Gilead’s local alliances on Hepatitis C drug Sovaldi set for a rough ride

California-based Gilead is set to stir the pot as it forges India-based alliances on its Hepatitis C drug sofosbuvir.

Multi-company agreements on the drug are expected to be announced later today.

Never before has a Hepatitis C drug attracted so much global attention. High-pitched debates on breakthrough drugs that are beyond the reach of patients because of their exorbitant prices – is a space that has in the past been occupied by cancer and HIV/AIDs drugs.

So why is Gilead’s sofosbuvir, marketed under the brandname Sovaldi, creating such a stir?

Sofosbuvir is the first of several oral hepatitis C drugs and it came into Gilead’s fold after it decided to buy Pharmasset for over $11 billion in late 2011. And it is known to be more effective, less toxic and easier to use.

The drug is pegged at $84,000 in the US for 12 weeks, though newer versions threaten to go higher in price.

In February, Gregg H Alton, Gilead’s Executive Vice-President, Corporate and Medical Affairs had told Business Line, they were in talks with a clutch of Indian companies to bring in sofosbuvir at about $2,000 for 24 weeks.

Gilead has in the past tied up with Mylan, Strides, Emcure and Ranbaxy for other drugs in India.

But this “alliance route” is unlikely to be smooth for Gilead’s sofosbuvir, as it is greeted in India by at least a handful of oppositions filed at the Indian Patent Office. These pre-grant oppositions are against granting patent protection to sofosbuvir.

A pre-grant opposition is a feature in the amended Patents Act that allows interested parties to oppose a patent application before a decision is taken by the Patent Office to grant or deny a patent.

A patent gives an inventor 20 years of exclusivity to market a product. And public health advocacy groups fear that such exclusivity could lead to monopolies in terms of pricing, making it unaffordable for a patient.

Opposed

In November last year, legal group I-MAK (Initiative for Medicines, Access & Knowledge) had filed a pre-grant opposition at the Kolkata patent office.

Gilead’s patent application had been opposed on the grounds that it was an “old science, known compound,” Tahir Amin, lawyer and director of US-based I-MAK.org, had then said.

“India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it,” he had added.

A slew of oppositions followed against sofosbuvir, from the Delhi Network of Positive People, the Indian Pharmaceutical Alliance (a forum of large Indian drug companies) and Hyderabad-based drugmaker Natco.

The Gilead representative, had in his earlier interaction with the correspondent said, that they would defend their patents, even as they push for local production of the product to help bring down prices.

But, the pitch gets further queered, if the Indian Patent Office rules against giving Gilead a patent on this drug. This would allow more Indian drug companies to make the drug, even without a tie-up with Gilead. What happens to Gilead’s local alliances on this drug, in such a situation, is something that will then play out in full public display.

Strangle exports?

While such a day is in the realm of speculation, public health advocates fear that voluntary agreements between innovators and generic drugmakers could “strangle” exports from Indian companies – as the terms of such agreements are seen to be restrictive.

Based on the terms of the licence, it is clear Gilead is ensuring that its main competitors from India are tied up and cannot supply middle-income countries excluded from the licence, which is where there is significant demand/ economies of scale for the generics and where access is hardest for low-income patients, explains Amin.

Such voluntary licensing deals are “a slow strangulation” of generic medicine supplies from India, where patents are involved. As generic companies get locked into such deals, public health groups will have to find alternative generics suppliers who are willing to supply to excluded countries where there are no patents/ patents pending and or willing to challenge patents, which will be difficult.

Gilead had in the past said its agreement would cover 60 low- and middle-income countries, and would include royalty payments.

With 180 million people living with Hepatitis C today, and 350,000 dying annually of it — price negotiations on this drug will be closely watched by both advocacy and patient groups.

>jyothi.datta@thehindu.co.in

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