Before getting into the criteria for patentability, which define the subject matter of patent protection, it is worth spending time considering some concepts which arise in patent law. They are, perhaps, a little idiosyncratic – but I am very keen to ensure you have a good grasp of the terminology.
Patents are granted for inventions that satisfy the criteria set out in the legislation. They must be novel, inventive, capable of industrial application and not specifically denied protection by the legislation. They may be in any field of technology, following an amendment made in the Patents Act 2004 before which biotechnology inventions were largely excluded. The Act does not, however, define an invention: the important concept, however, is that of a patentable invention, the meaning of which is clear enough from the Act.
In Hickton's Patent Syndicate v Patents & Machine Improvements Co Ltd,1 Fletcher Moulton LJ said:-
In my opinion invention may lie in the idea and it may lie in the way in which it is carried out, and it may lie in the combination of the two; but if there is invention in the idea plus the way of carrying it out, then it is good subject matter for letters patent.
It is not clear whether there is a separate requirement for an application to disclose an invention before a patent can be granted,2 or whether it is only necessary to meet the requirements for patentability. The cases in the English courts in which a separate requirement for an invention has been imposed have all been in the rarefied field of recombinent DNA. In Genentech Inc’s Patent3 Mustill LJ said that it was an essential requirement that ‘must be satisfied before a patent can properly be granted … that the applicant has made an “invention”’. On the other hand, an invention could be said to result from meeting the criteria for patentability.4 In Biogen v Medeva5 Lord Hoffmann and Lord Mustill disagreed about whether it was necessary to identify an invention, the former saying:
The Act does not define the concept of an invention. Section 1(1) was intended to reflect, ‘as nearly as practicable,’ Article 52 of the European Patent Convention: see section 130(7) of the 1977 Act. Article 52 also has no definition of an invention. It seems that the parties to the EPC were unable to agree upon one: see Singer and Singer, The European Patent Convention (English edn. 1995 by Ralph Lunzer), para. 52.04). But the reason why the parties were content to do without a definition was that they recognised that the question would almost invariably be academic. The four conditions in section 1(1) do a great deal more than restrict the class of ‘inventions’ which may be patented. They probably also contain every element of the concept of an invention in ordinary speech. I say probably, because in the absence of a definition one cannot say with certainty that one might not come across something which satisfied all the conditions but could not be described as an invention. But the draftsmen of the Convention and the Act, as well as counsel at the bar, were unable to think of any examples. Just in case one should appear, section 1(5) gives the Secretary of State power to vary the list of matters excluded by paragraph (d) to ‘for the purpose of maintaining them in conformity with developments in science and technology.’
As the four conditions are relatively familiar ground, elucidated by definitions in the Act and the jurisprudence of the courts and the EPO, it will normally be more convenient to start by deciding whether they are satisfied. In virtually every case this will be the end of the inquiry. There may one day be a case in which it is necessary to decide whether something which satisfies the conditions can be called an invention, but that question can wait until it arises.
One can of course imagine cases in which the alleged subject-matter is so obviously not an invention that it is tempting to take an axe to the problem by dismissing the claim without inquiring too closely into which of the conditions has not been satisfied. So in Genentech Inc's Patent6 Mustill L.J. said, by reference to the ordinary speech meaning of ‘invention’:
‘You cannot invent water, although you certainly can invent ways in which it may be
distilled or synthesised.’
This is obviously right and in such a case it may seem pedantic to say that water fails the condition in paragraph (a) of section 1(1) because it is not new. Unfortunately, most cases which come before the courts are more difficult. Judges would therefore be well advised to put on one side their intuitive sense of what constitutes an invention until they have considered the questions of novelty, inventiveness and so forth. In the present case, I think that Medeva's counsel was right to resist the invitation of the Court of Appeal to make submissions on whether the claims constituted an invention.
Lord Mustill might have felt it necessary to explain his earlier judgment. He said ‘in concurring with all your Lordships in the reasons for dismissing the appeal I should not be taken to accept, without full argument, that the need for an invention would always be academic, or that no such need is expressed by the words of section 1(1): nor indeed do I understand my noble and learned friend as advancing any conclusion to that effect. Certainly, in the great majority of cases, there will be no need to complicate the enquiry by looking outside the four conditions. The traditional law of patents is, however, in the course of adapting itself to new technologies, beyond contemplation when the foundations of that law were established. This process is not without strain, and I believe that in some instances a close conceptual analysis of the nature of patentability will not be a waste of time. Such a case was Genentech Inc.'s Patent where the claim was for a product already existing in nature, a subject far distant from the mechanical and chemical inventions to which so much of traditional patent law relates. There may well be others in the future.’
Recent EPO case law regards the requirement for an invention as a separate element, supported by the wording of Articles 52 and 53 (original and amended (EPC2000) versions). The EPO has unhelpfully refused to define what an invention is, but it has (more helpfully, but still not very) told us that the definition is very broad. Its view is that there has to be an invention before you can proceed to consider novelty. In identifying whether an invention is present, the EPO looks for technical character:7 there must be a ‘concrete apparatus in the sense of a physical entity, man-made for a utilitarian purpose’. Theories, mathematical methods or economic calculations are entirely abstract and cannot be considered inventions.8
The requirement for a technical character is reinforced by the exclusions from patentability in section 1(2), on which see paragraph 7.5.1 below.
It may be helpful – up to a point – to consider an invention as a technical solution to a technical problem. A technical effect must be present: for example, in one case the Technical Board of Appeal of the European Patent Office considered that the claimed method of allowing plastic cards to be read by any machine was part of a business operation as such and therefore unpatentable9.
The invention may take the form of a process or a product. The nature of the invention is determined by construing the claims in the patent – the part of the documentation that describe the legal monopoly – as interpreted by the description of the invention.10 Sometimes (and this often happens with pharmaceutical patents, where the product and the process by which it is made are closely related) the claims present the invention as a product and, subsequently, as a process. But a patent is limited to a single inventive concept, so if a class of products is claimed there might be a problem.11
The law often resorts to hypothetical characters. The reasonable person, and his or her ancestor the man on the Clapham omnibus, brings an objective perspective to many areas of law. The officious bystander helps judges decide what is in a contract that the parties omitted to record. The skilled person, or ‘the person skilled in the art’, or (when called upon to read patent documents) the ‘skilled addressee’, like their American cousin the person having ordinary skill in the art (such a mouthful as to require reduction to the ugly acronym PHOSITA) brings to patent law the knowledge (‘common general knowledge’) of an ordinary, unimaginative practitioner of whatever field of technology he or she inhabits, providing an important objective viewpoint to issues in patent law.
A student of patent law will encounter the skilled person in several places. Their knowledge determines whether something forms part of the state of the art, for novelty purposes. He or she is the judge (or rather jury) who decides whether an alleged invention is obvious. First, section 3 of the Patents Act 1977 (identical to Article 56 of the EPC) states:
An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (disregarding 2(3) above).
In what was for many years the most authoritative statement of how to apply the obviousness test in section 3, that set out by Oliver LJ (as he then was) in Windsurfing International v Tabur Marine (GB) Ltd.12, the skilled person is not just the most important role in the drama: the part has to be played by the judge.
There are, we think, four steps which require to be taken in answering the jury question. The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question. The third step is to identify what, if any, differences exist between the matter cited as being ‘known or used’ and the alleged invention. Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those difference constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.
The skilled person is also the reader for whose benefit the specification of a patent is written: Section 14(3) requires that:
The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.
(Article 83 EPC differs only in that it uses the words ‘carried out’ in place of ‘performed’.)
The sufficiency of a patent specification will be measured against the skilled person’s understanding of it, and if it does not disclose the invention in enough detail it will not be granted13 or, if it slips through, be liable to be revoked.14 The skilled person will also decide whether an invention is new, given what is already in the state of the art (Synthon v Beecham15), whether the patent has been amended in a way that is impermissible, making it invalid (an amendment, entirely logically, cannot make the patent wider than it was when filed, because to do so would give too early a date to the start of protection for the added matter), and whether it can be applied industrially (Eli Lilly v Human Genome S16).
