"Actavis is therefore preparing to launch a pregabalin product in the UK with a summary of product characteristics ('SmPC') limited to the treatment of epilepsy and general anxiety disorders (a so-called 'skinny label') in December 2014 or January 2015."
"We are of the opinion that, if your client intends to launch a generic product, it is required to take appropriate steps to ensure that it is not dispensed for the treatment of pain, including by ensuring that all pharmacists are aware that its generic product is not authorised for and should not be dispensed for the treatment of pain. As a starting point, this would seem to require an appropriate notice being placed on the outside of the packet of your client's product to ensure that this matter is brought to the attention of the pharmacist handling the product."
"Further, the late raising by your client of the packaging point appears to us and our client to be a tactical attempt to delay the imminent launch by our client of the pregabalin product targeted to the non-patent market. Our client is already packaging its product and the additional notice is in any event unnecessary, inappropriate, and, in our client's experience, unprecedented."
'This product is not authorised for the treatment of pain and mustshould not be dispensed for such purposespain.'
"i) The required intention is to put the invention into effect. The question is what the supplier knows or ought to know about the intention of the person who is in a position to put the invention into effect – the person at the end of the supply chain, [108]. ii) It is enough if the supplier knows (or it is obvious to a reasonable person in the circumstances) that some ultimate users will intend to use or adapt the 'means' so as to infringe, [107(i)] and [114]. iii) There is no requirement that the intention of the individual ultimate user must be known to the defendant at the moment of the alleged infringement, [124]. iv) Whilst it is the intention of the ultimate user which matters, a future intention of a future ultimate user is enough if that is what one would expect in all the circumstances, [125]. v) The knowledge and intention requirements are satisfied if, at the time of supply or offer to supply, the supplier knows, or it obvious to a reasonable person in the circumstances, that ultimate users will intend to put the invention into effect. This has to be proved on the usual standard of the balance of probabilities. It is not enough merely that the means are suitable for putting the invention into effect (for that is a separate requirement), but it is likely to be the case where the supplier proposes or recommends or even indicates the possibility of such use in his promotional material, [131]."
“the invention is either pregabalin for treating pain and/or neuropathic pain or the use of pregabalin for treating pain and or neuropathic pain.”
“For the purposes of this Act an invention for a patent … for which a patent has been granted shall, unless the context otherwise requires, be taken to be that specified in a claim of the specification of the … patent, … as interpreted by the description and any drawings contained in that specification, and the extent of the protection conferred by a patent or application for a patent shall be determined accordingly.”
“Legal rules which are not soundly based resemble proverbial bad pennies: they turn up again and again.”
“So the manufacture of an old substance for use in a new treatment was considered by the Enlarged Board to be novel. The justification for novelty was the new therapeutic use. And since the claim was to the manufacture of the compound, it was not a claim to a method of treatment. In BMS Jacob J wondered how such a claim might work so far as infringement is concerned and thought it might create difficulty. And so it might in some cases (e.g. where the product is just sold as a standard product, like aspirin tablets). But in many cases the difficulty may be more theoretical than real. This is because manufacturers, particularly for prescription medicines and probably many others, have to provide detailed instructions and information about the use(s) and dosage(s) of their products. So in practice you can tell whether someone has used X for the manufacture of a medicament for the treatment of Y. He will have to say that his product is for the treatment of Y on his product information leaflet.”
“In its essence the claim here is to the use of finasteride for the preparation of a medicament of the specified dosages. It is not aimed at and it does not touch the doctor – it is directed at the manufacturer.”
“If someone knowingly causes a breach of contract, it does not normally matter that it is the means by which he intends to achieve some further end or even that he would rather have been able to achieve that end without causing a breach. Mr Gye would very likely have preferred to be able to obtain Miss Wagner's services without her having to break her contract. But that did not matter. Again, people seldom knowingly cause loss by unlawful means out of simple disinterested malice. It is usually to achieve the further end of securing an economic advantage to themselves. … On the other hand, if the breach of contract is neither an end in itself nor a means to an end, but merely a foreseeable consequence, then in my opinion it cannot for this purpose be said to have been intended. That, I think, is what judges and writers mean when they say that the claimant must have been "targeted" or "aimed at". In my opinion the majority of the Court of Appeal was wrong to have allowed the action in Millar v Bassey [1994] EMLR 44 to proceed. Miss Bassey had broken her contract to perform for the recording company and it was a foreseeable consequence that the recording company would have to break its contracts with the accompanying musicians, but those breaches of contract were neither an end desired by Miss Bassey nor a means of achieving that end.”
