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England and Wales High Court (Patents Court) Decisions |
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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Generics (UK) Ltd & Ors v H Lundbeck A/S [2007] EWHC 1040 (Pat) (04 May 2007) URL: http://www.bailii.org/ew/cases/EWHC/Patents/2007/1040.html Cite as: [2007] RPC 32, [2007] EWHC 1040 (Pat), [2007] RPC 729 |
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HC06C00457 HC06C02767 |
CHANCERY DIVISION
PATENTS COURT
Strand, London, WC2A 2LL |
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B e f o r e :
____________________
| Generics (UK) Limited Arrow Generics Limited (3) Teva UK Limited and Teva Pharmaceuticals Limited |
Claimants |
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| - and - |
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| H. Lundbeck A/S |
Defendant |
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Mr Christopher Floyd QC and Mr Mark Chacksfield (instructed by Forsyth Simpson) for the Second Claimant
Mr Simon Thorley QC (instructed by Roiter Zucker) for the Third Claimant
Mr Andrew Waugh QC and Mr Justin Turner (instructed by Simmons & Simmons) for the Defendant
Hearing dates: 6 – 9, 12 – 16, 20 March 2007
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Crown Copyright ©
Mr Justice Kitchin :
Introduction
i) Claims 1 and 3 are alleged to be invalid for lack of novelty over:a) US Patent number 4,136,193 ("193");b) US Patent number 4,650,884 ("884").The lack of novelty attack turns upon a question of construction: Does the claim exclude the (+) enantiomer in the racemic mixture? Lundbeck has met this allegation with a conditional application to amend, which is opposed.ii) Claims 1, 3 and 6 are alleged to be invalid for obviousness in the light of the 193 and 884 patents and common general knowledge.
iii) Claims 1 and 3 are alleged to be invalid for insufficiency. It is said that the inventive concept disclosed by the Patent was not the idea of resolving citalopram. The scope of the invention lay, and lay only, in devising a way to obtain it. Claims 1 and 3 therefore extend beyond any possible inventive contribution of the Patent in that they monopolise all ways of arriving at (+) citalopram.
Background
Depression
Treatment of MDD
Stereochemistry
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Reactions at a carbon atom
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The Patent
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Followed by ring closure in the presence of base at low temperature:
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The salts are then converted back to the now pure enantiomers of the diol:
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Ring closure of the enantiomers is then effected via a labile ester:
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With stereoselective ring closure:
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The skilled addressee
The expert witnesses
Novelty
"The scope of the monopoly conferred by a product claim is defined by section 60(1)(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 aspect 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."
Amendment
Obviousness – general
i) Identify the inventive concept of the claim.ii) Assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and impute to him what was, at that date, common general knowledge in the art in question.
iii) Identify the difference(s) between the prior art under consideration and that in the inventive concept of the claim.
iv) Ask whether the difference(s) would have been obvious or required invention.
"[39] Given that position, what Mr Waugh endeavoured to do was to say that the Judge had wrongly applied an "obvious to try" test. It is necessary to say a little about this. The expression got into the law of obviousness by virtue of the Johns-Manville case, [1967] RPC 479. The facts were simple: there was a known process. The patent was for the old process using the new agent. It was held obvious as being "well worth trying out". Diplock LJ said:
"It is enough that the person versed in the art would assess the likelihood of success as sufficient to warrant actual trial"
[40] More recently, in this court I, with the concurrence of Peter Gibson and Scott Baker LJJ said:
"Mere possible inclusion of something within a research programme on the basis you will find out more and something might turn up is not enough. If it were otherwise there would be few inventions which were patentable. The only research which would be worthwhile (because of the prospect of protection) would be in areas totally devoid of prospect. The "obvious to try test really only works where it is more-or-less self evident that what is being tested ought to work", St Gobain v Fusion Provida [2005] EWCA Civ 177.
