India: Patent Office decisions now searchable and downloadable

The Indian Patent Office has taken a positive step in training/ educating and bringing transparency in regard to opposition of patent applications.
It has decided to put Opposition decisions on-line.
NOW, the Indian Patent Office decisions are available for every one to read and download.

Please visit this link on the Indian Patent Office's site.
Upon visiting the link, you will see a page that allows searching by 6 options:
a) Patent number;
b) Application number;
c) Applicant;
d) Opponent;
e) Controller &
f) Section number.

Now that decisions are readable and downloadable, I thank the entire Patent Office staff who have put efforts behind this venture. This effort will go a long way in training/ educating IP professionals on how to approach and fight patent oppositions.

TEST: I tried searching for opposition decisions from two Indian companies - Ajanta and Ranbaxy using Internet Explorer. I was able to download results, when clicked on application number hyper-link.

Roche v Cipla - Delhi High Court Interim Order

The Delhi High Court's Order in the patent infringement case involving Erlotinib, sold as "Tarceva", is a path-breaking judicial pronouncement on the law of interim injunctions involving patents and public health.

The Court recognised, for the first time in India, the need to consider public interest in allowing or rejecting an order of injunction. The American Cyanamid Approach, was followed diligently, again for the first time since its pronouncement by the House of Lords in 1975.
To read further views on Courts' views on injunctions, click here,

The Cipla order rejecting injunction can be found here
and
the order expediting trial, which is a welcome sign, can be found here.
Interesting reading this!

Valganciclovir: Ranbaxy files post grant opposition

Mint reports that Ranbaxy has filed a post-grant opposition to the Valganciclovir product patent [IN207232].

Cipla which had earlier stated that it would lodge in a post grant opposition has. as yet, not done so.

This news was posted on the genericIP blog, but I missed putting it here.

Sun opposes Risperidone related patent

Varun had posted this:

Mumbai-based Sun Pharmaceuticals Ltd. has filed a post-grant opposition in respect to Indian Patent No. 208191 issued to Janssen Pharmaceutica N.V. against the mail-box Application No. 188/CAL/1995. The opposition was filed on January 02, 2008 with the Mumbai Patent Office, which last year in July (dated July 20, 2007) published the grant of the ‘191 patent under section 43(2) of the Patents Act, 1970. The ‘191 patent relates to sustained-release micro-particle of risperidone.
After Varun put his post, the media also covered it: here.

My query:
What has got me thinking that if the patent application was filed at Kol patent office, then how was it granted by the BOM patent office?
Once an answer to that comes across, then we can understand the reason behind the Post grant Opposition being filed at the BOM patent office?

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.

Insulin - Wockhardt's opposition to Lilly's human insulin

Pharmabiz has an interesting article on Patent Oppositions, [article written by dear friend, Ashwini Sandu along with Raju Kumar].

While most of the cases referred are known to our readers via this blog/ other news sources, I found an interesting discussion on a Lilly application, which was hitherto not covered here as well as in news/ print media.

Straight from Pharmabiz:
"...Thus, in Eli Lilly and Company v. Wockhardt Ltd., [675/Cal/1995] dated June 14, 1995 the Controller held that a correct application of the problem solution approach rules out an inadvertent application of an impermissible ex post facto analysis and this has been one of the guiding principles of the Patent Offices in the assessment of inventive step.

The problem solution approach comprises:
(i) determining the closest prior art;
(ii) establishing the objective technical problem to be solved; and
(iii) considering, whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to a person skilled in the art.

The Controller held it clearly inherent within these stages for problem-solution determination to assess the inventive step involved examining the inventive step to looking forward from the prior art rather than looking backward from the claimed invention. It is this approach to the assessment of inventive step that brings out the technical contribution made by the claimed invention to the advancement of the state of the art.

The Controller further held that the problem formulated in the assessment of inventive step may contain no pointers to the claimed invention, which would otherwise lead to an application of the impermissible hindsight analysis of the inventive step...."

I read the application number but since I did not know as to what product was covered, I did some searching and believe that the underlying application is Lilly's Human Insulin [675/Cal/1995]. Sadly, the article does not give the outcome of the Opposition [i.e. Controller’s final decision].

Other details:
1)
Lilly filed the patent application [675/Cal/1995] for Insulin analog formulations. The application/ invention related to parenteral rapidly on setting formulations comprising human insulin analogs in a hexamer conformation, zinc ions, and at least three molecules of a phenolic derivative selected from the group consisting of m-cresol, phenol, or a mixture of m—cresol and phenol.
This application was filed from a US application: 08/260,634 having a priority of 16/June/1994. The US application later matured into US5474978 [the Orange book listed patent for Human insulin – parenteral; branded as Humalog(R)].

2)
This application was [possibly] not filed as a single EP application. There are individual country patents for this invention [e.g. GB2291427B/ FR2741078B etc.

There could have been following outcomes to the Indian opposition:
a) Lilly lost the application altogether/ or was required to amend claims, in either of which cases it may have gone for an appeal [if it wanted to];
b) Wockhardt may have lost the pre-grant opposition, in which case, the application now proceeds to grant and the battle then continues in the form a post grant opposition.
c) Alternatively, it could have been that Lilly conceded some claim ground and amended its claims in such a manner that Wockhardt is NOT affected by the amended claims and hence we may not see any thing more on this case :-)

PLEASE note that since the Opposition decision is NOT available with me, hence I am only guessing the above outcomes.

Interestingly, Lilly also following patent Indian applications on Human Insulin related subject matter:
677/CAL/1995;
566/CAL/1996 &
802/KOLNP/2004.

With [at least] the above three applications, I have a feeling that the present [675] decision is not the last that we have heard of Wockhardt/ Lilly and Insulin :-)

PEG Interferon: Post grant opposition

Roche was amongst the first recepients of product patents in the pharma space. It received product patent [IN198952] in India in 2006 for its product - Pegasys [pegylated interferon alpha 2a].

While the Pegasys product patent is under post grant opposition by Wockhardt; an NGO Sankalp too filed a post grant opposition in May 2007 against this product.
Copy of Sankalp's Opposition.