IPR and Medicines 26: Novartis' Glivec and India's IPR Ruling

A very good friend of mine here in Manila has a brother with leukemia. His physician recommended Gleevec or Glivec (generic molecule is "Imatinib") made by Novartis, as the medicine that can help him beat the disease. The problem was that Gleevec was very expensive, so the family approached a foundation. The foundation conducted a credit investigation re the financial capacity of the patient's family and determine how much free medicines they can get. The investigation agency suggested a "Plan 9", meaning Novartis through a foundation will give them nine months worth of medicines for free, but the family must buy the first three months supply of Glivec. This was sometime in September 2011.

A capsule of Glivec (photo here from wikipedia) then would cost P1,204.00, the 12 percent VAT + import tax + other taxes and fees included. The patient would need six boxes (60 capsules per box) or 360 capsules for three months, that would cost them P433,440, but the supply for the next nine months would be given free by Novartis.

The family looked for other options. One was to buy the medicine not from the Novartis med rep at the private hospital where the patient goes, but from the company med rep at the Philippine General Hospital (PGH). Second option was to buy from India or elsewhere, and after several emails with their friends in Delhi, they found that a generic alternative, Imatinib Mesylate, is available in India at a much lower price. 

There's a special case in India about Imatinib or Gleevec. The Indian High Court rejected the patent application of Novartis. So while Gleevec is patented in many countries, it was not in India. So many generic manufacturers produced their own versions of imatinib. And since they spent nothing on the long process of various clinical trials and medicine R&D that takes up to 12 years sometimes, they simply copied it from Novartis, they could sell the medicine at a much lower price. One Indian manufacturer could sell it at only about four percent of the original price of Novartis, exclusive of Philippine taxes like VAT.

Today, I read this news report from the NYT:

Top Court in India Rejects Novartis Drug PatentBy GARDINER HARRISPublished: April 1, 2013 

NEW DELHI — India’s Supreme Court rejected a Swiss drug maker’s patent application for a major cancer drug Monday in a landmark ruling that allows cheap copies of important medicines to continue being distributed in much of the world. 

The ruling allows Indian generic companies to continue making copycat versions of the Novartis drug Gleevec, which can have a miraculous effect on some forms of leukemia.

But the ruling’s effect will be felt well beyond the limited number of patients in India who need Gleevec because it will help maintain India’s role as the world’s most important provider of cheap medicines, which is critical in the global fight against HIV/AIDS and other diseases.

Novartis had hoped that India’s adoption under international pressure of a new patent law would lead the country to grant the company an exclusive license to produce Gleevec, which can cost up $70,000 per year. Indian generic versions cost about $2,500 year....

In recent decades, the United States has become increasingly insistent that countries wishing to do business there 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. 

The ruling Monday is bound to be seen with some concern by the United States and the international pharmaceutical industry and may be yet another blow to India’s standing among major multinational companies, many of whom view protection of their intellectual property as vital to their business interests.

In another news from yahoo finance, also today,

Novartis loses landmark India patent case on Glivec
Reuters 

By Kaustubh Kulkarni and Suchitra Mohanty

NEW DELHI/MUMBAI (Reuters) - India's top court rejected Swiss drugmaker Novartis AG's plea for patent protection of its cancer drug Glivec, a move likely to boost the prospects of Indian pharmaceutical firms over their foreign rivals.

The Supreme Court has set a legal precedent which appears not to favor patents on existing drugs sold in India, a move which does not bode well for foreign firms in ongoing intellectual property disputes in India, including Pfizer Inc and Roche Holding AG, analysts say.

Among the chief beneficiaries of Monday's ruling will be India's Cipla Ltd - whose shareholders include Oppenheimer Developing Markets Fund and Virtus Emerging Markets Opportunities Fund - and Natco Pharma Ltd, which already sell 'generic' Glivec in India that costs around one-tenth 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.

The decision shows that Indian law offers "limited intellectual property protection", Novartis said in a statement.  

... Shares in Novartis' Indian unit fell as much as 6.8 percent after the verdict, while Natco Pharma were up nearly 11 percent and Cipla up 2.5 percent, outperforming the benchmark Mumbai market which ticked up 0.1 percent.

India's domestic drugs market is the 14th-largest globally, but with annual growth of 13-14 percent and the world's second-biggest population, international pharmaceutical firms say it has massive potential at a time when traditional developed markets have slowed down.

The ruling may dampen that enthusiasm in the short term, said S. Majumdar, head of law firm S. Majumdar & Co based in the eastern city of Kolkata.
"But they (foreign pharmaceutical firms) will have to get used to it and learn to live with the law," he said.

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 ruling will make it tougher for them to win back patent protection.

Yes, multinational pharma companies will have to live with this reality of IPR non-respect in India and a few other developing countries. But the latter must also live with certain adjustments by the multinational innovator companies, like delayed launch or non-launch of certain new medicines in their countries but are readily available in countries where IPR is respected. Thus, new revolutionary medicines will be available in the US, Europe, Japan, Korea, Hong Kong, Singapore, etc. but not available in India or other countries where the IPR system is not properly protected. And this can be bad news for certain patients there.

About my friend and her brother with leukemia, I sympathize with them fully in their search for cheaper alternative medicines. But I really wish that (1) taxes on medicines in this country were abolished, that (2) more innovator companies are here to compete with each other both in price and new medicines, and (3) other treatments aside from medicine dependence can be discovered by the medical community.

Thus, instead of having "more government" interventions in the medicines sector, there should be less, so that more competition among innovator companies, among generic companies, can be expected.
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See also:
IPR and Medicines 22: CL on Anti-Cancer Drug Nexavar, March 14, 2012
IPR and Medicines 23: Profitability of Innovator Pharma Companies, March 16, 2012
IPR and Medicines 24: Balancing Costly Innovation and Cheaper Drugs, March 20, 2012
PR and Medicines 25: Patents, Diagnostics and Technology Transfer, October 02, 2012

Drug Innovation 6: Dealing with Drug-Resistant TB, November 30, 2012
Drug Innovation 7: IFPMA, Superbugs and Tropical Diseases, December 04, 2012
Drug Innovation 8: Treating Men's Cancer, December 20, 2012
Drug Innovation 9: Treating Lympho Leukemia and HIV/AIDS, January 10, 2013