[41] Judge Rich in the US Court of Appeal for the Federal Circuit said (I did not know this when I wrote St Gobain ) much the same thing in Tomlinson's Appn (1966) 363 F 2d 298 at 931:
"Slight reflection suggests, we think, that there is usually an element of 'obviousness to try' in any research endeavour that is not undertaken with complete blindness but rather with some semblance of a chance of success, and that patentability determinations based on that as the test would not only be contrary to statute but result in a marked deterioration of the whole patent system as an incentive to invest in those efforts and attempts which go by the name of 'research'."
[42] Mr Waugh submitted that was the correct approach and that it was that approach which was also followed in Australia (Hässle v Alphapharm (2002) 312 CLR 411), Canada (Aventis v Apotex (2005) [2005] FC 1504) and the USA (Tomlinson and re O'Farell (1988) 853 F 2d 894 also per Judge Rich).
[43] I have to say that I do not discern a shift in the position in this country following the 1977 Act as the majority of the Australian High Court thought had happened. It is perhaps noteworthy that currently Australian courts seem to be taking a very pro-patent view of obviousness and that patents are being upheld there which are not upheld elsewhere. The Hässle case and the Viagra case, Pfizer v Lilley (held by the Federal Court of Appeal non-obvious though invalid on other grounds) are perhaps examples of this. Whether, if that is so, it is good for the Australian economy is not my concern.
[44] I also take the view that one can overelaborate a discussion of the concept of "obviousness" so that it becomes metaphysical or endowed with unwritten and unwarranted doctrines, sub-doctrines or even sub-sub-doctrines. This can be coupled with a massive citation of authority (the opinions in the 84 printed page, 203 paragraph judgment, in Hässle have 307 footnotes, many of which are citations of authority); Diplock LJ warned against this in Johns Manville saying:
"I have endeavoured to refrain from coining a definition of 'obviousness' which counsel may be tempted to cite in subsequent cases relating to different types of claims."
I interpolate to say, he failed there! Continuing:
"Patent law can too easily be bedevilled by linguistics and the citation of a plethora of cases about inventions of different kinds. The correctness of a decision upon an issue of obviousness does not depend upon whether or not the decider has paraphrased the words of the Act in some particular verbal formula. I doubt whether there is any verbal formula which is appropriate to all classes of claims."
[45] That reminder cannot be repeated too often. The words of the law are simply:
"An invention shall be considered as involving an inventive step, if, having regard to the state of the art, it is not obvious to a person skilled in the art" (Art 56 EPC).
In the end the question is simply "was the invention obvious?" This involves taking into account a number of factors, for instance the attributes and cgk of the skilled man, the difference between what is claimed and the prior art, whether there is a motive provided or hinted by the prior art and so on. Some factors are more important than others. Sometimes commercial success can demonstrate that an idea was a good one. In others "obvious to try" may come into the assessment. But such a formula cannot itself necessarily provide the answer. Of particular importance is of course the nature of the invention itself."
The inventive concept of the claims
i) For claim 1, the inventive concept is the new antidepressant compound, (+) citalopram.ii) For claim 3, the inventive concept is a pharmaceutical composition of that compound.
iii) For claim 6, the inventive concept is the preparation of a (+) citalopram by converting the (-) diol in a stereoselective way to (+) citalopram.
The common general knowledge of the unimaginative addressee – general principles
"It has never been easy to differentiate between common general knowledge and that which is known by some. It has become particularly difficult with the modern ability to circulate and retrieve information. Employees of some companies, with the use of libraries and patent departments, will become aware of information soon after it is published in a whole variety of documents; whereas others, without such advantages, may never do so until that information is accepted generally and put into practice. The notional skilled addressee is the ordinary man who may not have the advantages that some employees of large companies may have. The information in a patent specification is addressed to such a man and must contain sufficient details for him to understand and apply the invention. It will only lack an inventive step if it is obvious to such a man.
