Final legal of battle over Anti-cancer Drug patent: Roche Vs Cipla

The recent decision accomplished in the Roche V. Cipla patent infringement case in the high Court over Cipla’s Generic version of Anti-cancer Drug Erlotinib. The case is the first Patent Litigation in India post India’s 2005 Product Patent Regime which included public interest and pricing issues in addition to India’s Section 3d that prevents evergreening. The case was followed by Pharma Giants worldwide. And finally Cipla has won the landmark Roche V. Cipla Patent.

Parties to the Suit

The landmark case took place between Roche which is a Swiss multinational health-care company that has its operations all throughout the world and Cipla which is an Indian Multinational Pharmaceutical and Biotechnology Company.
Brief facts
Roche’s patent claim was on the “Erlotinib Hydrochloride”- without being limited to any of its polymorph, however Roche was commercializing a particular polymorph of the claimed drug molecule(i.e. polymorph B), which was being marketed as Tarceva. Cipla manufactured and marketed the drug which was based on the polymorph B of Erlotinib Hydrochloride at one third the cost of Roche.
Roche’s plea for interim injunction against Cipla as dismissed by the learned single judge of the Delhi High Court on the ground of the public interest involve and the life-saving nature of the drug question
Roche’s appeal to the division bench of this court against the order passed the learned single judge. But it was also dismissed in the 2009, in the back of heavily public interest-centric of the patent Act, 1970, as amended from time to time, and a detailed discussion of the relative affordability of the drug to the common man. The decision is reported as F.Hoffman-La Roche V. Cipla Ltd (2009) 40 PTC 125 (Del)
The division bench further felt that Cipla had done enough to demonstrate a potentially credible challenge to the validity of Roch’s PATENT .IN’774 including raising sufficient doubt over whether IN’744 had complied with full disclosure required.

Roche appealed to Supreme Court

Supreme Court dismissed the special leave petition filed by Roche, challenging the order passed by the division bench of the Delhi High Court. However, the court ordered that the ongoing trial at the Delhi High Court be expedited. The order also clarified that nothing in the Division bench order would bind the trial court judge, who is expected to decide the case on final merits.

Case heard by the single judge

The single judge dismissed the claim of Roche. The single judge in his September, 2012 order held that Cipla was not infringing Roche’s patent and refused to grant any injunction against them.

Roche allegations

Roche’s patent was granted in February 2007 by the Indian Patent Office, which covered its patent right over the Erlotinib Hydrochloride molecule which has demonstrated breakthrough capabilities as an Epidermal Growth Factor Receptor(EGFR)inhibitor which spiked survival benefit in cancer including non small cell lung cancer (NSLC) patients. Roche’s alleged that Cipla had infringed its impugned drug under the name Tarceva by the marketing the generic version of the drug under the name Erlocip. Cipla’s drug was also Erlotinib Hydrochloride and manufacture of Polymorph B by Cipla was sufficient to trigger infringement to claim 1 of its patent IN 774.

Cipla allegations

Roche’s patent IN774 had not complied with full disclosure requirements as required under the section 8 patent Act,1970.Roche’s patent is invalid under section 64 (1)(f) of the Patent Act 1970 for lack of inventive step and for being obvious.
Not only did Roche’s patent specification fails to disclose how it was inventive but there were compelling evidence which indicated that it was more combination and less innovation.
That the closest prior art to IN ‘774 and EP 0566226(admitted prior art ) had extremely materially similar, of not identical structure .
That Roche’s had unsuccessfully applied for Polymorph B from of Erlotinib Hydrochloride (Patent IN/507/Del), acclaim which was rejected by the Indian patent office in 2008 with the findings on evergreening, structural similarities between IN ‘774 and a lack of conclusive comparative clinical data to prove efficiency.
That invention required to be product specific, where product has commercial manifestation, since infringement is relatable to “that product” which is patented and not to any “substance”.
While the patent sought to be enforced is for Polymorphs A+B, the product actually under manufacture by both Roche’s and Cipla is Polymorph B which ought to be assumed to be in the public domain and hence Cipla’s activities are non-infringement in nature.

Court decision

Justice Manmohan Singh has passed the judgement in favour of Cipla stating that Cipla did not infringe Roche’s Indian patent IN 196774. According to the Judge, it was scientifically proven that Cipla’s Generic Drug is the Polymorphic Form B which is not Roche’s patented Drug. The complete judgement is not yet available.
Conclusion
Roche-Cipla dispute over the lung the lung cancer drug “Erlotinib “was one of the initial dispute filed in the country and had been keenly watched ever since. The division bench of the Delhi High Court has referred to a plethora of judgments including that of foreign jurisdictions in order to arrive at the aforesaid decision. It is hoped that the final outcome of the infringement suit and the judgment would be helpful in deciding other similar pharmaceutical infringement disputes in India.