Choosing the perfect time to file a patent application often poses a dilemma for inventors. On one hand, the novelty requirement prompts applicants to file the invention as soon as possible, to prevent third parties from filing first or avoiding the appearance of new documents in the state of the art, which could prevent the application being granted.
On the other hand, the need to provide enough data to demonstrate that the inventive step requirement has been fulfilled encourages holders to do the opposite, in other words, to delay the filing of the application until relevant evidence is obtained.
This is an especially challenging situation for inventions in which data play a very important role in obtaining the grant of the patent, in particular pharmaceutical inventions, for which said data may have to be obtained by conducting trials that are often lengthy and expensive. Therefore, multiple factors involving financial, strategic, commercial and legal aspects have to be considered when deciding when to file.
Accepting post-filing data: different criteria
One controversial option to file as soon as possible, lowering the risk to lose exclusivity, is to provide experimental data after the application has been published, either during the examination procedure or even during the opposition procedure. This option, however, does not exist in all jurisdictions, and it is important to keep this in mind when trying to obtain protection on an international level.
In China, for example, this option is very limited. In the United States, Japan, Korea or Canada, on the other hand, the filing of post-application data is allowed under certain circumstances. In other words, the criteria differ depending on jurisdiction.
Post-filing data in Europe
Historically, the European Patent Office (EPO) has accepted post-filing data. It is a good idea to remember that when assessing inventive step the EPO uses the “problem-solution” approach. According to the guidelines for examination, this approach has three stages:
- Determining the closest prior art
- Establishing the objective technical problem to be solved, and
- Considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person
The European Office typically assesses whether the objective technical problem has been solved by using the experimental data provided in the patent application; that being said, it also usually allows data, such as post-publication data, to be provided during the examination procedure.
As a result of an opposition procedure lodged by the agrochemical powerhouse Syngenta against the Japanese company Sumitomo Chemical Company (case T 0116/18, EP2484209), the Technical Board of Appeal stated in the minutes of the hearing the willingness to request the EPO’s Enlarged Board of Appeal (EBA) to clarify the conditions under which experimental data filed after the publication of the patent application should be accepted.
More specifically, the points are aimed at clarifying whether this post-filing data must be considered when examining inventive step.
The reasons to call for a harmonization of this matter by the EBA is found in the preliminary opinion (points 8.5 to 8.7) handed down by the Board of Appeal before the hearing that took place last July and which focuses on the plausibility of the technical effect included in the first claim of the patent application EP2484209 on its filing date.
Ab-initio plausibility criterion
As set forth in said preliminary opinion, to date the Office has not established a standardised doctrine in this regard citing the following examples:
In cases T 488/16 (point 4.2), T 1329/04 (12) and T 433/05 (28), one condition for taking into account post-published evidence to demonstrate a certain effect is that it is already plausible at the filing date that said effect was obtained (ab-initio plausibility criterion).
However, the legal basis for such a criterion has been questioned. In fact, in numerous decisions, the ab-initio plausibility criterion was not applied. One such example is T 1422/12, where the technical effect in question was not even mentioned in the application as filed, but it was accepted since it concerned “the same field of use and did not change the character of the invention”.
In decision T 2371/13, the Board went even further and stated that disregarding post-published evidence “would be incompatible with the problem and solution approach”. A similar approach was adopted in decision T31/18, which adds that the technical effect mentioned in the application does not have to be “necessarily” supported by experimental evidence on the filing date and, moreover, it is not necessary to expect the applications to include an extensive amount of evidence of all the technical features since they may not be known at the filing date.
Burden of proof
In addition to the question of applying the ab-initio plausibility criterion or not, the Board of Appeal 3.3.02 (in charge of case T0116/18) also raises another important point to bear in mind in its preliminary opinion at the hearing: if necessary, who should bear the burden of proving the ab-initio plausibility of the technical effect in question? Should it be the holder or the opponent? This aspect also involves diverging case law.
Moreover, according to the Board, it shall be necessary to determine a third aspect relating to the type of evidence that could be filed by an opponent to demonstrate the lack of plausibility of an effect and whether he could use post-published data to that goal. If post-published data were accepted from the opponent, they should also be accepted from the patentee.
Points to be clarified by the Enlarged Board of Appeal
In essence, the Board of Appeal considers that the EBA shall clarify whether the plausibility criterion of a technical effect should be applied and, if so, what would be the legal basis for such a requirement, on whom would the burden of proof be placed, and what type of evidence would be admitted.
During the recent hearing, as recorded in the minutes of the hearing, the Chamber proposed that the parties ask the EBA the following questions:
If for acknowledgement of inventive step the patent proprietor relies on a technical effect and has submitted data or other evidence to prove such effect, such data or other evidence having been generated only after the priority or filing date of the patent (post-published data):
Should an exception to the principle of free evaluation of evidence (see e.g. G 1/12 reasons 31) be accepted in that the post-published data must be disregarded on the ground that the proof of the effect rests exclusively on such post-published data?
If the answer is yes (post published data must be disregarded if the proof of the effect rests exclusively on these data): can post-published data be taken into consideration if based on the information in the patent application the skilled person at the relevant date would have considered the effect plausible (ab initio plausibility)?
If the answer to the first question is yes (post published data must be disregarded if the proof of the effect rests exclusively on these data): can post-published data be taken into consideration if based on the information in the patent application the skilled person at the relevant date would have seen no reason to consider the effect implausible (ab initio implausibility)?
It shall be necessary to wait for the parties to give their input before knowing the final wording of the questions that the Board will remit to the EBA and even longer (probably at the end of 2022), for the Enlarged Board to clarify the criteria to be followed in these cases.
Recommendations regarding the provision of post-filing data
As mentioned at the beginning, regardless of the doctrine that shall be established at the EPO, the rest of the jurisdictions have their own criteria for determining whether or not to accept experimental data obtained after an application filing date, as well as the conditions that must be fulfilled for it to be accepted.
Furthermore, it is not easy to find a balance between filing the patent application as soon as possible and ensuring that said application includes all possible evidence to demonstrate the inventive step necessary to obtain the grant.
In any case, informing the patent attorney responsible for drafting the application of all possible technical effects (proven or not) of an invention is essential, even if evidence supporting them has not yet been obtained. Successfully securing optimal global protection for the invention will greatly depend on this.