthan Medical Services Corporation and
Dr. Narendra Gupta of Prayas & JSA Rajasthan. The workshop was attended by
more than 140 persons including Dr. Virendra Singh, Supdt, SMS Hospital
Jaipur, Dr. S.D. Sharma, Supdt. Children’s Hospital, Dr. Pradeep Sharma,
Supdt Mental Hospital attached to SMS Medical College, Jaipur and large
number of other senior faculty members including medical oncologists. There
was very intense question answer session after each presentation. Most
questions raised were relating to the quality, efficacy of generic
medicines and adherence to essential medicines list.

As reported earlier, the Govt. of Rajasthan has included Imatinib Mesylate
under the Free Medicines Scheme of Rajasthan and the innovator company
Novartis had offered to provide 30 capsules of 400 mgm of it sold by it
under the brand name Glivec in Rs. 8000 which it sells in Rs. 1,23,456/- in
the market. This offer came prior to the Supreme Court judgment. But, the
RMSC floated tenders which were opened on the last Friday. Five companies
participated in the tender and offered to provide the medicine in prices as

1. United Biotech: Rs. 654.84
2. West Coast Pharma : Rs. 883.38
3. Glenmark :Rs.  902.70
4. Naprod Life Science : Rs. 1101.60
5. Cipla : Rs. 2548.62

According to a senior oncologist SMS Medical College Jaipur there are more
than 9,000 patients undergoing treatment for chronic myeloid leukemia in
the state right now and the govt. of Rajasthan is determined to make
Imatinib Mesylate available completely free for all such patients at govt.
health facilities under the Chief Minister Free Medicine Scheme. This would
certainly come as a huge relief to all these patients in terms of the cost
of treatment which they all must be bearing out of their pockets till now.

Prayas, Centre For Health Equity,


Ever wondered why Novartis and Roche do not compete ? #Pharma


Glivec (Gleevec) film tablet made by Novartis.


Expectations of structural change and divestments will be reignited by the Symonds announcement, note analysts at Deutsche BankOne particular conundrum for investors is the 33 percent shareholding that Novartis holds in its compatriot Roche. Jimenez has ascribed an intangible value to the shareholding, which allows the company to have some say in any acquisitions Roche would choose to make that required the issuance of new shares. Investors may feel that the money could be spent more effectively elsewhere, particularly as Novartis’ financial stake in Roche is something of a Vasella heirloom and reminder that the former CEO often talked up the possibility of a Swiss mega merger.

 High-profile personnel changes at Novartis drive analyst speculation as CEO delivers consistent message 


(Ref: ViewPoints Desk)

In quick succession to the announced departure of chairman and former CEO Daniel Vasella in January, Novartis announced on Wednesday that Jon Symonds would leave the company at the end of 2013 after four years as CFO.

Despite CEO Joseph Jimenez using the company’s Q1 analyst call to drive home the message that Novartis remains committed to its current growth strategy, the departure of Symonds was a key focus for analysts in notes that were subsequently circulated to investors, and has fuelled speculation that further changes could be afoot.

Insight, Analysis & Opinion

Speaking about his pending departure at the end of the year, Symonds suggested that it was a positive time for a new CFO to take over. That man is the current CFO of Novartis’ pharmaceuticals division Harry Kirsch, who will preside over an emerging post-2013 growth narrative, added Symonds.

There remains some scepticism, however, and Bernstein analyst Tim Anderson suggested that the reason for Symonds departure is not completely clear. Furthermore, added Anderson, close proximity to the departure of Vasella raises the question ‘what next?’

Operationally, analyst reaction to Kirsch’s appointment was mixed. Echoing comments made by both Jimenez and Symonds on the Q1 conference call, analysts at Credit Suisse pointed to a strong record in driving productivity gains within the pharmaceuticals division (during a period characterised by EU austerity measures and generic competition) as a strong precedent for his impending role.

But it is the surprise nature of Symonds departure that analysts have found more difficult to interpret – one conclusion being that Jimenez is keen to appoint his own team and move the company away from the dominant shadow of Vasella (seeViewPoints: Was he worth it? Vasella commits loyalties to his Novartis legacy) Symonds was viewed by many analysts as a driver of improved capital allocation, with some suggesting that his operating role would be enhanced by the departure of the chairman.

Expectations of structural change and divestments will be reignited by the Symonds announcement, note analysts at Deutsche Bank. One particular conundrum for investors is the 33 percent shareholding that Novartis holds in its compatriot Roche. Jimenez has ascribed an intangible value to the shareholding, which allows the company to have some say in any acquisitions Roche would choose to make that required the issuance of new shares. Investors may feel that the money could be spent more effectively elsewhere, particularly as Novartis’ financial stake in Roche is something of a Vasella heirloom and reminder that the former CEO often talked up the possibility of a Swiss mega merger.

See also:



#India – The Law That Saved a Billion Lives

4 May 2013

A portrait of a fearless piece of Indian legislation that assures affordable medication to the world’s poor

BY Achal PrabhalaSudhir Krishnaswamy , Open Magazine
NEED FOR CHEAP DRUGS: Cancer patient Siddhart Maske seated outside the Tata cancer hospital in Mumbai

NEED FOR CHEAP DRUGS: Cancer patient Siddhart Maske seated outside the Tata cancer hospital in Mumbai

One day in September 2007, Arun Kumar (1), a serving officer in the Indian Army, took a routine blood test. To his surprise, he found his total leukocyte count (TLC) was at 13,000, a little beyond the normal range (4,000-11,000). The next day, it had climbed to 25,000. Four days later, his TLC had shot up to an alarming 125,000, and he was evacuated from his remote posting in eastern India and flown to a Command Hospital thousands of kilometres away. It was as his doctors suspected: Kumar had chronic myeloid leukaemia (CML). He was lucky for having caught the cancer in its incipient phase.

Kumar was lucky in other ways as well. For one thing, his form of cancer is treatable, thanks to a miracle cure called imatinib. For another, the Armed Forces take care of all his treatment costs while on active duty, and the Ex-Servicemen Contributory Health Scheme (ECHS) will cover him even after retirement. This is no small matter; imatinib is available in generic form from multiple suppliers in India, but a single dose costs Rs 1.2 lakh per annum—and he is likely to stay on medication for the rest of his life.

Despite these advantages, Kumar’s struggle against CML has not been without setbacks. He suffers from chronic indigestion, possibly as a result of his high medicine intake. The Command Hospital he is treated at is overburdened, and frequently runs out of imatinib. During these stockouts, which can last up to several weeks each year, he is on his own: he has to buy imatinib in the market, without reimbursement. Three years ago, his doctors noticed a sudden increase in the chromosomal aberration that indicates CML, and doubled his dosage of the medicine. Still, his body is responding well. Had he instead developed resistance to imatinib, he would have had to upgrade to dasatinib, a newer medicine that Bristol Myers-Squibb (BMS) launched in the market in 2006. BMS, an American pharmaceutical major, markets dasatinib in India under the brand Sprycel at a price of Rs 18 lakh per annum. Natco, an Indian manufacturer, produced a generic version of dasatinib that cost one-eighteenth of the BMS price, at about Rs 1 lakh; BMS sued Natco, and the case is currently in court.

