Generics (UK) Ltd v H Lundbeck A/S
| Jurisdiction | UK Non-devolved |
| Judge | LORD WALKER OF GESTINGTHORPE,LORD MANCE,LORD PHILLIPS OF WORTH MATRAVERS,LORD SCOTT OF FOSCOTE,LORD NEUBERGER OF ABBOTSBURY |
| Judgment Date | 25 February 2009 |
| Neutral Citation | [2009] UKHL 12 |
| Court | House of Lords |
| Date | 25 February 2009 |
and others
[2009] UKHL 12
Appellate Committee
Lord Phillips of Worth Matravers
Lord Scott of Foscote
Lord Walker of Gestingthorpe
Lord Mance
Lord Neuberger of Abbotsbury
HOUSE OF LORDS
Appellants:
Simon Thorley QC
Michael Tappin
Mark Chacksfield
Tom Mitcheson
(Generics (UK) Limited: Instructed by Taylor Wessing LLP)
(Arrow Generics Limited: Instructed by Forsyth Simpson)
(Teva (UK) Limited: Instructed by Roiter Zucker)
(Teva Pharmaceutical Industries Limited: Instructed by Roiter Zucker)
Respondents:
Andrew Waugh QC
Justin Turner
(Instructed by Simmons and Simmons; Howrey LLP)
My Lords,
I have had the benefit of reading in draft the speeches of each of your Lordships. They reach the same conclusion for the same reasons. I share both the conclusion and the reasoning and would, accordingly, dismiss this appeal.
My Lords,
Section 1(1) of the Patents Act 1977 lays down four conditions that must be satisfied if a patent for an invention is to be granted. The first of these is that "the invention is new". This condition is easy enough to understand if the invention is a process whereby something or other can be made or done. But I find it less easy to understand if the claimed invention is of a chemical product where, as here, the existence of the product is known, its chemical and molecular structure is known and, up to a point, its characteristics are known. The present case concerns a claim to a product patent. The product is the (+) enantiomer of citalopram. Citalopram is an organic compound, patented by the respondent many years ago and the patent for which has expired. Trade rivals can, and do, now make and market citalopram as an anti-depressant.
As my noble and learned friend Lord Neuberger of Abbotsbury has explained citalopram is a racemate, that is to say, a combination of two types of molecules, each a mirror image of the other, and each having the same chemical formula and, subject to the mirror image characteristic, the same stereochemical structure. What was not known prior to the teaching of the patent in issue in the present case was how to separate the (+) and (-) enantiomers of citalopram and, therefore, what their respective contributions were to the anti-depressant quality of citalopram. Having devised a novel means of separating the (+) and (-) enantiomers and subjected each to tests, the respondents have discovered that it is the (+) enantiomer that has the desired anti-depressant effect, and that the (-) enantiomer has, if anything, an inhibiting effect. A much more effective anti-depressant is, therefore, achieved by isolating and marketing the (+) enantiomer of citalopram. This is what the respondents have done and claim to be entitled to a patent monopoly to protect.
There can be no doubt that the respondent is entitled to patent protection for its process of separating the (+) and (-) enantiomers of citalopram. That is not in dispute. What is in dispute is their claim to a product patent for the (+) enantiomer. The appellants' objection, however, pressed before your Lordships by Mr Thorley QC, has not been that the (+) enantiomer lacked novelty but has been one of insufficiency. Lack of novelty was a point taken before Kitchin J and before the Court of Appeal but failed in both courts and has not been pursued on this appeal to the House.
My Lords, having had the great advantage of reading in draft the opinion of Lord Neuberger I find myself in full agreement with his reasons for concluding that the appeal on the insufficiency point must be dismissed and there is nothing I can usefully add on that issue. I want, however, to add a few words on the novelty point not because it has been in issue on this appeal but because I have found the proposition that the (+) enantiomer is, for the purposes of section 1(1) of the 1977 Act, a new product to be sufficiently puzzling as to require some examination.
Section 2 of the Act explains the concept of novelty:
"(1) An invention shall be taken to be new if it does not form part of the state of the art.
