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-The Times of India
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Big pharma may be crying hoarse over India's &quot;weak'' intellectual property environment, but over the past five years or so, they have introduced only a handful of their patented blockbusters in the country. That's not all. The contribution of patented drugs in the Rs 72,000-crore pharma retail market is not even 1%, indicating that multinationals have been traditionally slow and have a poor track record in introducing blockbusters here. This also busts the myth that India may &quot;suffer'' as it hasn't actually seen a huge swell of launches or the entire basket of products from MNCs since the Patent Act was modified in 2005.
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Details of patented drugs marketed in the country appear hazy. At best, market research firm, IMS Health, which tracks about 95% of the patented drugs market, estimates their share to be 0.9% (for the 12-month period ended Feb).
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Besides, there are direct-to-patient sales of niche cancer and HIV drugs, and also some through exclusive stockists and carry forward agents.
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Taking these into account, their share would go up marginally to 2% of the total drug sales in the country.
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Most of these medicines carry eye-popping price tags (see chart), and MNCs which market them register low volumes but high value through their sale.
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Some of the highest selling patented drugs in the market include diabetes drugs Januvia family (Merck), Galvus (Novartis) and Onglyza (BMS); Enbrel ( Wyeth), Victoza (Abbot and Novo Nordisk) and Trajenta ( Boehringer Ingelheim). Others like Erbitux (Merck), Remicade (Janssen/Fulford), Actemra ( Roche), Orencia (BMS), Fasturtec (Sanofi) and Entecavir (BMS) are used in life-threatening diseases like cancer and Hepatitis C.
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Says Kumar Hinduja, senior director strategy planning, IMS Health India, &quot;The share of patented drugs-brands captured by us-has grown from 0.3% to 0.9% over four years. These drugs are expected to grow and corner 6-8% of the total market by 2016.&quot;
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Incidentally, the IMS made this projection last year.
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Irked with the Supreme Court judgement on Novartis' Glivec, big pharma has been pretty vocal that going forward there would be a reluctance on the part of MNCs to launch innovative products given the negative environment in India. Novartis India VC and MD Ranjit Shahani had recently told TOI that the company will be cautious in investing in India, especially with regard to introduction of innovative medicines.
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Busting a few myths propagated by the pharma giants, professor Brook K Baker of Health GAP (Global Access Project) says in a blog, &quot;Big Pharma doesn't site its research and development facilities based on whether there is a maximalist patent regime there or not. It does R&amp;D for a global market, not for a particular country. For example, drug companies don't do diabetes research for Indian diabetics in India and for British diabetics in the UK. They site their research facilities where there are good scientists, good infrastructure, favourable taxes, etc.&quot;
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Defending the Indian patent law, he adds: &quot;Studies show that there have been hundreds of patents on medicines in India since it revised its Patent Act in 2005. In fact, those studies also show that India has probably been too lenient in granting weak patents and that it has not properly been applying section 3(d) to weed out evergreening. In sum, it is not impossible to get a patent on medicines in India, you simply have to meet lawful strict standards on what is inventive and patentable.&quot;
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Industry expert point out that wherever MNCs have launched niche drugs meant for cancer and HIV, they have imported minuscule quantities of these, only to satisfy the patent regulation of ``local working of the patent&quot;.
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In fact, a case in point is the compulsory licence which was issued to Natco on cancer drug, Nexavar, as the patent-holder Bayer had not adequately &quot;worked'' the patent, or not made the drug accessible at a reasonably affordable price.
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Section 83 of the Indian Patents Act says that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale, and to the fullest extent that is reasonably practicable without undue delay.
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Says Leena Menghaney, lawyer with MSF, an international humanitarian organization: &quot;India has time and again shown it balances intellectual property with the very real needs of people in developing countries and is developing jurisprudence that responds to right to health and public health. R&amp;D in new essential medicines is costly and it is important that financing for it is available. But paying for R&amp;D through monopoly pricing leads to rationing and exclusion of people in need. This is not acceptable. Companies should take guidance from this decision and leave the Indian Patents Act-which is carefully balanced to protect patents for innovations and the public interest-alone.&quot; 
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