Patents - Pfizer Ltd v GlaxoSmithKline Biological
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| Human Respiratory Syncytial Virus |
Patents Court (Mr Justice Mellor) Pfizer Ltd v GlaxoSmithKline Biologicals SA and another 2024] EWHC 2523 (Pat) (07 Oct 2024) Pfizer Ltd v GlaxoSmithKline Biologicals SA and another [2025] EWHC 52 (Pat) (16 Jan 2025)
This was a claim by Pfizer Ltd. ("Pfizer") for the revocation of EP (UK) 3 109 258 ("258") and EP (UK) 2 222 710 ("710") under s.72 (1) (a) of the Patents Act 1977 on the grounds that the inventions for which those patents were granted were not patentable. The patents were held by GlaxoSmithKline Biologicals SA and ID Biomedical Corporation of Quebec (collectively "GSK"). The reason for the litigation was that both Pfizer and GSK had developed vaccines for respiratory syncytial virus ("RSV") that were about to receive marketing approval in the UK. Pfizer challenged the validity of GSK's patents in order to clear the way for the launch of its own RSVPreF vaccine. GSK's response was that Pfizer's vaccine infringed both 258 and 710 and it counterclaimed for injunctions and other relief. The action and counterclaim came on for trial before Mr Justice Mellor in June 2023. He handed down judgment on 7 Oct 2024. In para [844] of his judgment, he held that the patents were invalid for obviousness and dismissed the counterclaim for infringement. His lordship delivered a further judgment on costs, interim payment, confidentiality and permission to appeal on 16 Jan 2025.
Revocation
S.72 (1) (a) of the Patents Act 1977 enables the High Court or the Comptroller-General of Patents, Designs and Trade Marks to revoke a patent on the grounds that the invention is not patentable. The conditions of patentability are listed in s.1 (1) of the Patents Act. One of those conditions is that the invention is new. Another is that the invention involves an inventive step. A patent can also be revoked under s.72 (1) (c) if the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.
Grounds of Revocation
Pfizer applied for the revocation of 258 on the ground that it lacked novelty over International application PCT/US2008/066223 ("WO456") for Methods and compositions relating to viral fusion proteins. It also alleged that both patents lacked an inventive step in that they were obvious over the following items of prior art:
ii) The public presentation Structures of the pre- and post-entry paramyxovirus F protein: implications for RSV vaccine and therapeutic development delivered by Prof Jardetzky at the RSV Symposium (the "Jardetzky Slides") (it is common ground that this would be read together with the Jardetzky Abstract);
iii) The oral disclosure of Prof Jardetzky which accompanied his slides in the Jardetzky Presentation (the "Oral Disclosure"). The nature of the Oral Disclosure is in dispute and is the subject of Prof Jardetzky's evidence;
iv) Structure of the parainfluenza virus 5 F protein in its metastable, prefusion conformation, Yin HS, Wen X, Paterson RG, Lamb RA, Jardetzky TS., Nature 2006 Jan 5; 439(7072):38-44 ("Yin"); and
v) The abstract entitled Generation of Soluble Respiratory Syncytial Virus Fusion Glycoprotein contained within the programme booklet from the 26th Annual Meeting of the American Society for Virology held at Oregon State University on 14 to 18 July 2007 (the "ASV Abstract").
"i) First, at [111]: 'A claim lacks novelty if it covers something that formed part of the state of the art at the priority date'.
ii) Second, at [112]: 'The teaching of the specification, once construed, is a pure question of fact, as is what the skilled man would do with that teaching without the exercise of inventive ingenuity.'
iii) Third, at [128]: 'As ever, the question is what is explicitly disclosed and what also is necessarily implicit in the teaching. The skilled man must be taken to read documents in an intelligent way, seeking to find what is disclosed as a matter of substance.'"
"A recombinant respiratory syncytial virus (RSV) antigen which assembles into a trimer, comprising a soluble F protein polypeptide comprising an F2 domain and an F1 domain of an RSV F protein polypeptide and comprising an amino acid sequence comprising a heterologous trimerization domain positioned C-terminal to the F1 domain that stabilizes the prefusion conformation of the F protein."
"...... 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."