“is meant to protect the use of a chemical substance in the therapeutic treatment of the human body that is prepared for this use, such as by a specific packaging of the tablet size, an inscription on the package, or an accompanying package insert.”
“Inherent in the “purpose-limited product protection” is a final element, namely a particular purpose actualisation. This forms a key constituent of the protected invention, which is only realised through the actualisation of the inherent purpose. If this purpose is neither aimed for nor attained in a purposive way, but instead a purpose other than that identified in the patent claim is actualised, then there is no utilisation of the patent (…) … For answering the question whether the purpose pursued is that identified in the patent or a different purpose, a practically reasonable yardstick must be applied that leaves no room for sophistry. The fact that a product is suitable - inter alia - for the purpose stated in the patent in suit does not mean that it also actualises that purpose. Instead, for utilisation of the teaching protected in the “purpose-limited claim”, it is also necessary that the purpose inherent in the patent in suit is achieved (actualised) to a practically considerable extent in the sense of the specific objective of the patented teaching.”
“This means that there must be a direct and purposive connection between the measure of manifest making up on the one hand and the production and sale of the product on the other hand, this connection holding the user unambiguously to the patent-protected use.”
“With its accession to the above mentioned discount agreement, the Respondent indirectly infringes (contributory infringement) claims 1 and 3 of the patent at issue (§ 10 of the German Patent Law), since the discount agreement was aimed at the prescription and supply of Pregabalin-type drugs for the treatment of neuropathic pain and, therefore, must be understood to include the pain indications that are covered by the patent at issue.”
“in advance of an imminent direct patent infringement. According to the case law of the Bundesgerichthof the elements of strict liability can arise even when no direct patent infringement follows.”
“At present the medicinal product is in any case to be regarded as manifestly prepared for use within the meaning of the production use patent in this case because it can be used as it stands for the treatment of neuropathic pain. No further physical steps or addition of physical means are needed, all that is needed is a definition of its purpose. This definition of purpose or use is currently made by the substituting pharmacist … It is within the nature of contributory patent infringement that acts done in the sphere of the buyer are attributed to the offering party, even if it has no control over such acts, because that is precisely what strict liability under § 10(1) Patent Act means. Legally, the Respondent must therefore for this reason accept that the actions of the pharmacist may be attributed to it precisely because the pharmacist’s act of substitution, as already explained, can reliably be foreseen, and is legally provided for.”
“This might be different in the hypothetical case - which does not occur in the case at hand – that proof would be furnished of the fact that due to the examination described in [the particular passage of the SmPC said to encourage the specified use] and the conclusion drawn from this Teva’s generic ribavarin – whether or not prompted to do so – is most certainly also prescribed for [the relevant patient group].”
“Sun therefore had to know that its product would be supplied for the patented indication at the end of the vertical trading chain. The sale of 142 units of the Generic Product over the months January and February 2014 alone entails that Sun must realise that its product will also be supplied and used for the patented application with [sic] a certainty bordering on probability. … Sun has argued that it cannot be reproached for these matters, as these are the consequences of the preference policy applied by [the insurer] and of the tender issued by [the insurer] which did not permit conditional subscription (only for use with the indication of Paget’s disease). The court of appeal is a priori of the opinion that this does not exonerate Sun. Under the given circumstances, in which it was clear to Sun in advance that [the insurer’s] procedures would unavoidably lead to the Generic Product also being used for osteoporosis and thus for the indication protected under the patent, it was up to Sun to do everything possible to prevent the Generic Product from being supplied for the treatment of osteoporosis, which could infringe the Novartis patent. Sun failed in this respect.”
“As touched upon previously in paragraph 2.5 above, the protection conferred by a patent is to be determined by interpretation of the terms of the claims, and the rights of the patent proprietor flow from the protection which is conferred. There is a clear distinction between the protection which is conferred and the rights which are conferred by a European patent, however. The protection conferred by a patent is determined by the terms of the claims (Article 69(1) EPC), and in particular by the categories of such claims and their technical features. In this connection, Article 69 EPC and its Protocol are to be applied, both in proceedings before the EPO and in proceedings within Contracting States, whenever it is necessary to determine the protection which is conferred. In contrast, the rights conferred on the proprietor of a European patent (Article 64(1) EPC) are the legal rights which the law of a designated Contracting State may confer upon the proprietor, for example, as regards what acts of third parties constitute infringement of the patent, and as regards the remedies which are available in respect of any infringement.”