Drug Regulation Patent

Access to Medicines for Hepatitis C: Part I – Gilead Annouces 300$ price for Sovaldi


hep cAfter a huge outcry over its exorbitant price, Gilead Science is offering its Hepatitis C (HCV) blockbuster drug ‘Sovaldi’ at a significant discount in India. As the Times of India reports, Sovaldi will now be available at a price of 900$/12 weeks which is roughly 1% of the US price (a whopping 84,000$/12 weeks). This announcement follows earlier accords with Egypt and Doctors Without Borders to sell the drug at this discounted price to low income countries. With an estimated 3% of the world’s population infected with the disease and 170 million chronic carriers at risk of developing liver cirrhosis and/or liver cancer, HCV is fast overshadowing HIV/AIDS in urgency and severity. India alone has an estimated 12 million people who are chronically infected with HCV, with 96,000 deaths annually due to the infection. Coupled with the fact that majority of HCV patients are poor and uninsured, the issue of access to medicines for patients becomes more acute, particularly in the developing world. In Part I of this post, I briefly outline the recent developments in relation to the drug in India. In Part II I give a general overview of the advocacy leading up to the price announcement and examine the role of TRIPS flexibilites that promote public health in achieving affordable prices for life saving drugs.

Sovaldi: Patent position in India

Gilead filed two patent applications for ‘Sovaldi’ via the PCT route in 2005 – Indian Application No. 3658/KOLNP/2009 for the pro-drug form of Sovaldi and Indian Application No. 6087/DELNP/2005 for the base product. This application subsequently divided out into pending divisional applications 1870/DELNP/2011, 1871/DELNP/2011 and 2079/DELNP/2011. Earlier in November I-MAK (Initiative for Medicines, Access and Knowledge) initiated a pre-grant opposition against the pro-drug patent on the grounds of violation of Section 3(d), lack of novelty and inventive step. A detailed analysis of these grounds can be found here. Subsequently I-MAK and the Delhi Network of positive people (DNP) also initiated a pre-grant challenge against the main base product patent and its divisionals on the grounds of prior claiming, lack of novelty, lack of inventive step, Section 8 violation(not furnishing foreign filing particulars) and the lack of enablement. The pre grant opposition can be accessed here. Both the oppositions are pending at the patent office.

Natco also filed a pre-grant opposition in April this year on similar grounds of obviousness, lack of novelty and section 3(d).

However, Gilead’s obstacles are unlikely to stop with these pre-grant oppositions. Even after significant price reduction at 900 USD (roughly Rs.54, 000) for 12 weeks Sovaldi remains unaffordable to many. As mentioned above, India alone has approximately 12 million people infected with Hepatitis C Virus, with 96,000 fatalities annually due to the infection. India is also home to 2.1 million people living with HIV and a huge number of people in this category are co-infected with HCV. Also depending on the duration of treatment 12 weeks -24 weeks the cost also increases. If I-MAK prevails in the pre-grant oppositions it may pave the way towards introduction of low cost generic versions in India. If not, it will be open to generic manufacturers to file for a compulsory license for the drug. One of the grounds for the grant of a CL is that the patented invention is not available to the public at a reasonably affordable price [section 84(1)(b)]. The IPAB in the Bayer CL case clearly held that “reasonably affordable price necessarily has to be fixed from the view point of the public.” Whether 300$ a bottle is reasonably affordable for the Indian public remains suspect. Will this fact persuade a further cut from Gilead? Look out for Part II for more. 

A special thanks to Madhulika for her inputs and suggestions.

2 comments.

  1. MADI

    EFFORTS SHOULD B MADE TO MAKE AVAILABLE THE DRUGS TO THEM WHO NEEDS IT IMMIDAITELY IRRESPECTIVE OF LEGAL AND POLITICAL HURDLES

    Reply
    1. Aisha

      Plz can u let me know about the availability of sovaldi in any of the liver
      Hospitals in North India??plz sedan rply in my mail..

      Reply

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