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

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23.  In other cases the scope for different embodiments may be quite limited. Mölnlycke provides a simple and homely example. It might have been thought that by the 1980’s there was little room for further improvements in the design and manufacture of one-piece disposable diapers. But there was a technical problem. For reasons of economy the diapers must be made with very thin plastic, usually polyethylene, which tears easily. The problem was to find a means of fastening and unfastening adhesive tapes or tabs (and refastening them if the baby was dry) without tearing the thin fabric. The inventive concept was a dedicated fastening surface consisting of a transverse plastic strip which was relatively strong, and inelastic and had “suitable surface properties". Simple though this was, the patent was attacked (unsuccessfully) on grounds of insufficiency as well as obviousness, because (it was said) the skilled man trying to carry out the invention could not answer the questions: How strong? How inelastic? Which of various forms of adhesion would be “suitable"? That was the context—as far removed as it could be from the mysteries of genetic engineering—of Morritt J’s misinterpretation (as Lord Hoffmann called it in Biogen at p 48) of the principle in Genentech I/Polypeptide Expression (T 292/85) [1989] OJ EPO 275.

24.  A “product-by-process” claim is a claim to a product, but described in such a way as to define it by the process by which it is produced. Such claims are discouraged by the European Patent Office (“EPO”). They are permitted by the EPO only where there is a claim to a new substance whose difference from a known substance cannot be described in chemical or physical terms (see Kirin-Amgen [2005] RPC 169 at paras 88-91, and also at para 109; note that erythropoietin itself could not have been patented because it was a known substance occurring in nature). The expression “product-by-process” was used in argument in Biogen (at p 27) and this submission was accepted, if not in those precise terms, by Lord Hoffmann in his opinion in the paragraph (at p 40) which is quoted in paragraph 26 below. Lord Hoffmann also used it, in relation to Biogen, in his judgment in the Court of Appeal (in para 33).

25.  A single chemical compound is a product for the purposes of UK patent law (the restrictive provisions of section 38A of the Patents Act 1907, as amended in 1919, having disappeared from the Patents Act 1949). It is moreover a product of a special character, since it is a product which, simply as a chemical compound (as in claim 1 of the patent in suit), can have only one embodiment (though if it is used in a pharmaceutical preparation it can of course have numerous embodiments in terms of dosages and non-active ingredients, as in claims 3 and 5 of the patent in suit). Statements of general principle relating to inventions with many embodiments may be irrelevant to an invention which consists of a single chemical compound.

The claims in Biogen and in the patent in suit

26.  That is in my opinion the fundamental reason why Biogen does not provide a direct answer to this appeal (although it is certainly material to the issue of “technical contribution”). The invention set out in claim 1 of the patent in suit in Biogen was one with a very large number of possible embodiments. As Lord Hoffmann put it in his opinion in Biogen (p 40, emphasis supplied):

“The claim is to a product, a molecule identified partly by the way in which it has been made (‘recombinant DNA’) and partly by what it does (the words following ‘characterised by’). It generalises what Professor Murray had done in two ways. First, as to the results he had achieved. He had made a particular form of recombinant plasmid (pBR322 with fragments of Dane particle DNA) which had transformed E coli and, he said, caused it to express the genes of HBcAg and HBsAg. The claim was for any recombinant DNA molecule which expressed the genes of any HBV antigen in any host cell. Secondly, there was generalisation of the method which he had used. He had made his DNA molecule from a standard pBR322 plasmid and large fragments from Dane particle DNA, chosen simply on the basis that they should be large. This was a technique imposed upon him by lack of information about the coding sequences. Thereafter, he employed conventional means to express the DNA in a conventional bacterial host. The claim was for any method of making a DNA molecule which would achieve the necessary expression.”

27.  Where classes of compounds are claimed, difficult interlocking problems as to construction and sufficiency may arise (as in American Home Products). They do not arise in this case. The fact that claim 1 is to a single chemical compound is what makes the present appeal unusual (and, I venture to say, relatively straightforward, once the issues of lack of novelty and obviousness are out of the way, as they are in your Lordships’ House).

