Patents - Astellas Pharma Industries Ltd v Teva Pharmaceutical Industries Ltd
Patents Court (Mr Justice Mellor) Astellas Pharma Industries Ltd v Teva Pharmaceutical Industries Ltd and others [2023] EWHC 2571 (Pat) (17 Oct 2023)
This was an action for patent infringement and a counterclaim for revocation. The patent in suit was European patent (UK) 2,345,410 entitled Pharmaceutical Composition for Modified Release and concerned a modified release pharmaceutical composition containing mirabegron (or a salt thereof) as an active ingredient. Astellas Pharma Industries Ltd, (Astellas) alleged that generic mirabegron tablets that Teva Pharmaceutical Industries Ltd. and Teva UK Ltd ("Teva") and Sandoz AG and Sandoz Ltd (Sandoz) proposed to launch would infringe the patent. Teva and Sandoz each counterclaimed for revocation of the patent on the grounds of obviousness, insufficiency and added matter. Astellas responded to the counterclaim by applying for the amendment of the patent. The applications to amend were opposed.
The Proceedings
The action and counterclaim came on for trial before Mr Justice Mellor between 21 and 29 July 2023. His lordship handed down judgment in Astellas Pharma Industries Ltd v Teva Pharmaceutical Industries Ltd and others [2023] EWHC 2571 (Pat) on 17 Oct 2023. By para [449] of his judgment he held that the patent as amended was valid but not infringed by Sandoz's mirabegron. Teva did not deny that its original product had infringed the patent but argued that its new product would not. No finding was made on whether the new product infringed because there was not enough time to bring that issue to trial.
The Proceedings
The action and counterclaim came on for trial before Mr Justice Mellor between 21 and 29 July 2023. His lordship handed down judgment in Astellas Pharma Industries Ltd v Teva Pharmaceutical Industries Ltd and others [2023] EWHC 2571 (Pat) on 17 Oct 2023. By para [449] of his judgment he held that the patent as amended was valid but not infringed by Sandoz's mirabegron. Teva did not deny that its original product had infringed the patent but argued that its new product would not. No finding was made on whether the new product infringed because there was not enough time to bring that issue to trial.
The Invention
Para 1 of the specification described the invention as "a pharmaceutical composition for modified release capable of reducing food effects, which are observed in conventional tablets, by combining an active ingredient with specific ingredients to control a releasing rate of the active ingredient" (see para [140] of the judgment). Mr Justice Mellor explained the meaning of "food effect" in para [112]:
"A drug or formulation may fare differently depending on whether the patient is in a fed or fasted state. A change in dissolution or drug absorption resulting in an altered pharmacokinetic profile due to the presence of food is termed a 'food effect',”
Drug-food interactions can be positive, negative or neutral. The composition consisted of (R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide or a pharmaceutically acceptable salt thereof, an additive which ensured penetration of water into the pharmaceutical composition (hereinafter sometimes referred to as a hydrophilic base), and a polymer which formed a hydrogel, in which the changes in AUC and Cmax caused by the intake of food could be decreased by controlling the releasing rate of the active ingredient. Although the specification did not identify the composition as mirabegron, it was common ground that that was what it was.