Today, Kumar is alive and well, and his cancer is barely detectable. His annual medicines bill is Rs 2.4 lakh, a sum he can afford only because his employer picks up the tab. That might sound like a large sum of money to expend on one patient alone, but it is in fact the lowest price at which imatinib can be bought anywhere in the world. Hospitals operated by the Forces—like all other government-run health facilities—buy generic imatinib exclusively through competitive tenders; if they were forced to buy Gleevec (spelt Glivec in Europe and other markets), a brand of imatinib marketed by the Swiss multinational Novartis—which introduced the medicine to the world in 2001—they would be looking at an annual bill of Rs 30 lakh for Kumar alone, which is to say, they would have to pay 12 times as much.

Unfortunately, such a price scenario is not idle speculation: until two weeks ago, India’s public health system—funded by taxpayer money—faced the prospect of either instantly multiplying its budget several times over, or, in the case of CML patients, treating only a twelvth of the people it was earlier supporting.

Thankfully, Kumar’s future is safe.

On 1 April 2013, Supreme Court Justices Aftab Alam and Ranjana Prakash Desai upheld previous decisions of the Intellectual Property Apellate Board (IPAB) and the Patent Controller in deciding that Novartis’ application covering a modification to the original imatinib compound was not worthy of patent protection—and thereby, market monopoly —in India. It was a judgment heard around the world. Mainstream media exploded with news of the Indian Supreme Court decision, marking a first for a lengthy document that put forth a complex technical argument based on the arcane workings of intellectual property, itself an arcane subject.

In the flurry of news coverage that ensued, perhaps no fact was mangled as much as the immediate impact of the decision on price and accessibility. The price of imatinib matters, and it matters to us now. In the wake of the judgment, a popular line of argument has been that no matter how low medicines are priced, there will still be millions of people who cannot afford them. This is true, but it is no justification for a higher price: it is a simple consequence of poverty. A low price still matters to the middle-class because it provides them affordable medicines, and it still matters to the desperately poor because it enables foundations, agencies and governments that fund public health to extend treatment coverage to more people who need it.

The other popular line of argument is that this judgment will have no effect on access to imatinib since most people get it free anyway. These exact words have appeared in the editorials and news reports of several publications over the past few weeks, never mind that the opposite is true. Consider the dissimulation that produces this argument. There are an estimated 42,000 people being treated for CML with imatinib in India today. Of these, Novartis claims 16,000 patients use its brand of imatinib, Gleevec. Novartis further claims that 90 per cent of these Gleevec users—about 15,000 patients—get the medicine free through a charitable programme run by the company. (The Cancer Patients Aid Association—CPAA—disputes these claims). Even if we take Novartis at its word, there are at least 27,000 patients—65 per cent of all people diagnosed with CML—who are paying for their imatinib, either directly or via their employers. Now hear Paul Herrling, head of corporate research at Novartis, conveniently mixing up his numbers, magically expanding the scope of his company’s charity, and setting the narrative: “90 per cent of all people diagnosed with that specific form of leukemia get Gleevec free.”

Regardless of the intent, perhaps we ought to be grateful for the sudden spurt of attention towards Indian patent law. It is well worth understanding. After all, it is the reason we are alive.


The Nobel Prize-winning relief organisation Médecins Sans Frontières (MSF) calls India ‘the pharmacy of the developing world’. It is a well-deserved distinction, and it took the better part of five decades to achieve. The Indian generic pharmaceutical industry took off in the 1970s, and continues to provide patients across India with what are arguably the cheapest certified medicines available in the world. After an early phase of consolidation, the Indian generic industry looked outwards—and began exporting its medicines with some success. Today, large swathes of Latin America, sub-Saharan Africa and Asia (not to mention some sections of the American and European market) depend on Indian generic medicines to a significant extent. An industry born of a straightforward strategy for pharmaceutical self-sufficiency has transformed into a world-class hub of low-cost medicine production.

It was no accident. Like so many transformations that mark our time, it began in the 1960s. Justice Bakshi Tek Chand and Justice Rajagopala Ayyangar, two pioneering patent law reformers of the period, laid the foundations on which the generic industry would be built. The Tek Chand Committee reviewed the Indian Patents and Designs Act of 1911, and argued that it did not encourage scientific research in India. The committee recommended that patents be put to use for the good of the Indian public, and that patented products be reasonably priced, failing which, compulsory licences ought to be issued (which would legally revoke the time-bound monopoly conferred by patent protection).

The Ayyangar Committee took the argument further, noting that far more patents were being granted to foreigners than Indians, and that Indian patents were not proving commercially successful. The Ayyangar Committee asked for the country’s patent law to be redesigned to respond to India’s needs as a developing country, and drew upon European precedents to exempt food, medicines and chemicals from product patents. This legal provision formed the cornerstone of India’s Patents Act of 1970, and enabled the emergence of the generic pharmaceutical industry we know today.

At the same time as Justices Tek Chand and Ayyangar were looking for ways to reform Indian patent law, a nascent pharmaceutical manufacturing base was coming into its own. The Bombay-based generic medicine pioneer Cipla, founded by Khwaja Abdul Hamied, had been operating for 35 years by then. Cipla and other firms of its kind made it clear to the Government that they needed to bypass product patents in order to grow, and it is likely that the presence of a capable manufacturing base hastened the introduction of a law that would help it expand. Once the law took shape, there was no looking back. The Patents Act of 1970 changed the game: the global landscape of medicines was forever altered, and for the better.

The period extending from the 1970s to the early 1990s was something of a golden age for the Indian generic industry. In the absence of binding international treaties that regulated patents, the State was more or less free to do as it pleased, and the generic industry took advantage of this to build its capacity and spread its wings. Then, in 1994, India signed the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), as part of its accession to the World Trade Organisation (WTO)—and the trouble began. The Indian State had no choice, really; WTO membership was an offer it couldn’t refuse if the country wanted to keep trading with the world.


In Novartis AG vs Union of India, Justice Alam traces the antecedents of Indian patent law. While he does not delve into the frenzied political bargaining that foreshadowed TRIPs, he does reflect on the deep concerns expressed within India—and in other countries reliant on Indian medicines—over the impact of product patents on the domestic generic industry. India’s experience of patents was limited, and the immediate crisis posed by signing up to TRIPs was an existential one: would the pharmacy of the developing world have to shut shop?