28.  In describing the issues before the House as relatively straightforward I do not in any way disparage the lengthy written and oral submissions which have been addressed to your Lordships. Those submissions have been of great assistance. But as the argument in the appeal has progressed I have formed the view that the appellants can succeed only if they persuade your Lordships that there is a general principle in EPC Article 84 and section 14(5)(c) of the Patents Act 1977 that requires a product claim to a single chemical compound to be restricted to the invention’s technical contribution to the art, and that that means the inventive concept (in this case the diol intermediate process).

Technical contribution

29.  During the oral argument before your Lordships there was some discussion of whether “inventive concept” means the same as “technical contribution to the art.” Neither expression is a statutory term of art. Lord Hoffmann used both expressions several times in his opinion in Biogen, the former mostly in section 10 (headed “Inventive Step”) and the latter mostly in section 12 (“Support for the Claims”). Mr Thorley QC submitted in his reply that the two expressions (as used in Lord Hoffmann’s opinion) are synonymous.

30.  I do not think that this is quite right. The expressions are certainly connected, but I do not think it is helpful (either in considering Lord Hoffmann’s opinion, or generally) to treat them as having precisely the same meaning. “Inventive concept” is concerned with the identification of the core (or kernel, or essence) of the invention—the idea or principle, of more or less general application (see Kirin-Amgen [2005] RPC 169 paras 112-113) which entitles the inventor’s achievement to be called inventive. The invention’s technical contribution to the art is concerned with the evaluation of its inventive concept—how far forward has it carried the state of the art? The inventive concept and the technical contribution may command equal respect but that will not always be the case.

31.  Biogen itself is, I think, a good illustration of this. Before your Lordships Lord Hoffmann’s opinion in Biogen has been subjected to closer and more searching scrutiny by the House than any that I can recall, with the possible exception of the House’s scrutiny in Deutsche Morgan Grenfell v Inland Revenue Commissioners [2007] 1 AC 558 of the speech of Lord Goff of Chieveley in Kleinwort Benson Ltd v Lincoln City Council [1999] 2 AC 349. If I may respectfully say so, Lord Hoffmann’s opinion in Biogen is a tour de force. I have frequently commended it to bar students as an example of how a great judge can suffuse even the most technical subject with intellectual excitement. But its vivid and powerful language must be read in the context of the facts and issues in that case.

32.  Biogen was a difficult and complicated case—much more complicated than the present appeal before the House. The first-instance hearing occupied two working weeks and the hearing in the Court of Appeal took even longer. It is noteworthy that despite the much-quoted passage in Lord Hoffmann’s opinion (at p 45) counselling caution in an appellate court’s review of a trial judge’s evaluation of the facts, Lord Hoffmann did differ from Aldous J in his identification of the inventive concept, and (at pp 45-46) he differed from the Court of Appeal (and agreed with Aldous J) on the issue of obviousness for the very reason that the Court of Appeal had unquestioningly accepted the judge’s view of the inventive concept. The better view was that the inventive concept was (p 45, emphasis supplied):

“The idea of trying to express unsequenced eukaryotic DNA in a prokaryotic [non-mammalian] host.”

33.  This was a striking achievement by Professor Murray (Lord Hoffmann, at p 52, called it “a brilliant Napoleonic victory”) which stole a march on researchers who were taking the more systematic route of sequencing the genome. But in terms of its technical contribution to the art it was not of lasting strategic importance because within a few months of Professor Murray’s achievement the genome had been sequenced. As Lord Hoffmann put it (p 52):

“Professor Murray invented a way of working with the genome in the dark. But he did not switch on the light and once the light was on his method was no longer needed. Nor, once they could use vectors for mammalian cells, would they be concerned with the same problem of introns which had so exercised those skilled in the art in 1978. Of course there might be other problems, but Biogen 1 did not teach how to solve them. The respondents Medeva who use restriction enzymes based on knowledge of the HBV genome and mammalian host cells, owe nothing to Professor Murray’s invention.”

In short, the invention’s technical contribution to the art was not (except as a matter of history) something of lasting importance; and the patent was insufficient (p 53) to sustain a claim to every method of using recombinant DNA technology to produce HBV antigens.

