Flawed patents on hepatitis C drugs latest to be challenged in global push for access

New Delhi/New York, 13 February 2017

Five new challenges against patents on crucial new medicines to treat hepatitis C filed in India and Argentina are the latest in a global push to ensure access to affordable treatment. The patent challenges could remove barriers to production and distribution of affordable generic versions of direct-acting antiviral (DAA) medicines, including sofosbuvir, daclatasvir and velpatasvir.

 Today in India, the Initiative for Medicines, Access & Knowledge (I-MAK) together with the Delhi Network of Positive People (DNP+) and supported by Médecins Sans Frontières (MSF), filed four cases: two patent challenges on daclatasvir, one on velpatasvir and a further challenge on sofosbuvir. Separately, in Argentina, Fundación Grupo Efecto Positivo (FGEP) filed a patent opposition on sofosbuvir with support from I-MAK.

Today’s filings are the latest attempts to overturn the abusive strategies of pharmaceutical corporations like Gilead who exploit the flaws in the patent system to obtain unjustified patents that block generic competition.

“80 million people worldwide are living with hepatitis C, and we need a wide range of combination treatments available at an affordable price. With patents blocking generic competition, treatment remains prohibitively expensive in many countries,” said Jessica Burry, pharmacist for MSF’s Access Campaign. “Sofosbuvir, velpatasvir and daclatasvir are all crucial to our line-up of first line treatment options that cure people of hepatitis C and stop the progression of liver disease.”

Patents on drugs not only prevent affordable generic versions from being produced or imported, but also restrict progressive innovation that could otherwise benefit patients. More than a decade ago, patent barriers were overcome to allow generic competition of antiretroviral (ARV) drugs, used to treat HIV, causing prices to drop by 99% and enabling more than 18 million people to access treatment today.  The lack of patent barriers also enabled generic pharmaceutical producers to develop improved ARV combination treatments and new formulations to serve unmet patient needs. 

There are multiple patent barriers that prevent the manufacture or importation of low-cost, quality DAA medicines, particularly in high- and middle-income countries.  Patent challenges – or patent oppositions as they’re more commonly known – are one strategy to open up access to millions of people left without affordable treatment options, after other strategies to directly engage pharmaceutical corporations have largely failed.

“Together with civil society groups, we have filed legal challenges on multiple invalid patents on three different hepatitis C drugs,” said Tahir Amin, Director of Intellectual Property for I-MAK. "It is time to challenge the unchecked power that pharmaceutical corporations hold through abuse of the patent system.”

People living with HIV, in collaboration with health organisations and legal aid groups, have already filed challenges to ‘evergreening’ patents on the drug sofosbuvir in several countries. ‘Evergreening’ refers to the practice of filing additional patents to extend the length of monopoly control over a product, and these challenges have successfully reduced the length of the monopoly for sofosbuvir in the EU and revoked a key patent on sofosbuvir in China and Ukraine. Decisions on challenges to sofosbuvir patents are pending in other countries, including Argentina, India, Brazil, Russia and Thailand.

“By systematically applying pressure to remove patent and regulatory barriers that stand in the way of production of more affordable generic versions of direct-acting antiviral medicines used to treat hepatitis C, civil society and vulnerable communities have already supported the introduction of generic competition in India and Egypt, where prices dropped to below USD $300 per 12-week treatment last year,” said Leena Menghaney, Head of South Asia for MSF’s Access Campaign.  “But the benefits of these price reductions are not available to all those who need treatment, particularly those people living in middle-income countries with high burdens of hepatitis C.”

Egyptian and Indian generic suppliers face multiple intellectual property barriers in the registration and export of DAA medicines to several middle-income countries. While licensing deals struck between Indian generic companies and pharmaceutical corporations enable access to lower-cost medicines for India and least-developed countries, by far the greatest burden of hepatitis C disease is found in middle-income countries. Many of these countries, including China, Ukraine, Thailand, Malaysia and Brazil, are excluded from licensing agreements that could enable importation of raw materials (active pharmaceutical ingredients, or APIs) or finished formulations of DAA medicines.

