Roche/Novartis
Short questions and answers about the court case initiated by Novartis in India (08.05.07)
What is the origine of the Novartis case?
In January 2006 the Indian patent office rejected Novartis patent application for a life-saving medicine against rare forms of cancer (Glivec®/Gleevec® - imatinib mesylate). In May 2006 Novartis filed a case not only against the decision of the Indian patent office, but also against the provision of the Indian Patents Act upon which the decision is based. This attack against the Indian law goes far beyond the Glivec® case. The trial started in August 2006 in Chennai High court of Justice (ex-Madras, Tamil Nadu state) and is still going on. In 2007 both cases were separated. The case against the decision of the Indian patent office was transferred to the Chennai Appeal Board on Intellectual Property Rights. The case against the Indian patents act should be dealt soon by the Chennai High Court.
Why Novartis court case goes far beyond the Glivec® case?
By challenging the Indian Patents Act Novartis targets all medicines that could be in the scope of the law. Novartis court case goes far beyond the only anticancer medicine Glivec®. It will impact other medicines dealing with other illnesses.
What contains the section of the Indian patent act section that Novartis attempts to invalidate?
Section 3 (d) of the Indian Patents Act specifies the notion of invention, in particular for substances. The notion of invention determines if a product is patentable or not, that is if the patent holder can be granted a monopoly on the production and commercialization of a product during 20 years.
This section 3(d) has two consequences for pharmaceutical products. On one side it prevents the patenting of new uses of a known substance (for example a substance patented for its action against a certain type of cancer cannot be patented afterwards for its action against another illness). On the other side it prevents the patenting of new forms of a known substance that does not improve its efficacy. That is exactly the reason why the Indian patent office did not grant a patent for Glivec® (see below). This provision is aiming at preventing the multiplication of unsignificant or abusive patents.
Why Novartis Glivec® is patented in certain countries and not in India?
The conditions for granting patents depend on national legislations and vary between the different countries. In 1993 Novartis filed an application for a patent on imatinib mesylate for the treatment of cancer. At this time Novartis could not request for a patent in India, since the Indian law did not grant patents on pharmaceutical products. Since the entry into force of the World Trade Organization (WTO) agreements in 1995 India has the obligation to grant patents on pharmaceutical products. The country was allowed a 10 years transition period (until the 1st of January 2005) in order to implement this obligation.
In 1998 Novartis filed an application in India for a new form of imatinib mesylate (the ß-crystalline form of imatinib mesylate). An Indian cancer organization, the Cancer Patient Aid Association (CPAA), filed an opposition to this patent application. It argued that the 1998 patent application was about a new form of a known substance that does not improve the efficacy. In January 2006 the Indian patent office had a similar conclusion as the CPAA and rejected Novartis patent application. The Switzerland-based company opposes this decision and challenges the provision of the Indian law upon which this decision is based (section 3(d) ).
Why Novartis cases against the Indian Patent Acts are to be taken very seriously?
Novartis cases are concerning for two main reasons. Fistly they threaten access to essential and life-saving medicines in poor countries. Secondly they attack the recognized policy space WTO members can implement the WTO agreements in manner that is in conformity with their needs and their interests.
Why these actions threaten access to essential and life-saving medicines?
Medicines against HIV/AIDS provided a good example. Between 2000 and 2002 the competition of generic medicines (especially Indian generics) dramatically brought down the price of first-line antiretroviral medicines from more than 10’000 dollars per patient per year to less than 150 dollars per patient per year. In other words the more producers for one medicine, the lower the price.
With the entry into force of the WTO agreements in 1995 all the member countries have to grant a 20 year patent protection on pharmaceutical products, including India and the other large developing countries that have the capacities to produce generic medicines (Brazil, China for example). This new regime is mainly beneficial for big pharmaceutical companies that own or control most of the patents on new medicines.
This new international regime delays and complicates the introduction of cheap generic versions of new essential and life-saving medicines in developing countries. The invalidation of section 3(d) of the Indian Patents Act would strengthen this trend. It would pave the way for a multitude of insignificant and abusive patents.
This is true in India where the overwhelming majority of the population lives in poverty (more than half the population lives with less than one dollar per day). This is true for other developing countries since India is one of the most important exporters of cheap generic medicines in the world. Indian generics provide more than half of HIV/AIDS medicines used in developing countries.
Why these Novartis cases threaten the freedom left to States by the WTO agreements?
Novartis challenges section 3(d) of the Indian law arguing that it does not comply with the World Trade Organization agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS). It is a dangerous attack. Those provisions (non patentability of new uses of known substances and non patentability of new forms of known substances that do not improve their efficacy) are flexibilities recognized by the TRIPS agreements. That means that they are part of the legitimate policy space that WTO States have to implement the TRIPS agreements in a manner adapted to their development level and to their public health needs.
