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Battle in India

In Uncategorized on January 13, 2010 at 9:39 am

Novartis, Gilead and Generic Drug Production

Hemali Thakkar, Staff Writer

As the prices of drugs increase, it is becoming more difficult for those living in the developing world to access generic drugs. One third of the world’s population lacks access to essential medicines, which translates to nearly one half of the population in the poorest regions.1

In recent years, India has become one of the main sources of inexpensive drugs for those living in the world’s low-income regions. Currently, Indian pharmaceutical companies provide two of the world’s most inexpensive therapies for treating HIV/AIDS. 1 Drugs manufactured in India cost as little as 1 – 2% of the price of those sold by large pharmaceutical companies, and a recent report on The World Medicines Situation illustrates that this is because “generic competition and differential pricing can contribute substantially to the affordability of medicines in low income countries.” 2 As a result, India’s cheap drug production makes drugs such as Tenofovir, an antiretroviral drug used to treat HIV, more accessible in resource poor settings. “There are many, many reasons why people are not getting access to essential medicines. [Generic drug production] is just one of the ways people are trying to rectify that imbalance,” says Dr. Kesselheim, M.D., J.D. in the Division of Pharmacoepidemiology and Pharmacoeconomics from Brigham and Women’s Hospital.3

With the rapid escalation of the middle class in India, pharmaceutical giants are ruthlessly trying to tap into this market by filing as many patents as possible on slightly modified forms of existing drugs.3 Section 3(d) of India’s Patents Act, enacted to safeguard public health, presents these companies with the biggest obstacle in their profit-seeking venture. In March 2005, India enacted Section 3(d) to curtail the ability of pharmaceutical giants from extending their patent rights on treatments that “do not result in increased efficacy” beyond a 20-year period by simply making small adjustments to already-known medicines.4,5 Not surprisingly, Swiss and US pharmaceutical giants Novartis and Gilead both challenged India’s Patent Act, Section 3(d) after having their patent applications for their respective drugs rejected by India’s Patent Office.6

Novartis and Gilead’s patents for already existing forms of treatment have led to a massive upheaval of response in the international health community. Protesters harshly criticized Gliead’s patent for Tenofovir and Novartis’s patent for Gleevec, a drug used to treat chronic myeloid leukemia because both drugs consist of already known substances and are not patentable under Section 3(d).

In response to such protests, these multibillion-dollar drug companies argued in their 2006 statement to the NGO community that patents “save lives by stimulating research.”7 Nevertheless, according to the world’s leading independent medical aid organization, Médecins Sans Frontières, “granting the patent would set a dangerous precedent,” thereby further limiting access to drugs in resource poor areas.8 The knowledge-action gap, which refers to the gap between our knowledge of disease and the implementation of that knowledge for the design and production of health systems, is widening. “There are problems with even getting the cheapest generic drugs to people who need them,” asserts Dr. Kesselheim.3 As a result, the number of drugs capable of treating global illnesses is increasing while access to such drugs in these resource-poor settings remains extremely limited.

Gilead slyly attempted to combat its patent challengers by providing voluntary licenses to these generic drug production companies in India. In return, these Indian companies were required to withdraw their patent opposition to Gilead and give the company exclusive rights to a drug that was not patentable under Indian law. 5 Gilead’s voluntary licenses have limited the sale of the drug to only India, allowing Gilead to maintain its competitive edge in markets in other parts of the world while preventing access to cheap versions of the same drug to those regions.

The conflict between large pharmaceuticals and Indian drug companies has united health experts, activists, local Indian pharmaceutical companies, and also those living with illnesses such as HIV/AIDS in preventing these pharmaceutical giants from restricting India from mass-producing generic drugs.

In August 2006, health activists celebrated the rejection of the Gilead patent challenge by the Madras High Court of India. According to Médecins Sans Frontières, granting the patent to Gilead would have prevented the cheap production of essential drugs until 2016, inhibited future generic drug production, and set a precedent for other pharmaceutical giants to follow suit. 8

With the battle against large pharmaceuticals still raging, India remains the leading generic drug manufacturer of the world, not yet infected by pharmaceutical giants. Nevertheless, the future is still unclear as pharmaceutical companies attempt to maneuver around India’s 2005 Patent legislation.

As the WHO claims, “by 2015, over 10 million deaths per year could be avoided by scaling up certain health interventions, the majority of which depend on essential medicines.”9 The question remains whether India will rise to meet these challenges in the coming years.

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1 Ramesh, Randeep. “Drug firms seek to stop generic HIV treatment”. NATAP. October 1, 2009 <http://www.natap.org/2006/news-Updates/051106_03.htm&gt;.

2 World Health Organization, “The World Medicines Situation”. 2004: 1-145.

3 Kesselheim, Aaron. Telephone INTERVIEW. 24 October 2009.
4 Batty, David. “The battle for cheap Aids drugs”. The Guardian. September 27, 2009 <http://www.guardian.co.uk/world/2007/may/09/aids.comment&gt;.
5 Park, Chen. “The Struggle for Affordable Medicnes”. Infochange. September 27, 2009 <http://infochangeindia.org/200703136078/Trade-Development/Backgrounder/The-struggle-for-affordablemedicines.html&gt;.

6 “The Novartis Case and Access to Affordable Drugs”. Care. September 27, 2009. <http://www.care.org/newsroom/articles/2007/06/20070613_novartis.asp&gt;.

7 Novartis. “An open letter from Novartis regarding the Glivec legal challenge in India”. January 29, 2007. <http://www.maketradefair.com/assets/english/novartisopen-letter-organizations.pdf&gt;.

8 Médecins Sans Frontiéres. “MSF Supports Opposition to Giliead’s Tenofovir Patent Application in India”. October 1, 2009. <http://doctorswithoutborders.org/press/release. cfm?id=1793&cat=press-release>.

9 World Health Organization. “10 facts on essential medicines”. October 17, 2009. <http://www.who.int/features/factfiles/essential_medicines/en/&gt;.

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