Novartis loses landmark India patent case on Glivec

[ravishingravi]

"(Reuters) - The Supreme Court dismissed Swiss drugmaker Novartis AG's (NOVN.VX) attempt to win patent protection for its cancer drug Glivec, a blow to Western pharmaceutical firms targeting India to drive sales and a victory for local makers of cheap generics. The decision sets a benchmark for intellectual property cases in India, where many patented drugs are unaffordable for most of its 1.2 billion people, and does not bode well for foreign firms engaged in ongoing disputes in India, including Pfizer Inc (PFE.N) and Roche Holding AG (ROG.VX), analysts said. It cements the role of local companies as big suppliers of inexpensive generics to India's rapidly growing $13 billion-a-year drugs market and also across the developing world. Among the chief beneficiaries of Monday's Supreme Court ruling will be India's Cipla Ltd (CIPL.NS) and Natco Pharma Ltd (NATP.NS), which already sell generic Glivec in India at around one-tenth of the price of the branded drug. "The multinational companies will have to find new ways of doing business in India," said Deepak Malik, healthcare analyst at brokerage Emkay Global, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs like Glivec. Ranjit Shahani, managing director of Novartis India Ltd (NOIN.BO), the firm's locally listed unit, said it would be cautious about investing in India, especially over introducing new drugs, and seek patent protection before launching any new products. It will continue to refrain from research and development activities there. "The intellectual property ecosystem in India is not very encouraging," Shahani told reporters in Mumbai after the ruling. Healthcare activists have asked the government to make medicines cheaper in a country where many patented drugs are too costly for most people, 40 percent of whom earn less than $1.25 a day, and where patented drugs account for under 10 percent of total drug sales. "This appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines," said Leena Menghaney, Medecins Sans Frontieres' Access Campaign manager for India. Over 16,000 patients in India use Glivec and the vast majority of those get it free of charge, Novartis says. By contrast, generic Glivec is used by more than 300,000 patients, according to industry reports. The U.S. industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said the decision reflected a deteriorating environment for innovation in India. "Protecting intellectual property is fundamental to the discovery of new medicines," the group said in a statement. "To solve the real health challenges of India's patients, it is critically important that India promote a policy environment that supports continued research and development of new medicines." U.S. pharmaceutical industry analysts said the ruling was in line with lower court decisions and therefore largely expected. "For other firms, rulings like this, and just the overall environment in India for branded drugs, make it less appealing. However, you are talking about a major geography," said Morningstar analyst Damien Conover. The Supreme Court's decision comes after a legal battle that began when Novartis was denied a patent for Glivec in 2006. EXTRA WORK Novartis had argued it was entitled to a patent for the amended version of Glivec because the original patented compound was never suitable for making into a pill. Developing the final chemically stable form took years of extra work and it was this effort that marked the real breakthrough in developing Glivec as a life-saving cancer medicine, the Swiss company said. Glivec is used to treat certain forms of leukemia and gastrointestinal cancer, as well as some other rare tumors. Shares in Novartis' Indian unit ended 1.8 percent lower after falling as much as 6.8 percent after the verdict. Natco Pharma stock ended 5.4 percent higher after earlier gaining nearly 11 percent and Cipla gained 1.3 percent, beating the benchmark index .BSESN which ticked up 0.15 percent. India's domestic drugs market is the 14th-largest globally, but with annual growth of 13 to 14 percent and the world's second-biggest population, international pharmaceutical firms say India has massive potential at a time when traditional developed markets have slowed down. The ruling may dampen enthusiasm from foreign pharmaceutical firms in the short term, said S. Majumdar, head of law firm S. Majumdar & Co based in the eastern city of Kolkata. "They will have to get used to it and learn to live with the law," he said. NOT SO EVERGREEN Pfizer's cancer drug Sutent and Roche's hepatitis C treatment Pegasys lost their patented status in India last year, decisions the companies are fighting to have reversed. The Supreme Court's latest ruling will make it tougher for them to win back patent protection. "Henceforth, multinational pharma companies are likely to want that their patents are first recognized in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co. India has refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound. By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China. Indian law bans firms from extending patents on their products by making slight changes to a compound, a practice known as "evergreening". The Supreme Court said Glivec does not satisfy a patent's "novelty" requirement, Pravin Anand, lawyer for Novartis, told reporters. Novartis can file a review petition within 90 days. Indian Trade Minister Anand Sharma called the ruling "a historic judgment" that reaffirmed legal provisions mandating the need for substantial innovation before new patents are issued on medicines." http://in.reuters.com/article/2013/04/01/india-drugs-patent-novartis-glivec-idINDEE93000920130401

