Minor Modification & Structural Similarity Not Sufficient to Establish Obviousness - I

Erlotinib PreGrant Opposition

Roche lawsuit against Cipla for willful infringement of Indian Patent No. 196774 covering anticancer drug compound Erlotinib still seems to be not reached any conclusion and is likely to be not near from over with next hearing scheduled on February 24, 2009. In counter attack, Cipla raised invalidity and non-infringement defenses against the ‘774 patent. Having earlier lost to obtain temporary injunction order, Roche later appealed against the Delhi High Court order rejecting temporary injunction on the ground of public interest. An Appellate Bench comprising Chief Justice AP Shah and Justice S. Muralidhar finished hearing the arguments and reserved its judgment. Readers interested knowing more detail on this may visit Shamnad’s blog who excellently and extensively covered Erlotinib litigation proceedings.

Recently we just got hold-on Erlotinib pre-grant opposition judgment and thought of posting an analysis over it. This pre-grant opposition is of great significance to Erlotinib litigation proceedings as Cipla’s counsel repeatedly and notably referred to it (read post by SpicyIP) and even argued the Court to disregard the Indian Patent Office (IPO) finding in favor of Roche particularly on the ground that the Controller (of Patents) merely addressed argument on “novelty” and did not even considered obviousness arguments during the pre-grant opposition. However, on reviewing Erlotinib pre-grant opposition judgment we found Cipla’s argument contradicting and fallacious. Not only the Controller considered the obviousness ground but specifically and prominently discussed the same during the pre-grant opposition hearing.

The pre-grant opposition was filed by Natco Pharma Ltd. and decided by the Assistant Controller on 4^th July 2007 after hearing made on 27^th June 2007. In its pre-grant opposition, Natco challenged the issuance of patent against the claims of Erlotinib Application 537/DEL/1996 on the grounds of obviousness and insufficient disclosure. Natco particularly cited EP 0566226A1, EP 06335507A1, EP 0635498A1, and EP 0520722A1 to support its obviousness arguments. However, on the date of hearing Natco filed an interlocutory petition to place additional non-patent literatures on record and to question amendments made in claims during the examination under sections 57 and 59 of the Patents Act, 1970. The Assistant Controller considered the petition to allow additional non-patent literatures to be taken on record to examine the strength of opposition but rejected Natco’s argument against claim amendment. While rejecting argument against claim amendment, the Assistant Controller argued that the amended claims are well within the preview of the original claims and are more restrictive in scope as compared to originally filed claims, and such amendment are not prohibited under section 57 and 59.