India has partly revoked Roche Holding AG request for patent for its breast cancer drug, a spokesman for the pharmaceutical company confirmed with Reuters on Sunday.
The Kolkata Patent Office has revoked the divisional patents of Herceptin as reported by a Swiss newspaper. The drugmaker received the notification on July 17 with a note that not all requirements were met.
The Swiss drugmaker is now considering their next steps.
The result is the latest in the frustrating series of rejections encountered by various Western pharmaceutical companies that wanted to penetrate the Indian market. Apparently, there were issues about intellectual property and pricing in the region.
It was also reported on Friday that GlaxoSmithKline's for breast cancer drug Tykerb was also revoked after a court decision in April preventing patients from using drugs that provide only small improvements when taken.
Roche has already modified its business model in India to make the drug more affordable to the public and to obtain authorization from the patent authorities since August 2012. They have reduced the price of two cancer drugs called Herceptin and MabThera by partnering with a local generic drugmaker Emcure Pharmaceutics.
Despite these strategies used by Roche, their application still got partially revoked.
India has been revoking applications from various pharmaceutical companies since last year. Some of these are Roche's hepatitis C drug Pegasys, Pfizer Inc's cancer drug Sutent, and Merck & Co's asthma treatment aerosol suspension formulation. The patent officials reasoned that they need more innovative drugs because these drugs were just offering incremental innovations.
The new drug approval process in India involves two processes: clinical trial and marketing authorization. However, there were issues in the region wherein some drugs are being approved without any clinical trial and some drugs banned in the Western countries being approved by the region. Another is that they are also said to be prioritizing their local generic drugmakers thus limiting the entrance of Western brands.
Despite the challenges encountered, Western drugmakers are still not willing to give up. The market in India is the world’s largest in terms of volume and ranks fourteenth in value. Comparing the revenue to U.S, India had a $21.4 billion turnover between 2008 and 2009 while the U.S had $12.26 billion, as reported by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers.