34.  Biogen is therefore an example of a brilliant inventive concept which did not however make a significant permanent contribution to the art, because of the pace at which the state of the art was advancing. Pharmaceutical research is a highly competitive activity, backed by huge resources, and there will always be winners and losers. Jacob LJ (at para 57) was rightly not moved by the thought that Professor Bogeso might be getting “more than he deserved". Had he spent seven years isolating the enantiomers and found that both were equally effective and non-toxic his invention would, at least in commercial terms, have made no significant technical contribution to the art. Neither Lundbeck nor any of its competitors would have wanted to manufacture escitalopram. But the inventive concept would have been no different. The technical contribution was, as the Court of Appeal recognised (paras 36 and 59) the isolated enantiomer now called escitalopram, but it would on this hypothesis have proved no more useful than the unresolved racemate citalopram.

Exxon

35.  My noble and learned friends Lord Mance and Lord Neuberger of Abbotsbury (whose opinions I have had the advantage of reading in draft) both draw attention to the importance of UK patent law aligning itself, so far as possible, with the jurisprudence of the EPO (and especially decisions of its Enlarged Boards of Appeal). National courts may reach different conclusions as to the evaluation of the evidence in the light of the relevant principles, but the principles themselves should be the same, stemming as they do from the EPC. There is no decision of an Enlarged Board of Appeal directly in point on the subject of technical contribution. The most relevant decision of a Technical Board of Appeal is Exxon, decided in 1993.

36.  The claimed invention was in the field of additives for fuel oils to prevent the oil filter in a diesel engine being clogged at low temperatures by the formation of very small ice crystals. It was an area in which much research had already been undertaken. The appellant made a main request and an auxiliary request, both of which failed on grounds related to EPC Articles 83 and 84. After the passage quoted at para 19 the Technical Board of Appeal continued (para 3.3):

“This means that the definitions in the claims should essentially correspond to the scope of the invention as disclosed in the description. In other words, as was stated in decision T 26/81 (OJ EPO 1982, 211, point 4 of the reasons), the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art.”

37.  The Board also stated (para 3.5):

“Although the requirements of Article 83 and Article 84 are directed to different parts of the patent application, since Article 83 relates to the disclosure of the invention, whilst Article 84 deals with the definition of the invention by the claims, the underlying purpose of the requirement of support by the description, insofar as its substantive aspect is concerned, and of the requirement of sufficient disclosure is the same, namely to ensure that the patent monopoly should be justified by the actual technical contribution to the art. Thus a claim may well be supported by the description in the sense that it corresponds to it, but still encompass subject-matter which is not sufficiently disclosed within the meaning of Article 83 EPC as it cannot be performed without undue burden, or vice versa.”

38.  These statements of principle appear to me to support the views that I have expressed. But for present purposes the most significant part of the decision in Exxon is in the later part of para 3.5:

“In the Board’s judgment, this case differs from those where a class of chemical compounds is claimed and only one method of preparing them is necessary to enable a skilled person to carry out the invention, ie to prepare all compounds of the claimed class. Rather, the present case is comparable to cases where a group of chemical compounds is claimed, and not all of the claimed compounds can be prepared by the methods disclosed in the description or being part of the common general knowledge (see eg T 206/83, OJ EPO 1987, 5). In the latter case, it was not held sufficient for the purpose of Article 83 EPC to disclose a method of obtaining only some members of the claimed class of chemical compositions.”

That statement could hardly be clearer. Claim 1 in the patent in suit is to a single chemical composition.

39.  Your Lordships were referred to other decisions of Technical Boards of Appeal of the EPO that are in line with the decision in Exxon. But it is not necessary to multiply statements of essentially the same point.

40.  For these reasons, which I understand to be essentially the same as those of Lord Mance and Lord Neuberger, I would dismiss this appeal.

LORD MANCE

My Lords,

41.  The issue on this appeal is short though fundamental. Where a patent claim relates to a product, rather than a method, is the patent liable to revocation on the ground of insufficiency under s.72(1)(c) of the Patent Act 1977 if the only inventive step involved in the product consists in the method by which it is made available and if its description and specification disclose only that inventive method and superior methods are found by others which owe nothing to that method? Can such a claim be said to have been supported in its full width by the description given, in the sense identified as necessary by Lord Hoffmann giving the main speech in this House in Biogen Inc. v. Medeva plc [1997] RPC 1, 47?

