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.