Cipla infringing Roche's patent in lung cancer drug: HC
In a setback to Cipla, the Delhi High Court today held that the Indian drug major was infringing Swiss pharmaceutical company Hoffman-La Roche's patent in lung cancer drug erlotinib hydrochloride, sold under the name of Tarceva.
A bench of justices Pradeep Nandrajog and Mukta Gupta arrived at the conclusion by noting that Cipla's lung cancer medicine, Erlocip, was one polymorphic form of the erlotinib hydrochloride compound, which may exist in several forms, and Roche's patent claim was not limited to any one such version.
"This (the patent) is a sufficiently broad claim that is clearly not limited to any polymorphic version of erlotinib hydrochloride, but to erlotinib hydrochloride itself. This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent. Therefore as Cipla s Erlocip is admittedly one particular polymorphic form of the erlotinib hydrochloride compound (polymorph B), it will clearly infringe the IN 774 patent (of Roche).
"We thus conclude this issue by noting that the single judge's finding that 'Tarceva' and 'Erlocip' were based on the polymorph B version of erlotinib hydrochloride, though correct factually, is irrelevant to the subject matter of the present patent as Cipla has clearly infringed Claim 1 of Roche's IN 774 patent in arriving at the said polymorph," the bench said.
It, however, did not grant any injunction in favour of Roche by restraining Cipla, saying the patent in favour of the Swiss company would expire in March 2016 and no such order had been passed by the single-judge and the Indian company had continued to manufacture and sell Erlocip.
"We decree that Cipla would be liable to render accounts concerning manufacture and sale of Erlocip, for which purpose suit filed by Roche against Cipla is restored with direction that it be listed before the joint registrar who would record evidence pertaining to the profits made by Cipla concerning the offending product.
"Thereafter the report of the joint registrar shall be placed before the single judge as per roster for appropriate orders," the bench also said while imposing costs of Rs five lakh on the Indian company.
The court in its 106-page judgment also said that as Cipla "could not establish prima facie that suit patent was obvious" therefore, its plea for invalidating Roche's patent on the ground of 'obviousness', "fails". .
A bench of justices Pradeep Nandrajog and Mukta Gupta arrived at the conclusion by noting that Cipla's lung cancer medicine, Erlocip, was one polymorphic form of the erlotinib hydrochloride compound, which may exist in several forms, and Roche's patent claim was not limited to any one such version.
"This (the patent) is a sufficiently broad claim that is clearly not limited to any polymorphic version of erlotinib hydrochloride, but to erlotinib hydrochloride itself. This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent. Therefore as Cipla s Erlocip is admittedly one particular polymorphic form of the erlotinib hydrochloride compound (polymorph B), it will clearly infringe the IN 774 patent (of Roche).
"We thus conclude this issue by noting that the single judge's finding that 'Tarceva' and 'Erlocip' were based on the polymorph B version of erlotinib hydrochloride, though correct factually, is irrelevant to the subject matter of the present patent as Cipla has clearly infringed Claim 1 of Roche's IN 774 patent in arriving at the said polymorph," the bench said.
It, however, did not grant any injunction in favour of Roche by restraining Cipla, saying the patent in favour of the Swiss company would expire in March 2016 and no such order had been passed by the single-judge and the Indian company had continued to manufacture and sell Erlocip.
"We decree that Cipla would be liable to render accounts concerning manufacture and sale of Erlocip, for which purpose suit filed by Roche against Cipla is restored with direction that it be listed before the joint registrar who would record evidence pertaining to the profits made by Cipla concerning the offending product.
"Thereafter the report of the joint registrar shall be placed before the single judge as per roster for appropriate orders," the bench also said while imposing costs of Rs five lakh on the Indian company.
The court in its 106-page judgment also said that as Cipla "could not establish prima facie that suit patent was obvious" therefore, its plea for invalidating Roche's patent on the ground of 'obviousness', "fails". .
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