Plausibility affects patent requirements
To patent an invention it must be novel, inventive and ‘enabled’
The main statutory requirements for patentability are that the invention must be novel, meaning it has not been made public before the patent was applied for, and inventive, meaning it is not just an obvious development of something that has already been made public. In addition, the patent application must describe the invention in sufficient detail to enable someone skilled in the relevant field of technology to make the invention. Patent applications are examined, typically over the course of a number of years, to ensure that these requirements are met before the patent is granted.
Applicants can typically lodge supporting data after filing a patent application
In most jurisdictions, including the United Kingdom, it is possible to submit data in support of the application to the patent office, even if that data was produced after the patent application was filed. In addition, it is often preferable to file patent applications sooner rather than later in order to reduce the chances of someone else disclosing the invention before the application has been filed, which would result in invention being found to lack novelty or inventiveness. Accordingly, it is common practice to file patent applications when only a small amount or even no data regarding the invention is available to include in the application on the understanding that data can be submitted later, if necessary.
Patent applications may be rejected if the invention is not deemed plausible
However, a developing principle in the United Kingdom and European Patent Office relates to whether the content of a patent application makes it plausible that the invention works as described. In the event that this is not the case, the examiner may object to the application on the grounds that it is not inventive or insufficiently disclosed, and is unlikely to allow the submission of data that was not included in the patent application in response to this objection.
Patent plausibility has been gaining acceptance in Europe over recent years
This principle was first set out explicitly in 2005 by the Technical Board of Appeal at the European Patent Office in T 1329/04 and has since been gaining acceptance and been adopted and developed in subsequent Technical Board of Appeal decisions and by various national courts, including those of England and Wales.
T 1329/04 concerned a nucleotide encoding a novel protein (GDF-9), the inventiveness of which depended on whether this protein was a member of the TGF-Beta superfamily of proteins. The Technical Board of Appeal noted that there were significant structural differences between GDF-9 and other members of the TGF-Beta superfamily and that the patent application did not include any data demonstrating that GDF-9 had a similar function or any other similarity to any other members of the TGF-Beta superfamily. Accordingly, the Technical Board of Appeal did not consider it to be plausible on the basis of the content of the patent application that GDF-9 was a member of the TGF-Beta superfamily and hence found the invention to lack inventiveness. Importantly, by the time of this decision, the applicant had generated data that supported GDF-9 being a member of the TGF-Beta superfamily, but the Board did not consider this to be relevant as the application as filed did not make it at least plausible that this was the case.
The content of a patent application must make it plausible that the invention works
Accordingly, the content of a patent application must make it at least plausible that the invention works and can be put into practice by a person skilled in the relevant field of technology. If this requirement for plausibility is not met, it would not be permitted to submit further data to the patent examiner in support of the application. This is the case even if this further data demonstrates that the invention does in fact work and can in fact be put into practice.
Data supporting plausibility should be included in the patent application at the time of filing
This issue of plausibility may arise for inventions in any field of technology, but is more likely in fields in which it is less likely to be self-evidence that the invention will work, such as pharmaceuticals, biotechnology, advanced physics, or if there is already a widespread belief in the field that the invention would not work. In these cases, care should be taken to ensure that data is included in the patent application at the time of filing to at least render the invention plausible.
Consider delaying filing until sufficient data is available
It is therefore advisable to consider whether there is any possibility of an invention being found to be implausible in the absence of data and, if this is the case, waiting until sufficient data is available for inclusion into the application to establish plausibility before proceeding with filing. However, precisely how much data is required will vary widely from case to case.
Warner-Lambert v Generics decision expected to clarify the issue of plausibility
The Supreme Court is currently considering the issue of plausibility in Warner-Lambert v Generics UKSC 2016/0197 and the decision in this case, which is expected shortly, is anticipated to provide some clarification on how the concept of plausibility is likely to be applied, at least by the courts of England and Wales.