A single judge bench of Delhi high court dismissed the claim of Indian wing of Roche company. Roche had accused Cipla of infringing there patent for the drug “Tarceva”, and backfiring, Cipla had asked for the revocation on the grounds that the current drug is in not in accordance with Section-3d and there is no proof of increased efficacy. In the final result the court said that the patent is valid in India and Cipla is not infringing it any way.
On 11th January, 2008 Cipla announced to print media and electronic media about launching a generic version of drug “Tarceva”. After reading the article Roche filed a complaint in the court. It was alleged that the said innovation was duly protected under law and that no person except those legally authorized to exercise legal rights associated with the aforementioned patented drug could be allowed or permitted to simulate, re-create it in any manner or in any other name. It was alleged that the defendant had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva (Erlotinib) and that such action of the defendant, as announced by it, would be in blatant violation of the legal rights of the plaintiffs.
The suit was filed on 15th January, 2008. The suit was valued at Rs. 20 lakhs and for the relief of damages; it was tentatively valued at Rs.1 crore. Along with the suit the plaintiffs filed an application under Order XXXIX Rule 1 Code of Civil Procedure 1908 (CPC), I.A. No. 642/2008, seeking ad-interim injunction restraining the defendant from infringing the plaintiffs patent in respect of Tarceva (Erlotinib).
On 21st January, 2008, the defendant filed its written statement to the injunction application along with documents. The defendant claimed that it had applied for drug approval for the Erlotinib tablet in May 2007 and the approval was granted in October, 2007. It was also stated in the statement that the current patent is invalid. A reference was made to Section 3(d) of the Act and it was submitted that Erlotinib is a derivative of a known patent “Quinazoline“. It was stated that there were at least three EU patents dating back to 1993 which disclosed the Quinazoline derivative. One of the said patents disclosed the exact chemical structure as found in the plaintiff’s patent except for one substitution which is “obvious to any person skilled in the art”. Further, the plaintiff had failed to prove that there was “any improved efficacy of the said drug”. It was claimed that there was no inventive step in the patent.
In the statement it was also stated that the dose of “Erlocip” will cost Rs.46, 000 for monthly dose whereas the cost of “Tarceva” is around Rs.1, 40,000. Thus the generic version pleaded in the public interest for the availability of cheap and affordable drugs.
Cipla Ltd. won the patent case against Swiss drug maker F Hoffmann-La Roche Ltd in the Delhi high court on 7th September, 2012. The case was for infringing the patented drug by Roche in India.
In the final judgement given by Justice Manmohan Singh, he said that it had been scientifically proven that Cipla’s generic version was a polymorph B variant of Roche’s patented drug and that it didn’t actually infringe any patent in India.