In the years following 1994, the Indian State struggled to reconcile its domestic patent law with the international regime it had acceded to. In part, this was because of the commonly held belief that TRIPs forced India to forgo the flexibility to mould its patent law to suit its needs. The feckless thrashing about by the Indian political class in the wake of TRIPs produced several failed ordinances, many aborted legislative attempts, and some modest legal reform between 1994 and 2005. Notably, it was in this period of indecision that the governments of the United States and the European Community launched formal complaints against India at the WTO—in 1996 and 1997, respectively—for failing to fulfil its obligation to provide interim protection to patent applications in advance of a new patent law. (By the terms of TRIPs, India was required to bring its patent law into line by 2005; it was also required to set up an equivalent system in the intervening period.) The WTO upheld the US and European complaints. As a result, India amended its patent law in 1999, setting up a ‘mailbox’ for patent applications and instituting a scheme of Exclusive Marketing Rights (EMR) to serve as a proxy for patent privileges in the run-up to patent protection.

Within the generic pharmaceutical industry, the period between 1994 and 2005 was characterised by confusion. Some generic manufacturers stuck to their guns: Cipla, for instance, made a brilliant, headline-grabbing move in 2001 by offering MSF the cocktail of medicines required to treat HIV and AIDS at a jaw-dropping price of $350 per annum—at a time when the prevailing price around the world was over $10,000. But as India further complied with TRIPs, the effects of full compliance were becoming clearer, and they did not bode well for the industry.

In the end, the demands were met by the 2005 amendment to the Patents Act. Unusually—or luckily—a curious combination of negotiating deadlocks, parliamentary unrest and the strong presence of the Left parties in the ruling coalition resulted in a strikingly bold and original law. The amendments finally made to Indian patent law were a culmination of the policy concerns expressed since 1994.

In his judgment, Justice Alam notes that Parliament paid particular attention to Novartis’ exorbitant pricing of Gleevec—the first medicine in India to have been granted an EMR—and used the experience as a lesson in understanding what could happen under a patent regime of unfettered monopolies. The amendments of 2005 complied with TRIPs and ushered in product patents and yet featured several distinguishing details. Significant among these was a higher threshold for inventiveness, which, while allowing for incremental innovation, demanded that the increment be amply demonstrated in the form of measurably greater efficacy.

At the outset, there was no doubt these largely unprecedented provisions would eventually be challenged. An early exercise to deflect international murmurs about the legitimacy of these provisions was the formation of a Technical Expert Group on Patent Law Issues, headed by Dr RA Mashelkar, the (then) head of the Council of Scientific and Industrial Research (CSIR). The Mashelkar Committee was established in April 2005 and tasked with examining a couple of crucial questions pertaining to the TRIPs-compatibility of Indian patent law. It took its time to deliver.

Soon after, Novartis’ application for patent protection on its beta crystalline modification of imatinib was examined. (The patent on the original compound was instituted before 1995, making it ineligible for consideration under Indian law.) In 2006, the Patent Controller rejected Novartis’ application on the grounds that it failed to satisfy several provisions, including section 3(d) of the Patents Act, which asks for a demonstration of increased efficacy to prove incremental innovation. Novartis appealed the decision to the IPAB, which rejected the application in 2009. As a last resort, Novartis filed a Special Leave Petition under Article 136 of the Indian Constitution to challenge the ruling of the IPAB, and this is how the case reached the Supreme Court.

For 15 years, Gleevec travelled through the courts like a bullet in slow motion fired at Indian patent law. Every step of the process was a cliffhanger; every outcome, at every stage of the challenge, had the potential to directly affect the lives of hundreds of millions of people at home and abroad.

Prior to the Supreme Court decision in this matter, Novartis had approached the Madras High Court, arguing—in a separate but related charge—that section 3(d) of the Indian Patents Act was unconstitutional. In effect, Novartis was trying to do what the Swiss government would not. Instead of the Swiss government hauling India to the WTO—as the US and EU had done before, and as is standard procedure in a sovereign dispute—Novartis was taking the Indian Government to court for violating its obligations to the WTO. In 2007, the Madras High Court rejected Novartis’ charge and declined to rule on India’s compliance with TRIPs. Novartis did not appeal. Curiously, however, the Mashelkar Committee submitted its own report to the Government a few months before the case was to be heard, and its conclusions supported Novartis. In the run-up to the hearing, Novartis brandished the Mashelkar Report as proof of the Indian Government’s complicity in the alleged flouting of international protocol. More curiously, it turned out that the conclusions of the Mashelkar Report were lifted verbatim from a paper commissioned by a lobby group of multinational pharmaceutical companies and executed by a (then) doctoral student, Shamnad Basheer. In the ensuing scandal, the report was withdrawn and Novartis lost a key prop in its argument. (Several years later, the report was rewritten, re-submitted to the Commerce Ministry’s Department of Industrial Policy & Promotion—and accepted.)

The Madras High Court’s ruling was primarily concerned with constitutional rights and goals. In contrast, the Supreme Court judgment of 2013 restricts itself to the discipline of patent law. Contrary to popular opinion, there is no reference made within the judgment to the Constitution or rights of patients. Justice Alam’s summary observation is that Indian patent law promotes breakthrough innovation while restraining monopoly claims for minor innovation—by which he means modifications that are trivial and do not substantially add value to the original innovation.

The historic nature of the judgment cannot be overstated: not only does it justify Indian patent law as it exists, thereby safeguarding access to medicines, it recasts the Indian patent regime as an agenda-setter for innovation, thus giving it the potential to change the game once more.

Twenty years after TRIPs made its début on the world stage, thanks to the Novartis judgment we can now safely say there is wide flexibility available to member states who wish to comply with it. To exploit this, however, and to make the system truly work for innovation and access, the Indian experience suggests that four factors are crucial. One: the intellectual capacity to create alternatives to standard interpretations of TRIPs, which depends on a robust academic and activist structure that is unafraid of originality. Two: organised patient groups and public interest lawyers who bear the moral impetus of an independent civil society; in the Novartis case, the CPAA and the Lawyers Collective played outstanding roles. Three: the driving commercial ambitions of a generic pharmaceutical industry that makes medicines for the domestic market. Four: an independent judiciary that is confident enough to withstand the public-relations onslaught and backroom bullying that typically accompany cases with major global implications.

Innovation is the point of the Novartis judgment. Innovation is also the point of every detractor of the judgment, including Novartis. The detraction is simple: that this spells the end of innovation in India. Behind this prediction of doom is a widely held notion that patents are an index of innovation.

