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England and Wales High Court (Patents Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Generics (UK) Ltd (t/a Mylan) v Richter Gedeon Vegyeszeti Gyar RT  EWHC 1666 (Pat) (22 May 2014)
Cite as:  EWHC 1666 (Pat)
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Strand, London, WC2A 2LL
B e f o r e :
| Generics (UK) Limited
(trading as Mylan)
|- and -
|Richter Gedeon Vegyeszeti Gyar RT
Michael Silverleaf QC & Lindsay Lane (instructed by Bristows LLP) for the Defendant
Hearing dates: 6/5/14-8/5/14
Crown Copyright ©
Mr Justice Sales :
The legal framework
"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 …."
"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."
" A.A. Yuzpe and his coworkers reported in The Journal of Reproductive Medicine [13(2), (1974)] the results of those studies where a pharmaceutical composition containing 100 µg of ethinyl-estradiol and 1.0 mg of norgestrel was used as postcoital contraceptive in a single dose. The composition was administered within five days of the unprotected coitus. Later the method was modified. On the one hand the period of the possible use of the composition was reduced from 5 days to 72 hours, on the other hand the dose was doubled that way that the administration was repeated 12 hours after the first one. [Fertility and Sterility, 28, 932-936, (1977), ibid. 37, 508-513 (1982); International Journal of Gynaecology and Obstetrics, 15, 133-136, (1977)]. This modification increased the success of the method.
 After the studies of A.A. Yuzpe and his coworkers several other trials were carried out to prove the efficacy of this combination. In these studies the total dose of ethinyl-estradiol was 0.2 mg combined with 2.0 mg of norgestrel or 1.0 mg of levonorgestrel. The results of the studies showed that although the above administration (Yuzpe regimen) caused less side-effects than the estrogens used earlier in high doses (mainly in the sixties), the relative incidence of nausea and vomiting was still very high (50 and 20% respectively). These side-effects are due to the estrogen effect and they cause the decrease in compliance, moreover, if vomiting occurs, it decreases the efficacy of the treatment.
 The use of levonorgestrel in emergency contraception was discovered in the 1990s. The results of the studies were reported in two well-documented publications [Lancet, 352, 428-433, (1998) and Human Reproduction, 8(3), 389-392, (1993)]. The efficacy of tablets containing only 0.75 mg of levonorgestrel and the combined tablets of Yuzpe method containing 0.1 mg of ethinyl-estradiol + 1.0 mg levonorgestrel were studied by administering the doses 12 hours apart within 48 as well as within 72 hours of unprotected coitus. The results showed that protection with two tablets containing 0.75 mg of levonorgestrel was better than with the Yuzpe regimen, but the women, who received only levonorgestrel observed less side-effects, which could be due to the lack of ethinyl-estradiol.
 The mechanism of action of levonorgestrel used as postcoital contraceptive was investigated in several studies. Keserü and Garmendia showed that the antiovulatory effect probably depends partly on the time elapsed between taking the last tablet and the time of ovulation, partly on the quantity of the applied hormone [Contraception, 10, (1974)]. According to other authors besides the inhibition of ovulation, other factors can also influence the contraceptive effect [Contraception, 63, 123-129, (2001)]. Levonorgestrel administered in the follicular phase decreased the proliferation activity of the endometrium, while in the luteal phase there was no effect [Contraception, 39(3), 275-289, (1989)].
 Several trials were conducted to show the effect of levonorgestrel on the cervical mucus, which could be observed a few hours after the administration. Levonorgestrel inhibits the sperms getting into the upper genital tract in such a way that it causes the thickening of the cervical mucus almost immediately after the absorption of the hormone. It was also shown that after the administration of 400 µg of levonorgestrel the alkalization of the intrauterine fluid starts already after 4 hours of administration and it lasts for approximately 48 hours. This effect can play a role in the inhibition of the movement of sperms, consequently in the contraceptive effect as well [Contraception, 11(1), (1975)].