Finally, as the addressee of the specification, the skilled person is also called upon to assist in the interpretation of the claims which form part of that specification. Although the legislation does not mention the skilled person in this context, the courts certainly do. His or her reading of the claims has been important since the House of Lords adopted a purposive approach to interpretation in Catnic Components v Hill & Smith Ltd.17
The skilled person may, as Jacob LJ pointed out in Leo v Sandoz18 be a team of people. In Dyson, the relevant qualifications were in mechanical or electrical engineering, and the skilled person was probably a team covering both. Such was the novelty of the Dyson patent that an expert in cyclonic airflows would not have been included. In Schlumberger Holdings Ltd v Electromagnetic Geoservices AS19 only a team could combine the necessary disciplines, and the question focussed on whether it would be obvious to assemble a strange bunch of experts. Where the technology is ground-breaking, the court decided, the skilled addressee will learn from the specification of the patent, so his or her characteristics may be different for different issues.
Even if the skilled person acts alone, he or she may still consult others. In Vericore Ltd v Vetripharm Ltd20, which concerned chemicals to treat sea-lice in fish, the skilled addressee would be either a toxicologist or an expert in fish health, and whichever played the main role they would consult the other.
So who is this fictional person? His or her characteristics – their qualifications and experience – are for the court to determine in each case. Precisely what they are will vary according to the field of technology involved and how advanced the invention is. It is well-established that he or she is an unimaginative skilled technician with no inventive capacity but with common general knowledge and some knowledge of related matters from other fields of activity: Johns-Manville Corporation’s Patent.21 In Genentech Inc’s Patent22 Mustill and Purchas LJJ considered that the relevant person would be a highly qualified specialist possessing a degree of inventiveness. Dillon LJ, on the other hand, considered that they would lack inventive capacity and the weight of authority seems to support him. It is however true that the skilled person in one field – vacuum cleaners, say – may have very different qualifications and experience from the skilled person in another field – stereochemistry, for example. In Catnic it was a builder or builder’s merchant, to whom the defendant’s lintel was as good as the patentee’s: he or she would treat the rear support member as vertical for his or her purposes. In Dyson the skilled addressee was educated to HND or perhaps degree level. In Re Genetech’s (Human Growth Hormone) Patent23 the skilled addressee was a team of post-doctoral researchers expert in recombinant DNA. In Research in Motion v Inpro Licensing24 the skilled addressee was likely to have a master’s degree in information technology.
One problem with this artificial construct is that finding an unimaginative skilled technician can be a difficult matter. In Dyson v Hoover,25 the parties’ expert witnesses were skilled in the art of using cyclones to clean airstreams but not in vacuum cleaner technology. Vacuum cleaner technicians, at the relevant date, worked exclusively with bags and filters: they might have a scant knowledge of cyclone technology, but the invention would have gone far beyond this. Even Mr Dyson (Sir James, as he is now) himself would not have been the right person – his inventive capacity is clearly enormous.
Clearly, the skilled person is not going to be an exciting or interesting person, at least not in their working life. In Koninklijke Philips Electronics NV v Princo Digital26 the skilled addressee was described as ‘determined but prosaic.’ In Rockwater Ltd v Technip France SA (formerly Coflexip SA)27 Jacob LJ put the point rather differently:
It is settled that [the skilled person], if real, would be very boring – a nerd. Lord Reid put it this way in Technograph v Mills & Rockley : ‘... the hypothetical addressee is a skilled technician who is well acquainted with workshop technique and who has carefully read the relevant literature. He is supposed to have an unlimited capacity to assimilate the contents of, it may be, scores of specifications but to be incapable of a scintilla of invention. When dealing with obviousness, unlike novelty, it is permissible to make a ‘mosaic’ out of the relevant documents, but it must be a mosaic which can be put together by an unimaginative man with no inventive capacity.’28
The no-mosaic rule makes him also very forgetful. He reads all the prior art, but unless it forms part of his background technical knowledge, having read (or learnt about) one piece of prior art, he forgets it before reading the next unless it can form an uninventive mosaic or there is a sufficient cross-reference that it is justified to read the documents as one.
He does, on the other hand, have a very good background technical knowledge – the so-called common general knowledge. Our courts have long set a standard for this which is set out in the oft-quoted passage from General Tire v Firestone Tire & Rubber29 which in turn approves what was said by Luxmoore J in British Acoustic Films.30 For brevity I do not quote this in full – Luxmoore J’s happy phrase ‘common stock of knowledge’ conveys the flavour of what this notional man knows. Other countries within the European Patent Convention apply, so far as I understand matters, essentially the same standard.
The man can, in appropriate cases, be a team – an assembly of nerds of different basic skills, all unimaginative. But the skilled man is not a complete android, for it is also settled that he will share the common prejudices or conservatism which prevail in the art concerned. None of the above is controversial. However, sometimes the requirement that the skilled man be uninventive is used by counsel for a patentee in an attempt to downgrade or dismiss the evidence of an expert called to say that a patent is obvious - ‘my witness is more nerdlike than his’ is the general theme. I do not find this a helpful approach. It is frequently invoked and Mr Waugh QC invoked it in this case in an effort to downgrade Rockwater’s expert evidence on obviousness given by Professor Witz. Mr Waugh said his witness, Mr Nash was more appropriately qualified than Professor Witz, that the latter, because he had patents in his name ‘was of an inventive turn of mind.’
On the other hand, Lord Justice Pill took exception to Sir Robin’s use of the word ‘nerd’. In his very short judgment in the Rockwater case he said:
About the ‘man skilled in the art’, he is described by Jacob LJ as a ‘nerd’ (paragraphs 7 and 11) and as ‘not a complete android’ (paragraph 10), which suggests that he is part of the way to being an android. A ‘nerd’ is defined in the Concise Oxford Dictionary (10th Edition 1999) as ‘a person who lacks social skills or is boringly studious’ and an ‘android’, in the same work, as ‘(in science fiction) a robot with a human appearance’. I hope that those working in this field will not regard ‘men skilled in the art’ as figures from science fiction who lack social skills. Jacob LJ, will think me less than supportive of the development of the language of the law but I do respectfully prefer, for its clarity, Lord Reid’s terminology cited at paragraph 7 of the judgment.
More helpfully, perhaps, but certainly less entertainingly, in RIM v Inpro Licensing SARL31 the skilled addressee of a patent concerning hand-held devices for accessing the Internet held a PhD in information technology.
So the skilled person has access to all the prior art, however obscure, and is familiar with it. But is he actually aware of all the prior art, or is what he knows is based on what a diligent searcher would find? The diligent searcher would presumably uncover much that the ordinary skilled technician would never find. The answer is not clear from the cases.
There is another side to the skilled person’s knowledge. Not only does he or she know what is in the state of the art: they also hold the prejudices that are found in their field. The skilled person in Dyson, a vacuum cleaner technician, would have had a prejudice in favour of bags and filters.
Dyson was a case in which the invention was truly ground-breaking. In such cases, it is possible for the skilled person to learn from the very patent specification which is under consideration. In Schlumberger v Geoservices32 the court observed that the skilled addressee’s characteristics will therefore be diinvofferent for different issues in the case.
Finally, the skilled person will be invoked to help the court decide whether an invention is capable of industrial application: Eli Lilley Co v Human Genome Sciences.33
The skilled person is
… deemed to have looked at and read publicly-available documents and to know of public uses in the prior art. He understands all languages and dialects. He never misses the obvious or stumbles on the inventive. He has no private idiosyncratic preferences or dislikes. He never thinks laterally. He differs from all real people in one or more of these characteristics ...34
Although the skilled person possesses not an iota of inventiveness35, they do have an urge to improve on the prior art.36 They are expected to carry out experiments which are commercially not worthwhile37 and to have sufficient time, and the best equipment, to do the work, no matter how advanced the field of work might be.38
If the Act obliged us with a definition of an invention, it would surely tell us that an invention is something that is new – never seen before. And indeed the legislation says just that: to be patentable, section 2(1) tells us, an invention must not be part of the state of the art at the priority date. The concept of ‘state of the art’ is widely defined in section 2(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. [Emphasis added.]
A more all-embracing piece of drafting is hard to imagine. The parliamentary draftsman (following, but not slavishly, the wording of Article 54 of the European Patent Convention) has used five expressions (emphasised above) to ensure that nothing slips through the net. The definition attempts to embrace the sum of human knowledge, with only a very small number of exceptions. It includes all information made available to the public at the application date (or the priority date if the invention claims priority from an earlier application made within the previous year, as the Paris Convention allows) whether in published form or anticipated by an earlier invention, and also includes applications for patents unpublished at that date but published later even though they are not actually available to the public.39 This can result in some rough justice: the second applicant can have no way of knowing at the priority date of unpublished patent applications lurking in the system. In the U.S. system, it used to be even worse, as the ‘first to invent’ rule meant that the applicant may not be the person entitled to the patent, and filing an application could prompt an earlier inventor to come out of the woodwork claiming the rights to the patent on the basis of work done perhaps decades ago. This might appear hard on the second applicant., but any other arrangement would be hard on the first applicant and could result in double patenting, which should remain a logical impossibility.
