CIPLA & BMS may settle patent dispute over Entecavir in India

US based pharma major Bristol-Myers Squibb (BMS) and Indian pharma company Cipla Ltd. are heading towards an amicable settlement on a long-stretched patent dispute concerning BMS’ hepatitis B drug Entecavir, a leading anti-viral drug for Hepatitis B patients that brings in more than a billion dollars each year globally for BMS.

Entecavir, being a pre-1995 molecule, was not patented in India as the Indian patent law did not provide patent protection for “products” till 1995. However, BMS filed a patent application for its once daily composition comprising Entecavir and got a patent in India for the same. The patent application (IN/PCT/2002/00891/MUM) was filed at Mumbai patent office by BMS in 2001 and it was granted (IN213457) in the year 2008.

Claim 1 of IN ‘457 read as:

  1. 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 % of entecavir, adhered to a carrier substrate of kind such as herein described, and pharmaceutically acceptable excipients such as herein described in an amount as herein described, wherein the said percentage is based on a total composition weight of 100 mg.

Claim 12 of IN ‘457 read as:

  1. A method of preparing a pharmaceutical composition of entecavir as claimed in claim 1 comprising (a) dissolving said entecavir and an adhesive substance in a solvent wherein said solvent is water or water having an acidic or basic pH, (b) spraying said solution obtained in step (a) onto a carrier substrate while said carrier substrate is in motion, (c) drying said coated carrier substrate from step (b) to remove said solvent, and (d) combining said dried coated carrier substrate from step (c) with other excepients as claimed herein above to form said pharmaceutical composition.

In 2010, Cipla, had filed a revocation application with the India’s Intellectual Property Appellate Board (IPAB) against BMS’ patent IN ‘457 covering a pharmaceutical composition comprising up to 1% of Entecavir effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient.

When the case came up before the IPAB, the counsel representing Bristol-Myers Squibb informed the patent tribunal that both the drug makers are in negotiations to settle the patent dispute. The IPAB bench comprising chairman justice KN Basha and DPS Parmar, technical member, patents, adjourned the matter since both the parties were exploring the possibilities of an amicable settlement.

BMS previously reached a settlement with Indian generic firm Natco Pharma concerning the drug. 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.

Generic drug producers such as Dr. Reddy’s and Cadila launched their generic versions of Entecavir (Baraclude) in India earlier in 2010 by designing around the once daily composition patent. Ranbaxy had also launched a generic product of the drug earlier in the Indian market.

US scenario of Entecavir: (Patent dispute between BMS & Teva)

Entecavir is protected by two patents in United States viz. US 5206244, product patent which covers the Entecavir molecule and US 6627224 which covers Entecavir compositions effective for once a day oral administration. Teva Pharmaceutical, an Isreal based generics major, challenged the Entecavir product patent in a US court and launched its generic version of Entecavir in US market. Teva successfully invalidated the Entecavir product patent based on obviousness ground and an appeal by BMS was denied by the US Court of Appeals for the Federal Circuit, in 2014.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com

Leave a Reply

Categories

Archives

  • March 2024
  • February 2024
  • January 2024
  • December 2023
  • November 2023
  • October 2023
  • September 2023
  • August 2023
  • July 2023
  • June 2023
  • May 2023
  • April 2023
  • March 2023
  • February 2023
  • January 2023
  • December 2022
  • November 2022
  • October 2022
  • September 2022
  • August 2022
  • July 2022
  • June 2022
  • May 2022
  • April 2022
  • March 2022
  • February 2022
  • January 2022
  • December 2021
  • November 2021
  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • February 2021
  • January 2021
  • December 2020
  • November 2020
  • October 2020
  • September 2020
  • August 2020
  • July 2020
  • June 2020
  • May 2020
  • April 2020
  • March 2020
  • February 2020
  • January 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • July 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • September 2010
  • July 2010
  • June 2010
  • May 2010
  • April 2010