[ravishingravi]

http://www.thehindu.com/news/national/landmark-verdict-gives-big-boost-to-cancer-patients/article4569056.ece

[Lurker]

Pathetic to see Indians spending hours chatting about Tendulkar but not about this. End of rant there. This particular cancer drug costs about 1lakh per month!! Who can afford that? Even upper middle class folks will have a hard time coming up with that kind of money. And even in USD terms it is almost $2000/month. That is extremely high even by US standards. If the cost comes down to 10,000/month so many lives can be saved. About time these chewtiyas are made to look at this the right way. Hopefully the decision wont be quashed. For whatever it is worth this has received a tremendous support in United States. Thanks for sharing Ravish :nice:

[Khalpat]

Pathetic to see Indians spending hours chatting about Tendulkar but not about this. End of rant there. This particular cancer drug costs about 1lakh per month!! Who can afford that? Even upper middle class folks will have a hard time coming up with that kind of money. And even in USD terms it is almost $2000/month. That is extremely high even by US standards. If the cost comes down to 10,000/month so many lives can be saved. About time these chewtiyas are made to look at this the right way. Hopefully the decision wont be quashed. For whatever it is worth this has received a tremendous support in United States. Thanks for sharing Ravish :nice:

But Lurker, what about the Pharma companies. They spend millions in discovering of a drug. It takes almost 12-15 years for a simple drug invention and anyways the patent for the drug is not for the whole life it is at the max for 20 years as per FDI norms. If Pharma companies keep on loosing patent I do not think these giants like Pfizer, Novartis, Merck etc will be very keen to invest on R & D of drugs.

[ravishingravi]

^that is the dilemma

[The Outsider]

But Lurker, what about the Pharma companies. They spend millions in discovering of a drug. It takes almost 12-15 years for a simple drug invention and anyways the patent for the drug is not for the whole life it is at the max for 20 years as per FDI norms. If Pharma companies keep on loosing patent I do not think these giants like Pfizer, Novartis, Merck etc will be very keen to invest on R & D of drugs.

The restriction being imposed is not on genuine innovations, but on cosmetic chemical changes that are made by drug companies to retain their hold on the patents and drugs. What determines a genuine innovation is a tricky question and I am skeptical about leaving it in the hand of judges who have no or little scientific training, but in most cases a well read person should be able to distinguish between a genuine innovation and a cosmetic change based on testimonies from experts.

[Mariyam]

But Lurker, what about the Pharma companies. They spend millions in discovering of a drug. It takes almost 12-15 years for a simple drug invention and anyways the patent for the drug is not for the whole life it is at the max for 20 years as per FDI norms. If Pharma companies keep on loosing patent I do not think these giants like Pfizer, Novartis, Merck etc will be very keen to invest on R & D of drugs.

The ruling isn't against R&D, per se. What the ruling decrees is that a pharma company can't hold on to the patent under the guise of R&D by some superficial alterations on an existing product. Whether or not a bench of SC judges are competent enough to judge what is genuine R&D and what isn't is a different matter. :P

[DomainK]

Kudos to the supreme court for the judgement. The pharma and healthcare business has become a joke world wide. Good that our poor patients have better and cheaper access to the drug now.

[Holysmoke]

There needs to be some kind of industry panel or some other regulatory body.... some solution to who decides whether it is a cosmetic change or a real innovation.

[ravishingravi]

The ruling isn't against R&D, per se. What the ruling decrees is that a pharma company can't hold on to the patent under the guise of R&D by some superficial alterations on an existing product. Whether or not a bench of SC judges are competent enough to judge what is genuine R&D and what isn't is a different matter. :P

Isi ko leke India ka naam kharab ho gaya hai. I doubt any foreign investors would either invest in R & D or bring their unique technology in India

[urbestfriend]

The ruling isn't against R&D, per se. What the ruling decrees is that a pharma company can't hold on to the patent under the guise of R&D by some superficial alterations on an existing product. Whether or not a bench of SC judges are competent enough to judge what is genuine R&D and what isn't is a different matter. :P

Its not like SC judges themselves read up chemistry books to ascertain whether R&D is genuine or not :haha: Obviously expert witnesses must have been used by prosecution for judges to arrive at this decision.