 The studies showed that two pharmaceutical compositions containing 0.75-0.75 mg of levonorgestrel used at 12 hours' interval within 72 hours after the unprotected coitus successfully inhibited the conceptions which otherwise might have occurred. The efficacy was significantly better than the efficacy of the Yuzpe regimen used worldwide earlier. Because of the lack of the estrogen component, side effects (nausea, feeling of sickness, vomiting) leading to the decrease in compliance and the efficacy of the treatment were observed far less frequently. The results of the clinical studies showed that the efficacy was the better the earlier the treatment started after the coitus. However, according to experience, if women wanted to follow the instructions correctly, they often delayed taking the first tablet so as taking the second dose after 12 hours would not fall on an extremely inconvenient time (for example 3 o'clock in the morning). The results of the studies showed that the prescription of 12 hours' interval between the two doses decreased the compliance. According to statistical data the majority of women took the second dose within 12 to 16 hours after the first one [Lancet, 352, 428-433, (1998)].
 The results of the study of the mechanism of action of levonorgestrel used as postcoital contraceptive showed that the anti-ovulatory effect had great importance. According to the literature [Contraception, 63, 123-129, (2001)] the anti-ovulatory effect is appr. 42% of the total effect, while the rest is distributed among the effects on the cervical mucus, the migration of sperms, zygote transport through the fallopian tube, the endometrium and the implantation. The anti-ovulatory effect depends partly on the quantity of the applied hormone, partly on the time elapsed between the administration and the expected time of ovulation. This seems to support the importance of the 12-hour interval.
 According to the above mentioned facts, taking 0.75 mg of levonorgestrel for emergency contraception twice at 12-hour interval within 72 hours of the coitus seemed to be reasonable. Despite of this we studied the possibility of applying the two doses at the same time within 72 hours of the unprotected coitus so as to eliminate the disadvantage of the 12-hour interval. Surprisingly it was found that the administration of two doses of 0.75 mg of levonorgestrel as an active ingredient at the same time did not cause a decrease in efficacy.
 Therefore the object of this invention is a dosage regimen for emergency contraception and a pharmaceutical composition for the application of this regimen. The regimen according to this invention is that a single dose containing only 1.5+0.2 mg of levonorgestrel as active ingredient is administered to women to be treated with a pharmaceutical composition within 72 hours of unprotected coitus. Further objects of this invention are the dosage units required to carry out the above regimen.
 The dosage units required to carry out the above regimen can be in solid or liquid state, and they can be for example tablets, film-coated tablets, coated tablets, capsules, pills or powder preparations. The lyophilized powder ampoule preparations – making the in situ preparation of liquid compositions possible – also belong to them. Liquid compositions can be for example solutions for injection or infusion.
 The efficacy of the regimen according to this invention was compared with the known regimen administering 0.75-0.75 mg of levonorgestrel 12 hours apart in the following trials.
 In a double-blind, randomized, multicentre, multinational trial 1,356 women received 0.75-0.75 mg of levonorgestrel at 12-hour interval in the traditional way, while 1,356 received in a single dose 1.5+ 0.2 mg of levonorgestrel within 72 hours of the unprotected coitus. In the group treated in the traditional way the conception rate was 1.77% while in the other group treated with a single dose it was 1.47%. The so-called "Prevented fraction" (this number shows how many percent of the conception which otherwise might happen is prevented by the treatment) was 77.3% in the group treated in the traditional way, while in the other it was 81.9%. These data support the advantage of the single dose treatment, although statistical significance can not be proven. The results of the trial proved that the conceptions which otherwise might have happened could be prevented by a single tablet containing twice 0.75 mg of levonorgestrel at least as effectively as by the known therapy.
 During the evaluation of undesired effects it was found that the incidence of nausea was 14.5% in the traditional group, while in the group treated with a single dose it was 13.7%. The incidence of vomiting was 1.4% in both groups. As the new regimen also has the advantageous properties resulting from the lack of estrogen component, the incidence of nausea, feeling of sickness, vomiting was apparently low. The incidence of other side-effects (diarrhoea, fatigue, dizziness, headache, breast tenderness, lower abdominal pain) was also not differing significantly.