"In addressing the statutory question of obviousness in section 3 of the 1977 Act it is common for English courts to adopt the so-called Windsurfing/Pozzoli structure which asks these questions
'(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?'
(Pozzoli SPA v BDMO SA [2007] EWCA Civ 588; [2007] FSR 37, para 23 per Jacob LJ)."
He explained:
"The fourth question is the statutory question and the first three questions or tasks, the second and third of which involve knowledge and consideration of the invention, are a means of disciplining the court’s approach to that fourth question: DSM NV’s Patent [2001] RPC 35, para 55 per Neuberger J; Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82; [2010] FSR 18, para 21 per Jacob LJ."
"The classic modern exposition of the law as to what constitutes common general knowledge is contained in the following repeatedly-cited passage from the judgment of Aldous LJ, building on earlier authorities, in Beloit Technologies Inc v Valmet Paper Machinery Inc [1997] RPC 489 at 494-495:
'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 court is trying to determine in a common sense way how the average skilled but non-inventive technician would have reacted to the pleaded prior art if it had been put before him in his work place or laboratory. The common general knowledge is the technical background of the notional man in the art against which the prior art must be considered. This is not limited to material he has memorised and has at the front of his mind. It includes all that material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art. This does not mean that everything on the shelf which is capable of being referred to without difficulty is common general knowledge nor does it mean that every word in a common text book is either. In the case of standard textbooks, it is likely that all or most of the main text will be common general knowledge. In many cases common general knowledge will include or be reflected in readily available trade literature which a man in the art would be expected to have at his elbow and regard as basic reliable information.'
[107] As Floyd J noted in Teva UK Ltd v Merck & Co Inc [2009] EWHC 2952 (Pat), [2010] FSR 17 at [101]-[103], there is room for argument as to whether common general knowledge has a territorial dimension. What if, for example, a particular fact was commonly known by those skilled in the art in the USA at the relevant date, but not by those skilled in the art in the UK? At one stage I thought that an issue of this kind was emerging in the present case. In the end, however, neither side argued for a territorial approach to the question of common general knowledge. Both counsel submitted that, to be common general knowledge, information must be generally known and generally accepted by the bulk of those working in the field in question.
[108] In several cases, notably Nutrinova Nutrition Specialties & Food Ingredients GmbH v Scanchem UK Ltd [2001] FSR 42 (Pumfrey J), Novartis AG v Ivax Pharmaceuticals UK Ltd [2006] EWHC 2506 (Pat) (unreported, Pumfrey J), and Ivax Pharmaceuticals UK Ltd v Akzo Nobel NV [2006] EWHC 1089 (Pat), [2007] RPC 3 (Lewison J), account has been taken of information that, while it was not part of the skilled addressee's common general knowledge, would have been acquired by him as a matter of routine before embarking on the problem to which the patented invention provides the solution.
[109] In Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2008] EWHC 2413 (Pat), [2009] RPC 4, Kitchin J quoted passages from Pumfrey J's judgments in Novartis v Ivax and Glaxo Group's Patent [2004] RPC 43 and commented at [40]:
'It seems to me that a subtle but potentially significant point of principle emerges from these passages. I can readily accept that, faced with a disclosure which forms part of the state of the art, it may be obvious for the skilled person to seek to acquire further information before he embarks on the problem to which the patent provides a solution. But that does not make all such information part of the common general knowledge. The distinction is a fine one but it may be important. If information is part of the common general knowledge then it forms part of the stock of knowledge which will inform and guide the skilled person's approach to the problem from the outset. It may, for example, affect the steps it will be obvious for him to take, including the nature and extent of any literature search.'
[110] In the Court of Appeal in that case [2009] EWCA Civ 646, [2009] RPC 23, Jacob LJ quoted the passage I have cited from Raychem and commented at [25]:
'Of course material readily and widely to hand can be and may be part of the common general knowledge of the skilled person – stuff he is taken to know in his head and which he will bring to bear on reading or learning of a particular piece of prior art. But there will be other material readily to hand which he will not carry in his head but which he will know he can find if he needs to do so (my emphasis). The whole passage is about material which the skilled man would refer to 'as a matter of course.' It by no means follows that the material should be taken to be known to the skilled man if he has no particular reason for referring to it.'
