Entecavir mystery reloaded: Cipla and BMS in talks over a potential settlement

Patent settlements are in the air! Reports indicate that Bristol-Myers Squibb and Cipla appear to be closing in on an agreement to settle a patent dispute relating to a pharmaceutical composition for once a day oral administration of Entecavir (a drug used to treat Hepatitis B). In 2010,  Cipla had filed a petition at the IPAB to revoke the composition patent. Readers may recall Natco and BMS had entered into a similar settlement over the Entecavir composition patent, after Natco had applied for revocation of the patent at the IPAB.

In India there is no product patent for Entecavir because Entecavir is a pre-95 (pre TRIPS)  molecule and India did not grant pharma product patents before 1995. The once daily composition is protected in India by IN213457.  Independent claim 1 of IN213457 reads as “A pharmaceutical composition effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient comprising up to 1% Entecavir adhered to a carrier substrate of kind and pharmaceutically acceptable excipients as herein described, wherein said percentage is based on a total composition weight of 100mg.”

The Indian composition claim is narrow and clearly limited to a particular method of preparation (i.e. Fluid bed granulation) of Entecavir composition. This explains why like many generics could design around this composition patent and launch their generic versions in India i.e. Dr. Reddy’s Entaliv, Zydus Cadila’s Entehep.

One cannot term this settlement as a pay for delay settlement (where the patentee typically pays a generic company to delay launch) since Cipla‘s generic version is already available in the market. However one can easily argue that unchallenged patents of questionable quality deter other smaller generic players from entering the market and the society pays the price for increased drug prices resulting from reduced competition. As I mentioned earlier, one question still remains a mystery : Why did Natco and Cipla choose to settle the patent dispute when other generic players in India found a way to avoid/design around the composition patent?

This case looks very interesting so stay tuned for updates!