India grants GILEAD a patent for sofosbuvir – Page3

India grants GILEAD a patent for sofosbuvir

Patent for sofosbuvir, hepatitis C $1000-per-pill treatment


The patent for sofosbuvir granted to Gilead this week raises many concerns. It gives Gilead an unlimited control over their licensed manufacturers. Rumors spread saying that the medication purchase will be restricted to Indian residents and that the amount of the medication one can buy will be limited. Apparently, only one bottle will be sold at once, and the next one could be obtained only four weeks later, and only if the empty bottle is returned. The bar-code system could also be implemented to improve the control over the medication purchase and use.

For the moment these are only rumors. Even if these measures are actually taken, the practical implementation will take time and in some rural areas of India will be simply impossible.

Patent for sofosbuvir: the end of medical tourism in India?

patent for sofosbuvir no more generics in india

Sofosbuvir-based Indian generics (Ledifos, MyHep and others) are already sold only with hepatologist’s prescription. Their price – 20,000 rupees per bottle – seems extremely attractive to Americans and Europeans, but is sky-high for an average Indian. It is hard to image the bar-code scanning system in some areas that don’t even have electricity.

If these restrictive measures are taken, not only the new hepatitis C treatment will be out of most Indian’s reach, but it will also cut down drastically medical tourism in India.

Other countries

Sofosbuvir patents have been rejected already in China, Egypt and Ukraine. It is probably not a simple coincidence that Gilead granted two licenses to the manufacturers in Egypt.

The patent oppositions have been filed in several other countries, including Argentina, Brazil, Russia and Thailand.

What’s the fuss about? Hepatitis C Facts

The liver-destroying virus of hepatitis C affects about 180 million people worldwide. It is primarily transmitted through blood-to-blood contact, even though sexual transmission is possible in high-risk groups. In 80% of the cases, the undetected and untreated hepatitis C infection becomes chronic and can thus lead to liver stiffness, liver cirrhosis, liver failure and liver cancer.

Hepatitis C is considered to be one of the most common causes of death from infectious disease, according to the study of Center for Disease Control and Prevention in the US. In 2013, the annual mortality from hepatitis C exceeded the total combined number of deaths from 60 other infectious diseases, including HIV, pneumococcal disease, and tuberculosis. Worse even, this data is based on death certificates which often state the immediate cause and overlook the root cause – hepatitis C – so the actual numbers of hepatitis C deaths might actually be even higher.

Sofosbuvir is a highly effective substance with minimal side affects. It is listed on the World Health Organisation Essential Medicines List, making it a high priority drug for hepatitis C treatment. Sofosbuvir-based drugs Sovaldi™ and Harvoni™ are FDA-approved in the US. The patent for sofosbuvir and its prodrugs belongs to Gilead Sciences.



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India grants GILEAD a patent for sofosbuvir – page2

India grants GILEAD a patent for sofosbuvir

Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of medical tourism?


patent for sofosbuvir brings gilead moneyPatents are meant to protect the companies from generic competition, allowing them to get the return on their R&D investment and to use the profit to develop new formulations. Unfortunately, without competition – and that’s the case with a patent for sofosbuvir – the pharmaceutical companies can set the unprecedented prices.

In 2014, Gilead earned $10.3 billion with Sovaldi™alone, and $25 billion in total – and roughly a half of this figure in 2013. Sofosbuvir was initially developed by a small company Pharmasset, which was acquired by Gilead in 2011 for $11.2 billion. Therefore, all R&D investment was paid off long time ago.

So  today, who needs protection more  – Gilead from the competition or hepatitis C patients from atrocious pricing strategies?

Patent for sofosbuvir granted, and now what?

A day after the patent was granted on new hepatitis C treatment, patient groups and companies are already planning to challenge it. Many health advocates claim that sofosbuvir does not deserve a patent and prepare to launch an appeal to the Patent Office’s decision.