(2) The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way …"
It is common ground that prior to the priority date claimed by the respondent for its "product" invention the (+) enantiomer of citalopram had not been made available to the public otherwise than as an unseparated part of the racemate that constituted the citalopram molecule. In its separated form the (+) enantiomer had not at any time before the priority date been made available to the public. It follows, therefore, that the (+) enantiomer was "new" for the purposes of section 1(1)(a) of the Act.
It is pertinent to note that European Patent Office jurisprudence upholds claims to product patents for separated enantiomers that had not previously been separated. In a decision given on 30 August 1988 in Case T 0296/87 the EPO asked itself the question (para.6)
"…whether a known chemical formula evidently containing a (single) asymmetrical carbon atom destroys the novelty not only of the compound in the form of its racemate, but also of its enantiomers …."
and held (para.6.2) that
"The novelty of the … enantiomers is … not destroyed by the description of the racemates"
and (in para.6.3) that
"The situation is different if the state of the art includes enantiomers … which are specifically named and can be produced" (emphasis added)
This EPO jurisprudence is, it appears, now well established and fully meets the doubts that I had had about novelty. I would, in agreement with the reasons given by Lord Neuberger, dismiss this appeal.
Introduction
My Lords,
The scientific background to this appeal and the essential features of the patent in suit are set out fully in the first-instance judgment of Kitchin J [2007] RPC 729, paras 8-25 and 26-35 respectively. The same material is covered more briefly at the beginning of the judgment of my noble and learned friend Lord Hoffmann when sitting in the Court of Appeal [2008] RPC 437, paras 1-5. I gratefully adopt Lord Hoffmann's summary:
"1. Citalopram is one of a class of anti-depressant drugs known as selective serotonin reuptake inhibitors ('SSRIs') which inhibit reuptake of the neurotransmitter serotonin by nerve cells and thereby promote neural transmission. This is claimed to alleviate the symptoms of depression, although the mechanism is far from clear and the claim remains controversial: see Kirsch et al, Initial Severity and Antidepressant Benefits (2008) 5 P LoS Medicine 260-268. Nevertheless, the SSRIs have had huge commercial success. Citalopram is sold in the United Kingdom under the brand name Cipramil and other SSRIs are fluoxetine (sold as Prozac) and paroxetine (Seroxat). The patent for Citalopram was held by the Danish company H Lundbeck A/S ('Lundbeck') but expired several years ago. Since then it has been sold in its generic form by a number of manufacturers.
2. Citalopram is a racemate, consisting of equal numbers of two molecules called enantiomers, which are made up of the same atoms and have much the same physical properties, but differ in the three-dimensional shape in which the atoms are bonded together. Such molecules are called chiral (from ?e?, a hand) because, like a pair of hands, they are mirror images which cannot be completely supraimposed on each other. They are conventionally designated (+) and (-). It has been well known for many years that, despite their similarities, the two enantiomers may bind to different proteins and produce different biological effects. The most notorious example was thalidomide, which consisted of a (+) enantiomer which was effective to prevent morning sickness in pregnant women and, unknown to the consumers, a (-) enantiomer which was teratogenic and caused severe birth defects.
3. The resolution of a racemate by separation into its enantiomers is not a straightforward matter. Because they have the same boiling point, they cannot be separated by conventional fractional distillation. For similar reasons, fractional crystallisation may not work. There are indirect methods of coming at the problem and Lundbeck began to try to find one of them from about 1980. It seems to have involved a good deal of trial and error and they were not successful until 1987.
4. When they had resolved the racemate, Lundbeck found that the reuptake inhibitory effect was caused entirely by the (+) enantiomer, which is called escitalopram. In 1989 they applied for the patent in suit, EP (UK) 0, 347, 066, with a priority date of 14 June 1988. The drug has been marketed with success under the brand name Cipralex. More recent research has shown that the (-) enantiomer actually slows down the inhibitory effect, so that the (+) enantiomer works better without it.
5. The patent is entitled 'New enantiomers and their isolation.' Three claims are in issue:
(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, [as] 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.'"
It will be apparent that claims 1 and 3 in the patent are to products (a...
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