In theory, they are. Patents are supposed to be temporary monopolies awarded by law as an incentive for publicly disclosed innovation. In reality, however, the global patent system has been gamed beyond recognition. In the preceding decades, as India struggled to refine its patent law, other countries turned their patent systems upside down. In the US, Europe and Japan, powerful pharmaceutical lobbies have managed to consistently weaken standards, creating a system that no longer has the capacity to recognise, much less reward, genuine innovation. Minor and mostly inconsequential innovations rule, and it’s a bitter victory, for they win at the cost of breakthrough innovation. A recent report in the British Medical Journal sums up 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 breakthrough innovation is more important than the incremental kind, as common sense indicates, why do pharmaceutical companies overwhelmingly focus on the latter? For one thing, breakthrough innovation takes time and money and necessarily involves a high risk of failure. For another, minor innovation—relative to its investment—produces very satisfying results. In a recent Public Library of Science study, researchers tallied the benefits of secondary patents in the US market from 17 years of data. They found that on average, a secondary patent adds between 6 and 7 years to the patent life of the original compound. To appreciate the financial windfall that a single year’s additional monopoly represents, consider atorvastatin, a blockbuster cholesterol medicine. The American pharmaceutical company Pfizer launched the medicine under the brandname Lipitor in 1996. At its peak, while under patent protection, Lipitor generated $12 billion in annual revenues. The moment it went off patent and had to compete with generic brands, Lipitor’s revenues plummeted to a little over $1 billion. Pharmaceutical companies chase secondary patents because they have the potential to extend monopolies and deliver exceptional returns for relatively little effort, and this is exactly the kind of lopsided incentive scheme that Indian patent law is designed to thwart.

The other big detraction—a detraction that almost wholly constitutes the innuendo around the Novartis judgment—is that Indian patent law is not TRIPs-compliant since it has not had its day at the WTO yet. There are several ways to think about this. First, the Madras High Court’s rebuff of Novartis’ constitutional challenge in 2007 implicitly addressed this question. Novartis did not appeal the judgment. Second, the WTO does not hand out certificates of compliance: a law that is unchallenged at the WTO is, by default, compliant. Third, if another sovereign entity—like the US or EU—wanted to haul India to the WTO Dispute Settlement Body, it has had plenty of time to do so: eight years to be specific. When India dithered on commitments made to the WTO in 1994, the US and EU formally hauled up India at once. They did so because they were confident they had a case—and they won. India was forced to rectify its mistakes. There is a reason the US and EU have not taken India to the WTO over the TRIPs-compatibility of its patent law. It is not that they are thrilled with the law or perfectly sure it is compliant. The reason India hasn’t yet faced a sovereign challenge on its patent law is that scholarship and evidence weighs in favour of its compliance—and no developed country wants to risk losing at the WTO, for a loss would serve as a licence to every country watching to replicate the Indian model with impunity.

And this brings us to the crux of the matter. India represents 1.3 per cent of the global pharmaceutical market by value. We are a poor country, and a resolutely low-cost generics market to boot. Certainly, there is money to be made here; it’s just that the money is little or nothing when set against the industry’s global bottomline. On its own, India cannot improve the way the industry innovates, regardless of the strength of its patent law, because it lacks clout.

The real problem for big pharma is the symbolic value of the Supreme Court’s justification of Indian patent law. You will not hear this problem expressed publicly, because expressing it will only make it worse, but rest assured CEOs in London, New York and Basel are worrying about it. The real threat posed by Indian patent law is that other countries may want it too. If that happens on a large enough scale—and it’s a big if—an unjustifiable business model will be upended and we may finally see innovation and access going hand-in-hand.


(1) – Name changed


(This piece draws, in part, on arguments previously expressed by the present authors in The Hindu on April 15, 2013, and by one of the present authors and Kajal Bhardwaj in Business Standard on April 6, 2013, in which the case of the anonymous Indian Army Officer, reported here at length, was discussed in summary. For further perspectives from cancer patients in India on the Novartis case, the Cancer Patients Aid Association has a useful compendium of reports. For a history of actions taken by Novartis over Gleevec in India through the last fifteen years, the Lawyers Collective HIV/AIDS Unit has compiled a comprehensive timeline with commentary.)


Achal Prabhala works on access to medicines; Sudhir Krishnaswamy is with the Centre for Law and Policy Research, and on the faculty of Azim Premji University


Novartis and Health – An analysis


Rajeev Dhavan on April 11, 2013 – 1


The Novartis judgment has started a huge war of words. The patent drug producers are livid. They declare: “Woe is us. This is the end of invention.”  The generic drug makers say: “Well done Supreme Court.  Now we can supply life saving drugs to India and the world at cheaper prices.”

First let us understand the judgment for what it is. The drug in question is Gleevec which is used by cancer patients. The foundation for it is Imatinib Mesylate (IM) free base which was an important discovery and undoubtedly a new invention attributed to Dr. Zimmerman. IM was converted into a salt in the crystalline form known as IM Alfa which was then improved into the IM Beta crystalline form. This Beta form was claimed to be an invention because it had better flow properties, thermo stability and lower hygroscopicity – in other words it was more stable and digestible.

Was the Beta form an invention? This was not just a technical question for the chemist. It had mighty implications in terms of ground realities in two significant ways. The life of the original Zimmerman patent would be extended by 20 years. If another “improvement” was accepted as a patentable invention, it would be extended for another 20 years. In patent law and practice, this phenomenon is known as “evergreening.” The second ground reality was that a patent is a “monopoly.” There are two kinds of patent monopolies: a process patent which protects how the patent is made; and a product patent which protects the product itself. A process patent is a low level protection. If a drug has a process patent, this means that anyone can make that drug by some other process. This was India’s solution in the original Patent Act, 1970. But a product patent is a master monopoly which, with “evergreening”, means that only that corporates or their licensees can make that product to the exclusion of all others.  This also means that the owner of the product can impose any price it wants. Ofcourse, countries can impose a compulsory license if there is scarcity, but that option comes with too many restrictions. This was the Euro-American solution devised by the TRIPS (Trade Related Intellectual Property Rights) treaty in the new WTO (World Trade Organization).

The Supreme Court took the view that Gleevec did not have novelty – in that IM was in the public domain of knowledge in a Cancer Research article and other publications. Nor could it be said that there was an inventive step because a person skilled in the task with what was known would be able to discover the IM in the crystalline form with the properties claimed for Gleevec. The narrow decision in the case concerns whether the product Gleevec could be given a product patent for the improvements. The answer was unequivocal. Novartis could not get a product patent but was entitled to a process patent to protect how it was made. Effectively, the ‘evergreening’ of Gleevec was stopped.

But, the court went further beyond the confines of the Euro-American patent law model which India accepted when it capitulated to accept TRIPS in the WTO negotiations. How TRIPS ordained patent monopolies as free trade is baffling. But, there was a loophole. TRIPS left it to the each country to “determine the appropriate method of implementing the provisions of this agreement within their own legal system and practice”. (Article 1). TRIPS also envisaged each country to innovate in a manner conducive to social and economic welfare and to balance of rights and obligations (Article 7) and “adopt measures to protect public health and promote social economic development”. (Article 8). A worried Indian Parliament decided that patents would have to meet one further test of patentability. In the area of medicine and chemicals, it was indicated that any change must be significantly efficacious. (Section 3(d) Indian Patent Act). The significance of the Novartis judgment lies in its interpretation of this section. It posed a more stringent test beyond novelty and inventiveness by requiring significant improvement in efficacy. It was not enough that the drug was more stable and easier to administer and absorb. A significant step requires a therapeutic efficacy which is curative. If this interpretation had not been forthcoming, every little change would have fortified an “evergreening”.

