This is written from the perspective of a European patent attorney practicing in the pharma and biotech fields.
1. For pharma and biotech cases data is often needed to show that the invention works, i.e. that the technical effect can be achieved by the means which are described. A mere description of how to carry out the invention is often not enough, and a lack of data can lead to objections of lack of sufficiency, support and even lack of inventive step (problem not being solved). The European Patent Office may use the test of whether it is ‘plausible’ the problem has been solved from the specification.
2. Ensure that further data generated in the priority year is incorporated into the application at Convention filing. When writing the priority application one must review whether the claims and description need to anticipate what the further data may show, for example more patient groups that could be supported by the new data.
3. When evaluating data be mindful of identifying all technical effects, no matter how minor and making a reference to them in the description. Fallbacks should be provided which will make it possible to limit the claims to any one technical effect if required.
4. Ensure that the claims and description have fallbacks which represent generalised features derived from the data. In particular consideration should be given as to whether ranges encompassing specific point values in the data need to be introduced into the claims and description. This obviously makes it easier to amend the claims to limit them to preferred features. However it is also a way of the Examiner appreciating the full impact of the data on the invention and on what is claimed.
5. Don’t prejudge the problem which is solved. That may change when prior art is identified in the search. The patent application needs to therefore be measured in the way the data is described, and preferably should not view the data as showing a single finding. The relevant part of the description should say: ‘The data shows that X activity of Y. It shows how Y could be used to treat Z. It shows preferred patient groups for treatment. It shows [the different aspects of the invention]’, i.e. reflecting all the different advantages made possible by the invention.
6. Specific advantages that should be considered beyond on the main technical effect include:
– does the data show some patient groups (e.g. with severe disease) might respond better?
– does the data indicate preferred doses, a preferred administration schedule or a preferred route of administration?
– does the data indicate other substances that could be coadministered to give further advantages?
7. The invention might not stop at the point of administration. Data showing pharmacokinetic properties could be useful to show additional advantages. That could affect how the problem is defined and so assist in arguing inventive step, i.e. the problem could become ‘a substance for treating cancer with X advantageous pharmacokinetic properties’.
8. Bear in mind that post-filing data can be filed during examination or in opposition to further support the data in the specification. When the application is drafted that post-filing data should be anticipated if it is not available for inclusion in the patent specification. It is difficult to predict how effective filing post-filing data will be in overcoming objections, but often it is helpful.
9. Post-filing data used to support arguments in examination or opposition can include third party, for example data published in journal articles.
10. Be wary of including data from other parties in the patent specification if it might affect inventorship. Even a minor contribution can lead to a person being deemed an inventor and therefore careful thought may need to be given to which data is included in the specification if it comes from different sources.