tag:blogger.com,1999:blog-5574479.post3639862933033010238..comments2024-03-28T09:05:22.006+00:00Comments on The IPKat: Warner-Lambert v Actavis Mark 3: a "lyrical" solution to a painful patent disputeVerónica RodrÃguez Arguijohttp://www.blogger.com/profile/05763207846940036921noreply@blogger.comBlogger66125tag:blogger.com,1999:blog-5574479.post-6617720025157260192015-03-06T09:46:44.235+00:002015-03-06T09:46:44.235+00:00I prefer the 80's classic "Srewloose"...I prefer the 80's classic "Srewloose".<br /><br />Most apt to the discussion (for those that see behavior reminiscent of a football match as a discussion) is "The Merchant of Screws", a tale of woe where an ironmonger (The Merchant) is locked in the stocks for daring to sell screws for off-label, un-regulated purposes, while the patentee can only look on and do nothing, except cry.<br /><br />Meanwhile in the adjacent stocks, Pfizer shareholders are enjoying throwing rotten tomatoes at their enemies thanks to a decree from Good King Arnold.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-61902035923366343512015-03-06T08:45:56.185+00:002015-03-06T08:45:56.185+00:00You forgot "is this a fixing means which I se...You forgot "is this a fixing means which I see before me?"Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-44956695678757614622015-03-06T08:23:31.213+00:002015-03-06T08:23:31.213+00:00Shakespeare's plays still have resonance in th...Shakespeare's plays still have resonance in the modern world<br /><br />To screw or not to screw?<br /><br />Taming of the screw.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-153680847277315272015-03-05T19:58:29.514+00:002015-03-05T19:58:29.514+00:00Will Mr. Anonymous please settle down and refrain ...Will Mr. Anonymous please settle down and refrain from the poor ad hominem attacks?<br /><br />If you have a point to make, please try to do so in a reasonable manner. There is no need (and even less effectiveness) in taking the avenue that you are taking.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-65146546526404992902015-03-05T19:42:58.764+00:002015-03-05T19:42:58.764+00:00This comment has been removed by a blog administrator.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-70255797165658644422015-03-05T18:25:25.929+00:002015-03-05T18:25:25.929+00:00I would guess that Anonymous @ 16:57 is the same A...I would guess that Anonymous @ 16:57 is the same Anonymous who continues to "dumb himself down" when it comes to analogies.<br /><br />The emotional (instead of reasonable) response to the word "evergreening" is a giveaway.<br /><br />Not sure exactly how a rant about the policies of the sovereign nation of India fits into the current thread discussion, but perhaps when the poster calms down and composes a more lucid offering, we may be able to see what (if any) points the author wanted to make.<br /><br />Great job 13:46.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-12172112737344373552015-03-05T16:57:02.621+00:002015-03-05T16:57:02.621+00:00Evergreening trick?
Nothing wrong with evergreeni...Evergreening trick?<br /><br />Nothing wrong with evergreening unless you are a cheapskate Indian generic company that takes but never gives and who can only survive because of their parasitic activity on the back of Western pharmaceutical companies.<br /><br />Nothing wrong with generics generally, either as that is how the system works. Just don't go whinging about it being a trick, when provided patentability criteria are met, patents for new uses are perfectly allowable.<br /><br />I'm not sure if you noticed, but anon at 13:46 was shown to commenting on irrelevancies. They are perfectly correct in one aspect, however, which is that if you are a cheapskate Indian generic with poor quality production practices, a lack of appropriate record keeping, an inability to keep equipment clean, or a tendency to falsify documents, for example, the US FDA will bean you from selling your trash in their country.<br /><br />I see Ranbaxy have still failed to prove their facilities meet FDA requirements.<br /><br />A lot of comments note the worthlessness of Swiss claims, yet they appearing to be putting the final nails in a coffin that does not contain Lyrica. Check out the decision that has gone Pfizer'a way. Maybe screws would have been better than nails?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-90594230549185843252015-03-05T15:23:36.624+00:002015-03-05T15:23:36.624+00:00I think the question is:
Is pregabalin an off-pat...I think the question is:<br /><br />Is pregabalin an off-patent item that has another (substantial) non-infringing use?<br /><br />Clearly, the answer to that question is yes.<br /><br />Thus, in the legal context, yes, pregabalin can be treated as a "screw" - that this, um, screws the separate "use" patent that seeks a subset of the freely available product is - and should be - a severe limitation on what can only be (rightfully) called an evergreening patent.<br /><br />Anonymous @ 13:46 supplies the final nails to those unwilling (or unable) to recognize the very real limitations of Swiss claims concerning items that being off-patent MUST be considered - of themselves - to be in the open domain for all. One cannot - and should not - be able to cheat the system on a item patent with ANY type of evergreening trick. Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-15855708591940498402015-03-05T14:53:35.773+00:002015-03-05T14:53:35.773+00:001. HMR 2012 does not override the UK Patents Act 1...1. HMR 2012 does not override the UK Patents Act 1977.<br /><br />2. The generics in this case have marketing authorisations or are in the process of obtaining them. They will launch their products with a skinny label in order not to infringe. There are no breaches of other 'legal instruments' because they have marketing approval.