Even as the Indian drug company Cipla and Swiss drug major Roche are engaged in a fierce battle over the launch of generic version of Roche's lung cancer drug Tarceva under the brand name Erlotinib by the Indian company, another patent application for Erlotinib is pending with the Indian Patent Office.
According to sources, a US-based company OSI Pharmaceuticals has filed the second application for the crystalline form B of Erlotinib for patent in India. The application was filed in India way back on 14th May, 2002 under the patent number IN/PCT/2002/00507.
The lung cancer medicine has already created ripples in the pharma industry in India. Picking up the loopholes in the country's product patent regime, which is in its early phase, the Indian drug company Cipla got permission for Erlotinib from the drug controller general of India (DCGI) and launched the product in the country even though Roche had received product patent for it from the Indian Patent Office last year.
Both the drug companies are now fighting the case in the Delhi High Court. The entry of the third party in the arena may create further ripples in the case.
Tarceva is a small molecule designed to target the human epidermal growth factor receptor (HER1) pathway, which is one of the factors critical to cell growth in numerous cancers, including non-small cell lung and pancreatic. HER1, also known as EGFR, is a component of the HER signaling pathway, which plays a role in the formation and growth of non-small cell lung and pancreatic cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell.
In November 2004, the US Food and Drug Administration (FDA) approved Tarceva for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva demonstrated, in a Phase III clinical trial, an increase in overall survival in advanced NSCLC patients.
In November 2005 the US FDA approved Tarceva in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy. In a Phase III trial, Tarceva showed an improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer.