Norton (Waterford) Ltd T/A Teva Pharmaceuticals Ireland v Boehringer Ingelheim Pharma GmbH & Company KG

• Jurisdiction: Ireland
• Judge: Mr Justice Maurice Collins
• Judgment Date: 14 March 2022
• Neutral Citation: [2022] IECA 58
• Court: Court of Appeal (Ireland)
• Docket Number: Court of Appeal Record Nos 2017/544

In the Matter of Irish Patent No EP (IE) 1379220 Filed on 27 May 2002 and Registered in the Name of Boehringer Ingelheim Pharma GmbH & Co KG

In Respect of an Alleged Invention for ‘Inhalation Capsules’

and

In the Matter of the Patents Act 1992 and the Patents (Amendment) Act 2006

Between

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Petitioner/Appellant

and

Boehringer Ingelheim Pharma GmbH & Co KG

Respondent

[2022] IECA 58

Noonan J

Haughton J

Collins J

Court of Appeal Record Nos 2017/544

THE COURT OF APPEAL

CIVIL

Patent – Designation – Revocation – Appellant seeking revocation of Irish designation of European Patent – Whether the Judge misunderstood and/or misapplied the principles of comity

Facts: The appellant, Norton (Waterford) Ltd (Teva), appealed to the Court of Appeal from an order of the High Court (Barrett J) dated 9 October 2017 (perfected on 3 November 2017) dismissing its claim for the revocation of the Irish designation of European Patent No (IE) 13799220 (the 220 Patent). Teva advanced a number of grounds by way of appeal: first, it said that the Judge misunderstood and/or misapplied the principles of comity articulated by Clarke J in Ranbaxy Laboratories Ltd v Warner Lambert Company [2007] IEHC 256 (Ranbaxy); secondly, Teva said that the Judge misunderstood and/or misapplied the law regarding Agrevo obviousness (Agrevo/Trizaoles (Case No T939/92, 12 September 1995)); it was said that the Judge failed to properly consider and address the distinct plausibility claim (relating to sufficiency rather than obviousness) made by Teva to the effect that the Patent did not make it plausible that the claimed technical effects of the invention would be found for all salts and physical forms claimed, rather than the single form set out in the examples; as regards inventive step/obviousness, Teva said that the Judge erred in his assessment of the evidence of Professor Buckton and, in particular, in adopting “a universal preference” for the evidence of Professor Birchall over that of Professor Buckton.

Held by Collins J that: the Judge failed to assess the evidence of Professor Buckton properly or fairly; while the Judge engaged with the substance of the evidence given by Professors Buckton and Birchall (with some significant exceptions), the Judge’s unjustified general preference for the evidence of Professor Birchall – a general preference repeated time and again in the course of the Judgment – fatally undermined the reliability of the evidential findings made by the Judge; had he not concluded that Teva’s appeal on the ground of Agrevo obviousness/lack of plausible technical contribution must succeed, he would have set aside the Judgment of the High Court on the conventional obviousness ground and directed a retrial on that issue; the conclusion that, in principle, the Judgment should be set aside and a retrial ordered was reinforced by the Judge’s disregard for the requirements of Ranbaxy and his failure to engage with the other decisions on the 220 Patent; the threshold test for Agrevo obviousness/lack of plausible technical contribution is that set out by Kitchin LJ at para 114 of Idenix Pharmaceuticals Inc v Gilead Sciences [2016] EWCA 1089, namely that “in light of the teaching in the specification and the common general knowledge” there “must be a real reason for supposing that the claimed invention will indeed have the promised technical effect”; in common with all other judges who had addressed this issue, he was of the view that there was nothing in the teaching of the 220 Patent which provided any reason for supposing that the claimed invention – the inventions within the scope of amended claims 6-8 of the Patent – would have the promised technical effects of stability of the active substance, high metering accuracy in the release of the active substance, complete emptying of the capsule and good perforation qualities with good stability and low brittleness; the specification of the 220 Patent, read in light of the common general knowledge, did not provide any real reason to think that the assertion that the claimed invention within the scope of the amended claims in dispute would deliver the claimed technical contribution of the invention was correct; the experimental data sought to be relied on by the respondent, Boehringer Ingelheim Pharma GmbH & Co. KG, was therefore inadmissible; in the circumstances, it was not necessary to address the issue of plausibility as to sufficiency.

Collins J held that, given that Teva appeared to have been wholly successful in its appeal, it was entitled to its costs of the appeal and the costs of the High Court.

Appeal allowed.