Claim 1
The only claim in dispute was claim 1 which the judge set out broken down into integers with the proposed amendments underlined at para [195] of his judgment:
"A: A pharmaceutical composition for modified release, comprising: (1) 10 mg to 200 mg of (R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylmethyl)amino]ethyl]acetic acid anilide, or a pharmaceutically acceptable salt thereof,
"A: A pharmaceutical composition for modified release, comprising: (1) 10 mg to 200 mg of (R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phenylmethyl)amino]ethyl]acetic acid anilide, or a pharmaceutically acceptable salt thereof,
B: (2) at least one additive which ensures penetration of water into the pharmaceutical composition and which has a solubility such that the volume of water required for dissolving 1 g of the additive is 10 mL or less, and
C: (3) a hydrogel-forming polymer having an average molecular weight of 100,000 to 5,000,000 or a viscosity of 12 mPa-s or more in a 5% aqueous solution at 25°C, 400 mPa･s or more in a 2% aqueous solution at 25˚C and 7,500 mPa･s or less in a 1% aqueous solution at 25°C;
D: wherein the additive which ensures penetration of water into the pharmaceutical composition is one compound, or two or more compounds selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, D-mannitol, lactose, sucrose, sodium chloride, and polyoxyethylene polyoxypropylene glycol and wherein the amount of the additive which ensures penetration of water into the pharmaceutical composition is 20% by weight to 60% by weight to the total weight of the pharmaceutical composition;
E: wherein the hydrogel-forming polymer is one compound, or two or more compounds selected from the group consisting of polyethylene oxide, hydroxypropyl methylcellulose, and hydroxypropyl cellulose and wherein the amount of the hydrogel-forming polymer is 10% by weight to 40% by weight with respect to the total weight of the pharmaceutical composition; and
F: wherein the drug dissolution rate from the pharmaceutical composition is 75% or less after 1.5 hours and at least 75% after 7 hours from the beginning of the dissolution test and wherein the dissolution test is carried out in accordance with the paddle method described in the United States Pharmacopoeia under the conditions that 900 mL of USP buffer, pH 6.8, is used and the paddle rotation speed is 50 to 200 rpm."
C: (3) a hydrogel-forming polymer having an average molecular weight of 100,000 to 5,000,000 or a viscosity of
D: wherein the additive which ensures penetration of water into the pharmaceutical composition is one compound, or two or more compounds selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, D-mannitol, lactose, sucrose, sodium chloride, and polyoxyethylene polyoxypropylene glycol and wherein the amount of the additive which ensures penetration of water into the pharmaceutical composition is 20% by weight to 60% by weight to the total weight of the pharmaceutical composition;
E: wherein the hydrogel-forming polymer is one compound, or two or more compounds selected from the group consisting of polyethylene oxide, hydroxypropyl methylcellulose, and hydroxypropyl cellulose and wherein the amount of the hydrogel-forming polymer is 10% by weight to 40% by weight with respect to the total weight of the pharmaceutical composition; and
F: wherein the drug dissolution rate from the pharmaceutical composition is 75% or less after 1.5 hours and at least 75% after 7 hours from the beginning of the dissolution test and wherein the dissolution test is carried out in accordance with the paddle method described in the United States Pharmacopoeia under the conditions that 900 mL of USP buffer, pH 6.8, is used and the paddle rotation speed is 50 to 200 rpm."
Construction
Mr Justice Mellor directed himself at para [197] that he had to give a "normal" construction to claim 1 and that construction had to be purposive. As it happened there was only one point in dispute, That point was the meaning of the words "pharmaceutical composition for modified release" in integer A. Astellas argued that it meant a formulation in which the dissolution rate of the drug from the formulation was less than 85% after 30 minutes from the beginning of a dissolution test carried out under the above conditions. The drug release was controlled to the extent that the effects of food were reduced. The judge agreed with that contention,
Insufficiency - the Relevant Law
Teva and Sandoz relied on s.72 (1) (c) of the Patents Act 1977:"Subject to the following provisions of this Act, the court or the comptroller may ..... by order revoke a patent for an invention on the application of any person (including the proprietor of the patent)] on (but only on) any of the following grounds, that is to say—
...................................................
(c) 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 ,,,,,,,"
They attacked the validity of the patent under this provision on two grounds:
- They complained that none of the claims contained any limitation on the amount of mirabegron in the claimed compositions.
- They contended that it was not possible to make a reasonable prediction that the invention would work with substantially all the products falling within the scope of claim 1. They added that that was the case for all of the proposed amended forms of claim 1, and on either party’s construction of Integer A. Accordingly, the claim's scope exceeded the technical contribution of the patent with the result that all the claims were invalid.
