Astrazeneca Ab v Hexal Ag and Others
| Jurisdiction | England & Wales |
| Judge | Lord Justice Mummery,Lord Justice McFarlane |
| Judgment Date | 30 April 2013 |
| Neutral Citation | [2013] EWCA Civ 454 |
| Date | 30 April 2013 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3/2012/1105, A3/2012/1107 & A3/2012/1108 |
[2013] EWCA Civ 454
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
THE HON MR JUSTICE ARNOLD
Claim Nos. HC11 C01095, HC11 C00553 & HC10 C04779
Royal Courts of Justice
Strand, London, WC2A 2LL
THE CHANCELLOR OF THE HIGH COURT
Lord Justice Mummery
and
Lord Justice McFarlane
Case No: A3/2012/1105, A3/2012/1107 & A3/2012/1108
MR SIMON THORLEY QC, MR PIERS ACLAND QC and MR MARK CHACKSFIELD (instructed by Bristows LLP) for the Appellant
MR DANIEL ALEXANDER QC and MR ADRIAN SPECK QC (instructed by Pinsent Masons LLP on behalf of Teva and Taylor Wessing LLP on behalf of the other respondents) for the Respondents
Hearing dates: 17th and 18th October 2012
Introductory summary
This case is about the validity of a European Patent (UK) No. 0, 907, 364 (the Patent). It is for sustained release formulations of an anti-psychotic drug called quetiapine.
According to the 6 claimant companies the Patent is invalid. They say that what is claimed in the Patent to be an inventive step would, at the priority date (May 1996), be obvious to the notional addressee skilled in the prior art.
The claimants crisply summarise the essence of their case on obviousness in this way. They point to the Patent as itself recognising the general desirability of a sustained release form of a pharmaceutical. The Patent specifically draws attention to the well-known advantages of such formulations: they are able to provide a stable and desired blood plasma level of the active ingredient, without the need for frequent administration. That recognition accords with the common general knowledge that sustained release formulations provide significant advantages: more stable dosing over a period and the possibility of less frequent administration. The use of the gelling agent involved was not inventive. The materials before the trial judge showed that there was clear motivation to make a more-convenient-to-take, once-a-day formulation. There was no technical reason to suppose that it would have been difficult to make such a formulation: indeed, it would have been straightforward. None of the points, which were put up by the defendant patentee to suggest that a skilled person (in this case a skilled team) would have been put off, would, in fact, have deterred the skilled person from actual trial.
The claimants cited in support the observations of Jacob LJ in what they say is a very similar case to this on the facts and the law: Actavis v. Novartis [2010] EWCA Civ 82; [2010] FSR 18 at [61]-[64]. In that case this court rejected an appeal against the finding of obviousness of a sustained release formulation of a drug fluvastatin, which involved no technical difficulty and produced improved patient compliance. Mr Simon Thorley QC appearing for the patentee, AstraZeneca AB, cautioned the court against reliance on Actavis v. Novartis. He submitted that that case turned on its own facts. In at least four respects those facts were to be contrasted with the facts in this case. There were significant differences between the Novartis patent and the Patent in this case. Mr Thorley QC cited a contrary recent authority on the question of obviousness in relation to sustained release formulations: Ratiopharm GmbH v. Napp Pharmaceutical Holdings Ltd [2008] EWHC 3070 (Pat); [2009] RPC 11; and [2009] EWCA Civ 252; [2009] RPC 18. In that case the claim for revocation of the patent in suit failed, whereas it succeeded in Novartis.
The Patent is valid according to AstraZeneca, which markets quetiapine under the name Seroquel XL in sustained release form prescribed for the treatment of schizophrenia, bipolar disorder and major depressive disorder. The essence of its case against obviousness is that, at the priority date, no dosage form of quetiapine was approved or on the market. It was inventive to think of what the Patent provides in the light of the problems alleged to exist. At the priority date there was no perceived advantage or motivation to formulate quetiapine as a sustained release dosage form. The skilled addressee would have been put off from doing so.