Section 3(d) was praised by the recent World Health Organisation Commission on Intellectual Property Rights, Innovation and Public Health chaired by Ms. Ruth Dreyfuss, former President of Switzerland and former Minister of health and research. To date, no WTO member, including Switzerland, has lodged any complaint in the WTO against these provisions. However, other developing countries have integrated these flexibilities or want to add them into their legislation (the Parliament of Philippines is discussing this issue at the moment). With its legal challenge Novartis aims at creating a precedent that would be extended to other countries.
Novartis declarations in favour of the use of certain safeguards of the TRIPS agreement (like compulsory licences) raise doubts. To date Novartis has not made any official statement to support countries like Thailand or Brazil that have used these compulsory licences. Novartis is member of several pharmaceutical industry associations that made an active lobby to restrict the TRIPS agreement safeguards (compulsory licences, parallel importations) and their implementation in developing countries.
Is it true that Novartis case against the Indian Patent Acts does not have any consequences for the generic versions of medicines patented in India between 1995 and 2005?
It is not that simple.
India must protect patents on pharmaceutical products since the 1st of January 1995, the date when the WTO TRIPS agreement entered into force. India started to examine patent applications on medicines only since the 1st of January 2005.
The Indian Patents Act (section 11A, subsection (7)) has a special regime for generic versions of medicines if the initial patent application was made between the 1st of January 1995 and the 31st of December 2004 and if these medicines were already on the Indian market before the 1st of January 2005 (so-called “grandfather” clause). Generics that enter into this category can stay on the Indian market even if their pharmaceutical substance is patented. However, the Indian law requires that the producers of those generics then pay a “reasonable royalty” to the patent holder. This means additional costs for the generics producers. Moreover, the question of the exportation in other countries is not clear yet.
Above all the central point remains: through its challenge against the Indian Patents Act, Novartis tries to have patents on what is not patentable under the current law (new uses of known substances, new forms of known substances) and in consequence to block generics production of those medicines.
What is the problem with Glivec®?
Imatinib mesylate (Glivec®/Gleevec®) is a medicine against a rare form of cancer, the chronic myeloid leukaemia. It does not cure it, but prevents its development. The patients undergoing treatment must take these medicines in a continuous manner if they do not want to develop the illness and die.
Novartis decided to sell its medicine at a high price all over the world, including in poor countries: prices vary from about 25’000 US dollars to more than 50’000 US dollars per patient per year (minimum dosage). In India, Novartis sells Glivec® at the price of 1.44 million roupies (26’000 US dollars) per patient per year. Generic versions of this medicine cost in India about 96’000 roupies (2100 US dollars) per patient per year. Through its court case Novartis intends to challenge this generics competition and to ensure its control on the Indian market and abroad. This high price policy for a life-saving medicine against cancer is not acceptable.
Why Novartis Glivec® donation program is not a solution?
Novartis established a donation program for Glivec® that is administered by an US foundation, the Max Foundation. Novartis states that it is providing Glivec® freely to 7000 patients in India.
However this donation program is problematic.
First of all, it does not solve the problem of the prohibitive prices of Glivec® in developing countries. Essential and life-saving medicines should be sold at affordable and socially acceptable prices.
Moreover, it is estimated that there are between 20’000 and 30’000 new cases of chronic myeloid leukaemia in India every year. This exceeds by far the 7000 patients under free treatment. Participation conditions to this program are burdensome for the patients (regular medical and economical review to determine whether the patient is still eligible, travels to a limited number of prescription centres, etc.).
Above all, these donation programs are no sustainable solutions for chronic treatments. Novartis itself mentions that it runs this program within its capability. It cannot ensure a life-long treatment to the patients. Moreover, donation programs undermine the development of local assistance and solidarity structures which can better ensure a long-term follow-up and that can serve as ground for the development of a medical coverage for poor patients.
Why the uniform approach is problematic?
Through its legal challenge in India Novartis tries to impose an uniform price and patent policy in industrialized countries as well as in developing countries. This uniform policy does not take into account the level of development and the health situation in those countries. Patents are a balance between the incentive towards research that they are meant to provide and the public interest to have access to new medicines. To this end, it is important that the countries can define what level of intellectual protection is the most appropriate and that they use the flexibilities contained in the international agreements. It is exactly what Novartis fights when it challenges section 3(d) of the Indian Patents Act.
Novartis recognizes that only 50 Indian patients are currently paying its anticancer medicine Glivec® in India. It recognizes that only the minority of wealthy Indians is a market for the company. It is not acceptable: this means that in order to sell its medicine to a minority of Indian patients that can afford it, Novartis is ready through high prices and pressures to strengthen patents on medicines to endanger the access to medicines for the majority of Indian patients and beyond. A policy that harms the majority is not socially sustainable. Charity programs cannot solve this injustice.
