Judgments - Kirin-Amgen Inc and others (Appellants) v. Hoechst Marion Roussel Limited and others (Respondents). Kirin-Amgen Inc and others (Respondents) v. Hoechst Marion Roussel Limited and others (Appellants) (Conjoined Appeals)

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    59.  First, Mr Watson says that in construing claim 1, the judge has read "a DNA sequence" to mean "an exogenous DNA sequence encoding for EPO" and thereby read into the claim words which are not there. Similarly in claim 26 he has read "expression … of a DNA sequence" to mean "expression of an exogenous DNA sequence coding for EPO". But in my opinion no words have been "read into" the claims. The meaning of the term "host cell" is wholly dependent on context. The notion of a host entails the notion of a guest. If the guest is not expressly identified, it must be inferred from context. One answer might have been that the guest was intended to be any DNA whatever. In that case, TKT's human cells are host to the sequences inserted by homologous recombination. But the judge has held, in my opinion rightly, that "host cell" in the context of the specification means "cell which is host to an exogenous DNA sequence encoding for EPO". This is not reading words into the claim any more than when one says that in a particular context "the City" means "the City of London."

    60.  Secondly, Mr Watson submits that the judge assumed that GA-EPO was made by the human cells (HT-1080) in which the EPO gene was endogenous. In fact, it was made by the R-223 cells selected by methotrexate by reason of their amplification of the gene. Such amplification would not have occurred without the introduction of the exogenous DNA upstream of the EPO gene in the original cells.

    61.  This seems to me a lawyer's point if ever there was one. The claims are concerned with the expression of EPO by a gene which is exogenous to the cell. But the genes which express EPO in the R-223 cells are not exogenous. They come into existence when the cell is formed by division and simply replicate the genes in the HT-1080 cells. The fact that exogenous DNA is needed to promote amplification seems to me irrelevant.

    62.  Thirdly, Mr Watson submits that a part of the EPO encoding sequence was exogenous to the cell. For reasons into which it is unnecessary to inquire, the TKT process removed 13 nucleotides from the beginning of the leader sequence in the natural gene and substituted ten others. But the amino acid residues for which these nucleotides coded were removed during the process of expression and formed no part of the mature protein. The EPO to which the claims refer is in my opinion the mature protein which was entirely encoded by endogenous DNA.

    The judge's application of the Protocol questions

    63.  Having thus construed the claims, the judge described his construction as "literal" and moved on to the Protocol questions. In what sense could the construction have been literal? The first difficulty about the application of the Protocol questions is to decide what is meant by a "primary, literal or acontextual meaning". The judge's construction could not possibly be described as acontextual. It was entirely dependent on context and reflected the evidence of how the claim would have been understood by men skilled in the art.

    64.  No one has ever made an acontextual statement. There is always some context to any utterance, however meagre. "Acontextual meaning" can refer only to the conventional rules for the use of language, such as one finds in a dictionary or grammar. But then, to compare acontextual meaning in that sense with contextual meaning is to compare apples with pears. The one refers to a general rule about how words or syntax should be used and the other to the fact of what on a specific occasion the language was used to mean. So, to make any sense of the terms "primary, literal or acontextual meaning" in the Protocol questions, it must be taken to mean a construction which assumes that the author used words strictly in accordance with their conventional meanings.

    65.  The notion of strict compliance with the conventional meanings of words or phrases sits most comfortably with the use of figures, measurements, angles and the like, when the question is whether they allow for some degree of tolerance or approximation. That was the case in Catnic and it is significant that the "quintet" of cases in which the German Bundesgerichtshof referred to Catnic and said that its approach accorded with that of the House of Lords were all concerned with figures and measurements. In such cases, the contrast with strict compliance is approximation and not the rather pretentious figures of speech mentioned in the Protocol questions.

    66.  No doubt there are other cases, not involving figures or measurements, in which the question is whether a word or phrase was used in a strictly conventional or some looser sense. But the present case illustrates the difficulty of applying the Protocol questions when no such question arises. No one suggests that "an exogenous DNA sequence coding for EPO" can have some looser meaning which includes "an endogenous DNA sequence coding for EPO". The question is rather whether the person skilled in the art would understand the invention as operating at a level of generality which makes it irrelevant whether the DNA which codes for EPO is exogenous or not. That is a difficult question to put through the mangle of the Protocol questions because the answer depends entirely upon what you think the invention is. Once you have decided that question, the Protocol questions answer themselves.

