Year 2012, has been a stupendous year for Indian generic companies. After the grant of first compulsory license to Natco Pharmaceuticals on 5th March, 2012, Cipla won the case against Swiss drug maker F Hoffmann-La Roche Ltd in the Delhi high court on 7th September, 2012. 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.
Background
On 11th January, 2008 Cipla announced to print media and electronic media about launching a generic version of drug “Tarceva”.
Roche was granted Indian Patent No. IN ‘774 in February 2007, under which per Claim 1, they had patent rights over the Erlotinib Hydrochloride (Tarceva) molecule which has demonstrated breakthrough capabilities as an Epidermal Growth Factor Receptor (EGFR) inhibitor, which spiked survival benefit in non-small cell lung cancer patients.
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 also alleged that the defendant had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva and that such action of the defendant, as announced by Cipla, would be in blatant violation of the legal rights of the plaintiffs.The suit was filed on 15th January, 2008. This 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.
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) 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.
▪ The closest prior art to IN ‘774 is Example 51 of EP ‘226 which was based on extremely similar structures. Cipla officials pointed to the fact that the IN ‘774 specification have no advancement on Example 51 and that more than one example in IN ‘774 is specifically disclosed in EP ‘226.
▪ The only distinction between IN ‘774 and Example 51 of EP ‘226 is the substitution of a methyl group with ethynyl at the third meta (3’) position which is obvious to a 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.
Final Decision
Cipla Ltd. won the patent case against Swiss drug maker F Hoffmann-La Roche Ltd. Cipla’s defence to Roche’s infringement claim was based on the claim that IN ‘774 is for an admixture of Polymorphs A and B of EH(Tarceva) but Erlocip is the stable form of Polymorph B, thus there can be no infringement.
In the final judgement given by Justice Manmohan Singh also said that Roche filed the case merely depending on the theoretical evidences and not on scientific evidences.
The final nails in Roche’s coffin were hammered in by the US ‘221 specification documents which clearly statethat Polymorph B is the sole efficacious commercial manifestation of Erlotinib Hydrochloride.
Roche’s patent on the drug was also called valid by the court.
Conclusion
With these two big decisions, MNCs have to re-strategise how to work in Indian market. Indian market is economically a multi billion industry for pharmaceuticals. None of the company that is in pharmaceutical sector would like to be left out from earning big bucks in this market. But with these two major decisions (Grant of compulsory license to Natco and Cipla win over Roche), going against MNCs would have left out them to rethink how to carry out their work in Indian market. Indian generic industry must be too happy with these decisions and in one way or the other, common man will also be benefitted from these decisions because courts have given these two decisions basically, keeping common man in mind.