“Gilead’s sofosbuvir was developed with previously published techniques that have been used repeatedly in other antiviral drugs and therefore does not deserve a patent. In fact, Gilead’s unjustified patents for sofosbuvir have already been rejected by China, Ukraine and Egypt. With pressure growing from US trade regime and from Gilead’s manipulative licensing deals, the patent office’s latest decision ignores the truth about sofosbuvir and fails to uphold the standards of Indian patent law. I-MAK and the Delhi Network of Positive People (DNP+) will appeal the decision to ensure the Indian patent system stays accountable to the integrity of the law and to the public’s health.”  Tahir Amin, co-director of the Initiative for Medicines, Access & Knowledge


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India grants GILEAD a patent for sofosbuvir – page1

India grants GILEAD a patent for sofosbuvir

Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of medical tourism?


People before profit patent for sofosbuvir

Gilead Sciences was seeking a patent for sofosbuvir since 2014, and had already seen their application rejected by India’s patent office in January 2015. After the rejection appeal, India was forced to reverse the course. The patent for sofosbuvir, the direct-action antiviral treatment for hepatitis C and the active component of the scandalously priced Sovaldi™ was now granted to Gilead.

The Indian Patent Office of New Delhi claimed this Monday that sofosbuvir was “novel” and “inventive”. Surprisingly, just 16 months ago the same patent office said the drug represented only minor changes to a previous formulation, and thus lacked the patent requirements.

Gilead announced that this decision would have no impact on availability of the compound, which is already licensed to several generic manufacturers in India. Despite Gilead’s statement, there are rising concerns that this move can stop affordable copies of antiviral treatment for hepatitis C or significantly limit its availability.

If the patent was not granted, the non-license companies could have entered the hepatitis C market, forcing the price to go down. Most importantly, these companies, not limited by license agreements, could have supplied to the “restricted” middle-income countries.


Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of generic hepatitis C treatment?

license agreement

Licensing agreements between Gilead and seven Indian companies were signed as early as September 2014. The number of the licensees has now increased to 13. Eight of these companies (Hetero, Natco, Mylan and Cipla, among others) have launched sales in India and other licensed territories. The license allows the distribution of new hepatitis C drug in 101 developing countries. The goal of this voluntary licensing program and “partnership” with Indian manufacturers, according to Gilead, is to enable access to antiviral treatment for hepatitis C for as many people as possible, as quickly as possible.

The major complication is that these licensed territories are so-called “resource-challenged countries”; the middle and high-income countries are excluded from the scope. This leaves approximately 50 million of people suffering from hepatitis C without access to the affordable treatment. With the price that Gilead is charging for its original, branded drug, it is out of question that the “middle-income” patients can afford the treatment.

Sovaldi™ was launched in the US at a list price of $28,000 for a 28-tablet bottle, or $1,000 a pill.

The generic version is sold in India at about $14 per pill.

The cost of the hepatitis C 12-week treatment course is around $84,000 in US, $50,000 in France and $1200 in India.



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New treatment for hepatitis C from India

New treatment for hepatitis C from India

Generic sofosbuvir and ledipasvir – used in a combination as a new treatment for hepatitis C – will cost 1/90 of their US price

Despite its amazing efficiency, little side effects and short treatment course, the new direct-action antiviral, sofosbuvir (used together with ribavirin, daclatasvir or ledipasvir as a new treatment for hepatitis C), is only prescribed to a tiny fraction of patients. And no wonder! At $1,000 per pill, it is the drug that the majority of the developed world simply can’t afford.

Gilead, the owner of sofosbuvir patent in the US, has been widely criticized for its outrageous pricing strategy. In India, however, their approach is very different. In September 2014, Big Pharma signed voluntarily licensing agreements with seven Indian generic drug manufacturers. According to these agreements, generic version of sofosbuvir can now be produced for sale in India and 90 other developing and middle-income countries – with a much more modest price tag.

new treatment for hepatitis C produced in India

The licensees are free to set their own price. While Gilead planned to sell original Sovaldi™ in India for $900, generic manufacturers will probably sell it for even less. Even at this discounted price the drug still won’t be affordable to Indians, the critics say, pointing out that GDP per capita in India is only $1480.

India GDP and Sovaldi price
Based on Wikipedia data. Currency: Indian Rupees.

The manufacturing costs of 12-weeks sofosbuvir treatment are less than $150, according to expert estimation.

While the new hepatitis C drug remains too expensive for Americans in the US, for Europeans in Europe and for Indians in India, Indian generics will be perfectly affordable for Western population. Even keeping in mind the travel costs, hep C-related medical tourism in India is likely to flourish.