[111] He went on to quote what Kitchin J had said at first instance in the passage I have cited and observed at [27]:
'I agree with that although I personally do not find the point of principle 'subtle'. It would be wholly subversive of patents and quite unfair to inventors if one could simply say 'piece of information A is in the standard literature, so is B (albeit in a different place or context), so an invention consisting of putting A and B together cannot be inventive.' The skilled man reads each specific piece of prior art with his common general knowledge. If that makes the invention obvious, then it does. But he does not read a specific citation with another specific citation in mind, unless the first causes him to do so or both are part of the matter taken to be in his head.'
[112] It follows that, 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."
Mr Justice Mellor applied these principles between [83] and [408] and delivered his interim conclusion at [384].
Inventive Concept
The learned judge identified the disputed claims of 258 in para [456] and those of 710 in para [457]. He construed the claims between [459] and [496]. He described the inventive concept of 258 at para [683] as follows:
"As to the inventive concept of EP258 it is to stabilise the prefusion conformation of the RSV F protein in a particular way, namely by use of a single polypeptide containing the F2 and F1 domains which is stabilised in the prefusion conformation by addition of a heterologous C terminal trimerization domain."
Differences between the Prior Art and Inventive Concepts
His lordship compared each of the items of prior art with the disputed claims as construed of each of the patents between para [633] and para [660]. He considered the parties' arguments between [662] and [699]. In the course of the trial, GSK had adduced secondary evidence as to why the inventions were not obvious. The judge referred to paras [77] and [85] of Lord Justice Jacob's judgment in Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819; [2010] RPC 33, paras [442] and [446] of Mr Justice Meade's in Gilead v NuCana [2023] EWHC 611 (Pat) and para [65] of Mr Justice Birss's in Accord v Medac [2016] EWHC 24 (Pat) in considering the legal principles relating to secondary evidence between para [701] and [702]. He discussed GSK's secondary evidence between para [713] and para [787].
Conclusion on Obviousness
His lordship set out his conclusion on whether the inventions lacked an inventive step at [799]:
"Overall, I had clear primary evidence of obviousness from impressive expert witnesses...... Against the prima facie clear case of obviousness on the primary evidence, I did not find the secondary evidence either complete enough or anywhere near persuasive enough to displace that prima facie case. In the circumstances, I find both EP258 and EP710 invalid for obviousness over each piece of prior art."
Insufficiency
The reason why a patent can be revoked under s.72 (1) (c) of the Patents Act 1977 on the ground that the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art is that s.14 (2) (b) requires every application for a patent to contain a specification and s.14 (3) requires the specification to disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art. Mr Justice Mellor cited Lord Justice Kitchin's summary of the law in para [239] of his judgment in Eli Lilly and Company v Human Genome Sciences Inc [2008] EWHC 1903 (Pat):
"The specification must disclose the invention clearly and completely enough for it to be performed by a person skilled in the art. The key elements of this requirement which bear on the present case are these:i) the first step is to identify the invention and that is to be done by reading and construing the claims;
ii) in the case of a product claim that means making or otherwise obtaining the product;
iii) in the case of a process claim, it means working the process;
iv) sufficiency of the disclosure must be assessed on the basis of the specification as a whole including the description and the claims;
v) the disclosure is aimed at the skilled person who may use his common general knowledge to supplement the information contained in the specification;
vi) the specification must be sufficient to allow the invention to be performed over the whole scope of the claim;
vii) the specification must be sufficient to allow the invention to be so performed without undue burden."
Mr Justice Aldous regarded his view to be consistent with that of the Technical Board of Appeal in T 226/85 Unilever/stable bleaches at [8]:
"The House of Lords did not throw any doubt on the principle that a claim is not rendered insufficient because there is some room for doubt, or fuzziness, at the edge of the claim. The claim in Kirin-Amgen was insufficient because it was conceptually uncertain."
"If the court cannot ascertain the boundary, having used all the interpretative tools at its disposal, it must conclude that the specification does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art."