However, no danger of double patenting arises if the earlier patent application has been withdrawn, even after publication. As it will not proceed to grant, the later application may be granted: Re Woolard’s Application.40
Patent law in the United States is somewhat different on this point. Unlike the European system, there no disclosure within 12 months preceding filing affects the novelty of the invention. In 2002 the UK Patent Office canvassed opinion on the introduction of such a ‘period of grace’, also floating a few other approaches, but so far nothing has been done following this consultation. It would certainly be a significant move by the UK away from established practice in Europe.
The U.S. system also lacks ‘early publication’ of the application, so the rest of the world is unaware of the applicant’s contribution to the state of the art until a patent is granted. These unpublished applications are known, for obvious reasons, as submarine patents.
The test for novelty is an objective one, and the test is administered through the eyes of the skilled addressee who plays such a large part in patent law. The place to look for novelty in a patent application is the claims: they are compared against the prior art to decide whether the invention is novel.
While the basic idea is easy enough, it is not usually the case that a piece of prior art clearly anticipates an invention. Questions of novelty can be tricky. The general test for novelty was set out long ago, before the 1977 Act, in General Tire and Rubber Co v Firestone Tyre and Rubber Co.41, though now the 2006 House of Lords case Synthon BV v SmithKline Beecham42 is the key authority. When assessing whether a prior publication anticipates the invention, General Tire tells us that the prior art must
Taking these requirements in turn:
Because the assessment is objective, if the prior art happens to fall within the scope of the later application it makes no difference that the earlier worker was unaware of the effect they may have created in the prior art.50 The prior art must be considered as it was at the time it was created, without regard to the later invention.
The invention will not be new if it is an inevitable consequence of carrying out a process which forms part of the state of the art.51
Under the EPC, the state of the art must anticipate all the technical features (or integers, as they are called) of the invention to a skilled person. Provided an invention has at least one different technical feature, it will be considered novel. The test under the Convention is whether technical features have been communicated to the public or laid open for inspection.52
An invention may, in the UK and under the EPC, be arrived at by combining the teaching of two or more documents. This does not however apply where one document refers to the other, and the skilled person would therefore read them together. This is what is referred to as ‘mosaicing’ and is more often encountered in the context of inventiveness (see below, section 7.3).
An earlier patent application that has been withdrawn, even after publication, does not form part of the state of the art. The earlier application will not proceed to grant, so in Re Woolard’s Application53 the High Court took the view that there was no danger of double patenting.
In Synthon Lord Hoffmann also explained that the information in the prior art must be accessible by any member of the public. It is the potential accessibility of the information that matters, not whether anyone has actually taken the trouble to find it and read it. All that is necessary for the information to be available to the public is that one person, unconstrained by confidentiality obligations, has it and can use it as he pleases.54 In PLG, Aldous J explained that the information must have been made available to one person who was free in law and equity to use it. Information obtained in breach of confidence does not destroy novelty. ***
In Catnic Components v C Evans & Co55 the question was whether the applicant’s invention was anticipated by an earlier one. The only people to whom the earlier invention (a new type of lintel) had been shown were under confidentiality obligations, so that did not amount to making it available to the public. The earlier inventor had only had a small section made up to his design, insufficient to use as a lintel. There was therefore no question of disclosure by use either.
Disclosure does not have to be widespread. In Fomento v Mentmore (supra) knowledge by a handful of people who were under no obligation of confidentiality was enough to invalidate a patent for a new method of making ballpoint pens. Pens embodying the claimed invention had been given to members of the public. In Windsurfing International v Tabur Marine (Great Britain) Limited56 a patent for a sailboard was anticipated by a 12 year old boy who had rigged up a board and used it on occasional weekends off Hayling Island.
Disclosure in circumstances of confidentiality or secret prior use does not amount to making available to the public. Professional advisers – lawyers and patent agents – are bound to treat information given to them by the inventor as confidential. Details can also be shown to interested parties under confidentiality agreements (often called ‘non-disclosure agreements’, though they must prohibit use as well as communication to another, and sometimes especially in the U.S. known as ‘Silicon Valley handshakes’), essential when seeking financial support or to interest a manufacturing company in exploiting it. Disclosures by exhibiting the invention anywhere in the world (other than at an approved trade exhibition), making public presentations, seeking press coverage and so forth should be avoided.
Delivering samples in confidence to people who knew they were secret and experimental did not prejudice the novelty of the invention.57
An invention may be ‘made available’ in several different ways: the Act mentions written and oral description, and use, adding ‘any other way’ to be on the safe side. So an invention could be disclosed in:
An invention may be made by finding a new use for something that already exists or is known (and therefore forms part of the state of the art). This commonly happens in the pharmaceuticals field: the second use might not form part of the state of the art.65 The inventor of the new use cannot claim exclusive rights in the thing itself, but ought to be able to claim the new use if it meets the requirements for patenting. The mere fact that the thing is in use may make the new use available and therefore part of the state of the art: secret use would not amount to a disclosure, but what about unwitting use? The invention may be in use, but non-one realises it, in which case the question is whether the use makes the invention available to the public.
There could be a disclosure of the invention where it is inherent in the prior use. In Merrell Dow v Norton (supra) the patentee of a drug found later that it worked by producing a substance in the liver, and patented this effect too. This gave it an extended period of patent protection. After the initial patent had expired, it sued the defendant for infringement by supplying the means to put the second patent into effect. The House of Lords held that the later patent was invalid, lacking novelty because the earlier patent taught how to make the drug and use it, and the production of the substance covered by the second patent was an inevitable consequence of working the first patent. However, this leaves open the possibility that where the inherent effect is neither taught by the earlier patent nor known by the public the later patent might be valid.
The English courts have been reluctant to hold patents valid where inherency is a problem. The EPO accepted in Mobil/Friction reducing additive 66 that novelty under Article 54 of the EPC is different from the test under earlier patent legislation and that inherency is not an absolute bar to patentability. A newly-found technical effect in a product (with dicta concerning processes) may not be available to the public: ultimately it would depend on the drafting of the claims and the extent to which the public could discover the effect by analysis. In Merrill Dow v Norton (supra) the House of Lords criticised this approach, but in Quantel v Spaceward Microsystems Ltd67 Falconer J followed it.
A different problem may arise where a product cannot be reverse engineered to reveal how it works. Only a disclosure that enables the public to have access to the invention will destroy novelty. 68
The novelty of an invention cannot be called into question by ‘mosaicing’ a number of items of prior art not in common general knowledge in order to show that the invention is anticipated.
Matter which has been obtained unlawfully or in breach of confidence, or which has been divulged in breach of confidence, is disregarded in considering the novelty of an invention (section 2(4)). Where a patent application is filed, there is a six month period during which no such disclosure will prejudice the application. An invention may also be displayed at an international exhibition during this period of grace.
The Act uses the concept of making available to the public (a concept with also appears in copyright law, with a somewhat different meaning69) but sometimes cases refer to disclosure and anticipation, which are different aspects of making available. An invention would be disclosed by a written or oral description: an earlier invention would be said to anticipate a later one, if the subject-matter was too close.
In addition to being novel, an invention must involve an inventive step. This requires non-obviousness to an unimaginative person skilled in the art, compared to what is already known. It might better be called an inventive leap – certainly the law is designed to ensure that it is more than just a small step. That hypothetical person must not only say ‘I’ve never seen that before’ but must add ‘and it’s brilliant’, or words to that effect: or at least must not add ‘but given what we already know it’s obvious.’
All matter forming part of the state of the art is to be taken into account, but not in this instance matters included in patent applications with earlier priority dates published after the invention’s priority date. As noted above, in Woven Plastic Products v British Ropes Ltd, the Court of Appeal held that a patent was invalid for want of inventiveness because of a Japanese petty patent application.
This requirement is not unrelated to the requirement of novelty. If an invention has already been disclosed it forms part of the prior art, and therefore (except in the special case of an earlier unpublished patent application) the invention cannot involve an inventive step. But the need for an inventive step goes further; even if the invention is new, it may be obvious, but no-one ever thought of it before.
