Neurim Pharmaceuticals (1991) Limited v Generics (UK) Limited t/a Viatris

In assessing patent plausibility, the court must consider the evidence as a whole and in its proper experimental context. A skilled person’s technical understanding of a questionnaire is not undermined merely because trial participants might have understood its wording differently. A further trial is unnecessary where the existing evidence permits the issue to be determined fairly.

Permission to appeal should be refused where the proposed grounds are essentially factual and disclose no realistic prospect of success. A permanent injunction should ordinarily take effect where the claimant has established entitlement to it and there is no genuine chance of a successful appeal. Any stay requires careful comparison of harm that can and cannot be adequately compensated by damages.

The judgment followed an earlier provisional judgment concerning the validity of a divisional patent relating to a second medical use. The claimant sought confirmation of the provisional conclusion that the patent was not insufficient for lack of plausibility. The defendant advanced a lay-patient argument, contending that trial participants might have understood references to sleep quality in an ordinary rather than technical sense.

The court also reconsidered permission to appeal, addressed the significance of an unadjudicated European Patent Office appeal, and determined applications for a permanent injunction and a stay pending any appeal.

1. Validity and plausibility. The court affirmed the provisional judgment, concluding that the patent and divisional were not insufficient. The lay-patient argument did not justify a different conclusion. The skilled person would expect clinicians conducting trials directed to technical sleep quality to conduct them competently, and the existing trial evidence was sufficient to determine the issue without further evidence.
2. Permission to appeal. Permission was refused. The issues arising from the main judgment and the lay-patient argument were essentially factual and disclosed no real prospect of success. The court had considered the matter afresh because the divisional had been addressed in a procedurally unusual second trial, but no appealable issue arose from impermissible read-across of the main judgment.
3. European Patent Office proceedings. The withdrawal of the EPO appeal produced no adjudicated decision. The EPO jurisdiction was a parallel jurisdiction capable of reaching a different conclusion, but even a contrary EPO decision would not itself provide a ground for appealing a different decision of the Patents Court.
4. Injunction and stay. A permanent injunction was granted and no stay was ordered. Applying the principles stated in Minnesota Mining & Manufacturing Company v Johnson & Johnson Limited, the court first considered whether there was a genuine chance of success on appeal. There was none. Even assuming such a chance existed, the relevant comparison was harm incapable of proper compensation in damages, not simply which party would suffer greater harm. Loss of first-mover advantage was regarded as quantifiable, whereas the consequences of undermining the claimant’s patent monopoly and allowing further market entry were more difficult to quantify.

The judgment describes earlier decisions in the same proceedings, including the Main Judgment ([2020] EWHC 3270 (Pat)), the Judgment on Consequential Matters ( [2021] EWHC 530 (Pat)), the Meade Judgment ( [2022] EWHC 109 (Pat)) and the Provisional Judgment ( [2022] EWHC 272 (Pat)). This judgment affirmed the provisional conclusion and determined consequential matters.