“is the use of [pregabalin] in pain therapy, as the compound exhibits analgesic/antihyperalgesic action.”
“The instant invention is a method of using a compound identified below in the treatment of pain, especially for treatment of chronic pain disorders. Such disorders include, but are not limited to, inflammatory pain, postoperative pain, osteoarthritis, pain associated with metastatic cancer, trigeminal neuralgia, acute herpetic and postherpetic neuralgia, diabetic neuropathy, causalgia, brachial plexus avulsion, occipital neuralgia, reflex sympathetic dystrophy, fibromyalgia, gout, phantom limb pain, burn pain, and other forms of neuralgic, neuropathic, and idiopathic pain syndromes.”
“The instant invention is a method of using [pregabalin] or a pharmaceutically acceptable salt thereof as an analgesic in the treatment of pain as listed above. Pain such as inflammatory pain, neuropathic pain, cancer pain, postoperative pain, and idiopathic pain which is pain of unknown origin, for example, phantom limb pain are included especially. Neuropathic pain is caused by injury or infection of peripheral sensory nerves. It includes, but is not limited to pain from peripheral nerve trauma, herpes virus infection, diabetes mellitus, causalgia, plexus avulsion, neuroma, limb amputation, and vasculitis. Neuropathic pain is also caused by nerve damage from chronic alcoholism, human immunodeficiency virus infection, hypothyroidism, uremia, or vitamin deficiencies. Neuropathic pain includes, but is not limited to pain caused by nerve injury such as, for example, the pain diabetics suffer from.”
“Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.”
“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.”
“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.”
“The presence of a cause/effect relationship is, thus, made plausible. For how incomplete the data might be, they nonetheless go one step further towards disclosing the invention without leaving an undue burden to the reader.”
“Otherwise stated, the subject-matter of claim 6, is limitless and untried downstream developments in relation to yet to be demonstrated molecular mechanisms. In the board’s judgment, it amounts to no more than an invitation to set up further research programs for which no guidance is forthcoming.”
“there is not enough evidence in the application to make at least plausible that a solution was found to the problem which was purportedly solved.”
“This cannot be regarded as supportive of an evidence which would have been given in the application as filed since there was not any. The said post-published documents are indeed the first disclosure going beyond speculation. For this reason, the post-published evidence may not be considered at all. Indeed, to do otherwise would imply that the recognition of the claimed subject-matter as a solution to a particular problem could vary as time went by. Here, for example, had the issue been examined before the publication date of the earliest relevant post-published document, GDF-9 would not have been seen as a plausible solution to the problem of finding a new member of the TGF-β superfamily and inventive step would have had to be denied whereas, when examined thereafter, GDF-9 would have to be acknowledged as one such member. This approach would be in contradiction with the principle that inventive step, as all other criteria for patentability, must be ascertained as from the effective date of the patent. The definition of an invention as being a contribution to the art, i.e. as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching solves indeed the problem that it purports to solve. Therefore, even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve.”
“The general principles are: … (iii) A merely “speculative” use will not suffice, so “a vague and speculative indication of possible objectives that might or might not be achievable” will not do (T 0870/04, para.21; T 0898/05, paras.6 and 21); (iv) The patent and common general knowledge must enable the skilled person “to reproduce” or “exploit” the claimed invention without “undue burden”, or having to carry out “a research programme" (T 0604/04, para.22; T0898/05, para.6); Where a patent discloses a new protein and its encoding gene: (v) The patent, when taken with common general knowledge, must demonstrate “a real as opposed to a purely theoretical possibility of exploitation” (T 0604/04, para. 15; T 0898/05, paras.6, 22 and 31); (vi) Merely identifying the structure of a protein, without attributing to it a “clear role”, or “suggest [ing]" any “practical use” for it, or suggesting “a vague and speculative indication of possible objectives that might be achieved", is not enough (T0870/04, paras.6-7, 11 and 21; T 0898/05, paras. 7,10 and 31); (vii) The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal (T 0898/05, paras. 21 and 31; T 1452/06, para.5); (viii) A "plausible" or “reasonably credible" claimed use, or an educated guess", can suffice (T 1329/04, paras.6 and 11; T 0640/04, para.6; T 0898/05, paras.8, 21, 27, and 31; T 1452/06, para.6; T 1165/06 para.25); (ix) Such plausibility can be assisted by being confirmed by “later evidence”, although later evidence on its own will not do (T 1329/04, para.12; T 0898/05, para.24; T 1452/06, para.6; T 1165/06, para.25); (x) the requirements of a plausible and specific possibility of exploitation can be at the biochemical, the cellular or the biological level (T0898/05, paras. 29-30).”
