Laboratorios Almirall SA v Boehringer Ingelheim International GMBH
| Jurisdiction | England & Wales |
| Judgment Date | 23 January 2009 |
| Neutral Citation | [2009] EWHC 102 (Pat),[2009] EWHC 439 (Pat) |
| Docket Number | Claim No TLC 702/07, IHC 580/08 |
| Court | Chancery Division (Patents Court) |
| Date | 23 January 2009 |
[2009] EWHC 102 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
His Honour Judge Fysh QC
(Sitting as a Judge of the High Court)
Claim No TLC 702/07, IHC 580/08
Dates of hearing: 10–14, 17, 18 November 2008 and 23 January 2009
INDEX
| I Introduction | 1 |
| The proceedings | 3 |
| Almirall's Forner patent | 7 |
| The Aclidinium story | |
| Boehringer's ‘270 patent: A history | 23 |
| Boehringer's ‘270 patent: Body and claims | 37 |
| Almirall's ‘819 patent: Body and claims | 49 |
| Issues to be determined | 62 |
| II Background | 66 |
| Medical and pharmacological background | 66 |
| Respiratory complaints: Asthma and COPD | 75 |
| Overlap between asthma and COPD | 81 |
| The treatment of asthma and COPD by 2003/04 | 82 |
| Combination therapies | 95 |
| Combination therapies in the treatment of respiratory disorders | |
| Guidelines, textbooks and articles | 105 |
| Guidelines | 107 |
| Textbooks and articles | |
| The Combivent® product literature | 127 |
| Summary to the Background section | 128 |
| III The skilled addressee | 131 |
| IV The witnesses | 133 |
| V Common general knowledge: What the experts said | 142 |
| VI Construction of para [0008] | 149 |
| VII Speculative patents and ex post facto justification | 174 |
| VIII The parties’ experiments | 183 |
| Boehringer's experiments | 186 |
| Almirall's experiments in reply | 197 |
| IX Validity of ‘270 | |
| Lack of novelty | 210 |
| The Law | 210 |
| Application No WO01/04118 (‘Forner’) | 215 |
| Obviousness: The Law | 226 |
| Insufficiency | 254 |
| X Amendment of ‘270 | 258 |
| XI Validity of ‘819 | 265 |
| Obviousness | 278 |
| Method of Therapy Objection | 283 |
| XII Conclusion | 291 |
I Introduction [1]
1. This is a patent revocation dispute within the pharmaceutical industry involving a substance called aclidinium. Aclidinium is an anticholinergic which is used in combination with a ß2-agonist in the treatment of respiratory disorders, particularly asthma and Chronic Obstructive Pulmonary Disease ('COPD’). Aclidinium is currently in Phase III clinical trials.
2. The issues involved are familiar enough in cases of this kind and to my mind would not be particularly difficult to resolve were it not for the experiments undertaken by both sides and the extensive evidence which they have generated. One of the parties' counsel suggested in closing that the case had in fact been 'hijacked' by these experiments. I agree; they have not proved to be as useful as the parties had no doubt intended.
The proceedings
3. In this action, the claimant, Laboratorios Almirall SA of Barcelona ('Almirall’), were represented by Mr Andrew Waugh QC and Mr Piers Acland. Almirall seek the revocation of European Patent (UK) No 1 651 270 (''270’) [2] which stands in the name of the defendant, Boehringer Ingelheim International GmbH of Ingelheim am Rhein, Germany ('Boehringer’). The priority date of '270 is 29 July 2003, to which there is no challenge.
4. Mr Simon Thorley QC and Mr Andrew Lykiardopoulos appeared for Boehringer. I understand that the anticholinergic field had been strongly represented for some time by Boehringer with a number of classic offerings, including ipratropium bromide (Atrovent®), oxitropium bromide (Oxivent®) and tiotropium bromide (Spiriva®). By 2002, Boehringer was also selling a combination treatment for respiratory disorders (primarily for COPD) called Combivent® containing an anticholinergic (ipratropium bromide) combined with a ß2-agonist (salbutamol (referred to as albuterol in the US) sulphate) within a single inhaler. The latter has been sold under the slogan ' The Power of Two' and soon became a market leader.
5. The title of '270 is ' Medicaments for inhalation comprising betamimetics and an anticholinergic'. The claims are thus directed to a combination of a particular anticholinergic with one (or more) betamimetics, the latter being better known as ??#223??-agonists (or in the present context, ß2-agonists). In '270, the combination is said to possess an ' unexpectedly beneficial therapeutic effect' in the treatment of respiratory illnesses but, I should say at the outset, the message conveyed to the addressee of '270 by this optimistic sentiment and its implications, were the subject of considerable debate.
