Istituto Gentili SpA Merck & Co. Inc. v Teva Pharmaceutical Industries Ltd. & Ors

Bone consists of calcium phosphate within an organic matrix made primarily of the protein collagen. It is renewed by a process of remodelling whereby old bone is resorbed (that is removed) by cells called osteoclasts and replaced by new bone by means of cells called osteoblasts. Normally the two processes balance each other but an imbalance can lead to the conditions known as osteoporosis, Paget’s disease and osteomalacia. A similar disorder of ectopic calcification called urolithiasis relates to the formation of gall and kidney stones.

The first appellant, Istituto Gentili SpA, is the patentee in relation to UK Patent No:2 118 042, for which the priority date is 15th April 1982, entitled “Pharmaceutical compositions containing pharmacologically active bisphosphonates”. The specification states that such a composition is “suitable for the treatment of urolithiasis and capable of inhibiting the bone reabsorption”. The validity of one or more claims in this patent were challenged by the respondents on grounds of want of novelty and obviousness. In respect of want of novelty they claimed that claim 1 had been anticipated by the publication in November 1981 of European Patent Application No:0 039 033A (“Blum”). In relation to obviousness they relied on common general knowledge and, amongst other prior publications, (i) Blum, (ii) a paper entitled “Synthesis and acid-base and complexing properties of [certain bisphosphonates]” by Kabachnik and others published in February 1978 and the paper by Yu.E.Vel’tischev and others specified in note 3 thereto (“Kabachnik”) and (iii) a paper by Fleisch and others, published in 1981, entitled “Disphosphonates: History and Mechanisms of Action” (“Fleisch”).

The second appellant, Merck & Co Inc., is the patentee in relation to European Patent (UK) 0 998 292, for which the priority date is July 1997, in respect of an invention claimed as “use of alendronic acid...for the manufacture of a medicament inhibiting bone resorption for treating osteoporosis...adapted for oral administration in a unit dosage form which comprises about 70mg of alendronic....acid...” The respondents contended that this patent is invalidated by s.4(2) Patents Act 1977 on the grounds that the invention is for “a method of treatment of the human..body..by therapy”. They also alleged that it lacked novelty and was obvious by reference to publications of ‘Lunar News’ in April and July 1996.

The various proceedings relating to both patents were heard together by Jacob J in November 2002. By his order made on 23rd January 2003 he revoked both patents and gave the patentees permission to appeal. In relation to the first patent (“042”) he held that claim 1 was anticipated by Blum and that claims 1, 2 and 7 were obvious by reference to each of Blum, Kabachnik and Fleisch. In relation to the second patent (“292”) he interpreted claim 1 as referring to a particular dosing regime not the preparation of a single dose of 70mg of alendronate. On the basis of that construction and applying the decision of the Court of Appeal in Bristol-Myers Squibb v Baker Norton [2001] RPC 1 he concluded that s.4(2) rendered the patent invalid. In addition he found that 292 lacked novelty and was obvious on all the grounds alleged.

The respective patentees appealed against each of these conclusions. In addition Merck sought permission to amend 292 so as to delete three paragraphs of the specification referred to by Jacob J on the issue of construction relevant to s.4(2). In relation to 042 Counsel for the patentee accepted that if the order revoking that patent was to be set aside then he had to satisfy us that Jacob J was wrong on both want of novelty and obviousness by reference to each of Blum, Kabachnik and Fleisch. Having heard argument from both sides on want of novelty and obviousness by reference to Blum we indicated that we were satisfied that the judge was right so that further argument on obviousness by reference to Kabachnik or Fleisch was not necessary for the conclusion of the appeal. Accordingly I express no view on whether Jacob J was right in respect of the latter issues.

In relation to 292 it was apparent from the written arguments that if Jacob J was right on the interpretation of the claim and the application of s.4(2) then the issues of want of novelty and obviousness did not arise either. Accordingly we heard argument from both sides on whether or not permission to amend the specification should be granted, whether or not the judge was right on the issue of construction and whether or not on the basis of that construction he correctly applied s.4(2). We concluded that permission to amend should be refused and that Jacob J was right on both the issue of construction and the application of s.4(2). On this basis want of novelty was conceded. I should record, in case the matter goes further, that counsel for the appellants reserved for future argument the question whether Bristol-Myers Squibb v Baker Norton [2001] RPC 1 had been correctly decided. The issue of obviousness by reference to either issue of Lunar News was neither argued nor conceded and I express no view on it.