Unapproved

No redactions required

JUDGMENT of Mr Justice Maurice Collins delivered on 14 March 2022

TABLE OF CONTENTS

I — PRELIMINARY	3
II—THE HIGH COURT HEARING AND JUDGMENT	5
III — THE 220 PATENT AND THE AMENDED CLAIMS	8
IV — THE APPEAL	12
V – OGURA (1998)	13
VI — LITIGATION ELSEWHERE: ABOUT THE 220 PATENT AND THE ISSUE OF COMITY	14
The European Patent Convention	14
Other Litigation re the 220 Patent	16
Germany	16
Norway	17
The Netherlands	18
Spain	20
Comity	24
Ranbaxy	24
Gilead Sciences Ltd v Mylan SAS	25
Authority from England and Wales	26
The Judge's Treatment of the Comity Issue	27
VII — THE JUDGE'S ASSESSMENT OF THE EVIDENCE	31
Did the Judge wrongly discount the evidence of Professor Buckton?	31
The Judgment	32
Experience “at the Coalface” – the evidence	35
Teva's challenge to the Judge's assessment	36
Professor Buckton's inability to recall whether he had seen Ogura before the priority date	39
Footnote 13 of Professor Buckton's First Report	39
Assessment	40
VIII – AGREVO OBVIOUSNESS/LACK OF PLAUSIBLE TECHNICAL CONTRIBUTION	45
The Judge's Reasoning	46
The Applicable Test	54
My Conclusions as to the Applicable Test	65
Applying the Test Here	66
IX – PLAUSIBILITY AS TO SUFFICIENCY	76
X — CONCLUSIONS	76

I — PRELIMINARY

1 The Appellant (“ Teva”) appeals from an Order of the High Court (Barrett J) dated 9 October 2017 (perfected on 3 November 2017) dismissing its claim for the revocation of the Irish designation of European Patent No (IE) 13799220 (“ the 220 Patent” or “the Patent”). The reasons for the High Court's decision are set out in the Judge's comprehensive judgment of 26 July 2017 (“ the High Court Judgment” or “ the Judgment”).

2 As will appear, Ireland is but the latest stop in a litigation caravan concerning the 220 Patent that has already visited a large number of other jurisdictions within the European Patent Organisation. To date, all such litigation has arrived at a common conclusion, namely that the 220 Patent is invalid. The decision of the High Court is – so Teva says – a “ complete outlier” and one of its grounds of appeal is that the Judge failed to have any adequate regard to the various decisions that upheld the same objections to the 220 Patent that Teva advanced unsuccessfully at trial here.

3 The 220 Patent is for “ Inhalation Capsules”. The priority date of the Patent is 1 June 2001. The claimed invention relates to “ capsules for inhalation (inhalettes) consisting of specific materials with a reduced moisture content, which contain the active substance tiotropium in the form of powdered preparations and are characterised by increased stability.” 1 Tiotropium (as tiotropium bromide) is a bronchodilator used in the management of chronic obstructive pulmonary disease (COPD) and asthma. It is the subject of separate patent protection. The 220 Patent – which is owned by the Respondent (“ Boehringer”) — protects the inhalation capsules rather than the active substance.

4 The 220 Patent is said to protect Boehringer's SPIRIVA inhaler product. The SPIRIVA inhaler is a dry powder inhaler (DPI) that uses capsules made from gelatin 2/polyethyleneglycol (PEG), containing a precise amount of tiotropium bromide formulated with a lactose excipient (an inactive substance that serves as the vehicle or medium for the active substance). The SPIRIVA product is, commercially, a highly valuable one.

5 Teva brought revocation proceedings in October 2014. In its Amended Particulars of Objection (dated 23 March 2015) Teva pleaded (1) that the subject-matter of the 220 Patent did not involve any inventive step and was obvious to a person skilled in the art having regard to the state of the art (what I shall refer to as “ conventional obviousness”); (2) that, even if not obvious in the conventional sense, there was no disclosure in the Patent to suggest that that claimed capsules for invention possessed any technical benefit or solved any technical problem – the claims (it was said) represented an arbitrary selection and there was no data in the Patent to make it plausible that the claimed capsules solved the problems the Patent claimed they did (which, for reasons that will become apparent, I shall refer to “ Agrevo obviousness”) and (3) that the specification of the Patent was insufficient to allow the invention to be performed by a skilled person ( insufficiency).

6 In the face of that challenge, and as it had done elsewhere, Boehringer sought to amend the 220 Patent, indicating that it did not intend to defend the Patent as granted. The proposed amendments concern only the claims in the Patent. The proposed amended claims are 13 in number. In its Statement of Opposition to the amendment application, Teva seeks to challenge claims 6 – 13 only. The common thread of these claims is that all involve the use of hydroxypropylmethylcellulose (frequently referred to as hypromellose) (HPMC) as the capsule material. Further...