tag:blogger.com,1999:blog-6377401824680246858.post5558828757010546613..comments2024-03-05T15:49:16.751+00:00Comments on The SPC blog: A more “fit for purpose” SPC Regulation?roberthttp://www.blogger.com/profile/03575489215896576032noreply@blogger.comBlogger12125tag:blogger.com,1999:blog-6377401824680246858.post-50629653339847699152012-08-14T16:09:36.514+01:002012-08-14T16:09:36.514+01:00"You would not be the first person who gave i..."You would not be the first person who gave incorrect first EU MA dates in order to get an SPC...."<br /><br />LOL - They've paid their fine now!<br /><br />"Para 25 suggests that the decision is not limited to new uses only when in a different species."<br /><br />Yes, but para 26 suggests otherwise - "only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first MA of 'that product' as a medicinal product exploiting that new use within the meaning of [...]"<br /><br />"and authorised for a therapeutic use corresponding to that protected by the patent relied upon" clearly ties together the therapeutic indication in the basic patent and later MA. So if you have two MAs for the same active ingredient for treating the same disease but with different excipients, say, and you have a patent which reads on to only the product protected by the later MA which is the first MA?!Olorinnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-73434205541139748282012-08-08T07:12:12.185+01:002012-08-08T07:12:12.185+01:00Re 7 August 2012 15:14 (Sam).
You would not be t...Re 7 August 2012 15:14 (Sam). <br /><br />You would not be the first person who gave incorrect first EU MA dates in order to get an SPC....Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-14106330893668069272012-08-07T15:14:33.919+01:002012-08-07T15:14:33.919+01:00Re: Anonymous 7 August 2012 07:38, Sir I am not gi...Re: Anonymous 7 August 2012 07:38, Sir I am not giving the exact MA date of rabeprazole, lansoprazole or omeprazole. I am giving MA date for an example to understand the case impact of C-130/11 Neurim Pharmaceuticals.<br /><br />Regards<br />SamAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-22200583040730223542012-08-07T07:38:57.494+01:002012-08-07T07:38:57.494+01:00Er, what planet is Anonymous 6 Aug 16:08 on....?
...Er, what planet is Anonymous 6 Aug 16:08 on....?<br /><br />You say: "Rabeprazole MA Date: 10-Feb-2010; lansoprazole MA Date: 10-Feb-2011". <br /><br />Not so fast. <br /><br />Rabeprazole - first MA in the EU -08 May 1998 (UK)<br /><br />Lansoprazole - first MA in the EU - 11 Dec 1990 (France)Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-60509095870902200362012-08-06T21:26:39.581+01:002012-08-06T21:26:39.581+01:00Anonymous 26 July 2012 15:01 - you are most defini...Anonymous 26 July 2012 15:01 - you are most definitely not alone. The only thing that this decision has made absolutely clear is that the CJEU has guaranteed its SPC-related work flow for the next few years.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-88730086362713703562012-08-06T16:08:03.420+01:002012-08-06T16:08:03.420+01:00I am Sam (Anonymous 26 July 2012 13:18), For insta...I am Sam (Anonymous 26 July 2012 13:18), For instance the single patent which markushly and as compound claims three drugs i.e. rabeprazole, lansoprazole and omeprazole. <br />All drugs got Marketing authorisation at different time and in such way that each drug are eligible for SPC. <br />(Priority Date: 10-Dec-2002; International Filing date: 10Dec-2003; patent Granted date: 05-Feb 2009, Rabeprazole MA Date: 10-Feb-2010; lansoprazole MA Date: 10-Feb-2011; omeprazole MA Date: 10-Feb-2012).<br />Then it is possible that we get three SPC for each said drug which is claimed in same basic patent. (Please provide your valuable suggestion)Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-14137664026109656202012-08-02T12:36:04.555+01:002012-08-02T12:36:04.555+01:00Am I alone, or is this the most unclear and least ...Am I alone, or is this the most unclear and least satisfactorily reasoned SPC decision yet from the CJEU? How can it not even comment on Yissum and Pharmacia Italia when the fact situations in those cases were so similar? Presumably, they remain good law, and Answer 1 deliberately is restricted to the earlier authorisation being for a veterinary use and one that does not fall within the limits of the protection conferred by the basic patent. But how does that square with the statements made in paras 25 and 26?<br /><br />If the earlier authorisation is for a different human use, how is that distinguished from Yissum? Surely it is a matter of form over substance that you can take account of the therapeutic use of the product when considering Article 3(d) (Neurim) but not allow it to form part of the definition of the product in general like in an EPC2000 "Product for therapeutic use" claim (as in Yissum).<br /><br />So how are you now supposed to construe Article 3(c) in the situation where there is an earlier SPC under a different patent to a different use?<br /><br />And why are Answers 1 and 2 couched in different terms? Surely, the same considerations of what counts as an earlier authorisation should be the same (setting aside territorial considerations) in Article 3 and Article 13?<br /><br />The CJEU is supposed to provide clarity. Perhaps the real question is whether the CJEU is fit for the purpose of construing the SPC Regulation?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-60788394260645084052012-07-26T15:01:28.978+01:002012-07-26T15:01:28.978+01:00Re Anonymous 26 July 2012 13:18
You don't hav...Re Anonymous 26 July 2012 13:18<br /><br />You don't have to file multiple patents but what you do have to use is the same MA for each SPC you file under a patent. The SPC for each product or application will all end on the same date which provides market certainty.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-13688827726917211732012-07-26T14:51:24.488+01:002012-07-26T14:51:24.488+01:00Para 25 suggests that the decision is not limited ...Para 25 suggests that the decision is not limited to new uses only when in a different species.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-84392078339784162032012-07-26T14:43:04.033+01:002012-07-26T14:43:04.033+01:00Surely in the case of non-active components, new f...Surely in the case of non-active components, new formulations and inventive excipients you apply the test of whether the earlier MA is an authorisation of a product within the limits of protection conferred by the basic patent?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-79284233574478980902012-07-26T13:18:38.426+01:002012-07-26T13:18:38.426+01:00This means for getting SPC, we have to file sepera...This means for getting SPC, we have to file seperate patents for each indication or combination. <br />I have one more question: Is divisonal application can consider as diffent patent for getting SPCAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-47434012011970130762012-07-20T16:53:34.534+01:002012-07-20T16:53:34.534+01:00How can you say that "The CJEU has not applie...How can you say that "The CJEU has not applied the same test" when they say in paragraph 30 "the MA referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC"?Anonymousnoreply@blogger.com