The argument that research will suffer is simply wrong. Scientists rely on the past research of others. There are actually few ‘eureka’ moments in technical research. But patent holding companies want to increase these ‘’eureka’ moments, exacting a heavy price for their products. Research shows that the wide spectrum research cost is recovered in less than five years. There is an invisible government subsidy because research costs are tax deductible. Innovation will continue. In fact, the competition for innovation will become more intense as “patent” companies do not seek evregreening monopolies for small changes but only significant curative ones. Meanwhile competitive sales between companies will make medicine more affordable.

India’s parliament has shown the way by adding the criteria of significant change of curative dimensions. The Supreme Court has interpreted this addition valiantly and creatively. The world was waiting for decision like this. With evergreening de-monopolized, Cipla and others can now provide life saving drugs to Indians and others all over the world at much lower prices.


Rajeev Dhavan is a Senior Advocate of the Supreme Court.



Debunking Pharma’s Cant Against the Novartis Judgment: Myth and Fact

Professor Brook K. Baker, Senior Policy Analyst Health GAP
April 2, 2013, IP

Novartis, its fellow Big Pharma multinationals, Chambers of Commerce, and PhRMA have all roundly denounced India’s Supreme Court’s decision invalidating Novartis’ patent application for Glivec (Gleevec in the United States) and its affirmation of strict anti-evergreening standards of patentability and inventive step in India.  As usual, Big Pharma cannot tell the truth about what India has done, what international intellectual property rules require, and what the impact of this decision will be on product introductions in India and innovation of new medicines.  Because journalists continue to carry Pharma canards and since observers are anxious to understand whether India’s decision is legal or purely instrumental to advance industrial policy in favor of Indian generics, I debunk the major myths with what I hope are convincing facts.

Myth 1:  India was obligated to issue a patent on Glivec because it is a superior medicine and because 40 other countries have done so.

Fact:  Prior to the effective date of the WTO TRIPS Agreement (January 1, 1995), there was no provision in international law whatsoever requiring any country in the world to grant patents on pharmaceutical products.  None.  Accordingly, India lawfully adopted a patent law in 1970 that refused to grant patents on pharmaceutical or food products.

When India signed the TRIPS Agreement and became a member of the WTO, it was not required to retroactively grant patents on pharmaceutical products that had been invented before the effective date of the TRIPS Agreement (subject only and arguably to a 1-year grace period for filing after a first application elsewhere).

The initial patent on the active pharmaceutical ingredient in Glivec, imatinib, had first been filed in the U.S. in in April of 1993.  That application was later withdrawn and a second application was filed on April 28, 1994, but it had a so-called priority date back in 1992.  Accordingly, India was under no obligation whatsoever to recognize this first application, not only because a patent application on it was never filed in India but because India had lawfully declined to grant pharmaceutical product patents at the time of invention.

Thus, it is completely irrelevant that other countries granted patents on the first Glivec patent application.  Likewise, it is irrelevant that that Novartis continued to research and modify that compound and that Glivec is an excellent cancer medicine.  Everyone agrees it’s an excellent cancer medicine, but that doesn’t mean it is automatically or retroactively entitled to a patent monopoly.

Myth 2:  India was obligated to issue a patent on Glivec’s “improved beta crystalline form of imatinib mesylate” discovered/invented in 1997 because it was a new medicine and 40 other countries granted a patent.

Fact:  This is the crux of the Indian Supreme Court‘s decision upholding the strict standards on inventive step and standards of patentability that India adopted in section 2(1)(j) and (ja) and section 3(d).  India had flexibility under Art. 1.1 of the TRIPS define strict standards for novelty, inventive step, and industrial applicability.  It chose to limit evergreening of pharmaceutical patents by preventing patents on new form, uses, dosages, formulations, and combinations of known medicines or know substances.  The “beta crystalline” patent application that Novartis filed in India in 1998, with a 1997 priority date, fell squarely in the middle of the prohibited category.  It was purportedly a “new form” of the previously invented substance imatinib and its salt imatinib mesylate.

Even if the beta-crystalline form was the optimized active pharmaceutical ingredient in Glivec (a fact that Novartis did not claim either to the Food and Drug Administration in the United States nor drug regulatory authorities in India), that does not make the modification of the previously known substance patentable.

Novartis claims in its press statements that because Glivec was never marketed using imatinib in its original form and that its beta crystalline form was not a modification of an existding medicine is specious.  The Indian Patent Act section 3(d) refers to modification of “known substances,” not just known existing medicines.

Myth 3:  Novartis’ new and improved beta crystalline form of imatinib mesylate showed increased efficacy – it was a “better” drug.

Fact:  As the Indian Supreme Court confirmed, section 3(d)’s standard of enhanced efficacy requires that the revised medicines show significantly enhanced therapeutic efficacy when involving a medicine that treats human disease.  Novartis only offered evidence of better flow properties, improved temperature stability, and reduced hygroscopy.  None of these physical features affect treatment as such.  Similarly, Novartis offered some after-the-fact evidence on increased bio-availability but it did so in comparison to imatinib only not imatinib myselate, the appropriate comparison.  Even then, increased bioavailability does not directly equate, on its own, with enhanced therapeutic efficacy.

Accordingly, contrary to its claims, Novartis offered no relevant evidence whatsoever that its secondary patent application on Glivec showed enhanced efficacy as required by section 3(d).

Myth 4:  India is just favoring its generic industry by this ruling.

Fact:  Of course, this ruling will benefit Indian generic companies because they are fulling capable of manufacturing generic imatinib mesylate to global standards.  However, this ruling also means that companies in countries where Glivec is not patented could also manufacture and export to India.  Novartis claims that its patent in Glivec is protected in 40 countries, but that means it does not have a patent in many others.  With no patent bar in a country of production and no patent bar in India, a generic company in any of those countries could also benefit from the denial of the India patent on Glivec.

Myth 5:  This decision means that India does not respect intellectual property rights and that it is impossible to get a patent on a medicine in India.

Fact:  Contrary to this claim, India’s Patent Act clearly allows patents on medicines that are either brand new (don’t involve a known substance) or are modified sufficiently to offer enhanced efficacy in the treatment or prevention of human illness.  Studies show that there have been hundreds of patents on medicines in India since it revised its Patent Act in 2005.  In fact, those studies show that India has probably been too lenient in grating weak patents and that it has not properly been applying section 3(d) to weed out evergreening patents.  In sum, it is not impossible to get a patent on medicines in India, you simply have to meet lawful strict standards on what is inventive and patentable.