It follows that evidence that a fact is known or even well-known to a witness does not establish that that fact forms part of the common general knowledge. Neither does it follow that it will form part of the common general knowledge if it is recorded in a document. As stated by the Court of Appeal in General Tire & Rubber Co. v. Firestone Tyre & Rubber Co. Ltd. [1972] R.P.C. 457, at page 482, line 33:
"The two classes of documents which call for consideration in relation to common general knowledge in the instant case were individual patent specifications and widely read publications'. As to the former, it is clear that individual patent specifications and their contents do not normally form part of the relevant common general knowledge, though there may be specifications which are so well known amongst those versed in the art that upon evidence of that state of affairs they form part of such knowledge, and also there may occasionally be particular industries (such as that of colour photography) in which the evidence may show that all specifications form part of the relevant knowledge.
As regards scientific papers generally, it was said by Luxmoore, J. in British Acoustic Films (53 R.P.C. 221 at 250):
"In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art."
And a little later, distinguishing between what has been written and what has been used, he said:
"It is certainly difficult to appreciate how the use of something which has in fact never been used in a particular art can ever be held to be common general knowledge in the art."
Those passages have often been quoted, and there has not been cited to us any case in which they have been criticised. We accept them as correctly stating in general the law on this point, though reserving for further consideration whether the words 'accepted without question' may not be putting the position rather high: for the purposes of this case we are disposed, without wishing to put forward any full definition, to substitute the words 'generally regarded as a good basis for further action'."
Common general knowledge – the issues
i) What the addressee would have known as to the likely activity of enantiomers and whether he would have had any motive to resolve a racemate of an SSRI into its enantiomers.ii) What the addressee would have known of the various possible techniques for resolving racemates and, in particular, what he would have known about chiral HPLC and its use on an analytical and preparative scale.
Areas of agreement
Motive to resolve
" There are two principal reasons for requesting a detailed presentation of the synthetic pathway and/or manufacturing process. First, a particular synthetic pathway will typically be uniquely associated with a set of impurities (actual and potential), and also a specific solid-state form. The impurities may have significant clinical or toxicological effects. It should be noted that (even in racemates) enantiomers may be considered as impurities. Proper control of the synthetic process monitors impurity levels during the process and in the final bulk drug substance. When a change is made or proposed in a synthetic process, a different ratio or even different set of impurities may arise, and the control testing may need modification. The "United States Pharmacopeia" (USP) also states that tests, besides those provided in drug substance monographs, may be necessary when a change in the source of material or processing occurs."
"When the NDS [new drug substance] is asymmetric (e.g., contains one or more chiral centers, or has cis-trans or other types of isomers), the sponsor should ideally (and prior to the submission of an IND) have either separated the various potential stereoisomers of the NDS or synthesized them independently. Physical/chemical information about each stereoisomer should be provided (in detail) or may be requested. Individual stereoisomers may need to be studied for pharmacological and toxicological properties (and/or for safety and efficacy).
Appropriate specifications and tests to control the ratios of any admixtures (e.g., ratios of enantiomers, and/or solid-state forms) for batches of drug substances used in toxicological and/or clinical studies should be established, so that results can be extrapolated to the drug substance prepared for marketing."
"When the drug concerned is a racemate, it is recommended to investigate the absorption, distribution, metabolism and excretion of each optical isomer."
This would of course require resolution of the enantiomers and the administration of each enantiomer separately.
"The regulatory authorities are beginning to respond to the scientific and clinical maelstrom concerning the issue of racemates and enantiomers. In the United States the Food and Drug Administration has both an ongoing intramural discussion and an extramural debate with industry which is likely to lead to the promulgation of guidelines. Matters are further advanced within the EEC, where at present the Committee for Proprietory Medicinal Products is considering a draft guideline statement on isomerism for inclusion in its 'Notice to Applicants'. If adopted, as looks likely, new submissions for drugs with chiral centres will have to provide information inter alia on the following points: isomer ratio and batch to batch consistency; a discussion of the toxicological and pharmacological properties of the isomers, enantiomer specific metabolism and kinetics and the extrapolation of preclinical data (particularly if species differences occur in the handling of stereoisomers); and a discussion of possible clinical problems that may arise in relation to stereoisomers. "
i) the activity of the individual enantiomers of a racemate might well be different;ii) an inactive enantiomer might properly be considered an impurity;
iii) an inactive enantiomer might nevertheless have pharmacological or toxicological effects;
iv) in the course of drug development, a manufacturer should therefore consider both enantiomers, as well as the racemate, to be potential drugs;
v) when filing an IND application with the FDA the applicant should ideally have either separated the various enantiomers or synthesised them separately and provided data in relation to each of them.