Accordingly in this judgment I give my reasons for concluding that:

I start with an explanation of what bisphosphonates are. I have taken it from paragraphs 4 to 8 of the judgment of Jacob J supplemented by the document setting out the parties’ contentions on common general knowledge put before him at the trial. Bisphosphonates are synthetic compounds. They have not been found to occur naturally. They are characterised by two carbon-phosphorus bonds. There are no known enzymes that can cleave such bonds with the consequence that bisphosphonates are absorbed, stored and excreted from the body unaltered. Their physiochemical effect is similar to that of pyrophosphate in that they bind strongly to the surface of solid-phase calcium phosphate and by doing so inhibit the formation, delay the aggregation and slow down the dissolution of calcium phosphate crystals.

The P-C-P bisphosphonates with which this case is concerned have the following general chemical structure:

The two R groups can be varied. By 1982 three bisphosphonates had been studied clinically. Their structures and shortened chemical names were as follows:

Alendronate, with which this case is concerned, is similar to pamidronate, save that the alkyl chain is one C longer. It is the C₄ compound. So its structure is:

Other aminohydroxybisphosphonates featuring in the case are the C₅ and the C_6. The former has no short name so I will refer to it as “Anondronate”, the latter is called neridronate. In a number of places different terminology is used. To simplify matters I have, like Jacob J, used the above-names wherever possible, including in quotations from the patents.

The first reported clinical uses of bisphosphonates to treat bone disorders were in the late 1960s/early 1970s with publications in the Lancet and elsewhere on clinical trials involving the use of etidronate to treat heterotopic ossification and Paget’s disease. The first reported clinical use of pamidronate to treat Paget’s disease was in the late 1970s and of clodronate was in 1979/80. The main pharmacological effect of bisphosphonates is to inhibit bone resorption and this is the basis of their therapeutic activity. Inhibition of bone mineralisation was known to occur especially with etidronate, but there was a narrow therapeutic window between doses required to inhibit bone resorption and those that impaired bone mineralisation.

It is not suggested that the state of the art altered materially between the publication of Blum in November 1981 and the priority date of 042 in April 1982. Accordingly it is appropriate to describe at this stage the extent of common general knowledge, as found by Jacob J, in April 1982. As set out in paragraph 28 of his judgment it included the following matters:

As I have already indicated Blum is a European Patent Application which was published on 4th November 1981. It is described as a better way of making C₄, C₅, and C₆ bisphosphonates. It states

As I have also indicated the title of the invention is “Pharmaceutical compositions containing pharmacologically active bisphosphonates”. The priority date is 15th April 1982. It starts with the statement that

There follows a lengthy passage to which Jacob J referred in paragraphs 18 to 22 dealing with the composition of R₁ and R₂ as shown in the general formula. Jacob J pointed out some oddities in this passage which I do not need to repeat. But it is relevant to note, as he observed, that the specification did not acknowledge that

In relation to certain pharmacological tests the specification states

The relevant claims are as follows:

The first issue referred to in paragraph 7 above is whether claim 1 of 042 was wanting in novelty or, as it is sometimes put, was anticipated by Blum. The relevant statutory provisions are contained in ss.1(1)(a) and 2(1) and (2) Patents Act 1977. They provide that

It is common ground before us, as it was before Jacob J, that the principles to be applied in accordance with the Act are as described by Sachs LJ in giving the judgment of the Court in The General Tire Company v The Firestone Tyre and Rubber Co Ltd [1972] RPC 457. Though long the passage is worth quoting in full. At page 485 he said

Having referred to this passage and the relevant excerpt from Blum Jacob J expressed his conclusion in the following terms:

The patentee submits that Jacob J was wrong. The argument is summarised in the written argument of counsel for the patentee as follows:

I can deal with the second and third points quite shortly. The suggestion that the judge ignored the reference to cosmetic preparations implies that he should have read the passage conjunctively so that Blum was referring to the production of preparations which were both cosmetic and pharmaceutical. So read the relevant property of the bisphosphonate was that of a complexing agent. In my view so to interpret Blum would be to ignore both the usual principles of interpretation and the state of the art. There is nothing in Blum itself to support such an interpretation and, as the judge concluded, the skilled man would not so understand it. In any event the state of the art and common general knowledge included the use of etidronate in the treatment of Paget’s disease. Such use was pharmaceutical but not cosmetic.

