Novartis vs. India: Battle the world watches, restarts

The mother of pharma battles restarts today. Implications range from future of India story to painting the judiciary with an unfair brush!

rohit

Rohit Bansal | November 20, 2012




Today could be the eighteenth day of India’s $12-billion pharma Mahabharata. Or maybe, that isn’t the literal way to describe what could still take a few more weeks of heavy-duty court craft. But we’re certainly in the home stretch. Beginning November 20, two of India’s most respected judges, Justice Aftab Alam and Justice Ranjana Prakash Desai, begin to hear Gopal Subramaniam, lead counsel for Swiss drug maker Novartis and former Solicitor-General, for his final arguments. The other side, Harish Salve and Prathiba Singh, finished theirs some weeks back.

This is a battle beyond a cancer drug. What Alam and Desai might decide won’t just be a news headline across the world’s trade policy community. In fact, the two judges won’t even decide the course of India’s $12-billion (Rs 65,000 crore) drug industry. The implications will play out in the lives of patients across a raft of ailments in the entire developing world.

So, here are the two scenarios.

If the judges say Novartis indeed deserves a patent for imatinib mesylate (marketed as Glivec and priced up to $90,000 or about Rs 50 lakh per year) innovation companies across the world will salute Indian judiciary for protecting what they claim are rights that have been hurt recently in two cases. One involved Bayer and the other Roche. Both losses in India’s courts have been liberally used to paint the entire judicial system as uncaring for folks who spend billions of research dollars to create new molecules that, ironically, save Indian lives. By implication, Indian judges, these commentators crib, are ready to turn their eyes away from theft that home-grown patent busters inflict on what bona fide inventors take decades to create. This group pitches a potential Novartis win as a huge leg-up for the India story, a compelling case for foreign drug makers not being forced to overfly India. Who would risk their new blockbuster in a country that’ll rip them off! A Novartis win will end fears that prolonged litigation notwithstanding (Novartis took Indian patent authorities to court in 2006!) not all Indian judges favour the somewhat emotional “access” argument. Conversely, there’s place under the sun for the original owner. After all, Novartis (and Bayer and Roche before them) in any case shares part of its social contract giving the poor free medicines.

Scenario (B) on the other hand, emerges if judges Alam and Desai find themselves on the side of Salve and Singh. Both have drilled serious holes in the Glivec ship. That India's patent law (Section 3-d being the most contentious section) must be read in a language that the poor understand. And not only is the Novartis molecule no big deal, the free medicine part is a PR exercise with no corresponding coverage to the millions who are left out. What Salve and Singh have sought to prove is that not just the poor in India, but the entire planet wherever cheaper generics manufactured in India make a difference, see the apex court defining society’s choice between life and death.

Which of these scenarios work better for us?

To help you take sides, here’s some of the legalese crunched for dummies.

A new form of a known medicine can only be patented only if it shows significantly improved therapeutic efficacy over existing compounds; Novartis and the “innovator’s gang” are being accused of trying to run with the common industry practice of extending, or 'evergreening’, their patent monopolies for routine modifications of known compounds.??

Medecins Sans Frontieres (MSF-Doctors without Borders) claims Novartis' patent application was on a new form of the imatinib molecule already described several years previously in patents in the US and other developed countries.??

They term the case in India as Novartis’ final bid to undermine a key public health safeguard in our patent law presciently designed to prevent those like Novartis from abusive patenting practices which keep medicine prices high.??

“If successful, the move would have a devastating impact on access to essential medicines across the developing world,” MSF said Monday.

Understandable. These folks rely on affordable generic drugs produced in India to carry out their work in 68 countries.

India, both warring sides appreciate, is the developing world’s pharma factory. The stakes therefore run several times of India’s $12-billion market, 90 per cent of it being in generics.

It bears repetition that “3(d)” led to Novartis being denied a patent for chronic myeloid leukemia and intestinal cancer. Novartis is contesting the Indian patent office’s and the appellate body’s decisions to reject its application for a patent on the salt form of imatinib.

MSF says a win for Novartis will set a dangerous precedent, severely weakening India’s legal norms against “evergreening.”

“A single medicine can have several applications for separate patents, each relating to a different aspect of the same medicine. This would inevitably lead to patents being granted far more widely in the country, blocking the competition among multiple producers which drives down prices, and restricting access to affordable medicines for millions in India and across the developing world,” MSF said.

Besides arguments from generic companies and the counsel for the government, the Cancer Patients Aid Association also deposed to defend India’s strict patentability criteria.

Those supporting the Novartis claim say Glivec is a sign of pioneering pharmaceutical research. Above all, Novartis’s is a ‘life-saving’ drug, just as Roche’s anti-cancer drug Tarceva (Rs 140,000 per month versus Cipla’s Erlocip for Rs 25,000 pm was) or Bayer’s Nexavar.

I would recommend a robust counter argument, including explanatory interpretations on “3-d” and the role Novartis may be overplaying in the evolution of Glivec, by Prof Dwijen Rangnekar of the University of Warwick (read here).

Also, I would question lawyers/advisors to multinationals who are scaring their clients by painting Indian judges with a broad brush. Which judge won’t be put off by imported drugs costing an arm and a leg? A firmer footing is to demonstrate local manufacturing (eg what Gilead has done with Viread via voluntary, non-exclusive licences to Indian manufacturers) and thereby show the judges an economic multiplier within India.

Indian courts don’t kill innovation and patents. They balance between the extreme polarities of access and innovation.

That said, surely, there’s a lot more billing in threat construction. But the truth, albeit a relatively unpublicised one, is that Indian companies have won several patent dharmayuddhas!
 
(Tweets @therohitbansal)
 

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