“These cases are in my opinion far from the facts of this case. The specification did claim that a taxol coated stent would prevent restenosis and Conor did not suggest that the claim was not plausible. That would have been inconsistent with the evidence of its experts that taxol was just the thing to try.”
“… important types of neuropathic pain such as pain from stroke and multiple sclerosis had no relationship to central sensitisation, since they do not involve any peripheral damage. So the claim is still too broad.”
“Pain initiated or caused by a primary lesion or dysfunction in the nervous system. Note: see also Neurogenic Pain and Central Pain. Peripheral neuropathic pain occurs when the lesion or dysfunction affects the peripheral nervous system. Central pain may be retained as the term when the lesion or dysfunction affects the central nervous system.”
“This mode represents true pathology and its contribution to neuropathic and central pain disorders is only just beginning to become apparent.”
“(i) neuropathic pain was characterised by secondary hyperalgesia and allodynia in the sense that these symptoms were present in the large majority of patients, but a significant minority did not display these symptoms. (ii) secondary hyperalgesia and allodynia involved central augmentation. In some cases this would be central sensitisation, but not in all cases.”
“… I consider that the evidence is finely balanced. In addition to the general points made above, Warner-Lambert's case suffers from the problem that it has not been established that it was common general knowledge that the rat paw formalin test was predictive of efficacy for neuropathic pain. Moreover, as discussed above, Prof Woolf accepted that the carrageenin and post-operative pain models did not assist in this regard. Nevertheless, I have concluded on balance that, given that plausibility is a relatively low threshold, the data contained in the specification, when read with the common general knowledge, just make it plausible that pregabalin would be effective to treat peripheral neuropathic pain. This is because the common general knowledge as to (i) the involvement of central sensitisation (at least as an amplifying mechanism) in both inflammatory pain and peripheral neuropathic pain and (ii) the role played by central sensitisation in the rat paw formalin test would have suggested to the skilled team that it was possible that a drug which was effective for inflammatory pain, in particular as modelled by the second phase of the formalin test, would also be effective in peripheral neuropathic pain, although this would not necessarily be the case. This conclusion is supported by the evidence not only of Prof Woolf, but also of Dr Scadding and Prof Wood in cross-examination. Dr Scadding said that, when he read the Patent, he thought that it "could be the case" that pregabalin would be effective for (peripheral) neuropathic pain, although a demonstration of that was missing. Prof Wood more or less accepted that it was a credible suggestion, although he made it clear that he would want to test it experimentally.”
“The cause of fibromyalgia pain was at the priority date (as it is today) unknown”. iii) Prof Woolf had included a sentence in his first report which appeared to distinguish between neuropathic pain and pain in fibromyalgia. iv) Fibromyalgia is not mentioned anywhere in the chapter in the Textbook of Pain dealing with neuropathic pain. v) Professor Clauw had said that fibromyalgia was encompassed within the IASP definition of neuropathic pain. This was because the definition extended to “dysfunction” of the nervous system, and not only to “lesions”. vi) Other passages in Professor Clauw’s evidence referred to the fact that, historically, fibromyalgia had been labelled “idiopathic” by clinicians; and dealt separately with fibromyalgia as a condition in contrast to established neuropathic pain conditions such as PHN and DPN. vii) In paragraph 195 of the judgment, the judge says that Professor Clauw “also explained in cross-examination that the same drugs were used to treat fibromyalgia as other forms of neuropathic pain”
“Q. But the mechanisms that produce the symptoms of fibromyalgia were still speculative; is that right? A. The precise mechanisms were speculative but again the drugs, for example, that we used to treat fibromyalgia in 1996 are exactly the same drugs that were being used to treat neuropathic pain.”
“Many of the pain conditions that our group has studied (e.g. fibromyalgia ...) were previously labelled “idiopathic” by clinicians because there was no clear pathology in the tissues that seemed likely responsible for causing these pain states. Now these conditions are more or less acknowledged by clinicians to be diseases of the central nervous system (CNS) …”
“By the Priority Date, research had shown that the underlying etiologies of neuropathic pains, including postherpetic neuralgia, diabetic peripheral neuropathy, and post-operative pain, as well as conditions such as fibromyalgia, may have some relation to central augmentation/sensitization.”