Myth 6:  Neither Novartis or other drug companies will patent their medicines in India or bring new medicines to the market.

Fact:  Novartis officials made this sad-face prediction on April 1 but by April 2 they had withdrawn this claim and clarified that they would still seek patents in India.  And every other Big Pharma company will do so both to gain access to the world’s third largest market by volume (one that is growing at an annual rate of 15-20% and that will have $49-$74 billion a year in sales by 2020) and to block Indian generic companies from producing either for the domestic market or the export market (where India is now the largest volume exporter of generics in the world).  Big Pharma companies will continue to seek patent monopolies on truly novel medicines and those with major therapeutic improvements – full stop.  They will seek to sell to India’s growing middle-class and to middle–classes in other countries that Indian generics might otherwise supply.

What Big Pharma won’t be able to do is to file new patent applications over and over again on minor modifications and thereby gain many added years of monopoly protections and supra-competitive profits.  They’ll still make money, but not as much as they had hoped for.

Myth 7:  Pharma won’t do any future research and development in India or invest in India.

Fact:  Big Pharma doesn’t site its research and development facilities based on whether there is a maximalist patent regime there or not.  Big Pharma does R&D for a global market, not for a particular country.  For example, drug companies don’t do diabetes research for Indian diabetics in India and for British diabetics in the UK.  They site their research facilities where there are good scientists, good infrastructure, favorable taxes, etc.  Moreover, Big Pharma companies are buying up Indian generics, contracting manufacturing, and doing clinical trials in India hand over fist.  Maybe they’re not currently siting their latest greenfield R&D facilities in India, but you can’t bet such decisions have nothing to do with India’s patent regime.

Myth 8:  The Novartis decision undermines the global search for new medicines.

Fact:  Of all the canards, this is probably the most ludicrous.  Big Pharma makes the vast majority of its profits on sales to rich patients in rich countries.  Nearly 75% of global drugs sales by dollar volume in 2011 was in Europe, North America, and Japan.  Indian sales comprised less that 2% of global sales.  Drug giants do not make R&D decisions or shut down promising drug candidates because they didn’t squeeze a little extra profit out of small market.

To the contrary, drug companies waste a lot of research dollars now trying to evergreen existing medicines instead of focusing on truly innovative medicines.  They spend nearly 2 1/2 times on marketing and administration as they spend on R&D.  Despite the “risks” of R&D they still retain more in profits than they actually spend each year on R&D.

In sum, the Novartis decision will have little or nothing to do with Big Pharma’s R&D efforts.  But this doesn’t mean that continuing innovation isn’t important.  Nonetheless, it makes little sense to hold poor patients and poor countries hostage for 20 years selling monopoly protected medicines at prices they can’t afford.  We need a better system for investing in therapeutically targeted innovation, with a variety of push and pull mechanisms, and a better system for sharing global R&D costs that is delinked from the market for selling “generic” medicines at low-cost with minimal mark-ups.

Myth 9:  India is engaged in other unlawful IP practices such as issuing compulsory licenses.

Fact:  India has issued one compulsory license on an extraordinarily expensive cancer medicine sold by Bayer.  Some other high-price cancer medicines are under review to see if India wants to issue government use license (licenses that will leave the lucrative private sector to Big Pharma).  However, TRIPS Article 31 specifically allows for compulsory licenses as does the 130 year old Paris Convention as does the 2001 Doha Declaration on the TRIPS Agreement and Public Health.  Virtually all countries, including the United States, have compulsory licensing rules on the book.  Such licenses are not limited to emergencies or infectious diseases, despite what Pharma officials say (and the press uncritically reports).  Such licenses can even favor local producers.

Myth 10:  Novartis was litigating on principle – all that Big Pharma wants is a fair chance to earn enough money to make the next generation of life-saving medicines.

Fact:  Big Pharma and its enablers in Europe and the US are ruthlessly trying to expand its patent and data monopolies through court suits, free trade agreements, diplomatic pressures, and biased technical assistance.  The US in its Trans Pacific Partnership Agreement negotiations is trying to mandate patent standards that would require patents on new forms, uses, and formulations of existing medicines – in essence outlawing section 3(d).  It is also trying to obtain separate monopolies on clinical trial data and win mandatory extensions of patent terms.  The EU sought many of the same terms in direct free trade negotiations with India but has not been successful in most of its efforts.  But it is still seeking investor right and IP enforcement rules that will strengthen Pharma’s hand.  For example, investor clause rules in NAFTA are currently being used by Eli Lilly to extort $100 million from Canada from having revoked a patent on an ADHD medicines pursuant to well-established national law.  Eli Lilly, through private non-reviewable arbitration, is claiming that its reasonable expectations of monopoly profits are being frustrated and that Canada has to have US style levels of protection.  It’s important to note in this regard that investor–state dispute resolution, if adopted in India, would have permitted Novartis to bring the same kind of claim against India regardless of what the Supreme Court had ruled.

Pharma does not want an even playing field.  It wants longer, broader, and stronger monopolies.  It persists in promoting medicines off label, hiding adverse results, bribing foreign regulators, and funding Congress and the executive to fight its battles and to expand its empire.

These ten myths, in one form or another, are creating a fog-bank of disinformation in the wake of the historic Novartis decision.  In sum, the Indian Novartis decision is both legal and wise – it reduces the risk of unwarranted patent monopolies and speeds access to low cost generic medicines of assured quality, both in India and elsewhere.  The panicked reaction of Novartis, Big Pharma and their apologists is the tantrum of a bully who is frustrated because it wanted freedom to steal more candy on the playground.  The press should do a much better job directly confronting Pharma’s myths or at least soliciting opposing views.

Professor Brook K. Baker

Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056




Drug Patent Rights India Wins First Round Novartis Full Text of Judgement


The instances of Multinationals stealing indigenous medicines is well-known.

So are the capricious overpricing of life saving Drugs, like Cancer Drugs.

The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on Monday. It also ruled that under the license Natco must pay 7 per cent in royalties on net sales to Bayer.

Bayer sells a one month supply of the drug for about $5,600. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much.

Western pharmaceutical companies have been pushing for stronger patent protections inIndia to regulate the country’s $26 billion US generics industry, which they say frequently flouts intellectual property rights. However, health activists and aid groups counter that Indian generics are a lifesaver for patients in poor countries who cannot afford Western prices to treat diseases such as cancer, malaria and HIV.’

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

India drew first blood in a Patent case in The Supreme Court .


‘People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while…

Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.

Cost of Glivec used for targeted therapy in CML patients: 1 lakh per month (approx)

Cost of its generic versions : 8,000 -10 ,000 per month

No. of cancer centres in India: 450 approx (half are in the private sector)

The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.

“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.