" To discuss biological activity of a racemate without at least noting the possibility of differential or even opposing effects of the enantiomers is foolhardy, especially when many examples of such situations are known. Nowadays, enantiomeric impurities are often quite simple to monitor. "
"Whilst many pharmaceuticals are still produced in racemic form there is a growing appreciation of the different biological effects of enantiomeric molecules and as a result the preparation of optically pure ß-amino-alcohols has attracted considerable attention. "
Methods for separating racemates
General
Resolving an intermediate
Resolution by chiral HPLC
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Availability of chiral resolution media and columns
Pirkle CSPs
Ligand exchange CSPs
Protein based CSPs
Inclusion complex CSPs
Polysaccharide CSPs
The review articles
"The use of chiral stationary phases (CSPs) for the direct analytical and preparative chromatographic separation of enantiomers has attained increasing prominence in the past decade. The reasons for this popularity are clear: The advantages inherent in any chromatographic separation (rapid analysis and separation of complex mixtures, reproducibility, flexibility) are extended to a hitherto demanding preparative and analytical problem, namely, how does one go about separating enantiomers?"
"As the analytical separation of enantiomers becomes more common, the demand for analogous preparative scale separations will grow. Research on preparative scale chiral columns is currently underway in several laboratories. Some preparative and semi-preparative columns are now available. What is needed is a process that can efficiently isolate kilogram and greater quantities of optically pure compounds. Scaling sensitive analytical separations up to preparative size generally results in a significant loss of resolution. Consequently, large selectivity factors are often needed for effective large-scale separations. The number of racemates which have large as (on currently available CSPs) is much smaller than those with small as. Thus, many future preparative separations may use specifically designed CSPs that have large selectivity factors, good reproducibility, and good regeneration properties for a given separation. Another possible approach is to use multidimensional separation procedures, which can greatly increase selectivity.
Currently, the LC separation of optical isomers is a popular, highly visible area of research. Rapid advances are being made that will have a significant effect on many areas of science and technology. At some not too distant time, the chromatographic separation of enantiomers will be considered routine and perhaps even uninteresting. This in itself will be a tribute to the success of the many researchers who have worked and are working in what was once considered one of the more difficult areas of separations. "
Dr Pochapsky and Dr Collicott
Conclusions in relation to chiral HPLC
Identify the differences between the prior art and the alleged invention
193
884
Obviousness - do the differences constitute steps that would have been obvious to the skilled man or did they require and degree of invention?
The amino diol case
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"Many methods have been developed for the synthesis of saturated heterocyclic systems, and often these are specific for the heterocycle concerned. One general method, however, is defined by the following formulae:
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Cyclization takes place by nucleophilic displacement of the functional group at one end of the chain by that at the other end."
Again, it is to be noted that this is a saturated system.
The chiral HPLC case
i) It would occur to any skilled team who had not been able to or who had difficulty in obtaining enantiomers of citalopram by classical methods to look to chiral HPLC as a method of obtaining them.ii) The skilled team would recognise that citalopram was a reasonably promising candidate for resolution; although it would not be known in advance that it would be successful.
iii) The team would not be deterred from trying by general considerations of "unpredictability" in this as in any other field of chemistry.
iv) The obvious approach would be to do a literature search and see what guidance was available and what columns were available, and to obtain the manufacturers' literature on suitable column types; they would prefer columns and media where preparative work was described as possible and where preparative columns were commercially available.
v) They would exclude columns which would plainly not work such as the Pirkle and ligand exchange columns.