 The incidence of menstrual disorders was not increased either by the single administration of 1.5 mg dose of levonorgestrel compared to the administration of two 0.75 mg doses. The incidence of menstrual disorders was 30.9% in both groups.
 The results of the comparative study show that a single dose of 1.5+ 0.2 mg of levonorgestrel surprisingly prevented the conception which otherwise might have occurred with the same success as if this amount of active ingredient were administered twice at 12-hour interval within 72 hours of the unprotected coitus. However, the single administration increases the compliance and decreases the possibility of incorrect use by women. Regarding side-effects it has the same advantageous properties as the known double dosed composition containing only levonorgestrel for emergency contraception. …"
"1. Pharmaceutical composition as single application dose, characterized by containing 1.5+ 0.2 mg of levonorgestrel as active ingredient in admixture with known excipients, diluents, flavoring or aromatising agents, stabilizers, as well as formulation-promoting or formulation-providing additives, commonly used in the pharmaceutical practice.
2. Use of 1.5+ 0.2 mg levonorgestrel for the preparation of a pharmaceutical for emergency contraception.
3. The use as claimed in claim 2, wherein the pharmaceutical is for the administration of a single application dose up to 72 hours of the coitus."
Table II: Mifepristone and two regimens of levonorgestrel for emergency contraception.
|Group (code unbroken)||Clinical pregnancies||Pregnancy rate||Relative risk||Expected pregnancies||Fraction prevented (%)|
"Mifepristone is used in Shanghai as the emergency contraceptive method of choice, but its introduction into other countries will be hampered by its potential use in much higher doses as an abortifacient.
The most recent WHO study is comparing three regimens: two doses of 750 µg levonorgestrel given 12 h apart; a single dose of 1.5 g levonorgestrel; and a single dose of 10 mg mifepristone. This study is still in progress but an interim comparison between the groups was presented by Dr von Hertzen. The code has yet to be broken but there is, as yet, little difference between the groups (Table II).
There was an interesting debate after the presentations. Dr Ho confirmed that all the pregnancies in the Hong Kong study had been terminated but that there was no evidence that there was any risk of teratogenicity if the women had subsequently wished to continue with their pregnancy.
A criticism from the floor was that the session had not dealt with the use of intrauterine contraceptive devices (IUCDs) for emergency contraception. A recent Chinese study had resulted in no pregnancies after over 2000 insertions, making this method the most effective of all. Dr Glasier agreed, but made the point that total efficacy depends on availability of service and it is difficult to provide frequent IUCD insertion sessions for women who are often young, nulliparous and anxious.
The issue of providing emergency contraception without prescription was debated. Dr Glasier had given an emergency contraceptive preparation to a number of women to keep in their handbag in case of emergency. This had not increased their use of the method.
The suggested summary from the floor was that a single dose of 1.5 g levonorgestrel was the preferred oral method because there was no difference between groups in the most recent WHO study, but Dr Glasier advised great caution with this assumption as the trial was still incomplete. The last few subjects could alter the data and it was wrong to try to guess which group was which, however tempting this might be."
14 The place of "inventive concept" in relation to obviousness also calls for some discussion. It will be recalled that it forms the first step of the well-known Windsurfing Windsurfing International Inc v Tabur Marine (Great Britain) Ltd] test of Oliver L.J.  R.P.C. 59 3 at 73. The test provides a structured approach to the problem and is often useful. I set it out adding my own numbering:
(1) The first step is to identify the inventive concept embodied in the patent in suit.
(2) 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.
(3) The third step is to identify what, if any, differences exist between the matter cited as being "known or used" and the alleged invention.
(4) Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.
15 I think the test requires some restatement and elaboration. First one must actually conduct the first two operations in the opposite order—mantle first, then concept. For it is only through the eyes of the skilled man that one properly understand what such a man would understand the patentee to have meant and thereby set about identifying the concept.
16 Next, that first step actually involves two steps, identification of the attributes of the notional "person skilled in the art" (the statutory term) and second identification of the common general knowledge (cgk) of such a person.