    67.  The judge thought that the invention was the discovery of the sequence of the EPO gene and the associated information. It followed that any method of making EPO which used that information, whether by the expression of exogenous or endogenous DNA, would operate in the same way and that this would be obvious to the person skilled in the art. Furthermore, there was no reason why the patentee should have wished to insist upon any particular method of using the information to obtain the expression of EPO.

    68.  The Court of Appeal, on the other hand, thought that the invention was a way of making EPO. The information about the sequence of the gene was necessary to enable the invention to be performed but was not and could not be the invention itself. It followed that a different way of making EPO worked in a different way from that described in the invention and that this would have been obvious to a person skilled in the art. The Court of Appeal added that if they had answered the first two Protocol questions in favour of Amgen they would also have answered the third in its favour. That is a somewhat unreal hypothesis and seems only to mean that if upon the true construction of the claims the invention was broad enough to include any method of making EPO, they would not have understood the patentee to be insisting on any particular method.

    69.  I shall say in a moment why I agree with the Court of Appeal, but I want first to emphasise a point I have already made about the use of the Protocol questions. The determination of the extent of protection conferred by a European patent is an examination in which there is only one compulsory question, namely that set by article 69 and its Protocol: what would a person skilled in the art have understood the patentee to have used the language of the claim to mean? Everything else, including the Protocol questions, is only guidance to a judge trying to answer that question. But there is no point in going through the motions of answering the Protocol questions when you cannot sensibly do so until you have construed the claim. In such a case - and the present is in my opinion such a case - they simply provide a formal justification for a conclusion which has already been reached on other grounds.

    70.  I agree with the Court of Appeal that the invention should normally be taken as having been claimed at the same level of generality as that at which it is defined in the claims. It would be unusual for the person skilled in the art to understand a specification to be claiming an invention at a higher level of generality than that chosen by the patentee. That means that once the judge had construed the claims as he did, he had answered the question of infringement. It could only cause confusion to try to answer the Protocol questions as well.

    71.  No doubt there will be patent lawyers who are dismayed at the notion that the Protocol questions do not provide an answer in every case. They may feel cast adrift on a sea of interpretative uncertainty. But that is the fate of all who have to understand what people mean by using language. The Protocol questions are useful in many cases, but they are not a substitute for trying to understand what the person skilled in the art would have understood the patentee to mean by the language of the claims.

    72.  This is perhaps an appropriate point at which to mention what may appear to be a difference between the German, United Kingdom and Netherlands approach to these questions. It used to be thought that despite article 69 and the Protocol, there remained serious differences between the approaches to construction of the United Kingdom on the one hand and Germany and the Netherlands on the other. And it is true that in the early years of the EPC, there was a view in the German and Netherlands courts that the Convention had made no difference and that the Protocol entitled the courts of Contracting States to go on deciding the extent of protection exactly as before. The position in the Netherlands is described by Professor Brinkhof in the article Is there a European Doctrine of Equivalence? (2002) IIC 911 to which I have already referred.

    73.  But I do not think that this is any longer true. The highest courts in both Germany (see Batteriekastenschnur [1989] GRUR 903, 904) and the Netherlands (see Ciba-Geigy/Oté Optics (1995) Nederlandse Jurisprudentie 39) have said that the effect of article 69 is to give the claims what the European Patent Office has called a "central role": see BAYER/Plant growth regulating agent [1990] EPOR 257, 261. The Bundesgerichtshof said in the Batteriekastenschnur case that the claims are no longer merely a point of departure but the decisive basis (maßgebliche Grundlage) for determining the extent of protection.

    74.  In addressing the 10th Symposium of European Patent Judges in Luxembourg in 2000, the distinguished German patent lawyer Dr Rüdiger Rogge (then presiding judge of the 10th (intellectual property) Senate of the Bundesgerichtshof) said that he regarded the decisions of other countries on the extent of protection afforded by article 69 as important contributions to the jurisprudence of his own country. The same is true of the judges of the United Kingdom.