Julien Reinhard, 8th May 2007
In January 2006 the Indian patent office rejected Novartis patent application for a life-saving medicine against rare forms of cancer (Glivec®/Gleevec® - imatinib mesylate). In May 2006 Novartis filed a case not only against the decision of the Indian patent office, but also against the provision of the Indian Patents Act upon which the decision is based. This attack against the Indian law goes far beyond the Glivec® case. The trial started in August 2006 in Chennai High court of Justice (ex-Madras, Tamil Nadu state) and is still going on. In 2007 both cases were separated. The case against the decision of the Indian patent office was transferred to the Chennai Appeal Board on Intellectual Property Rights. The case against the Indian patents act should be dealt soon by the Chennai High Court.
Why Novartis court case goes far beyond the Glivec® case?
By challenging the Indian Patents Act Novartis targets all medicines that could be in the scope of the law. Novartis court case goes far beyond the only anticancer medicine Glivec®. It will impact other medicines dealing with other illnesses.
What contains the section of the Indian patent act section that Novartis attempts to invalidate?
Section 3 (d) of the Indian Patents Act specifies the notion of invention, in particular for substances. The notion of invention determines if a product is patentable or not, that is if the patent holder can be granted a monopoly on the production and commercialization of a product during 20 years.
This section 3(d) has two consequences for pharmaceutical products. On one side it prevents the patenting of new uses of a known substance (for example a substance patented for its action against a certain type of cancer cannot be patented afterwards for its action against another illness). On the other side it prevents the patenting of new forms of a known substance that does not improve its efficacy. That is exactly the reason why the Indian patent office did not grant a patent for Glivec® (see below). This provision is aiming at preventing the multiplication of unsignificant or abusive patents.
Why Novartis Glivec® is patented in certain countries and not in India?
The conditions for granting patents depend on national legislations and vary between the different countries. In 1993 Novartis filed an application for a patent on imatinib mesylate for the treatment of cancer. At this time Novartis could not request for a patent in India, since the Indian law did not grant patents on pharmaceutical products. Since the entry into force of the World Trade Organization (WTO) agreements in 1995 India has the obligation to grant patents on pharmaceutical products. The country was allowed a 10 years transition period (until the 1st of January 2005) in order to implement this obligation.
In 1998 Novartis filed an application in India for a new form of imatinib mesylate (the ß-crystalline form of imatinib mesylate). An Indian cancer organization, the Cancer Patient Aid Association (CPAA), filed an opposition to this patent application. It argued that the 1998 patent application was about a new form of a known substance that does not improve the efficacy. In January 2006 the Indian patent office had a similar conclusion as the CPAA and rejected Novartis patent application. The Switzerland-based company opposes this decision and challenges the provision of the Indian law upon which this decision is based (section 3(d) ).
Why Novartis cases against the Indian Patent Acts are to be taken very seriously?
Novartis cases are concerning for two main reasons. Fistly they threaten access to essential and life-saving medicines in poor countries. Secondly they attack the recognized policy space WTO members can implement the WTO agreements in manner that is in conformity with their needs and their interests.
Why these actions threaten access to essential and life-saving medicines?
Medicines against HIV/AIDS provided a good example. Between 2000 and 2002 the competition of generic medicines (especially Indian generics) dramatically brought down the price of first-line antiretroviral medicines from more than 10’000 dollars per patient per year to less than 150 dollars per patient per year. In other words the more producers for one medicine, the lower the price.
With the entry into force of the WTO agreements in 1995 all the member countries have to grant a 20 year patent protection on pharmaceutical products, including India and the other large developing countries that have the capacities to produce generic medicines (Brazil, China for example). This new regime is mainly beneficial for big pharmaceutical companies that own or control most of the patents on new medicines.
This new international regime delays and complicates the introduction of cheap generic versions of new essential and life-saving medicines in developing countries. The invalidation of section 3(d) of the Indian Patents Act would strengthen this trend. It would pave the way for a multitude of insignificant and abusive patents.
This is true in India where the overwhelming majority of the population lives in poverty (more than half the population lives with less than one dollar per day). This is true for other developing countries since India is one of the most important exporters of cheap generic medicines in the world. Indian generics provide more than half of HIV/AIDS medicines used in developing countries.
Why these Novartis cases threaten the freedom left to States by the WTO agreements?
Novartis challenges section 3(d) of the Indian law arguing that it does not comply with the World Trade Organization agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS). It is a dangerous attack. Those provisions (non patentability of new uses of known substances and non patentability of new forms of known substances that do not improve their efficacy) are flexibilities recognized by the TRIPS agreements. That means that they are part of the legitimate policy space that WTO States have to implement the TRIPS agreements in a manner adapted to their development level and to their public health needs.
