Friday, May 19, 2006
***INTERNATIONAL ACTION ALERT***
Support Indian People Living with HIV/AIDS in Opposition to Gilead's Patent
Application:
Take action today: Tell the government of India to reject the patent application by Gilead for a key AIDS drug, tenofovir, because it is not patentable under Indian law.
Background: On May 9 2006, the Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People filed an opposition at the Delhi Patent Office to Gilead's patent request for a key AIDS drug: tenofovir disoproxil fumarate (TDF). (Gilead's brand name for TDF is Viread.)
TDF is a crucial AIDS drug that is urgently needed in the developing world, particularly for people who have become resistant to older drugs and need second-line HIV treatment at an affordable price. A patent monopoly on TDF in India would prevent generic competition, blocking access and keeping prices high in India, sub-Saharan Africa and throughout the developing world. Future generic production of fixed-dose combination pills containing TDF would also also be blocked.
TDF is not patentable in India--TDF consists of a salt (fumaric acid) formed out of a known compound (tenofovir disoproxil). The process of forming a salt out of an existing compound is common practice within the pharmaceutical industry. TDF does not meet the standard for patentability under Indian law, which states that "new forms of a known substance" such as a salt, which does not increase the efficacy of the known substance, are not inventions, and are therefore not patentable.
Now that the opposition has been filed, the Government of India needs to feel pressure from around the world, particularly from people living with HIV/AIDS in countries that desperately need access to generic TDF.
Upcoming events, like the UN General Assembly Special Session (UNGASS) AIDS Review May 31-June 2 in New York are key opportunities to send a message to the Government of India and the international community that Gilead's frivolous patent application must be rejected--TDF is not patentable in India.
Take action today: Call, fax and e mail Indian government representatives and tell them India should NOT grant a patent on TDF.
1. Ms K. Sujatha Rao
Director General, National AIDS Control Organization
Ministry of Health & Family Welfare
Government of India
9th Floor, Chandralok Building
36, Janpath
New Delhi 110001
India
email: sujatharao@yahoo.com
asdg@nacoindia.org
tel: +91 11 233 25331
fax: +91 11 2372 1746
2. Dr. Manmohan Singh
Prime Minister
The Prime Minister's Office
South Block, Raisina Hill,
New Delhi 110 011
tel: 91 11 230 12312
fax: 91 11 230 19545 / 91 11 230 16857
Key messages:
Tell Ms Sujatha Rao and Prime Minister Monmohan Singh's offices:
Who you are and where you are calling from, particularly if you are in a country that imports generic AIDS drugs from India;
That in order to ensure the sustainability of AIDS programs in India and around the world, the TDF patent should NOT be granted; Gilead's patent application is frivolous and TDF is not patentable
Do not be mislead by a Gilead offer to do "voluntary licensing" of TDF to a generic Indian manufacturer: TDF is not patentable in India, so a promise of voluntary licensing is irrelevant, and an attempt to distract from the bottom line: the patent SHOULD NOT be granted
Their decision on whether or not to grant a patent on TDF will have an international impact on the availability and affordability of this key medicine
People living with HIV/AIDS and AIDS organizations are watching them closely, and call on them NOT to grant a patent for this critical drug. TDF does not meet the standard for patentability according to the India Patent Act; furthermore, on health grounds alone this patent should not be granted.
For more information: Below are briefing notes and a press statement from Medecins Sans Frontieres.
----------------BACKGROUND MATERIALS----------------
MSF Supports Opposition to Gilead's tenofovir Patent Application in India
Patenting Tenofovir Would Set Dangerous Precedent for Global Access to Newer Essential Drugs:
New Delhi/ Geneva, 10 May 2006 --- The medical humanitarian organization Medecins Sans Frontieres (MSF) is today expressing its support for Indian civil society groups in their battle against a patent application by Gilead Sciences for the key AIDS drug tenofovir. People living with HIV/AIDS in India opposed the patent application yesterday on the grounds that the drug consists of a previously known compound, and should not be considered an invention according to India's Patent Act.