42.  The claim is to the (+) enantiomer, one of two mirror image enantiomers making up the racemate citalopram. Citalopram is an anti-depressant drug for which H Lundbeck A/S (“Lundbeck”) had held a patent which had expired. The preparation or separation of its individual enantiomers, in order to identify to which the beneficial effects of citalopram might be due, was an obviously desirable goal, and their testing was trivial. The inventive step taken by Lundbeck lay in finding a way in which to prepare or separate the individual enantiomers. See per Kitchin J [2007] RPC 32, para. 264. Once done, this proved that the beneficial effects of citalopram were attributable to the (+) enantiomer. Lundbeck claimed accordingly to patent by claims 1 and 3 the (+) enantiomer (under the description escitalopram) and its pharmaceutical composition. These are the claims in issue, which Kitchin J held invalid and the Court of Appeal upheld. Claim 6 related to the particular method which Lundbeck used to prepare escitalopram and is now accepted as valid.

43.  The courts below held and it is not now in issue that claims 1 and 3 were not open to objection on the grounds of either lack of novelty or obviousness, and that the preparation or separation of escitalopram involved an inventive step satisfying s. 1(1)(a) and (b) of the 1977 Act. The conclusion that escitalopram was novel derived from an application of the House’s previous decision in Synthon BV v. SmithKline Beecham Plc [2005] UKHL 59; [2006] RPC 10. The prior art did not disclose any subject matter which, if performed, would necessarily result in an infringement of claims 1 and 3, and there was no disclosure enabling an ordinary skilled person to make (or “perform”) escitalopram by using common general knowledge. The prior disclosure of the racemate citalopram did not disclose either of its individual enantiomers. No-one previously had been able to prepare, separate or make available the individual enantiomers. The challenge made under s.72(1)(c) read against the background of s.14(3) and (5) is to the sufficiency of the enabling disclosure, having regard to the later development of superior methods of preparing escitalopram.

44.  The essential difference in the courts below was that Kitchin J confined the legitimate scope of the patent claim by reference to the inventive step, while the Court of Appeal held that a patent claim to a single novel product embraces all methods of producing that product, even if the description and specification cover only one such method and others emerge owing nothing to it. The question now is which answer should be adopted.

45.  As a matter of principle or philosophy or from a utilitarian viewpoint, arguments could be advanced in favour of either: see for example the early discussion paper prepared by a Committee of Experts of the Council of Europe dated Paris, 30th November 1951 (CM/WP IV (51) 27). Considerations such as equity, incentivisation to research and development and administrative and legal simplicity can all be deployed. The approach taken by Kitchin J ties the scope of any patent for an invention, whether relating to a product or to a process, to the inventive step or technical contribution involved in the invention. (The concepts of inventive step or technical contribution appear to have been treated by Lord Hoffmann in Biogen Inc. v. Medeva plc as effectively synonymous: compare e.g. p.43 lines 45-48, p.45 lines 3-10, p.49 lines19-22, p.51 line 43 - p.52 line 7 and p.52 line 34; but, if technical contribution is given some other meaning, then in that event the scope of the patent could simply be tied to the inventive step.) The alternative approach says that, once a novel product has been created by some inventive step or technical contribution, a patent may be sustained in respect of the product, however it might in future prove possible to make it. That is the approach taken in the Court of Appeal, and (although the present point was not there in issue) it gains some support (not surprisingly) from a passage in Lord Hoffmann’s speech (with which other members of the House agreed) some three months later in Conor Medsystems Inc. v. Angiotech Pharmaceuticals Inc. [2008] UKHL 49, [2008] 4 All ER 621, para. 17.

