Novartis pharmaceuticals Takes the Indian Government to Court

[zootinali]

The drug company Novartis is taking India to court to stop the production of affordable medicines by generic drug manufacturers. Millions of people in developing countries depend on these lifesaving medicines to stay alive and healthy. Ahead of the final hearing at India’s supreme court, join our campaign and call for a stop to this attack on generic medicines.

About the Novartis Drop the Case Campaign

In 2006 the drug company Novartis took the Indian government to court over its patent law, in a move that threatened access to affordable medicines produced in India for millions of people across the developing world. The company wanted to get the law changed so that they could more easily extend the patents on their products, and stop generic companies producing the same medicines at a fraction of the price.

Doctors Without Borders/Médecins Sans Frontières's (MSF’s) Drop the Case campaign, launched in response to this move, gathered nearly half a million signatures calling on the company to drop its case. But six years later, the legal battle continues. India’s supreme court is now due to give the final judgement on the case this year. MSF has renewed its campaign calling for the company to stop its attack on generic medicines.

Why India Is the "Pharmacy of the Developing World"

India is often called the "pharmacy of the developing world" because it produces affordable generic versions of medicines that are used the world over. More than 80 percent of the antiretroviral medicines (ARVs) used by MSF in its HIV/AIDS programs come from producers of generics based in India, just as 80 percent of the ARVs purchased with donor funds globally come from India. MSF also relies on Indian generics for malaria and tuberculosis treatments. India became the key producer of affordable medicines because, until 2005, the country did not grant patents on medicines, allowing generic manufacturers to freely produce more affordable versions of medicines patented elsewhere. Fierce competition among producers drove prices down dramatically—whereas ARVs for one person per year cost US$10,000 in 2000, today they cost just less than 1 percent of that figure.

India Starts Granting—and Rejecting—Patents

India had to start granting patents for medicines in 2005 because of its obligations as a member of the World Trade Organization. This means that price-busting competition between generic and originator drug producers will be blocked for drugs that receive patents—for example for several newer medicines to treat HIV/AIDS. When designing its patent law, however, India decided that only drugs that show an improved therapeutic effect over existing ones deserve patents. This part of the law—Section 3(d)—intends to prevent companies from continually extending their 20-year drug patents by making minor changes or improvements—a process called "evergreening." Along these lines, the Indian patent examiner in 2006 rejected the patent that Swiss pharmaceutical company Novartis sought for the leukemia drug imatinib mesylate (marketed as Gleevec), because it was based on a compound that already existed.


Novartis Takes the Indian Government to Court

In response to its drug patent being rejected, Novartis took the Indian government to court in 2006, not only challenging the rejection of its patent, but also the part of India’s law, Section 3(d), that formed the basis of the decision. If Section 3(d) were overturned, it would mean patenting would become much more widespread in India, severely limiting the production of more affordable generics.


MSF Launches the Original DROP THE CASE Campaign—and the Fight Continues

Nearly half a million people signed the Drop the Case petition, including Archbishop Desmond Tutu, author John Le Carré, and former Swiss president Ruth Dreifuss. The campaign resulted in extensive media coverage and increased public awareness of the role of India as "pharmacy of the developing world." While the company never dropped its case, the Madras High Court in August 2007 ruled against Novartis. Undeterred, the company has continued to appeal against each legal reversal, with the result that India’s final court—the supreme court—is now due to hear the case in February 2012.

Timeline

1994—India signs the World Trade Organization's (WTO's) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement), which means that it must now start granting patents on medicines no later than 2005.

2003—Novartis launches its imatinib mesylate as a blood cancer medicine (brand name: Gleevec) in the United States at $2,600 per patient per month. Generic versions of Gleevec soon become available in India for under $200 per patient per month.

2005—India changes its patent law to comply with the TRIPS Agreement, and medicines can now be patented. But the law stipulates that only true medical innovations will be granted patents. Section 3(d) of the law specifies that new forms and new uses of known substances cannot be patented, unless they demonstrate a significant increase in efficacy.

2005—India’s patent office starts examining patent applications on medicines including Novartis’s patent application for imatinib mesylate.

January 2006—Novartis’s patent application on imatinib mesylate (Gleevec) is rejected by an Indian patent office on several grounds, including on Section 3(d) that it is simply a new form of a known substance.

