Indian Patent Office approves patent for Gilead's hepatitis C drug Solvadi

May 11, 2016 13:13 IST

Gilead   SciencesThe Controller General of Patents, Designs and Trademark on 9 May 2016 granted the patent to Gilead Sciences for its Hepatitis C drug Sofosbuvir (brand name Sovaldi) in India.

The drug, which has a list price of 1000 US dollar a pill in the United States, was rejected for a patent by the Indian patent authority in January 2015. It was rejected on the basis that it represented only minor changes to a previous formulation, and the company already had licensing deals with manufacturers in India.

About Indian Patent Office

The Indian Patent Office is administered by the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM).

It is a subordinate office of the Government of India and administers the Indian law of Patents, Designs and Trade Marks.

The CGPDTM reports to the Department of Industrial Policy and Promotion (DIPP) under the Ministry of Commerce and Industry.

CGPDTM has five main administrative sections, which are Patents, Designs, Trademarks, Geographical indications, and Patent Information System.

The patent office is headquartered at Kolkata. The office of the CGPDTM is in Mumbai.

About Sofosbuvir

Sofosbuvir is a nucleotide analogue used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection.

It has been marketed since 2013.

Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects and a two- to four-fold reduced duration of therapy.

Sofosbuvir inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA. It was discovered at Pharmasset and developed by Gilead Sciences.

The price of sofosbuvir is quoted in various media sources as 84000 US dollar to 168000 US dollar for a course of treatment in the U.S.

It is on the World Health Organization's List of Essential Medicines.

About Gilead Sciences

Gilead Sciences is an American biopharmaceutical company that discovers, develops and commercializes therapeutics.

In 2006, Gilead acquired two companies, which were developing drugs to treat patients with pulmonary diseases.

The company's name and logo refer to the Balm of Gilead, inspired by a 1965 play by Lanford Wilson featuring the underworld adventures of the patrons of the namesake cafe.

About Hepatitis C

Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver.

The virus persists in the liver in about 75% to 85% of those initially infected.

HCV is spread primarily by blood-to-blood contact associated with intravenous drug use, poorly sterilized medical equipment, needlestick injuries in healthcare, and transfusions. It may also be spread from an infected mother to her baby during birth.

There is no vaccine against hepatitis C.

Chronic infection can be cured about 90% of the time with treatments that include the medications sofosbuvir or simeprevir.

An estimated 130–200 million people worldwide are infected with hepatitis C.

It occurs most commonly in Africa and Central and East Asia.

The existence of hepatitis C, originally identifiable only as a type of non-A non-B hepatitis, was suggested in the 1970s and proven in 1989.

Hepatitis C infects only humans and chimpanzees.

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