India Cancer Patients Seek To Use Courts For Access To Patented Drugs

By Tatum Anderson for Intellectual Property Watch
One of the most vocal voices for the interests of cancer patients in India says it will use the courts to force the Indian government to declare cancer a national emergency, in an attempt to make cancer drugs affordable to sufferers.

The Cancer Patients Aid Association (CPAA) wants the Indian government to issue permits, called compulsory licences, for a number of drugs it has deemed unaffordable. Such permits would allow generic pharmaceutical companies to manufacture the drugs instead of the patent holders. It believes that the prices would then drop considerably.

Under Indian patent law, no one can apply for a compulsory licence for the first three years after a patent has been granted, unless the government declares one of four emergency criteria: a national emergency, extreme urgency, a case for public non-commercial use or a patentee has employed anti-competitive practices. (After three years anyone can apply for a licence under much broader set of criteria.)

The idea, said Y K Sapru, CEO and founder of the 38-year-old organisation, is to establish the exact meaning of a national emergency. “The act says a compulsory licence can be given when there is a national emergency, then the issue of what that national emergency is can be debated.”

The CPAA thinks cancer is a national emergency because cancer drugs are so expensive that Indian cancer sufferers die because they cannot afford them. Some drugs can cost several thousand or even hundreds of thousands of rupees per month, while many sufferers live on less than 40 rupees (about $1) per day, it said.

“Our contention is that the manufacturers are pricing the products at an international price,” said Sapru. “And as 98 percent of India’s population is not covered by any form of health insurance, many who suffer from the cancer will die because they won’t have access to the life-saving drugs.”

The association has compiled a list of 20 medicines it feels are vital but prohibitively expensive for most cancer patients (see table below). They include drugs made by international companies like Pfizer and Novartis. Interestingly, the list also includes drugs made by some domestic generics companies.

First, CPAA plans to send a letter shortly to the country’s Ministry for Health and Family Welfare requesting that it declare such an emergency. Later it will turn to the courts if no action is taken.

The CPAA’s actions are taken seriously in India. It has filed formal oppositions against countless patent applications at the Indian patent office, negotiated cheaper prices for some drugs and was a key member of the opposition in a court case brought by Swiss manufacturer Novartis last year (IPW, Public Health, 7 August 2008).

The strategy is a considerable departure from CPAA’s traditional role of fighting individual patents – like the one filed by Novartis – on the basis of frivolous patenting.

That method is used throughout the industry. India’s generic manufacturer Cipla is currently arguing that it should be able to manufacture copies of Swiss manufacturer Roche’s Tarceva on this basis. Cipla last week won the right to continue manufacturing the drug until the case is settled.

Calling for price controls and compulsory licences is essentially a fast-track way of trying to reduce prices of several drug prices en masse, rather than the lengthy process of opposing patent applications one at a time.

The plan is to take this particular compulsory licence initiative as far as it will go, to the Supreme Court if necessary, said Sapru. “If they [the health ministry] don’t think that it is a national emergency then we will talk about the constitutional rights of a human being above any other right that the constitution will give because he owns the patent,” he said.

Tahir Amin, a lawyer from I-MAK specialising in Indian public health, said he believes that CPAA could mount a challenge under the constitution, specifically under Article 21 – the right to life.

The criteria under which compulsory licences can be issued are being hotly debated. World Trade Organization rules on intellectual property rights have built-in flexibilities in public health situations. Nevertheless, Thailand’s decision to grant compulsory licences for cancer drugs on the basis of public non-commercial use within the country’s public sector health system has drawn huge criticism from those who believe compulsory licences should only be used as a last resort.

At home, India may be heading for more controversy as its patent office considers whether to grant a compulsory licence to Indian generic company Natco that would allow it to export a copy of Roche’s cancer drug Tarceva, to Nepal.

Opponents say although compulsory licences were designed for use in national emergencies, cancer should not be classed as one.

