India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
As Gilead's HCV patents come under threat across the world should Pharma be worried?
Gilead Sciences has seen its fair share of global scrutiny over the past few years, initially related to its pricing strategy for HIV drugs, and most notably following the launch of its breakthrough Hepatitis C virus (HCV) drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir + ledipasvir). At the same time, the company is ranked fifth in the overall Access to Medicines Index, and tops the ratings for its equitable pricing strategies.
Indeed, the firm has taken several steps to ensure access to its treatments across a wide range of markets with variable levels of economic development either through exclusive contracts with generics manufacturers, or by adopting a three-tiered pricing model according to which prices vary by country based on average per capita income levels and the prevalence of hepatitis C in a given nation; the breakthrough treatment is heavily targeted by advocacy campaigns on a global scale.
Even in the United States, where the free market ideal is considered sacred, legislators and payers have raised concerns regarding the pricing strategy utilised by the firm for these curative HCV drugs In May of this year, Senator Bernard Sanders urged the US Secretary of Veterans Affairs (VA) to use his authority to override the HCV patents in order to expand treatment access to all HCV-infected veterans while managing to avoid incurring unsustainable costs on the programme. Nearly 220,000 veterans are estimated to be infected with HCV, however even with the negotiated VA discount on the HCV therapy, so far only 20,000 veterans have been treated for the infection.
Brazil, Russia, Ukraine, Argentina, and China
Last month, the Initiative for Medicines, Access, and Knowledge (I-MAK), a not-for-profit advocacy organisation announced that it had partnered with several international advocacy groups, including Brazil's Grupo de Trabalho sobre Propriedade Intelectual (GTPI), the All-Ukrainian Network of the People Living with HIV/AIDS, Russia's International Treatment Preparedness Coalition, and Argentina's Fundación Grupo Efecto Positivo (Fundación GEP), and filed multiple coordinated patent challenge lawsuits against Gilead in order to expand access to HCV drugs to millions of infected individuals globally. The lawsuits were filed in Argentina, Brazil, China, Russia, and Ukraine, where I-MAK has alleged that the US firm was "abusing patent laws by claiming existing public knowledge as its own", according to a press release issued by the advocacy organisation, specifically with regards to Sovaldi (sofosbuvir) that was developed using allegedly previously published data from an existing compound. The co-founder of the organisation, Tahir Amin, argued that Gilead is charging high prices for assets it allegedly does not own. Gilead has not provided an official response to the allegations in question yet.
Last week, I-MAK announced that China's State Intellectual Property Office (SIPO) has rejected Gilead's new prodrug patent application for Sovaldi. Although the firm still has another patent protecting the drug in China, the development is seen as a victory by I-MAK and brings the advocacy group one step closer to potentially allowing generic versions of the treatment to enter the market in China.
According to Médecins San Frontières, the cost of a 12-week course of treatment with Sovaldi could range between USD2,000 and USD15,000 in countries such as Brazil and China - keeping the treatment out of reach for the poorer populations. Meanwhile, a study at the University of Liverpool (UK) estimated the production costs for a 12-week supply of generic sofosbuvir to be around USD101. This of course does not factor in any additional costs or research and development expenditure.
Europe, India, and Egypt
The lawsuits against Gilead follow similar litigation filed by I-MAK in 2014 in Europe together with Doctors of the World (Médecins du Monde) and in India with the Delhi Network of Positive People where the patent for sofosbuvir is still pending. Gilead has appealed the latest Indian patent office ruling against Sovaldi in 2015, and according to I-MAK, Egypt rejected the sofosbuvir patent in 2014, although the government announced in July of that year that it had reached an agreement with Gilead to market the drug at EGP2,200 (USD307.67) per packet - a widely-known 99% discount compared to the price in the US.
A snowball effect?
Over 59 million individuals are estimated to be infected with HCV in Argentina, Brazil, China, India, Russia, and Ukraine - and over 180 million globally. According to Lorena Di Giano, the executive director of Fundación GEP, nearly 73% of those infected with HCV worldwide fall within middle-income countries, where infection rates are high and getting access to treatment at affordable prices remains challenging for low-income sub-populations. Although Russia is not considered a middle-income country, an estimated 6 million individuals are infected with HCV, and the cost of treatment for this substantial population is just "too high", according to Sergey Golovin, senior advocacy manager for the Treatment Preparedness Coalition. The World Health Organization has recently added Sovaldi along with other new HCV anti-virals to its Essential Medicines List, but it called for reduced prices in order to boost access.
In 2009, I-MAK, together with advocacy groups in India, won an HIV patent challenge against Gilead for its HIV/hepatitis B drug Viread (tenofovir), however intellectual property rights in India have been heavily compromised in the past. China took a similar stance on Viread in 2013. If I-MAK's current initiative against Sovaldi is successful, Gilead will probably face increasing challenges in these heavily populated markets, but it remains to be seen if the lawsuit claims will actually be upheld in court.
What would be even more concerning is if this form of global attack on intellectual property gains popularity and momentum, not just for HCV drugs, but for other premium-priced specialty medications such as new oncology drugs or novel cardiovascular treatments… and becomes a global industry-wide threat.
Interested in more on the pricing debate around Sovaldi? Access our recent study.
Margaret Labban is a life sciences analyst for IHS
Posted 26 June 2015
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