The meaning of ‘obvious’ is not elaborated on in the Act. In the General Tire case, above, the Court thought it unnecessary to go further than the dictionary definition, and took it to mean ‘very plain’. The test for obviousness was laid down by the Court of Appeal in Windsurfing, a 1949 Act case, and has since been adapted to the language of the 1977 Act.70 In Pozzoli SpA v BDMO SA and Moulage Industriel de Perseigne SA71 - a fairly recent example among many cases – the Court of Appeal restated and elaborated the well-established test:
The test is an objective one. In the Pozzoli case, the Court of Appeal also addressed the situation where there was a technical prejudice against the invention: when an idea demonstrated that an established prejudice was unfounded, there could be a patentable invention, but where the patent merely covered an old idea that was thought not to work without explaining how or why it did in fact work, it could not be justified.
The skilled person comes equipped with what is referred to in the cases as ‘common general knowledge’. In General Tire,72 Sachs J described it as standard texts or material accepted without question by those in that line of work: but it does not include the patent literature, because that is simply not on the skilled addressee’s reading list. It is discussed in some detail in Benoit Technologies Inc. v. Valmet Paper Machinery Inc.73
The skilled addressee’s common general knowledge has been described in other ways in other cases:
Where the technology of the patent is particularly sophisticated, and the skilled addressee therefore relatively well-informed, common general knowledge may be worldwide77: otherwise, the skilled addressee is likely to only what is available locally.
The courts often warn against assuming that the skilled addressee has too high a level of knowledge. It is a very different concept from the state of the art: information may be known to some people in the field but not others. Just because it is available somewhere does not mean that the skilled addressee will have read it, and they will not all have the same access to the information.78 Common general knowledge is common and general to the average skilled person in the relevant field.
The skilled worker is assumed to read the prior art carefully, though lacking inventive capacity he may fail to realise the importance of some of it. He will attach different weight to different items, depending in part on how accessible it is.79
Where the problem has been identified the inventive step may reside in choosing the starting point from several alternatives. The selection and combination of particular features may constitute inventiveness.80 Inventiveness may be present if the skilled man finds something unexpected when pursuing another problem. It may also be that he selects a line of research with no problem in mind to begin with,81 although merely deciding to st off on a course of experiments to find a solution to a particular problem does not constitute an inventive step.82 Inventiveness may lie in just identifying the problem.83
Other useful tests that the courts have employed include:
In Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd89 the invention (a method for making printed circuit boards using silk screening) was not an immediate commercial success because manufacturers could sell all they wanted using old manufacturing techniques. The invention was not used for some years, but then it was highly successful.
However, in Tetra Molectric Ltd v Japan Imports Ltd90 the use of piezo-electric crystals to ignite a butane cigarette lighter was held to be obvious. The properties of the material had been known about for many years, and the mere fact that the cigarette lighter enjoyed considerable commercial success did not help. Moreover, the claims did not disclose anything which would have provided a commercially successful lighter: technical problems made it difficult to make a lighter using the technology, but the patent claims did not reveal the answer. Indeed, they disclosed several ways of making unsuccessful lighters. The court observed that failure to recognise an obvious solution to a problem could be because the problem had not been recognised, that there was no pressing need for a solution, or that other solutions were preferred.
Commercial success may also be attributed to other factors, such as advertising, appearance of the product, get-up, price or marketing.91
A second use of existing technology may satisfy the inventive step requirement (though novelty may be difficult to prove). In Parks Cramer v Thornton92 the patentee solved a long-standing problem concerning cleaning the floor between textile machines. The invention consisted basically of an overhead vacuum cleaner. In the High Court the Judge considered this obvious. The Court of Appeal overturned the first instance judgement, giving weight to the many unsuccessful attempts to solve the problem and to the immediate commercial success of the invention. In Re Pfizer Ltd.’s Patent93 the Court of Appeal upheld an application by Lilly and revoked a patent that had been granted over a second use of the drug Viagra. Given what was known about its properties, using it to treat impotence was obvious.
A collocation (where an invention brings together two known devices each of which performs its own normal function) does not constitute an invention. If however it gives rise to a synergy, or to unexpected results, there may be an inventive step94. The important case of SABAF v MFI and Meneghetti95 shows the distinction. The patent claimed a burner for gas cookers and hobs in which primary air for the burner was drawn from above the hob unit. A flow path under the flame spreader provided a Venturi effect. Each integer was known, although not in combination. Neither made the other function differently, and there was no combined effect – they both just carried on doing what they had always done. At first instance, Laddie J found the patent invalid as nothing more than a collocation of two obvious features. The Court of Appeal, applying the Windsurfing principles, reversed this decision, holding that there was no separate test for ‘collocation obviousness’ and that the Windsurfing approach would have led to a finding that there was an inventive step because of the combination of two features. In British Celanese v Cortaulds96, however, a lack of co-operation between the features had meant that there was no inventive step. The EPO Guidelines for Examination said much the same. In the House of Lords, Lord Hoffman took a slightly different approach. He said that the first step had to be to determine what the invention was – here, ‘were you dealing with one invention or two or more inventions?’. He went on: ‘Two inventions do not become one invention because they are included in the same hardware. A compact motor car may contain many inventions, each operating independently of each other but all designed to contribute to the overall goal of having a compact car. That does not make the car a single invention.’ Laddie J had held that he was dealing two separate inventions, neither of which was novel over the prior art. The patentee introduced a new counter-argument, that the invention was a true combination invention, but this was rejected on the facts.
Under the EPC, inventiveness may be achieved by combining the teaching of more than one document, but only where the combination would not be obvious to a skilled person. In opposition proceedings, the EPO will identify the document that represents the closest prior art and consider whether the invention is obvious compared to this. The Opposition Division of the EPO will first identify the technical problem solved by the invention. It will ask:
To answer the last point, the Opposition Division of the EPC will look for pointers in the prior art that direct the skilled person to the invention, and will consider whether there is a reasonable prospect of success. Other indications (such as long-felt want, commercial success) will also be considered.
Mosaicing may be done with prior art to establish that an invention is obvious, but the exercise begs the question, if this were obvious why was it not done before?
This requirement – formerly expressed, in the Patents Act 1949, as a requirement that an invention be a manner of manufacture – is quite easily satisfied, though note that it excludes methods of treatment (section 4(2), (3)). However, just because something (e.g. a new drug) is used in treatment does not make it unpatentable. Actual use in industry is not required. It is commonly stated in the textbooks that perpetual motion machines are therefore unpatentable.
The expression ‘industry’ must be understood in its broadest sense. It includes agriculture: indeed, almost any useful, practical activity is regarded as industry. There is no requirement that large-scale production is possible. Purely intellectual or aesthetic activities are not regarded as industry. The requirement is that the invention is made and used in any kind of industry: ‘industry does not exist to make that which is useless for any known purpose’.97
Public policy demands that medical practitioners and veterinary surgeons should not be constrained by other peoples’ patents when treating patients.98 Under the 1977 Act, methods of treatment themselves (including surgery, therapy and diagnostic methods) were therefore not considered capable of industrial application (section 4(2)) but just because a product is invented for use in a method of treatment did not stop it being patented. Section 2(6) specifically allows patents to be granted for first medical uses of substances, within a method of treatment. Second and subsequent uses of a pharmaceutical product may also be patented. Practice in the EPO (followed by the Patents Court) has long permitted claims to ‘the use of X in the preparation of a medicament for the treatment of Y’, known as the Swiss form99 but following the changes made by the Patents Act 2004 it is no longer necessary to use this technique and claims to new uses and methods will be permitted.100
There are two distinct groups of exclusions and exceptions to patentability set out in the EPC and in the Patents Act 1977. First, there are those items, listed in EPC Article 52(2) and s. 1(2), which are deemed unpatentable because they are not technical in nature. Second, there are inventions which do have technical effect, but which are denied protection on policy grounds. These are set out in EPC Article 53, together with the provisions in the Biotech Directive, and are incorporated into UK law by the Patents Ac 1977, s. 1(3), Schedule A2 and s. 4A (inserted by the Patents Act 2004).
