What happens to my patents if the results are delayed?

Experimental results are often a very important component of patent applications in the life sciences in order to demonstrate that the invention works, which is a requirement in the patent context. Delayed experimental results can be handled in different ways depending on where you are in the patent application process.

Situation 1: First patent application (priority application)
As it is not possible to add new data to a patent application after the filing date, it may be wise to consider postponing the filing of the application until results have been generated. This presupposes that the invention can be kept secret until the filing of the application, otherwise the novelty of the invention will be lost and thus the possibility of patenting it. Therefore, if publication of the invention is imminent, e.g. through a public presentation, an article or a thesis that cannot be postponed, it is better to file the patent application without experimental results and make the best of the situation, even if there is an increased risk that the patent authorities will consider that the invention is not sufficiently clearly described or not disclosed, and that the patent application will therefore not be granted.

Situation 2: Second patent application (e.g. PCT application)
Within 12 months from the filing of a first patent application, a second patent application can be filed with priority from the first one (see priority here: https://www.prv.se/sv/patent/ansoka-om-patent/innan-ansokan/prioritet/). As the 12-month deadline cannot, as a general rule, be extended and as it is not possible to file supplements to the application that are not supported by the information on the invention already filed, if the results are important for the granting of the application, one can consider withdrawing the first patent application and re-filing it once results have been generated, thus creating a new “first patent application”. This assumes that no publication of the invention has taken place, either by you or by anyone else, before the application is resubmitted. It also requires that the earlier, withdrawn application leaves no rights behind, which in practice means that it must be fully completed and not linked to other patent applications. Please contact your patent attorney if you are considering this option.

Situation 3: National application process
In some situations, experimental results are needed to respond to an injunction, e.g. in the US or before the European Patent Office (EPO). This may be the case if the patent applicant has to prove a certain claimed effect of the invention. In such a situation, it can be examined whether it is possible to request an extension of the deadline under the national law of the country concerned. As patent law is not harmonized, different rules apply in different countries, and taking into account that some patent offices have been completely closed during periods of the Corona pandemic, there may be possibilities in some countries to request the reinstatement of deadlines that could not be met.

Do I need to think about anything in particular regarding an application for Supplementary Protection Certificate (SPC)?
The deadline for applying for a supplementary protection certificate (SPC) is 6 months after the granting of the marketing authorization for the product, so temporary interruptions or delays in clinical trials do not automatically mean that the entitlement to a SPC changes. The risk is that the delay in the studies will be so long that the 20-year term of the patent will end before the market authorization is granted, after which you can no longer apply for supplementary protection. As all supplementary protection certificates are applied for at the respective national patent offices, it is not possible to make a general statement about which deadlines can be extended due to reasons related to the pandemic; this must be examined on a case-by-case basis.

Can we request an extension of deadlines due to the coronavirus pandemic?
In a national application process, it is often possible to request an extension of deadlines, consult your national patent attorney. See also the comment above (Situation 3).

However, in general, it cannot be expected that the statutory deadlines in the patent application process can be postponed by the patent authorities due to circumstances related to the current pandemic. For example, the period for claiming priority in the novelty assessment of a second patent application (the “priority period”) cannot be expected to be overridden, except to the extent that there are specific exceptions in law.

Louise Jonshammar Johanna Bergh

Attorney at law Partner, European Patent Attorney

AWA Sweden AB AWA Sweden AB

Here you will find SwedenBIO’s information page related to Covid-19:
https://swedenbio.se/om-life-science/covid-19/