When can data generated after the filing date of a patent (“post-filed data”) be used to support inventive step at the EPO? A possible new referral to the Enlarged Board of Appeal may clarify this. In this article, partner Nick Lee, a veteran of this topic following his involvement in the seminal Factor-9/John Hopkins T1329/04 Board of Appeal decision, briefly reviews the EPO’s current position on the use of post-filed data and explores the questions that have now been posed.
Post-filed data to support inventive step?
The question of whether and when post-filed data can be used to support inventive step at the EPO is one that has not been definitively answered. It seems that the Enlarged Board of Appeal (EBA) may shortly be asked to rule on this question in connection with pending appeal T0116/18 relating to EP2484209.
Until 2005, the EPO’s general position was that post-filed data could be used in support of inventive step. However, in the Technical Board of Appeal (TBA) decision T1329/04, the notion of “plausibility” was introduced, limiting the circumstances in which such data could be used. That is, post-filed data could only be relied on if it was already plausible at the filing date of the patent that the effect relied upon for an inventive step could be achieved.
T1329/04 has been highly influential on the EPO’s approach to post-filed data following its publication in 2005. Since then, subsequent decisions have questioned whether the plausibility standard is correct (e.g., T1422/12, T2371/13, T0031/18). There have also been questions as to whether, even if the plausibility standard is correct, it is up to the proprietor to show there is plausibility at the filing date (as in T1329/04) or an opponent to show there is not plausibility at the filing date (as in, for example, T0184/16). It seems that at least some of this may be clarified by the EBA, though assuming a referral to the EBA is made, it will likely be one to two years before a decision is issued.
In T0116/18, the TBA was presented with a case relating to a combination of insecticides. In response to the opponent’s arguments, there was no inventive step in the combination, the proprietor filed post-filed data allegedly showing the combination was synergistic. The opponent, in turn, argued plausibility had not been established for at least some of the combinations encompassed by the claims, and therefore, the post-filed data should not be considered.
In its preliminary opinion, the TBA stated it saw a divergence in the case law and that a referral to the EBA may be necessary. At the subsequent hearing, after listening to the parties’ submissions, the TBA declined to give a decision, stated that it intended to refer the matter to the EBA and invited the parties to comment on its proposed questions for the EBA. The TBA is currently considering the parties’ comments on the proposed questions ahead of the likely referral to the EBA.
What are the questions for the EBA to consider?
There are currently three questions under consideration, as follows:
If for acknowledgement of inventive step the patent proprietor relies on a technical effect and has submitted data or other evidence to proof such effect, such data or other evidence having been generated only after the priority or filing date of the patent (post-published data):
1. "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?
(In other words, if an inventive step relies only on post-filed data, should those data be disregarded?)
2. "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)?"
(In other words, if an inventive step relies only on post-filed data, is the burden on the proprietor to show plausibility?)
3. "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)?"
(Or, is the burden on the opponent to show plausibility?)
How could this affect Life Sciences patents and applications in particular?
Our view is that it is unlikely the EBA will lower the standard for admission of post-filed data supporting inventive step, given the general reluctance of the EPO to grant patents based purely on speculation. The question is what standard will be set.
One possible outcome of the EBA referral is that the opportunities to rely upon post-filed data in support of inventive step are restricted further. This may mean applicants will need to include more data in their applications, which could require delaying filing until such data are available or filing applications with narrower language that more closely matches the data that are available at the time. Clearly this would make matters more difficult for applicants, in particular in the life sciences sector, where it can take many months (or longer!) to generate supporting data. Paradoxically, this could lead to more speculative filings, as applicants have to predict what results they might expect from ongoing research. If the referral goes ahead, interested parties will have an opportunity to put forward their position to the Enlarged Board in the form of amicus briefs, and we would expect those to be numerous for such an important topic.
Finally, there is the question of what will happen to those cases – whether they be pending applications or patents under opposition or appeal – where this post-filed data point has an impact on the outcome. The pragmatic thing to do would be to defer consideration of those cases until the EBA has given its decision. Previously, the EPO has taken the pragmatic option in similar circumstances and we expect it to do so again now. So it seems likely that consideration of cases that rely on post-filed data to support their inventive step will be suspended and they will not be decided for another one to two years.
We await the outcome of this appeal with interest. If you would like know more, please get in touch with Nick Lee, or your usual Kilburn & Strode advisor.