Hue and cry about revocation of Herceptin patents in India Vs. Real facts and analysis of the case

Recent statement by Roche’s spokesperson regarding revocation of Herceptin Patent in India and its (mis)interpretation by world media led to the series of confusions. World media saw this news again through its pre-conceived notion about India’s weak intellectual regime and blindly followed it. Indian Government later opposed this statement and gave clarification about the whole issue.

I would rather put the facts of the present case for your better understanding and would try to clear doubts regarding situation.

First, patent office has not partly revoked any patent on Herceptin as with the present case. The said issue is with the patent applications filed by Genentech (Roche) viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 (both filed on Aug.11, 2008). These are not yet granted, so what media has interpreted was absolutely wrong about revocation. Patent office instead has refused both applications u/s 16 (divisional application) of Indian patent Act.  To qualify as a divisional application, the application in question must be distinct invention and filed before the parent application is granted, abandoned or deemed to withdrawn.

1.      Both these patent application are divisional of 1638/KOLNP/2005, which is again divided out of IN/PCT/2000/00391/KOL (Granted as IN205534 on Apr.05, 2007). According to Indian Patent Act one cannot file the divisional application from divisional application. Therefore these applications cannot be regarded as proper divisional u/s 16(1) of the Act.

2.      Applicant concealed this fact and stated 1638 application as parent application for the both applications (viz. 3272 and 3273) and filed same with patent office. But these applications are considered to be divisional of IN/PCT/2000/00391/KOL. 391’ application was granted on Apr 05, 2007 and both these applications were filed on Aug.11, 2008, much after the grant date. Therefore they cannot be considered as timely filed as per the Act.

3.      For the sake if we consider that both these applications divided out of 1638/KOLNP/2005, but request for examination (RFE) was not timely filed for 1638 application and therefore deemed to withdrawn as of Feb.16, 2006. Therefore any divisional application filed after this date cannot be considered as divisional application according to Act.

4.      Again both these applications (3272 and 3273) cannot stand as their RFE also filed after due date ie Feb. 11, 2009. Therefore as per section 11B(1), these applications cannot be examined further.

The above objections/grounds were also communicated to the applicant before refusing the applications but hearing was not attended by applicant. Therefore both applications viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 are not considered to be divisional applications within the meaning of section 16 of the Act and also they have not been properly filed complying the requirements of Acts.