Counsel for the respondents submitted that the distinction suggested by the third point is without a difference because what the skilled man thought on reading Blum is the same as what Blum teaches. I understood from the oral submissions of counsel for the patentee that the point is that made by Sachs LJ in the last two sentences of the quotation from the judgment of the court in General Tire set out in paragraph 21 above. Does Blum contain clear and unmistakeable directions to do what is set out in claim 1 of 042? But so formulated the point is the same as that summarised in paragraph (i).

The argument on that point as developed orally was that in the passage relied on in Blum the reference to “Owing to their properties...” is a reference to their complexing power which would bring to the mind of the skilled man the possibility of inhibiting mineralisation and therefore narrowing, possibly to the point of extinction, the therapeutic window referred to in paragraph 14(d) above. Accordingly, so it was submitted, the skilled man would not read it as a direction to make and use the preparation in the treatment of bone disorders. Similarly counsel for the patentee relied on the omission of any statement in Blum as to the use for which the pharmaceutical preparation was suitable and should be devoted nor how and for what purpose C₄, C₅ or C₆ should be used in its preparation. Specifically the patentee relied on the fact that Blum does not direct the use of C₄ as an active ingredient.

In support of this submission we were referred to the evidence of Professor Russell, currently Norman Collison Professor of Musculoskeletal Sciences at Oxford Medical School, the expert witness for the respondents. It is clear that his evidence was preferred by the judge to that of Professor Papapoulos, Professor of Medicine and Director of Bone and Mineral Research at Leiden University, the expert witness for the patentee. Jacob J described the evidence of the latter as “rather rigid and a little extreme”. In both his witness statement and under cross-examination Professor Russell referred to “the potential use” of the compounds referred to in Blum for some clinical application. This, it was argued, is not a sufficiently clear and unmistakeable direction.

Ultimately the issue was one of fact for the judge. In my view he was right for the reasons he gave. In deference to the argument of counsel before us I would amplify them somewhat. First, the direction in Blum was to use all three bisphosphonates, in particular C₄, in the production of a pharmaceutical preparation. Second, the evidence showed that those bisphosphonates had never been used in such a preparation in any way other than as the active ingredient. This is why the judge said in paragraph 33(b) of his judgment that the idea of some other use would not cross the mind of the skilled man. In addition he pointed out in paragraph 33(d) that use as a stabiliser would be unthinkable. Third, the skilled man would know of the uses of etidronate and pamidronate in the treatment of bone disorders. Accordingly, if and in so far as it is necessary to show that Blum was indicating not only a pharmaceutical use as an active ingredient but also that it should be used in the treatment of bone disorders this would be clearly understood by the skilled man. Even if use in the treatment of bone disorders was not known, use in the treatment of ectopic calcification was. That was also a pharmaceutical use even if of historical interest only. Fourth, the fact that Professor Russell referred to “the potential use of these compounds for clinical applications to treat medical disorders of excess bone destruction” does not detract from the fact that there was a clear and unmistakeable direction to use them as active ingredients in the production of a pharmaceutical preparation. The extent to which such preparations may, in the event, prove to be clinically valuable does not detract from the nature or clearness of that direction.

In summary, therefore, I agree with the judge on his factual conclusion. In any event it is clear that there was ample evidence to support it. That conclusion is sufficient to justify the dismissal of the patentee’s appeal in respect of claim 1 of 042. But as we heard full argument on the question of obviousness by reference to Blum I should deal with that issue too in relation to claim 1 as well as claims 2 and 7.

