|MERRELL DOW PHARMACEUTICALS INC AND OTHERS||(APPELLANTS)|
|H.N. NORTON & CO. LIMITED||(RESPONDENTS)|
|AND ONE OTHER ACTION|
Lord Jauncey of Tullichettle
Lord Lloyd of Berwick
LORD JAUNCEY OF TULLICHETTLE
LORD LLOYD OF BERWICK
1. The Patent in Suit
- Merrell Dow Pharmaceuticals Inc is a U.S. company with a U.K. subsidiary. I shall call them both “Merrell Dow”. About 25 years ago Merrell Dow discovered an anti-histamine drug called terfenadine. It is used by people who suffer from hay fever and similar allergies and has the advantage that, unlike some other anti-histamines, it does not have the side-effect of making one drowsy. In 1972 Merrell Dow obtained a patent for terfenadine in the United Kingdom. After a period of extension under the Patents Act 1977, it finally expired in December 1992. Other pharmaceutical companies then started to make and market terfenadine.
- In these proceedings Merrell Dow claim that their monopoly in terfenadine continues by virtue of a later patent which still has another 5 years to run. It was obtained in the following circumstances. After they had patented terfenadine, they did some research into the way it worked. They found that it passed through the stomach to be absorbed in the small intestine and was then 99.5% metabolised in the liver. This was why it had no side-effects. They analysed the chemical composition of the acid metabolite formed in the liver. Its chemical name is 4-[4-(4-hydroxydiphenylmethyl-l-piperidinyl)-l-hydroxybutyl]-∝∝-dimethylbenzeneacetic acid, but I shall call it the acid metabolite. No one had identified it before. So they patented the acid metabolite as claim 24 of a patent granted in 1980 for a number of related anti-histamine products. This is the patent in suit.
2. The Claim for Infringement
- A patent for a product is infringed by anyone who makes the product without the consent of the proprietor: see section 60(l)(a) of the Act of 1977. Merrell Dow’s research, which they made public at a symposium in Strasbourg in January 1982, showed that one cannot swallow terfenadine without shortly afterwards making the acid metabolite in one’s liver. This is claimed to be an act falling within section 60(1)(a). It is not however alleged to be an infringement, because section 60(5)(a) exempts any act “done privately and for purposes which are not commercial.” Nevertheless, say Merrell Dow, another pharmaceutical company cannot supply terfenadine to the public without infringing under section 60(2):
“Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom.”
- Merrell Dow say that supplying terfenadine commercially is an infringement under this subsection because it involves knowingly supplying consumers with the means, relating to an essential element for the making of the acid metabolite, for putting the invention into effect. So they retain their monopoly in marketing terfenadine until the metabolite patent expires in the year 2000. Indeed, the monopoly is stronger than it was under the terfenadine patent during its last four years of extension under the Patents Act 1977 because it is not subject to licences of right.
3. The Proceedings
- Merrell Dow has commenced two actions for infringement against other pharmaceutical companies. This appeal come before your Lordships’ House in consequence of motions to strike them out as disclosing no cause of action. The motions were heard by Aldous J., who was invited to decide as a matter of law (under RSC Ord 14A) that on the undisputed facts which I have stated, the patent was invalid. Several grounds were put forward but I need trouble your Lordships with only one, namely, that so far as the claim to the acid metabolite includes its manufacture by the action of terfenadine in the human body, the patent was invalid because the invention was not new. It was on this ground that Aldous J. dismissed the actions and his decision was affirmed by the Court of Appeal. Your Lordships decided in the first instance to hear argument on this point alone. The hearing was then adjourned. Since I understand your Lordships to be of the opinion that the Court of Appeal and Aldous J. were right and the other points have not been argued, I shall say nothing about them.
2. (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.
- The 1977 Act was passed to give effect to the European Patent Convention (“EPC”). Section 130(7) says that various sections, including section 2, were “so framed as to have, as nearly as practicable, the same effects in the United Kingdom as the corresponding provisions of the [EPC].” The provision which corresponds to section 2 is Article 54:
“(1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.”
