25 January, 2016
Patent infringement between Hoffmann La Roche and Cipla Ltd.
The Division Bench (‘DB’) of the Delhi High Court (‘Delhi HC’) by its order dated November 27, 2015 decided a longstanding pharmaceutical patent infringement case between Hoffmann La Roche (‘Roche’) and Cipla Ltd (‘Cipla’).4 By its ruling, the DB set aside the decision of the Single Judge5 and held that Cipla’s cancer drug Erlocip infringes Roche’s patent IN ‘774. However, the Delhi HC did not grant a permanent injunction as Roche’s patent expires in 2016. The Delhi HC ordered Cipla to render accounts concerning manufacture and sale of Erlocip and also decreed costs in favour of Roche amounting to a sum of ¤500,000 (approximately US$ 7,500).
This decision is significant, as it prescribes the approach to determine patent infringement i.e., by comparing the patentee’s patent claims with the defendant’s infringing product. The decision also throws light on the test for obviousness and claim construction by laying down step-wise guidelines for the same.
History
This litigation arises in respect of Roche’s 2007 patent IN ‘774 for the molecule – Erlotinib Hydrochloride. Roche had been marketing a polymorphic form of this molecule under the brand name Tarceva.
In 2008, Roche sued Cipla for patent infringement, thereby seeking to injunct Cipla from manufacturing and marketing Erlocip (which is a polymorph B of Erlotinib Hydrochloride). The Single Judge, by an order dated March 19, 2008,6 denied grant of an interim injunction pri- marily on the ground of public interest since Erlocip was more affordable than Roche’s Tarceva. Roche’s appeal to the DB as well as its SLP before the Supreme Court against this interim order was dismissed.
After the trial, the Single Judge, by an order dated September 7, 20127 upheld the validity of Roche’s IN ‘774 patent. However, on comparing Cipla’s product (Erlocip) to Roche’s product (Tarceva), the Single Judge held that Roche could not prove by positive evidence that Cipla’s product was infringing. Therefore, the Single Judge held that there was no infringement.
Division Bench Ruling
Cipla claimed that Roche’s patent was invalid under Section 64(1)(f) of the Patents Act, 1970 (‘Patents Act’) for lack of inventive step and obviousness. However, the DB upheld the validity of Roche’s patent. By adopting a 5-step test to determine ‘obviousness’, which includes: the identification of an ordinary person skilled in the art, identification of the inventive concept, imputation of common general knowledge to the ordinary personal skilled in the art and an assessment of whether the differences between the prior art and the alleged invention would have been obvious to the ordinary person skilled in the art, the DB held that Roche’s patent was not obvious.
On the question of infringement however, the Delhi HC clarified that the approach taken by the Single Bench was incorrect. In assessing patent infringement, the Delhi HC held that examination is with respect to the patent claim, i.e. IN ‘774, and the defendant’s product, i.e. Erlocip. The Delhi HC held that Roche’s patent claim was broad enough to cover Erlotinib Hydrochloride itself and it was not restricted to any particular polymorphic form of Erlotinib Hydrochloride. Based on the fact that Roche had applied for another patent specifically for polymorph B of Erlotinib Hydrochloride, which was subsequently rejected under Section 3(d) of the Patents Act, Cipla had contended that it was not possible to construe the claims in IN ‘774 to include the polymorph B, as polymorph B was a new invention in itself. The Delhi HC, however, relied on the deeming fiction in relation to salts, polymorphs etc. under Section 3(d) to hold that these substances are considered to be the same substance as the known substance (in this case Erlotinib Hydrochloride) and therefore held that Cipla’s cancer drug Erlocip infringes Roche’s patent IN ‘774. The Delhi HC held that polymorph B, i.e. Erlocip, is subsumed within the Roche’s patent.
4 Hoffmann La Roche v. Cipla Ltd, RFA(OS) 92/2012 & 103/2012, Delhi High Court.
5 Hoffmann La Roche v. Cipla Ltd , 2012(52)PTC1(Del).
6 Hoffmann La Roche v. Cipla Ltd , 2008(37)PTC71(Del)
7 Hoffmann La Roche v. Cipla Ltd , 2012(52)PTC1(Del).
For further information, please contact:
Zia Mody, Partner, AZB & Partners
zia.mody@azbpartners.com