46.  The question to be decided on this appeal is which of these two approaches applies under domestic legislation, the Patents Act 1977. But the provisions of that Act are to be read as having, as nearly as possible, the same effects in the United Kingdom as the corresponding provisions of the European Patent Convention with which the Act was intended to bring United Kingdom law into conformity (see s.130(7)). Both the statute and the Convention leave much room for judicial interpretation, and I do not myself think that the answer to the problem that the House has to address is axiomatic in the light of the language of either. My noble and learned friend, Lord Walker of Gestingthorpe said in the case of Synthon that “In the interpretation and application of patent statutes judge-made doctrine has over the years done much to clarify the abstract generalities of the statutes and to secure uniformity in their application” (para. 57), while adding that: “Nevertheless it is salutary to be reminded, from time to time, that the general concepts which are the common currency of patent lawyers are founded on a statutory text, and cannot have any other firm foundation” (para. 58). Account must not only be taken of domestic judge-made doctrine; the jurisprudence of the European Patent Office under the Convention will always carry much persuasive weight in United Kingdom courts: see Merrell Dow Pharmaceuticals Inc. v. H N Norton & Co. Ltd. [1996] RPC 76, 82; Conor Medsystems Inc. v. Angtiotech Pharmaceuticals Inc. (above),para 3, per Lord Hoffmann.

47.  There are passages in Lord Hoffmann’s speech in Biogen Inc. v. Medeva plc which can be read as supporting an approach tying the scope of any patent, whether to a product or to a process, to the inventive step or technical contribution involved in its creation, and as justifying this on utilitarian grounds. Thus Lord Hoffmann referred at p.49 to the Technical Board of Appeal in Exxon/Fuel Oils (T 409/91) [1994] OJ EPO 653, para. 3.3 as reasserting “well-established principles for what amounts to sufficiency of disclosure", when it said that the requirement for the claims to be supported by the description (article 84 of the European Patent Convention, mirrored in s.14(5)(c) of the Patents Act 1977) “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". Lord Hoffmann also said at p.52 in Biogen Inc. v. Medeva plc that Professor Murray “showed by his invention” (the word being here used I think to mean inventive step) that “it could be done", i.e. that “known recombinant techniques could …. be used to make the antigens in a prokaryotic host cell” (see p.51 lines 46-47). He continued:

“Those who followed, even by different routes, could have greater confidence by reason of his success. I do not think this is enough to justify a monopoly of the whole field. I suppose it could be said that Samuel Morse had shown that electric telegraphy could be done. The Wright Brothers showed that heavier-than-air flight was possible, but that did not entitle them to a monopoly of heavier-than-air flying machines. …. The technical contribution made in such cases deserves to be recognised. But care is needed not to stifle further research and healthy competition by allowing the first person who has found a way of achieving an obviously desirable goal to monopolise every other way of doing so. (See Merges and Nelson, On the Complex Economics of Patent Scope (1990) 90 Columbia Law Review 839.)”

48.  It is a theme of Robert P Merges and Richard R Nelson’s article in the Columbia Law Review that the scope of patent protection should or might in one way or another be tied more closely to the relevant inventive step. But in the present connection their main concern related to a different issue to the present, namely the recognition under American law of the possibility of a valid patent in respect of a synthetically created version of a substance available in a natural form. Thus, at p.903 when discussing the “special problem that crops up in the chemical patent field” when there is invented “a synthetic version of a substance found in humans or animals", Merges and Nelson suggest that “the argument is not convincing that what the original inventor invented was the product, in addition to her particular process for making it". (They are throughout refreshingly ready to acknowledge the value of the female contribution.) In returning to the point at p.914, they acknowledge that “the tradition [under American law] of granting a product rather than a process patent goes back as far as Parke-Davis & Co. v. H K Mulford & Co 189 F 95 (CCSDNY 1911) when Learned Hand upheld a product patent on purified human adrenalin", continuing:

“In such cases protection consistent with the actual achievement of the inventor would have been provided if the initial patent had been for a process, or at most a “product-by-process", rather than for a product. And inventive efforts to come up with a significantly better process to make the product would not be blocked. These concerns seems to have animated a recent British case denying broad claims for Genentech’s t-PA drug [Genentech Inc’s Patent [1989] RPC 147].

One perhaps controversial way to achieve this would be to recognise a reverse equivalents defence [that is, an American law defence available to an alleged infringer who has made so far changed in principle a product described in a patent claim that it performs in a substantially different way] when a recombinant product is accused of infringing a prior purification patent.”

In the present case, there is no question of escitalopram having been either naturally or synthetically available before Lundbeck found a method of making it, and it is also not possible under United Kingdom law to patent a synthetic version of a product which is already available naturally, so that the problem under American law which concerned Merges and Nelson could not anyway arise.

 
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