vi) They would rapidly see there was a limited shortlist of columns from three classes, namely: Beta-cyclodextrins, Daicel polysaccharide and protein based columns.
vii) Protein columns would be disfavoured because of their poor potential for preparative work.
viii) Other columns such as microcrystalline cellulose triacetate would have also have been worth trying; perhaps also polymethyl methacrylates.
ix) The upshot would have been a list of columns essentially including the polysaccharide, inclusion complex and protein based CSPs.
x) There were very few manufacturers, the principal ones being Daicel, Machery-Nagel and Astec.
xi) The skilled person would then prioritise the testing of the various possible columns and would be likely to choose beta-cyclodextrin and Chiralcel OD.
xii) The skilled person would try and get separation on an analytical size column and then scale up.
"The cross-examination of the respondents' expert followed with customary skill the familiar "step by step" course. I do not find it persuasive. Once an invention has been made it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention that he claims in his specification if he started from something that was already known. But it is only because the invention has been made and has proved successful that it is possible to postulate from what starting point and by what particular combination of steps the inventor could have arrived at his invention. It may be that taken in isolation none of the steps which it is now possible to postulate, if taken in isolation, appears to call for any inventive ingenuity. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to that result. "
"Notwithstanding the wide variety of chiral columns available, no satisfactory rationale has yet been developed for selecting a particular packing material for a specific problem. Given the relatively high cost of columns, there is an urgent need to establish a suitable set of guidelines and rules for designing chiral separations in LC. Here it is most likely that an expert systems approach may prove fruitful, when the database of expertise has been sufficiently well developed. "
"A variety of new, modified, and improved stationary phases will continue to be introduced over the next few years. Some of these will be commercialised. This will greatly increase the number and type of enantiomers amenable to rapid LC determination. Rationales will develop by which one can quickly choose the one or two columns most likely to separate any of a great many enantiomers."
The Lundbeck work
The use of chiral acids
Other strategies
Resolution of intermediates
Resolution of derivatives
Asymmetric synthesis
Chiral HPLC
Success was achieved
Conclusions from the Lundbeck work
The unexpected superior efficacy of escitalopram
Efficacy of citalopram
Clinical data
Can Lundbeck rely on the unexpected benefits?
"Formally I think the experiments were irrelevant. Curiously Mr Thorley, for the purpose of his argument before me, accepted this. Whether or not there was synergy demonstrated by experiments conducted after the date of the patent cannot help show obviousness or non-obviousness. Nor can the amended claim be better if only the components of the amended claim (as opposed to the unamended claim) can be shown to demonstrate synergy. The patent does not draw any such distinction and it would be quite wrong for later acquired knowledge to be used to justify the amended claim."
"It is sometimes thought that a patent may be saved from a finding of obviousness if a combination otherwise obvious has some unexpected advantage, and, in particular, an advantage caused by an unpredictable co-operation between the elements of the combination. I do not consider that such an approach is in general justified. There is a limited class of cases in which the patentee has identified an advantageous feature possessed by some members only of a class otherwise old or obvious, has described the advantageous effect in his specification and has limited his claim to the members of the class possessing this advantageous feature. Such a claim may be justified on the basis of what is called selection. Unexpected bonus effects not described in the specification cannot form the basis for a valid claim of this kind. "
"If a synergistic effect is to be relied on, it must be possessed by everything covered by the claim, and it must be described in the specification. No effect is described in the present specification that is not the natural prediction from the properties of the two components of the combination."
Commercial success
i) that there was, at the priority date of the Patent, a long felt want for improved antidepressants;ii) the commercial embodiment of the Patent, escitalopram, has been commercially successful notwithstanding the availability of citalopram which is unpatented and cheaper than escitalopram;
iii) the commercial success of escitalopram is due to the superior therapeutic properties of escitalopram over citalopram;
iv) and the commercial success of escitalopram is secondary evidence that the claims of the patent are inventive in that it indicates that third parties had not appreciated the benefits to be gained from separating the (-) enantiomer from the (+) enantiomer of citalopram or that they had failed to separate the (-) enantiomer from the (+) enantiomer.