If Gilead were granted this patent, generic production of tenofovir in India, where a generic version has been marketed since 2005, could be prevented until 2018, and any existing production would be in jeopardy. In addition, future generic production of fixed-dose combination pills containing tenofovir would also be blocked. Such combination drugs have had a major impact in helping scale up global AIDS treatment by simplifying it.
“Granting this patent would set a dangerous precedent. Limiting production of tenofovir and that of other newer essential drugs to a single company keeps prices high because generic competition is blocked,” said Ellen t Hoen, Director for Policy and Advocacy at MSF’s Campaign for Access to Essential Medicines.
Access to tenofovir in resource-poor settings is extremely limited. While Gilead, the patent-holder in most developed countries, has announced that it will offer the drug at a discount to 97 developing countries, the company has been extremely slow in making the drug available in these countries.
In MSF’s HIV treatment project in Khayelitsha, South Africa, where nearly 4,000 patients receive antiretroviral drugs, the difficulty in accessing tenofovir has resulted in only 40 patients with only the most urgent needs receiving the drug.
”We need tenofovir for more and more of our patients, but the supply from Gilead has simply been too unreliable, so we can't put more patients on it,” said Dr. Eric Goemaere of MSF in South Africa. “We have all been waiting impatiently to get tenofovir as a generic from India. Our project is a microcosm for what is to come elsewhere, and it is clear the world desperately needs more sources of this essential drug,” he added.
Tenofovir (tenofovir disoproxil fumarate TDF) is commonly prescribed as part of first-line antiretroviral treatment in the US and Europe. It is increasingly needed in resource-poor settings, both for patients starting treatment for the first time, because it leads to fewer side effects than other commonly used drugs, and for those patients who have been on therapy for several years. The latest World Health Organization (WHO) antiretroviral treatment guidelines recognize the importance of tenofovir for resource-limited settings, recommending its use in first and second-line regimens. But at the same time as tenofovir's importance is being underlined, access to it may be severely restricted.
The Indian Network for People Living with HIV/AIDS, represented by the Alternative Law Forum, Bangalore registered their opposition to the patent at the Delhi patent office yesterday. The public interest lawyers are arguing that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is a common practice within the pharmaceutical industry, and should not be considered patentable under Indian law.
“For many of us living with HIV/AIDS, newer drugs like tenofovir offer new hope of continuing treatment. With patents interfering with our lives we have no choice but to oppose them,” said Loon Gangte, from the Delhi Network of Positive People, speaking at a press conference in Delhi.
Under the 2005 Indian Patents Act, anyone can submit comments in opposition of a patent before the patent office decides to grant or reject it. Cancer patients and generic drug manufacturers recently opposed a Novartis patent application for Gleevec (imatinib mesylate), an anti-cancer drug, on the grounds that the application claimed a new form of an old drug. The patent was subsequently rejected by the patent office.
MSF has been providing antiretroviral treatment to people living with HIV/AIDS since 2000. Over 60,000 patients currently receive ARVs through MSF worldwide.
----------------------------------------------------------------------------------------------------------
Briefing Note:
May 2006
Opposition to tenofovir patent application in India:
The Indian Network for People Living with HIV/AIDS (INP+), the Delhi Network:
of Positive People are opposing a patent application filed by Gilead Sciences in India on tenofovir disoproxil fumarate (TDF), a key AIDS drug. The organizations represent people living with HIV/AIDS in developing countries, and officially registered their pre-grant patent opposition at the Delhi patent office on May 9th 2006.
The Alternative Law Forum, Bangalore providing the legal support to INP+ argues that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is common practice within the pharmaceutical industry, and should not be considered a new invention.
Medecins Sans Frontieres (MSF) supports Indian civil society groups in their legal battle of opposing the TDF patent application, as it wants to be able to access and use the drug in its HIV/ AIDS treatment projects around the world.