“Despite the deadly toll of the hepatitis C epidemic, Gilead and Bristol-Myers Squibb still have far too much control over who can access their lifesaving DAA medicines, and the lack of access is ultimately costing people their lives,” said Loon Gangte, Regional Coordinator, International Treatment Preparedness Coalition-South Asia and Founder of DNP+. “Millions of people in India can’t afford the generic treatments strictly licensed by Gilead and BMS, and millions more people in high- and middle-income countries can’t legally purchase the generic medicines currently being produced in countries like India and Egypt.  We need a sustainable supply of low-cost, quality hepatitis C medicines to save lives and contain the disease in all countries."

Additional Notes for Editors:

Gilead has licenced sofosbuvir and velpatasvir to 11 generic manufacturers in India, but the number of countries able to access these generic versions represents only half the global burden of disease. A detailed analysis of the licensing agreement is available here: https://msfaccess.org/content/msf-analysis-gilead-hepatitis-c-license-march-2015

Egyptian companies were not included in any licensing deals and have freedom to operate and supply low cost generic DAAs where there are no granted patents. Once patents are granted in a country, they have a chilling effect on the introduction of more affordable DAAs that are essential to create universal access to the cure for hepatitis C. 

List of oppositions

In India, two cases challenge the crystalline forms of sofosbuvir and daclatasvir and should be rejected for not being in compliance with Indian law.  India's law recognizes that crystalline forms of known medicines are not inventions and should not be awarded patents. This approach was confirmed by the Indian Supreme Court on 1 April 2013, which refused a patent by holding that a crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step (Novartis vs Union of India).

A critical third opposition shows that the patent on velpatasvir is an obvious structural change to an earlier hepatitis C drug, ledipasvir.  This is a classic example of Gilead gaming the patent system in order to strengthen its control on the hepatitis C market. The fourth opposition also seeks to open up the supply of raw materials from India by challenging the patent on the intermediate form of daclatasvir.

In Argentina, people living with HIV have challenged the patent on sofosbuvir in light of evidence that discloses substantially similar antiviral compounds for treating hepatitis C. Civil society has a strong case as Gilead has also failed to fully disclose/describe the invention claimed in a sufficient manner, a requirement of patent law that is often ignored by pharmaceutical corporations.

Copy of these patent oppositions filed in India are available on Patent Oppositions Database (an online platform that provides support, information and collaborative tools for groups and individuals wanting to challenge patents on medicines) and can be accessed using the following links:





I-MAK, Indian Health Advocates Appeal Patent Office Reversal on Gilead’s Hepatitis C Drug

Patent and Health Experts Denounce Indian Patent Office’s Sofosbuvir Reversal, Vow to Fight for Public Health and Accountability to the Law

CONTACT: Niketa Kumar, Niketa.Kumar@berlinrosen.com, (646) 200-5289

Anjali Cadambi, Anjali.Cadambi@berlinrosen.com, (503) 984-4020

NEW YORK – To ensure Gilead cannot claim existing public knowledge as its own and help the millions of people around the world with hepatitis C get the medicine they need to survive, the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) filed an appeal today with the Delhi High Court. I-MAK and DNP+ are appealing the Indian patent office’s deeply flawed about-face granting Gilead an unmerited patent for sofosbuvir, the base compound in its hepatitis C drug. Last year, the Indian patent office rejected Gilead’s patent, ruling that the main compound in sofosbuvir was a “molecule with minor changes” and has the “same use in treatment of HCV infection and flavivirus injection” compared with an earlier compound.

“The facts of the case are undeniable: sofosbuvir, the base compound in Gilead’s hepatitis C drugs, was developed with previously published techniques that have been used repeatedly in other antiviral drugs,” said Tahir Amin, co-director of I-MAK. “Despite the growing pressure on India’s patent office from the U.S. trade regime and from Gilead’s manipulative licensing deals, we’re confident that we will win and ensure the Indian patent system stays accountable to the integrity of the law and to the public’s health.”