Guy Willis, a spokesman for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) which represents originator companies, told Intellectual Property Watch that cancer patients do not have access to adequate drugs because the Indian government has not invested enough in its public healthcare infrastructure.

This is not a problem that emergency compulsory licences can fix, he said. “It is the systematic failure of the Indian government to give enough resources and I don’t think you can classify a systemic failure as an emergency,” he said. “It implies something that is very deep-seated and is not going to be addressed by emergency measures.”

In addition, Willis adds that enabling generic manufacturing does not necessarily lead to more affordable prices. “The generic versions of cancer drugs are cheaper perhaps than the originator versions but the cost of a year’s treatment is still several multiples of the average Indian salary. They don’t improve access,” he said.

CPAA’s list of unaffordable drugs contains medicines made by generic companies including, ironically, Natco, which has applied for a compulsory licence under another provision within the Indian law.

CPAA’s Sapru said the association also will be trying to convince the Indian government to apply existing pricing control regulations to drugmakers producing cancer drugs (such controls have already been imposed on Cipla for another drug). “We are not even making a distinction between the multinationals and the generics because there are some generic drugs which are also expensive,” he said.

Tatum Anderson may be reached at info@ip-watch.ch.

The Cancer Patients Aid Association’s List of 20 Vital but Prohibitively Expensive Cancer Medications

Drug Name	Chemical Name	Indications	Company Name
Herceptin	trastuzumab	For the treatment of certain types of breast cancer.	Genentech
Mabthera	rituximab	For the treatment of non-Hodgkins lymphoma that has relapsed or has not responded to other treatments.	Roche
Rituxan	rituximab	For the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin’s lymphoma.	Genentech
Neupogen	filgrastim	To treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions.	Amgen
Erbitux	cetuximab	To treat cancers of the colon and rectum as well as head and neck cancer.	ImClone Systems
Avastin	bevacizumab	For metastatic carcinoma of the colon or rectum, for first-line treatment of patients non-squamous, non-small cell lung cancer, for certain kinds of breast cancer.	Genentech
Lenalid	lenalidomide	For the treatment of Myelo Dysplastic Syndrome (MDS), which is a condition resulting in a low amount of red blood cells.	Celgene
Xeloda	capecitabine	A chemotherapy drug that is given as a treatment for some types of cancer, including advanced bowel cancer or breast cancer.	Hoffman-LaRoche
Geftinat	geftinib	For the treatment of lung cancer, particularly non-small cell lung cancer.	Natco Pharma Limited
Tarceva	erlotinib	For the treatment of certain kinds of lung cancer and pancreatic cancer.	OSI Pharmaceuticals
Fludara	fludarabine	For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment.	Cerner Multum
Zoladex	goserelin acetate	Relieves the symptoms of advanced prostate cancer in men and advanced breast cancer in premenopausal women.	Astra-Zeneca
Leucovorin	leucovorin	Indicated after high-dose methotrexate therapy in osteosarcoma.	Roche
Bexxar	tositumomab and iodine 1131 tositumomab	For the treatment of patients with specific types of non-Hodgkin’s lymphoma.	Corixa and GlaxoSmithKline (co -developed)
Hycamtin	topotecan	For the treatment of relapsed small cell lung cancer.	GlaxoSmithKline
Iressa	geftinib	To treat several types of lung cancer.	Astra-Zeneca
Arimidex	anastrozole	Blocks the use of estrogen by certain types of breast tumors that need estrogen to grow in the body; used in postmenopausal women.	Astra-Zeneca
Sutent	sunitinib	For the treatment of renal cell carcinoma, and imanitib-resistant gastrointestinal stromal tumor.	Pfizer
Glivec	imatinib	For the treatment of chronic myelogenous leukemia, gastrointestinal stromal tumors, and a number of other malignancies.	Novartis
Femara	letrozole	For the treatment of postmenopausal women with hormone receptor-positive early breast cancer.	Novartis