The relevant provisions of Patents Act 1977 are ss.1(1)(b) and 3. They provide that

It is common ground that the principles to be applied in accordance with the Act are as described by Oliver LJ in giving the judgment of the court in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59. At page 73 he said

In David J. Instance v Denny Bros Printing Ltd [2002] RPC 14 Aldous LJ, with whom the other members of the court agreed, pointed out (paragraph 16) that though the structured approach of Windsurfing is useful it is not essential provided that the judge dons the mantle of the skilled man and asks himself the right question. He also pointed out that the approach of an appellate court to questions of obviousness should be that indicated by the House of Lords in Designers Guild Ltd v Russell Williams (Textiles) Ltd [2001] FSR 11, namely

The reasoning and conclusion of Jacob J are set out in paragraphs 36 to 40 of his judgment. He said

The patentee contends that Jacob J was wrong. A helpful summary of counsel’s submission is contained in paragraph 88 of their written argument. They submit

In support of this submission we were referred to a number of authorities to the effect that the next step must be considered to be at least worthwhile if it is to be obvious. Thus in Johns-Manville Corporation’s Patent [1967] RPC 479, 493 Diplock LJ described it as “well worth trying out”, in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346, Lord Reid described it as “worth trying” and in Norton Healthcare Ltd v Beecham Group plc (Court of Appeal 19th June 1997 unreported) Aldous LJ pointed to the need in cases where it was necessary to show that it was obvious to try the next step that there was “an expectation of a good result”.

Counsel for the patentee again relied on the evidence of Professor Russell as to the “potential use” of the compounds referred to in Blum for some clinical application. What he asked rhetorically is there in Blum pointing to C₄, C₅ and C₆ for testing as opposed to all the other bisphosphonates? The fact that they were potential candidates is not, he submitted, enough.

The answer to that rhetorical question lies in the evidence of Professor Russell. In his first report (para 5.8) he said:

Professor Russell was extensively cross-examined by leading counsel for the patentee, but did not qualify the evidence in his reports I have quoted in the previous paragraph. With regard to the last sentence of Blum quoted in paragraph 15 above he said:

Counsel then suggested to Professor Russell that there would be no expectation that the bisphosphonates in the Blum patent [C₄, C₅, and C₆] would be likely to have as good or better potency with less side-effects than pamidronate itself. He replied:

I consider that this evidence from a person the judge described as “a fair and in my view objective witness” showed quite clearly that C₄ was “worth trying” as indicated in the dicta to which I have referred in paragraph 35 above. Accordingly there was evidence to justify the judge’s conclusions in paragraphs 37-39 of his judgment which I have quoted in paragraph 33 above. In my view the judge was entitled, having formed the views of the evidence of Professors Russell and Papapoulos to which I have already referred, to accept the evidence of the former in preference to that of the latter. Further he was fully entitled to prefer the oral evidence of Professor Russell to the opinion of Professor Fleisch expressed in an article published in 1983 on which he, that is Professor Fleisch, had not been cross-examined. I see no ground for interfering with the judge’s decision on what, in the end of the day, is a question of fact even if, as I understood to be conceded (Transcript Day 2 page 103 lines 13-18 and Day 3 page 36 line 20 to page 37 line 7), the judge’s reliance on Dr Newton in paragraph 39 was misplaced if and in so far as it related to Blum rather than Fleisch. Accordingly the patentee’s appeal from the order of Jacob J revoking 042 fails on this ground also.

As Jacob J recorded, things had moved on between the priority date of 042 in April 1982 and the priority date of 292 in July 1997. By the latter date common general knowledge included the following matters:

292 was described in its title as a “Method for Inhibiting Bone Resorption”. Claim 1 in its original form was

In both the original and amended versions of the specification paragraphs 0108, 0109 and 0110 stated:

In his judgment Jacob J dealt first with a question of interpretation of the claim. In paragraphs 69 and 70 he said:

On 6th October 2003, that is 15 days before the hearing of this appeal started, the patentee applied to amend the specification to delete paragraphs 0108 to 0110. This was opposed by the respondents on the grounds that the amendment was unnecessary or, if necessary, was precluded by s.76(3)(a) Patents Act 1977 or should be refused as a matter of discretion under s.75(1).