6. The sole anticholinergic mentioned in'270 is a quinuclidine derivative. It is a chiral, ionic molecule, whose 'flat' structure is shown as formula 1 in '270. Its use, always in combination, is claimed whether in its racemic or enantiomeric forms. The R-enantiomer became known as aclidinium [3], and a sub-dispute in the case is whether (or to what extent) the S-enantiomer has any relevant therapeutic benefit whatever.
Almirall's Forner patent
7. Another important twist to the history of the dispute is this: that before the priority date of '270, Almirall had specifically disclosed the substance represented by formula 1- and its racemates and enantiomers (among other quinuclidine derivatives) in a published patent application (No WO 01/04118 – hereafter 'Forner' [4]). Forner had stated that the new quinculidines were therapeutically useful in the treatment of inter alia, asthma and COPD. Moreover, for this application, Forner also taught that they could be used in combination with inter alia ß2-agonists. Perhaps not surprisingly, Forner features as prior art in this case. Mr Thorley in fact referred to Forner as a 'spoiling' patent but I think that this is a harsh description. What followed (such as the patents in suit) could well be regarded as the first buds of a customary 'evergreening' – which in the context of the pharma industry, may (or may not) be patentable.
8. A little later, after the priority date of '270, Almirall itself applied for a patent covering a combination of the R-enantiomer (only [5]) of the substance represented by formula 1, with long-acting ß2-agonists. This UK patent, GB No 2 419 819 (‘819’) [6], was filed in May 2005 claiming priority from 31 May 2004 and is the subject of a counterclaim by Boehringer for revocation. There is also no challenge to that priority date. '819 is entitled ' Combinations comprising antimuscarinic agents and beta-adrenergic agonists'. Almirall contends that this combination is novel and inventive, pointing to a particular advantage of the aclidinium in that, when combined with long-acting ??#223?? 2-agonists, it is said to give rise to fewer cardiac side effects than in existing combinations of anticholinergics with ß2-agonists.
9. I should say that in the period between the two applications there was no material change in the 'common general knowledge' of the art. This was common ground. Therefore, when counsel and the witnesses referred to events in '2003/04' (as they often did), they were in fact referring to about the same time. I shall do likewise unless the context otherwise requires.
10. In May 2008, Boehringer counterclaimed in this action for the revocation of '819 [7] contending that if their '270 patent is invalid on the ground of obviousness (as Almirall allege), then so too is Almirall's '819 patent invalid. As regards the prior art material relied on, the Boehringer pleading mirrors Almirall's in this respect. The dispute thus contains sundry two-edged swords – as the pleadings show.
11. But there is an important addendum to Boehringer's counterclaim which concerns claim 20, the last claim, of '819.
12. Save only in relation to claim 20, Mr Waugh said that Almirall was not proposing to gainsay Boehringer's contention concerning the validity of '819 in this litigation [8] (though he was not conceding it). This led Boehringer to add an alternative attack directed specifically to this claim. In the event that 'claim 20 is not held to be obvious' it was unpatentable as it was directed to ' a method of treatment of the human …body by therapy', using the 'medicament of claims 10, 18 and 19' and was thus contrary to the Patents Act 1977 (PA '77’), s 4A (1). Almirall's riposte was that claim 20 was a legitimate 'Swiss type' claim.
13. Almirall alleges that the '270 patent is:
(a) Anticipated and/or rendered obvious by the earlier Forner application – to which I have briefly referred. This had been published in January 2001.
(b) Obvious in the light of the contents of two so-called 'posters' dated 18 and 19 May 2003 relating to a trial undertaken by a team comprising inter alia a Dr V Schelfhout, who was working on anticholinergics at the University of Ghent in Belgium with Almirall's support, and
(c) Insufficient.
14. 'Posters' in this context are typically notices of research work which are deliberately displayed by their authors (and/or sponsors) for general viewing whilst a medical conference is in progress – in this case at that of The American Thoracic Society in Seattle on the two following days in May 2003. In this case there is no dispute that the two 'Schelfhout' posters ( Schelfhout I and Schelfhout II as they came to be called), were 'made available to the public' in this way.
15. Then, in August 2008, Boehringer decided to apply to amend the '270 patent, restricting the claims to four particularly preferred ??#223??-agonists [9] The Comptroller has indicated that in his view, this proposed amendment is unobjectionable. Almirall on the other hand, oppose the amendment on the ground that it adds subject matter. Mr Thorley said that if the proposed...
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...Appeal in Ranbaxy UK Ltd v Warner-Lambert Co [2007] RPC 4 at [40] and Laboratorios Almirall SA v Boehringer Ingelheim International Gmbh [2009] FSR 12 at [212] – [214]. However, if the instructions (or teachings) at a particular intermediate step are unclear and admit of various possibiliti......
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Dien Ghin Electronic (S) Pte Ltd v Khek Tai Ting (trading as Soon Heng Digitax)
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