Biontech SE & Anor v Curevac SE

Where the applicable patent-law test is unclear or developing, pleadings need not define the legal standard with absolute precision. They must identify the relevant facts and evidence. Where ab initio implausibility is in issue, the party attacking the patent must identify positive reasons why the skilled addressee would doubt the asserted technical effect. The patentee need not ordinarily supply those reasons. Any factual case relied upon for that purpose should be identified in good time.

This was a procedural and case-management decision in patent proceedings concerning EP 1 857 122. CureVac accepted that the patent was invalid on the current law stated in Warner-Lambert. CureVac nevertheless maintained a position based on paragraph [0019] of the specification, specified post-published material, expert evidence, and the possibility that the Supreme Court might revisit the applicable law at trial.

The court was required to determine the appropriate scope of the pleadings and evidence, including which party should identify factual matters relevant to ab initio implausibility, and to revise the trial timetable.

1. The court held that pleadings need not identify legal standards with absolute precision where the law is unclear or developing. The proper focus is on ensuring that the relevant facts are identified in the pleadings and evidence.

2. For the possible trial scenario in which the ab initio implausibility test applied, the test required reasons to doubt the technical effect. Those reasons had to come from the party attacking the patent. It was not realistic to require the patentee to put forward reasons undermining its own technical effect.

3. Pfizer and BioNTech were therefore required, by appropriate procedural means, to identify any factual matters on which they relied to show that the skilled addressee would consider the technical effect implausible. The judge regarded timely identification as appropriate, particularly because the defendants had already had an opportunity to consider the issue.

4. The court also revised the trial timetable. EP 1 857 122 was to be dealt with from 8 July and concluded by lunchtime on 9 July. Professor Qian was to be moved elsewhere in the timetable, and Professor Ashe’s evidence was to conclude by lunchtime on 18 July.