tag:blogger.com,1999:blog-5574479.post6065908963901232031..comments2024-03-29T06:53:23.405+00:00Comments on The IPKat: The Opinion of the Advocate General in the case C-443/17 (Abraxis case). A lost case for second medical indication SPCs? Verónica Rodríguez Arguijohttp://www.blogger.com/profile/05763207846940036921noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-5574479.post-1094468628526095212018-12-24T16:35:28.134+00:002018-12-24T16:35:28.134+00:00I think that patent practitioners have not yet rea...I think that patent practitioners have not yet realised the implications of the CJEU being part of the EU, i.e. it will interpret EU legislation according to the relevant policy objective, and not according to the what it says 'literally'. The SPC system is about protecting the finding of new drugs, and not about new ways of using known drugs in the eyes of the EU, and so we can expect CJEU decisions to mirror that. By pointing this out I am hoping to prevent my fellow European practitioners going through the same pain that US attorneys have been through in seeing the US Supreme Court using 'eligibility' to radically change what is patentable in the US. Expect the CJEU to increasingly do the same to patent law here, as per the relevant policy objective. For too long the Enlarged Board of the EPO has protected us from considering wider issues, but any Supreme Court cannot ignore them, and we are about to get a taste of that as the UPC gets up and running and the CJEU becomes an important source of patent law. مرحباnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-77131495069453088092018-12-23T13:07:39.805+00:002018-12-23T13:07:39.805+00:00Well the author seems to have a strong opinion on...Well the author seems to have a strong opinion on this. However, where is the data that shows that pharma companies need more time than their patent rights in order to recoup investments relating to formulations rather than actual drug discovery? The latter is far more costly and time consuming - and indeed involves much more risk and wasted R&D spend on projects that do nowhere in the end due to tox issues etc. Hence, the SPC system was designed to provide assistance to fund drug discovery and the explanatory memorandum, the articles of the SPC regs and the previous caselaw all dictate that SPCs are meant to cover new active substances or combinations. I think that new legislation should indeed be required to change this - it is not the job of the court. However, there would need to be data on which to base any such new legislation. Working in the industry - it is clear to me that the costs for reformulation just cannot be considered to be anything like in the same ballpark (and thus require 5 more years of exclusivity). I would be very surprised if any convincing data to the contrary can be adducedAnonymousnoreply@blogger.com