"...... the Boards of Appeal consistently decide the issue of obviousness on the basis of an objective assessment of the technical results achieved by the claimed subject-matter, compared with the results obtained according to the state of the art. It is then assumed that the inventor did in fact seek to achieve these results and, therefore, these results are taken to be the basis for defining the technical problem (or, in other words, the objective) of the claimed invention. … The next step is then to decide whether the state of the art suggested the claimed solution of this technical problem in the way proposed by the patent in suit …”
"[39]. As with any consideration of obviousness, the technical results or effects must be shared by everything falling within the claim under attack. This follows from the fundamental principle of patent law, which underpins many of the grounds of objection to validity, that the extent of the monopoly conferred by a patent must be justified by the technical contribution to the art. If some of the products covered by a claim demonstrate a particular property, but others do not, then the technical problem cannot be formulated by reference to that property. Either the products which do not exhibit the property must be excised from the claim by amendment, or the problem must be formulated by reference to some other, perhaps more mundane, technical contribution common to the whole claim."
"The technical contribution of the Patents extends to the use of a PreF antigen as an immunogen to protect against RSV. The claims are limited to embodiments in which the prefusion conformation is stabilized. The skilled person knows how to stabilise the PreF antigen according to the specification. In the words of Floyd LJ, those claims are 'restricted to the subject matter which makes good the technical contribution' and are not, therefore, invalid on the AgrEvo basis."
Pfizer argued that the patent specifications only rendered plausible that the claimed RSV F antigens would be effective in preventing or treating RSV-associated diseases when administered with an adjuvant. Pfizer submitted that the specification did not make such use plausible without an adjuvant. That was so for the exemplified, and even more so for other (non-exemplified) antigens that could be made in accordance with the claims.
"First one must identify what it is which falls within the scope of the claimed class. Second one must determine what it means to say that the invention works. In other words what is it for? Once you know those two things, the third step can be taken: to answer the question whether it is possible to make a reasonable prediction the invention will work with substantially everything falling within the scope of the claim."
"When asking whether a claim is plausible across its breadth, one does not look at every potential variant. Here we are talking about adjuvants. The patent is not about adjuvants, that is not the problem. It does not set up a problem about adjuvants and seek to solve that. The fact that antigen may be presented in different ways, some of which may be more efficacious than others, does not mean that the problem is not solved across the breadth of the claim."
I discussed the topic in Arrow Declarations on 16 Oct 2021. Mr Justice Mellor described an Arrow declaration as "a declaration that a product, process or use was lacking in novelty or obvious as at the priority date of a patent application" at para [832] of his judgment. He added that the point of such a declaration is that it is in effect a declaration that the claimant will have a Gillette defence to any subsequent claim for patent infringement in relation to that product, process or use. A Gillette defence is a squeeze first used in Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465. An alleged infringement is either anticipated or obvious or it falls outside the scope of the claim.
i) justice to the claimant;
ii) justice to the defendant;
iii) whether the declaration will serve a useful purpose. The attainment of commercial certainty in patent cases can constitute a useful purpose. The spin-off value of a judgment in other countries may be such a factor, but a declaration sought solely for the benefit of foreign courts will rarely be justified; and
iv) whether or not there are any other special reasons why the court should or should not grant the declaration.
On appeal, Lord Justice Floyd said in para [98] of his judgment in Fujifilm Kyowa Kirin Biologics Co Ltd v AbbVie Biotechnology Ltd [2017] EWCA Civ 1:
"... we do not consider that there is any issue of principle which prevents the granting of Arrow declarations in appropriate cases. Drawing the threads together:
(i) A declaration that a product, process or use was old or obvious at a particular date does not necessarily offend against s.74 of the Act.
(ii) Such a declaration may offend against the Act where it is a disguised attack on the validity of a granted patent.
(iii) Such declarations do not offend against the scheme of the EPC or the Act simply because the declaration is sought against the background of pending divisional applications by the counter-party.
(iv) On the other hand the existence of pending applications cannot itself be a sufficient justification for granting a declaration.
(v) Whether such a declaration is justified depends on whether a sufficient case can be made for the exercise of the court's discretion in accordance with established principles."
"Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say—
(b) where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent;
(c) where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise."
"Article 1
General principles
Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.
Article 2
Equivalents
For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims."