<br /><br />3. No-one is interested in or has proposed breaching patient confidentiality.<br /><br />Your point is?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-74233976785935290532015-03-05T13:46:05.402+00:002015-03-05T13:46:05.402+00:00Regulation 167 of Human Medicines Regulations 2012...Regulation 167 of Human Medicines Regulations 2012 allows a doctor in the UK to prescribe drugs off licence and also to prescribe drugs with no marketing authorisation in the first place. There is nothing in the Patents Act 1977 (as amended) which would mean that a doctor writing a prescription for pregabalin for pain would breach the Act, and similarly nothing being breached by the pharmacists etc. <br /><br />Breaches of several legal instruments (including conditions of marketing authorisation, various parts of the HMR 2012 etc.) would occur if the manufacturer and/or distributer of the generic product marketed the generic product with a claim for use in pain; however no breach is committed if they do not market the product for such an indication, whatever the final or intended use by the prescriber.<br /><br />In terms of confidentiality, the pharmacist, the wholesaler and the manufacturer do not have an automatic legal right to know the diagnosis of the patient. In fact, neither do NHS management. Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-33014976977762815682015-03-05T12:56:49.296+00:002015-03-05T12:56:49.296+00:00So pregabalin is a staple commercial product?
In ...So pregabalin is a staple commercial product?<br /><br />In fact, you are saying that everything that isn't patented is a staple commercial product?<br /><br />Therefore, in order to infringe Section 60(2), the means supplied must itself be patented.<br /><br />Interesting. I shall ponder that over afternoon tea.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-25225305236851889322015-03-05T12:22:39.483+00:002015-03-05T12:22:39.483+00:00The Anonymous at 9:46 fights too hard to refute th...The Anonymous at 9:46 fights too hard to refute the analogy, and simply evidences a lack of understanding of what analogies are for.<br /><br />Clearly, medicine is not the same as fastening devices.<br /><br />The (rather clear) point though is that like a screw, if the medicine has alternative - and off-patent - uses, it too may qualify for the description of a staple commercial product.<br /><br />Perhaps in a hurry not to see this, the one so aggrieved with the analogy skipped actually reading the first comment at 15:54 and the express points that the analogy was used for. (and for your own sake, try not to think of this as "dumbing down" as you tend to simply stop thinking when you do that - dumbing yourself down.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-80158432516445866052015-03-05T09:46:04.707+00:002015-03-05T09:46:04.707+00:00What examples are there of patented new uses of sc...What examples are there of patented new uses of screws? A screw is a known fixing means and therefore its use as a fixing means for a new (itself patentable) article would be obvious. Are people saying that the use of a screw may have been obvious to try, but without any reasonable chance of success, but then in practice it was unexpectedly shown to work? I would say this makes the argument against obviousness a complete fallacy.<br /><br />In the Lyrica case the patented new use, pain, was not something that could have been expected or considered worthy of testing for.<br /><br />On infringement, without any credible patentable invention for the new use of a screw, I fail to see how it is possible to debate the comparison with a drug, and specifically Lyrica.<br /><br />If there was such a patent and the screw is a standard screw then, as highlighted earlier, it would surely be considered a staple commercial product. Section 60(2) (supplying means relating to essential element) does not apply by virtue of S.60(3). Pregabalin could not be considered to be a staple commercial product.<br /><br />Of course, Justice Arnold completely dismissed 60(2) out of hand, but he was clearly wrong to do so. The position requires more analysis. Pfizer have been criticized for a weak case, but I see the problem lying firmly at the door of their counsel. In the US, litigation counsel would not be left floundering in court unprepared and unable to respond in such a fashion. I fear UK patent law practice has lost its way.<br /><br />If the screw is not a staple commercial product, supply of the screw in accordance with S.60(2) would be infringement. Proving infringement would rest on the availability of evidence, which may be in the form of promotional material from the supplier. However, even if it is decided the screw is not a staple commercial product, it is general sold in such a way so that tracking its sale and intended use would be practically impossible.<br /><br />In the Lyrica case the situation is very different. In every single example the reason for the prescription is known. The pharmacist, NHS, CCGs, etc, all know the reason for the majority of the sales of the drug.<br /><br />This is chalk and cheese.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-3422004558920992402015-03-03T22:55:00.650+00:002015-03-03T22:55:00.650+00:00The Wellcome Trust is very well respected and thei...The Wellcome Trust is very well respected and their comments on the issue are of value.<br /><br />http://blog.wellcome.ac.uk/2012/10/29/lost-in-translation/<br />Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-3925212472955661172015-03-03T22:51:32.093+00:002015-03-03T22:51:32.093+00:00Miss, Miss, he's being mean to me again, Miss!...Miss, Miss, he's being mean to me again, Miss!!! Send him back to the corner with his hat miss.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-36928704610377498822015-03-03T19:52:52.660+00:002015-03-03T19:52:52.660+00:00Analogies are for dumbing down...?
