Pills and Patents

It's never been clearer than in the battle between patents and generics: all around the world and in the USA, Big Pharma's "free market" is the arch enemy of public health.

The story of the ruling by the Supreme Court of India against Novartis is told clearly in the lead article of today's NY Times : "Low Cost Drugs in Poor Nations Get Lift in Court", by Garnier Harris and Katie Thomas (4/2/2013).  If you don't have access to it, here are  extended quotes, which I'll follow with a comment:

"People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while.

"Production of the generic drugs in India, the world’s biggest provider of cheap medicines, 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 developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

"Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the 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…. (my emphasis — LW)

"Gleevec is widely recognized as one of the most important medical discoveries in decades. In a televised interview, Ranjit Shahani, vice chairman of the Indian subsidiary of Novartis, said that companies like Novartis would invest less money in research in India as a result of the ruling. 'We hope that the ecosystem for intellectual property in the country improves,' he said.

"India exports about $10 billion worth of generic medicine every year. India and China together produce more than 80 percent of the active ingredients of all drugs used in the United States.

"In Monday’s decision, India’s Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a true invention. ….

"Leena Menghaney, a patient advocate at Doctors Without Borders, said that the ruling was a reprieve from more expensive medicines, but only for a while….

"Others decried the ruling, saying it was further evidence that India does not respect the intellectual property rights of pharmaceutical companies. Last year, India granted what is known as a compulsory license to a generic drug manufacturer to begin making copies of Bayer’s cancer drug Nexavar, and revoked Pfizer’s patent for another cancer drug, Sutent. Both companies have appealed the decisions.

“ 'It really is in our view another example of what I would characterize as a deteriorating innovation environment in India,” said Chip Davis, the executive vice president of advocacy at the Pharmaceutical Research and Manufacturers of America, the industry trade group. “The Indian government and the Indian courts have come down on the side that doesn’t recognize the value of innovation and the value of strong intellectual property, which we believe is essential.'

"In the United States, companies can get a new patent for a drug by altering its formula or changing its dosage. The companies contend that even minor improvements in medicines — changing a pill dosage to once a day instead of twice a day — can have a significant impact on patient wellness. But critics say a majority of drug patents given in the United States are for tiny changes that often provide patients few meaningful benefits but allow drug companies to continue charging high prices for years beyond the original patent life.

"They point to AstraZeneca, for example, which extended for years its franchise around the huge-selling heartburn pill Prilosec by slightly altering the chemical structure and renaming the medicine Nexium. Amgen has won so many patents on its expensive erythropoietin-stimulating drugs that the company has maintained exclusive sales rights for 24 years, double the usual period. A result of this practice is that the United States pays the highest drug prices in the world, prices that only a tiny fraction could afford in India, where more than two-thirds of the population lives on less than $2 a day.

"While advocates for the pharmaceutical industry argue that fairly liberal rules on patents spur innovation, a growing number of countries are questioning why they should pay high prices for new drugs. Argentina and the Philippines have passed laws similar to the one enacted in India, placing strict limits on patents. And Brazil and Thailand have been issuing compulsory licenses for AIDS drugs for years under multilateral agreements that allow such actions on public health grounds.....

"The United States government has become increasingly insistent in recent years that other countries adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States. Washington is currently negotiating the terms of a new Pacific Rim trade agreement, called the Trans-Pacific Partnership, which might be completed later this year. The pharmaceutical industry has lobbied the United States to require other countries to enforce tougher patent restrictions, although the details are still being worked out."

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The story doesn't need a heck-of-a-lot of comment. The developing countries will not accomodate Big Pharma at the expense of the health needs of their vast populations. Neither should we. The lament that  research and innovation will suffer if people can afford their medical needs is a serenade of fear — fear that super profits will erode if access to proper medical care gains universal recognition as a human right. What's more, the rapid progress of many developing countries in the production of generics gives the lie to notions that all wisdom, initiative and competence reside in our part of the world and depend on satisfying the greed of the drug and insurance monopolies. 

The fact is that the developing countries are doing far more to improve the access of most Americans to affordable medicine than our vaunted "free enterprise" establishment. Thank you, India.