Section 3(d) was praised by the recent World Health Organisation Commission on Intellectual Property Rights, Innovation and Public Health chaired by Ms. Ruth Dreyfuss, former President of Switzerland and former Minister of health and research. To date, no WTO member, including Switzerland, has lodged any complaint in the WTO against these provisions. However, other developing countries have integrated these flexibilities or want to add them into their legislation (the Parliament of Philippines is discussing this issue at the moment). With its legal challenge Novartis aims at creating a precedent that would be extended to other countries.
Novartis declarations in favour of the use of certain safeguards of the TRIPS agreement (like compulsory licences) raise doubts. To date Novartis has not made any official statement to support countries like Thailand or Brazil that have used these compulsory licences. Novartis is member of several pharmaceutical industry associations that made an active lobby to restrict the TRIPS agreement safeguards (compulsory licences, parallel importations) and their implementation in developing countries.
Is it true that Novartis case against the Indian Patent Acts does not have any consequences for the generic versions of medicines patented in India between 1995 and 2005?
It is not that simple.
India must protect patents on pharmaceutical products since the 1st of January 1995, the date when the WTO TRIPS agreement entered into force. India started to examine patent applications on medicines only since the 1st of January 2005.
The Indian Patents Act (section 11A, subsection (7)) has a special regime for generic versions of medicines if the initial patent application was made between the 1st of January 1995 and the 31st of December 2004 and if these medicines were already on the Indian market before the 1st of January 2005 (so-called “grandfather” clause). Generics that enter into this category can stay on the Indian market even if their pharmaceutical substance is patented. However, the Indian law requires that the producers of those generics then pay a “reasonable royalty” to the patent holder. This means additional costs for the generics producers. Moreover, the question of the exportation in other countries is not clear yet.
Above all the central point remains: through its challenge against the Indian Patents Act, Novartis tries to have patents on what is not patentable under the current law (new uses of known substances, new forms of known substances) and in consequence to block generics production of those medicines.
What is the problem with Glivec®?
Imatinib mesylate (Glivec®/Gleevec®) is a medicine against a rare form of cancer, the chronic myeloid leukaemia. It does not cure it, but prevents its development. The patients undergoing treatment must take these medicines in a continuous manner if they do not want to develop the illness and die.
Novartis decided to sell its medicine at a high price all over the world, including in poor countries: prices vary from about 25’000 US dollars to more than 50’000 US dollars per patient per year (minimum dosage). In India, Novartis sells Glivec® at the price of 1.44 million roupies (26’000 US dollars) per patient per year. Generic versions of this medicine cost in India about 96’000 roupies (2100 US dollars) per patient per year. Through its court case Novartis intends to challenge this generics competition and to ensure its control on the Indian market and abroad. This high price policy for a life-saving medicine against cancer is not acceptable.
Why Novartis Glivec® donation program is not a solution?
Novartis established a donation program for Glivec® that is administered by an US foundation, the Max Foundation. Novartis states that it is providing Glivec® freely to 7000 patients in India.
However this donation program is problematic.
First of all, it does not solve the problem of the prohibitive prices of Glivec® in developing countries. Essential and life-saving medicines should be sold at affordable and socially acceptable prices.
Moreover, it is estimated that there are between 20’000 and 30’000 new cases of chronic myeloid leukaemia in India every year. This exceeds by far the 7000 patients under free treatment. Participation conditions to this program are burdensome for the patients (regular medical and economical review to determine whether the patient is still eligible, travels to a limited number of prescription centres, etc.).
Above all, these donation programs are no sustainable solutions for chronic treatments. Novartis itself mentions that it runs this program within its capability. It cannot ensure a life-long treatment to the patients. Moreover, donation programs undermine the development of local assistance and solidarity structures which can better ensure a long-term follow-up and that can serve as ground for the development of a medical coverage for poor patients.
Why the uniform approach is problematic?
Through its legal challenge in India Novartis tries to impose an uniform price and patent policy in industrialized countries as well as in developing countries. This uniform policy does not take into account the level of development and the health situation in those countries. Patents are a balance between the incentive towards research that they are meant to provide and the public interest to have access to new medicines. To this end, it is important that the countries can define what level of intellectual protection is the most appropriate and that they use the flexibilities contained in the international agreements. It is exactly what Novartis fights when it challenges section 3(d) of the Indian Patents Act.
Novartis recognizes that only 50 Indian patients are currently paying its anticancer medicine Glivec® in India. It recognizes that only the minority of wealthy Indians is a market for the company. It is not acceptable: this means that in order to sell its medicine to a minority of Indian patients that can afford it, Novartis is ready through high prices and pressures to strengthen patents on medicines to endanger the access to medicines for the majority of Indian patients and beyond. A policy that harms the majority is not socially sustainable. Charity programs cannot solve this injustice.
Julien Reinhard, 8th May 2007
