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hi i'm michael casibaro i'm a cardiologist at saint luke's mid-america heart institute in this uh analysis of impulse trial uh we looked at the effects of amperage flows in agility to inhibitor on health status which is symptoms uh physical limitations and quality of life in patients uh hospitalized with acute heart failure just to take a step back we presented the main result of impulse at the american heart association a few months ago and it was just published recently and uh it's important to keep in mind that patients hospitalized with acute heart failure uh experience very high burden of symptoms in physical limitations and poor quality of life and we have dearths of therapies that can be effective in improving those outcomes in the main impulse study we previously showed that ampligly floating is compared with placebo significantly improved what we call total clinical benefit which is a composite direct composite of death recurrent heart failure events and change in cancer cardiomyopathy questionnaire which is a measure of symptoms physical limitations in quality of life but in this analysis specifically we wanted to concentrate on the effects of public loads and on those very um outcomes uh very important outcomes to patients with uh acute heart failure which is the symptom burdens the burden of physical limitations and the poor quality of life impulse trial enrolled over 500 patients as it were hospitalized with acute heart failure it's really a new trial in many ways because uh it included patients uh with acute heart failure regardless of the ejection fraction so both those who reduce the preserved ejection fraction uh were enrolled as well as those with or without diabetes and also those with either worsening chronic heart failure or de novo heart failure which means that with a new diagnosis because heart failure patients were hospitalized with so all of those patient types of patients were included in the study and while in hospitals they were randomized to either ampugleflozen or placebo and treat it for 90 days specifically for the outcomes that we concentrated on in this analysis cancer cardiomyopathy questionnaire which is the gold standard of health status that was assessed at randomization as well as 15 30 and 90 days so uh in this particular analysis there were two key objectives one is to evaluate the effect of epiglottis and on the primary endpoint which was a total clinical benefit uh across the tortillas of cancer karma cardiomyopathy questionnaire scores so essentially to try to understand what is the clinical total clinical benefit of tempegoflozen differs depending on the degree of symptomatic impairment of baseline and second perhaps even more importantly uh to look at the effect of amperglucen on symptoms physical limitations and quality of life uh during the treatment period so you know what happens after 15 30 and 90 days of treatment so in terms of what we found for the first objective we saw that amped the flows and as compared with placebo significantly benefit patients in terms of a total political benefit against that hierarchical composite of death heartfelt events and change in cancer crime obstacle questionnaire to a similar extent regardless of the degree of symptomatic impairment at baseline and for the second objective we found that patients treated with example floating had significantly greater improvement in the symptoms as well as physical limitations and quality of life over time and importantly that benefit emerged already at 15 days and was sustained up to 90 days so very very quick onset of benefit and then consistent benefit over time right so as i mentioned earlier we have dearth of treatments in acute heart failure that have been proven to significantly uh improve symptoms physical limitations quality of life and this patient populations that's really symptomatical and functionally impaired and i think the message from this data is that uh sglt2 inhibition for patients acutely hospitalized with heart failure is a treatment that won't just potentially improve clinical events but also make patients feel better and be able uh enable them to be able to do more which is a critical uh goal of care in this patient population so yet another very important incentive to potentially think about initiating as jilted inhibitors in the hospital in patients with heart failure regardless of what type of heart failure they have whether it's reduced or preserved ejection fraction whether it's chronic decompensated or your normal heart failure because we saw the results on health status were very consistent across all of those subgroups well i think we already have a lot of data on agility to inhibition and heart failure all different types of heart failure but in the acute heart valley space there is more data coming i think importantly um so there are ongoing studies looking at dapagliflozin in acute decompensated heart failure uh i think that will further batterize the evidence space and then also very importantly we also have uh in heart failure with preserved ejection traction uh a second large outcome trial with topical flows and deliver which will be the largest trial of patients with half pathways the longest duration of follow-up so really will help hopefully solidify the evidence base for patients with heart failure and preserve the app which is really in need of additional therapies
Thanks for your comment Olin Dornan, have a nice day.
