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England and Wales Court of Appeal (Civil Division) Decisions |
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You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Astrazeneca AB v Hexal AG & Ors [2013] EWCA Civ 454 (30 April 2013) URL: http://www.bailii.org/ew/cases/EWCA/Civ/2013/454.html Cite as: [2013] EWCA Civ 454 |
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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
Strand, London, WC2A 2LL |
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B e f o r e :
LORD JUSTICE MUMMERY
and
LORD JUSTICE McFARLANE
____________________
ASTRAZENECA AB |
Appellant |
|
- and - |
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HEXAL AG & ORS |
Respondent |
____________________
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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
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Crown Copyright ©
Lord Justice Mummery:
Introductory summary
The issues
General background
"It is desirable in the treatment of a number of diseases, both therapeutically and prophylactically, to provide the active pharmaceutical ingredient in a sustained release form. Desirably the sustained release provides a generally uniform and constant rate of release over an extended period of time which achieves a stable and desired blood (plasma) level of active ingredient without the need for frequent administration of the medicament."
Obviousness: law
Obviousness: judgment below
The skilled team and its leader
"6. The only dispute between the parties was as to which member of the team should be regarded as the leader. The Claimants contend that the Patent is primarily directed to the formulator. AstraZeneca contends that the development of a new formulation of quetiapine would be primarily driven by clinical considerations and to that extent would be led by the clinician. The formulator would then use his knowledge and experience to try to prepare an appropriate formulation and method of manufacture for that formulation in accordance with the clinician's instructions as to what was required. In my judgment those contentions are not inconsistent with each other: AstraZeneca is looking at the position prior to the Patent, whereas the Claimants are looking at the position after the Patent. I therefore accept both contentions. Either way, as both sides accept, there would be a notional conversation between the members of the team, in which the advantages and disadvantages of potential formulations would be considered."
The common general knowledge
"64. …The conclusion which I draw from the evidence as a whole is that the perception of the skilled team would have been that once daily dosing was to be preferred to twice daily both because it might lead to better patient compliance, although there was no hard evidence that it did so, and because it was more convenient to patients and, particularly, carers. Furthermore, the skilled team would have been well aware that one of the advantages of sustained release formulations was that they enabled less frequent administration, and in particular once a day rather than twice a day."
The Patent
Claim 1: the inventive concept
"It is desirable in the treatment of a number of diseases, both therapeutically and prophylactically, to provide the active pharmaceutical ingredient in a sustained release form. Desirably the sustained release provides a generally uniform and constant rate of release over an extended period of time which achieves a stable and desired blood (plasma) level of the active ingredient without the need for frequent administration of the medicament."
Prior art-Gefvert
"108. My conclusion from this evidence is that the skilled team would conclude from Gefvert that a single 450 mg dose of an immediate release formulation daily would not be efficacious. The skilled team would regard once daily administration as desirable for the reasons given in paragraph 64 above. (Incidentally, there is no evidence before me that sustained release quetiapine in fact has any other advantage.) To achieve once daily administration, a sustained release formulation and a higher dose of an immediate release formulation would both be obvious possibilities. "
The Dutch judgment
AstraZeneca's grounds of appeal and submissions
Skilled team point: role of different members
Motivation for once daily formulation
Failure to address totality of factors
Discussion and conclusions
General
"The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort in pursuing them and the expectation of success."
Skilled team membership: role of different members
Motivation for once- daily formulation
Failure to address factors regarding effectiveness of sustained release formulation
Erroneous approach in law
Dutch decision.
Result
Lord Justice McFarlane:
Sir Terence Etherton: