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Judgments - Generics (UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents)

HOUSE OF LORDS

SESSION 2008-09

[2009] UKHL 12

on appeal from:[2008]EWCA Civ 311

OPINIONS

OF THE LORDS OF APPEAL

FOR JUDGMENT IN THE CAUSE

Generics (UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents)

Appellate Committee

Lord Phillips of Worth Matravers

Lord Scott of Foscote

Lord Walker of Gestingthorpe

Lord Mance

Lord Neuberger of Abbotsbury

Counsel

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)

Hearing dates:

12, 13, 14 and 15 JANUARY 2009

ON

WEDNESDAY 25 FEBRUARY 2009

HOUSE OF LORDS

OPINIONS OF THE LORDS OF APPEAL FOR JUDGMENT

IN THE CAUSE

Generics (UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents)

[2009] UKHL 12

LORD PHILLIPS OF WORTH MATRAVERS

My Lords,

1.  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.

LORD SCOTT OF FOSCOTE

My Lords,

2.  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.

3.  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.

4.  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.

5.  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.

6.  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.

7.  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)

8.  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.

LORD WALKER OF GESTINGTHORPE

My Lords,

Introduction

9.  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 ?îi?, 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.’”

10.  It will be apparent that claims 1 and 3 in the patent are to products (a chemical compound and a pharmaceutical preparation with that compound as its active ingredient); claim 6 is to a process. The distinction between product claims and process claims, especially in relation to the appropriate test for sufficiency, is at the heart of this appeal. The sufficiency of the claims is now the only issue in the appeal. Initially the appellants (all companies which make or market generic forms of citalopram) attacked claims 1 and 3 as lacking novelty (because of the disclosure of the racemate in the patent which the respondent, Lundbeck, holds for citalopram); they attacked claims 1, 3 and 6 as invalidated by obviousness; and they attacked claims 1 and 3 as invalidated by insufficiency, in that they claimed the (+) enantiomer in general terms (that is, however it was produced) but disclosed only two methods of producing it.

11.  The attacks based on lack of novelty and obviousness failed in both courts below, and are not renewed before your Lordships. But on sufficiency the lower courts reached different conclusions. Kitchin J (paras 250 to 265) held claims 1 and 3 to be invalid for insufficiency. He based this conclusion very largely on the decision of your Lordships’ House in Biogen Inc v Medeva Plc [1997] RPC 1 (“Biogen“), in which the leading speech was given by Lord Hoffmann. The Court of Appeal (Lord Hoffmann and Smith and Jacob LJJ) reached a different conclusion. Lord Hoffmann (with whom the Lords Justices agreed, Jacob LJ adding some brief reasons of his own) sympathised with what he called “the judge’s instinctive reaction to the inherent breadth of a product claim.” But the judge had, in Lord Hoffmann’s opinion, extracted too broad a principle from Biogen, which was not a simple product claim but a “product-by-process” claim, and moreover a claim to a wide class of such products.

12.  The distinction between product claims and process claims is assumed, rather than spelled out, in the Patents Act 1977 (which notoriously does not define “invention", but in section 1 lays down various inclusionary or exclusionary conditions for patentable inventions). The distinction is implicit in section 60 (1) (meaning of infringement), which defines infringement primarily by reference to these terms:

“(a) where the invention is a product, he makes [etc] the product . . .

(b) where the invention is a process, he uses the process [etc] . . .

(c) where the invention is a process, he disposes of [etc] any product obtained directly by means of that process . . .”

13.  The distinction is however not always straightforward. Although there is a requirement that an application for a patent should be limited so as to “relate to one invention only or to a group of inventions so linked as to form a general inventive concept” (EPC Art 82; compare Patents Act 1977 section 14(5)(d) which has “single inventive concept”), it is commonplace (as in the patent in suit) for the claims to be a mixture of product claims and process claims.

14.  The appellants’ case, reduced to its simplest form, is that the Court of Appeal’s decision is an unwarranted departure from Biogen, and infringes the general legal principle (stated by the Technical Board of Appeal in para 3.3 of its decision in Fuel Oils/EXXON (T 409/91) [1994] OJEPO 653,—”Exxon“—by way of explanation of “support” in Art 84 of the EPC),

“that 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.”

Lord Hoffmann cited this passage in Biogen, at p.49, and again in his judgment in the Court of Appeal in this case, para 35. The respondent’s case, again in its simplest form, is that the relevant claims are claims to a product, not a process, and that (as Lord Hoffmann put it in para 36 of his judgment in the Court of Appeal):

“When a product claim satisfies the requirements of section 1 of the 1977 Act, the technical contribution to the art is the product and not the process by which it was made, even if that process was the only inventive step.”

Sufficiency

15.  I shall have more to say about product claims, but I must now address sufficiency. The three commonest grounds for attacking the validity of a patent are (a) lack of novelty (that is, the invention does not go beyond the state of the art); (b) obviousness (that is, that there is an advance in the state of the art, but it is an obvious advance lacking any inventive step); and (c) insufficiency. Insufficiency is less easily summarised because it is generally used (though the terminology is not always uniform) to link two concepts, drawn from EPC Articles 83 and 84:

“83.   Disclosure of the Invention

       The European patent application must disclose the   invention in a manner sufficiently clear and   complete for it to be carried out by a person skilled   in the art.

84.  The Claims

       The claims shall define the matter for which   protection is sought. They shall be clear and   concise and be supported by the description.”

16.  The word “sufficiently” in Article 83 echoes the primary requirement of sufficiency which is expressed in almost identical words in section 14(3) of the Patents Act 1977:

“The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.”

Article 84 is reproduced in section 14(5)(c):

“The claim or claims shall—

. . .

(c) be supported by the description.”

The significance of the reference to the “person skilled in the art", and this notional technician’s approach to the task of performing an invention, have often been described by the court. There are helpful passages in the judgment of Aldous J in Mentor Corp v Hollister Inc [1991] FSR 557, 562 and in the judgment of Lloyd LJ in the same case [1993] RPC 7, 10-13.

17.  Some judges have in the past been puzzled that section 72 of the Patents Act 1977 (power to revoke patents on application) reproduces (in subsection (1)(c)) the substance and wording of the requirement in section 14(3), but does not appear to reproduce section 14(5)(c). That puzzle was near the surface of the discussion, but was not in terms resolved, by this House in Asahi Kasei Kogyo KK’s Application [1991] RPC 485 (“Asahi“). That appeal raised an issue on section 5(2)(a) of the Patents Act 1977 (which also refers to an invention being “supported”). Lord Oliver of Aylmerton, with the agreement of the rest of the House (and with Lord Jauncey of Tullichettle delivering a concurring opinion), seems to have treated the requirements of section 14(3) as necessarily including those of section 14(5)(c). Lord Oliver said at pp 535-6:

“The Act does not contain any definition of the word ‘supported’ but some assistance can be obtained from the provisions of section 14(5) which require the claim in an application to be ‘supported’ by the description. That must, I think, involve the conclusion that if that which is contained in the description of the specification does not enable the claim to be established, it cannot be said to ‘support’ it, for the Act can hardly have contemplated a complete application for a patent lacking some of the material necessary to sustain the claims made. Since, therefore, subsection (3) of section 14 requires in terms that the specification disclose the invention in a way which will enable it to be performed by a person skilled in the art (i.e. it must contain an ‘enabling disclosure’) it follows that a description in an earlier application which contains no enabling disclosure will not ‘support’ the invention so as to enable it, as an invention, to claim priority from the date of that application under section 5(2)(a).”

18.  That is how Lord Hoffmann (with the concurrence of the rest of the House) understood Asahi in Biogen. He stated (at p 47):

“The explanation of section 14(5)(c) in Asahi seems to me to provide an answer to a point which puzzled the Court of Appeal in Genentech Inc’s Patent [1989] RPC 147. The Court noted that although section 14(5)(c) is a statutory requirement for a valid patent application, non-compliance is not a ground for revocation of a patent which has been granted. Section 72(1) states exhaustively the grounds upon which a patent may be revoked. These grounds do not, as such, include non-compliance with section 14(5). But the substantive effect of section 14(5)(c), namely that the description should, together with the rest of the specification, constitute an enabling disclosure, is given effect by section 72(1)(c). There is accordingly no gap or illogicality in the scheme of the Act.”