I-MAK and DNP+ have filed the appeal on the grounds that the Indian patent office’s latest and unfounded decision is contrary to the public interest, fails to assess the full scientific and legal evidence presented and ignores key Indian patent law and judicial precedents. 

As recent news reports have detailed, the Indian patent office and officials at the highest levels of the Indian government are facing heavy pressure from the U.S. and pharmaceutical companies like Gilead to weaken patent laws and policies in favor of corporate interests. Following challenges by I-MAK and its partners, China, Ukraine and Egypt have already rejected Gilead’s sofosbuvir patents. 

“The health and wellbeing of millions in India, and around the globe, depends on the rejection of unmerited patents, which create barriers to treatment and block access to life-saving drugs,” said Loon Gangte of the Delhi Network of Positive People and Regional Co-ordinator of ITPC-South Asia. “This latest decision by the Indian patent office will only deepen the public health crisis, and force millions of patients around the world to continue to pay exorbitantly high prices. Patients everywhere, including those countries with high HCV burden excluded by Gilead’s licenses deserve affordable access to care, so that they can lead healthy lives.”

Despite the company’s rhetoric, Gilead’s licensing deals – in India and other countries – are designed to serve the company and increase profits, not to serve patients and increase access to needed hepatitis C drugs. Like unmerited patents, these schemes manipulate the market, violate patients’ rights and block millions of people from getting life-saving medicines.

The hepatitis C virus, which the World Health Organization has called a “viral time bomb,” affects about 150 million people globally. This month, the Centers for Disease Control and Prevention released new data which found hepatitis C kills more Americans than any other infectious disease.

I-MAK’s successful patent challenges in countries around the world have helped government health programs and patients save hundreds of millions of dollars and get the medicine they need to survive and lead healthy lives.


Gilead denied patent for hepatitis C drug sofosbuvir in India

14 January 2015

The Indian Patent Controller has today rejected one of Gilead’s key patent applications which covered the drug sofosbuvir, used to treat hepatitis C (HCV). The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.


Challenges to some of the most important patent applications on sofosbuvir (a ‘patent opposition’ - a form of citizen review allowed in many countries) were filed in India by the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013 and March 2014.


Gilead has signed voluntary licence agreements with multiple generic producers in India, but these agreements impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restrictions on medical providers and patients with respect to distribution and use of the drug. With the patent being denied, other companies that have not signed the licence are now free to produce. Entry by additional generic manufacturers should increase the open competition needed to bring prices down dramatically, especially in those countries that have been excluded from the voluntary licence agreement, and thereby increase access to the medicine. Countries where the drug is unaffordable, and which were excluded from the licences, should make every effort to import more affordable generic versions from other producers who did not sign a licence in India.


MSF is in the process of expanding treatment for people with hepatitis C in nine countries, and has been negotiating access to this medicine, which is expected to become the backbone of any HCV regimen in the coming years.


Below are responses to the news by Doctors Without Borders/ Médecins Sans Frontières (MSF), the Initiative for Medicines, Access &Knowledge (I-MAK.org), the Delhi Network of Positive People (DNP+), and Dr. Andrew Hill, Researcher at Liverpool University


“Sofosbuvir has proved to be a billion-dollar blockbuster drug and we hope today’s decision opens the floodgates for more open competition that could rapidly lower the price. This drug makes hepatitis C treatment more effective and easier for patients and doctors, so broad access to affordable versions will allow treatment to be scaled up dramatically.  Gilead’s drug access programme for developing countries is already showing its limitations, with the company planning to impose conditions for the supply and distribution of the drug to patients and treatment providers in developing countries, in order to protect the company’s ability to charge unaffordable prices in wealthy countries. Getting sofosbuvir out of the stronghold of Gilead’s monopoly will be crucial to expanding treatment for people with hepatitis C globally.


“India’s status as the ‘pharmacy of the developing world’ is once again in the spotlight and this is a good opportunity for generic producers in India to swiftly ramp up production to levels needed to treat the 185 million people infected with hepatitis C worldwide.” 