S.76(3)(a) precludes an amendment to the specification “if it...results in the specification disclosing additional matter”. Counsel for the respondents submitted that the proposed amendment disclosed additional matter. The additional matter relied on would be the further teaching of the importance of the quantity of the single dose. Instead of any number of pills aggregating a dose of about 70mg it would teach that a single pill comprising 70mg of alendronate was essential. This was disputed by counsel for the patentee. He contended that the proposed amendment would not add matter at all. By contrast it would restrict the ambit of claim 1.

In my view it is necessary to approach this question on the assumption that the amendment, if made, will affect the interpretation of claim 1. But in that event it will be seen that the deletion of the three paragraphs in question adds to the teaching of the patent by pointing out the importance, as claimed, of a single pill or other administration comprising 70mg or thereabouts of alendronate. It is true that such an addition will have the effect of restricting the ambit of claim 1. The decision of Aldous J in Bonzel v Intervention (No.3) [1991] RPC 553, 574 shows that what is material is the addition of any subject matter relevant to the claimed invention and that such addition may be accomplished by either addition to or deletion from the specification.

On that basis in my view the objection taken under s.76(3)(a) is well founded. If the question is, as counsel for the patentee submitted, whether the proposed amendment would widen or restrict the scope of the claim then it would not be precluded by the subsection. But that is not the question. The right question is whether the proposed amendment would result in the specification disclosing additional matter. The basis on which I am considering this issue, namely that the amendment will alter the scope of claim 1, indicates that the answer must be in the affirmative. It adds to the teaching of the patent the requirement for a single pill or other administration vehicle comprising 70mg of alendronate. The fact that it does so by deletion is neither here nor there.

In addition I consider that the application should be refused as a matter of discretion under s.75 Patents Act 1977. The amendment now sought goes well beyond that allowed by Jacob J at the trial. It was made two weeks before the hearing of this appeal. No explanation has been forthcoming as to why it was not sought at the time of the application for the first amendment nor why the application is made now, nearly nine months after the judgment of Jacob J.

I have quoted the relevant passages in the judgment of Jacob J in paragraph 44 above. Counsel for the patentee contends that the judge was wrong to conclude that the claim was to a particular dosing regime. He points out that in October 1995 the patentee marketed alendronate under the trade name of Fosamax as a 10mg daily dose for the treatment of osteoporosis. Instructions for its use indicated that it had to be taken with a glass of water first thing in the morning not less than 30 minutes before any food or drink was consumed with the patient remaining in an upright position for 30 minutes thereafter. Problems with oesophagitis came to the patentee’s notice in March 1996. This led to the issue of further instructions emphasising the importance of observing the instructions for use.

292 as first amended describes the field of the invention in paragraph [0001] as relating to

In paragraph [0047] it is stated that

Counsel for the patentee emphasises that the claim is for “oral administration in a unit dosage form which comprises about 70mg of alendronic [acid]..” He contends that the addition of the word “unit” shows that a single administration of 70mg of alendronate is required. He relies on definitions of the word “unit” appearing in the 10th Edition of The Concise Oxford English Dictionary and volume XIX of the 2nd Edition of the Oxford English Dictionary. He submits that none of the meanings appearing in either dictionary envisages multi-dosing in more than one unit aggregating 70mg of alendronate.

I am unable to accept this submission. S.125(3) Patents Act 1977 enjoins us to apply the Protocol on the Interpretation of Article 69 of the European Patent Convention. That provides that

S.125(1) Patents Act 1977 provides that the invention is to be taken to be that

Nowhere in the lengthy specification is there any suggestion that there is merit in taking a single pill comprising 70mg of alendronate, rather than 2 of 35 mg each or any other combination aggregating a dose of 70mg. It is hard to see how such a method of administration could be translated into taking the medicament in liquid form as envisaged by claim 5. Moreover if the claims were so interpreted, in the absence of the provisions of s.4(2) Patents Act 1977 they would scarcely provide the fair protection for the patentee the protocol envisages. Counsel for the patentee accepted that on his interpretation the administration of two pills one of 60mg and the other of 10mg of alendronate would not infringe the patent. Further the word “unit” in a medical or scientific context is apt to connote quantity, dimension or other magnitude. This is evident from such well known works as Black’s Medical Dictionary as well as the Oxford English Dictionary to which we were referred. Accordingly even though claim 1 refers to “a unit dosage form which comprises about 70mg of alendronate” the word unit does not require the administration of a single pill or other dosage form as opposed to an aggregate, however made up, of 70mg of alendronate.