May 2006—Novartis files two legal challenges in the Madras High Court. One is to appeal the rejection of the patent. The second is to have Section 3(d) of the Indian Patents Act declared contrary to the TRIPS Agreement and to the Indian Constitution.

December 2006—MSF launches an international petition calling on Novartis to "Drop the case." Four hundred fifty thousand people sign on but the company does not back down.

August 2007—The Madras High Court rules against Novartis in its case to overturn Section 3(d) in India’s patent law. The Madras High Court also rules that "efficacy" under Section 3(d) would require Novartis show an increase in therapeutic efficacy. MSF hands over its petition of close to half a million signatures to Novartis in Basel.

August 2007—The scientist behind the discovery of imatinib, Brian Druker, writes an opinion piece publicly stating that “the price at which imatinib has been offered for sale by Novartis around the world has caused me considerable discomfort. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.”

June 2009—The Intellectual Property Appellate Board which is responsible for hearing appeals on patent applications rejects Novartis’s appeal and confirms that imatinib mesylate does not deserve a patent, on the grounds that the company was unable to show significant increase in efficacy as required under Section 3(d) of India’s patent law.

August 2009—Novartis approaches the Supreme Court of India in a new case—this time seeking to challenge the interpretation and application of Section 3(d) by Indian courts and patent offices.

Final arguments are due to start before the Supreme Court on 28th February 2012.

Briefing Documents: Access: The Novartis Drop the Case Campaign | Doctors Without Borders
Novartis India keeps fingers crossed as SC hears Glivec patent case - Economic Times

 

[Götterdämmerung]

I'm all for cheap drugs for the poors. Also for access to knowledge for developing countries, that's why the current IPR should be reformed drastically.

 

[chromaffin]

profits do matter but never at the cost of health..the purpose for which these companies are formed should outweigh other functional needs..but, it seems they like to see the health of their fellow beings through currency notes..

 

[somebozo]

The drug company Novartis is taking India to court to stop the production of affordable medicines by generic drug manufacturers.

Translation:
million should suffer so corporate west can ensure their profitablity!

 

[Capt.Popeye]

I wonder if Novartis will get any joy out of this legal wrangling (they haven't thus far).
Generic Drug making and as a corollary affordable medication is here to stay. Nobody but nobody will be able to stop that.

 

[ZABASHO]

the thing is, that money matters in the real world. Without adequate availability of that resource to the pharmaceutical companies, they won't be able to attract and retain the best of talents, they wont be able provide next gen research facilities and equipment or provide for adequate number of clinical trials even.
Why else you think the breakthroughs are not achieved by govt. organisations in the field of medicine or are abysmal compared to the results generated by the pharma companies.

The complex thing here is that the medicine is a property of the pharma companies and sorry but the govt. cant tell them what or what not to do with it. If the govt. is unable to afford for the health care of its own people that does not give it a right to steal. It is the govt. which is at fault here not the pharma company.

 

[Capt.Popeye]

the thing is, that money matters in the real world. Without adequate availability of that resource to the pharmaceutical companies, they won't be able to attract and retain the best of talents, they wont be able provide next gen research facilities and equipment or provide for adequate number of clinical trials even.
Why else you think the breakthroughs are not achieved by govt. organisations in the field of medicine or are abysmal compared to the results generated by the pharma companies.

The complex thing here is that the medicine is a property of the pharma companies and sorry but the govt. cant tell them what or what not to do with it. If the govt. is unable to afford for the health care of its own people that does not give it a right to steal. It is the govt. which is at fault here not the pharma company.

Its nowhere as simple or simplistic that you have made it sound in your post.

First of all, the primary issue is not between GoI and Novartis. It is between Novartis and their non-acceptance of Indian Patent Laws. Please do not forget that Indian laws finally have to conform to the letter and spirit of the Indian Constitution, not the Swiss Constitution etc. From the chronology outlined in Post#1, Novartis first contested Indian Patent Law wrt TRIPS and also its Constutionality. When that was knocked down they are now contesting the interpretation and application of Indian Patent Law. While Novartis is entitled to this action, whether it will be maintainable remains to be seen.

About the GoI's role in Medicare, the Constitution certainly (as a Directive Principle) would enjoin it to provide Medicare to citizens. But that is not limited or even specific to 'making drugs'. At best it will obligate the Govt. to assist availability and affordability of medicines/drugs among a multitude of facilities. In facilitating that obligation, Govt has certain powers as well; one of them being the DPCO which if I am not mistaken is an Act now.