17 What now becomes stage (2), identifying the inventive concept, also needs some elaboration. As I pointed out in Unilever Plc v Chefaro Proprietaries Ltd  R.P.C. 567 at 580:
"It is the inventive concept of the claim in question which must be considered, not some generalised concept to be derived from the specification as a whole. Different claims can, and generally will, have different inventive concepts. The first stage of identification of the concept is likely to be a question of construction: what does the claim mean? It might be thought there is no second stage—the concept is what the claim covers and that is that. But that is too wooden and not what courts, applying Windsurfing stage one, have done. It is too wooden because if one merely construes the claim one does not distinguish between portions which matter and portions which, although limitations on the ambit of the claim, do not. One is trying to identify the essence of the claim in this exercise."
18 So what one is seeking to do is to strip out unnecessary verbiage, to do what Mummery L.J. described as make a précis.
19 In some cases the parties cannot agree on what the concept is. If one is not careful such a disagreement can develop into an unnecessary satellite debate. In the end what matters is/are the difference(s) between what is claimed and the prior art. It is those differences which form the "step" to be considered at stage (4). So if a disagreement about the inventive concept of a claim starts getting too involved, the sensible way to proceed is to forget it and simply to work on the features of the claim.
20 In other cases, however, one need not get into finer points of construction—even without them the concept is fairly apparent—in Windsurfing , for instance, it was the "free sail" concept. In yet other cases it is not even practical to try to identify a concept—a chemical class claim would often be a good example of this.
21 There is one other point to note. Identification of the concept is not the place where one takes into account the prior art. You are not at this point asking what was new. Of course the claim may identify that which was old (often by a pre-characterising clause) and what the patentee thinks is new (if there is characterising clause) but that does not matter at this point.
22 The third step also requires a little reformulation— Windsurfing was a case under the 1949 Act where the statutory words for the prior art were "known or used". The European Patent Convention uses the words "state of the art".
23 The fourth step needs no restatement, though it is worth making explicit that by invention is meant what is claimed. In the result I would restate the Windsurfing questions thus:
(1)(a) Identify the notional "person skilled in the art";
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?
Obviousness: Lions in the path and paper tigers
24 Sometimes a patentee seeks to defend his invention from a charge of obviousness by saying that there was a technical prejudice against it. Such an argument was run here. The judge said:
" Mr Carr submitted that the idea of overcoming a prejudice must consist in overcoming a false prejudice; in other words a mistaken technical belief that deters the unimaginative skilled person from pursuing a particular path. Mr Carr characterised this kind of false belief as a 'lion in the path' (see Bunyan: The Pilgrim's Progress, The Third Stage: 'Fear not the lions, for they are chained, and are placed there for trial of faith where it is, and for discovery of those that have none: keep in the midst of the path, and no hurt shall come unto thee.'). In such a case the patent reveals that the belief was mistaken, and thus contributes to the art. If on the other hand the perceived technical problem exists in the same form both before and after the claimed invention, then the prejudice has not been overcome at all. In such circumstances overcoming the prejudice cannot be part of the inventive concept, although the technical means for dealing with the perceived problem can be. I accept this submission."
25 I would not analyse it that way myself. There is an intellectual oddity about anti-obviousness or anti-anticipation arguments based on "technical prejudice." It is this: a prejudice can only come into play once you have had the idea. You cannot reject an idea as technically unfeasible or impractical unless you have had it first. And if you have had it first, how can the idea be anything other than old or obvious? Yet when a patent demonstrates that an established prejudice is unfounded—that what was considered unfeasible does in fact work, it would be contrary to the point of the patent system to hold the disclosure unpatentable.
26 I put it this way in Union Carbide Corp v BP Chemicals Ltd  RPC 1 , 13:
"Invention can lie in finding out that that which those in the art thought ought not be done, ought to be done. From the point of view of the purpose of patent law it would be odd if there were no patent incentive for those who investigate the prejudices of the prior art."
27 Patentability is justified because the prior idea which was thought not to work must, as a piece of prior art, be taken as it would be understood by the person skilled in the art. He will read it with the prejudice of such a person. So that which forms part of the state of the art really consists of two things in combination, the idea and the prejudice that it would not work or be impractical. A patentee who contributes something new by showing that, contrary to the mistaken prejudice, the idea will work or is practical has shown something new. He has shown that an apparent "lion in the path" is merely a paper tiger. Then his contribution is novel and non-obvious and he deserves his patent.