    75.  The German courts have their own guidelines for dealing with equivalents, which have some resemblance to the Protocol questions. In the "quintet" of cases before the Bundesgerichtshof (see, for example, Kunstoffrohrteil [2002] GRUR 511 and Schneidemesser 1 [2003] ENPR 12 309) which concerned questions of whether figures or measurements in a claim allow some degree of approximation (and, if so, what degree), the court expressly said that its approach was similar to that adopted in Catnic. But there are differences from the Protocol questions which are lucidly explained by Dr Peter Meier-Beck (currently a judge of the 10th Senate) in a paper to be published in the International Review of Intellectual Property and Competition Law (IIC). For example, German judges do not ask whether a variant "works in the same way" but whether it solves the problem underlying the invention by means which have the same technical effect. That may be a better way of putting the question because it avoids the ambiguity illustrated by American Home Products Corporation v Novartis Pharmaceuticals UK Ltd [2001] RPC 159 over whether "works in the same way" involves an assumption that it works at all. On the other hand, as is illustrated by the present case, everything will depend upon what you regard as "the problem underlying the invention." It seems to me, however, that the German courts are also approaching the question of equivalents with a view to answering the same ultimate question as that which I have suggested is raised by Article 69, namely what a person skilled in the art would have thought the patentee was using the language of the claim to mean.

    The decision of the Court of Appeal

    76.  I agree with the Court of Appeal on construction for a number of reasons. First, I think that the judge's construction pays no attention to the claims. It does not even use them as "guidelines" but goes straight to Table VI and declares that to be the invention. Secondly, I think that the Court of Appeal was right in saying that Table VI could not have been the invention. Standing alone, it was a "discovery…as such" within the meaning of section 1(2) of the Act: see Genentech Inc's Patent [1989] RPC 147, per Purchas LJ at p 204 and per Dillon LJ at p 237. On the other hand, as Whitford J said in the Genentech case ([1987] RPC 553, 566):

    "It is trite law that you cannot patent a discovery, but if on the basis of that discovery you can tell people how it can be usefully employed, then a patentable invention may result. This in my view would be the case, even though once you have made the discovery, the way in which it can be usefully employed is obvious enough."

    77.  In such a case, while it may be true to say, as the Court of Appeal did ([2003] RPC 31, 62) that Table VI lay "at the heart of the invention", it was not the invention. An invention is a practical product or process, not information about the natural world. That seems to me to accord with the social contract between the state and the inventor which underlies patent law. The state gives the inventor a monopoly in return for an immediate disclosure of all the information necessary to enable performance of the invention. That disclosure is not only to enable other people to perform the invention after the patent has expired. If that were all, the inventor might as well be allowed to keep it secret during the life of the patent. It is also to enable anyone to make immediate use of the information for any purpose which does not infringe the claims. The specifications of valid and subsisting patents are an important source of information for further research, as is abundantly shown by a reading of the sources cited in the specification for the patent in suit. Of course a patentee may in some cases be able to frame his claim to a product or process so broadly that in practice it will be impossible to use the information he has disclosed, even to develop important improvements, in a way which does not infringe. But it cannot be right to give him a monopoly of the use of the information as such.

    New technology

    78.  The effect of the construction for which Amgen contends is that claim 1 should be read as including any DNA sequence, whether exogenous or endogenous, which expresses EPO in consequence of the application to the cell of any form of DNA recombinant technology. It would have been easy to draft such a claim. Whether the specification would have been sufficient to support it, in the sense of enabling expression by any form of DNA recombinant technology, is another matter to which I shall return when I deal with validity. But the person skilled in the art (who must, in my opinion, be assumed to know the basic principles of patentability) might well have thought that the claims were restricted to existing technology because of doubts about sufficiency rather than lack of foresight about possible developments. Amgen would have been well aware in 1983 that recombinant technology was developing rapidly and that artificial homologous recombination had been achieved in bacterial and yeast cells and that its use in mammalian cells was regarded as a desirable goal.