In support of their contention, Teva and Sandoz referred the judge to paras [98] to [101] of Lord Justice Kitchin's judgment in Regeneron Pharmaceuticals Inc v Bayer Pharma AG and another [2013] RPC 28, [2013] EWCA Civ 93:
“[98] Fourth, it is permissible to define an invention using general terms provided the patent discloses a principle of general application in the sense that it can reasonably be expected the invention will work with anything falling within the scope of these terms. As Lord Hoffmann said in Biogen Inc v. Medeva Plc [1996] UKHL 18, [1997] RPC 1, (1997) 38 BMLR 149:
‘If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms. The patentee need not show that he has proved its application in every individual instance. On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them.
Thus if the patent has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect: see May & Baker Ltd v Boots Pure Drug Co. Ltd. (1950) 67 R.P.C. 23, 50. On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them.’
[99] In Kirin-Amgen Inc and others v Hoechst Marion Roussel Ltd and others [2004] UKHL 46, [2005] RPC 9, (2005) 28(7) IPD 28049, [2005] RPC 169, [2005] 1 All ER 667Lord Hoffmann further explained the concept of a principle of general application in this way:
'[112] In my opinion there is nothing difficult or mysterious about [a principle of general application]. It simply means an element of the claim which is stated in general terms. Such a claim is sufficiently enabled if one can reasonably expect the invention to work with anything which falls within the general term. For example, in Genentech I/Polypeptide expression (T 292/85) [1989] O.J. EPO 275, the patentee claimed in general terms a plasmid suitable for transforming a bacterial host which included an expression control sequence to enable the expression of exogenous DNA as a recoverable polypeptide. The patentee had obviously not tried the invention on every plasmid, every bacterial host or every sequence of exogenous DNA. But the Technical Board of Appeal found that the invention was fully enabled because it could reasonably be expected to work with any of them.
[113] This is an example of an invention of striking breadth and originality. But the notion of a ‘principle of general application’ applies to any element of the claim, however humble, which is stated in general terms. A reference to a requirement of ‘connecting means’ is enabled if the invention can reasonably be expected to work with any means of connection. The patentee does not have to have experimented with all of them.'
[100] It must therefore be possible to make a reasonable prediction the invention will work with substantially everything falling within the scope of the claim or, put another way, the assertion that the invention will work across the scope of the claim must be plausible or credible. The products and methods within the claim are then tied together by a unifying characteristic or a common principle. If it is possible to make such a prediction then it cannot be said the claim is insufficient simply because the patentee has not demonstrated the invention works in every case.
[101 On the other hand, if it is not possible to make such a prediction or if it is shown the prediction is wrong and the invention does not work with substantially all the products or methods falling within the scope of the claim then the scope of the monopoly will exceed the technical contribution the patentee has made to the art and the claim will be insufficient. It may also be invalid for obviousness, there being no invention in simply providing a class of products or methods which have no technically useful properties or purpose."
Next. Mr Justice Mellor considered the criterion for plausibility which Lord Sumption stated at para [36] of his judgment in Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan)and another (rev 1) [2018] RPC 21, [2019] Bus LR 360, (2019) 165 BMLR 14, [2018] UKSC 56, [2019] 3 All ER 95: “the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true”. Quoting from para [46] of Lord Justice Floyd's judgment in Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) and others [2016] EWCA Civ 1006, (2017) 153 BMLR 28, [2017] RPC 1, Lord Sumption explained what the threshold was designed to guard again:
"...... the requirement of plausibility is a low, threshold test. It is designed to prohibit speculative claiming, which would otherwise allow the armchair inventor a monopoly over a field of endeavour to which he has made no contribution. It is not designed to prohibit patents for good faith predictions which have some, albeit manifestly incomplete, basis. Such claims may turn out to be insufficient nonetheless if the prediction turns out to be untrue. A patent which accurately predicts that an invention will work is, however, not likely to be revoked on the ground that the prediction was based on the slimmest of evidence. Thus, the claims will easily be seen not to be speculative where the inventor provides a reasonably credible theory as to why the invention will or might work. The same is true where the data in the specification is such that the reader is encouraged to try the invention.”