Some already propose innovative – and often daring – solutions to import new treatment for hepatitis C to their home country (read here).

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New hepatitis C treatment in India: People Before Profit or Smart Strategic Decision?

New hepatitis C treatment, sofosbuvir in India: People Before Profit or Smart Strategic Decision?

New hepatitis C treatment is novel and creative, but not novel and creative enough

new hepatitis c treatment in India


On 13 January 2015 India has rejected Gilead’s patent application for the new hepatitis C treatment, sofosbuvir. HCV advocates all over the world applauded to this brave decision, but little do we know about the reasons behind it.

India’s patent system: a reason for thriving pharmaceutical industry

India’s patent system is quite controversial, and particularly in what concerns pharmaceutical industry. Until 2005, only “process patents” existed according to India’s Patents Act. This basically meant that pharmaceutical companies could recreate another company’s product by simply making changes to production process. Process patent system was the reason why Indian pharmaceutical industry prospered and became one of the world’s largest.

India has made it to the list of the countries that “present the most significant concerns regarding insufficient [intellectual property rights] protection or enforcement”, according to United States Trade Representative.

The current India’s patent system was put in place in 2005 and allows the companies patenting the substance and not just the process of producing it. However, to avoid all the cheating when the companies make minor changes in order to refresh their patent, a provision was put in place (so-called section 3(d)):

“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant [are not inventions within the meaning of this act].”

Section 3(d) and the therapeutic efficacy requirement was cited in the patent office’s decision to reject Gilead’s patent application.

New hepatitis C treatment is novel and creative, but creativity is not the point

The decision agrees that the changes described in the application make sofosbuvir “novel and inventive.” However, “a molecule with minor changes in addition to the novelty must show significantly enhanced therapeutic efficacy as compared to the nearest prior art molecule which is structurally and functionally close,” decision says. This “closest prior art,” in case of sofosbuvir, is a compound D1 (patent WO2001/92282).

According to the Patent’s Office Decision, the application does not have sufficient data to prove this required therapeutic efficacy improvement. Attention though, it might only mean that Gilead needs to acquire more data before filing another patent application, and that the battle over the patent for the miraculously effective new hepatitis C treatment isn’t final yet.

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Big Pharma loses a battle for sofosbuvir patent

Big Pharma loses a battle for sofosbuvir patent…

new hepatitis C treatment in India

New hepatitis C treatment drug, sofosbuvir, was already patented in numerous countries, including the United States. On 13 January 2015, the Indian Patent Office made a striking decision that can become one of the most prominent ones in modern medical history. A patent application for the new direct-action antiviral drug sofosbuvir – used in a combination as the new hepatitis C treatment –  was rejected.

The main reason for rejection is that sofosbuvir lacks novelty or inventive manufacturing steps required under the Indian Patents Act.

How is it possible? Is this decision final?

Explanations here.

New hepatitis C treatment at affordable price? Myth or reality?

Final or not, this decision means that new hepatitis C treatment will be soon available – and at price that doesn’t bite, too! – to hepatitis C sufferers in India and poor neighboring countries. Some patients in middle- and high-income countries, where access to treatment is restricted, might also benefit from new affordable hepatitis C treatment in India.

Medical tourism always played an important role in India’s economy. For the last twenty years India has been a pharmacy of the third world’s countries, with its pharmaceutical industry ranking the 3rd in terms of volume and 14th in terms of value.

Big Pharma loses a patent… and signs licensing agreements to produce new hepatitis C treatment in India

Gilead, the pharmaceutical company applying for sofosbuvir patent, seems to be prepared for this turn of events. Three months ago, on 15 September 2014, it already signed voluntary license deals with seven Indian generic manufacturers. These deals will allow boosting the production in India by transferring Gilead’s manufacturing process to the licensees in exchange for 7% royalty payment. The generic manufacturers are free to set their own pricing strategy for Indian market. The launch of generic versions of sofosbuvir is expected by the third quarter of 2015.

Gilead was already accused for extortionate prices of new medicines for hepatitis C in the US. At $1,000 per pill, it is highly unlikely that the original version of Sovaldi™ can make it to the Indian market. This smart move with licensed generics will allow Big Pharma getting their share from new hepatitis C treatment in India and securing their revenue coming from the third world – the revenue that otherwise would not have existed at all.

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