[DomainK]

Isi ko leke India ka naam kharab ho gaya hai. I doubt any foreign investors would either invest in R & D or bring their unique technology in India

Isko leke India ka naam kharab nahi hua hai. India ka naam has been forever kharab when it comes to pharmaceutical patents and intellectual property rights. The government of India has always made high priced drugs at reasonable prices in India. It has been a consistent policy. It has been heavily criticized in the international level, but India has never relented. Let me find an old thread for you. Here: http://www.indiancricketfans.com/showthread.php?t=279567

[Mariyam]

Isi ko leke India ka naam kharab ho gaya hai. I doubt any foreign investors would either invest in R & D or bring their unique technology in India

I would care about the needy affording medicines here, than worry about what some technocrat in Brussels/Geneva thinks about India and her IP laws. Sure, it will make the foreign pharma companies skeptical. India was supposed to be their 'cash cow'. But it will also make the local pharma companies focus more on R&D, if they don't have access to foreign funds for re-search or to the latest technology in medicine. I envision only good to come from this ruling.

[Crookbond]

An important statistic - India manufactures over 1/5th of the generic medicines in the whole world. India is also the largest supplier of pharmaceutical drugs to Africa.

[rkt.india]

What is the criteria of deciding the cost of patented drugs in the market?

[Crookbond]

^ Whatever the company decides to sell at? :dontknow:

[Ram]

Good job by the Supreme Court of India. I would have been stunned otherwise if they had ruled otherwise. It would have been extremely ironical since, only a few years ago, the court had ruled that all commercial broadcasters in India had to share their cricketing feed with Doordarshan since they deemed cricket to be 'national past-time/hobby', that 'belonged to all Indians'. Anyways, coming back to the pharma companies, their usual argument 'oh well, if our drugs keep going off patent protection, we will have to end up curb our spending on R&D, limiting future discovery of life-saving drugs' is utter bollocks. Guess what Novartis - If you want to stop investing in R&D because you lose money to generic manufacturers, be my guest. Dont dont research. Our good ol friend 'Free-market' will find somebody else who will do the research instead of you and reap the benefits later. And btw, 20 years is a long time to keep a drug on patent protection and milk it as much as possible. Just because you increase the dosage of a pill and call it something else, does not make it an 'innovation'. On a general note, it is really great to see the Indian establishment stand up for Indian people - First the central govt. and the way it steadfastly handled the Italian marines issues and now the Supreme court and its ruling against Novartis. And make no mistake - this has huge implications for the drug Industry and the health/welfare of several hundred million people in the world. Our generic manufacturers are the lifeline of almost all of the poor people in under-developed countries.

[Ram]

What is the criteria of deciding the cost of patented drugs in the market?

Depends on how many yachts the CEO wants to buy.

[coffee_rules]

I wish the Supreme Courts also takes note of how the Indian Pharmaceutical companies are producing the medicine so cheaply by polluting the water in rural areas. They are blatantly dumping waste onto drinking water, including lead and mercury. As such, there are no environmental laws that the companies have to abide by, even if there are, they don't follow them, by bribing the appropriate ministry. http://www.huffingtonpost.com/2009/01/26/worlds-highest-drug-pollu_n_160867.html

World's Highest Drug Pollution Levels Found In Indian Stream PATANCHERU, India — When researchers analyzed vials of treated wastewater taken from a plant where about 90 Indian drug factories dump their residues, they were shocked. Enough of a single, powerful antibiotic was being spewed into one stream each day to treat every person in a city of 90,000. And it wasn't just ciprofloxacin being detected. The supposedly cleaned water was a floating medicine cabinet _ a soup of 21 different active pharmaceutical ingredients, used in generics for treatment of hypertension, heart disease, chronic liver ailments, depression, gonorrhea, ulcers and other ailments. Half of the drugs measured at the highest levels of pharmaceuticals ever detected in the environment, researchers say. Those Indian factories produce drugs for much of the world, including many Americans. The result: Some of India's poor are unwittingly consuming an array of chemicals that may be harmful, and could lead to the proliferation of drug-resistant bacteria. ... Patancheru became a hub for largely unregulated chemical and drug factories in the 1980s, creating what one local newspaper has termed an "ecological sacrifice zone" with its waste. Since then, India has become one of the world's leading exporters of pharmaceuticals, and the U.S. _ which spent $1.4 billion on Indian-made drugs in 2007 _ is its largest customer. A spokesman for the Pharmaceutical Research and Manufacturers of America, representing major U.S. drugmakers, said they could not comment about the Indian pollution because the Patancheru plants are making generic drugs and their members are branded. A spokesman for the Generic Pharmaceutical Association said the issues of Indian factory pollution are "not within the scope of the activities" of their group.

[Crookbond]

More than pollution, it is the testing which is carried in the Indian market (sometimes at the expense of of people's lives) that is more worrying.