- It is therefore the duty of the U.K. courts to construe section 2 so that, so far as possible, it has the same effect as Article 54. For this purpose, it must have regard to the decisions of the European Patent Office (“EPO”) on the construction of the EPC. These decisions are not strictly binding upon courts in the U.K. but they are of great persuasive authority; first, because they are decisions of expert courts (the Boards of Appeal and Enlarged Board of Appeal of the EPO) involved daily in the administration of the EPC and secondly, because it would be highly undesirable for the provisions of the EPC to be construed differently in the EPO from the way they are interpreted in the national courts of a Contracting State.
5. The Invention
- Before coming to the question of whether the invention was new, one must first be clear about what it was. Claim 24 of the patent in suit was to the acid metabolite as a product. The scope of the monopoly conferred by a product claim is defined by section 60(l)(a), which provides that where the invention is a product, a person infringes the patent if, without the consent of the proprietor, he “makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise.” For this purpose it does not matter how the product is made or what form it takes. The monopoly covers every method of manufacture and every form which comes within the description in the claim. So claim 24 includes the making of the acid metabolite in one’s liver just as much as making it by synthetic process; in the body as well as in isolation. Nor does it matter whether or not the infringer knows that he is making, using etc. the patented product. Liability is absolute.
- The corollary of this principle is that the novelty of the invention must be co-extensive with the monopoly. If there is any method of manufacture or form of the product which is part of the state of the art, then to that extent the invention is not new. As the Enlarged Board of Appeal of the EPO said in its Decision G02/88 MOBIL/Friction reducing additive  EPOR 73, 83:
“It is generally accepted as a principle underlying the EPC that a patent which claims a physical entity per se, confers absolute protection upon such physical entity; that is, wherever it exists and whatever its context. … It follows that if it can be shown that such physical entity (that is, a compound) is already in the state of the art (for example in the context of a particular activity), then a claim to the physical entity per se lacks novelty.”
- In this case, the respondents would have no objection to a claim to the synthesisation of the acid metabolite or to the product in isolation. The only respect in which they say it is not new is when made by terfenadine as part of the human body. It may be possible for Merrell Dow to amend the specification to exclude manufacture in this manner and form. In ordering the patent to be revoked, Aldous J. granted a stay pending an application to amend. Your Lordships need not therefore be concerned with the fact that a good deal of the ground covered by the patent is admittedly new. The argument may proceed as if the invention were confined to making the acid metabolite in the manner and form which the respondents challenge. In the rest of this judgment, when I speak of “the invention,” I shall therefore mean the making of the acid metabolite within the human body by the ingestion of terfenadine.
6. The Intuitive Response
- Mr. Thorley Q.C., who appeared for Merrell Dow, realistically acknowledged that a U.K. patent lawyer’s intuitive response to his claim was likely to be one of incredulity. A patent is granted for a new invention. But in 1980 there was nothing new about terfenadine. Full information about its chemical composition and method of use had been published in its patent specification in 1972. Participants in clinical trials had actually been taking the drug. Making and using terfenadine was therefore part of the state of the art. What did the acid metabolite patent teach the person who was using terfenadine? It gave him some information about how the product worked in terms of chemical reactions within the body. But it did not enable him to do anything which he had not been doing before.
- Why, therefore, should the later patent confer a right to stop people from doing what they had done before? Ever since the power of the Crown to grant monopolies was curbed by Parliament and the courts at the beginning of the seventeenth century, it has been a fundamental principle of U.K. patent law that the Crown could not grant a patent which would enable the patentee to stop another trader from doing what he had done before. In this case it so happens that Merrell Dow held both the terfenadine patent and the acid metabolite patent. So the problem did not emerge until the first patent had expired. But the argument would have been exactly the same if someone else had discovered and patented the acid metabolite. If Mr. Thorley is right, he would have been entitled to stop Merrell Dow selling terfenadine.
- Other extraordinary consequences were discussed in argument. Someone discovers an interesting-looking chemical and patents it. It is later discovered that this chemical is made in a temporary and unstable form during the cooking of a well-known dish according to a recipe in Elizabeth David. Can the patentee bring infringement proceedings against anyone who uses the recipe on a commercial scale? Examples to reinforce one’s initial incredulity could be multiplied.
