Twenty years ago, Ranbaxy was a home-spun drug-maker. The Indian Patents Act allowed companies to make chemically-similar versions of innovative drugs.

Visionaries in the pharmaceutical sector, like Parvinder Singh (Ranbaxy’s key architect and member of its promoter family) and Anji Reddy (founder of Dr Reddy’s Laboratories), were alive. And the pharmaceutical industry did not have a dedicated department in the Government to direct its affairs.

Over the last two decades, that landscape has transformed — dramatically, if you will.

Ranbaxy now has a foreign owner, after its promoter-family sold its entire stake to Japanese drug-maker Daiichi Sankyo in 2008. In fact, more local drug companies have sold out, either entirely or in part.

Making history

India amended its Patents Act in 2005 to honour product patents, in the process creating a more difficult terrain for companies making similar versions of innovative drugs.

Parvinder Singh passed away in 1999; Anji Reddy, earlier this year.

And the fledgling Department of Pharmaceuticals now steers policy, governing the Rs 1-lakh-crore pharmaceutical industry.

Having taken global strides in the past, the domestic pharmaceutical industry now finds itself in the thick of history in the making. The amended Patents Act is, in a sense, getting pushed and prodded by companies seeking their rights to sell medicines in the local market. And as these cases get resolved, they are setting historic benchmarks.

Domestic industry also finds itself at the base of a steep climb. A journey made difficult by the increasing cost of research and the over-zealous enforcement of intellectual property (IP), encountered at times in global markets.

In fact, IP protection is a key factor in the global arena, as companies protect data and the IP generated in the course of their research. There are overt and covert moves in the global pharmaceutical industry involving IP. And a constant worry for local drug-makers is whether such property is being secretly brought into trade frameworks, buried in the fine-print of Free Trade Agreements, like a Trojan horse!

The journey from the mid-1990s has seen the pharmaceutical industry scale significant peaks. They were heady times, as Indian drug-makers took battles to the backyard of multinational drug-makers.

The erstwhile Ranbaxy and Dr Reddy’s began challenging patents in the global markets, to be able to sell their products overseas. Cipla set the cat among the pigeons, in a sense, offering its version of anti-AIDS drugs at a fraction of the price multinationals were selling the original at in African markets.

Dizzy heights

In the dizzy days leading up to 2008, Indian drug-makers were out on a shopping spree abroad, with Ranbaxy, Dr Reddy’s and Wockhardt buying companies in France, Germany and so on. And as early rumblings on high healthcare costs and medicine prices were beginning to be heard in global markets, Indian generic drug-makers marched ahead, providing chemically similar generic medicines at a lower price.

In the early 2000s, domestic companies were fighting patents, winning some and bringing in for themselves “windfall gains” (then a buzzword for market analysts).

Generic drugs

Where Indian generic drug-makers scored was in making similar versions of a drug without infringing the innovator’s patents, thereby bringing in an innovation or convenience to the patient.

So, for example, there were paediatric versions of medicines that previously did not have any. Or, as in the AIDS drugs case, Indian drug-makers brought in combination medicines that improved treatment protocols.

Thanks to a combination drug that merged three original medicines into one, for instance, a HIV patient could replace taking six medicines a day, with just two. The convenient three-in-one medicine brought in better compliance, as patients became more regular in taking the medicine as prescribed by the doctor. The clincher in these developments was that the generically-similar medicine came at a much lower price than that of the multinational company’s original drug. This helped build up the Indian drug-makers’ reputation of being pharmacy to the world. Such inexpensive drugs were being supplied to regulated and semi-regulated markets.

Naturally, battle-lines were drawn by the multinational drug majors, affronted by this generics competition. Their high prices were because they had invested a lot in research, development and marketing of the drug, they contended. And these were costs that generic drug-makers did not incur, as they merely made similar versions of a known drug, they added.

Old order and the new

The battle continues till date, and equally fiercely in the domestic market. As India joined the World Trade Organisation and adopted the TRIPS (Trade Related aspects of Intellectual Property Rights) agreement, it brought into the country all its trappings.