“Q. … Then there follows a reference to neuropathic pain, and what the patent says is: “neuropathic pain is caused by injury or infection of peripheral sensory nerves.”
“Q. … Do you accept that there was some confusion about the terminology in the early ‘90s? A. Yes, there was. So, one always would have to look at the context to see what was being meant? A. Precisely. Q. So, for example, when an author used the term “neuropathic pain”, whether or not he or she meant to include central pain would have to be looked at in context? A. Yes, although by then people were using the broader terminology of “neuropathic pain” to include central pain. Q. But there might be instances where they were not? A. Exactly, and one would have to look very carefully, as you point out, at the context in which it was being used.”
“Q. I think you accept that the reader of the patent would be interested in the suggestion that pregabalin could be used to treat chronic pain? A. Yes. Q. The experiments demonstrate the effect of pregabalin and gabapentin to reduce hyperalgesia and allodynia in rat models? A. Yes. Q. As we discussed this morning, you would be aware that hyperalgesia and allodynia were common symptoms both in neuropathic pain and in inflammatory pain? A. Yes. Q. So it is a credible claim, is it not, Doctor, that pregabalin can be used to treat all the pain conditions set out in paragraph [0003]? A. It is credible, but my first reaction, my Lord, if I may say, when I saw the patent was that these claims for neuropathic pain were based on two animal models which I certainly regarded as being models of inflammatory pain... But that was my first reaction. I thought, well, the thing that is-- this could be the case, what is missing here is demonstration that these drugs are effective or not effective in an established model of neuropathic pain. Q. Can I suggest that the skilled clinician would also recognise that the maintenance of all the conditions referred to in paragraph [003] was contributed to by central sensitisation? A. Yes, to some extent… Q. The recognition of the central sensitisation component is further basis for thinking that the claim that pregabalin can be used to treat the pain conditions set out is credible? A. It is credible, but, as I’ve said, the skilled clinician would not be able to interpret these in the way that we have been discussing here over the last three days; and I believe it is the case, when I read this through -- but there is not mention of central sensitisation within this document. So there is no pointer that that is what the interpretation of how these results should be interpreted. Again, I find that odd. Q. As we discussed this morning, Doctor, you recognise that central sensitisation contributed to both inflammatory pain types and neuropathic pain types at the priority dates? A. Yes. Q. And I think that you heard the evidence from Prof Wood yesterday, when he accepted that central sensitisation also played a role in the formalin test? A. Yes. I do not deny that at all. Q. So, on that basis, these claims are supported by the data in the patent? A. Yes.”
“(1) In any proceedings before the court or the comptroller in which the validity of a patent is put in issue the court or, as the case may be, the comptroller may, subject to section 76 below, allow the proprietor of the patent to amend the specification of the patent in such manner, and subject to such terms as to advertising the proposed amendment and as to costs, expenses or otherwise, as the court or comptroller thinks fit. (2) A person may give notice to the court or the comptroller of his opposition to an amendment proposed by the proprietor of the patent under this section, and if he does so the court or the comptroller shall notify the proprietor and consider the opposition in deciding whether the amendment or any amendment should be allowed. (3) An amendment of a specification of a patent under this section shall have effect and be deemed always to have had effect from the grant of the patent…”
“Therefore under section 125 you look to a claim to see what the invention is (or inventions are) and thereafter when considering validity under section 72(1)(a) ascertain whether that invention is (or those inventions are) patentable. If one of those inventions is a patentable invention then the patent is partially valid.”