Several abstract, non-technical things which may otherwise appear to be patentable are not regarded as inventions by virtue of s1(2), which reinforces the patent system’s aim of protecting technical effects rather than inchoate ideas. These are:
Note that the list is not exhaustive, so the courts may include other matters. Crucially, the exclusion applies to these matters as such, so (as we will see) a novel technical effect that lies outside the prohibited area may be patentable. In the third and fourth cases, there is often an interaction between an apparatus and the prohibited matter – for example, between a computer and a program. The important question is whether the end result is a novel and non-obvious technical effect, or whether the prohibited matter remains the predominant factor104. This gives indirect protection to the excluded subject-matter, and may apply even if the practical application of a discovery is inherent in the discovery itself or if it is obvious once the discovery has been made105. In the fields of computer programs (where a program may cause a computer- controlled machine to do something new) and biotechnological inventions (where a discovery may lead to the creation of a new pharmaceutical product) the courts have refined this basic proposition.
We will now consider these exclusions in turn in greater detail – some of them in very great detail.
7.5.1.1Discoveries, scientific theories or mathematical methods
These amount to abstract ideas. There is no applied technology. There is, however, a fine dividing line between a patent which claims a discovery and one which claims its practical application. In Chiron v Organon (No 12)106 the Court of Appeal held that although the identification of Hepatitis C amounted to a discovery, the patent was valid because what was claimed were testing kits which enabled doctors to identify whether someone had the disease (see also the views of Aldous LJ in Re Fujitsu's Application107).
7.5.1.2Aesthetic creations
Aesthetic creations, including for example architect's plans - E. & R's Application, 108 are excluded: they have no technical effect and their protection is best left to copyright.
7.5.1.3Methods of performing a mental act, etc.
This exclusion demonstrates neatly the technical contribution point in VICOM. In Raytheon’s Application109 patentability for an automated ship identification system was denied as the alleged invention merely mechanised a task previously done by the human eye, and in Merrill Lynch's Application110 an automated dealing system was held to be no different than the previous method of trading in securities. What constitute mental acts will be construed narrowly.111
7.5.1.4Computer programs
Copyright is almost universally regarded as the most appropriate means for protecting computer programs – but many inventions use computer programs in some way, and that should not necessarily disqualify them from being protected, so there is a difficult line to draw. They were not patentable under the 1949 Act because they were not a ‘manner of manufacture’ (the predecessor of the industrial application requirement of the 1977 Act) but they could form part of a machine or industrial process. The leading U.S. Supreme Court case of Diamond v Diehr112 established that if the operation of a programmed computer gives rise to a technical effect an application for a patent may succeed, and software patents (not a very accurate description) have become widespread since.
The present state of the law is highly confused and it is in more or less constant flux. The latest statement of the law is to be found in Court of Appeal’s judgments in Aerotel v. Telco; Macrossan’s Application 113 and in Symbian Ltd v Comptroller-General of Patents 114, but before considering that case we need to look back in time, to understand how the law has developed. Indeed, that case contains a review of the case law, both in the EPC and in the English courts, and identifies three distinct phases in the case law of the EPO. Whether the UK case law is compatible with the emerging approach of the EPO Boards of Appeal is an interesting question.
Phase 1 (1988-1999): ‘technical effect’
Following VICOM115, the EPO would ask whether a machine, as programmed, achieved a technical effect. During this period the English courts took the same approach. In a number of cases the patent was held to be invalid for lack of technical effect. In Merrill Lynch’s Application116 the invention was a ‘data processing system for making a trading market in at least one security in which the system proprietor is acting as principal.’ In Re Gale’s Application 117 it was a method of calculating square roots, stored on read-only memory. (The court held that the type of storage medium was not relevant, a statement which 26 years later seems quite unnecessary but which at the time was important.) In Re Fujitsu’s Application118 the claimed invention was a method for in silico modelling of crystelline structures: Aldous LJ’s specifically adopted the VICOM approach and his general observations about the need for a technical contribution.
One case in which the courts upheld the validity of a software patent was Quantel v Spaceward Microsystems119 which involved a computersied video graphics system.
Phase 2 (1999-2002): ‘technical character’
Following IBM/Computer programs120 only computer programs that amounted to abstract ideas, and lacked technical character, were excluded. If a program had a technical effect it would therefore be patentable. A computer program would have a technical character if it produced additional technical effects going beyond the normal physical interaction between software and hardware. In the IBM case the EPO expressed concern that the US and Japanese patent systems were more generous towards software patents than the European system: the UK Patent Office subsequently published a practice notice expressly adopting the criteria set out by the EPO in IBM.
Phase 3 (2002-): ‘any hardware’
In PBS PARTNERSHIP/Controlling pensions benefit system121 the EPO adopted the ‘any hardware’ approach: the apparatus used to run a program would be patentable, but the process that operated it would not. In the UK, Aerotel laid down a four-part test, which the IPO has adopted in spite of the fact that a Board of Appeal at the EPO has disapproved it, saying it is not compatible with the Convention:
The second step, that of identifying the contribution, was highlighted as being the most problematical since it may be difficult to determine what the contribution actually is.
The House of Lords refused leave to appeal in that case, so the Court of Appeal’s judgment remains the last word. In the Symbian case, the judge (Patten J) held that the Patent Office had been wrong to turn down the application, taking too narrow a view of the technical effect of the invention. The Patent Office announced that it would be continuing as before and appealing against this judgment.
The latest statement of the law is DUNS LICENSING ASSOCIATES/Estimating sales activity122 which asks, first, whether there is an invention (something tangible) and then considers whether it is new, inventive and capable of industrial application. The Board of Appeal’s judgment was critical of the UK’s approach in Aerotel.
Reference to the Enlarged Board
Meanwhile, in a referral dated 22 October 2008 under Article 112(1)(b) EPC (which applies where two or more Boards of Appeal have given conflicting rulings), the European Patent Office’s Enlarged Board of Appeal, a rarely-convened committee charged with considering the biggest questions of European patent law, was given the task of considering the state of the law on software patents – which, far from falling into line throughout the countries of the Convention, seemed to be getting more diverse. It gave its opinion on 12 May 2010,123 confirming that the ‘any hardware’ approach was still correct but actually formally (and rather unhelpfully) concluding that the referral was inadmissible because there was no conflict between decisions of Boards of Appeal.
TRIPS, Article 27
Abortive proposal for an EC directive on computer-implemented inventions
The Commission published its Proposal for a directive on the patentability of computer-implemented inventions on 20 February 2002124. Despite its subtlety and limited ambitions, being a harmonising rather than a reforming measure, the Directive attracted the opprobrium of opponents of extending IP protection for computer programs. The lobbying of the European Parliament was energetic, but progress on the Directive was made to the point where adoption was becoming a foreseeable event, when in December 2004 the Polish government insisted that the Commission be sent back to the drawing board. So it is likely to be some time before the Directive gets on to the statute book, if it ever does.
Had it become law, the exclusion for computer programs (in Article 52 of the EPC) would have been deleted, to the extent that a Directive could affect the content of the Convention. This was considered necessary, at least in part, to comply with Article 27 of TRIPS.
7.5.1.5The presentation of information.
This exclusion is much less exciting than some of the others, and has given rise to less case law. Examples of unsuccessful patents in this category include Re Townsend's Application125 (which concerned an attempt to patent an advent calendar) and Re Crawford’s Patent Application126 (which concerned a display system for buses). Remember, though, that the exclusion (like all those in s1(2)) applies only to the subject-matter as such, so a new apparatus for presenting information would not be excluded.
There are further exclusions on public policy grounds (contained in s.4), addressing the issue by stating that even if otherwise patentable, patents will not be granted for certain inventions. These are inventions encouraging offensive, immoral or antisocial behaviour (in former times, many years ago now, used to deny protection to contraceptives). Merely because an invention is illegal does not mean it is immoral. In Onco-Mouse/Harvard127 the EPO weighed the possible suffering to animals and environmental risks against the benefit to humankind.
The Patents Act was amended in 2000, implementing the directive on the legal protection of biotechnology inventions. Before the amendment, many biotechnology inventions were excluded from patentability. The unamended Act expressly excluded from patentability and invention comprising a variety of animal or plant or biological process (but not microbiological process). If the invention were a new animal or plant variety, it could not be patented.