Dr. Manica Balasegaram, Executive Director, MSF Access Campaign


“The move to reject Gilead’s patent application really opens up the playing field, so we hope to now see many other generic companies starting to produce more affordable versions of this drug.  The bottom line here is that India’s patent law doesn’t give monopolies for old science, for compounds that are already in the public domain. Gilead’s strategy of charging as much as US$84,000 per treatment for a drug that is predicted to be simple and cheap to produce, and is now un-patentable in India, has been exposed for what it is – seeking to squeeze as much profit out of the sick as possible.”

Tahir Amin, lawyer and Director of the Initiative for Medicines, Access &Knowledge (I-MAK.org)


“This is a happy day for the millions of people who urgently need hepatitis C treatment across the globe. People with hepatitis C everywhere should be able to have access to this treatment, but millions of our friends in middle-income countries have been left out in the cold by Gilead. This decision provides hope that people in countries that have been excluded from Gilead’s licensing deals will be able to access low-cost generic versions of sofosbuvir.”

Vikas Ahuja, Delhi Network of Positive People (DNP+)


“We know from various manufacturers in India that they could produce this drug in the future for as little as $101 for the full three month treatment course.  That’s roughly $1 per pill, which is a big improvement over the $1,000 per pill Gilead is charging in some countries. At the current prices, sofosbuvir is unaffordable for widespread use in most countries of the world.”

 Dr. Andrew Hill, Senior Research Fellow, Department of Pharmacology and Therapeutics,

Liverpool University




Gilead attempt to secure patent on hepatitis C drug opposed in India

 ‘Patent opposition’ seeks to ensure production of affordable generics


New Delhi/New York, 22 November 2013—


Médecins Sans Frontières (MSF) supports the ‘patent opposition’ just filed at India’s Patent Office by the Initiative for Medicines, Access & Knowledge (I-MAK), which aims to prevent US pharmaceutical company Gilead/Pharmasset from gaining a patent in India on sofosbuvir, a drug for hepatitis C that is coming to market soon with an anticipated exorbitant price.


Gilead is expected to charge around $80,000 for one treatment course of sofosbuvir in the US. Even if offered at a fraction of this price in developing countries, this drug will be priced out of reach. The patent opposition—a form of citizen review allowed in many countries—offers technical grounds to show a drug does not merit patenting under India's Patents Act. This opposition was filed to ensure that affordable generic versions of sofosbuvir can be produced to help the millions of people infected with chronic hepatitis C in developing countries access the drug. 


“Old science, existing compound,” said Tahir Amin, lawyer and director of I-MAK.org. “India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it.”


Sofosbuvir is the first of several oral hepatitis C drugs expected to come to market in the coming year. It cures hepatitis C in a much shorter time period than today’s available treatment, and for some forms of hepatitis C, eliminates the need to use the injectable drug pegylated interferon, which can be difficult to administer and causes many serious side effects. Gilead is anticipated to receive marketing approval for sofosbuvir in the US on 8 December.


MSF has started providing hepatitis C treatment for a small number of people co-infected with HIV in its clinic in Mumbai, but cost (as high as $5,000 per patient) and complexity of today’s available treatment means that patient numbers remain extremely low despite considerable needs.


“In our projects, we need access to medicines like sofosbuvir that are easier for patients to take so we can expand treatment to more people. If the drug is unaffordable, the majority of the most vulnerable groups will remain untreated,” said Dr. Simon Janes, medical coordinator with MSF in India. “We know from our experience providing HIV treatment over more than a decade in dozens of developing countries that treatment needs to be simple and affordable—preferably less than $500 to start with. An unaffordable price for this drug will have a chilling effect on funders and governments who need to start financing and providing treatment.”


The World Health Organization estimates there are 184 million people infected with hepatitis C worldwide, with the disease causing half a million deaths each year. The vast majority of these people live in developing countries where—with the exception of Brazil and Egypt—there is no provision for universal access to hepatitis C treatment in public healthcare programmes.