In Lord Sumption's view, the test was too low. He said at para [36] of his judgment in Warner-Lambert:
"…Plausibility is not a distinct condition of validity with a life of its own, but a standard against which that must be demonstrated. Its adoption is a mitigation of the principle in favour of patentability. It reflects the practical difficulty of demonstrating therapeutic efficacy to any higher standard at the stage when the patent application must in practice be made. The test is relatively undemanding. But it cannot be deprived of all meaning or reduced, as Floyd LJ’s statement does, to little more than a test of good faith. Indeed, if the threshold were as low as he suggests, it would be unlikely to serve even the limited purpose that he assigns to it of barring speculative or armchair claims."
"...... the requirement of plausibility is a low, threshold test. It is designed to prohibit speculative claiming, which would otherwise allow the armchair inventor a monopoly over a field of endeavour to which he has made no contribution. It is not designed to prohibit patents for good faith predictions which have some, albeit manifestly incomplete, basis. Such claims may turn out to be insufficient nonetheless if the prediction turns out to be untrue. A patent which accurately predicts that an invention will work is, however, not likely to be revoked on the ground that the prediction was based on the slimmest of evidence. Thus, the claims will easily be seen not to be speculative where the inventor provides a reasonably credible theory as to why the invention will or might work. The same is true where the data in the specification is such that the reader is encouraged to try the invention.”
In Lord Sumption's view, the test was too low. He said at para [36] of his judgment in Warner-Lambert:
"…Plausibility is not a distinct condition of validity with a life of its own, but a standard against which that must be demonstrated. Its adoption is a mitigation of the principle in favour of patentability. It reflects the practical difficulty of demonstrating therapeutic efficacy to any higher standard at the stage when the patent application must in practice be made. The test is relatively undemanding. But it cannot be deprived of all meaning or reduced, as Floyd LJ’s statement does, to little more than a test of good faith. Indeed, if the threshold were as low as he suggests, it would be unlikely to serve even the limited purpose that he assigns to it of barring speculative or armchair claims."
His lordship thought that “some reason for supposing" was the relevant threshold for plausibility and that had to appear in the specification.
Mr Justice Mellor referred to para [53] of Lord Justice Birss's judgment in FibroGen Inc v Akebia Therapeutics Inc [2021] EWCA Civ 1279 in which he had proposed a three-step test of reasonable prediction:
"To apply the reasonable prediction principle one has to take three steps. 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."
Applying the Principles
Teva and Sandoz contended that a composition of mirabegron that satisfied integers A, B, C, D and E fell within claim 1 thereby fulfilling the first step of the test. As for the second, "working" meant the reduction of food effect. They argued that it was not credible that substantially every formulation within the dissolution range would necessarily show the required reduction in food effect compared to a conventional composition of mirabegron. That was belied by the wording of the specification and the expert evidence (see paras [249] to [277]). The judge concluded that the composition would work right across the scope of the claim with the result that the insufficiency attack failed.
Mr Justice Mellor referred to para [53] of Lord Justice Birss's judgment in FibroGen Inc v Akebia Therapeutics Inc [2021] EWCA Civ 1279 in which he had proposed a three-step test of reasonable prediction:
"To apply the reasonable prediction principle one has to take three steps. 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."
Applying the Principles
Teva and Sandoz contended that a composition of mirabegron that satisfied integers A, B, C, D and E fell within claim 1 thereby fulfilling the first step of the test. As for the second, "working" meant the reduction of food effect. They argued that it was not credible that substantially every formulation within the dissolution range would necessarily show the required reduction in food effect compared to a conventional composition of mirabegron. That was belied by the wording of the specification and the expert evidence (see paras [249] to [277]). The judge concluded that the composition would work right across the scope of the claim with the result that the insufficiency attack failed.
Inventive Step - Relevant Law
S.72 (1) (a) of the Patents Act 1977 provides that a patent may be revoked if the invention is not a patentable invention. One of the conditions for the grant of a patent is that it involves an inventive step. S.3 of the Act states that 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 s. 2 (2) and disregarding s 2 (3).