As committed by the Government, the Patents Act was amended in 2005 to allow product patents. Against this backdrop, two key judgements were recently delivered. The Supreme Court dismissed, just earlier this month, Novartis’ plea to get patent protection on its blood cancer drug Glivec. Ending a seven-year-long case, the court ruled that the particular form of the drug did not meet the criteria of being inventive, among other things.

In a different judgement — this time from the Patent Office — the country’s first compulsory license was issued to Natco Pharma, allowing it to make a local, inexpensive version of Bayer’s advanced kidney cancer drug Nexavar, on the payment of royalty.

These are just two of a handful of critical patent-related cases being fought in the country, and being intensely debated online and off-line, across the world.

While there is no great dissonance on whether original or break-through products need protection, the concern when it comes to medicines is that product-patent protection could put certain medicines beyond the reach of patients.

Patents protect a product for 20 years, allowing their manufacturers to sell locally without any competition. Legal battles underway, at present in the country, have to do with ensuring that frivolous patents do not get a fresh bout of protection, under the guise of bringing in a so-called innovation on an existing medicine.

In fact, Section 3 (d) in the Indian Patents Act stymies such incremental innovation — much to the cheer of public health workers, and anguish of drug-majors, who say an incremental innovation could mean a leap in the efficacy of the medicine or convenience for the patient.

Patent battles

So from Pfizer to Bayer to Roche to Merck Sharp and Dohme, multinationals are locked in patent-related battles. And fighting them are a whole different crop of domestic companies, including Natco, Glenmark and the old war-horse Cipla. In fact, the domestic pharmaceutical landscape is changing and the old order is giving way to the new. Sun Pharma had recently concluded a high-profile acquisition of Israeli generic-drugs-maker Taro, after it fought a protracted battle across geographies, and several years for it. Lupin silently chips away and grows, making small but meaningful acquisitions in significant markets like Japan.

Besides the unthinkable happening in 2008, when the Indian drug industry’s poster boy Ranbaxy’s owners sold out in a $4-billion-plus deal — the global economic slowdown brought another promising local drug company to its knees.

Reeling under debt of over Rs 3,800 crore, Wockhardt had to deal with the fallout of its expensive overseas acquisitions and litigation by unhappy lenders. The company has managed to claw back from the brink to good health, with some sensible debt restructuring, supported by the banks.

But the domestic drugscape has been dotted with dramatic events — as local players sold out entirely or in part, from 2006. Orchid sold its injectibles business to Hospira, Mylan bought into Matrix, Sanofi bought out Shantha Biotech and Piramal Healthcare sold its domestic medicines business to Abbott.

Soon enough, the pharmaceutical sector came in for intense scrutiny, after seven such acquisitions took place in five years. The Government was concerned at the threat to the country’s “health security”, if this strategic sector saw more sell-outs, and future acquisitions of domestic operations were put under a stringent approval process.

Healthcare needs a shot

With the aim of protecting the health of the people, the Government has been keeping an eye on foreign buys of local companies, patent-related battles or rising medicine prices.

Skewed medicine prices in the market-place are also now being addressed by the Government, under the watch of the Supreme Court. Even so, the Government may be playing only a part of its larger role.

It needs to expand its healthcare horizon. Its spend on health is still abysmally low (hovering at less than one per cent of GDP) — a shameful reality that needs to be set right if the country is to be known as a truly progressive welfare state.

A huge section of the population — not just those below poverty line, but many from the regular salaried class — finds healthcare costs prohibitive.

There is a patchy health-insurance and no reliable social security net in place for citizens, specially the elderly or the economically disadvantaged.

A more dynamic environment that encourages and supports local research needs to be brought in if the country wants its pharmaceutical industry to ride the next wave of growth. Industry and research institutions need to lean on one another to be able to bring out medicines tailored to the local population, at least to start with.

The industry will have to build on existing strengths, adapt and morph into a research-driven creature if it wants to survive the steep climb up ahead.

jyothi.datta@thehindu.co.in

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