tag:blogger.com,1999:blog-5574479.post2628822307806315847..comments2024-03-29T13:59:42.629+00:00Comments on The IPKat: One in the eye for Pfizer glaucoma patent policy?Verónica RodrÃguez Arguijohttp://www.blogger.com/profile/05763207846940036921noreply@blogger.comBlogger10125tag:blogger.com,1999:blog-5574479.post-80644259986558590132012-02-16T20:07:09.787+00:002012-02-16T20:07:09.787+00:00Surely a case of never mind the law just follow th...Surely a case of never mind the law just follow the policy? Super Mario was able to deliver it along with his repeal of the patent linkage law to show that one Mediterranean state can do what the Commission wants.<br /><br />One can't help thinking that the Competition Authority redacted the confidential e-mails just to hide how flimsy the case of sinister intent really was. It would be entertaining to see how the attorneys who missed the deadline were described there - but Pfizer seem to have chosen not to tell the real story about their attempts to avoid losing their rights on a formality.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-61099033140910113492012-02-16T13:30:34.225+00:002012-02-16T13:30:34.225+00:00this sounds like a pretty clear case of "abus...this sounds like a pretty clear case of "abuse of process". And given that the fine was less than the profit it overall seems to have paid off. Not good (unless the 14m damage to the public is to be collected on top of the fine).<br />But if Pfizer get away with still a profit after fine, there remains an incentive for (what appears to me as) inequitable conduct.Kharolnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-86484866139867685622012-02-16T13:04:52.054+00:002012-02-16T13:04:52.054+00:00As for your 'what we should be able to agree u...<i>As for your 'what we should be able to agree upon...", well why should we?</i><br /><br />Maybe because it was in the package? The introduction to the Regulation reads:<br /><br />"This European Union (EU) Regulation aims to improve the health and quality of life of children in Europe by ensuring that new medicines for children and medicines already on the market are fully adapted to their specific needs."<br /><br />Nothing about "extending the life of an old patent for a medicine that is hardly ever going to be administered to children". (Please note that I wrote the "stated" aim: I certainly prefer not to delve into the individual consciences of the lawmakers.)<br /><br />My realism is at very healthy levels, thank you, as is my cynicism. So much so, in fact, that when I read Anonymous@4:55 point that the whole paediatric extension must have been hunky-dory because the PIP was approved by "the regulatory authority", I can't avoid noticing that the "regulatory authority" in question is the Paediatric Committee of the European Medicines Agency, which has come <a href="http://www.pharmalot.com/2011/11/ema-is-investigated-over-conflicts-of-interest/" rel="nofollow">under quite some flak</a> for its conflicts of interest.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-67959077838977734182012-02-16T10:06:59.398+00:002012-02-16T10:06:59.398+00:00What anon at 9:06 needs to realise is that everyth...What anon at 9:06 needs to realise is that everything in the patent world is monopolistic and therefore directly affects competition. As educated patent lawyers some of us are also aware of competition law and can determine that the courts of member states sometime get it wrong. The EU Commission itself is under the impression that everything a pharma company does in respect of patents is anti-competitive, so it is no surprise to find others 'at it' as well.<br /><br />As for your 'what we should be able to agree upon...", well why should we? And, no we shouldn't.<br /><br />I believe Pfizer are currently working on a lifestyle product (typical self-interest!) called a 'realism pill'. I'll be sure to have them send you a sample.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-76124750042940221652012-02-16T09:06:31.617+00:002012-02-16T09:06:31.617+00:00Anonymous@10:43 should ask Pfizer for one of their...Anonymous@10:43 should ask Pfizer for one of their "chill pills". <br /><br />The main outstanding question here is whether the divisional was a case of double patenting. The ICA believes so, although it seems to be hardly qualified to know, whereas Pfizer quite disingenuously argues that the Opposition Division didn't revoke the patent on grounds of double-patenting, but rather because of extension of subject-matter. This is disingenuous because, of course, double patenting is not a ground for opposition.<br /><br />The most important take-away lesson from this case is that, even if something is allowable under <i>patent law</i> (which Pfizer's manoeuvres indeed appear to have been), it does not necessarily mean that it is OK under <i>competition law</i>. Thoughtful patent lawyers and attorneys should keep that in mind and stay informed about the strictures of competition law as well (as Samsung's legal staff is probably learning right now with regard to standard-essential patents).