F. Hoffman- La Roche Ltd. and Anr. v. Cipla Ltd.
[(2015) 225 DLT 391 (DB): (2016) 65 PTC 1 (DB)]
Coram: Division Bench comprising Hon’ble Mr. Justices Pradeep Nandrajog and Mukta Gupta, JJ.
Forum: Hon’ble High Court of Delhi
Case No.: RFA (OS) Nos.92/2012 with 103/2012
Date of Decision: November 27, 2015.

Facts & Background/ Procedural Posture:

  • F. Hoffman-La Roche, a pharmaceutical company, filed a lawsuit against Cipla, another pharmaceutical corporation, which was adjudicated by the Delhi High Court.
  • The dispute revolved around Plaintiff's drug 'Erlotinib,' marketed as TARCEVA, and the compound Erlotinib Hydrochloride, utilized by both parties.
  • F. Hoffman- La Roche initiated TARCEVA's sale in February 2007.
    In January 2008, reports emerged that Cipla intended to launch a generic version of 'Erlotinib,' prompting Roche to initiate infringement proceedings against Cipla.
  • In 2008, Cipla launched a generic version of Erlotinib, initiating production and marketing at a price significantly lower than Roche's.
  • Roche's request for an interim injunction was declined by a Single Judge of the Delhi High Court in March 2008, emphasizing public interest and the life-saving nature of the drug.
  • The Division Bench upheld the Single Judge's decision in April 2009, focusing on public interest and comparing the affordability of both drugs.
  • The Supreme Court also dismissed Roche's special leave petition, leading to a trial where two main issues were addressed: the potential revocation of Roche's IN '774 patent and whether Cipla's manufacturing of Erlocip infringed on it.
  • The parties then returned to the Single Judge for the trial on the main relief; and stated that the burden was on Roche to prove Cipla's drug infringement of IN '774. However, there was lack of evidence regarding infringement. It was concluded that Cipla had not infringed Roche's patent.
  • Hence, the present appeal was filed.


Main Issues:

  1. Whether Roche’s compound patent, i.e. Patent No. 196774, is valid?
  2. Whether Cipla’s product, Erlocip which is Polymorph B of the compound Erlotinib, infringes Roche’s patent for the compound Erlotinib?