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14 Jan 2015

BMS, Natco Pharma settle patent dispute

The patent disupte between US-based pharma major Bristol-Myers Squibb (BMS) and Indian pharma company Natco Pharma Ltd over entecavir, a pharmaceutical combination for treating Hepatitis B has been settled amicably, both the companies informed Intellectual Property Appellate Board (IPAB).

Now lets look into the case in depth –

  • Bristol-Myers Squibb and Natco Pharma informed India’s Intellectual Property Appellate Board (IPAB) that a settlement has been reached regarding a patent dispute over the hepatitis B drug entecavir, Business Standard reported Monday.
  • The companies requested that the terms of the agreement are not disclosed to any third party.
  • “The registry is directed to make an endorsement on the top of the records as confidential and not permitted for any inspection or for furnishing certified copies to any parties in respect of the above mentioned topics,” said Justice K N Basha.
  • In the dispute, Natco had filed an application seeking to invalidate a patent for entecavir, which is marketed by Bristol-Myers Squibb as Baraclude.
  • The drug’s patent had previously been revoked in the US following a challenge by Teva, while Cadila Healthcare, Natco and Ranbaxy later launched generic versions of the product.


In 2010, Zydus Cadila and Natco Pharma launched their generic versions of Baraclude. Zydus Cadila launched its product under the brand Entehep and Natco Pharma started marketing it as X-vir. Ranbaxy has also launched a generic product of the drug earlier in the market, say reports.

The patent which was disputed by Natco Pharma and settled in IPAB is for a pharmaceutical composition effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient comprising up to one per cent of entecavir, among other ingredients.

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