Roche Hepatitis C Drug Patent Revoked in India, Opens Door for Generic Copycats

On Friday, India’s Intellectual Property Appellate Board revoked its patent on Pegasys, a hepatitis C treatment marketed by the Swiss pharmaceutical giant, Roche Holding. It was the second blow to Roche in almost two months, following a finding in September that a generic version of the cancer treatment Tarceva, called Erlocip, didn’t infringe on its patent, The Wall Street Journal reported.

The Board denied patent protection for the expensive treatment drug, which it had originally granted in 2006, based on challenges made by the generic drug maker Wockhardt, Ltd. and Sankalp Rehabilitation Trust, a Mumbai-based patient advocacy group, that the drug was neither novel nor inventive, criteria required for a patent in India, according to The WSJ.

This latest denial comes on the heels of patent protection rejection for several expensive therapies that have been granted protection in other parts of the world, and is particularly significant, the paper points out, because it shows the challenges multinationals are facing as they attempt to break into the country’s fast-growing pharmaceutical industry.

According to a PriceWaterhouseCoopers report released Monday, "IndiaPharma Inc: Gearing Up For The Next Level Of Growth," the Indian pharma industry is likely to be in the top 10 global markets by 2020, growing to $74 billion, The Times of India reported. The report added that emerging markets will be the next major growth drivers for the pharma industry over the next decade.

The website Pharmalot said the Pegasys decision is likely to “intensify the battle between global drugmakers, patient advocates and the government over the delicate balance between intellectual property rights and affordable access to life-saving medicines.”