Case No: A3/2007/1387
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION, PATENTS COURT
Mr Justice Kitchin
05CO3689 / 06CO0457 / 06CO2767
Strand, London, WC2A 2LL
B e f o r e :
LADY JUSTICE SMITH
LORD JUSTICE JACOB
| H. Lundbeck A/S
|- and -
|(1) Generics (UK) Limited & Ors
(2) Arrow Generics Limited
(3) Teva UK Limited and Teva Pharmaceuticals Limited
WordWave International Limited
A Merrill Communications Company
190 Fleet Street, London EC4A 2AG
Tel No: 020 7404 1400, Fax No: 020 7831 8838
Official Shorthand Writers to the Court)
Mr Simon Thorley QC and Mr Michael Tappin (instructed by Taylor Wessing) for the Respondent (1)
Mr Simon Thorley QC and Mr Mark Chacksfield (instructed by Forsyth Simpson) for the Respondent (2)
Mr Simon Thorley QC and Mr Thomas Hinchliffe (instructed by Roiter Zucker) for the Respondent (3)
Crown Copyright ©
Lord Hoffmann :
(a) Claim 1, to the enantiomer itself: "(+) -1-(3-dimenthylaminopropyl)-1-(4´-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile… and non-toxic addition salts thereof."
(b) Claim 3, to a "pharmaceutical composition in unit dosage form comprising, an active ingredient, a compound as defined in claim 1."
(c) Claim 6, to "a method", (which I shall describe later) "for the preparation of a compound as defined in claim 1".
(a) Claims 1 and 3 lack novelty by reason of the disclosure of the racemate in Lundbeck's patent for citalopram;
(b) Claims 1, 3 and 6 are invalid for obviousness;
(c) Claims 1 and 3 are invalid for insufficiency because they claim the enantiomer made by any method, but the specification discloses only two ways of making it.
"Claim 1 is a product claim directed to the specific enantiomer of the formula ((+)- I), which the Board interprets as the pure (+) – enantiomer."
"In practice, the skilled team in 1988 would in my view have been unlikely to have spent a lot of time considering these types of issues. The reaction looked promising, and as the experiments concerned are simple and quick to perform, the skilled team would have gone ahead and tried them."
"Mr Waugh: …[Y]ou say [3rd witness statement, paragraph 7] 'In practice, the skilled team in 1988 would in my view have been unlikely to have spent a lot of time considering these types of issues.'
A. Absolutely right.
Q. I think this was set running inasmuch as you introduced Baldwin's rules into your report.
A. Yes…the skilled person would look at the system and say that looks fine as far as Baldwin's rules are concerned and try the experiment. In the high expectation that the experiment would be a very facile ring closure and that it would work."
"The skilled person would not have proceeded down the diol route unless he was satisfied that there was a real prospect of an SN2 reaction working. This was by no means a one way street. There were a number of avenues of research open to him…
In the light of all the evidence I do not believe the skilled person would have been so satisfied from a consideration of [Baldwin's Rules]."
"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 involved in pursuing them and the expectation of success."
"[T]he court may revoke a patent [on the ground that] the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art"
"A recombinant DNA molecule characterised by a DNA sequence coding for a polypeptide or a fragment thereof displaying HBV antigen specificity, said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule and being expressed to produce a polypeptide displaying HBV antigen specificity when a suitable host cell transformed with said recombinant DNA molecule is cultured, the transformed host cell not producing any human serum proteins and any primate serum proteins other than the polypeptide displaying HBV antigen specificity."
I summarised this claim (at p. 40) as being for 'a molecule identified partly by the way it has been made ('recombinant DNA') and partly by what it does (the words following 'characterised by'.)
"the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported or justified."
"It is the view of the Board that a product which can be envisaged as such with all its characteristics determining its identity together with its properties in use, i.e. an otherwise obvious entity, may become nevertheless non-obvious and claimable as such if there is no known way or applicable (analogy) method in the art to make it and the claimed methods for its preparation are therefore the first to achieve this in an inventive manner. (My emphasis)."
"The patent in suit does not deny…that the combination of properties defining the claimed products had been a desideratum which the skilled community had striven to achieve. These properties, however, had been considered to be irreconcilable. According to the [jurisprudence] of the Boards of Appeal [citation of Kawasaki Steel] such a desired product, which may appear obvious per se, may be considered non-obvious and claimable as such, if there is no known method in the art to make it and the claimed methods for its preparation are the first to produce it and so do in an inventive manner."
"disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art".
"Another point to be noticed in connection with the use made by the Germans of our patent procedure is their use of what are called 'product claims'. These claims are claims to any new product per se irrespective of the process by which it is made and are in the form eg 'as a new product the dyestuffs made as above or by any other process'. The consequence of such claims especially in chemical manufacture is that the inventor of a process producing a new chemical product is enabled to attack as infringements products produced not only by the process discovered by him but by any other method. These are, in my opinion, in the majority of instances, obstructive and injurious claims, and they very largely aid the establishment of a monopoly in the case of chemical manufacture as they prevent research and invention on analogous lines by other persons."
"In the case of inventions relating to substances prepared or produced by chemical processes or intended for food or medicine, the specification shall not include claims for the substance itself except when prepared or produced by the methods or processes of manufacture particularly described and ascertained or by their obvious chemical equivalents…"
"It has been strongly urged that this limitation on the claiming of new substances should be removed as not being in accordance with modern technological developments. It has been argued that the real invention lies in the discovery of a new substance, with new and useful properties, and that the process of manufacture often involves little novelty in itself. Many valuable new substances are produced by synthesising a large number of possible compounds by known methods and then determining which of the new substances have useful properties."
Lady Justice Smith :
Lord Justice Jacob :
"The extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported or justified."
In the context of substance claims the technical contribution includes provision of the substance itself – one that could not be provided before. Merely because it was wanted before does not diminish the technical contribution.
"4.1 The area defined by the claims must be as precise as the invention allows. As a general rule, claims which attempt to define the invention by a result to be achieved should not be allowed, in particular if they only amount to claiming the underlying technical problem."
"4.10 Result to be achieved
The area defined by the claims must be as precise as the invention allows. As a general rule, claims which attempt to define the invention by a result to be achieved should not be allowed, in particular if they only amount to claiming the underlying technical problem. However, they may be allowed if the invention either can only be defined in such terms or cannot otherwise be defined more precisely without unduly restricting the scope of the claims and if the result is one which can be directly and positively verified by tests or procedures adequately specified in the description or known to the person skilled in the art and which do not require undue experimentation (see T 68/85, OJ 6/1987, 228)."