Those provisions had been considered by Lord Hodge between paras [52] and [73] of his judgment in Actavis Group PTC EHF and others v ICOS Corporation and another (2019) 167 BMLR 1, [2020] 1 All ER 213, [2019] UKSC 15, [2019] Bus LR 1318, [2019] RPC 9. Mr Justice Mellor referred to the salient points of that judgment between paras [281] and [283] of his own:
"[281] First, the statutory question is whether the invention is obvious, having regard to the state of the art at the Priority Date. In some cases, it is helpful to answer this question by adopting the structured approach set out in Pozzoli. In other cases, it is helpful to adopt the problem/solution approach (PSA) favoured by the EPO. But neither approach can replace the statutory question itself. It must be assessed by reference to the facts and circumstances of the case.
[282] Second, Lord Hodge at [63] endorsed the statement of Kitchin J (as he then was) in Generics (UK) Ltd and others v H Lundbeck A/S [2007] EWHC 1040 (Pat), [2007] RPC 729, [2007] RPC 32 at [72]:
'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.'
[283] Third, he went on to identify a non-exhaustive list of factors which may be relevant in the assessment from [64]. As Astellas pointed out, the factor that the Defendants seem to rely upon in this case is 'obvious to try'. This was considered by Lord Hodge at [65] where he said:
'First, it is relevant to consider whether at the priority date something was 'obvious to try', in other words whether it was obvious to undertake a specific piece of research which had a reasonable or fair prospect of success: Conor v Angiotech (above) para 42 per Lord Hoffmann; MedImmune Ltd v Novartis Pharmaceuticals UK Ltd and others [2012] EWCA Civ 1234; [2013] RPC 27, paras 90 and 91 per Kitchin LJ. In many cases the consideration that there is a likelihood of success which is sufficient to warrant an actual trial is an important pointer to obviousness. But as Kitchin LJ said in Novartis AG v Generics (UK) Ltd (t/a Mylan) [2012] EWCA Civ 1623, para 55, there is no requirement that it is manifest that a test ought to work; that would impose a straightjacket which would preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable. As Birss J observed in this case (para 276), some experiments which are undertaken without any particular expectation as to result are obvious. The relevance of the 'obvious to try' consideration and its weight when balanced against other relevant considerations depend on the particular facts of the case.'”
"[281] First, the statutory question is whether the invention is obvious, having regard to the state of the art at the Priority Date. In some cases, it is helpful to answer this question by adopting the structured approach set out in Pozzoli. In other cases, it is helpful to adopt the problem/solution approach (PSA) favoured by the EPO. But neither approach can replace the statutory question itself. It must be assessed by reference to the facts and circumstances of the case.
[282] Second, Lord Hodge at [63] endorsed the statement of Kitchin J (as he then was) in Generics (UK) Ltd and others v H Lundbeck A/S [2007] EWHC 1040 (Pat), [2007] RPC 729, [2007] RPC 32 at [72]:
'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.'
[283] Third, he went on to identify a non-exhaustive list of factors which may be relevant in the assessment from [64]. As Astellas pointed out, the factor that the Defendants seem to rely upon in this case is 'obvious to try'. This was considered by Lord Hodge at [65] where he said:
'First, it is relevant to consider whether at the priority date something was 'obvious to try', in other words whether it was obvious to undertake a specific piece of research which had a reasonable or fair prospect of success: Conor v Angiotech (above) para 42 per Lord Hoffmann; MedImmune Ltd v Novartis Pharmaceuticals UK Ltd and others [2012] EWCA Civ 1234; [2013] RPC 27, paras 90 and 91 per Kitchin LJ. In many cases the consideration that there is a likelihood of success which is sufficient to warrant an actual trial is an important pointer to obviousness. But as Kitchin LJ said in Novartis AG v Generics (UK) Ltd (t/a Mylan) [2012] EWCA Civ 1623, para 55, there is no requirement that it is manifest that a test ought to work; that would impose a straightjacket which would preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable. As Birss J observed in this case (para 276), some experiments which are undertaken without any particular expectation as to result are obvious. The relevance of the 'obvious to try' consideration and its weight when balanced against other relevant considerations depend on the particular facts of the case.'”
