TWN Info Service on Intellectual Property Issues (Sept06/03)

12 September 2006

GSK WITHDRAWS COMBIVIR PATENT APPLICATION FROM INDIA AND THAILAND

Please find below a selection of the latest news stories on the withdrawal of combivir patent application in India and Thailand. Combivir, a fixed dose combination of two existing drugs, zidovudine and lamivudine, is used in the first line of treatment and is the backbone of AIDS therapy.

This patent application was opposed in India through pre-grant opposition by a group of people living with HIV AIDS while civil society in Thailand has been protesting against the patenting of this crucial treatment as it would deny thousands of people living with HIV AIDS the necessary medication. The challenge and opposition has primarily been on the grounds that Combivir is merely a combination of  two existing drugs and thus there is nothing “novel” or “inventive” about Combivir itself and thus the treatment should not be patented.

In any case the patent application has now been withdrawn. Following this development, patent offices worldwide are encouraged to re-examine the patent application on Combivir (where it has been granted and refuse the application, where it has not been granted) on the basis that it does not fulfill the patentability criteria. Attached is the patent opposition on Combivir that was filed in India by civil society groups. It states clearly the grounds for opposition.

The withdrawal of the patent application means that manufacturing countries such as India and Thailand can continue with their production and export of those drugs.

Best Wishes
Sangeeta S.
Third World Network
Geneva

GSK withdraws Combivir patent plea

P.T. Jyothi Datta

Withdrawal syndrome

Combivir, a fixed dose combination of two existing drugs, zidovudine and lamivudine, is used in the first line of treatment and is the backbone of AIDS therapy Patient networks hope that Combivir's withdrawal will set a precedent for other AIDS drugs such as abacavir, tenofovir, nevirapine syrup and atazanavir which are also under challenge.

Mumbai , Aug. 20

Drug-maker GlaxoSmithKline (GSK) has confirmed that it has withdrawn its patent application in India for the AIDS-drug Combivir. The move sets a precedent and comes even as local HIV/AIDS-patient networks challenge patent applications on a clutch of AIDS drugs at the Indian Patent Office.

Patient networks had in March opposed the multinational's patent application on Combivir at the Patent Office in Kolkata. But GSK denies that it was pressure from these networks that forced the withdrawal.

The withdrawal is a "routine business decision" and was done months prior to these demonstrations, GSK Pharmaceutical's spokesperson in India told Business Line confirming the development.

Last week, GSK said in a communiqué from Thailand: "In June 2006, GSK instructed its agents in Thailand and India to withdraw this patent application. This means that GSK has no patent protection on Combid/ Combivir in Thailand or India, and is not seeking any."

Combivir is used in the first line of treatment and is the backbone of AIDS-therapy. It is a fixed-dose combination of two existing AIDS drugs - zidovudine and lamivudine.

GSK's patent application on Combivir was opposed in India on technical and health grounds by the Manipur Network of Positive People, under the aegis of the Indian Network of People Living with HIV/AIDS.

But the GSK official said that conditions prevailing in India earlier merited the patent application. Subsequently, as part of a constant review, the decision was taken to withdraw the application, he added.

GSK's decision to withdraw the patent application is a good development and it should stick to its commitment, said a representative with the access- programme of international humanitarian group Medecins Sans Frontieres (Doctors without Borders).

GSK should officially intimate other stakeholders in India, such as the positive-people's networks on the withdrawal, as it has done in Thailand, the representative said.

Meanwhile, legal-representatives for the patient-networks say that their enquiries at the Patent Office in Kolkata have not come up against an official intimation on the withdrawal from GSK.

But patients are hoping that the withdrawal sets a precedent and spills over to other AIDS drugs such as abacavir, tenofovir, nevirapine syrup and atazanavir whose patent applications are also being challenged by patient-networks.

But for starters, they are reserving their celebrations till they get an official intimation from GSK on the withdrawal of Combivir's patent application.

GlaxoSmithKline withdraws AIDS drug patent plan in Thailand, India

BANGKOK (AFX) - British pharmaceutical firm GlaxoSmithKline has dropped its controversial application to patent a key AIDS drug in Thailand and India, the company and international HIV campaigners said.

Glaxo, which introduced the drug Combid to Thailand four years ago, told AFP that it had informed the Thai government of its intention to withdraw the patent applications for Combid in Thailand earlier this month.

'We already informed Thai officials of our decision to withdraw the application,' a Glaxo spokeswoman in Bangkok said.

A letter was submitted to the Department of Intellectual Property a day after local and international AIDS campaigners and some 500 HIV patients staged a protest in front of the Glaxo office in Bangkok on August 7.

'The letter passed through its legal advisor in Thailand, it did not explain the reason why Glaxo withdrew its application,' Kannikar Kijtiwatchakul of Doctors without Borders told AFP.

'But in fact, Glaxo knows it is not qualified to patent the drug which is not newly invented.'

The drug combines existing medications into a single pill, making it easier for patients to comply with their treatment programs.

But according to the AIDS Access Foundation, the medication does not merit a patent because combining existing drugs does not constitute a new invention.

Thailand's Government Pharmaceutical Organization has produced and distributed its own generic version at one-fifth the price for years.

Of the 600,000 Thais with HIV, about 80,000 are receiving treatment. Some 18,000 new cases were reported last year.

Thailand's treatment program has been widely credited with slashing the number of deaths from AIDS by about 75 percent last year.

A World Bank report Wednesday called Thailand's program 'a useful beacon for other developing countries' seeking to provide treatment to people with HIV.

PRE-GRANT REPRESENTATION BY WAY OF OPPOSITION UNDER SECTION 25(1) OF THE PATENTS ACT 1970(39 OF 1970) AND RULE 55 (1) OF THE RULES AS AMENDED BY THE PATENTS (AMENDMENT) ACT, 2005