The UK implemented the EC directive on the legal protection of biotechnology inventions (98/44/EC) in the Patents Regulations 2000128, which amend the Patents Act 1977. The regulations were approved on 28 July 2000 and their main features are:
Before the 2000 Regulations came into force, many biotechnology inventions were excluded from patentability. The Act, as it stood before the amendment, expressly excluded from patentability an invention comprising a variety of animal or plant or biological process (but NOT microbiological process). If the invention were a new animal or plant variety, it could not be patented. Microbiological processes were however patentable (see American Cyanamid Co (Dann’s) Patent129) as are their products. Genetically engineered plants and animals could be patented, as could naturally-occurring chemical codes and cellular substances – like genes or hormones – as long as they are isolated from the body by novel technical means, and a use is clearly specified for them.130 The distinctions are hard to draw, and developments in genetic engineering have rendered them rather meaningless. The result of genetic engineering may not be a new variety, as in Onco Mouse where the EPO granted the patent on the basis that the mouse was not a new variety of animal but a modified version of a known animal.
Plant varieties are protected under a separate regime: see the Plant Varieties and Seeds Act 1964 as amended by the Plant Varieties Act 1983, and the International Convention for the Protection of New Varieties of Plants.
The Patent Office has clarified the position on inventions involving human embryonic stem cells, which are not expressly mentioned in the legislation. In a Practice Note, the Office states that processes for obtaining stem cells from human embryos will not be patentable. Embryonic stem cells that have the potential to develop into an entire human being are not patentable because of the exclusion in the Act, as amended, but those that lack the potential to develop into an entire human being may give rise to patentable inventions.
The commercial exploitation of stem cells that lack the potential to develop into human beings is considered to be desirable because of the potential of such matter to deliver new treatments for diseases. The Patent Office takes the view that this takes this area outside the exclusion of inventions that are contrary to public policy or morality. Provided inventions meet the normal requirements of novelty and non-obviousness, patents can be granted for inventions involving these cells.
If the commercial exploitation of an invention would be contrary to public policy or morality, a patent will not be granted for it.131 Note carefully that this is not the same thing as saying that a patent will not be granted if the invention is contrary to public policy or morality. But just because the exploitation of an invention is against the law in the United Kingdom or any part of it, does not mean that it exploitation will be regarded as contrary to public policy or morality. Law, public policy and morality appear to be unconnected.
There is no case law on the provisions of the Patents Act. There have been challenges to European patents on the grounds of morality under Article 53(a) of the European Patent Convention: the EPO has taken a robust approach to challenges under this provision, taking the view that so long as as a claimed invention has a legitimate use it is not up to the EPO to enforce moral rules.
Just because an invention is controversial, that is not a bar to its patentability. The EPO has to balance the benefits to society against harm to living matter, but the owners is on those mounting the challenge who have to demonstrate conclusively commended hazards. Nevertheless, it remains the responsibility of regulatory authorities rather than the European patent office to deal with risks, and it is not for patent law to regulate research.132
One case in which the European patent office did decide that a patent should not be granted is WARF/stem cells.133 The invention involves the use of human embryonic stem cell cultures, and (by combining Article 53(a) with the Implementing Regulations derived from Article 6 (2) of the Biotechnology Directive, the Enlarged Board of Appeal concluded that a patent could not be granted for an invention which necessarily involve the use and destruction of human embryos. The patent itself was not contrary to public policy, but the performing of the invention was unacceptable. The board explained that inventions relating to human stem cells or stem cell cultures which did not involve the destruction of embryos would be a different matter.
Patent protection is unavailable for any variety of animal or plant, or any essentially biological process for the production of animals or plants, other than a microbiological or other technical process or the product of such a process.134
This wording excludes the possibility of patent in many things that are found in nature. We have already seen that a patent cannot be granted for a discovery as such, and this further exclusion once again highlights the difference between discovery and the technical application of a discovery. Traditionally, the important difference was between what was found in nature the one hand, and either process to reproducing that natural substance in the laboratory or the synthetic equivalent of that substance resulting from the process on the other hand.135 The principle is now found in Article 5 (2) of the Biotech Directive.
Paragraph 3(f) of Schedule A2 sets out four separate elements. Crucial to the application of these elements is the principle that the wording of the claims is all-important. Presentation might not be everything, but it certainly accounts for a great deal.
Firstly, paragraph 3(f) tells us that animal varieties may not be patented. The use of the word ‘varieties’ is key here: it implies that we have to consider a taxonomy – in descending order, animals in general, then animal species, and finally varieties within that species. To decide whether a patent relates to an animal variety requires consideration of the claims. A genetically engineered mouse is not an animal variety.136
With plant varieties, the question is whether the applicant has claimed plants generally or a plant variety. Only a claim to a plant variety is excluded. In LUBRIZOL/hybrid plants,137 plants and their seeds were not within the definition of a plant variety. In PLANT GENETIC SYSTEMS/glutamine synthetase inhibitors138 genetically modified tobacco plants were herbicide-resistant were held not to be applied variety. Again, there is an implicit taxonomy here, and a plant variety is the lowest level of the classification system. There is a specific reason to deny plant varieties patent protection which does not apply to animal varieties: there is a whole separate legal mechanism for protecting plant varieties under the International Convention for the Protection of New Varieties of Plants of 1961, as amended in 1991. This is known as the UPOV Convention.
Thirdly, essentially biological processes may not be patented and here EPO says that the test is whether the claims relate on the one hand to human, technical intervention, or on the other hand to traditional cross-breeding methods. The latter may not be patented, but the former can be.
Fourthly, microbiological processes are patentable, and the EPO distinguishes these from biological processes by considering whether they are visible to the human eye.
Although TRIPS lets Contracting States permit patents for them, methods of treatment of the human or animal body, whether by surgery or therapy, and methods of diagnosis, are excluded from patentability under the EPC.139 The underlying policy reasons for the exclusion is easy to understand: medical practitioners (including veterinary surgeons) should not have to worry about patents when treating patients140 - which makes it odd that TRIPS should take a different view, although that might just have been because there were Contracting States where the investor-friendly counter-argument prevailed, such as Australia.141
The Patents Act 1949 contained a similar exclusion, and provides us with a number of cases which are full of contradictions. Using sound waves as an anaesthetic,142 a system of abortion,143 and a method of filing teeth144 were all refused while a system for evaluating health screening tests,145 contraception146 and a method for making a wound dressing147 were allowed. It is however now clear that ‘method of treatment’ is to be given a generous interpretation – enough, certainly, to cover a system of immunisation.148
The policy underlying the EPC has led the EPO to take a broad view of the exclusion. In CYGNUS/Diagnostic methods149 the Board of Appeal held that the expression ‘methods of diagnosis’ did not necessarily mean all the steps involved in reaching a medical diagnosis. In MEDI-PHYSICS/Treatment by surgery150 the fact that one of the several steps that made up the invention involved a surgical procedure was enough to exclude the whole claim. The treatment does not have to be administered personally by a doctor or veterinary surgeon.151
The contradictory cases mentioned above have not entirely disappeared. Cosmetic treatment has been held to fall outside the exclusion. In an extreme case, Whitford J upheld a method of killing ectoparasites on humans, saying that ‘these applications lay on the absolute frontier of the law.’ The law he was applying was, however, the 1949 Act, although the principle remains still holds.
Although a broad interpretation of the exclusion is thought to be appropriate (contrary to the view usually taken of exclusions, incidentally), several important exceptions make clear that inventions which might be thought to involve methods of treatment etcetera remain patentable.
First, by s.4A(2), equipment and substances used in methods of treatment can be patented (assuming, of course, that they meet the other requirements for patentability). The pharmaceutical industry is safe.
Second, by s.4(3), it is possible to obtain a patent for a known substance used for the first time in a method of treatment. This follows from Article 54(4) of the EPC, added in the 2004 amendments. Although the substance is not novel, the invention obtains the necessary novelty from the medical use, notwithstanding that the medical use itself is excluded from patentability. The case law of the EPO extends this principle to cover second medical uses, and more.152
This was accepted, at first reluctantly, by the English courts.153 In American Home Products Corp v Novartis Pharmaceuticals Ltd154 a substance used at first as an anti-fungal agent was found to be useful in transplant surgery and the patent was upheld. Now, s.4A(4) puts the second medical use on a statutory footing. However, what amounts to a second medical use is narrowly construed: if a naturally-occurring substance is already patented, it is not possible to get another patent after research has established the optimum dosage,155 although there is no reason why a patent should not be granted for a dosage regime that was new and not directed to a method of treatment.156
Second medical use claims used to have to follow what was known as the Swiss form (because it was first used in the Swiss patent office): ‘use of X for the manufacture of a medicament for treatment of V’. Subsequent amendments to Article 54 and s.4A(4) have made this unnecessary.
