Patent litigation in India is gathering considerable international attention with the issue of generics and a provision in the Indian patent law preventing ‘evergreening’. Last year, Justice Ravinder Bhatt of the High Court of Delhi passed an order rejecting an interim prayer of the plaintiff, F. Hoffman-La Roche Ltd (‘Roche’), to injunct the defendant, Cipla Ltd (‘Cipla’), from manufacturing a generic version of its drug Erlotinib for treating advanced or metastatic non small cell lung cancer (NSCLC). Although the main ground of rejection of the interim prayer in F. Hoffman-La Roche Ltd & Anr v. Cipla Ltd was Section 3(d) of the Indian Patents Act, 1970 that prevents “evergreening” of a drug, it created ripples among the IP community owing to certain observations by Justice Bhatt on public interest. On April 24, 2009, a two-judge Bench of the High Court of Delhi (the Division Bench) rejected an appeal filed by Roche against the said order and imposed on it costs of Indian Rupees 500,000 (approximately USD 10,000).
Proceedings before the Single Judge
The genesis of the suit was certain media reports in January 2008 that Cipla was about to launch a generic version of Erlotinib. Roche’s claims before the Single Judge in the interim application were briefly as follows: • Erlotinib was administered in the form of a tablet and had been imported and sold under the trademark ‘Tarceva’ in India sometime since April 2006;
• A patent had been granted to Roche by the patent office in New Delhi bearing number 196774 (hereinafter “774”) on February 23, 2007; • Cipla had no rights to manufacture, sell or offer to sell any version of Erlotinib and any such action as announced by Cipla would be in blatant violation of the legal rights of Roche;
In defense, Cipla raised the following arguments before the Single Judge: • The complete specification of the patent was not disclosed in the plaint and was provided to Cipla only at the hearing of the interim injunction application
• 774 patent was hit by Section 3(d) of the Patent Act as Erlotinib was a derivative of a known patent “Quinazoline” and that there were at least three EU patents dating back to 1993 which disclosed the Quinazoline derivative;
• One such patent disclosed the exact chemical structure of the 774 patent except for one substitution which was “obvious to any person skilled in the art”.
• Roche had not proved that there was “any improved efficacy of the said drug”;
• Roche’s product was highly priced and in any event no sales figures had been given by Roche;
• Roche’s tablet cost Indian Rupees 4800 (approximately USD 100) and Cipla’s cost 1600 (approximately USD 30) and in the context of life saving drugs, it was in the public interest that the drug should be made available at cheap and affordable prices.
Section 3 of the Patent Act lists what are not inventions and sub section (d) is as follows:
“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” Just a day before hearing the arguments in the interim injunction application in the suit, Cipla filed an application for rejection of the plaint on the following brief grounds:
• Roche had suppressed that the 774 patent which was in relation to Erlotinib Hydrochloride in the form of polymorphs A and B had been known to it in the year 2000 as it corresponded to one of its US patents;
• Since Roche itself stated that the compound was not stable enough to be manufactured as a tablet, Cipla purchased a sample of the Tarceva manufactured in August 2006 and performed an x-ray diffraction to determine the crystalline structure of the same. A report obtained...