- Mr. Thorley meets these arguments head-on. He says that the 1977 Act overturned the previous principles of U.K. patent law. It was passed, as its long title said, to introduce a new law of patents. Under the EPC, it is no longer the case that a patent cannot enable the patentee to stop someone doing what he has done before. Under the definition of the state of the art in section 2(2), it is not enough that something should have been done before. It requires that information about what was being done should have been made available to the public. In this case, Mr. Thorley says that no information about the acid metabolite had been made available to the public before the priority date of the later patent. Parliament, says Mr. Thorley, was aware that this change of principle might produce hardships and anomalies. It provided to some extent for such cases in section 64 of the 1977 Act. This gives a person who, before the priority date, was doing or making effective and serious preparations to do an act which would have been an infringement if the patent was in force, a personal right to continue doing that act. But the section is narrowly drawn. It has no application in this case because none of the defendants were marketing terfenadine before the priority date of the acid metabolite patent. Nevertheless, Mr. Thorley says that the very existence of section 64 shows that Parliament recognised that the effect of the new law was that people might find themselves unable to go on doing what they or someone else had done before.
- These are serious arguments which cannot be dismissed simply on the grounds that they produce results which seem contrary to common sense. I must therefore invite your Lordships to look more closely at the grounds upon which the respondents say that, although the acid metabolite as a chemical compound had not previously been identified, its manufacture in the body by the ingestion of terfenadine was nevertheless part of the state of the art.
7. Two Kinds of Anticipation?
- An anticipation is the traditional English term for that part of the state of the art which is inconsistent with the invention being new. The word is not used in the 1977 Act but is nevertheless convenient. In this case, Mr. Floyd Q.C., who appeared for H. N. Norton & Co. Ltd., the respondents in the first appeal, said that the invention had been anticipated in two ways. First, he said it had been used before the priority date. According to the paragraph 5 of the Joint Statement of Facts and Issues put before your Lordships, “Terfenadine was made available to and used by volunteers in clinical trials in 1977/1978.” They had made the acid metabolite in their livers and experienced its anti-histamine effects. Secondly, Mr. Floyd said before the priority date the invention had been disclosed in the specification of the terfenadine patent. That was a publicly available document which told one how to make terfenadine and that it should be taken for its anti-histamine effect. The inevitable result of following those instructions was to make the acid metabolite. I shall call these two arguments anticipation by use and anticipation by disclosure.
8. Anticipation by Use.
- Mr. Floyd Q.C. did not put anticipation by use in the forefront of his argument. His main submission was based on disclosure in the terfenadine specification. Mr. Alastair Wilson Q.C., who appeared for Perm Pharmaceuticals Ltd. and Generics (UK) Ltd., the respondents in the second appeal, did not argue anticipation by use at all. I nevertheless propose to deal with it first, because I think that the discussion may illuminate the issues which arise on the alternative argument.
- It is important to notice that anticipation by use relies solely upon the fact that the volunteers in the clinical trials took terfenadine and therefore made the acid metabolite. There is no suggestion in the Agreed Statement of Facts and Issues that the volunteers were also at liberty to analyse the terfenadine to discover its composition. If it was open to them to have done so, they would have been in the same position as if they had read the terfenadine specification and the arguments for anticipation by use would have been the same as for anticipation by disclosure. If anticipation by use is to be treated as a separate argument, it must be assumed that the volunteers were given terfenadine capsules by employees of Merrell Dow for the sole purpose of swallowing them. They took them without knowing their composition and produced within themselves a substance which was not then readily capable of being identified but is now known to have been the acid metabolite.
(a) The Old Law
- I think that there can be no doubt that under the Patents Act 1949, uninformative use of the kind I have described would have invalidated the patent. One of the grounds for revocation in section 32(1) was (e): “the invention … is not new having regard to what was known or used, before the priority date of the claim, in the United Kingdom.” (Emphasis added) Ground 32(1)(I) was that before the priority date the invention was “secretly used” in the United Kingdom. In Bristol-Myers Co. (Johnson’s) Application  R.P.C. 127 this House decided that use included secret or otherwise uninformative use. (I distinguish between secret and uninformative use because the House decided by a majority that “secret” meant that information about the invention had been deliberately concealed. It did not include a case in which the manufacturer was also unaware of the relevant facts.) Bristol-Meyers had applied for a patent with a product claim for an ampicillin compound which was found to be more stable than alternative forms. Beechams were able to show, from samples providentially retained, that before the priority date they had made some quantities of that particular compound, although at the time they did not know or care which ampicillin compound it was and were unaware of the advantages discovered by Bristol-Myers. Furthermore, they had marketed the ampicillin in a form which made it impossible to discover what the original compound had been. Thus the anticipation upon which Beechams relied conveyed no relevant information about the product to the general public. The compound in the hands of the reasonably skilled member of the public told him nothing about its distinctive chemical form or how he could make it or what the advantages of that form would be. Nevertheless, the compound was anticipated by use.