1(1909) 26 RPC 339.
2EPO Guidelines, C-IV, 1.1 and 2.2, and EPC 2000 Regs 27 and 29.
3[1989] RPC 147 (CA).
4Chiron Corpraton v Organon Teknika Ltd (No 12) [1996] FSR 153 (also CA, but different judges). This case accorded with the EPO’s approach at that time, in HOWARD FLOREY/Relaxin [1995] EPOR 541 and is supported by the closing words of the capital to section 1(1) of the Act, ‘that is to say ...’.
5See for example Biogen v Medeva [1996] UKHL 18, [1997] RPC 1 where all ways to make a product were claimed but only one method of doing so was disclosed.
6[1989] R.P.C. 147, 264.
7T 931/95, PBS PARTNERSHIP/Controlling Pension Benefits System [2002] EPOR 522.
8For the EPO Boards of Appeal’s current thinking on the matter see PBS (note 7 supra), HITACHI/Auction Method [2004] EPOR 548, and DUNS LICENSING ASSOCIATES/Estimating Sales Activity [2007] EPOR 349.
9IBM/Card Reader [1994] EPOR 89. For a more recent example of a patent being held by the English courts not to involve a new technical effect, see Schlumberger v Electromagnetic Geoservices [2009] EWHC 58 (Pat) and the passages from the judgment of Lord Hoffmann in Sabaf SPA v MFI Furniture Centres Ltd [2004] UKHL 45.
10Per Hobhouse LJ in Biogen v Medeva plc [1995] RPC 25, 87, disapproving Aldous J’s comment in Chiron Corp v Organon Teknika Ltd (No 3) [1994] FSR 202, [1996] FSR 153 (CA) to the effect that the invention was to be determined by the wording of the claim only.
11See for example Biogen v Medeva [1996] UKHL 18, [1997] RPC 1 where all ways to make a product were claimed but only one method of doing so was disclosed.
12[1985] RPC 59 at 73.
13See para 8.4.2.1.
14See para 10.7.
15[2005] UKHL 59, [2006] RPC 10, overruling [2003] EWCA Civ 861, [2003] RPC 6 (CA) which in turn overruled [2003] RPC 43.
16Supra., note 13
17[1981] FSR 60, [1982] RPC 183 (HL).
18[2009] EWCA Civ 1188. See also Valensi v British Radio Corporation [1972] RPC 373 at 450 – but note the date: this is a 1949 Act case. Re Genentech’s (Human Growth Hormone) Patent [1989] RPC 613 is also worth looking at on this point.
20[2003] EWHC 111.
21[1967] RPC 479.
22[1989] RPC 147, 214 and 279.
23[1989] RPC 613.
24[2006] RPC 517.
25[2000] EWHC Patents 62 (3rd October, 2000).
26[2003] EWHC 1598.
27[2004] EWCA Civ 381.
28 [1972] RPC 346 at p.355.
29 [1972] RPC 457 at 482.
30 53 RPC 221 at 250.
31[2006] RPC 517.
32[2010] RPC 851.
34Lilly Icos Ltd v Pfizer Ltd [2001] FSR 201, ara 62.
35Per Lord Reid in Technograph, [1972] RPC 346 at 355.
36Per Lord Oliver in Windsurfing, pages 69 to 71.
37Hallen v Brabantia [1991] RPC 195.
38Genetech Inc’s Patent [1989] RPC 147.
39Section 2(3).
40 [2002] EWHC 535. Both applications in the case were filed by the same applicant, who instructed his patent agents to withdraw the earlier one. However, they failed to do so until publication was imminent, so that when they wrote to the Patent Office to abandon the earlier application the publication had passed the point of no return. The Comptroller held that the contents of the earlier application formed part of the state of the art for the purposes of section 2(3) of the Patents Act 1977, equivalent to Article 54 of the European Patent Convention. The Court held that the section had to be interpreted in a manner consistent with Article 54(3), the aim of which was to prevent double patenting, and that would be a problem only if both applications were pursued to grant. This would be impossible if the earlier application were withdrawn in time, and the earlier application would not have to be treated as forming part of the state of the art.
41[1972] RPC 45.
42[2005] UKHL 59, [2006] RPC 10, overruling [2003] EWCA Civ 861, [2003] RPC 6 (CA) which in turn overruled [2003] RPC 43.
43See Fomento v Mentmore [1956] RPC 8 and Merrell Dow Pharmaceuticals Inc. v H N Norton & Co Ltd. [1994] RPC 1 (Pat Ct), [1995] RPC 233 (CA), [1995] UKHL 14, [1996] RPC 422 (HL).
44See Hill v Evans (1862) 31 LJ Ch 457, Asahi (supra), and BSH Industry’s Patents [1995] RPC 183 in which the instructions were ambiguous and the reasonable man in resolving the ambiguity would have to take one of two courses, and would sensibly choose the one that was the respondent’s invention, making the invention obvious though not destroying its novelty. See also Molins v Industrial Machinery Co Ltd (1938) 55 RPC 31 and Hickman v Andrews [1983] RPC 147.
45[2005] UKHL 59, [2006] RPC 10, overruling [2003] EWCA Civ 861, [2003] RPC 6 (CA) which in turn overruled [2003] RPC 43.
46 Per Sachs LJ in General Tire and Rubber Co v Firestone Tyre and Rubber Co, supra., note 41.
47See Du Pont’s (Witsiepe’s) Application [1982] FSR 303 (HL).
48See van der Lely v Bamfords [1963] RPC 61.
49Union Carbide Corp v BP Chemicals [1997] EWHC 373 (Pat) (Jacob J), [1998] EWCA Civ 1863 (CA)
50See Molins v Industrial Machinery Co Ltd , Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd, supra., note 43.
51See Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd., supra., note 43.
52See Mobil Oil [1990] OJ EPO 93.
53 Supra., note 40, and section 7.1.4.
54Humpherson v Syer (1887) 4 RPC 407 (CA).
55[1983] FSR 401.
56[1985] RPC 59.
57Pall Corp v Commercial Hydraulics (Bedford) Ltd [1990] FSR 329.
58Section 130(1). A document is taken to be ‘published’ if it can be inspected as of right at any place in the UK by members of the public. Whether they have to pay to do so is immaterial. So extensive are the holdings of the British Library (including the Science Reference and Information Service, which keeps patent information from around the world) that the scope of this definition is very wide indeed.
59Japan Styrene Paper/Foam Particles [1991] EPOR 94.
60Woven Plastics Ltd. v British Ropes Ltd.[1970] FSR 47 (CA), a 1949 Act case on obviousness. Lord Justice Widgery as he then was indicated that he thought that this went ‘beyond the bounds of reason’, but the case had been argued on the footing that this was correct.
61[1985] RPC 59.
62[1993] RPC 107.
63Milliken Denmark AS v Walk Off Mats Ltd [1996] FSR 292 (Pat) (Jacob J).
64[1992] F.S.R. 478 (Patents Couty Court), [1994] F.S.R. 160 (CA) (but the appeal related only to costs).
65Section 4(2) used to state that methods of treatment or diagnosis were not capable of industrial application. Now section 4A(1) (following the Patents Act 2004) excludes such inventions from patentability, but section 4A(2) contains a saving for inventions consisting of a substance or compound for use in such a method, and sub-sections (3)a and (4) take care of what forms part of the state of the art in such cases. See below.
66[1990] EPOR 73.
67[1990] RPC 83, 108.
68See Pall Corp. v Commercial Hydraulic: Quantel v Spaceward:, PLG Research Ltd v Ardon International Ltd [1993] FSR 197 (Pat Ct), [1995] RPC 287, [1995] FSR 116 (CA), Lux:, and Prout v British Gas[1992] FSR 478
69See paragraph 22.5.
70Molnlycke AB v Proctor and Gamble Ltd (No 5) [1994] RPC 49, [1992] FSR 549, PLG note 29, supra at 134-141, Cartonneries de Thulin SA v CTP White Knight Ltd 25 May 2000, Instance v Denny Bros. Printing Ltd., Storage Computer UK Ltd v Hitachi Data Systems [2003] EWCA Civ 1155 and most significantly Biogen v Medeva [1997] RPC 1, where Lord Hoffmann confirmed this approach but was not uncritical of it.
71[2007] EWCA Civ 558.
72At 497, 500.
73[1997] RPC 489, 494.