Mr Justice Mellor also quoted paras [90] and ]91] from Lord Justice Kitchin's judgment in Medimmune:
“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.
“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.
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.”
Mr Justice Mellor also referred to the following passage from Mr Justice Floyd's judgment in Omnipharm Ltd v. Merial [2011] EWHC 3393:
“i) There is but one statutory question: was the invention obvious? It is to be answered by reference to the non-exhaustive list of factors identified by Kitchin J in Generics v Lundbeck, including whether it was obvious to try the invention as a solution to a technical problem, as well as the nature of the invention itself.
ii) 'Obvious to try' is not an independent ground of invalidating a patent under the statute, but one of a variety of factors considered in an overall assessment of inventive step. It must be coupled with a fair expectation of success, the degree of success necessary depending on the other factors present in the individual case.
iii) Where an invention is claimed plausibly in terms that it would achieve a technical effect, it is correct to ask whether it was obvious that the invention would achieve that effect, and wrong to ask whether the invention might achieve that effect.”
“i) There is but one statutory question: was the invention obvious? It is to be answered by reference to the non-exhaustive list of factors identified by Kitchin J in Generics v Lundbeck, including whether it was obvious to try the invention as a solution to a technical problem, as well as the nature of the invention itself.
ii) 'Obvious to try' is not an independent ground of invalidating a patent under the statute, but one of a variety of factors considered in an overall assessment of inventive step. It must be coupled with a fair expectation of success, the degree of success necessary depending on the other factors present in the individual case.
iii) Where an invention is claimed plausibly in terms that it would achieve a technical effect, it is correct to ask whether it was obvious that the invention would achieve that effect, and wrong to ask whether the invention might achieve that effect.”
Mr Justice Mellor noted that Sir Robin Jacob had emphasized at para [29] of his judgment in Teva UK Ltd and another Leo Pharma A/s [2015] EWCA Civ 779 the importance of assessing the question of obviousness by reference to what real-life skilled people would think and do. Mr Justice Mellor recalled Mr Justice Laddie's conservation in Brugger and others v Medic-Aid Ltd [1996] RPC 635 which the Supreme Court approved in Actavis:
“[I]f a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well."
The judge noted that Lord Hodge had added in Actavis that “[a]s a result, the need to make value judgments on how to proceed in the course of a research programme is not necessarily a pointer against obviousness.” He recalled the Supreme Court's observation in that same case that if a skilled team engages in familiar and routine testing and it is obvious to undertake that testing as part of routine development, that is sufficient for obviousness. The end result of those routine tests does not need to be known or to be anticipated or expected. It is obtained by the application of routine work.
He quoted paras [36] and [37] from Lord Justice Jacob's judgment in Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82; [2010] FSR 18 in which he discussed the law concerning arbitrary parameters:
"[36] Another aspect of obviousness which is not readily answered by the PSA is illustrated by the 5¼ inch plate paradox. This runs like this. Suppose the patent claim is for a plate of diameter 5¼ inches. And suppose no-one can find a plate of that particular diameter in the prior art. Then (a) it is novel and (b) it is non-obvious for there is no particular reason to choose that diameter. The conclusion, that the plate is patentable, is so absurd that it cannot be so.
[37]. What then is the answer to the paradox? It is this: the 5¼ inch limitation is purely arbitrary and non-technical. It solves no problem and advances the art not at all. It is not inventive. And although 'inventive step' is defined as being one which is not obvious, one must always remember the purpose of that definition - to define what is inventive. That which is not inventive by any criteria is not made so by the definition. Trivial limitations, such as specifying the plate diameter, or painting a known machine blue for no technical reason are treated as obvious because they are not inventive."
“[I]f a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well."
The judge noted that Lord Hodge had added in Actavis that “[a]s a result, the need to make value judgments on how to proceed in the course of a research programme is not necessarily a pointer against obviousness.” He recalled the Supreme Court's observation in that same case that if a skilled team engages in familiar and routine testing and it is obvious to undertake that testing as part of routine development, that is sufficient for obviousness. The end result of those routine tests does not need to be known or to be anticipated or expected. It is obtained by the application of routine work.