“But Henderson v Henderson abuse of process, as now understood, although separate and distinct from cause of action estoppel and issue estoppel, has much in common with them. The underlying public interest is the same: that there should be finality in litigation and that a party should not be twice vexed in the same matter. This public interest is reinforced by the current emphasis on efficiency and economy in the conduct of litigation, in the interests of the parties and the public as a whole. The bringing of a claim or the raising of a defence in later proceedings may, without more, amount to abuse if the court is satisfied (the onus being on the party alleging abuse) that the claim or defence should have been raised in the earlier proceedings if it was to be raised at all. I would not accept that it is necessary, before abuse may be found, to identify any additional element such as a collateral attack on a previous decision or some dishonesty, but where those elements are present the later proceedings will be much more obviously abusive, and there will rarely be a finding of abuse unless the later proceeding involves what the court regards as unjust harassment of a party. It is, however, wrong to hold that because a matter could have been raised in earlier proceedings it should have been, so as to render the raising of it in later proceedings necessarily abusive. That is to adopt too dogmatic an approach to what should in my opinion be a broad, merits-based judgment which takes account of the public and private interests involved and also takes account of all the facts of the case, focusing attention on the crucial question whether, in all the circumstances, a party is misusing or abusing the process of the court by seeking to raise before it the issue which could have been raised before. As one cannot comprehensively list all possible forms of abuse, so one cannot formulate any hard and fast rule to determine whether, on given facts, abuse is to be found or not. Thus while I would accept that lack of funds would not ordinarily excuse a failure to raise in earlier proceedings an issue which could and should have been raised then, I would not regard it as necessarily irrelevant, particularly if it appears that the lack of funds has been caused by the party against whom it is sought to claim. While the result may often be the same, it is in my view preferable to ask whether in all the circumstances a party's conduct is an abuse than to ask whether the conduct is an abuse and then, if it is, to ask whether the abuse is excused or justified by special circumstances. Properly applied, and whatever the legitimacy of its descent, the rule has in my view a valuable part to play in protecting the interests of justice.”
“97. In Nikken, the patentee once the court had found his patent to be invalid applied to amend by a re-writing amendment of the same general sort as is sought here. The trial judge refused this in the exercise of his discretion and because he found the amendment unallowable. This court upheld his decision on discretion and did not need to consider the second point. 98. All three members of the Court gave judgments. I said at [8] after having pointed out thats.75(1) of the Patents Act 1977 says the Court "may allow the proprietor of the patent to amend": There are different situations in which the exercise of the discretion to allow amendment of a patent may be sought: (a) before a trial; (b) after trial, at which certain claims have been held valid but other claims held invalid, the patentee simply wishing to delete the invalid claims (I would include here also the case where the patentee wishes to re-write the claims so as to exclude various dependencies as in Hallen v Brabantia[1990] FSR 134 . There the patentee is in effect continuing to claim which he had claimed before but in a much smaller way); and (c) after a trial in which all claims have been held invalid but the patentee wishes to insert what he hopes are validating amendments. 99. I would only add that classes (a) and possibly (b) are really cases of a partially valid patent, a situation which the Act recognises in s.63. This provides that the court may grant relief in such a case. It will usually (probably invariably) only do so on terms that the patent is amended to cut out the invalid claims. Mr Alexander in his skeleton argument half suggested that the present case was one of a partially invalid patent. Not so. Floyd J held all the claims invalid. This is a class (c) type. 100. I described the position for such a type in Nikken: [11] Class (c) involves something different, a proposed claim which was not under attack and could not have been under attack prior to trial. If the court is to allow such a claim to be propounded after trial, there is almost bound to be a further battle which would arise in the proposed amendment proceedings. That battle will be over whether or not the proposed amended claim is valid. I say "almost bound" because I can just conceive a case where the point was covered by the main litigation in some way or other. I should have added that a further battle may also arise about the allowability of the amendments. In this case if IPCom were allowed to apply for the amendments, there would indeed be battles both about allowability (and clarity) and validity. 101. In Nikken I then went on to say that an exercise of discretion to allow two trials would be improper for three reasons which I can summarise here: (a) It would breach the general procedural rule laid down as long ago as 1843 in Henderson v Henderson (1843) 3 Hare 100, that a party should normally not be allowed to advance in a second proceeding matter he could have advanced in the first. (b) That rule had been applied in patent cases by this Court in Windsurfing v Tabur Marine[1985] RPC 59 and Aldous J in Lubrizol v Esso[1998] RPC 727 . I said Aldous J had epitomised the position when he said, at p.790: I believe it is a fundamental principle of patent litigation that a party must bring before the court the issues that he seeks to have resolved, so as to enable the court to conclude the litigation between the parties. (c) The general court rules were "dead against" allowing amendment proceedings requiring a second trial after a first trial had determined the patent was invalid. I put it this way: [19] … The whole code is governed by the overriding objective contained in Part 1.1.1. 