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 :-)