“The world is waking up to a new crisis with hepatitis C,” said Olga Stefanishina of the Ukrainian Community Advisory Board. “More and more people are being diagnosed with chronic hepatitis C but are left to die because there’s no affordable treatment. With this patent opposition in India, we are starting the fight for better treatment that people can afford and governments can provide. We have no time to wait for charity or country-by-country negotiations—low cost generic drugs must be made available to all high-burden countries without discrimination.”


India has been called the ‘pharmacy of the developing world,’ because it produces many affordable generic versions of drugs patented elsewhere. More than 80% of the HIV medicines used in developing countries come from India, which is able to produce these medicines because its patent law sets the bar high for which medicines do and do not merit patenting, allowing generic manufacturers to compete for the market and drive prices down.


“The hepatitis C drugs coming out of the drug pipeline, including sofosbuvir, are compounds that are relatively simple and cheap to make,” said Dr. Andrew Hill, a pharmacologist at Liverpool University who has published a study showing that sofosbuvir could be produced for as little as US $62-$134 for a 12-week treatment course. “The profit projections for the oral hepatitis C drugs are staggering, and stand in no relation to what it costs to make these drugs.”





INDIA REJECTS SHAM PATENT APPLICATION FOR LIFESAVING HIV DRUG: Pharmaceuticals in India now free to help HIV patients worldwide

January 2, 2011


New York, NY – This weekend, India rejected an unmerited drug patent application, paving the way for access to lifesaving medication for HIV patients across the world. This groundbreaking victory for patients sets an important precedent to stop pharmaceutical companies from gaming the patent system, marking a new era of hope for millions of people living with HIV all over the world. 


This drug combination, Lopinavir/Ritonavir, is considered to be the front line of defense for HIV positive patients who have failed to stay healthy with the first round of medicines available today. India, the world’s leading supplier of affordable medicines, can now supply this drug to patients across the globe who are desperately waiting for treatment.


The impact of the case is tremendous. There are over 33 million people living with HIV today and of these nearly 15 million require access to HIV drugs. Cost-savings generated over a three-year period by introducing generic Lopinavir/Ritonavir to 43 low- and middle-income countries would be sufficient to start 130,000 new patients on HIV treatment who currently lack access. That is 130,000 lives that could be saved from opening up the market for this drug alone.


Cheaper generic versions of this drug are ready to reach patients in India and across the world. Most recently, the Clinton Health Access Initiative has negotiated a price of $440 per patient, per year for generic versions of this drug from four suppliers. Enabling competition amongst Indian suppliers has been demonstrated to consistently drive down prices on HIV medicines, from $10,000 per patient per year in 2000, to as little as $79 today.


This affordable pricing by generic suppliers in India is in stark contrast to the unaffordable pricing by Abbott Laboratories on HIV drugs across the world over the last decade. “Abbott’s track record on pricing this drug unfairly for poorer countries motivated us to take on this case”, stated Tahir Amin, Director of the Initiative for Medicines, Access & Knowledge, the not-for-profit organization who brought the legal action. “They have gamed the patent system for nearly twenty years to extend the patent life on this drug. The time has come to say, ‘enough is enough’.”


I-MAK reports that Abbott Laboratories holds at least 75 patents on Lopinavir/Ritonavir alone. The rejection of this patent application in India was for a combination of existing drugs and techniques. The Indian Patent Office has put a halt to Abbott Laboratories patenting which, simply put, was not an invention.


For more information, contact Tahir Amin at 1-917-455-6601 or tahir.m.amin@gmail.com, or Priti Radhakrishnan at 1-917-703-2876 or priti.radhakrishnan@gmail.com.


Documents on the case are available at http://www.i-mak.org/lopinavirritonavir.


About I-MAK


I-MAK is a team of lawyers and scientists increasing access to affordable medicines by making sure the patent system works. We work globally to ensure that patents do not act as a barrier to research and restrict the public’s access to affordable medicines. We offer free legal assistance to patients worldwide on issues of access to medicines. Previously, I-MAK has supported patient groups in India in filing against the Lopinavir and Ritonavir patents individually, as well as against the known soft-gel capsule of this drug combination. I-MAK has also filed challenges to Abbott’s patent in Europe.