Tenofovir - A Crucial Drug for AIDS Treatment:
TDF is clearly emerging as an important option for patients starting AIDS treatment for the first time, and those who have been on antiretroviral treatment therapy (ART) for some time and require access to newer drugs due to occurrence of toxic effects or as they develop resistance to first-line drug regimens. Because there are fewer known side effects associated with the use of TDF in adults, it is commonly prescribed in the US and Europe, where the drug is widely available at a priced of over USD 5,000 per patient per year.
In its HIV/AIDS treatment projects in South Africa, MSF has been trying to access TDF, as patients who experience long-term side effects from other drugs need to be switched to a TDF-based regimen. MSF would like to be able to provide TDF to its patients who urgently require the drug.
The updated World Health Organization (WHO) ART guidelines for HIV/AIDS treatment in developing countries recognize the importance of TDF and recommend the drug for first and second-line regimens.It is ironic that at the same time as the WHO is underlining the importance of and recommending TDF, there is a risk that it may remain inaccessible to many patients in developing countries, if this patent were granted.
Very Limited Access to Gilead’s tenofovir in Developing Countries:
MSF has experienced serious difficulties in trying to access TDF in countries where it operates, due to the fact that the drug is not widely registered for use and marketed in developing countries. Gilead, the only producer of TDF until 2005, had announced greater availability of TDF in 2002 with a preferential price for low-income countries. So far Gilead has made limited progress in making the drug widely available.
Another barrier to TDFs use is its high cost in countries not eligible for the discounted price of $208 per patient per year. Gilead has made no offer to provide TDF at a discounted price to middle-income countries like Brazil, India, Thailand and China. In developed countries, Gilead's price for TDF is $ 5718 per patient per year.
If Tenofovir is Patented in India, Generic Production is at Risk:
Indian pharmaceutical companies have been working on developing generic versions of TDF. A generic version of TDF is already being marketed in India. Yet, if Gilead were granted a patent on TDF, such generic production of the drug in India would be likely to stop, making prospects of accessing generic versions of the drug worldwide slim, as many developing countries rely on Indian generics. A TDF patent in India would lead to Indian drug manufacturers having to withdraw their generic TDF from the market, and any other generic production of the drug would be effectively blocked until 2018.
In addition, a patent on TDF would further compromise ART in developing countries as it would act as a barrier for developing fixed-dose combinations, or FDCs, which combine two or three drugs in a single pill, such as TDF/3TC and EFV. Because FDCs significantly reduce pill burden and increase adherence to treatment, they have become the backbone of scaling up AIDS treatment in developing countries. A patent on any of the drugs comprising the FDC makes it impossible for a generic company to produce the
FDC. Despite the fact that antiretrovirals like lamivudine (3TC) and efavirenz (EFV) are not under patent in India, Gilead's patent on TDF would prevent Indian generic companies from developing this much-needed FDC.
AIDS Treatment Budgets are Likely to be Affected if TDF is Patented
Developing countries scaling up AIDS treatment programs under the WHO 3 by 5:
Initiative will be seriously affected. Currently 1.3 million people living with HIV/AIDS (PLHA) are accessing treatment under the 3 by 5 Initiative. In India, the National AIDS Control Organisation (NACO) provides 20,000 PLHAs with antiretroviral therapy. Unavailability of ARV drugs included in the WHO ART treatment guidelines for resource poor settings may impact the political will of developing countries to provide HIV/AIDS treatment.
The international medical humanitarian agency MSF began providing HIV/AIDS treatment in 2000 and is currently providing it to over 60,000 patients in nearly 30 countries including Thailand, South Africa and India. MSF hopes to source TDF from India in the near future, as Indian manufacturers are the source of 84% of antiretrovirals MSF uses in its AIDS treatment projects across the globe.
