IPR and Medicines 28: Politicizing Innovation, Rewarding Rent-Seeking

Indian government's intellectual property rights (IPR) system for medicines seems hazy. For instance, it did not give full patent protection for medicines before, until India joined the WTO in 2005. Even then, many innovator drugs have no IPR protection, like the case of popular anti-leukemia drug molecule imatinib, brand "Glivec" or "Gleevec" made by Novartis.

According to wikipedia, anti-chronic myelogenous leukemia (CML) drug imatinib, "more than 90% of patients will be able to keep the disease in check for at least five years, so that CML becomes a chronic, manageable condition."

So Novartis in effect is sort of a "hero" to many leukemia patients for coming up with this revolutionary drug. But many sectors in India (and elsewhere around the world) did not look at it this way. Rather, Novartis is looked upon as a blood-sucking multinational who profits from the sick and dying leukemia patients. Thus, its effort to seek IPR protection through a patent was not recognized by an Intellectual Property agency or office in India. So it went to the Indian Supreme Court to obtain such patent and after about a decade of legal and health debates, the SC has ruled against the company's request.

From wikipedia article about leukemia, there are four kinds of this disease. Their respective medication are as follows (image also from wiki):

(1) Acute lymphoblasticinduction chemotherapy.... For adults,... prednisone, vincristine, and an anthracycline ....L-asparaginase or cyclophosphamide. For children... (prednisone, L-asparaginase, and vincristine)Consolidation therapy or intensification therapy ...  antimetabolite drugs such as methotrexate and 6-mercaptopurine (6-MP) 

(2) Chronic lymphocyticcombination chemotherapy with chlorambucil or cyclophosphamide, plus a corticosteroidsuch as prednisone or prednisolone....  fludarabine, pentostatin, or cladribine.... Younger patients may consider allogeneic or autologous bone marrow transplantation.

(3) Acute myelogenousMany different anti-cancer drugs are effective for the treatment of AML

(4) Chronic myelogenousstandard of care is imatinib (Gleevec) therapy

For Hairy cell leukemia,  . cladribine, ...  pentostatin... , rituximab ... Interferon-alpha. And for T-cell prolymphocytic...  purine analogues (pentostatin, fludarabine, cladribine), chlorambucil, and various forms of combination chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone CHOP, cyclophosphamide, vincristine, prednisone [COP], vincristine, doxorubicin, prednisone, etoposide, cyclophosphamide, bleomycin VAPEC-B). Alemtuzumab...

So there are many existing drugs against leukemia, depending on the cell type and on whether it is acute or chronic. So they are all non-patented or off-patent already in India?

Novartis and other innovator companies are brave to introduce their new and more revolutionary medicines to Indian patients without IPR protection. Or if they have have one, they have to live with the fact that a patent-confiscation government tool called compulsory licensing (CL) can be imposed by the Indian government anytime.

One result of this situation is an uneven competition. An innovator company that spent huge amount of money and many years in R&D and multiple clinical trials, must sell at a high price to recoup its high spending. Then generic producers that spent nothing to discover the original drug molecule but can produce their own brands of the same molecule can sell at a much lower price.

How can the former adjust with this reality? Plain old economic sense would dictate market segmentation -- different (or tiered) pricing for different buyers or patients with different budget. And for really poor patients, zero cost to them via public-private partnerships or via civil society partnerships. I am told by a friend that Novartis in India has various drug donation programs, like partnership with the Max Foundation, a cancer patient advocacy organization, and gave the Glivec International Patient Assistance Program (GIPAP) providing more than US$ 1.7 billion worth of Glivec to poor patients in India. In effect, the company was giving not cheap but free medicines to the poor, funded by high pricing to richer patients who can afford it.

I also read this interesting article, and I like the first of six "side effects" of the Glivec ruling in India: Patenting is a political act. It is not a scientific or economic act. One must go through strictly political process to obtain a patent. Or if one has it, go through the same political process to retain and protect it, until the patent has  expired. The author, William Looney, wrote,

what constitutes true innovation in an age where scientific advances are transforming the very definition of a drug?  This is a question that extends far beyond patent law into basic value judgments like how society should spend limited resources on medical technologies, in a way that balances patient access with the economic incentives needed to seed their development in the first place.  

It is not good to politicize innovation. There is too much politics in our lives already. Wages, fares, prices of certain commodities, setting up a business, closing a business, hiring and firing workers and managers, they are covered by politics. To extend politics to products of scientific discovery, when none of the money spent for such activity came from taxes, is OA.  

The climate for IPR in India has become more uncertain. Last year, the Indian government issued their first compulsory license, which permits local companies to make generic copies of a patented medicine for a small fee. Since January 2013, three additional compulsory licenses were issued for three different cancer drugs.

As more politics raid products of innovation, more rent seeking behavior is rewarded. This is not the proper role of government, to pick winners and losers based on certain subjective if not arbitrary criteria. The proper role of the government in this case, is to leave players to do their own thing so long as public health is not endangered. So if there are 30 or 50 innovator companies who would race with each other in producing a new medicine against prostate cancer or breast cancer or other killer diseases, so be it. These are on top of existing drugs and treatment against those diseases that are off-patent already. Let those innovator companies price their own products. For sure, competition among them will force them to develop various types of pricing and drug donation programs.

Less politics, less government intervention in the drug innovation business and competition. This is one cool way to ensure that present and future patients suffering from killer diseases can find solace and hope to lengthen their lives.

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See also:
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
IPR and Medicines 26: Novartis' Glivec and India's IPR Ruling, April 01, 2013, 
IPR and Medicines 27: More on Glivec and India's SC Decision, 

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.