28 Where, however, the patentee merely patents an old idea thought not to work or to be practical and does not explain how or why, contrary to the prejudice, that it does work or is practical, things are different. Then his patent contributes nothing to human knowledge. The lion remains at least apparent (it may even be real) and the patent cannot be justified.
29 This analysis does not require a different way of looking at the inventive concept depending on whether or not the patentee has shown the prejudice is unjustified as the judge thought at . It is simply that in the former case the patentee has disclosed something novel and non-obvious, and in the latter not. The inventive concept, as I have said, is the essence of what is in the claim and not dependent on any question about a prejudice being overcome."
"89. It is step (4) which is key and requires the court to consider whether the claimed invention was obvious to the skilled but unimaginative addressee at the priority date. He is equipped with the common general knowledge; he is deemed to have read or listened to the prior disclosure properly and in that sense with interest; he has the prejudices, preferences and attitudes of those in the field; and he has no knowledge of the invention.
90. One of the matters which it may be appropriate to take into account is whether it was obvious to try a particular route to an improved product or process. There may be no certainty of success but the skilled person might nevertheless assess the prospects of success as being sufficient to warrant a trial. In some circumstances this may be sufficient to render an invention obvious. On the other hand, there are areas of technology such as pharmaceuticals and biotechnology which are heavily dependent on research, and where workers are faced with many possible avenues to explore but have little idea if any one of them will prove fruitful. Nevertheless they do pursue them in the hope that they will find new and useful products. They plainly would not carry out this work if the prospects of success were so low as not to make them worthwhile. But denial of patent protection in all such cases would act as a significant deterrent to research.
91. For these reasons, the judgments of the courts in England and Wales and of the Boards of Appeal of the EPO often reveal an enquiry by the tribunal into whether it was obvious to pursue a particular approach with a reasonable or fair expectation of success as opposed to a hope to succeed. Whether a route has a reasonable or fair prospect of success will depend upon all the circumstances including an ability rationally to predict a successful outcome, how long the project may take, the extent to which the field is unexplored, the complexity or otherwise of any necessary experiments, whether such experiments can be performed by routine means and whether the skilled person will have to make a series of correct decisions along the way. Lord Hoffmann summarised the position in this way in Conor at :
"In the Court of Appeal, Jacob LJ dealt comprehensively with the question of when an invention could be considered obvious on the ground that it was obvious to try. He correctly summarised the authorities, starting with the judgment of Diplock LJ in Johns-Manville Corporation's Patent  RPC 479, by saying that the notion of something being obvious to try was useful only in a case where there was a fair expectation of success. How much of an expectation would be needed depended on the particular facts of the case."
92. Moreover, whether a route is obvious to try is only one of many considerations which it may be appropriate for the court to take into account. In Generics (UK) Ltd v H Lundbeck,  EWCA Civ 311,  RPC 19, at  and in Conor  UKHL 49,  RPC 28 at , Lord Hoffmann approved this statement of principle which I made at first instance in Lundbeck:
"The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success."
93. Ultimately the court has to evaluate all the relevant circumstances in order to answer a single and relatively simple question of fact: was it obvious to the skilled but unimaginative addressee to make a product or carry out a process falling within the claim. As Aldous LJ said in Norton Healthcare v Beecham Group Plc (unreported, 19 June 1997):
"Each case depends upon the invention and the surrounding facts. No formula can be substituted for the words of the statute. In every case the Court has to weigh up the evidence and decide whether the invention was obvious. This is the statutory task."
