“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.”
“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'.” "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'.”
“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.”
“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. ”
“ 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 β-amino-alcohols has attracted considerable attention. ”
“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 αs (on currently available CSPs) is much smaller than those with small αs. 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. ”
“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: 164. <center><IMG alt="Diagram 18" hspace=15 src="1040(image18).png" border=0> </center> Cyclization takes place by nucleophilic displacement of the functional group at one end of the chain by that at the other end.”
“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.”
“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.”
“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.”
"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." "
"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."
"[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. ”
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