"The truth is that, when once it had been found …. that the problem had waited solution for many years, and that the device is in fact novel and superior to what had gone before, and has been widely used, and used in preference to alternative devices, it is, I think, practically impossible to say there is not present that scintilla of invention necessary to support the patent."
Insufficiency
In fact the Board in Genentech I/Polypeptide expression was doing no more than apply a principle of patent law which has long been established in the United Kingdom, namely, that the specification must enable the invention to be performed to the full extent of the monopoly claimed. If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms. The patentee need not show that he has proved its application in every individual instance. On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them.
Thus if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect: see May & Baker Ltd. v. Boots Pure Drug Co. Ltd. (1950) 67 R.P.C. 23, 50. On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them.
Since Genentech I/Polypeptide expression the E.P.O. has several times reasserted the well established principles for what amounts to sufficiency of disclosure. In particular, in Exxon/Fuel Oils (T 409/91) [1994] O.J. E.P.O. 653, paragraph 3.3, the Technical Board of Appeal said of the provision in the European Patent Convention equivalent to section 14(5)(c) of the Act:
"Furthermore, Article 84 EPC also requires that the claims must be supported by the description, in other words, it is the definition of the invention in the claims that needs support. In the Board's judgment, this requirement reflects the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified."
But the fact that the skilled man following the teaching of Biogen 1 would have been able to make HBcAg and HBsAg in bacterial cells, or indeed in any cells, does not conclude the matter. I think that in concentrating upon the question of whether Professor Murray's invention could, so to speak, deliver the goods across the full width of the patent or priority document, the courts and the E.P.O. allowed their attention to be diverted from what seems to me in this particular case the critical issue. It is not whether the claimed invention could deliver the goods, but whether the claims cover other ways in which they might be delivered: ways which owe nothing to the teaching of the patent or any principle which it disclosed.
It will be remembered that in Genentech I/Polypeptide expression the Technical Board spoke of the need for the patent to give protection against other ways of achieving the same effect "in a manner which could not have been envisaged without the invention". This shows that there is more than one way in which the breadth of a claim may exceed the technical contribution to the art embodied in the invention. The patent may claim results which it does not enable, such as making a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made. Or it may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention.
One example of an excessive claim of the latter kind is the famous case of O'Reilly v. Morse (1854) 56 U.S. (15 How.) 62 in the Supreme Court of the United States. Samuel Morse was the first person to discover a practical method of electric telegraphy and took out a patent in which he claimed any use of electricity for "making or printing intelligible characters, signs, or letter, at any distances". The Supreme Court rejected the claim as too broad. Professor Chisum, in his book on Patents (vol. 1, § 1.03[2] summarises the decision as follows:
"Before Morse's invention, the scientific community saw the possibility of achieving communication by the .galvanic' current but did not know any means of achieving that result. Morse discovered one means and attempted to claim all others."
A similar English case is British United Shoe Machinery Co. Ltd. v. Simon Collier Ltd. (1908) 26 R.P.C. 21. The patentee invented a piece of machinery for automatically trimming the soles of boots and shoes by means of a cam. One of the claims was in general terms for automatic means of trimming soles. Parker J. said, at pages 49-50:
"[T]he problem was simply how to do automatically what could already be done by the skill of the workman. On the other hand, the principle which the inventor applies for the solution of the problem is the capacity of a cam to vary the relative positions of two parts of a machine while the machine is running. Assuming this principle to be new, it might be possible for the inventor, having shown one method of applying it to the solution of the problem, to protect himself during the life of his patent from any other method of applying it for the same purpose, but I do not think that the novelty of the principle applied would enable him to make a valid claim for all means of solving the problem whether the same or a different principle were applied to its solution."
"…care was needed not to stifle further research and healthy competition by allowing the first person who has found a way of achieving an obviously desirable goal to monopolise every other way of doing so. "
Conclusion