Finally and most importantly; while Pharma Cos are commercial entities and are entitled to make profits, the law does not allow them to make exorbitant or unreasonable profits. This principle has withstood legal scrutiny in the courts time and again when the DPCO was challenged and the pricing policies of Pharma Cos. blatantly exposed. Any claim that R & D costs are astronomical in magnitude to justify exorbitant profit margins has been proved hollow when other Pharma Cos have succeded in making molecules of path-breaking drugs at substantially lower costs. How do you think that Indian Cos could secure markets and acquire companies abroad? First they used the generic formula route, then built their own R & D to create own medicines.

Your arguments are not very well founded and are to some extent plainly specious.

 

[Dharmachakra]

This is INSANE to simply put.

No democratic government would want millions of its people suffer due to lack of medicines. Indian gov despite of helping its own citizens is also helping the other developing and under developed nations with generic drugs.

We aint the capitalist west,who only cares about the profits and companies growth trajectories. Many pharma cos in India including the ones operated by GOI were setup for a purpose of helping people that are in need.

Becos an XYZ company is loosing its revenue, we cant put millions of lives at stake. This is much worse than nuking of hiroshima and nagasaki where 300000 killed brutally.Now we are looking at 100`s of millions world wide.

I for one is totally against patenting of any kind off life saving medicine or equipment,be it in India or anywhere on this planet.

As a fellow human, we should be helping in saving of other humans life, but looking at the unhealthy as a rain-check of profits.

 

[ashokdeiva]

the thing is, that money matters in the real world. Without adequate availability of that resource to the pharmaceutical companies, they won't be able to attract and retain the best of talents, they wont be able provide next gen research facilities and equipment or provide for adequate number of clinical trials even.
Why else you think the breakthroughs are not achieved by govt. organisations in the field of medicine or are abysmal compared to the results generated by the pharma companies.

The complex thing here is that the medicine is a property of the pharma companies and sorry but the govt. cant tell them what or what not to do with it. If the govt. is unable to afford for the health care of its own people that does not give it a right to steal. It is the govt. which is at fault here not the pharma company.

Sorry mate, had the people who invented polio vaccination thought the same they would have earned millions, but they made the medicine free and thats the reason you, me and million more did not have to suffer.
May be the next time some of your next of kin gets infected with some deadly dicease such as cancer, and when you spend lakhs of rupess, you'll curse these companise which drain your source of income.

Sorry for being a little harsh, but that was needed to make you understand.

 

[fallstuff]

Indian Supreme Court actually has a point. When a drug nears the end of the exclusive patent right, the makes tend to make minor variation to that drug and file patent for that drug.

This is just a ploy to get more money, the companies are in for money.

 

[ZABASHO]

Indian laws do need to conforn to our own constitution but also as being a member of the WTO, India does have a right to protect IP rights.
Secondly, anybody tell me, where will the funding come from if the pharma industry doesn't see any growth in the field. The simplest fact is, it is a business. A despicable but a very real one. Who are we to say what are unreasonable profits. It is a product of a particular entity and if they want to sell it, it should be their right to decide on the price. When the govt. did not support them with federal funding in research, I ask, why bother now.
Instead of stealing from the pharma companies, the GoI rather pay up the difference money to make the drugs affordable to the citizens. How about medical insurance, what has our govt. achieved in that field?

As to the directive in the constitution, it is arbitrary, it can be deciphered to suit whoever one chooses. But the duty to provide for medicare should rest with the govt. not medical corporations. DPCO is as stupid and insane as congress trying to enforce tax laws retrospectively, and perhaps Novartis is right in challenging such an order.

helping other developing countries.... perhaps UN should do that, who made India the master. And if UN has no problem, then pharma companies should preach at UN, perhaps even WTO, not singularly point at India.

My point is simple, if the govt. wants to have a say in the selling price of a drug, it better also take a stake in the R&D costs of the same. And since GoI values human life so much, why not extend stem cell research/cloning, the practices that hold far more promise than these drugs.


But I do agree with fallstuff, some or perhaps most of the pharma companies do make minor variations to a drug nearing its patent's end, and this practice is something that should be scrutinized by the judicial system.