He quoted paras [36] and [37] from Lord Justice Jacob's judgment in Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82; [2010] FSR 18 in which he discussed the law concerning arbitrary parameters:
"[36] Another aspect of obviousness which is not readily answered by the PSA is illustrated by the 5¼ inch plate paradox. This runs like this. Suppose the patent claim is for a plate of diameter 5¼ inches. And suppose no-one can find a plate of that particular diameter in the prior art. Then (a) it is novel and (b) it is non-obvious for there is no particular reason to choose that diameter. The conclusion, that the plate is patentable, is so absurd that it cannot be so.
[37]. What then is the answer to the paradox? It is this: the 5¼ inch limitation is purely arbitrary and non-technical. It solves no problem and advances the art not at all. It is not inventive. And although 'inventive step' is defined as being one which is not obvious, one must always remember the purpose of that definition - to define what is inventive. That which is not inventive by any criteria is not made so by the definition. Trivial limitations, such as specifying the plate diameter, or painting a known machine blue for no technical reason are treated as obvious because they are not inventive."
The underlining and heavy type in this passage were added by Teva and Sandoz.
Referring to para [73] of Lord Justice Floyd's judgment in Koninklijke Philips N.V. v Asustek Computer Incorporation and others [2019] EWCA Civ 2230 at [73] and para [28] pf Lord Justice Jacpb's in Pozzoli SpA v BDMO SA and another [2007] 1 Bus LR D117, [2007] Bus LR D117, [2007] EWCA Civ 588, [2007] FSR 37, [2007] BusLR D117. Mr Justice Mellor said at para [291] of his own judgment that "a patentee cannot rely upon a perceived problem in taking a particular course of action in support of inventive step, unless the patent itself overcomes that problem,"
He recalled paras [207] and [208] of Mr Justice Birss's judgment in Optis Cellular Technology LLC and others v Apple Retail UK Ltd and others [2020] EWHC 2746 (Pat) which were approved by Mr Justice Meade at para [212] of his judgment in Philip Morris Products, SA and another v RAI Strategic Holdings, Inc and another : [2021] EWHC 537 (Pat) that although having an arbitrary feature in a claim is not a ground of invalidity if a claim is found to contain an arbitrary limitation in it, then that limitation cannot assist the patentee in defending an obviousness case.
Referring to para [73] of Lord Justice Floyd's judgment in Koninklijke Philips N.V. v Asustek Computer Incorporation and others [2019] EWCA Civ 2230 at [73] and para [28] pf Lord Justice Jacpb's in Pozzoli SpA v BDMO SA and another [2007] 1 Bus LR D117, [2007] Bus LR D117, [2007] EWCA Civ 588, [2007] FSR 37, [2007] BusLR D117. Mr Justice Mellor said at para [291] of his own judgment that "a patentee cannot rely upon a perceived problem in taking a particular course of action in support of inventive step, unless the patent itself overcomes that problem,"
He recalled paras [207] and [208] of Mr Justice Birss's judgment in Optis Cellular Technology LLC and others v Apple Retail UK Ltd and others [2020] EWHC 2746 (Pat) which were approved by Mr Justice Meade at para [212] of his judgment in Philip Morris Products, SA and another v RAI Strategic Holdings, Inc and another : [2021] EWHC 537 (Pat) that although having an arbitrary feature in a claim is not a ground of invalidity if a claim is found to contain an arbitrary limitation in it, then that limitation cannot assist the patentee in defending an obviousness case.
Finally, although neither party had carried out a formal Pozzoli analysis, his lordship indicated at para [293] that he had applied it in his judgment. Lord Hodge outlined the analysis conveniently in para [60] of his judgment in Actavis:
“(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?”
Mr Justice Mellor's analysis is summarized between para [418] and [422] of his judgment.
