1.
How Important And Valuable Is The Case?
Knowing how important a case is allows you to decide how
much resource you want to commit when drafting it. If this is going to be the main case
protecting the company’s main product then careful thought will need to be
given to it being in the best shape possible to undergo examination, opposition
and even litigation. That might mean
providing more disclosure, for example in the form of fallback positions, and
perhaps reviewing the quality of the data that is used. However it should also be borne in mind that
more disclosure will increase costs, particularly translation costs at national
phasing.
2.
What Is The Purpose Of The Case?
A patent case has a commercial purpose which might be
distinct from protecting the immediate implications of the experimental finding. The claims will need to reflect that. For example if the experimental work was done
on disease X, but only related condition Y is of importance, then treatment of
disease X might not even be mentioned in the claims. Such considerations will also determine how
the rest of the application is written and how the contribution is described.
3.
The Prior Art Effect On Your Subsequent Cases
Any application you file will be prior art against your subsequent
cases. It is therefore important to consider
during the drafting process what future patent applications are likely to be
filed and whether are perceived to be more important. Consideration should then be given to how
this might affect drafting of the present case.
For example you may decide to avoid mentioning certain embodiments, e.g.
combinations with other drugs, to minimise the prior art effect.
4.
Consider The Prior Art Effect On Competitor
Cases
If you are in the situation where competitors are filing on
similar subject matter, then it might be worthwhile to think about how to your
application could be used to make it more difficult for them to gain patent protection
in the area with subsequently filed cases.
One way of doing this is to draft the application so that it will make
it more difficult for competitors to gain claims directed to a selection
invention, for example by providing appropriate point disclosures within
specified ranges. In the case of inventions relating to therapy it might be
helpful to introduce disclosure relating to different patient groups, ranges of
dosages and to describe all the relevant disease types.
5.
The Invention Is Only Defined In Examination
The problem being solved can change substantially depending
on the prior art that is being cited.
The application needs to be drafted in a way that takes account of
this. All contributions and subconcepts need
to be listed and there needs to be disclosure which gives flexibility to the
way the invention is defined.
6.
Write The Summary Of The Invention Carefully
The summary of the invention needs to give a succinct
description of what has been found and what the claimed invention essentially is. This should be done in a way that does not
limit the arguments that can be used in examination. Often it is helpful to use very general
terms, such as ‘The invention concerns treatment of condition A. The inventors have investigated the binding
between X and Y, which has allowed regulators of the binding to be identified
which can be used to treat A’. This phrasing allows flexibility in the
arguments that can be used to defend the claims. Inventive step could be argued on the choice
of focusing on X and Y, the finding of unexpected binding properties, the
identification of regulators able to affect binding or the realisation that
such regulators can be used to treat condition A.
7.
Consider All Layers Of The Invention
Biotech inventions can sometimes be seen at different
levels. Where this is possible
consideration should be given to how best to view and present the
invention. For example if a polymorphism
in the insulin gene is found to affect calcium levels, then the invention can
be seen as:
(i)
finding a link between the polymorphism and calcium
levels
(ii)
finding a link between insulin and calcium levels
(iii)
finding a link between factors that affect
insulin expression or activity and activities affected by calcium ions
Clearly the prior art and considerations of
support/sufficiency will affect how best to view and present the invention and thus
how broadly to draft the claims.
8.
Consider All Product Claims And Novelty Over
Nature
Where a product is found in nature there should be basis for
claiming it in isolated form, preferably with defined levels of purity. It might also be worthwhile to consider
claiming it in the different forms it occurs in the invention, for example as
part of a viral capsid or in combination with substance X.
9.
Are There Claimable Data/Computer Aspects
In cases where data is the product of a method of the
invention consideration should be given to whether analysis of the data on a
computer would be patentable. For
example if presence of gene polymorphisms is being used as the basis of
diagnosis then it may be possible to claim comparing the results of the
diagnostic test with a database of polymorphisms to determine the disease
condition. Further claims to choosing or
manufacturing the appropriate medication based on the data might also be
possible.
10.
Think About In Vivo Generation Of Substances.
Consider whether you need to cover administration of a
pro-drug or other substance that only gives rise to the active compound in
vivo.
