Further difficulties

As we have reported previously, pharmaceutical companies have suffered numerous setbacks in India in relation to obtaining and enforcing patent rights. In the latest setback for Pharma companies, patents covering Allergan’s Ganfort and Combigan glaucoma drugs have been revoked. The patent covering Combigan was revoked on the basis that Allergan had not disclosed details of patents in other jurisdictions, as is required under Indian law, and because the claims did not appear to be inventive in so far as they defined a combination of known compounds that each appeared to perform their known function. The patent covering Ganfort was held to lack inventive step.

Again, these decisions highlight the importance of showing an improved (preferably, surprisingly improved) efficacy of pharmaceuticals comprising known compounds or derivatives thereof. One of the decisions also highlights the importance of complying with formal requirements in India.

A novel approach

In other news, according to PharmAsia News, Roche has elected not to pursue some patents protecting trastuzumab (Herceptin®). These patents would allegedly provide protection until 2019. Perhaps Roche considered that given the recent decisions coming out of India, the patents provided questionable protection. Moreover, the difficulties in demonstrating biosimilarity of complex biologics may mean that a biosimilar version of trastuzumab is still some time off. Roche has also adopted the approach of introducing improved version of their drugs before patent protection expires, in the case if trastuzumab this is the immunoconjugate Kadcyla (ado-trastuzumab emtansine, or trastuzumab-DM1).