- Roslyn Geitner, Staff Member
hello everyone in this video we'll look at patent expiration dates we'll start with the general rules of when patents expire but mainly we'll be looking at the calculated patent expiration dates feature in the ifi claims database we'll see how that information is displayed in ifi records and the ways to search it we'll look at the calculated expiration date in a typical record and then we'll turn to the several kinds of exceptional situations where a patent term might be either shortened or extended and how that information is displayed and searched in ifi so let's get started the rule of thumb is that patent protection expires 20 years after the application was filed that's the law in most countries and has been the rule in the united states since 1978. there are some exceptions which we'll talk about but let's begin with a typical case we're looking at the legal status section of a u.s patent record in ifi claims and you see where it says that the calculated expiration date is september 25th 2039 this calculated expiration date is simply the application date plus 20 years if we go to the bibliographic tab for a moment you see the application date is september 25 2019. and the calculated expiration date can be searched in ifi using the expiration date or expd field the options for the search format are much like with any other date field in dialogue you can search for an exact date like this or for a whole year or select both a year and a month you can look for a range by using a hyphen in between two date values you can use the greater than symbol to look for expiration dates after any date or year or use the less than symbol to look for expirations before a certain date or year the expd search can be run alone or in combination with other searches such as a patent assignee search here we're looking for any microsoft patents that are calculated to expire in 2021 or 2022 you might do this kind of search for competitive intelligence for example or for your own company as a way to track which of your important patents are coming up on an expiration date or you can limit a term search by calculated expiration date as we see here the use case for this would be what's called a freedom to operate search where you're interested in using a certain type of technology and you want to know if it's currently under patent protection or when the relevant patents are due to expire so the calculated expiration date search is very flexible and it's easy to do in ifi claims and most of the time it's just a very straightforward calculation from the application date but there are several reasons why a patent's life span might be made either shorter or longer than the norm the most common reason by far for a patent to expire on some date other than the 20th anniversary of the application is if the patent owner fails to pay the required maintenance fees these fees are payable three years after the patent is issued then again seven years and again 11 years after issue there's a six-month payment window then a six-month grace period and if the fee is not paid the patent office will market expired and when that happens the ifi record will show it like this the patent status entry says expired fee related but notice this does not affect the calculated expiration date entry which in this case remains searchable in the record as march 12 2028 20 years after the application so if your goal is determining which patents are active and which are not you wouldn't use the calculated expiration date search alone that's not its purpose for more on using the patent status indicators in ifi i would encourage you to check out the separate video on that and i'll put a link down in the description there are two different ways in title 35 of the us code for a patent owner to seek an extension or adjustment of the expiration date beyond the normal 20 years the first would be a patent term adjustment under section 154 if the patent office has not yet issued a patent within three years after the application was filed then depending on the reasons and other factors the patent owner can apply for an adjustment to give the patent a later expiration date if that request is granted then the record in ifi reflects it in the way that you see here note that the original calculated expiration date of september 14 2035 is still searchable in the expd field and so is the adjusted expiration date of april 5 2036 so both dates are kept in the record for search purposes a patent term extension under section 156 is something different this has to do only with pharmaceuticals it's part of what's known as the hatch waxman act and this section lets the owner of a pharma patent apply for a longer period of patent protection based on delays that may have occurred not at the patent office but in the process of testing and approval by the fda the idea is that an extension gives the drug company a longer opportunity to recoup the expenses involved in the long process of developing the drug and getting it approved the calculation method is complicated but the patent office can grant an extension of up to five years often it's shorter and if an extension is granted this is what it looks like in an ifi record for search purposes again as in a section 154 term adjustment the original calculated expiration date is still searchable but the extended expiration date is indexed as well so either date could determine the limits of your search results this record for example would be retrieved if you searched for records with an expiration date before the end of 2006 but when you looked at the record you'd see that it was extended into 2007 by the same token if you search for records with an expiration date during 2007 you would again get this record but you could see that originally it was going to expire in 2006 before it was extended into 2007. this way the expd search is more inclusive and it's easy to tell from the record how the expiration date has changed a terminal disclaimer is a type of limit on the duration of a patent it's used for example when a patent owner wants to get an additional patent on an improved version of something it is patented already but because the patents are similar they need to overcome a rejection based on double patenting so if a patent is subject to a terminal disclaimer it means that this patent will expire on the same date as another usually older patent held by the same owner this can get complicated so the ifi record does not try to calculate the possible effect of a terminal disclaimer instead the record just shows the normally calculated expiration date but it flags the presence of a terminal disclaimer so that you can investigate further as needed the existence of a terminal disclaimer is also noted on the face of the original patent as we see here so that's it this video by the way is the last of a three-part series on search enhancements found in the database ifi claims the first one was on ifi's probable assignee feature as a way to find patent applications that would otherwise remain hidden from assignee searches the second was on the patent status feature in ifi
Thanks Kelvin your participation is very much appreciated
- Roslyn Geitner
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I've studied venezuelan history at Lander University in Greenwood and I am an expert in purchasing. I usually feel okay. My previous job was medical photographer I held this position for 7 years, I love talking about chess and lassoing. Huge fan of Quentin Tarantino I practice mixed martial arts and collect paper currency.
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