Indian Court Limits Frivolous Drug Patenting, Clearing Path to Affordable Medicines

Should pharmaceutical patents—which result in monopolistic pricing of medicines—apply to any new drug, regardless of how it was made and whether it offers anything new?

This question was answered recently in a courageous decision by the Intellectual Property Appellate Board of India (IPAB), in a suit brought by Open Society Foundations’ grantee the Lawyers Collective on behalf of Sankalp Rehabilitation Trust, a Mumbai organization that works with drug dependent patients. In this case, IPAB ruled to revoke the patent held by the pharmaceutical company Roche for its hepatitis C drug, Pegasys, on the grounds that the process used to develop the medicine was not novel or innovative enough to warrant a patent. Since patented Pegasys costs between US$10,000-15,000 per treatment, this ruling is an important first step toward making hepatitis C medicines more accessible by allowing for future production of more affordable generics.  

IPAB’s decision was made possible because of India’s stringent patent law which includes safeguards to address public health needs. For example, the law prevents companies from obtaining patents on medicines that don’t involve an ‘inventive step’—i.e. the process to make the medicine cannot be obvious to those skilled in the art. This was the main argument used in the Pegasys case. Another critical safeguard prevents patents from being granted on medicines that show no significant therapeutic benefit beyond existing drugs. These safeguards, and India’s ability to make quality medicines in its own factories, has kept generic drug production high while keeping prices low. In fact, India has been dubbed the pharmacy of the developing world, most notably for HIV/AIDS medicines. The IPAB decision may mean that India will become the supplier of affordable generic treatment for hepatitis C, a disease affecting roughly 180 million people worldwide but for which treatment—as also highlighted in previous blogs—remains unaffordable. 

Drug companies consistently argue that patents are needed to stimulate innovation and to cover the costs of developing new medicines. The truth however, is that real innovation is rare. Most medicines brought to market in the last two decades are so-called ‘me-too drugs’—medicines that present no therapeutic benefit beyond existing drugs. And as one of the most profitable industries in the world—fourth only after mining, crude oil production, and commercial banking—profits for multinational drug companies are astronomical. Take Pegasys for example. In 2012 alone the drug generated nearly US$970 million in sales, and has been on the market for years.  Suffice it to say, Roche has already recouped its research and development costs. The time is ripe for affordable generic alternatives and substantial price reduction of this medicine. 

As a victory for civil society organizations involved in increasing access to medicines, IPAB’s decision sets the important precedent that NGOs represent the public interest—despite Roche’s claims that NGOs and patient organizations like Sankalp are not legitimate third parties with the authority to challenge patents. While the court sided with the patients in this case, trade negotiators from the US and EU are pressuring the country to take away the right to challenge patents—even if experience shows that frivolous patents abound.  Through so called “free trade agreements,” including with India, Western governments are pushing for stronger intellectual property protections on pharmaceuticals all over the world, and asking poorer countries to deny NGOs the ability to challenge patents. 

As the Don’t Trade Our Lives Away Listserv highlights in countless examples, the battle for affordable medicines is taking place all over the world. The Pegasys case is one victory, but many more are needed to ensure that the millions of people who cannot afford expensive drugs have access to lifesaving medicines.

18 Comments

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as a bereavement mother, for the last 18 years President of a childhood cancer foundation, representing Latam at the International Confederation, I am working at Int´l working groups on Advocacy and EM access for kids with cancer. I would like to know more about OSFs work in that sense and future actions. Thank you!!

Strategists for future battles against frivolous drug patents claims may consider the following approaches:

1. All drugs, like all agricultural and industrial products, have natural components and, hence they are already cost-of-material subsidized; the drug companies must show this component item by item in their accounts and, make it public.
2. All inventions are based on past knowledge and, hence they are already cost-of-knowledge subsidized; this component too should be reflected in the accounts.
3. These subsidies must get reflected in the price of drugs.
THESE ARGUMENTS CAN BE EASILY FORMULATED IN LIGHT OF CONDORCET'S POLEMICS AGAINST DIDEROT ON COPYRIGHTS in his FRAGMENTS ON THE FREEDOM OF THE PRESS, 1776.

Having worked for the UN in the developing world for over twenty years, and now retired, this has been one of the most important and much discussed really criminal activities which whould be regulated most firmly and legally.

In Bangladesh, a medical and agricultural center away from Dakha produced it own medicines as they could ot afford Merck, Glaxo and so on. I have Hepatitis C and, unless the new cure, if it does work, comes on the market, Abbott will make at least US$80 billion, but I will not be able to afford the cure. That is really neaither here nor there, but there are many people throughout the world who die from lack of the correct and affordable medicines. I am, therefore, with you all the way, as usual.

