Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

India Upholds Gilead’s Patent For Hepatitis C Drug, Sovaldi

XTALKS VITALS NEWS

India

Doctors Without Borders, along with a number of other humanitarian groups, were opposed to the decision because it could affect patient access to the treatment.

Share this!

May 12, 2016 | by Sarah Massey, M.Sc.

After previously rejecting Gilead’s patent application for the hepatitis C drug, Sovaldi, the Indian Patent Office has reconsidered their decision by awarding a patent to the drugmaker. Doctors Without Borders, along with a number of other humanitarian groups, were opposed to the decision because it could affect patient access to the treatment.

As India has one of the largest generics manufacturing sectors, and supplies many of these drugs to the rest of the world, their patentability standards have become a source of conflict between patient groups and pharmaceutical developers. By patenting Sovaldi in the country, most generics manufacturers will be prohibited from making less-expensive alternatives.

Gilead’s Sovaldi and Harvoni are among a new class of direct-acting antiviral drugs for hepatitis C. Though it carries a high price tag in developed countries - $84,000 for a 12-week treatment course in the US – it represents a cure for the viral infection in over 90 percent of patients.

While Gilead offers the drug at a discounted price to low-income and developing countries, Doctors Without Borders claims the company is failing to close the gap for patients in middle-income countries. According to Tahir Amin, director of intellectual property at IMAK, one of the advocacy groups opposed to the ruling, the decision is “flawed, ignores the scientific facts, and fails to uphold the standards of Indian patent law to ensure only new inventions are patented.”

The Indian Patent Office rejected Gilead’s initial application for Sovaldi in January of 2015, saying that drug did not represent a significant improvement over earlier compounds. After filing an appeal, Gilead received the news that the Patent Office reversed their initial ruling, deciding that the active compound in Sovaldi – sofosbuvir – is a “novel, inventive and patentable.”



“This decision will now stop those Indian generic companies [that] were planning to enter the market independently from supplying 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 sofosbuvir produced under Gilead’s licensing deal,” said Leena Menghaney, South Asia regional head of Doctors Without Border's Access Campaign. Gilead has licensed 11 generic manufacturers to make Solvaldi and distribute the drug to 101 developing countries.

“The recognition of intellectual property 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,” a Gilead spokesman told Stat News. “It is the company’s goal to enable access to these medicines for as many people as possible, as quickly as possible.”


Keywords: Hepatitis C, India, Patent


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Lavazza Acquires Controlling Stake in Canada’s Kicking Horse Coffee

May 26, 2017 - Italian coffee company Lavazza, has secured an 80 percent equity stake in Canadian organic and fair-trade coffee company Kicking Horse Coffee, in a deal worth CAD$215 million.

Featured In: Food News


FDA First: Keytruda Approved for Cancer Treatment Based on Biomarker Alone

May 25, 2017 - For the first time, the FDA has approved a cancer treatment for solid tumors based on the presence of a biomarker, as opposed to specifying a tissue of origin.

Featured In: Biotech News


One Year of Medically Assisted Dying in Canada

May 25, 2017 - In June of 2016, the federal government of Canada passed legislation to legalize medically assisted dying.

Featured In: Life Science News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Top 5 Most Impactful Tweets in Life Sciences During the Last Week

REGISTER FOR THESE WEBINARS

EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider


Thermal Processing Systems for the Food Industry: A Guide to Selecting Thermal Equipment and Technology


Rare Disease & Orphan Drug Development: Cost-Efficient Trial Design to Minimize Cash Burn


eTMF Workflows: Active eTMF to Improve the Quality of Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.