<br /><br />In the present case, we probably still haven't seen the endgame. I'm impatient to see how this will ultimately play in court.<br /><br />What we should be able to agree upon, in any case, is that it certainly wasn't the stated aim of the lawmakers, when they introduced pediatric SPCs, to allow the pharmaceutical industry to further extend the patent term for a drug for such an un-pediatric condition as glaucoma (according to the ICA's decision, less than 1% of are glaucoma patients are underage).Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-90837735278876036022012-02-15T22:43:44.720+00:002012-02-15T22:43:44.720+00:00"The divisional (which must have been a secon..."The divisional (which must have been a second- or third-generation divisional, because it was filed years after the grant of the first patent"<br /><br />Shock! Horror! Divisional applications filed after the filing date of the parent (though legally having the same fd)! Those pesky pharma companies need bringing down a peg or two.<br /><br />Thank heavens for the latest news of R&D site closures by astrazeneca to follow on from those of Pfizer. The sooner these good for nothing companies are extinguished the better!!!!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-77775991798493652322012-02-15T10:34:37.767+00:002012-02-15T10:34:37.767+00:00I am also finding it difficult to see what Pfizer ...I am also finding it difficult to see what Pfizer has done wrong in Italy in this instance?<br /><br />Even if it is accepted that they missed the date to file an SPC as alleged above and that their divisional will eventually be found invalid by the BoA, Pfizer would appear to have merely attempted by all (legal) means possible to extend their Patent rights so as to maximise the profits they can obtain from a product which they own the rights to?<br /><br />If the generics thought this was unfair they are entitled before the law to seek to remedy this situation, which indeed it appears they have done so.<br /><br />I do not state that no IP related crooked dealing occur, but we as fellow IP professionals should perhaps keep our odium for those times when clear wrong doing has been found, rather than when a team of IP professionals have just done their job to the best of their abilities!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-12674233684926484512012-02-14T21:27:40.840+00:002012-02-14T21:27:40.840+00:00The extract translated by Mr. Selas leaves out som...The extract translated by Mr. Selas leaves out some interesting tidbits that doubtlessly contributed to the ICA's decision. Firstly, the original patentee had missed the deadline for requesting the SPC on the first patent in Italy and another country (which has been redacted). The divisional (which must have been a second- or third-generation divisional, because it was filed years after the grant of the first patent) was filed after Pfizer became aware of this and only validated in those countries where the SPC deadline for the first patent had been missed. According to the ICA (but here's where things become rather confuse), it covered the same active principle as the first patent, and was thus a case of double patenting. This is disputed by Pfizer. The divisional was eventually invalidated in first-instance opposition proceedings (for extension of subject-matter), but the appeal is apparently stil running. The request for the pediatric SPC, however, was filed <i>after</i> the decision of the Oposition Division.<br />The ICA has apparently also been very negatively influenced by the internal Pfizer communications gathered during its investigation. Unfortunately (for us curious cats, not for Pfizer) those juicy bits are all redacted from the ICA's decision..Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-87268861382386410672012-02-14T16:55:12.387+00:002012-02-14T16:55:12.387+00:00I am having real problems trying to see what Pfize...I am having real problems trying to see what Pfizer did wrong here. <br /><br />It is explicit that the paediatric extension is awarded for drugs which undergo paediatric tests, irrespective of the results of those tests. The very fact that xalatan was awarded a PIP shows that the regulatory authority was happy - in principle - that the drug could be used in paeds if suitable. Were this not the case, xalatan would not have received a PIP. <br /><br />And often there are very valid bona fide reasons to base SPCs of divisional applications.<br /><br />I hope this decision will be appealed and that Pfizer win on appeal. The ICA clearly doesn't understand IP.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-52508335864406994542012-02-14T15:58:39.527+00:002012-02-14T15:58:39.527+00:00I don't follow "the absence of a new drug...I don't follow "the absence of a new drug, which normally follows the divisional application" in para 198 of the decision, and "no new drug was forthcoming from the divisional application" in the post. From where comes the idea that divisional applications are filed or should be filed in relation to a new drug?Darren Smythhttps://www.blogger.com/profile/04252776942038752516noreply@blogger.com