My very best wishes.
diana m de marco

As a Pharmacist myself I support the protection of innovation, but I hate cheating and greed. Adding value to an existing drug molecule cannot in my opinion be termed innovation. I therefore support the Court ruling on this matter.

This is a necessary step to combat unscrupulous pressur e from EU and US

This is the first step thanks to OSF andSankalp Rehabilitation Center in spearheading affordable- generic drugs thgat are affordable for patients needing them. When a patent is awarded to any drug company -it is for a term certain for them to cover their costs in developing (R&D) NEW drugs-and not for altering 1 ingredient-1 new step (using baking formulas- result is the same). Drug companies are 'dusting off' old medicines- take Thalidomine for a new use- Roche has plenty of 'old medicines' that are now converted to 'NEW' medicines and no patent offices are even diligent in searching that drug companies once already had a patent or were selling said medicines. When EU and US are trying to pressure India for 'intellectual properties' in pharmaceutical manufacturing - it is really trying to estop patients in dire need of drugs/therapeutical treatments thus endangering their very lives. Public Health matters- affordable 'generic' or new introduction of existing medicines matters.

If the patent is frivolous and provides no added therapeutic benefit, why would the open society waste money on taking the case to court other than to make a political statement? I wish the money had gone to the poor patients instead, rather than the healthy lawyers.

People should be able to trust that affordable medicine will be there should they need it. There are no subsidies to jump in and take care of everyone no matter what. The mighty dollar is not more important than people's lives.

This is brilliant. Freeing the patients who need to live and live better from the greed factor of the pharma companies is just the right thing to do. Health is not a privilege, but a right. There cannot be a price tag for someone's "right".

Best regards,
Sam

We seniors with diganosed ed have this same problem with viagra/cialis/levitra. We have additional problem that NO insarance coverage is allowed. Religious beliefs?

Dear Open Society,

First, Thank you you George for making a huge difference in our world!! Drug treatments are astronomical. As for patents...I think businesses
need to work within some form of restraint. Courses of
these teatments are beyond most people tp pay. I hasten to add, we would be far better off addressing clean air, water and land. Carcinogenic substances are compromising what we drink, breath and eat. Consequently, our bodies are not able to keep up the fight against disease. Cancer and the breakdown of our bodies systems are the result. I would like to challenge OS to pursue initiatives to enforce good laws protecting our air, water etc. and not allow free passes to the most likely polluters who passed legislation to do just that. To operate outside the laws the rest of business and citizens are bound by. Immunology, plant based diets will reduce health care costs an estimated 80% over ones lifetime. Attack pharma by reducing their client base vs. their patent base.

Yours in the "Blessed Hope",

Peter

whish to get good support from the community

Thats cheating by the drug comppany and i wish the would pay for what ever the cost the public.

An extremely important and brilliant example on how to stop those bussinesses based on cheeting governments bodies and the public. An example to be followed by other civil society organizations in other countries, even though the process is sometimes time and money consuming. There is a need to strengthen collaboration among CSOa. Congratulationns to that Indian Court.

I do not believe that drugs should be produced for a profit nor should drug research be subject to private industry. All drugs should be available to anyone who needs them. I believe that funds should be taken away from the "defense" budget. Medicine and the care of people are more "defense" than killing them. I say this as a physician.

Thank you for your comments. Life-saving medicines should indeed not be treated as luxury goods, accessible only for those who can afford them. Different rules based on social justice and the right to health must govern their availability; a principle that was enshrined in international law as part of the Doha Declaration on the TRIPS agreement and Public Health, which allows countries to adopt public health safeguards when designing and implementing their patent laws. Unfortunately, countries like India are continuously challenged for exercising this sovereign right. In that context, we are eagerly awaiting a decision by the Indian Supreme Court on a case launched by the pharmaceutical giant Novartis that challenges section 3d of India’s patent law— a critical health safeguard that prevents frivolous patenting. For more information about this groundbreaking case, please visit the Lawyers Collective and MSF sites:

http://www.lawyerscollective.org/news/archived-news-a-articles/126-novar...

http://www.msfaccess.org/novartis-drop-the-case

If people could not afford the treatments, it makes no sense to have written Right to Health in UN charter........ The purpose of this drugs are all about saving more and more lives of people who are in vulnerable conditions, not for making chaos out of it

The decision by the Indian court is an important one as frivolous patents keep the prices of medicines high and make it impossible for many people outside the wealthy West to get the medication they need. I agree that is was important too that an NGO was allowed to challenge the pharmaceutical company in court as that is not the way the WTO (and the industries and Western countries) like to see it ;-). Thanks to OSF for making this possible.

But as you wrote: this struggle will not be over after this court decision. Large pharmaceutical companies will use all their international political, financial and juridical power to fight what they see as “an infringement on their rights”. A small NGO needs the backing of a large organization to OSF to be able to keep up the fight. It is important and very good that you support this so strongly ;-).

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