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Roche patent revocation may have a bearing on other cases

India's Intellectual Property Appellate Board has revoked the patent granted in India to F. Hoffmann-La Roche AG (Roche) for pegylated interferon alfa-2a, a medicine used to treat hepatitis C, citing lack of evidence that the drug was better than existing treatments available in the market.

E. Kumar Sharma | November 5, 2012 | Updated 21:02 IST

The concluding line of the order was terse: "The grant of Patent No.198952 is set aside. M.P.No.85 of 2012 is dismissed and M.P.No.111 of 2012 is ordered. No costs."

With those words, delivered on Friday, November 2, India's Intellectual Property Appellate Board (IPAB) revoked the patent granted in India to F. Hoffmann-La Roche AG (Roche) for pegylated interferon alfa-2a, a medicine used to treat hepatitis C.

Roche, the third biggest pharmaceuticals company in the world, sells the drug under the brand name Pegasys.

IPAB revoked the Indian patent citing lack of evidence that the drug was better than existing treatments available in the market.

In absolute numbers, the market for hepatitis C drugs is large. Studies, industry experts point out, put the figure at around one per cent of India's population, or around 12 million people. The figure could be bigger as most of the studies are based on urban population figures.*

Infected blood is said to be the main cause of this virus in India. But with testing of blood becoming stringent before use in Indian hospitals, the market for this drug may exist only for another 15 or 20 years. Blood screening has been taking place quite stringently since 2000 and those last affected may show symptoms only in 15 to 20 years.

Treatment is very expensive. The current cost, depending on the type of hepatitis C virus, varies from Rs 3.5 lakh to Rs 6.5 lakh for a six-month to one-year treatment regimen with drugs such as Pegasys.

Today, generic versions of another drug, interferon (alpha 2b), are also available in India. The cost of this treatment regimen varies from Rs 1.5 to 2.5 lakh, for the same period.

The IPAB order implies that the generic version of Pegasys may become available in India in the near future. However, that would depend on whether Roche decides to appeal the ruling.

It can also opt to tie up with an Indian company and launch the drug at a much lower price or just follow a differentiated pricing policy. In other words, it could have one price for foreign markets and another for India.

Some doctors believe that Roche may also be looking at an Indian version of the drug. The company is said to have soft launched a product called Exxura, made with a local partner in India, to reduce the treatment cost by almost half. BT is yet to get this confirmed by Roche.

Whatever Roche chooses to do, the pricing of Pegasys, and other drugs in this segment, bears watching.

This is the second significant ruling on a patent this year. In March, the Indian Patent Office granted Hyderabad-based Natco Pharma a "compulsory licence" to sell a generic version of German company Bayer AG's kidney and liver cancer drug, Nexavar. It was the first instance of an Indian company getting a compulsory licence. The move was an attempt by the government to ensure that a "life-extending drug" is available to the poor at affordable prices. Natco charges Rs 8,800 for a month's dosage of 120 tablets as against Bayer's price of Rs 2.8 lakh for the same dosage.

Although the cases of Nexavar and Pegasys are different - in the first one a compulsory licence was granted while in the second, a patent was revoked - some see a link in the effort to make drugs more affordable in India.

Both rulings could have a bearing on other cases that come up in future.

* An earlier version of this story put the market for Hepatitis C drugs at 120 million.

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