1.1.2 specifies some examples of cases of dealing with a case justly. 2(b) is "saving expense". Plainly a second trial would cause increased expense. 2(d) is ensuring that it is "dealt with expeditiously and fairly". Having two bites of the cherry is doing neither of those things. [20] The rules descend into more detail. Under the court's duty to manage cases, 1.4 requires the court actively to manage cases and 1.4.2 says that active case management includes "identifying the issues at an early stage and dealing with as many aspects of the case as it can on the same occasion". 102. Moreover I considered that a case involving the validity of a patent concerned not merely the private rights of the parties but also the public interest and the court was "particularly entitled to have regard to that". 103. I also said that: [25] In the real world patentees, faced with a real problem about the construction of their claims, ought to face up to them early and decide whether they need an amendment or might need an amendment. That is one of the purposes of the rule, to make people face up to their cases at an early stage, not at a late stage. That of course also applies to the validity of the claims. 104. Both Laws LJ and Waller LJ delivered short, but emphatic concurring judgments. Laws LJ said: [33] I agree. I wish only to underline my firm support for the view, which is a major and emphatic theme of my Lord, Jacob LJ's judgment, that the result of this appeal is driven by the principle of the general law given by Henderson and clothed with renewed vigour by the overriding objective of the CPR, that in any given litigation the parties are required to bring forward their whole case. It provides [the report says "provokes"] certainty and [the report says "of"] economy and minimises expense, and it applies as powerfully in this area of the law as any other. And Waller LJ: [34] In one sense the question is whether there should be some special rule in patent cases. In any other litigation it would be unfair to allow a party to amend his case post judgment so as to allow an opportunity to succeed after a further trial, however small. The question is whether there is something special about patent litigation. The authorities do not support the proposition that there is something special. Indeed, those authorities cited both by the judge and by my Lord go to the opposite effect. Those are reinforced, as I would see it, by the new CPR. I am relieved to find the position to be so.”
“However where a party fails to advance a case he could have advanced much earlier and does so without any real justification, he is abusing the process and the other party is therefore entitled to object. It is not normally procedurally fair to subject the other side to successive cases when you could readily have put them all in one go.”
“(1) Subject to Art. 139 a European patent may be revoked with effect for a Contracting State only on the grounds that [the grounds are specified]. (2) If the grounds for revocation affect the European patent only in part, the patent shall be limited by a corresponding amendment of the claims and revoked in part. (3) In proceedings before the competent court or authority relating to the validity of the European patent, the proprietor of the patent shall have the right to limit the patent by amending the claims. The patent as thus limited shall form the basis of the proceedings.”
“16. Applying that here, plainly there would be a second trial, the very thing that Oliver LJ is saying ought not to happen. Mr Baldwin's only answer is that the second trial would be a little one. That will not do.”
“141. … even if Warner-Lambert could be forgiven for not having spotted the point before, I consider that Mylan and Actavis made their case crystal clear in their skeleton argument exchanged a week before trial. Warner-Lambert did not complain at that stage that it had been taken by surprise. Nor did Warner-Lambert launch a conditional application to amend claim 3. Instead, Warner-Lambert chose to stand its ground and fight on claim 3 as it stood. During the trial, Warner-Lambert elected to try and deal with the problem primarily by advancing a narrow construction of claim 3.”
“147. I entirely accept that a key purpose of the patent system is to incentivise research for the benefit of the public, and nowhere more so than in the pharmaceutical field. On the other hand, another key purpose of the patent system is to ensure that monopolies are properly justified, and in particular that the scope of the patentee's monopoly reflects his technical contribution to the art. One way in which the latter purpose is achieved is by allowing any party to challenge the validity of a patent for the benefit of all the patentee's actual and potential competitors. In my view the principles on post-trial validating amendments which have been developed by the courts take account of these competing considerations. They do so in a way which favours finality, consistently with the general policy of the courts concerning litigation. While it is true that parties like Sandoz could bring their own claims for revocation, they would have to start from scratch with the delay which that would entail. Thus I consider that the public interest is another minor factor in favour of Mylan and Actavis' argument on abuse of process.”
