Patent denied on Gilead's Hepatitis C drug Sovaldi

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26 Aug, 2025 12:21

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It's the controversial anti-evergreening patent law at work again. In what came as a shock to US biotech giant Gilead, the Indian Patent Office denied a patent for its blockbuster Hepatitis C drug Sovaldi, citing lack of invention. The order shakes the global pharma industry and opens up a legal can of worms.However, it is a big welcome step for Hepatitis C patients in developing countries as it opens up opportunity for cheaper generic versions of this drug, reports CNBC TV18’s Archana Shukla.Indian drug maker Natco and patient aid group I-MAK (Initiative for Medicines, Access &Knowledge) entity had filed pre-grant opposition saying the base compound, chemical name Sofosbuvir, is not inventive enough as compared to a previous known formulation.The order is a big set back for Gilead. The patent denial comes close to a decade after Gilead first filed its patent application and was close to a launch in the Indian market. Gilead's blockbuster drug Sovaldi changed hepatitis C treatment when it was approved in 2013 in US, as it cures the disease in nearly 90 percent of patients in a six month dose cycle. However, the patent denial has opened up the market and any company that has in-house technology to convert the base compound into pro-drug (Sovaldi) can manufacture and sell it in India. India has nearly 18 million Hepatitis C patients. The order has also placed Natco as a potential beneficiary, with industry speculating if Natco could be closer to a generic launch in India, which has nearly 18 million Hepatitis C patients. Natco, however, declined to comment.Pricing will be an important factor to watch out for the company that is ready to launch the drug. Girish Bhakru of HSBC Securities in a note said, "We believe pricing will be a critical factor in deciding the opportunity. We assume a USD 20 per pill in India against USD 1000 per pill in US is reasonable and translates to overall USD 3-5 billion opportunity."In an attempt to deal with the clamor on Sovaldi's exorbitant pricing of USD 1000 per day in the US, Gilead had announced a tiered pricing for developing markets. It was positioning to launch Sovaldi is India at a price of USD 900 for 12 weeks of therapy.Additionally, Gilead signed voluntary license agreements with 7 Indian generic companies to launch cheaper versions of Sovaldi in 91 low income countries, including India. The seven companies include Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. However, the deal saw opposition from patient-aid group.Dr Manica Balasegaram, Executive Director, MSF Access Campaign says, "Gilead's drug access program for developing countries is already showing its limitations, with the company planning to impose conditions for the supply and distribution of the drug to patients and treatment providers in developing countries, in order to protect the company's ability to charge unaffordable prices in wealthy countries. Getting sofosbuvir out of the stronghold of Gilead's monopoly will be crucial for expanding treatment to people with Hepatitis C globally."  Balasegaram added that this is a good opportunity for generic producers in India to swiftly ramp up production to levels needed to treat the 185 million people infected with Hepatitis C worldwide. The 7 generic companies under voluntary licensing had indicated pricing it lower than USD 300 per month. But now prices are expected to be lower and an export to countries outside the voluntary license deal is also possible.Tahir Amin, lawyer and Director, I-MAK in a statement said, "The bottom line here is that India's patent law doesn't give monopolies for old science, for compounds that are already in the public domain. Gilead's strategy of charging as much as USD 84,000 per treatment for a drug that is predicted to be simple and cheap to produce, and is now un-patentable in India, has been exposed for what it is - seeking to squeeze as much profit out of the sick as possible."The orderThe patent has been denied on the base compound of Sofosbuvir, while a version of pro-drug's (actual drug Sovaldi) patent application is pending approval at the Calcutta High Court.In his 35 page order, the patent controller has said that the data submitted by Gilead "cannot be considered sufficient and appropriate to show the enhancement of the therapeutic efficacy," hence failing the test of Section 3(d).Section 3(d) of the Indian Patent Act bars patents on different versions of a known compound, saying that such inventions are patentable only if "they differ significantly in properties with regard to efficacy."The order goes on to call for more clinical trial data. It says, "The applicants showed the cytotoxcity data to prove the difference in properties which is insufficient to prove significant increase in the therapeutic efficacy. The data does not show any clinical trials to prove the improvement in the therapeutic efficacy." Some patent experts say the order raises more questions than answers. Swaraj Paul Barooah of Spicyip said, the observation on therapeutic efficacy “seems a little off, as 3(d)'s 'known substance' should not (and does not) include any prior art simply because it is the 'nearest' prior art molecule that is structurally and functionally close.In his note, Barooah also added that by asking for such clinical trial data, the order opens itself up for criticism. "Asking for clinical trial data at the patent stage is asking for an excessively high level of proof, and certainly is unreasonable to ask." Gilead is expected to appeal against the order and this will certainly turn into a heated patent battle, one that the whole world will be closely watching.