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Top court in india rejects novartis drug patent - nytimes.com

Top Court in India Rejects Novartis Drug Patent - NYTimes.com Low-Cost Drugs in Poor Nations Get a Lift in Indian Court
NEW DELHI — People in developing countries worldwide will continue to have ac-cess to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at leastfor a while.
Production of the generic drugs in India, the world’s biggest provider of cheap medi-cines, was ensured on Monday in a ruling by the Indian Supreme Court.
The debate over global drug pricing is one of the most contentious issues between de-veloped countries and the developing world. While poorer nations maintain theyhave a moral obligation to make cheaper, generic drugs available to their populations— by limiting patents in some cases — the brand name pharmaceutical companiescontend the profits they reap are essential to their ability to develop and manufactureinnovative medicines.
Specifically, the decision allows Indian makers of generic drugs to continue makingcopycat versions of the drug Gleevec, which is made by It is spelled Glivecin Europe and elsewhere. The drug provides such effective treatment for some formsof leukemia that the Food and Drug Administration approved the medicine in theUnited States in 2001 in record time. The ruling will also help India maintain its roleas the world’s most important provider of inexpensive medicines, which is critical inthe global fight against deadly diseases. Gleevec, for example, can cost as much as$70,000 a year, while Indian generic versions cost about $2,500 a year.
The ruling comes at a challenging time for the pharmaceutical industry, which is in-creasingly looking to emerging markets to compensate for lackluster drug sales in theUnited States and Europe. At the same time, it is facing other challenges to its patentprotections in countries like Argentina, the Philippines, Thailand and Brazil.
“I think other countries will now be looking at India and saying, ‘Well, hold on aminute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative forMedicines, Access and Knowledge, a group based in New York that works on patentcases to foster access to drugs.
In trade agreements — including one being negotiated between the United States andcountries in the Pacific Rim — the drug industry has lobbied for stricter patent re-strictions that would more closely resemble protections in the United States.
http://www.nytimes.com/2013/04/02/business/global/top-court-in-…?nl=todaysheadlines&emc=edit_th_20130402&_r=0&pagewanted=print Top Court in India Rejects Novartis Drug Patent - NYTimes.com Gleevec is widely recognized as one of the most important medical discoveries indecades. In a televised interview, Ranjit Shahani, vice chairman of the Indian sub-sidiary of Novartis, said that companies like Novartis would invest less money in re-search in India as a result of the ruling. “We hope that the ecosystem for intellectualproperty in the country improves,” he said.
India exports about $10 billion worth of generic medicine every year. India and Chi-na together produce more than 80 percent of the active ingredients of all drugs usedin the United States.
In Monday’s decision, India’s Supreme Court ruled that the patent that Novartissought for Gleevec did not represent a true invention. The ruling is something of ananomaly. Passed under international pressure, India’s 2005 patent law for the firsttime allowed for patents on medicines, but only for drugs discovered after 1995. In1993, Novartis patented a version of Gleevec that it later abandoned in development,but the Indian judges ruled that the early and later versions were not differentenough for the later one to merit a separate patent.
Leena Menghaney, a patient advocate at Doctors Without Borders, said that the rul-ing was a reprieve from more expensive medicines, but only for a while.
“The great thing about this ruling is that we don’t have to worry about the drugswe’re currently using,” Ms. Menghaney said. “But the million-dollar question is whatis going to happen for new drugs that have not yet come out.” Others decried the ruling, saying it was further evidence that India does not respectthe intellectual property rights of pharmaceutical companies. Last year, India grantedwhat is known as a compulsory license to a generic drug manufacturer to begin mak-ing copies of and revoked Pfizer’s patent for anotheroth companies have appealed the decisions.
“It really is in our view another example of what I would characterize as a deteriorat-ing innovation environment in India,” said Chip Davis, the executive vice presidentof advocacy at the Pharmaceutical Research and Manufacturers of America, the in-dustry trade group. “The Indian government and the Indian courts have come downon the side that doesn’t recognize the value of innovation and the value of strong in-tellectual property, which we believe is essential.” http://www.nytimes.com/2013/04/02/business/global/top-court-in-…?nl=todaysheadlines&emc=edit_th_20130402&_r=0&pagewanted=print Top Court in India Rejects Novartis Drug Patent - NYTimes.com Anand Grover, a lawyer who argued the case on behalf of Cancer Patients Aid Asso-ciation in India, said the ruling confirmed that India had a very high bar for approv-ing patents on medicines.
“What is happening in the United States is that a lot of money is being wasted onnew forms of old drugs,” Mr. Grover said. Because of Monday’s ruling, “that will nothappen in India.” In the United States, companies can get a new patent for a drug by altering its formu-la or changing its dosage. The companies contend that even minor improvements inmedicines — changing a pill dosage to once a day instead of twice a day — can havea significant impact on patient wellness. But critics say a majority of drug patents giv-en in the United States are for tiny changes that often provide patients few meaning-ful benefits but allow drug companies to continue charging high prices for years be-yond the original patent life.
They point to AstraZeneca, for example, which extended for years its franchisearound the huge-selling heartburn pill Prilosec by slightly altering the chemical struc-ture and renaming the medicine Nexium. Amgen has won so many patents on its ex-pensive erythropoietin-stimulating drugs that the company has maintained exclusivesales rights for 24 years, double the usual period. A result of this practice is that theUnited States pays the highest drug prices in the world, prices that only a tiny frac-tion could afford in India, where more than two-thirds of the population lives on lessthan $2 a day.
While advocates for the pharmaceutical industry argue that fairly liberal rules onpatents spur innovation, a growing number of countries are questioning why theyshould pay high prices for new drugs. Argentina and the Philippines have passedlaws similar to the one enacted in India, placing strict limits on patents. And Braziland Thailand have been issuing compulsory licenses for AIDS drugs for years undermultilateral agreements that allow such actions on public health grounds.
As the economies of emerging markets grow, the countries’ refusal to pay higher pre-miums for newer drugs could significantly reduce the money needed for innovation.
The drug industry makes more than a third of its sales in the United States, a depen-dence that many in the industry fear is unsustainable, especially since sales of pre-scription drugs actually dropped in the United States in 2012, according to the re-search firm IMS Health. Sales in emerging markets like Brazil and China are expected http://www.nytimes.com/2013/04/02/business/global/top-court-in-…?nl=todaysheadlines&emc=edit_th_20130402&_r=0&pagewanted=print Top Court in India Rejects Novartis Drug Patent - NYTimes.com to account for 30 percent of global pharmaceutical spending by 2016, up from 20 per-cent in 2011, according to IMS Health.
The United States government has become increasingly insistent in recent years thatother countries adopt far more stringent patent protection rules, with the result thatpoorer patients often lose access to cheap generic copies of medicines when their gov-ernments undertake trade agreements with the United States. Washington is current-ly negotiating the terms of a new Pacific Rim trade agreement, called the Trans-Pacif-ic Partnership, which might be completed later this year. The pharmaceutical indus-try has lobbied the United States to require other countries to enforce tougher patentrestrictions, although the details are still being worked out.
Gardiner Harris reported from New Delhi, and Katie Thomas from New York. http://www.nytimes.com/2013/04/02/business/global/top-court-in-…?nl=todaysheadlines&emc=edit_th_20130402&_r=0&pagewanted=print

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