In trade agreements — including one being negotiated between the United States and countries in the Pacific Rim — the drug industry has lobbied for stricter patent restrictions that would more closely resemble protections in the United States.



Novartis case: Supreme Court’s historic decision on Section 3(d) #TRIPS #Patent

A demonstration against Swiss drug manufacturer Novartis in Mumbai, Maharashtra, on Dec. 21, 2012.

Anand Grover | Apr 2, 2013,

After 2005 India started granting product patents on medicines. However, Section S

ection 3(d), one of the safeguards introduced by Parliament, seeks to prevent patenting of new forms of known substances unless they exhibit enhanced efficacy. Were it not for section 3(d), the standards for grant of product patents on medicines in India would be lower, almost identical to the standards in countries such as the United States andEuropean Union, where a large number of patents are granted on minor modifications of a single medicine.


Section 3(d), along with other safeguards such as allowing patent oppositions by public interest groups, has been used as one of the grounds to successfully challenge patents for minor modifications of several antiretroviral (ARV) medicines used to treat people living with HIV.Section 3(d) also became the basis for the refusal of a patent toNovartis for the beta-crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukemia (CML), a type of blood cancer. In 1998, Novartis filed a patent application in India for this medicine. In 2005, the Chennai Patent office heard patent oppositions to this application including one filed by the Cancer Patients Aid Association (CPAA). The CPAA challenge was spurred by great concern over the price Novartis set for its version of the drug (sold as Gleevec) at Rs 1,20,000 ($2,400) per month as against the generic versions that were available at a cost of around Rs 8,000 to Rs 12,000 per month.

In 2006, the Patent Office rejected Novartis’ patent application on several grounds, including section 3(d). Novartis immediately challenged the constitutional validity of Section 3(d) before the Madras High Court arguing that the term “efficacy” was vague. In 2007, dismissing the challenge, the Madras High Court held that the word “efficacy” had a definite meaning in the pharmaceutical field, i.e. therapeutic efficacy. In 2009, the Intellectual Property Appellate Board (IPAB) rejected Novartis appeal against the patent application rejection on the ground that it did not satisfy section 3(d). Novartis then approached the Supreme Court asking for a liberal interpretation of section 3(d) that would allow it to get a patent on imatinib mesylate.

Novartis tried to argue that the physico-chemical properties of the polymorph form of the imatinib molecule, i.e. better flow properties, better thermodynamic stability and lower hygroscopicity, resulted in improved efficacy. The Supreme Court firmly rejected this contention holding that in the case of medicines, efficacy means “therapeutic efficacy” and these properties while they may be beneficial to some patients do not meet this standard. The Supreme Court also held that patent applicants must prove the increase in therapeutic efficacy based on research data in vivo in animals.

Eight years after India’s patent law was amended, the Supreme Court decision has firmly established the legality and validity of Section 3(d) and has lain to rest the controversy raked up around the section by the pharmaceutical industry. The Commerce Minister has said that India’s law is fully in compliance with the TRIPS Agreement. However, on April 15, commerce minister Anand Sharma travels to Brussels to potentially sign the EU-India FTA that threatens to impose on India obligations far in excess of the TRIPS Agreement; obligations known to undermine generic production and access to medicines.

The Indian Parliament has balanced India’s obligations under TRIPS with the right to health through Section 3(d). The Supreme Court has unequivocally interpreted the true intention and spirit of this provision. It behooves the Indian government to respect the Parliament and the Supreme Court and ensure that it does not sign away these hard fought victories by health and public interest groups in trade negotiations.

The author is a senior advocate and director, Lawyers Collective

#India- SC rejects Novartis’s patent plea for cancer drug Glivec #goodnews

Vidya Krishnan , livemint

Court says Glivec does not meet any standard of ‘novelty or inventiveness’ to qualify for a patent

First Published: Mon, Apr 01 2013.
Shares of Novartis India fell as much as 7% after the Supreme Court judgement. The stock later recovered a bit to trade at `577, down 3.64%, at 11:18am.
Shares of Novartis India fell as much as 7% after the Supreme Court judgement. The stock later recovered a bit to trade at `577, down 3.64%, at 11:18am.

Updated: Mon, Apr 01 2013. 11 54 AM IST
New Delhi: Swiss drug maker Novartis AG’s seven-year battle to win an Indian patent for its blockbuster anti-cancer drug Glivecended on Monday with the Supreme court dismissing the company’s appeal.
In its ruling, the apex court said that Novartis’s “application for patent on the beta-crystalline salt does not meet any standard of novelty or inventiveness”, and therefore the company cannot be given any patent for this drug.
Shares of Novartis India Ltd fell as much as 7% after the Supreme Court judgement. The stock later recovered a bit to trade at Rs.577, down 3.64%, at 11:18am.
The judgement has provided clarity on the so-called evergreening and incremental innovation by pharmaceutical companies in order to retain patents.
Reacting to the ruling, Anand Grover, senior counsel appearing for Cancer Aid Patients Society, said: “It is a very good day for cancer patients. We are very happy. It is a myth spread by the company that judgement will affect research and development expenditures by companies—these companies want to make money without innovation.”
“The court noted that the product—beta crystalline—was known prior to 1995 through an earlier patent Novartis held. The implication of the judgement is that the Indian provision has been completely upheld and patents would be granted only for genuine inventions and litigative patenting will not be allowed,” said Pratibha Singh, an intellectual property lawyer who appeared for Cipla.
The ruling has been keenly followed across the world by pharmaceutical companies, humanitarian aid organizations and generic drug manufacturers as it will have far reaching implications on access to life-saving essential drugs under patents.
After a series of decisions that have gone against the big drug makers with respect to intellectual property rights in the past year, Paul Herrling, Novartis’s head of tropical disease research had said on Wednesday that the company is prepared for a negative response.
The case over patents for Glivec—a blockbuster anti-cancer drug made by Novartis—reached the courts when India denied patent for it in 2006 as the drug wasn’t considered a new molecule, but an altered version of one that had already been in the market for around 15 years. Basel-based Novartis had challenged the rejection of its patent application for Glivec by the Indian patent office and subsequently by the Intellectual Property Appellate Board.
Further, the company had challenged India’s interpretation of section 3 (d), which relates to what constitutes a new molecule, essentially to ensure that companies to not extend patents by simply modifying an already existing drug without any consequent changes in therapeutic effects.


Pharma vs India: a case of life or death for the world’s poor #Health #drugs

WEB EXCLUSIVE, New International  Oct , 2012

Irekia under a CC License<br /><br />

Cases being heard in Indian courts could ‘open the floodgates’ for pharmaceutical companies to challenge generic drug production and keep prices ridiculously high, explains Nick Harvey.

It’s a worrying time for the poor and the sick. Two cases brought to India’s courts by transnational pharmaceutical companies could massively effect whether people in the Global South can access life-saving medicines. The most significant of these involves Swiss drugmaker Novartis which was refused a patent in India for its anti-cancer drug Glivec (imatinib) and is now challenging the country’s patent law.

