Astrazeneca
Canada Inc. v. Ranbaxy Pharmaceuticals Canada Inc., 2013 FC
232

Astrazeneca
brought an application under section 5 the PM(NOC) Regulations defending
Canadian Patent No. 2,170,647 (the ‘647 patent) against Ranbaxy’s allegation of
invalidity on grounds of obviousness. The ‘647 patent covers enteric coating of
omeprazole tablets.

The
allegation that the ‘647 patent is invalid for obviousness is not justified.

In the
present case, experimentation was required to determine the appropriate
composition of enteric coating. It is therefore necessary to use the “obvious
to try” test set out in SCC’s Sanofi decision. The Court proceeded to
assess the following factors:

Is it
more or less self-evident that what is being tried ought to work?

To
establish obviousness, the invention must be self-evident from the prior art.
In this case, the need for a solution is evident from the prior art; namely, an
enteric coating suitable for dispersed omeprazole delivery, however, that
solution is not provided for in the prior art. The prior art teaches away from
the existence of such a solution or alternately indicates that such a solution
is extremely complex and technically difficult to produce. Therefore, the
enteric coating is not self-evident.

What is
the extent, nature and amount of effort required to achieve the invention? Are
routine trials carried out or is the experimentation prolonged and arduous,
such that the trials would not be considered routine?

The
evidence points to a significant amount of effort required to obtain the
desired result. The nature of the effort required to achieve the invention was
significant scientific research. The experimentation required was prolonged,
complex and, as evidenced by the limited number of studies investigating the
process, far from routine.

Is there
a motive provided in the prior art to find the solution the patent addresses?

There is a
motive provided in the prior art to find the solution the patent addresses.

In the
context of the “obvious to try” test, motivation disclosed in the prior art
would be indicative of a marketplace that would actively seek the
(subsequently) patented solution. If other parties were motivated to find the
solution and yet were unable or unwilling to do so prior to the patent being
obtained, this factor would point to a solution that was not “obvious to try”.

Furthermore,
even if it was obvious to seek a solution for enteric coating for omeprazole,
it was not an easy solution and would likely have dissuaded a person skilled in
the art.

Considering
all of the evidence, the “obvious to try” test has not been satisfied as it was
not “. . . more or less self-evident to try to obtain the invention”.