74[1998] RPC 31, [1999] RPC 497, CA.
75[2001] RPC 133, per Aldous LJ.
76Per Jacob LJ, note 27, at paras 16 to 21.
77Re Genentech’s (Human Growth Hormone) Patent [1989] RPC 613.
78Beloit Technologies Inc v Valmet Paper Mills [1995] RPC 705.
79Beloit Technologies Inc v Valmet Paper Mills [1995] RPC 705.
80PLG, supra, Assidoman Multipack Ltd v The Mead Corporation [1995] FSR 225.
81Beecham’s (Amoxycillin) Application [1980] RPC 261 (CA).
82Biogen v Medeva, supra.
83Parks-Cramer Co v G W Thornton & Sons Ltd [1966] RPC 407.
84Olin Mathieson v Biorex [1970] RPC 157, Johns-Manville Corporation’s Patent, supra, Bayer’s (Baatz-Carbonless Copying paper) Application [1982] EPO RPC 321, [1981] OJ EPO 206, Fives-Cail Babcock’s Application [1982] OJ EPO 225.
85[1989] RPC 307.
86[1989] FSR 180.
87[1984] RPC 35.
88Lucas v Gaedor [1978] RPC 297.
89[1972] RPC 346.
90[1976] RPC 547.
91Molnlycke AB v Proctor and Gamble Ltd (No 5), supra.
92[1966] RPC 407.
93 [2002] EWCA Civ 1.
94See Williams v Nye (1890) 7 RPC 62 (CA).
95 [2004] UKHL 45. MFI took no part in the proceedings having settled the action at an early stage.
96 (1935) 52 RPC 171, 193.
97Chiron v Murex [1996] RPC 535, 606-7 (CA).
98John Wyeth & Brothers’ Application: Schering AG’s Application [1985] RPC 545.
99See Esai’s Application [1987] OJ EPO 147 and John Wyeth’s and Schering’s Applications (supra).
100Section 4A(3) and (4), and see the UK Intellectual Property Office’s Practice Note on the subject.
101What is a discovery is not defined in the statute. It is taken to mean the disclosure of some pre-existing law of nature: see Re Genentech Inc’s Patent (note 35, supra), and compare Chiron Corp (note 3, supra).
102In Lux a method of operating portable road traffic signals was not patentable as such. In Furuno Electric Co’s Application [1991] IPD 14040 a claim to inferring the position of fish shoals from radar images of flocks of sea birds was invalid: it was a mental act. See also Raytheon Co’s Application [1993] RPC 427, which provides a good survey of the case law.
103 In Townsend’s Application [2004] EWHC 482 (Pat), the applicant’s appeal against refusal of his patent application for an advent calendar was refused. He proposed in the application that additional information should be placed in the doors of the advent calendar to indicate which of multiple users could open each door. The Deputy Director of the Patent Office considered that this amounted to ‘presentation of information’ and there was therefore no invention for the purposes of the Act. The applicant argued that the phrase could mean ‘provision of information’ or it could mean ‘expression of information’: his markings provided information but did not express it. The exclusion, he argued, was only intended to cover how information is provided. The court, however, disagreed and held that presentation of information embraced providing information: that was the natural and primary meaning of the words.
104See Hillier’s Application [1969] RPC 267, Pitman’s Application [1969] RPC 646, ITS Rubber’s Application [1979] RPC 318, FMM’s Application (1941) 58 RPC 115, W’s Application (1914) 31 RPC 141, Organon [1970] RPC 574.
105Per Nicholls LJ in Gale’s Application [1991] RPC 305: see also Genentech Inc v Wellcome Foundation [1989] RPC 147.
106[1996] FSR 153.
107[1997] RPC 608.
108(1945) 62 RPC 87).
109[1993] RPC 427.
110[1989] RPC 561.
111Halliburton’s Application [2011] EWHC 2508.
112450 U.S. 175 (1981).
113[2006] EWCA Civ 1371 (27 October 2006), [2007] RPC 7.
114[2008] EWCA Civ 1066 (08 October 2008), [2009] RPC 1.
115See also KOCH & STERZEL/X-ray apparatus [1988] EPOR 72.
116[1989] RPC 561.
117[1991] RPC 305
118[1997] RPC 610.
119[1990] RPC 93.
120[1999] EPOR 301.
121[2002] EPOR 522.
122[2007] EPOR 349.
123G 3/08 PRESIDENT’S REFERENCE/Patentability of programs for computers (12 May 2010).
124 COM (2002) 92 final.
125[2004] EWHC 482.
126[2006] RPC 345
127[1991] EPOR 525.
128SI 2000 No 2037.
129[1971] RPC 425.
130The controversy over the ‘patenting’ of the human genome involved at least possible misconceptions about what can and what cannot be patented, though it is worth bearing in mind that it is probably what was patentable under the U.S. law that caused most concern. In theory at least, it is not possible to patent the genome, only technical effects in the form for example of new products that flow from the research. In Eli Lilly & Company v Human Genome Sciences Inc [2008] EWHC 1903 (Pat) (31 July 2008) the High Court (Kitchin J) held a patent for a newly-discovered protein invalid, saying:
Whatever the merit of the discovery of Neutrokine-a, the specification contains no more than speculation about how it might be useful. It does not teach the person skilled in the art how to solve any technical problem and its teaching as to the range of applications of Neutrokine-a is implausible. Moreover, the claims to therapeutic and diagnostic products are insufficient in any event.
This was a field in which many researchers were active. The application was filed at a time when rapid advances were being made in terms of the public availability of gene sequences and how they might be searched. Not surprisingly, other teams found Neutrokine-a soon after the priority date. Perhaps anticipating this, HGS filed its application very promptly. But in doing so it failed to disclose how the protein might be used and it required a research programme to make good this deficiency. HGS secured broad protection over an unexplored technical field without providing an adequate compensating benefit to the public.
131S.1(3) PA77, Article 6(1) Biotech Directive.
132HSARVARD/Onco-mouse [1990] EPOR 501, PLANT GENETIC SYSTEMS/Glutamine synthetase inhibitors [1995] EPOR 357, HOWARD FLOREY/Relaxin [1995] EPOR 541, LELAND STANFOrD/Modmed Animal [2002] EPOR 16.
133[2009] EPOR 129.
134See Article 53 (b) and Patents Act 1977 schedule A2, paragraph 3(f), and compare article 4 of the biotech directive and article 27 (3)(b) of TRIPS.
135See the comments of Lord Wilberforce in Re American Cyanamid (Dan's) Patent [1971] RPC 425 and American Cyanamid v Berk [1876] RPC 231..
136HARVARD/Onco-mouse [1990] EPOR 501.
137[1990] EPOR 173.
138[1995] epor 357.
139Article 53(c) EPC, Patents Act 1977 s.4A. Although I think the wording is perfectly clear, G1/07 MEDI-PHYSICS/Treatment by surgery (Enlarged Board of Appeal, 15 February 2010) stresses that surgery, therapy or diagnosis are independent alternatives – the invention only has to be one of them to be excluded.
140Wyeth/Schering’s Applications [1985] RPC 545.
141See Asif E, Exclusion of Diagnostic, Therapeutic and Surgical Methods from Patentability (2013) JIPR 18(3) 242.
142Neva’s Application [1968] RPC 481.
143Upjohn (Kirton’s) Application [1976] RPC 324.
144Lee Pharmaceuticals’ Application [1975] FSR 435.
145Bio-Digital’s Application [1973] RPC 668.
146Schering’s Application [1971] RPC 337.
147Nolan’s Application [1977] FSR 435.
148Unilever (Davis’s) Application [1983] RPC 219.
149[2006] EPOR 161.
150G 001/07. The Enlarged Board of Appeal declined to provide a definition of ‘surgical’, which would have been helpful but the value of which would have been limited given the constant developments in medical science.
151T0019/86 DUPHAR/Pigs II [1989] EPOR 10, T0116/85, WELLCOME/Pigs I [1988] EPOR 1.
152EISAI/Second medical indication [1979-85] EPOR: B: 241.
153Wyeth/Schering’s Applications [1985] RPC 545.
154[2001] RPC 159.
155Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc. [2001] RPC 1.
156Actavis UK Ltd v Merck & Co Inc. [2009] 1 WLR 1186 (CA), G 2/08 ABBOTT RESPIRATORY/Dosage regime (Enlarged Board of Appeal, 19 February 2010).