Lord Mustill (at p 31) expressly concurred in this. In dividing his opinion into sections Lord Hoffmann distinguished between “support for the claims” (section 12) and “sufficiency” (section 14) but he applied the same reasoning to both.

19.  There is therefore high authority that the requirements of section 14(3) and section 14(5)(c) are closely connected. The main difference between them is that section 14(3) relates to the specification as a whole, whereas section 14(5)(c) relates to the claims which define the monopoly sought by the inventor. I repeat in a fuller form the citation from EXXON set out in para 14 above:

“Furthermore, Article 84 EPC also requires that the claims must be supported by the description, in other words it is the definition of the invention in the claims that needs support. In the Board’s judgment, this requirement reflects the general legal principle that 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...”

20.  Section 14(3) and (5)(c) operate together, as EPC Articles 83 and 84 operate together, to spell out the need for an “enabling disclosure", which is central to the law of patents: see Lord Oliver in Asahi at pp531-532, and Lord Hoffmann in Biogen at pp46-51 and in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 169 (“Kirin-Amgen“) at paras 102-116. The disclosure must be such as to enable the invention to be performed (that is, to be carried out if it is a process, or to be made if it is a product) to the full extent of the claims. The question whether there is sufficient enabling disclosure often interacts with a question of construction as to the extent of the claims. For instance in American Home Products Corp v Novartis Pharmaceuticals UK Ltd [2001] RPC 159 (“American Home Products“) the disclosure would have been insufficient if the claims had extended, not merely to rapamycin (a known antifungal antibiotic which proved effective as an immunosuppressant) but also to derivatives of rapamycin. The Court of Appeal held that the claims should be narrowly construed, and on that basis there was sufficient enabling disclosure.

21.  The main thrust of the appellants’ case is that Lundbeck made only a limited technical contribution to the resolution of citalopram, because it fully disclosed only one method of producing the (+) enantiomer, that is by the route of resolution of the diol intermediate. Therefore, it is said, the Exxon principle invalidates claims 1 and 3 because (although expressed as ordinary product claims) they are really in the nature of product-by-process claims, and should have been limited to escitalopram as produced by the diol intermediate method. In considering this argument I find it necessary to return to some fairly basic points of patent law—commonplace to the specialist in this field, but not necessarily obvious to the non-specialist.

Product claims

22.  Judges have often observed that the wide abstract terms in which patent law is expressed must always be related to the facts of the particular case. That is especially true in relation to the sufficiency of a product claim, since the term “product” covers such an extremely wide variety. A product may be as simple as a baby’s disposable diaper (see Mölnlycke AB v Procter & Gamble Ltd [1992] FSR 549—”Mölnlycke“) or a corkscrew (see Hallen Co v Brabantia (UK) Ltd [1991] RPC 195) or as complex as an “heavier-than-air flying machine” referred to by Lord Hoffmann in Biogen, or a class of microscopic organisms, produced by recombinant DNA technology, such as was considered by this House in Biogen and Kirin-Amgen. Where the product is manufactured the specification is likely to include drawings as well as a verbal description, but the drawings are almost always described as an example (or embodiment). Otherwise (in the absence from United Kingdom patent law of a doctrine of equivalents—see Kirin-Amgen [2005] RPC 169, paras 36 ff) competitors would probably be able, by some small variation in design, to exploit the inventive concept without infringement. For similar reasons (especially in the field of chemical compounds) patent applications are likely to seek to obtain protection, not for a single compound, but for a class of compounds, and sometimes an almost unimaginably large class (see for instance Pharmacia Corp v Merck & Co Inc [2002] RPC 41, where claim 1 is set out, in an accessible form, in para 11; Arden LJ recorded, in para 150, that it comprised “literally trillions” of formulae).

 
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