BACKGROUND ON INDIAN PATENT ACT AND PRE-GRANT OPPOSITIONS:
Indian Patents: One Year On:
About this time last year, the Indian Parliament approved the country's new Patent Act, thereby allowing pharmaceutical products to be patented in India. This new law put some serious constraints on generic competition but also included some potentially important features such as "automatic licensing" and the possibility for anyone to object to a patent before it is granted.
Although the law was not passed until last year, from as early as 1995, companies could start filing patent applications for pharmaceuticals in India with the patent offices. The Indian patent office started to examine these thousands of patent applications last year after the revision of the Indian patent law. Many patent applications for antiretroviral drugs (ARVs) such as tenofovir (tenofovir disoproxil fumarate TDF) and Combivir (zidovudine/lamivudine, or AZT/3TC) are waiting to be approved or rejected.
First Patent Granted in India in March 2006:
On March 3rd 2006, Roche announced it was "becoming the first pharmaceutical company in India to receive a product patent under the new patent regime". The patent was granted on peginterferon alfa-2a (Pegasys), a new generation hepatitis C therapy.
Because no generic versions of this product are being manufactured yet, any generic competition will be impossible until the new patents term runs out in 2017 unless the Indian government grants a compulsory license to another pharmaceutical company. Thus, this drug will only be available as a Roche product at about $5,000 per six-month treatment course, a price that obviously rules out the use of this drug in developing country settings.
Not all Patent Applications Lead to Patents:
Not all patent applications are valid. Many of the applications do not claim real inventions and therefore should not deserve a patent. Many patent applications are for a new use of old drugs, or simply for derivatives of old drugs or combinations of old drugs. The Indian Patent Act, if rigorously interpreted, provides several grounds for rejecting a patent, for instance if the pharmaceutical substance claimed is only a new form of a known substance.
Gleevec Patent Application was Rejected
On January 25th 2006, the Indian patent office rejected Novartis' patent application for its anti-cancer drug imatinib mesylate (Gleevac) on the grounds that the application claims a new form of a known substance (Novartis’ patent application was related to a particular crystal form of the salt of imatinib mesylate). The rejection was a major victory for the
Cancer Patient Aid Association of India and some Indian generic companies, which had both submitted a pre-grant opposition to the patent office. The rejection of the Gleevac patent gives reason for optimism.
Essential Drug Patents in the "mailbox" Waiting for Examination:
One of the next on the list for examination by the Indian Patent Office is Gilead’s patent for tenofovir disoproxil fumarate (Viread), as the patent application was filed with the Delhi Patent office in 1998. The Lawyers Collective, in collaboration with the Alternative Law Forum, is currently drawing up an extensive list of drugs based on medical needs and for which patent applications are pending in India.
What is the Pre-Grant Opposition System?
Due to the volume of patent applications, patent examiners often miss information related to the patent application under consideration about it being just an improvement of an old drug and not a new chemical entity. If attention is brought to information that shows that the patent application is for a derivative or a new use of a known drug, the possibility of invalid patents being granted is reduced. Opposing patent applications in the case of ARV drugs is feasible, as research has indicated that most of the patent claims for patent protection are for known pharmaceutical substances like polymorphs, salts, and combinations.
Anyone can bring such information to the attention of the patent controller through the pre-grant opposition process (as provided under Section 25 of the Indian Patents Act), and generic companies have already filed a number of pre-grant oppositions. In addition to companies, patient groups (INP+ and other state networks) and public interest organisations are also working to oppose patent applications for essential drugs.
On March 30th 2006, The Indian Network for People Living with HIV/AIDS (INP+), the Manipur Network of Positive People (MNP+), represented by the Lawyers’ Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by GlaxoSmithKline (GSK) for Combivir, a fixed-dose combination of two essential AIDS drugs zidovudine/lamivudine. The opposition is based on technical and health grounds. Clearly concerned that the granting of such a patent will increase the burden on developing countries already struggling to treat patients, INP+ objected to the Combivir patent application on the ground that it does not claim a new invention but instead simply the combination of two existing drugs.
