Teva UK Ltd v Boehringer Ingelheim Pharma GmbH & Co KG

Factual and Procedural Background

This opinion concerns a renewed application for permission to appeal in a patent revocation action from a decision of a first instance judge dated 21 October 2015. The patent in question relates to capsules used in dry powder inhalers for delivering an active ingredient to patients with respiratory conditions. The primary dispute centers on the use of hydroxypropyl methyl cellulose (HPMC) as a capsule material with a specified low moisture content. The applicant challenges the first instance judge's conclusions on obviousness and motivation to follow prior art, seeking permission to appeal the refusal of permission granted at first instance.

Legal Issues Presented

1. Whether the practice of granting permission to appeal more readily in patent cases, as suggested in the White Book and the Pozzoli SPA v BDMO SA case, remains appropriate.
2. Whether the technical complexity of patent cases justifies a distinct approach to the grant of permission to appeal compared to other specialist technical cases.
3. Whether the first instance judge erred in principle in his evaluation of the obviousness of the claimed invention, specifically regarding the motivation to use HPMC capsules with moisture content below 2%.

Arguments of the Parties

Appellant's Arguments

• The appellant argued that the first instance judge wrongly concluded that the skilled person would be motivated to follow the prior art teaching to use HPMC capsules with low moisture content.
• The appellant relied on expert evidence from a formulation expert to show that the skilled person would only seek to keep the formulation dry enough for stability, not necessarily drier than existing gelatine capsules.
• The appellant contended that the judge erred in dismissing the significance of drying capsules to below 2% moisture content, arguing that the patent made plausible technical advantages at this level which should have been considered for obviousness.

Respondent's Arguments

• The respondent contended that the judge's evaluation was correct and that the skilled person would see an immediate advantage in adopting HPMC due to its naturally lower moisture content compared to gelatine.
• The respondent maintained that the judge was entitled to find the precise moisture level below 2% arbitrary and that the appellant was improperly attempting to dissect the judge’s overall evaluative judgment on obviousness.
• The respondent accepted the public interest in patent law but argued it did not justify a more lenient approach to permission to appeal.

Table of Precedents Cited

Court's Reasoning and Analysis

The court began by examining the White Book's statement that permission to appeal may be granted more readily in patent cases, which is based on Pozzoli. It identified two components: that trial judges should be more ready to grant permission in technical cases, and that appellate judges may be more ready to grant it if the trial judge refuses. The court questioned the continued validity of this practice, noting that procedural rules have evolved, particularly CPR 52.5, which now requires applications for permission to appeal to be determined on paper unless an oral hearing is necessary. This procedural context allows for thorough consideration of complex cases without resorting to a more lenient standard.

The court emphasized that technical complexity should not influence the grant of permission to appeal and that patent cases should be treated no differently from other cases. It acknowledged the specialized expertise of Patents Court judges and the importance of their evaluative judgments, which appellate courts will not disturb absent an error of principle.

Regarding the substantive patent issue, the court analyzed the prior art and expert evidence, concluding that the skilled person would be motivated to adopt HPMC capsules due to their naturally lower moisture content compared to gelatine. The court found no error in the trial judge's dismissal of the significance of drying below 2% moisture content, viewing it as an arbitrary distinction. The court considered the appellant's attempt to dissect the judge’s overall evaluative judgment as lacking a real prospect of success.

Holding and Implications

The court refused permission to appeal in the patent revocation action.

The direct effect of this decision is to uphold the first instance judge's refusal to grant permission to appeal, thereby ending the appellant's attempt to challenge the judge's evaluative findings on obviousness. The court explicitly rejected the notion that patent cases warrant a more lenient approach to permission to appeal based on technical complexity, aligning patent appeals with the general principles applicable to specialist courts. No new precedent was established beyond clarifying the inapplicability of the Pozzoli approach under current procedural rules.