15 April 2013 Business pharmaceuticals

The Crab And The Patent

The SC ruling on Novartis’s cancer drug Glivec makes things just a bit easier for poor patients
The Crab And The Patent
Tribhuvan Tiwari
The Crab And The Patent
Five myths   ...and how they go bust

India is breaking international rules on intellectual property, preventing patents.   No. Brand-new drugs, drugs that are an improvement (and do not involve a known curative) and meds that enhance efficacy will get patented.
The decision puts research in India at risk and will prevent new drug patents.    India’s pharma market could be worth over $50 bn by 2020, a fertile and fast-growing market. Yet, R&D caters to worldwide, not local, demand.
India is obliged to grant Glivec a patent as it is patented in 40 countries.   India is not obliged to do so as it lawfully declined to grant pharmaceutical product patents at the time of invention of Imatinib.
India is just favouring its generic industry by imposing a strict legal burden on patenting.    Yes, this ruling will benefit Indian generic companies. Anywhere Glivec is not patented, companies can manufacture and export to India.
The Novartis decision undermines the global search for new medicines.   Nearly 75% of global drugs sales by dollar volume in 2011 was in Europe, North America, and Japan. Indian sales are less that 2% of global sales.

—From a note on the SC judgement by Prof Brook K. Baker.


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Sourabh Ghosh was a student when he was diagnosed with cancer.  This was 13 years ago, before Swiss drugmaker Novartis launched Glivec, its blockbuster leukemia therapy in India. Ghosh was put on available medicines, which ngos occ­assionally helped pay for, but times were hard, the bills hefty. Ghosh then moved to Switzerland for higher studies. There, Novartis’s drug donation programme got him Glivec free of cost for the first time. He then went to the US, where insurance covered the drug.

It is when Ghosh returned to India in 2008 that his problems with accessing Glivec, a medicine known to work wonders but which must be taken every day throughout life, began. In India Glivec costs Rs 1.25 lakh a month. This puts the drug firmly beyond the reach of even well employed patients like Ghosh, an assistant professor at IIT Delhi. So much so that Novartis (and all companies marketing “high-value” specialised drugs) rarely sell through regular retail channels. To keep commissions off stic­ker price, networks of agents sell expensive, branded drugs. “I was told that since my employer can afford to pay for Glivec, I could not qualify for Novartis’s free drug programme,” says Ghosh.

Today, 16,380 people get Glivec from Novartis as part of a project it started in 2002 and gets the non-profit Max Foundation to administer. The project was revamped in 2009, setting up a fin­ancial evaluation and “co-pay” system to screen beneficiaries. “No patient pays for more than 80 days of Glivec a year. Most get it completely free,” says its head, Viji Venkatesh. The foundation does not set or know the financial criteria for eligibility­—Venkatesh says IndiaBulls oversees that aspect.

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“Pharma firms tinker with drugs and repatent them, blocking generics forever. The ruling makes doing this illegal.”
D.G. Shah, Pharma analyst

Roughly 250 applicants seek its benefits every month through a select network of doctors and hospitals. Roughly a third, about 1,000 per year, are app­roved. For the rejected, there is only one way out. Like Ghosh, they switch to “generic” Glivec, the lower-cost, locally manufactured versions of Novartis’s wonder drug. Several Indian companies make generic Glivec, as it is not patented here, and Ghosh picked brand Veenat, made in Hyderabad by Natco. Natco Pharma’s general manager (legal) and company secretary M. Adinarayana says Veenat does good business, worth Rs 24 crore a year, with the MRP at roughly Rs 10,500 and more discounts to go.

Novartis’s India head Ranjit Shahani defends the programme and pricing strategy saying, “We have distributed Glivec worth more than $1.7 billion to patients free of charge since 2002.” Practically everyone—95 per cent of consumers—gets it absolutely free. He did not say how the patients are selected or what the financial criteria are.

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Against this backdrop, Novartis has struggled for 15 years to secure an Indian patent for Glivec. “If it had been approved, those diagnosed with two rare but dangerous forms of cancer would find a key treatment slip beyond reach,” says Y.K. Sapru, who heads the Cancer Patients Aid Association, a non-profit that assists cancer patients and opposed Novartis’s patent bid in court. Finally, the Supreme Court itself ruled on April 1 that India’s patent law is indeed compatible with international norms; that the refusal did not exceed flexibility allowed under the rules; and that product patents are entirely acc­eptable—it’s just that Glivec couldn’t make a strong enough case.

“The court’s decision discourages innovative drug discovery essential to advancing medical science for patients in need of new treatments,” says Shahani. “We will be cautious in our investments in India, especially with respect to innovative medicines.”

While Novartis chafes, health activists and ngos say the verdict has put paid to “evergreening” of drugs in India. “Patented medicines, after some tinkering, are re-patented by pharma companies keeping generic versions out indefinitely. This judgement makes it clear that is against the rules,” says D.G. Shah, a pharma analyst who runs Vision Consulting Group.

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“Our life-saving breakthrough for cancer, Glivec, has got patents in 40 countries. So the SC ruling is really disappointing.”
Ranjit Shahani, CMD, Novartis India

Four Indian generic drug-makers—Cipla, Ranbaxy, Natco and Hetero—also opposed the patent, which would have given Novartis 20 years of exclusive rights to make and sell Glivec’s latest version. For patients, the ruling is doubtless a blessing. “With cancer, even the well-off middle class finds it tough to cope. The poor suffer dramatic reversals in fortune after a diagnosis,” says Dr Ramesh Sarin, a leading oncologist at Apollo Hospitals in Delhi. Take Abdul Jabbar, a tempo driver and musician from Pugal, Rajasthan. He tots up several hundred kilometres taking his sick grandmother, too old to operate, by taxi to buy inexpensive anti-cancer generics in Bikaner. “Medicines cost Rs 5,000-6,000 and taxis cost half as much,” he says. So far, Jabbar’s grandmother’s symptoms, chiefly pain, are unabated except for a few minutes a day. They seem to be muddling through, with little help, changing the regimen at will once side-effects emerge. The cancer story gets starker in rural areas, as public health facilities dwindle and sup­er-drugs are rarely stocked, unless generics become accessible.

Pharma executives acknowledge behind the scene that the judgement will force new strategies for India across diseases, not just cancer. “Some companies like gsk are beginning to explore tiered pricing across a broader class of medicines, expressly in least developed and low-income countries, more cautiously elsewhere,” says Dr Brook K. Baker, Health Global Access Project, Northeastern University School of Law.

Drug monopolies have been challenged by Indian generic firms, which wouldn’t have happened without government support. Roche’s patent for a liver drug was withdrawn last year. Generics major Glenmark and Merck are in a patent war over diabetes drugs. Bayer’s challenge to Natco’s Nexavar (for liver cancers) was dismissed rec­ently. A bigger global battle will occur this summer as the EU, US and others talk about intellectual property. What matters for India is that an Abdul or Sourabh should equally qualify for every life-saving drug.

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