tag:blogger.com,1999:blog-5574479.post3122638514385726774..comments2024-03-28T16:45:51.051+00:00Comments on The IPKat: Taking it personally: patents, medicines and genetic markersVerónica RodrÃguez Arguijohttp://www.blogger.com/profile/05763207846940036921noreply@blogger.comBlogger13125tag:blogger.com,1999:blog-5574479.post-30100375062511218132014-06-25T14:35:56.849+01:002014-06-25T14:35:56.849+01:00epi information June 2014 refers to the EPO mentio...epi information June 2014 refers to the EPO mentioning T734/12 at a meeting with the epi on 20 November 2013, so clearly this is a case which the EPO wants to highlight for its approach on novelty of patient groups.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-87978693223133543722013-11-15T10:32:45.997+00:002013-11-15T10:32:45.997+00:00Subsequent decisions T108/09 and T734/12 show the ...Subsequent decisions T108/09 and T734/12 show the Boards of Appeal are taking a lenient approachAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-51742576543710852312013-08-27T12:36:41.162+01:002013-08-27T12:36:41.162+01:00Paras 22 to 29 of T734/12 has interesting comments...Paras 22 to 29 of T734/12 has interesting comments on patient groupsSulemanhttp://www.hollyip.comnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-12825764774560251372012-08-24T16:18:01.610+01:002012-08-24T16:18:01.610+01:00Let's imagine pathogens A and B. Some people ...Let's imagine pathogens A and B. Some people are infected by A, some by B, some by both A and B. X is a well-known drug against A. A doctor finds that the drug works better (e.g. has less side effects) on patients who are infected with A and B than on patients who are infected only on A, and he finds that it is because there's a component in B that, when contacted with X, causes an effect on pathogen A which is beneficial to the patient.<br /><br />If somebody claims "use of X to treat patients infected with A and B", of course that overlaps with the group of patients "infected with A". But because there is a new TECHNICAL EFFECT, the use is new.<br /><br />Now if there was no technical effect i.e. X works just as well on patients infected with A as on those infected with A and B, then claiming X for treating patients infected with A and B creates a new group of patients, but one that overlaps with the generic group (patients having A) but because there is no technical effect this new group does not lead to novelty (because it's an arbitrary group). That's what the decisions mean, and if you read them well, you'll see that they all agree on that.<br />Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-78002799756175654202012-08-22T17:07:17.768+01:002012-08-22T17:07:17.768+01:00It is true that T1399/04 identified the factual si...It is true that T1399/04 identified the factual situation to be different to T233/96. However, T1399/04 also disagreed with the way T233/96 interpreted T19/86 and T893/90 in formulating the two-part test (see point 35 of Reasons for the Decision "The present Board does not see basis for this interpretation in the relevant parts of decisions T19/86 (points (5) to (8) and T893/90 (points (4.2) to (4.6))". Therefore T1399/04 did disagree with the rationale applied by T233/96. <br /><br />Also, whilst T836/01 and T1642/06 do indeed involve cases where the claimed invention relies upon a different technical effect from the prior art, the point still remains that the claimed patient groups overlapped with the prior art patient groups. Contrary to T233/96 which requires the claimed patient group to be non-overlapping with the prior art, T1642/06 states that "The overlap in the therapeutic application of the use of the prior art and the use of the claim is irrelevant, because the technical effect stated in the claim identifies a new clinical situation and remains different from that of the prior art" (point 2.1.2, 3rd para, of Reasons for the Decision). Thus the later cases do seem to be taking a different approach to the strict rationale used in T233/96, particularly with regard to the requirement for non-overlapping patient groups.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-3975309724402865252012-08-20T15:53:12.569+01:002012-08-20T15:53:12.569+01:00"The earliest case to tackle the issue seems ..."The earliest case to tackle the issue seems to have been T233/96 which gave a strict two-part test for novelty requiring the patient groups to be non-overlapping and for there to be a functional relationship between the biomarker and the therapy, i.e. the patient group could not be an arbitrary group. However, subsequent case law has not followed the test. In T1399/04 the Board cited T233/96, but took a different view, generously allowing claims which covered more than 50% of a prior art patient group. Decisions T836/01 and T1642/06 also allowed claims where patient groups overlapped with the prior art."<br /><br />Well obviously you haven't read T1399/04 carefully because it does not say that T233/96 is wrong, it says that "the present case differs obviously from the situation underlying decision T 233/96." In T836, novelty was recognized because "the claimed invention relies upon a different technical effect from the one disclosed in document (1)" thus novelty had nothing to do with the group of patients. Same in T1642.<br /><br />Again, patent attorneys who do not get their ways invent a fake controversy, allege that the EPO's examiners and boards are not consistent and claim that the cure is to grant everything they want.<br />Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-1816060026642933072012-08-20T12:36:09.284+01:002012-08-20T12:36:09.284+01:00To Freyberg:
I would say, in the case of hercepti...To Freyberg:<br /><br />I would say, in the case of herceptin it is different because HER2 is not just a marker: HER2 is the target of the drug (herceptin), thus there is a direct technical relationship between the presence of HER2 and the efficacy of herceptin. You know that the drug would not work if the patient did not express HER2 thus you would not treat her with that drug. But when it's just "a" molecular marker like an SNP, you don't know.<br /><br />In many cases, the presence of some genomic markers like SNP's just CORRELATES with some feature of the patient (e.g. a particular sensitivity to a drug) without presence of a true CAUSAL relationship between the presence of the marker (SNP) and the sensitivity to the drug. There will always be some patients who have the marker but who nevertheless will be neither more nor less sensitive than other patients to the drug (because the correlation will not be 100%) and vice versa. I would say, in that case it is still the same medical use (thus not novel) because you're trying to treat the same disease using the same means, and based on the same molecular mechanism (technical effect).<br /><br />Imagine that a doctor realizes that a drug works better with patients whose name starts with the letter "A". Does that make the use of the drug new on these patients ? Of course not. It's just treating the same patients for the same disease with the same drug. <br />Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-70504149966990757722012-08-20T10:55:04.949+01:002012-08-20T10:55:04.949+01:00In response to Derek again: your arguments might w...In response to Derek again: your arguments might work in getting a case through. My previous response to you essentially describes ways in which Examiners might disagree, i.e. saying that whether or not a patient is 'known' to have a biomarker is not a technical feature that will give novelty. I would say the question is very much an open one. I suspect in the real world some Examiners may agree with you and some may not.Sulemanhttp://www.hollyip.comnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-70393674158841011492012-08-20T01:47:20.494+01:002012-08-20T01:47:20.494+01:00@Suleman:
Thank you for your response, but I don&#...@Suleman:<br />Thank you for your response, but I don't understand the reasoning (not yours) of "structurally they are the same as the prior art group in respect of possessing features relevant to the claim". Surely the point of biomarker testing is to find people who benefit from a particular therapy, as HER2 and Herceptin, and the group of people who benefit from Herceptin (those who are HER2-positive) is distinct from the group of those who do not (those who are HER2-negative); and that feature (known biomarker presence) is relevant to the claim because the claim says in effect "treat those who will benefit, not those who won't". But I have yet to read the cases you cite, and perhaps I will find enlightenment there.<br />@Anonymous (18 August, 10:32:00 PM):<br />My proposed claim does not lack novelty merely because a patient with the biomarker has been treated, as long as the patient is not <i>known to</i> have the biomarker, nor do Suleman's alternatives for similar reasons. Possessing the biomarker is a characteristic of the patient regardless of knowledge (hence the novelty problem mentioned by Suleman in his original note if the treatment has already been given without testing for the biomarker), being known to possess it requires something more and that is where the novelty is created.Derek Freybergnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-22310322598049913372012-08-18T22:32:38.773+01:002012-08-18T22:32:38.773+01:00If a patient with the biomarker has been treated w...If a patient with the biomarker has been treated with the medicine and their access to the medicine was not under a duty of confidence then the claim as proposed (including that proposed by Derek) lacks novelty.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-40768067552921174322012-08-18T11:16:56.827+01:002012-08-18T11:16:56.827+01:00I think that the underlying problem here is that t...I think that the underlying problem here is that the use of biomarkers is a therapeutical method, which has been explicitly excluded by the European lawmaker from patentability. To an outsider, all this talk about "personalized medicine" looks like a rather transparent attempt to undermine this exclusion, using an exception introduced in the examination of novelty which was specifically introduced to allow the patentability of known substances for second medical uses, <b>without</b> allowing medical methods themselves.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-56919527471982040072012-08-17T20:45:18.132+01:002012-08-17T20:45:18.132+01:00In response to Derek's comment: your point is ...In response to Derek's comment: your point is very interesting. Similar strategies involve defining the patient as one who 'has been selected on the basis of possessing biomarker Z' or one that 'has been tested for possessing biomarker Z wherein the test was positive'. However the problem with this approach is that Examiners can say that knowledge of the patients to be treated does not result in a 'new patient group' because structurally they are the same as the prior art group in respect of possessing features relevant to the claim. Testing them for possessing biomarker Z did not give them a physical feature that can be used to define a new patient group. However of course on a good day, an Examiner might let such a claim through, so it's worth trying.Sulemanhttp://www.hollyip.comnoreply@blogger.comtag:blogger.com,1999:blog-5574479.post-14568521817057708712012-08-17T17:35:25.847+01:002012-08-17T17:35:25.847+01:00I can see the novelty problem with "Substance...I can see the novelty problem with "Substance X for use in a method of treating condition Y in an individual with biomarker Z" even if the biomarker is previously (a) not known or (b) not recognized as affecting the therapy, but is it perhaps avoidable by a minor modification of the claim to "Substance X for use in a method of treating condition Y in an individual known to have biomarker Z"?Derek Freybergnoreply@blogger.com