Pozzoli step (1)
"A patent specification is addressed to those likely to have a practical interest in the subject matter of the invention, and such persons are those with practical knowledge and experience of the kind of work in which the invention is intended to be used. The addressee comes to a reading of the specification with the common general knowledge of persons skilled in the relevant art, and he or she reads it knowing that its purpose is to describe and demarcate an invention. He (or she) is unimaginative and has no inventive capacity. In some cases the patent is addressed to a team of persons with different skills."
i) The Patent is for a new regimen for use of a drug (levonorgestrel) which was already known to be an effective emergency contraceptive when used in a two dose regimen. The natural and obvious addressee of the Patent is the person with a practical interest in making use of the new regimen, namely a clinician practising in the field of emergency contraception;
ii) The description in the Patent of the new regimen, how it emerged from the WHO research study and regarding the evidence for its effectiveness is all directed at the level of understanding of such a clinician. The claims regarding the incidence and type of side-effects and the equivalent effectiveness of the one dose and two dose regimens (see paras. - of the Patent) are not complex or difficult to understand. Such references as they contain to statistical concepts (e.g. "statistical significance cannot be proven", in para. ; "The incidence of other side-effects … was also not differing significantly", in para. ) were well within the scope of understanding of medical statistics which an ordinary clinician would acquire as part of their basic medical training, as Professor Bland explained it in his evidence, and in line with Professor Sasieni's evidence;
iii) The point at (ii) above is reinforced by the fact that aspects of the claims of efficacy set out in the Patent are not made with the rigour which one would expect an expert medical statistician to employ, but are pitched at an audience operating at a more general level of understanding. In particular, Professor Bland confirmed the point put to him in cross-examination, that a statistician would not have regarded the statement made at the end of para.  ("The results of the trial proved [etc]…") as one which was justified in medical statistical terms, having regard to the nature of the trial and the comparison being made. Professor Sasieni pointed out that the Patent does not include any statistical analyses or complex statistical concepts;
iv) A clinician, as the primary addressee of the teaching in the Patent, would not feel any need to have resort to a specialist medical statistician either to understand that teaching or to have the confidence to put it into practice. The description of the trial indicates that it was a properly designed and conducted trial. There would be no reason for a clinician to doubt that the trial design and the interpretation of the results had been conducted with proper statistical rigour by the team carrying out the trial, without the clinician feeling any need to reconstruct and understand the detail of it any further than as set out in the Patent itself. If a clinician did wish to go back to the underlying research in more detail, they would discover that it was a trial carried out by a leading clinician in the field under the auspices of the WHO. The clinician would have full confidence that they could rely on the Patent and put the new regimen into practice without feeling any need to take matters up with an expert medical statistician;
v) Concepts of statistical significance are not the determining guide for use of the teaching in the Patent. As Mr Kubba and Professor Sasieni explained, statistical analysis may indicate results which are statistically significant (i.e. unlikely to be attributable simply to chance), yet at a level which a clinician would regard as having no significant bearing on treatment and no clinical relevance. For the teaching in the Patent, on the basis of there being a sufficient indication of broad equivalence in efficacy and incidence of side-effects as between the two dose and the one dose regimens for use of levonorgestrel (which would be capable of assessment by a relevant clinician, as explained above), any minor but statistically significant differences in outcome between them would be subordinate to a clinical assessment regarding whether to proceed to use the one dose regimen, and if judged not to be of clinical relevance would not be such as to inhibit use of the invention in the Patent. Thus, although Professor Bland pointed out that a statistical confidence interval analysis in relation to the results given in Table II in the Killick article would indicate that the data were consistent with either a doubling or a halving of the risk of pregnancy for the first group (A) compared to the second (B) and a doubling or reduction by a quarter for the third group (C) compared to either of the others (and, of course, the reader did not know which group was testing which treatment), a clinician could still (as Mr Kubba indicated) derive from the information presented the idea that the treatments were sufficiently similar in their efficacy, having regard to the small differences between them in terms of absolute risk of failure (as distinct from relative risk), as to make any of them viable for clinical use for emergency contraception, when weighed together with other clinically-relevant benefits they might offer.
"… even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge."
Arnold J's review of the law, and in particular para. , was approved by the Court of Appeal on the appeal in that case:  EWCA Civ 1260;  FSR 8, at .
Pozzoli step (2)
Pozzoli step (3)
Pozzoli step (4)
(2) Lack of sufficiency