Mr Thorley QC emphasised the importance of noting at the very outset that the claimants did not advance any case at trial that there was any motivation or desire for a sustained release formulation of quetiapine per se. The claimants' case was that there was a motivation to provide a once-a-day formulation of quetiapine. That would in turn lead to a consideration of sustained release formulations. Absent the alleged desire for once-daily dosing, it was not suggested that the skilled addressee would have had any reason to consider a sustained release formulation of quetiapine.
According to the excellent judgment of Arnold J, handed down after a 5 day trial of 3 actions with 4 expert witnesses, the claimants are right about obviousness. There was no inventive step. He revoked the Patent by his order dated 24 April 2012 on the ground that, in the light of the prior art and the common general knowledge, the relevant claim was obvious. He found that the skilled person would regard a once-a-day formulation as desirable; that, in order to achieve that result, a sustained release formulation and a higher dose of an immediate release formulation would both be obvious possibilities; that the skilled person would not expect, from his common general knowledge or from a literature search, that quetiapine was likely to saturate on first pass metabolism and would not, therefore, be deterred from developing a sustained release formulation, nor would its expectation of success be adversely affected; and the skilled person could achieve success without difficulty.
According to AstraZeneca's Notice of Appeal the judge was wrong about practically everything that he decided in his judgment, save, it seems, for his order granting AstraZeneca permission to appeal and a stay of the order for revocation pending the outcome of the appeal.
The grounds of appeal relied on by AstraZeneca have been revised, as explained below, but are still quite lengthy. They are that the judge erred in principle in not considering the allegation of obviousness on the basis advanced by the claimants in their evidence regarding the development of a new formulation of quetiapine starting from Gefvert (see below) and the clinician's reasons for recommending once-daily dosing in preference to twice-daily dosing, and the requirement for those recommendations to be based on clinical considerations. The judge did not consider whether the clinician's common general knowledge provided any, or any sufficient, motivation to overcome the teaching in Gefvert that once-daily dosing of quetiapine was unlikely to be efficacious. In any event, the judge erred in his analysis of the situation. He should have considered matters in the round, but instead considered matters on an impermissible stepwise basis without ultimately considering the cumulative effect of all the relevant factors.
In particular, the judge erred in identifying the roles of the different members of the notional skilled team, which he identified as the skilled addressee, at different stages in the notional project, such as who should be regarded as the leader, the clinician or the formulator; in concluding that there was any motivation for the skilled addressee clinician to propose the development of a once-a-day formulation; in adopting an impermissible "step wise" approach to the question of inventive step and to the identified factors that would have led the skilled addressee to have concerns over the development and effectiveness of a once-a-day sustained release formulation of quetiapine and would put a skilled person off from actual trial in detail; and in adopting the wrong approach in law to the issue of obviousness, contrary to what is laid down in the authorities.
A central criticism of the judgment is that it failed to address AstraZeneca's case as a whole on the key question. That question was the skilled addressee's expectation of success in being able to make an improved formulation of quetiapine using sustained release technology in the combined light of the totality of the points made by AstraZeneca, such as reduced efficiency, side effects, lack of information on key matters and other concerns.
Had the judge not erred, he would, AstraZeneca contends, have reached the same conclusion as reached by the District Court of the Hague (see below) and held Claim 1 to be valid for the same reasons. There was no, or insufficient, motive for the clinician to recommend once-daily dosing of quetiapine in the light of Gefvert and his common general knowledge, coupled with the fact that the prospect of making a sustained release formulation with an adequate efficacy and side-effect profile was at best uncertain.
The response of the claimants to those criticisms of the judgment by AstraZeneca is that there is nothing in any of them that could lead this court to overturn the judgment of Arnold J: this appeal is a re-run of the arguments on evidential points and factual matters rejected by Arnold J. He was the judge of fact. This court is not. The facts were decided by the Judge against AstraZeneca in accordance with the evidence and he reached his conclusions by applying the correct legal principles relevant to the statutory test of obviousness.
According to the judgments of patent courts in some other jurisdictions, there is a considerable range of informed legal opinion about the alleged...
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