Drug Regulation Patent

I-MAK takes on Sovaldi patents around the world


Screen Shot 2015-06-09 at 2.39.26 amThe Initiative for Medicines, Access & Knowledge (I-MAK), along with various other local organizations, has launched challenges on Gilead’s patent applications for it’s Hepatitis C drug, Sovaldi (sofosbuvir) in 5 countries – Argentina, Brazil, China, Russia and Ukraine. These 5 countries together account for about 30%-40% of the Hepatitis C patients in the world (about 40 – 60 million out of an estimated 150 million to 185 million patients across the world). However, for reasons best known to Gilead, these 5 countries are amongst the 50 odd middle-income countries that were excluded from the list of 91 countries that Gilead has allowed its 11 Indian generic company licensees to make sales to.

Gilead, as readers may remember, had a key patent application for Sovaldi rejected by the Indian Patent Office earlier this year for failing to clear Section 3(d). There too, I-MAK, as well as Natco, had submitted pre-grant oppositions. (Following a writ due to procedural infirmities, Gilead’s patent application has been remanded back to the patent office for a fresh hearing. However, there’s no reason to think that the patent office’s decision on merits will change). As per FirstWord Pharma, “The advocacy group stated that despite its efficacy, the active ingredient in Sovaldi was developed using existing knowledge and a previously existing compound. I-MAK co-founder Priti Radhakrishnan remarked “by freeing [Sovaldi] from unjustified patents, we can fight this deadly disease and get more people the medicine they need to live healthy, productive lives.” “.

While the US price is currently an obscene $84,000 for a 12 week treatment, licensed generic prices (Natco, for e.g.) are about $960, including a 7% royalty rate being paid to Gilead. This extreme price difference is already sparking interest in “Sovaldi” tourism! Nonetheless, Gilead has hit back with some stringent requirements including proof of citizenship and residency in some countries where the cheaper drug is available – raising fears that such restrictive conditions preclude poorer sections of the affected populace from accessing the drugs. Interestingly, a Bangladeshi company called Incepta Pharmaceuticals, recently came out with their own generic version of Sovaldi and as Sovaldi is not patented in Bangladesh, they are selling it for $900 in Bangladesh. Interestingly, not only did they quickly make their own version of the drug, they also got it onto the market quicker than most of the licensed companies. It’ll be interesting to see if Incepta charges into key middle income markets to compete with the licensed generics. With the freedom from Gilead’s restrictive agreement conditions and not having a 7% royalty rate to worry about, they could be very well placed to out-compete the licensed generics.

While some are saying that Gilead is proposing to charge $7,500 in Brazil, other reports say that prices for a 12 week treatment in these 5 countries are likely to range from $2,000 to $15,000. Meanwhile, a study from Liverpool says that the pills could be manufactured for as little as $101 per treatment. With I-MAK and its various partner organizations being fairly confident that Sovaldi is not deserving of a patent, it’ll be interesting to see if Gilead caves in and decides it is safer to include these countries in its licences, or if they’re confident enough that they’ll either be granted their patent, and/or won’t have non-licensed generic competitors to worry about in those markets.

For those who don’t remember/know, Gilead didn’t innovate the drug themselves, but bought the whole innovator company Pharmasset for $11 billion dollars in the end of 2011. After launching at the very end of 2013, Gilead sold $10.3 billion of Sovaldi in 2014 alone. It’s estimated that in total, Gilead has now sold over $16 billion of Sovaldi. In the meanwhile, the World Health Organization has included the Hepatitis C drug in its list of essential medicines, meaning the WHO believes its necessary for these drugs to be made available at an affordable price. The WHO is apparently in talks with Incepta, for its pre-qualification program for bulk purchases, and much of how this whole situation plays out may ride on this.

However, getting back to the trigger of this post — A huge round of appreciation to I-MAK and the various organizations they’ve partnered with, for taking up this incredible task of challenging these patents in these 5 crucial countries!!

For our previous posts on Sovaldi pricing, see

Access to Medicines for Hepatitis C: Part I – Gilead Annouces 300$ price for Sovaldi” and “Access to Medicines for Hepatitis C: Part II – Evaluating the Arsenal
Additional tidbit: Interestingly, even the hedge fund investors who reaped substantial profits off of Gilead, have been protested against recently!

Swaraj Paul Barooah

Swaraj Paul Barooah

Follow @swarajpb Swaraj has a deep interest in IP, Innovation and Information policy, especially when they involve issues relating to Access to Knowledge, Innovation incentive mechanisms, Digital Freedoms, Open Access, Education, Health and Development. After his BA, LLB (hons) from Nalsar Univ of Law, Hyderabad, he went on to do his LLM from UC Berkeley in 2010. He is now pursuing his J.S.D. degree from UC Berkeley where he is focusing on Drug Innovation Policy and Access to Medicines. Aside from SpicyIP, he is also engaged as a consultant on various IP matters, and is a visiting faculty member at Nalsar Univ of Law. He is also in the process of starting up a New Delhi based "IP, Innovation & Information Policy" focused think-tank.

One comment.

  1. Anonymous

    “However, there’s no reason to think that the patent office’s decision on merits will change”. I wonder how you reach this conclusion especially since the procedural infirmity pointed out was the lack of a hearing. The Indian Patent Office may change its mind once it gives the patentee an opportunity to be heard. Without hearing the arguments/ submissions made by Gilead in this second round, how do you reach this conclusion??

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