Were there any doubt about the matter, and I do not think there is, then the provisions of paragraphs [0108] to [0110] would resolve it in favour of the respondents. Indeed the very fact that no application to amend the specification so as to exclude these paragraphs until two weeks before the hearing of this appeal indicates that they were regarded as consistent with the other provisions of the specification.

Accordingly I conclude that the judge was right on the interpretation of the patent for the reasons he gave. It follows from this interpretation, as was conceded, that claim 1 is not novel. There were in existence pills containing 10mg and other quantities. A 70mg pill could not be new in the sense required by s.2 Patents Act 1977.

In paragraph 80 of his judgment Jacob J concluded with regret that on the basis of his interpretation of claim 1 and applying the decision of this court in Bristol-Myers Squibb v Baker Norton [2001] RPC 1 s.4(2) applied so as to deny patent protection to the claimed invention. As I have indicated the patentee recognises that we are bound by that decision and having upheld the judge on the question of interpretation are bound to reach the same result. As I have also indicated the patentee reserves the right to contend elsewhere that Bristol-Myers Squibb v Baker Norton was wrongly decided.

For all these reasons I conclude that:

Like Buxton LJ I am concerned that the role of this court has once again not been fully appreciated by the patentees. An immense amount of paper was produced which could not have been relevant to any issue of principle. We heard much argument which, on analysis, did not amount to more than a contention that the judge had wrongly decided the facts. I agree that the practice suggested by Buxton LJ should be adopted in all appeals of this nature. It appears to me that the issue might usefully be considered by the Civil Procedure Rule Committee with a view to amending Rule 52 or the practice direction supplementing that rule both in respect of patent appeals and also all other appeals in which the principle applied by the House of Lords in Designers Guild Ltd v Russell Williams (Textiles) Ltd [2001] FSR 11 and by this court in David J. Instance v Denny Bros Printing Ltd [2002] RPC 14 is material.

I agree that this appeal should be dismissed for the reasons given by the Vice-Chancellor. I add only a few words on a point of procedure.

This appeal obliges the court to set out yet again its proper role when faced with appeals in patent cases that complain of findings by the trial judge on issues of fact, and on issues of judgement in particular relating to anticipation and obviousness. Although the law as to the court’s powers is clearly settled, the present appeal showed that the practice in this area still does not in every respect comply with that law. I therefore venture some observations about how such cases should be conducted in the future.

The appellants correctly recognised the guidance given by this court in Instance v Denny [2002] RPC 14[15], supported by many other cases, including the authority of the House of Lords in Designers Guild v Russell Williams (Textiles) [2001] FSR 11, that this court should interfere with the view of the trial judge only if he can be shown to have erred “in principle”. The latter phrase has never been defined, and probably cannot be and does not need to be. At the least, however, it can be said that an error of principle can only arise if the judge has departed from a rule or practice that applies also outside the boundaries of the facts of the instant case; that rule or practice can be coherently encapsulated in verbal form; and can be demonstrated to be binding on the judge. In particular, it is likely to be very difficult to establish that such matters of principle are involved in decisions made by the judge in assessing technical evidence and its bearing on the issues that he has to decide.

The Grounds of Appeal frequently, though not invariably, preceded their complaints by asserting that the judge erred “in principle”, but in no case was the relevant principle identified or justified in the manner outlined above, and some assertions were made that on no view could involve errors of principle. Thus, the judge was said to be “wrong” [Grounds of Appeal, §19] in not acting on the papers generated by the CEMO conference in relation to the issue of the activity of neridronate (despite the evidence of Professor Russell and Dr Newton having criticised the conclusions drawn from those papers); he was said to have “wrongly evaluated the evidence” [Grounds of Appeal, §30] in relation to the obviousness of the 292 patent; and he was said to have been “wrong to conclude” on the evidence that in the light of Fleisch no avenue of investigation other than alendronate readily suggested itself.