There could be significant impact on access to medicines in countries such as India. Irekia under a CC License

‘People are already dying because they can’t get treatment and if Novartis wins things will become worse,’ says Eldred Tellis, who runs a centre for drug users and people living with HIV in Mumbai. ‘They are targeting India because many quality generic drugs are produced here for many people.’

Thanks to India’s 1970 Patents Act, around one-fifth of the world’s generic drugs – containing the same active ingredients as a patented drug but made by a different company at a fraction of the price – are made in the country. As well supplying India’s huge population, these drugs are shipped to poor countries around the world.

‘We source 80 per cent of our global HIVmedicines, as well as other medicines, from India – as do the Global Fund,’ says Michelle Childs, Director of Policy and Advocacy at Médecins Sans Frontières (MSF). ‘So what happens in India can immediately affect other countries and set a precedent for them.’

The problem with patents

Novartis is challenging a clause in the Indian law, ‘Section 3d,’ that prevents drugs being patented that are modifications of existing drugs, a tactic known as ‘evergreening’ used to extend patent periods. The company originally failed to patent Glivec in India as it was discovered before the country was forced to start patenting drugs in 2005. The latest patent application is based on a salt form of Glivec (imatinib mesylate), which, although being easier to absorb, is arguably no more effective.

Studies have found the majority of global research and development (R&D) money is used to produce these minor variations, leading not only to high prices but a lack of genuinely new drugs.

‘About 85 per cent of all new drugs are proven to be little or no better, clinically, than existing drugs,’ says Donald Light, professor of comparative healthcare at the University of Medicine and Dentistry of New Jersey. ‘They are all better than placebo but they are not better than last year’s drug that was better than placebo.’

As these cases move through the Indian courts, the bottom line remains that they could significantly impact access to medicines for the world’s poor.

This is at odds with the pharmaceutical industry argument that the patent system is there to allow companies to receive more money to make new medicines. Producing new drugs is, they say, such an expensive business that only the big companies can afford to do it.

‘These are potentially dangerous substances so you really need to do a lot of research,’ says Mark Grayson, deputy vice-president of Pharmaceutical Research and Manufacturers of America (PhRMA). ‘You need to do clinical trials, even after the drug is on the market; you need production plants to be sterile, drugs need to be safe, all these costs need to be borne and they are not cheap.’

What they fail to mention is that the majority of R&D for developing new drugs is publicly funded. This was the case for Glivec, which was also awarded ‘orphan drug status’ in the US, allowing Novartis to receive tax breaks that paid for a large proportion of the clinical trials. under a CC license<br /><br />

‘The vast majority of the original research on Glivec came from charities and the government,’ says Jamie Love, Director of Knowledge Ecology International (KEI), an intellectual property pressure group. ‘But at the very end Novartis comes in and gets a patent on it and makes a couple of billion dollars a year.’

These mammoth profits are generated by aggressive pricing. When this court case began in 2006, Novartis sold Glivec for $2,200 per person per month, while the generic version was produced in India for a tenth of that price. That companies could be facing such huge losses to generic competition has wound up the neoliberal press in the US with the Wall Street Journal calling it a ‘drug disaster.’

Countries are allowed by the World Trade Organization to produce generic drugs if there is a major public health imperative, a practice known as compulsory licensing. India issued its first compulsory licence in March, ordering German drugmaker Bayer to allow a generic manufacturer to make its cancer drug Nexavar (sorafenib) for one-thirtieth of the usual $5,000 price tag. India’s patent controller argued that not only had Bayer failed to make the drug ‘reasonably affordable’, it had failed to supply the drug in large enough quantities, a decision Bayer is challenging in the courts.

‘With a patent comes obligations, one of which is you make your medicine available in the quantities needed,’ says Michelle Childs.

Targeting the poor

As these cases move through the Indian courts, the bottom line remains that they could significantly impact access to medicines for the world’s poor. If both Novartis and Bayer win, the floodgates could open for companies to challenge the laws and licences that allow generic drug production.

With the vast majority of profits in the pharmaceutical sector being made in wealthy countries, why are poor countries being targeted so aggressively? The answer, like so many others, relates to inequality. While not currently profitable, poorer countries are seen as ‘emerging markets’ because of their burgeoning middle classes.

Most of the people affected by high drug prices will die knowing nothing about patents, laws, licences or pharmaceutical companies

‘The drug companies see India as a market of 100 million, although that’s less than 10 per cent of the population,’ says Jamie Love. ‘These are the people they care about, as they are the ones with enough money.’

This desire to keep the Indian élite onside may be why Novartis’s chairperson Daniel Vasellareportedly donated hundreds of ancient Indian sculptures to a Mumbai museum last month. But most of the people affected by high drug prices will never visit a museum. And most will die knowing nothing about patents, laws, licences or pharmaceutical companies.

‘The people we work with on the ground have no idea what’s going on right now in the courts,’ says Eldred Tellis. ‘But we do, and we know that Novartis losing is their best chance to live.’


Novartis Update: Supreme Court adjourns final hearing to 11 September 2012

As directed by the Supreme Court of India on 10 July 2012, the petition filed by Novartis AG, 
challenging the Intellectual Property Appellate Board’s rejection of its appeal against the 
Indian Patent Office’s refusal to grant it a patent for the beta-crystalline form of imatinib 
mesylate, and related matters were listed today before a bench comprising Justice Aftab Alam 
and Justice Ranjana Desai. The case has now been re-scheduled to 11 September 2012.

In July 2012 itself, when Novartis sought an adjournment on account of the unavailability of 
one of its counsel, the Court had indicated that it could not be certain about its schedule 
and had informed the parties that, while the matter would be listed on 22 August 2012, it was 
not certain if final hearing would commence on 22 August 2012.

As the day progressed, it became evident that the hearing of the matter listed at item no. 1 
(a case that was already part-heard and relating to collection of voice sample vis-à-vis the 
fundamental right against self-incrimination) would continue today and tomorrow.
Therefore, when the Court reconvened after lunch, Novartis’ counsel mentioned the matter to 
ascertain when the final hearing of the Novartis matter would commence.

Alluding to the objections regarding maintainability of Novartis’
petition before the Supreme Court, Mr. Gopal Subramaniam, senior counsel appearing for 
Novartis, said that Novartis would argue both the issue of maintainability of its special 
leave petition as well as the merits of the case and that Novartis would take three days to 
argue the matter.

After ascertaining the court’s schedule and the convenience of the counsel arguing for all 
parties, the matter has now finally been re-scheduled to 11 September 2012 for final hearing. 
The matters will be listed at item no. 1 on the causelist on 11 September 2012.

In solidarity,
Lawyers Collective HIV/AIDS Unit


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