“148. Applying the broad merits-based test articulated by Lord Bingham in Johnson v Gore Wood, I consider that the application to amend claim 3 is an abuse of process because it could and should have been made prior to trial. Warner-Lambert not only had ample opportunity to make a conditional application to amend prior to trial, but also ought to have appreciated, for the reasons explained above, that it needed to do so if it wished to contend a claim limited in that manner would be independently valid. If the amendment application was allowed to proceed, it could not be determined fairly without a second trial on validity. Furthermore, there is a risk that such a second trial would delay the overall resolution of the dispute. Accordingly, in my view, the amendment application amounts to unjust harassment of Mylan and Actavis. It would also be contrary to the interests of other generic suppliers of pregabalin. It is true that the consequence (subject to the outcome of the appeals) will be that claim 3 is invalid and must be deleted, but that consequence is attributable to Warner-Lambert electing to defend the insufficiency attack on claim 3 in the way in which it did, which proved unsuccessful (subject to the outcome of the appeals), and not making a conditional application to amend before trial. As the cases show, Warner-Lambert is not the first patentee to have made that mistake.”
“…in my judgment the court has to be satisfied that [the respondent] will not be at risk of prejudice if the new point is allowed because it might have adduced other evidence at trial, or otherwise conduct the case differently. It should consider for itself, as best it can, what factual issues are likely to be raised by the new case. Moreover, in circumstances such as the present, where there has been no disclosure relative to the new way in which the appellant seeks to put his case and virtually no opportunity to consider the matter, I do not consider that the court can reasonably expect the party against whom the amendment is sought to be made to be specific about the evidence he would have adduced had the point been raised earlier. If there is any area of doubt, the benefit of it must be given to the party against whom the amendment is sought. It is the party who should have raised the point at trial who should bear any risk of prejudice.”
“81. It would therefore appear from these cases that what the German courts look for in these circumstances is some outward manifestation in the manufacture itself (which may include the packaging, but not advertising) which can be specifically attributed to the new use. But it may be that the desire to avoid "sophistry" and an investigation into the facts involving the drawing of inferences as to what the manufacturer's knowledge or intention may have been, has resulted in the introduction of a rule which may be narrower than is legally necessary. If a manufacturer is actively inducing, for example by advertising, the use of his product for the patented indication, it is difficult to see, on any basis, why the manufacture is not "for" the patented indication”
“… the defendants have marketed their [drug] by having applied for and received the administrative approval for the same for the new patented therapeutic indication or had performed another procedure directed at strengthening the use of the same for that new indication.”
“Thus it can be found that Sandoz has only marketed the indications for which they have received a marketing authorisation, has included a leaflet that only refers to the two indications epilepsy and GAD, has largely informed physicians and pharmacists at the time of the launch of [its generic pregabalin] through the email sent at the beginning of October. Regarding the messages to be sent to the health authorities, it appears that Pfizer has done it to alert them of their rights and of the need to protect such rights so that it was irrelevant for Sandoz itself to send a letter. It should be further noted that Sandoz has agreed to send a more explicit message to physicians and pharmacists in the city and in hospitals to describe how to prescribe or dispense [its generic pregabalin] in order to avoid infringement of the patentee’s rights. Therefore, there is no active infringement on the basis of direct infringement.”
“138. … I consider it is arguable to say that when section 60(2) speaks of "putting the invention into effect", it may be legitimate to look not just at whether any one person is carrying out the invention in a sense which would give rise to liability of that person for an act of infringement. It may be that the invention is put into effect if pregabalin is manufactured by one person and supplied to another who intentionally uses it for the treatment of pain. In those circumstances, a person who supplies pregabalin with the requisite knowledge (i.e. that prescribed in section 60(2) itself) does provide means suitable and intended to put the invention into effect, albeit by the combination of manufacturer and user, rather than by any one person alone. It may be that this is the reasoning which underlies the decisions in the Dutch and German cases which I have referred to.”
“684. The fundamental difficulty with Pfizer's claim under section 60(2) remains, as it has always done, that claims 1 and 3 of the Patent are claims to processes of manufacture, but there is no act of manufacture by any party downstream from Actavis, nor even the prospect of such an act. This is so even if manufacturing (or "preparation", to use the word in the claims) for this purpose includes packaging with appropriate instructions. In particular, there is no act of manufacture by pharmacists, nor any prospect of such an act. It follows that, although there is no difficulty in concluding that Lecaent's active ingredient is "means, relating to an essential element of the invention, for putting the invention into effect", Lecaent is not suitable for putting, or intended to put, the invention into effect: either the invention has already been put into effect by the time that Lecaent leaves Actavis' hands or it is not put into effect at all. Accordingly, I conclude that Actavis have not infringed claims 1 and 3 of the Patent pursuant to section 60(2).”