- The reasoning of the House was founded upon two principles of the old U.K. patent law. The first, to which I have already referred, was that the Crown could not grant a patent which would enable the patentee to stop another trader from doing what he had done before. It did not matter that he had been doing it secretly or otherwise uninformatively. The second was that the test for anticipation before the priority date was in this respect coextensive with the test for infringement afterwards. If the use would have been an infringement afterwards, it must have been an anticipation before. For the purposes of infringement, it was not necessary that the defendant should have realised that he was doing an infringing act. Such knowledge was therefore equally unnecessary for anticipation.
(b) The New Law
- Mr Floyd submitted that Bristol-Myers Co. (Johnson’s) Application  R.P.C. 127 was still good law. In section 2(2), the state of the art comprised “all matter,” which could be “a product, a process, information about either, or anything else” which had been “made available to the public” in any way, including by “use.” Mr. Floyd said that “all matter” must include products or processes which conveyed no information about themselves.
- Otherwise, why make separate mention of “information about either”? The product itself therefore counted as part of the state of the art and could be made available to the public by use. Thus the acid metabolite had been made available to the public by use, even though such use conveyed no information to the public about the nature of the product or how to make it.
- I think that this argument, which in any event depends upon a rather refined inclusio unius construction of the parenthetical expansion of the words “all matter,” dissolves completely when one looks, as one must, at Article 54. This provision makes it clear that to be part of the state of the art, the invention must have been made available to the public. An invention is a piece of information. Making matter available to the public within the meaning of section 2(2) therefore requires the communication of information. The use of a product makes the invention part of the state of the art only so far as that use makes available the necessary information.
- The 1977 Act therefore introduced a substantial qualification into the old principle that a patent cannot be used to stop someone doing what he has done before. If the previous use was secret or uninformative, then subject to section 64, it can. Likewise, a gap has opened between the tests for infringement and anticipation. Acts done secretly or without knowledge of the relevant facts, which would amount to infringements after the grant of the patent, will not count as anticipations before.
- This construction of section 2(2) is supported by a number of authorities both in the courts of this country and the EPO. I shall refer to only two. In PLG Research Ltd. v. Ardon International Ltd.  F.S.R. 197, 225, Aldous J. said:
“Mr. Thorley submitted that if a product had been made available to the public, it was not possible thereafter to patent the product whether claimed as a product claim or a product-by-process claim. That submission is too broad. Under the 1977 Act, patents may be granted for an invention covering a product that has been put on the market provided the product does not provide an enabling disclosure of the invention claimed. In most cases, prior sale of the product will make available information as to its contents and its method of manufacture, but it is possible to imagine circumstances where that will not happen. In such cases a subsequent patent may be obtained and the only safeguard given to the public is section 64 of the Act.”
“[T]he Enlarged Board would emphasise that under Article 54(2) EPC the question to be decided is what has been ‘made available’ to the public: the question is not what may have been ‘inherent’ in what was made available (by a prior written description, or in what has previously been used (prior use), for example). Under the EPC, a hidden or secret use, because it has not been made available to the public, is not a ground of objection to [the] validity of a European patent. In this respect, the provisions of the EPC may differ from the previous national laws of some Contracting States, and even from the current national laws of some non-Contracting States. Thus, the question of ‘inherency’ does not arise as such under Article 54. Any vested right derived from prior use of an invention is a matter for national law …”
9. Anticipation by disclosure
- I turn therefore to the ground upon which the respondents succeeded before Aldous J. and the Court of Appeal, namely that the disclosure in the terfenadine specification had made the invention part of the state of the art. This is different from the argument on anticipation by use because it relies not upon the mere use of the product by members of the public but upon the communication of information. The question is whether the specification conveyed sufficient information to enable the skilled reader to work the invention.
