Astra: the bad news continues [more]

I had earlier blogged on Astra's Indian patent problems, here.
Pharmabiz now reports on another Astra patent application rejection [article written by dear friend, Ashwini Sandu along with Raju Kumar].

This time its omeprazole formulation application.
Straight from Pharmabiz:

"... in Torrent Pharmaceuticals Limited v. Astra Aktiebolag (1354/DEL/98 dated May 21, 1998), at issue was the claimed formulation which was similar to the formulation taught by the prior art except that the claimed invention recited a selective quality of HPMC as the preferred binding agent and/or separating layer whereas the prior art taught HPMC generally.
Therefore, the question before the controller was whether the use of specific quality of HPMC used in the claimed formulation made it patentable over the prior art.
The Controller found that there was apparently no difference between the claimed formulation and the formulation taught by the prior art apart from the alleged selection of HPMC quality, which led to an improvement in the consistency of production of coated tablets having more than 75% release rate.

Hence, the claimed invention was deemed novel and not obvious in view of the asserted advantages.
However, the Controller took cognizance of the fact that the claimed invention did not show any improvement in therapeutic efficacy compared with the prior art. Accordingly, it was found that the benefit claimed by the invention in dispute was not accruable to the user in terms of the therapeutic quality of the product but only to the manufacturer in terms of the consistency in production. Accordingly, the claimed invention was found to fail the requirements of Section 3(d) of the Patents Act…”

The present application [1354/DEL/98] relates to Omeprazole/ Esomeprazole formulations containing specific type of HPMC. This is the same as US6090827. This is a NON Orange book patent for Esomeprazole/ Omeprazole.

So, the total tally of Astra rejections now looks like this:
a) 1354/DEL/98 Relating to Omeprazole/ Esomeprazole formulations --> Rejected;
b) 1344/DEL/1998 : Esomeprazole tri-hydrate [Nexium] product patent application --> Rejected;
c) 841/DEL/1996 : Gifitinib/ Gefitinib [Iressa] product patent application --> Rejected.