The battle for more affordable versions of Gilead’s Hepatitis C drug sofosbuvir is set to continue, as patient and legal groups prepare to challenge the patent on the medicine.

Earlier this week, the Indian Patent Office granted the California-based company a patent on sofosbuvir, a decision that would allow only the company and its licensed partners to sell the drug for a fixed period of time.

“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,” said Tahir Amin, Co-founder and Director of the US-based legal group I-MAK ( Intellectual Property, Initiative for Medicines, Access & Knowledge). I-MAK (among others) had challenged the patent application.

“Sofosbuvir is not deserving of a patent – it was developed using previously published techniques that have been used repeatedly in other antiviral drugs. In fact, Gilead’s unjustified patents on sofosbuvir have already been rejected by China, Ukraine and Egypt. Unfortunately, the Indian patent office’s decision is flawed, ignores the scientific facts and fails to uphold the standards of Indian patent law to ensure only new inventions are patented,” said Amin.

The latest decision by the Indian Patent Office has raised eyebrows, as in January 2015, it had rejected Gilead’s patent application.

Incidentally, last year’s decision came before US President Obama’s visit to India, while the latest decision comes ahead of Prime Minister Modi’s visit to the US.

Loon Gangte with DNP+ told BusinessLine that they would challenge the latest decision on sofosbuvir’s patent at the Delhi High Court.

Referring to Gilead’s alliance with a clutch of Indian drug companies including Cipla, Hetero, Ranbaxy (now a Sun Pharma company) and multinational generic drug maker Mylan, Gangte said, Gilead has restricted control on the drug in the Indian market.

About 50 million patients across the world will not be served by the alliance partners (who are selling the drug at a lower price), and this sets a wrong precedent, he said.

However, Leena Menghaney with MSF’s Access Campaign said that decision to grant the patent ignored recent proceedings in the US against Gilead on the same application, where Gilead was found to be infringing two of Merck’s patents, clearly defeating Gilead’s claim that its application on the drug was novel. 

The decision may not immediately impact Indian patients, she said.

“The decision will impact those Indian companies which were planning to enter the market independently to supply not just patients in India but also those in middle-income countries with large numbers of people living with hepatitis C, which Gilead currently forbids from receiving the medicine produced under Gilead’s licensing deal,” she added. 

Gilead's response

Welcoming the Indian Patent Office’s decision to grant a patent on the active metabolites of sofosbuvir, Gilead said, “the recognition of intellectual property (IP) is central to investment in pharmaceutical research and development, and this decision underlines the scientific innovation involved in the development of this breakthrough treatment for chronic hepatitis C.”

Addressing concerns over reduced access to the medicine, the company said, “In developing countries the issuing of patents is often cited as a barrier to access, however the company believes that if used responsibly IP does not hinder access, supporting a sustainable model of voluntary generic licensing for more than a decade. This licensing program enables the manufacture and distribution of high-quality, low-cost versions of the company’s medicines for HIV, hepatitis B and hepatitis C.”

This decision from the IPO (New Delhi) strengthens the partnership between Gilead and the innovative Indian manufacturing industry, a partnership which that has helped expand treatment to resource-challenged countries, it added. At least eight of the 11 India licensees have launched multiple versions of this product, the company spokesperson said.

Besides, this patent application has been granted in 18 other countries, and has recently been approved for grant in Europe. The Merck trial is unrelated to the assessment and approval of this patent application, the company clarified.

(This news report was modified to add Gilead's comments)