Strict Procedural Requirement at Indian Patent Office

Recently, Controller has given decision for the two divisional applications which are related to Herceptin, Drug for Breast Cancer developed by Genentech.  Herceptin (Trastuzumab) is a monoclonal antibody that interferes with the HER2/neu receptor. Trastuzumab costs about US$70,000 for a full course of treatment and brought in $327 million in revenue for Genentech in the fourth quarter of 2007. A news (inEconomic times) regarding the compulsory license has also been there but still DIPP is under consideration for this drug.  Below is shown patent situation for the Herceptin in India:  

 

(i).   IN 205534 (Main patent for Herceptin) – As per the e-register (Indian Patent office) of this patent has been ceased on 3 May, 2013. From the e-Register, it appears that Genentech has paid last maintaince fee in Mar, 2012 and this time perhaps they have missed the deadline.

 

(ii). 1638/KOLNP/2005 (divisional application) - This application is still under opposition by Glenmark Pharmaceutical Limited.

 

(iii).      3272/KOLNP/2008 & 3273/KOLNP/2008 (divisional application): Both applications are held abandoned by IPAB recently on Jul 17, 2013. The reason for the abandonment of the two applications is summarised below:

 

ü  Missed out a day in Filing request for examination: Last date for Request for examination for these application was Feb 11, 2009 as per sec 24 B (iv) of Indian Patent Act, but Genentech has filed the examination request one day late i.e. Feb 12, 2009.

 

ü  Not divisional as per Patent act: Applications was filed as divisional of 1638/KOLNP/2005 which is also divisional of Main patent. It was held that there is no scope in patent act for filing further divisional application of a divisional application. In spite of this, if a divisional is further divided, later application will be considered as divisional of first parent application. In this case, original parent application was granted in Apr, 2007 and divisional applications (3272 & 3273) were filed in Aug, 2008 i.e. after the grant of Main Patent.

 

ü  Not a proper divisional on the basis of plurality of the invention.

 

Genentech is also provided with an opportunity to be heard for the above matter, but they did not appear for the hearing. So this is another mistake on part of Genentech.

 

Above situation indicate that patent office is having strict compliance requirements, which needs to be fulfilled. Even a delay of one day or a single mistake can cost a lot for the Patent applicant. Also, there is now only one application of Herceptin (1638) which if granted can block the generic players to enter in the market. Also need to check the step taken by the Genentech to save its Main Patent whether they will request for restoration?