In other cases, whilst there might have been a matter of principle involved, it was difficult to extract what that principle was. Thus, in §5 the Grounds complained that the judge “erred as a matter of principle….in holding that a medicinal chemist would form part of a notional research team constituting the “skilled man”’. The objection appeared to be that medicinal chemists were not working in “the field” (scil., of bisphosphonates) at the priority date of the 042 patent because pharmaceutical companies were not working in that field. That submission has very wide implications, and if correct as a matter of principle would seem to protect any step from one field of application to another against an attack on grounds of obviousness. The complaint was in any event unfounded, for the reasons given by the judge in §26 of the judgment. Its nature would however have been much easier to understand if the “principle” said to have been infringed by the judge had been spelled out.

Next, in some cases “principles” were stated or implied, but not then acted on. The appellants complained [Grounds, § 3(iii)] that the judge had wrongly construed Blum, by giving no or no sufficient weight to the words “owing to their properties”. It would no doubt be an error of principle simply to ignore a phrase in a document; but the judge certainly did attend to the properties described by Blum, and sets them out in §31 of his judgment In truth, as §10 of the Grounds showed, the complaint was not in the general terms asserted in § 3(iii) of the Grounds, but rather that the judge failed to draw the conclusion, urged on him by the appellant, but as my Lord points out in §27 above contrary to the evidence before him, that the high complexing powers referred to in Blum’s description indicated that the preparation had no relevance to use as an active agent in bone resorption. That did not involve any issue of principle, but only a matter of judgement well within the peculiar sphere of the judge. Somewhat similarly, the error of principle in alleged in § 3(ii) of the Grounds in identifying the common general knowledge in relation to the 042 patent turned out [Grounds of Appeal, §8] to consist simply of a failure to accept within the knowledge various matters asserted by the Appellants.

Apart from issues relating to patent 292 that do not arise for decision I have succeeded in identifying only three complaints within the Grounds that could properly be said to raise issues of principle. Those are

Failure to construe claim 1 of patent 292 according to its literal wording

Failure to take into account the motivation of the skilled man [Grounds, §14]

In assessing anticipation, considering ‘what the “skilled man” would think about [the] disclosed properties” [Grounds, §11].

Not even all of these, so stated, proved on inspection to involve any, or at least any supportable, point of principle. Had the appellant been required to set out authority for point (ii), it would rapidly have become apparent that there is no such principle as stated. That is clear not least from the observations of this court in Pharmacia v Merck [2002] RPC 41 [123]-[124]. Rather, the complaint was, again, as to the judge’s assessment of the evidence: a complaint that, as my Lord has demonstrated in §§ 34-40 above, was not open to the appellants. Point (iii) proved, during argument, not to be an independent issue at all: see §25 above. Here again, had the provenance and authority for the principle been set out, the true nature of the complaint would have been immediately apparent.

In the light of experience in this appeal, I would venture to suggest that in future, when it is sought to challenge the trial judge’s conclusions on anticipation or obviousness, the Grounds of Appeal should, in respect of each complaint, contain a succinct statement of the principle that the judge is said to have infringed. It should further be demonstrated, unless the matter is self-evident, what is the authority for that principle. I have already indicated in the context of this appeal a number of instances in which that requirement, if applied, would have produced a much clearer understanding of the issues.

If such a discipline is adopted, it may well become apparent that many of the complaints are unsustainable. That would have the effect that the jurisprudence of this court and of the House of Lords in respect of such appeals would be honoured in practice as well as in theory. It should also produced a much more economic and focussed disposal of the appeal; for instance, in the present case, it would not have been thought necessary to copy for the court 21 files, containing in effect all of the material that had been before the trial judge.

I would further venture to suggest that trial judges may wish to have this approach in mind when considering whether to grant permission to appeal. I appreciate that it may not be appropriate at that stage to produce full Grounds of Appeal, but counsel might be asked to demonstrate, before permission is granted, that issues of principle will indeed be engaged in the appeal.

I agree with both judgments and have nothing to add.