- Mr. Thorley says that no one can know about something which he does not know exists. It follows that if he does not know that the product exists, he cannot know how to work an invention for making that product in any form. The prior art contained in the terfenadine specification gave no indication that it would have the effect of creating the acid metabolite in the human body. Therefore it did not contain sufficient information to enable the skilled reader to make the substance in that or any other form. It did not make the acid metabolite available to the public.
- What does Mr. Thorley mean when he says that no one knew that the acid metabolite existed? What Merrell Dow’s research revealed was that something was created in the liver which could be given a chemical description. But the same thing may be known under one description and not known under another. For example, the inhabitants of a village may know the elderly gentleman of military bearing as a prize-winning rose grower without knowing that he had won the VC in the war. In answer to the question: “Do you know the holder of the VC in your village?” they would truthfully answer “I did not know that such a person existed.”
- There is an infinite variety of descriptions under which the same thing may be known. Things may be described according what they look like, how they are made, what they do and in many other ways. Under what description must it be known in order to justify the statement that one knows that it exists? This depends entirely upon the purpose for which the question is being asked. Let me elaborate upon an example which was mentioned in argument. The Amazonian Indians have known for centuries that cinchona bark can be used to treat malarial and other fevers. They used it in the form of powdered bark. In 1820, French scientists discovered that the active ingredient, an alkaloid called quinine, could be extracted and used more effectively in the form of sulphate of quinine. In 1944, the structure of the alkaloid molecule (C20H24N2O2) was discovered. This meant that the substance could be synthesised.
- Imagine a scientist telling an Amazonian Indian about the discoveries of 1820 and 1944. He says: “We have found that the reason why the bark is good for fevers is that it contains an alkaloid with a rather complicated chemical structure which reacts with the red corpuscles in the bloodstream. It is called quinine.” The Indian replies: “That is very interesting. In my tribe, we call it the magic spirit of the bark.” Does the Indian know about quinine? My Lords, under the description of a quality of the bark which makes it useful for treating fevers, he obviously does. I do not think it matters that he chooses to label it in animistic rather than chemical terms. He knows that the bark has a quality which makes it good for fever and that is one description of quinine.
- On the other hand, in a different context, the Amazonian Indian would not know about quinine. If shown pills of quinine sulphate, he would not associate them with the cinchona bark. He does not know quinine under the description of a substance in the form of pills. And he certainly would not know about the artificially synthesised alkaloid.
- I recognise that there is a distinction between cinchona bark and terfenadine. The former is a substance occurring in nature and the latter is an artificial product. This might have been relevant if the medicinal qualities of the bark had been unknown and a person who discovered them had tried to patent the bark or the natural alkaloid. But the distinction is not material to the present question, which is essentially an epistemological one: what does it mean to know something, so that it can be part of the state of the art? The quinine example shows that there are descriptions under which something may in a relevant sense be known without anyone being aware of its chemical composition or even that it has an identifiable molecular structure. This proposition is unaffected by whether the substance is natural or artificial.
- So far I have been considering what it means to know about something in ordinary everyday life. Do the same principles apply in the law of patents? Or does patent law have a specialised epistemology of its own? Mr. Thorley argues that it does. He says that for a substance to be known so as to be part of the state of the art within the meaning of section 2, it must be known (or be readily capable of being known) by its chemical composition. No other description will do. He says that by 1977 the science of chemistry had advanced so far that the chemical composition of virtually everything was either known or readily ascertainable by analysis. Therefore the legislature assumed that knowledge that something existed could safely be equated with knowledge of its chemical composition. Section 64 would provide a safety net for people like Amazonian Indians who were doing things with substances which did not readily yield to analysis.
- My Lords, I think that on this point the Patents Act 1977 is perfectly clear. Section 2(2) does not purport to confine the state of the art about products to knowledge of their chemical composition. It is the invention which must be new and which must therefore not be part of the state of the art. It is therefore part of the state of the art if the information which has been disclosed enables the public to know the product under a description sufficient to work the invention.