"In my view ........... a problem of infringement is best approached by addressing two issues, each of which is to be considered through the eyes of the notional addressee of the patent in suit, ie the person skilled in the relevant art. Those issues are: (i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not, (ii) does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial? If the answer to either issue is “yes”, there is an infringement; otherwise, there is not. Such an approach complies with article 2 of the Protocol, as issue (ii) squarely raises the principle of equivalents, but limits its ambit to those variants which contain immaterial variations from the invention. It is also apparent that the two issues comply with article 1 of the Protocol in that they involve balancing the competing interests of the patentee and of clarity, just as much as they seek to balance the encouragement of inventions and their disclosure with the need for a competitive market. In my view, issue (i) self-evidently raises a question of interpretation, whereas issue (ii) raises a question which would normally have to be answered by reference to the facts and expert evidence."
"The whole approach to interpretation and scope of protection therefore involves the following steps, considered through the eyes of the notional addressee:
(i) Does the variant infringe any of the claims as a matter of normal interpretation?
(ii) If not, does the variant nevertheless infringe because it varies from the invention in a way or ways which is or are immaterial? This is to be determined by asking these three questions:
(a) Notwithstanding that it is not within the literal (that is to say, I interpolate, normal) meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?
(b) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
(c) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?"
There was a very significant disparity between the costs incurred on each side. Pfizer's total costs were estimated at £6.312 million while GSK's were estimated at £3.67 million. The judge referred to his summaries of the applicable principles at para [35] of his judgment in Lifestyle Equities v Berkshire Polo Club [2023] EWHC 2923 (Ch) where he set out the three questions commonly addressed on costs in IP actions:
"(a) Who is the overall winner? There is then the assumption that the overall costs should be awarded to the winner.
(b) Are there any suitably circumscribed issues which it is appropriate in the circumstances for the winner to be deprived of their costs of?
(c) Is it appropriate to go further and award the losing party their costs of that issue from the winning party?"
"[5]. At [39], I also referred to the following summary from Pigot v Environment Agency [2020] Costs LR 825 at [6]:
(1) The mere fact that the successful party was not successful on every issue does not, of itself, justify an issue-based cost order…
(2) Such an order may be appropriate if there is a discrete or distinct issue, the raising of which caused additional costs to be incurred. Such an order may also be appropriate if the overall costs were materially increased by the unreasonable raising of one or more issues on which the successful party failed.
(3) Where there is a discrete issue which caused additional costs to be incurred, if the issue was raised reasonably, the successful party is likely to be deprived of its costs of the issue. If the issue was raised unreasonably, the successful party is likely also to be ordered to pay the costs of the issue incurred by the unsuccessful party…
(4) Where an issue based costs order is appropriate, the court should attempt to reflect it by ordering payment of a proportion of the receiving party's costs if that is practicable.
(5) An issue based costs order should reflect the extent to which the costs were increased by the raising of the issue; costs which would have been incurred even if the issue had not been raised should be paid by the unsuccessful party.
(6) Before making an issue-based costs order, it is important to stand back and ask whether, applying the principles set out in CPR r.44.2, it is in all the circumstances of the case the right result. The aim must always be to make an order that reflects the overall justice of the case.
[7] Finally, Biogen drew attention to the wise words of Henry Carr J in Hospira v Cubist [2016] EWHC 2661 (Pat) on the meaning of the phrase 'suitably exceptional' which was used in some earlier formulations of the third question i.e. when it might be appropriate to award costs to be paid by the successful party. Henry Carr J explained:
'In my view, this apparent dichotomy may be resolved by a proper understanding of the phrase "suitably exceptional". It is intended to indicate that if the unsuccessful party succeeds on a particular issue, that is not, on its own, sufficient to award costs against the successful party. There must be something which makes it appropriate and just to order not only that the successful party does not recover his costs, but also that it should pay the costs of the relevant issue. On the other hand, it is not intended to imply that such awards of costs will be extremely rare. Where there is a discrete issue, which required substantial expenditure of costs, it may be just in all the circumstances to order payment of costs.'"
GSK applied for permission to appeal on 32 grounds extending over 7 pages, accompanied by a detailed Skeleton Argument of 70 paragraphs. The judge viewed it as "a rather scatter gun approach" when the issues developed in oral argument related to (i) the skilled team, (ii) their common general knowledge, (iii) the construction of 'polypeptide' and infringement of 710 by equivalence and (iv) obviousness. He considered each of those grounds and concluded that none would have a real prospect of success on appeal. He therefore refused permission to appeal.
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