With all due r...Analogies are for dumbing down...?<br /><br />With all due respect, you are just far too full of yourself. Combine that with your errors and that is just not a good combination.<br /><br />Best of luck to you in understanding this.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-51401745017777698562015-03-03T18:55:56.068+00:002015-03-03T18:55:56.068+00:00Less of the blasphemy.Less of the blasphemy.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-29389852084890673762015-03-03T18:38:13.419+00:002015-03-03T18:38:13.419+00:00Oh sweet Jesus. Silence, please, children. Oh sweet Jesus. Silence, please, children. Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-86618047366185802952015-03-03T08:38:14.632+00:002015-03-03T08:38:14.632+00:00Analogies are for those who do not understand an i...Analogies are for those who do not understand an issue and need it dumbing down to compare it to something they do understand (screw, hammer, doughnut). Analogies are therefore inherently bad. The term 'bad' is inherent in an analogy, hence my use of 'bad analogy' is an error as I am saying bad bad. This, aside from the fact that your analogy is bad for being about a thing that cannot be patented in a use-limited way like a pharmaceutical, it is simply bad for being an analogy.<br /><br />Notice that two people (one of the me) at the same time and without knowledge of one another's existence, each independently sated that your analogy was bad.<br /><br />Does that answer your question? <br /><br />Now, rather than get hung up on the defence of your analogy why not discuss the facts and legalities of the case? No need to dumb things down on our behalf.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-9150766191083307362015-03-02T23:46:36.484+00:002015-03-02T23:46:36.484+00:00You keep on saying "bad analogy" - but n...You keep on saying "bad analogy" - but nothing else.<br /><br />It is you that has done nothing here. I await <i>some</i> hint at reasoning.<br /><br />On the other hand, the scope of a "use" patent is clear - as is it abundantly clear that a "use" patent for some THING in the public domain is necessarily constrained. Exactly as the analogy would indicate.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-16244380453921610792015-03-02T23:22:04.973+00:002015-03-02T23:22:04.973+00:00We know use of a screw and a screw for use are dif...We know use of a screw and a screw for use are different. The point with pharma claims is determining their scope.<br /><br />Screws are still a bad analogy and the use of any analogy is unnecessary. fell free to get back to the facts. I have no problem with 'defeat' but you haven't done anything to deserve it yet.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-33885677326612334602015-03-02T23:04:54.053+00:002015-03-02T23:04:54.053+00:00A screw for use
and
use of a screw
Are two radi...A screw for use<br /><br />and<br /><br />use of a screw<br /><br />Are two radically different things (even in Switzerland).<br /><br />Your mocking "call that a victory" aside, you can call your defeat anything you want.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-88355994834378631412015-03-02T21:46:43.462+00:002015-03-02T21:46:43.462+00:00I'm sure by the context of the discussion you ...I'm sure by the context of the discussion you understand that I was referring to "A screw for use.." style claim.<br /><br />But, if that is a considered a victory, you are welcome to it.<br /><br />Swiss claim = ? Use of a screw in the manufacture of a fixing means for fixing a 'novel thing'?<br /><br />It is still a bad analogy.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-23436222016309271392015-03-02T19:03:30.126+00:002015-03-02T19:03:30.126+00:00The Anonymous @ 18:29 who declares that a new use ...The Anonymous @ 18:29 who declares that a new use of a screw is not patentable is grossly mistaken.<br /><br />New uses of old things are eminently patentable as process patents.<br /><br />"<i>No, that's you that is</i>" - indeed.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-68223192446629629312015-03-02T18:35:35.664+00:002015-03-02T18:35:35.664+00:00Anyhow cont.
Lyrica is protected by a second medi...Anyhow cont.<br /><br />Lyrica is protected by a second medical use patent, the drug itself being off-patent and shortly to be sold by many generic suppliers. Those generics are prevented by the patent from including the pain indication on their label and from marketing their product as suitable for pain. NHS prescribers will not as of this afternoon be prescribing generic pregabalin for pain, but will be presribing by the Lyrica brand. When presented with a Lyrica prescription, every pharmacist must prescribe Lyrica.<br /><br />So, when you say such patent 'may' have value, the facts prove just how big that value is. Take a look at the UK sales figures alone to see juts how valuable this patent is.Anonymousnoreply@blogger.com