- For most of the purposes of a product claim, knowledge of its chemical composition will be necessary to enable the public to work the invention. It is something they will need to know in order to be able to make it. So in Decision GOl/92 Availability to the Public  EPOR 241 the President of the EPO referred to the Enlarged Board of Appeal the question of the circumstances in which making a product available to the public would count as making available its chemical composition. The Board answered that the composition or internal structure of a product become part of the state of the art if it is possible for a skilled person to discover it and reproduce it without undue burden. Mr. Thorley took this case to mean that in no context can a product be part of the state of the art unless its chemical composition is readily discoverable. But that is not what the case says. The Board was asked about the circumstances in which the chemical composition of a product becomes part of the state of the art. It was not asked about the circumstances in which knowing its chemical composition was necessary for the purpose of treating the product as part of the state of the art.
- Other decisions of the EPO seem to me to make it clear that, at least for some purposes, products need not be known under their chemical description in order to be part of the state of the art. In Decision T12/81 BAYER/Diastereomers [1979-85] EPOR Vol. B. 308, 312, the Technical Board of Appeal said:
“… [T]he concept of novelty must not be given such a narrow interpretation that only what has already been described in the same terms is prejudicial to it. The purpose of Art. 54(1) EPC is to prevent the state of the art being patented again. Art. 54(2) EPC defines the state of the art as comprising everything made available to the public before the date of filing in any way, including by written description. There are many ways of describing a substance in chemistry and this is usually done by giving its precise scientific designation. But the latter is not always available on the date of filing . . . [It] is the practice of a number of patent offices to accept the process parameter, in the form of a product-by-process claim, for closer characterisation of inventions relating to chemical substances. To the Board’s knowledge this is also the practice at the European Patent Office. If inventions relating to chemical substances defined by claims of this kind are patented, it necessarily follows that the resulting patent documents, once they enter the state of the art, will be prejudicial to the novelty of applications claiming the same substance although in a different and perhaps more closely defined form.”
- In other words, if the recipe which inevitably produces the substance is part of the state of the art, so is the substance as made by that recipe. Decision T303/86 CPC/Flavour Concentrates  2 EPOR 95 was a case about actual recipes for cooking. The application was to patent a process for making flavour concentrates from vegetable or animal substances by extraction with fat solvents under pressure in the presence of water. The claim specified certain parameters for the ratio between the vapour pressure of the water in the meat or vegetables and the vapour pressure of the free water. Opposition was based upon two cook-book recipes for pressure-frying chickens and making stews which in non-technical terms disclosed processes having the same effect. The Technical Board of Appeal said (at p. 98):
“It is sufficient to destroy the novelty of the claimed process that this process and the known process are identical with respect to starting material and reaction conditions since processes identical in these features must inevitably yield identical products.”
- Furthermore, it did not matter that the cook did not realise that he was not only frying a chicken, but also making a “flavour concentrate” in the surplus oil. It was enough, as the Board said, that “some flavour of the fried chicken is extracted into the oil during the frying process even if this is not the desired result of that process.”
- Mr Thorley said that CPC/Flavour Concentrates can be explained on the ground that the flavour concentrates as made according to the cooking recipes could have been analysed and chemically identified. Perhaps they could. But this was not the ground for the Board’s decision. It proceeded on the basis that for the purpose of being part of the state of the art, a process for making flavour concentrates was sufficiently described by a recipe for cooking food which did not expressly refer to the flavour concentrates but would inevitably have the effect of making them.
