by Nomad
An Indian court has thrown a monkey wrench in an American pharma's plan to reap exorbitant profits from its Hepatitis cure.
This orally-administered drug, Sovaldi (sofosbuvir), was, from the clinical trial reports, not a life-long treatment, like HIV drugs but a genuine cure for the disease itself. The therapy required a 12-week therapy but at the end, the patient would be free of the disease.
In 2012, when Bristol-Myers Squibb (BMS) announced the final trial results conducted with Gilead Sciences for the treatment of hepatitis C (HCV), the news seemed too good to be true. A 100% cure rate within 12 weeks. The possible side effects, such as, headache, fatigue, and nausea, were minor compared to other treatment drugs.
All good news? A victory for modern medical science, right?
Not quite.
All good news? A victory for modern medical science, right?
Not quite.
According to a press release by Médecins Sans Frontières
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.
Although the corporate decision was widely criticized at the
time, the pharma companies seemed determined to put the profit margin at the top
of its priority. Some say that decision was indefensible.
Challenge in Indian Court
According to one report, this example of what some see as corporate extortion has been challenged in Indian courts. The Indian authorities have taken a strict approach to granting pharma exclusive patents in favor of generic production. In a recent patent decision, the Patent Office Controller of India rejected the patent application by Gilead on the grounds- admittedly weak- that the drug was not unique.
A look at the decision shows that a provision in India's law continues to stop patent applications if they fail to show sufficient novelty and inventive step -- and are subject to opposition.
With this decision, the court' has now effectively taken the patent controls out of the hands of pharma companies and under the control of generic manufacturers, without licensing from the US patent holder.
It wouldn't be the first time a Western pharma has met its match in India courts.
The pharmaceutical giant, Novartis was denied a patient in India for its high-profile cancer drug Glivec (imatinib).
That decision was appealed. However, much to the pharma's dismay, the high court upheld the lower court's decision to reject Norvatis's patent. That ruling was based on the grounds that the drug in question was, like the Gilead case, simply a newer version of a “known substance.”
In the present case, Gilead has not said if it will appeal the decision to reject its patent.
Inexcusable?
According to one source, this disease now kills more people than AIDS and is the number one reason for liver transplants.
Estimates by Indian health authorities say that the prevalence of HCV infection in India is around 1% in a total population of 1.22 billion. Authorities speculate that something around 19 million Indians are infected with HCV.
However, most people who have chronic Hepatitis C do not experience symptoms in the early stages or even in the advanced stages so without widespread screening those numbers are quite likely to be much higher.
The annual median per capita income in India stood at $616, the 99th
position among 131 countries. A year's salary therefore would not be enough to
buy a single pill. Clearly the issue is related to larger problems in the world
economies and
A
year ago, thirty-eight activists from 22 countries joined forces at the
first-ever Hepatitis C Virus (HCV) World Community Advisory Board (CAB) to
demand equitable access to treatment for hepatitis C virus (HCV) from six
multinational pharmaceutical companies.
Yet, as one advocacy group notes, AbbVie, Bristol-Myers Squibb, Gilead, Janssen,
Merck, and Roche refused to provide a plan for equitable access to treatment
for HCV.
All of the companies refused to commit to price reductions that would allow affordable access for low- and middle-income countries (LMICs), home to more than 85 percent of the 185 million people living with HCV. Even Roche and Merck, producers of older, soon-to-be-obsolete HCV drugs, refused to lower prices to affordable levels.
Shiba Phurailatpam, regional coordinator of the Asia Pacific
Network of People Living with HIV/AIDS (APN+). declared:
“This level of greed is inexcusable, and keeps the cure out of reach for almost everyone who needs these drugs."
Actually the issue not exactly as clear cut as all that.
The organization, Regulatory Affairs Professionals Society (RAPS) reported that Gilead Science, under pressure by health organizations and by negative publicity, agreed to make the drug available at a "cheaper" price in India.
In September 2014, it worked out a voluntary licensing arrangement with seven Indian generic drug manufacturers to produce the drug for sale in India and 90 other developing and middle-income countries.
The plan allowed Gilead to its brand name version in India for $900 (per pill), generic manufacturers would have been able to sell the generic form for less.
Now that arrangement appears to have been rendered null and void by the Indian courts. Judges have have now effectively taken the patent controls out of the hands of pharma companies and put it under the control of generic manufacturers without licensing from the US patent holder.
Gilead has not said if it will appeal the decision to reject its patent.
India Under Pressure
Intellectual Property Watch has in the past reported how the United States has attempted to pressure India to adopt intellectual property measures like those found in the US and in the European Union.
Intellectual Property Watch has in the past reported how the United States has attempted to pressure India to adopt intellectual property measures like those found in the US and in the European Union.
The question now anxiously being asked:
Can India, the “pharmacy of the world”, resolve the friction between pharmaceutical patents and access to affordable medicines without putting off foreign investors?
The decision by the India courts, according to health activists, has made the morally-correct call, but at what cost to future Western investment. Should any developing economy forced to choose between the health of its poor and abiding by patents rights that benefit the shareholders of foreign companies?
The pharma companies would argue that the first responsibility for any corporation is to its shareholders. They are not charitable institutions. Additionally, patents -like humans- have a limited lifespan before becoming available for generic manufacturing.
The patent holder therefore must make as much profit as possible during this time to cover the costs of research and development, clinical trials, marketing and other related costs. The question of morality (or mortality) never comes into it, as far as they are concerned.
And they have every reason to fight India (or any developing country) on the challenge to this business model.
Ironically, as it stands, it could now be cheaper for HCV patients in Europe and even in the US to travel to India for the 12-week drug treatment - half-way around the world- rather than to pay the lofty price that American pharma corporation are demanding.