    79.  Amgen submit that although homologous recombination was a known phenomenon in 1983, its use to achieve "gene activation" was unknown. The method of manufacture by DNA recombinant technology referred to in the claim was the only one known at the priority date. At the time, it was in practice equivalent to a general claim for manufacture by recombinant DNA technology. It should therefore be construed as such. Amgen say that if the claims cannot be construed in terms sufficiently general to include methods unknown at the priority date, the value of a patent would be destroyed as soon as some new technology for achieving the same result was invented.

    80.  I do not dispute that a claim may, upon its proper construction, cover products or processes which involve the use of technology unknown at the time the claim was drafted. The question is whether the person skilled in the art would understand the description in a way which was sufficiently general to include the new technology. There is no difficulty in principle about construing general terms to include embodiments which were unknown at the time the document was written. One frequently does that in construing legislation, for example, by construing "carriage" in a 19th century statute to include a motor car. In such cases it is particularly important not to be too literal. It may be clear from the language, context and background that the patentee intended to refer in general terms to, for example, every way of achieving a certain result, even though he has used language which is in some respects inappropriate in relation to a new way of achieving that result: compare Regina (Quintavalle) v Secretary of State for Health [2003] 2 AC 687. In the present case, however, I agree with the Court of Appeal (and with the judge, before he came to apply the Protocol questions) that the man skilled in the art would not have understood the claim as sufficiently general to include gene activation. He would have understood it to be limited to the expression of an exogenous DNA sequence which coded for EPO.

    81.  The argument over whether the claim can include the new technology is linked to a dispute over the meaning of the second Protocol question. When one asks whether it would have been obvious to the person skilled in the art that the variant worked in the same way as the invention, does one assume that it works? Otherwise, in the case of a technology which was unknown at the priority date, the person skilled in the art would probably say that it was by no means obvious that it would work in the same way because it was not obvious that it would work at all.

    82.  Some might say, in answer to this question, that it depends on the nature of the invention. For example, in American Home Products Corporation v Novartis Pharmaceuticals UK Ltd [2001] RPC 159 the alleged invention was a second medical use for the known drug rapamycin, which was found to have an immuno-suppressive effect. The question was whether a claim to rapamycin should be construed as including derivatives of rapamycin. The evidence was that the person skilled in the art would be unable to say without experimentation that any particular derivative would have an immuno-suppressive effect. In applying the second Protocol question, it would have been absurd to ask whether, assuming that a derivative "worked" in the sense of having an immuno-suppressive effect, it worked "in the same way". That would really be to beg the question. Neither the product nor the process was new: the whole point of the invention was the newly discovered immuno-suppressive effect.

    83.  On the other hand, in Improver Corporation v Remington Consumer Products Ltd [1990] FSR 181 the invention was based upon the discovery that an arcuate rod with slits, when rotated at high speed, would take the hair off the skin by means of the opening and closing of the slits. The claim was to a rod in the form of an "helical spring" but the alleged infringer had found that an arcuate rod of vulcanised rubber with slits would do just as well. In answering the second Protocol question, I said that it did not matter that it would not have been obvious to the person skilled in the art to substitute a rubber rod. The question was whether such a rod would work in the same way as an helical spring. I went on, however, to say (in answer to the third question) that "helical spring" could not be generalised to mean any arcuate rod with slits. It meant an helical spring.

    84.  So perhaps a better answer to the dispute over the second Protocol question is that new technology is another situation in which the Protocol questions may be unhelpful. On the other hand, if the claim can properly be construed in a way which is sufficiently general to include the new technology, the Protocol questions tend to answer themselves.

    85.  For these reasons I would hold that TKT did not infringe any of the claims and dismiss Amgen's appeal.


    86.  TKT appeals against the rejection by both the judge and the Court of Appeal of its challenge to claim 26 on the ground of anticipation. This raises a point of principle about what counts as a new product.

    87.  Section 1(1)(a) of the Act says that a patent may be granted only for an invention which is new and section 2(1) says that an invention shall be taken to be new if it does not form part of the state of the art. The Act assumes that any invention will be either a product or a process (see the definition of infringement in section 60.) Claim 26 is to a product, namely a polypeptide which is the expression in a host cell of a DNA sequence in accordance with claim 1. Such a product is EPO and the question is whether it is new or the same as the EPO which was already part of the state of the art, namely the uEPO which Miyake and others had purified from urine.