- In this case, knowledge of the acid metabolite was in my view made available to the public by the terfenadine specification under the description “a part of the chemical reaction in the human body produced by the ingestion of terfenadine and having an anti-histamine effect.” Was this description sufficient to make the product part of the state of the art? For many purposes, obviously not. It would not enable anyone to work the invention in the form of isolating or synthesising the acid metabolite. But for the purpose of working the invention by making the acid metabolite in the body by ingesting terfenadine, I think it plainly was. It enabled the public to work the invention by making the acid metabolite in their livers. The fact that they would not have been able to describe the chemical reaction in these terms does mean that they were not working the invention. Whether or not a person is working a product invention is an objective fact independent of what he knows or thinks about what he is doing. (The position may be different when the invention is a use for a product; in such a case, a person may only be working the invention when he is using it for the patented purpose: see the discussion of the MOBIL case in the next section). The Amazonian Indian who treats himself with powdered bark for fever is using quinine, even if he thinks that the reason why the treatment is effective is that the tree is favoured by the Gods. The teachings of his traditional medicine contain enough information to enable him to do exactly what a scientist in the forest would have done if he wanted to treat a fever but had no supplies of quinine sulphate. The volunteers in the clinical trials who took terfenadine were doing exactly what they would have done if they had attended Merrell Dow’s Strasbourg symposium and decided to try making the acid metabolite in their livers by ingesting terfenadine.
- It may be helpful at this point to highlight the similarities and the distinctions between the case for anticipation by use, which I have rejected, and the case for anticipation by disclosure, which I have accepted. In both cases no one was aware that the acid metabolite was being made. In the case of anticipation by use, however, the acts relied upon conveyed no information which would have enabled anyone work the invention, i.e. to make the acid metabolite. The anticipation in this form relies solely upon the fact that the acid metabolite was made, as the anticipation in Bristol-Myers Co. (Johnson’s) Application  R.P.C. 127 relied solely upon the fact that ampicillin trihydrate had been made and sold to the public. It disavows any reliance upon extraneous information, such as the formula for making terfenadine and the instructions to take it for its anti-histamine effect. Anticipation by disclosure, on the other hand, relies upon the communication to the public of information which enables it to do an act having the inevitable consequence of making the acid metabolite. The terfenadine specification teaches that the ingestion of terfenadine will produce a chemical reaction in the body and for the purposes of working the invention in this form, this is a sufficient description of the making of the acid metabolite. Under that description the acid metabolite was part of the state of the art.
10. The MOBIL case.
- Mr. Thorley claimed support from the decision of the Enlarged Board of Appeal, to which I have already referred, in Decision G02/88 MOBIL/Friction reducing additive  EPOR 73. Mobil had attempted to patent a substance for use as a friction reducing additive in lubricating oil. This was opposed by Chevron, who were able to show that the substance was already known and in use for inhibiting rust-formation in ferrous metal. There was no dispute that this put an end to the product claim, which would have entitled Mobil to a monopoly of the product for every possible use. But Mobil then applied to amend the application to restrict it to the use of the substance for reducing friction, saying that its usefulness for this purpose had not been previously appreciated. The Technical Board of Appeal, hearing an appeal by Mobil from a successful opposition by Chevron, referred three questions to the Enlarged Board of Appeal, of which the third was:
“Is a claim to the use of a compound for a particular non-medical purpose novel for the purpose of Art 54 EPC, having regard to a prior publication which discloses the use of that compound for a different non-medical purpose, so that the only novel feature in the claim is the purpose for which the compound is used?”
(The reference to “non-medical” purpose is because patents for a second use of medical products give rise to certain special problems under the EPC. It can for present purposes be ignored.)
- The Enlarged Board accepted Chevron’s submission that while using an old substance in a new way to achieve a new purpose might be novel, the use of an old substance in an old way to achieve a new purpose would not. In the latter case, the only difference would lie in the mind of the user: he would be doing the same thing with the same substance but with a different purpose in mind. One might expect this to lead to the conclusion that if the additive was the same and it was being used in the same way (e.g. by pouring it into the engine) then an attempt to patent its use as a friction reducer when it was previously thought only to inhibit rust should fail.
- The Board went on to say, however, that a claim for the use of an old compound in an old way for a new purpose (B) could be interpreted to include “the function of achieving purpose B (because this is the technical result).” In such case, the fact that the substance achieved that purpose would be an objective “functional technical feature” of the invention, not residing only in the mind of the user. Thus the fact that the substance did reduce friction was a new technical feature which, if novel, could constitute a patentable invention.