Skilled Addressee
According to para [18] of Mr Justice Mellor's judgment the parties agreed that the patient was addressed to a team which would include a clinician and a formulator,. There was some dispute as to the respective contributions of the team members. At para [28] the judge said:
"The Skilled Formulator has the principal role in the Team, but, unless the context otherwise requires, the terms Skilled Formulator and Skilled Team are synonymous."
"The Skilled Formulator has the principal role in the Team, but, unless the context otherwise requires, the terms Skilled Formulator and Skilled Team are synonymous."
Common General Knowledge
His lordship discussed the agreed common general knowledge between paras [27] and [122]. He considered the disputed CGK between [123] and [137].
Inventive Concept
In para [418] the judge said that it was not sensible to try to identify the inventive concept of claim 1, It was better and safer simply to proceed on the wording of the claim. I have discussed that wording above,
Prior Art
Teva and Sandoz relied on the following citations:
"i) 'Controlled-Release Oral Delivery Systems', Joseph A. Fix et al., ACS Symposium Series, American Chemical Society: Washington DC, 2000; 752;14-24 (Fix);
ii) 'The Pharmacokinetic Profile of Tamsulosin Oral Controlled Absorption System (OCAS®)”, Michel, M., European Urology Supplements Volume 4, Issue 2 (2005) 15–24 (Michel);
iii) 'The Oral Controlled Absorption System (OCAS®): The Evolution of Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)', Chapple, C., European Urology Supplements Volume 4, Issue 7 (2005) 20-22 (Chapple) when read with Michel.
"i) 'Controlled-Release Oral Delivery Systems', Joseph A. Fix et al., ACS Symposium Series, American Chemical Society: Washington DC, 2000; 752;14-24 (Fix);
ii) 'The Pharmacokinetic Profile of Tamsulosin Oral Controlled Absorption System (OCAS®)”, Michel, M., European Urology Supplements Volume 4, Issue 2 (2005) 15–24 (Michel);
iii) 'The Oral Controlled Absorption System (OCAS®): The Evolution of Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)', Chapple, C., European Urology Supplements Volume 4, Issue 7 (2005) 20-22 (Chapple) when read with Michel.
The judge explained the major issues relating to Fix in para [295]. He considered:
- What Fix disclosed to the skilled team between [297] and [344];
- What the skilled team would do having considered Fix between [345] and [397];
- The nature of the project which the Skilled Team would be prepared to undertake between [398] and [403]; and
- Whether the project could lead to a formulation which fell within claim 1 between [404] and [417].
Differences between Fix and Claim 1
I) Fix was concerned with acetaminophen and nicardipine hydrochloride, and not mirabegron,
ii) Dissolution limits which were dependent on combinations of the ingredients.
The learned judge considered each of the routes between Fix and claim 1 at para [421] and decided that none of them was obvious.
Michel and Chapple
He carried out a similar analysis between para [423] and para [431] and reached the same conclusion.
Added Matter
Two other grounds of revocation under s.72 (1) are:
"(d)the matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent, as filed, or, if the patent was granted on a new application filed under section 8 (3), 12 or 37 (4) above or as mentioned in section 15 (9)] above, in the earlier application, as filed;
(e) the protection conferred by the patent has been extended by an amendment which should not have been allowed."
Two other grounds of revocation under s.72 (1) are:
"(d)the matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent, as filed, or, if the patent was granted on a new application filed under section 8 (3), 12 or 37 (4) above or as mentioned in section 15 (9)] above, in the earlier application, as filed;
(e) the protection conferred by the patent has been extended by an amendment which should not have been allowed."
According to para [4] of the judgment, an attack on the validity of the patent was launched under both provisions. Para [432] stated that one complaint was cured by amendment. Para [433] indicated that the other was abandoned by the end of the trial.
Infringement
I have already mentioned the outcome of the infringement proceedings. On the judge's construction of claim 1 as amended, Sandoz's product did not infringe, There was no dispute that Teva's original product infringed. As I noted above, it was not possible for the court to determine in these proceedings whether its latest product infringes.
Comment
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