For a people's drug policy

The apex court judgement against Novartis clearly rules out frivolous patents, which is normally the rule in Big Pharma world tweaking existing mole

Two years after Independence, a committee was formed under the chairmanship of Justice Bakshi Tek Chand, a retired judge of the Lahore High Court, to suggest modifications to the patent regime of British India, making it people-oriented without impinging on research and innovation undertaken by commercial entities.

The panel observed that the patent act should clearly indicate how food and medicines are made available to the public at the “cheapest price”, commensurate with giving “reasonable compensation to the patentee”.

This remained the underlying guiding principle of a second panel, headed by Justice N Rajagopala Ayyangar, whose recommendations eventually led to the creation of the Patents Act, 1970 that came into force on April 20, 1972 and continued till 2005, when India finally opened its doors to product patents in accordance with commitments made at the World Trade Organisation.
But a safeguard was built into Section 3 which describes what are not inventions. Clause “d” of Section 3 stipulates new forms of a known substance cannot enjoy patent protection. The law makes it clear that salts (and other derivatives) of a known substance shall be considered the same unless they differ significantly in efficacy.

When the new regime dawned on April 5, 2005, there were 9000 patent applications in the mailbox, waiting to be examined by patent offices in accordance with the new law. Novartis’ ‘Gleevec’ (Imatinib Mesylate), a medicine used in the treatment of blood cancer and some types of tumours, was one of the first patents that came under scrutiny. It was in the news because of the sharp price difference – Rs 1,20,000 per patient per month for Novartis medicine and Rs 8000-12,000 for Indian copies. It also figured prominently in the Parliament debate that preceded the patent law amendment.

Patent examiner found Novartis arguments flawed and rejected the company’s claim of better efficacy, much to the joy of Indian generic manufacturers. The multinational challenged the ruling in the Chennai High Court. The legal wrangling went on for seven years. Finally the Supreme Court too did not find any merit in the Novartis plea.

The medicine (Imatinib) was invented by Jurg Zimmermann, one of the top oncologists of Novartis. The firm owned patents on this molecule in the USA and Europe. But controversy erupted when the company, in an “evergreening” tactic, did a minor tweaking of the molecule to produce a salt (mesylate) and claimed patent protection in India.

Evergreening means sequential accumulation of secondary patents on drugs, including alternative forms of active ingredients, new formulations, dosages and uses. Because secondary patents are filed later in the life of a drug (well after the primary patent), they can extend the monopoly enjoyed by pharmaceutical companies. Some scholars are of the opinion that innovative efforts associated with secondary patents are less substantial and there is broader agreement that secondary patents are less likely to satisfy traditional patentability criteria and, thus, are more vulnerable legally.

“The core issues were whether, and how, countries with newly introduced pharmaceutical patent regimes limit “evergreening” of existing molecules and patent portfolios,” says Bhven N Sampat, a professor of health policy and management in Columbia University in a policy paper that appeared in July 6 issue of Science last year.

The apex court saw through the Novartis arguments of imatinib mesylate having better bioavailability, solubility and more stability, which the company argued, led to improved efficacy. “One does not have to be an expert in chemistry to know that salts normally have much better solubility than compounds in free base form... in the case of a medicine that claims to cure a disease, the test of efficacy can only be therapeutic efficacy.

The court ruled Novartis did not produce any evidence to suggest beta crystalline form of the molecule has better therapeutic efficacy. “The patent applications appears to be a loosely assembled cut and paste job drawing heavily upon the Zimmermann patent,” the court observed.

While selling the drug, the company on the pack always declared it was selling imatinib mesylate and not its beta crystalline salt as it claimed in the court. Novartis successfully stopped Natco pharma from selling its product (Veenat) in the UK on the basis of Zimmermann patent but in Indian courts and patent office, it claimed patent on the beta crystalline salt saying it was different than Zimmermann patent.

“The case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent on Imatinib Mesylate,which would otherwise not be permissible in this country,” the SC said.

Frivolous patents

“The judgement clearly rules out frivolous patents, which is normally the rule in Big Pharma world – tweaking existing molecules to show new use of drugs – typically called evergreening. Since India is a pharmacy of the global south now, this will improve affordability of life saving medicines,” said Shakti Selvaraj, a researcher on pharmaceutical economics at Public Health Foundation of India. '
“Evergreening strategy will definitely be out of the drawing board for India,” said Ajaykumar Sharma, associate director in the market research firm, Frost and Sullivan.

Reacting to the SC judgement, Novartis said it would take cautious steps in investing further and may even consider shifting its research from India. What the company did not say is, it does not have any research base in India in the first place. “In the absence of any checks in the account books, pharmaceutical companies include all types of expenses within R&D which range from quality control and clinical trial expenses to rent and staff salary. And still they get substantial tax benefits because all these expenses are shown as R&D,” said C M Gulhati, a former consultant to World Health Organisation and editor of an industry journal titled ‘Monthly Index of Medical Specialities’.

This, however, is not the end of the road for incremental innovation in pharma industry as being portrayed by a section of activists. “We have held that the subject product, the beta crystalline form of imatinib Mesylate does not qualify the test of Section 3 (d) of the Act but that is not to say that Section 3 (d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgement to mean that Section 3 (d) was amended with the intent to undo the fundamental changes brought in the patent regime. That is not said in this judgement,” says the ruling.

India, pharmacy of the developing world

Indian generic drug companies are a major source of affordable medicines in around 200, mostly developing countries all over the world. 

Here’s a look at how many lives depend on India all over the world:

*85 pc of Doctors Without Borders, patients depend on Indian generic AIDS medicines,
* 50 pc of PLWA (People Living With Aids) in the developing world depend on Indian generics,
* 67 pc of medicines exports from India go to developing countries,
* Approximately 50 pc of the essential medicines that UNICEF distributes in developing countries go from India,
* 75-80 pc of all medicines distributed by the International Dispensary Association (IDA) are manufactured in India,
* In Zimbabwe, 75 pc of tenders for medicines for all public sector health facilities are from India.

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