- I think it is fair to say that, in the United Kingdom at least, this aspect of the Board’s decision has been criticised on the ground that a patent for an old product used in an old way for a new purpose makes it difficult to apply the traditional U.K. doctrine of infringement. Liability for infringement is, as I have said, absolute. It depends upon whether the act in question falls within the claims and pays no attention to the alleged infringer’s state of mind. But this doctrine may be difficult to apply to a patent for the use of a known substance in a known way for a new purpose. How does one tell whether the person putting the additive into his engine is legitimately using it to inhibit rust or infringing by using it to reduce friction? In this appeal, however, we are not concerned with this aspect of the case. The part upon which Mr Thorley relies is the decision that the claimed technical feature, i.e. the friction reducing quality, was novel even though it was ‘inherent’ in the substance. The Board said, in a passage which I have already quoted:
“… under Article 54(2) EPC the question to be decided is what has been ‘made available’ to the public: the question is not what may have been ‘inherent’ in what was made available (by a prior written description, or in what has previously been used (prior use), for example). Under the EPC, a hidden or secret use, because it has not been made available to the public, is not a ground of objection to [the] validity of a European patent.”
- My Lords, I do not think that this principle is in issue in this appeal. I have accepted it fully in the discussion of anticipation by use, in which the above passage has already been quoted. It was applied by the Technical Board of Appeal to the facts of MOBIL/Friction reducing additive when that case went back to the Technical Board of Appeal after the decision in principle by the Enlarged Board: see  EPOR 514. The Technical Board decided that so far as friction reduction had been an inevitable concomitant of the use of the additive for other purposes, it was a case of uninformative use like Bristol-Myers Co. (Johnson’s) Application  R.P.C. 127. Or to put the same thing in another way, a description of the product by its chemical composition or as “something in the lubricating oil which inhibits rust formation” or any other of the descriptions under which it was previously known would not enable anyone to use it for the purpose of reducing friction, even though this would be the inevitable consequence of doing so. It did not therefore prevent the invention in the form sanctioned by the Enlarged Board from being novel.
- But the argument in this appeal for anticipation by disclosure involves no “doctrine of inherency.” It does not claim that the acid metabolite must be deemed to have been made available by the teachings of the terfenadine patent even though all information about it remained hidden. It claims instead that the acid metabolite was sufficiently disclosed under the description “an anti-histamine chemical reaction in the human body which occurs after taking terfenadine.” The respondents say that for the purposes of the particular invention in issue, the specification contained sufficient information about the acid metabolite to make it part of the state of the art. For the reasons I have given, I think it did. I would therefore dismiss the appeal.
Merrell Dow Pharmaceuticals Inc. and others (Appellants)
Upon Report from the Appellate Committee to whom was referred the Cause Merrell Dow Pharmaceuticals Inc. and others against H.N. Norton & Co. Limited and one other action, That the Committee had heard Counsel as well on Monday the 19th as on Tuesday the 20th, Wednesday the 21st, Thursday the 22nd, Monday the 26th, Tuesday the 27th and Wednesday the 28th days of June last upon the Petition and Appeal of Merrell Dow Pharmaceuticals Inc. of 2110 E. Galbraith Road, Cincinnati, Ohio 45215-6300, USA and Marion Merrell Dow Limited of Lakeside House, Stockley Park, Uxbridge, Middlesex UB11 1BE, praying that the matter of the Order set forth in the Schedule thereto, namely an Order of Her Majesty’s Court of Appeal of the 16th day of February 1994, might be reviewed before Her Majesty the Queen in Her Court of Parliament and that the said Order might be reversed, varied or altered or that the Petitioners might have such other relief in the premises as to Her Majesty the Queen in Her Court of Parliament might seem meet; as upon the cases of H.N. Norton & Co. Limited, and Penn Pharmaceuticals Limited and Generics (UK) Limited, lodged in answer to the said Appeal; and due consideration had this day of what was offered on either side in this Cause:
It is Ordered and Adjudged, by the Lord Spiritual and Temporal in the Court of Parliament of Her Majesty the Queen assembled, That the said Order of Her Majesty’s Court of Appeal of the 16th day of February 1994 complained of in the said Appeal be, and the same is hereby, Affirmed and that the said Petition and Appeal be, and the same is hereby, dismissed this House: And it is further Ordered, That the Appellants do pay or cause to be paid to the said Respondents the Costs incurred by them in respect of the said Appeal to this House, the amount thereof to be certified by the Clerk of the Parliaments if not agreed between the parties.