    88.  The practice in the United Kingdom under the Patents Act 1949 and earlier was to treat the fact that a product was made by a new process as sufficient to distinguish it from an identical product which was already part of the state of the art. This was not particularly logical, because the history of how a product was made is not an attribute which it carries around and makes it something new. It was still the same product, even if made in a different way. But the English practice had practical advantages when the extent of protection conferred by a patent was undefined (as it was until 1977) and it was assumed that a process claim could be infringed only by using that process in the United Kingdom. A product-by-process claim had the advantage of enabling the inventor of a new process to pursue not only the manufacturer who infringed his claim to the process but also, by virtue of the separate "product-by-process" claim, anyone who dealt in a product which had been made by that process. That was particularly useful in the case of the importation of a product made by someone outside the jurisdiction by a process which would have infringed the process claim if it had been made in this country.

    89.  The EPC, however, contains a provision which allows a patentee to rely directly on his process claim to allege infringement of a product made (whether within the jurisdiction or abroad) by that process. This is article 64(2) (given effect in United Kingdom domestic law by section 60(1)(c) of the Act):

    "If the subject-matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process."

    90.  This provision largely removes the practical argument for allowing product-by-process claims. The European Patent Office has therefore been able to accept the logical argument that a new process is not enough to make the product new. It will not ordinarily accept a "product-by-process" claim. A patentee who wishes to complain of dealings in a product made by his patented process must rely on his process claim and article 64(2). The principle is clearly stated by the Technical Board of Appeal in International Flavors & Fragrances Inc [1984] OJ EPO 309, in which the United Kingdom was singled out as the only Member State of the EPC which accepted product-by-process claims.

    91.  The only case in which the EPO will accept a claim to a product defined in terms of its process of manufacture is when the product is new in the sense of being different from any existing product in the state of the art but the difference cannot be described in chemical or physical terms. As the Board said in International Flavors (at paragraph 8):

    "This may well be the only way to define certain natural products or macromolecular materials of unidentified or complex composition which have not yet been defined structurally."

    92.  When the application for the patent in suit was made to the EPO, both claims 19 and 26 were product claims in which the product was described wholly or partly in terms of the way it was made. In the case of claim 19, it was a claim to EPO which was (a) in the form of Table VI ("or any allelic variant or derivative thereof") and (b) "the product of … expression of an exogenous DNA sequence". The Technical Board found on the evidence that EPO which complied with these descriptions would not necessarily be different from uEPO and therefore rejected the claim. Amgen were therefore put to finding some distinction between the patented EPO and uEPO. They amended the claim by adding the words "and which has higher molecular weight by SDS-PAGE from erythropoietin isolated from urinary sources." I shall come back to the sufficiency of such a claim but there is no doubt that the product would, by definition, be different from uEPO.

    93.  In the case of claim 26, the EPO was defined as the product of the expression, in a eucaryotic host of a DNA sequence according to claim 1. This is verbally different from the definition in claim 19, which applies to the expression of any exogenous DNA sequence, although whether this makes any practical difference is another matter. The Technical Board found on the evidence that expression in a eucaryotic host ?

    "will ensure glycosylation of the product, thus distinguishing it from the prior art."

    94.  The Board went on to say:

    "The Board is on the evidence prepared to presume that the limitation to the polypeptide being a product makeable using the DNA of Claim 1 is a technical feature which ensures that it has a glycosylation pattern different from the known uEPO."

    95.  I must confess to being a little puzzled by these findings. It is unclear to me whether the technical feature which ensured novelty was the use of a eucaryotic host cell (as the first quotation above suggests) or whether it was the use of DNA according to claim 1 (as the second quotation suggests). It is true that glycosylation occurs only in eucaryotic cells, but that is no distinction from the prior art because human cells are eucaryotic. Likewise, the DNA of Claim 1 was alleged to be the human EPO gene as sequenced by Dr Lin. Nor can I quite understand why the Board arrived at a different conclusion in respect of the facts relevant to claim 19. But for present purposes none of this matters: the decision of the Board on claim 26 was based upon a finding of fact that it was necessarily different from uEPO.

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