THE government has upheld the patent of Swiss drug major Hoffmann La Roche's hepatitis C drug, Pegasys. It is the first drug to be given patent in India after the country adopted new patent regime in 2005.
Last year, domestic major Wockhardt and Mumbai-based NGO Sankalp had filed oppositions against Pegasy's patent alleging that the drug is a known molecule and cannot be granted patent under the Indian laws. As per section 3(d) of the Indian patent laws, drugs with mere modifications cannot be granted patent, unless it has significantly enhanced efficacy than any existing drugs.
In its order last month, Chennai Patent Office's assistant drug controller of patents and designs dismissed the challenges of both Wockhardt and Sankalp saying that the drug is indeed 'novel and involves an inventive step'. Roche officials confirmed the order, terming it as a positive development.
As per Varun Chhonkar, a patent consultant, Roche proved that Pegasys provides better efficacy than the existing molecules. Therefore, the patent is valid."
This means that Roche will have exclusive marketing rights for Pegasys for 20 years (until 2016) in India and Indian drug companies cannot develop low-cost reverseengineered versions of Pegasys. The ruling is, therefore, expected to come as a setback to an estimated 12.5 million Hepatitis C infected people as Pegasys cost about Rs 2.25 lakh for a 6-month course.
However, Roche India MD Girish Telang has been earlier quoted saying that the introduction of Pegasys has reduced the treatment costs for Hepatitis C patients to about onethird and the rate of cure has gone up to 80-95% from 30-35% earlier.
Since 2005, when India ushered in the patent regime, a host of Indian companies and patient groups have been filing a series of patent challenges of global innovator companies. They say innovator companies are merely tweaking with existing molecules to evergreen their patents and this will increase the cost of healthcare treatment.
But, innovator companies say that unlike generic companies, who merely copy innovator companies - drugs, they have to invest million of dollars to develop a new drug. Globally, it takes $1 billion to develop a new drug, and therefore, their research should be rewarded to take forward their drug development programmes.
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