[[transcripts generated automatically by WIPO speech-to-text]] I am sorry, good morning, Will now start the third session of the 33 rd session of the SCP, I will start By reading my summary of yesterday's debate on quality of patents good. You please put the summary on screen for me, then I will be really getting a question to 7, quality of patents, including opposition system, discussions were based on the comments SCP/17/7,8,10, SCP/18/9, SCP/19/4, SCP/20 / 11 th, SCP/23/4, SCP/24/3, SCP/28/8, SCP/30/9 and SCP/30 / WO/3 and 8/Rev and SCP/33/4. The Committee continued discussion on a study on approaches to the quality of patents grants process, document SCP / In addition, Member States shared information on the use of artificial intelligence for examination of patent applications, the Committee continued discussion on the issues and Proposals relating to this agenda item, including the proposal by the Delegations of Brazil and Spain, the document SCP/31/8 Rev and proposal by the Delegation of the United States of America SCP/33 / So some other Delegations suggested other activities to be carried out by the Committee with respect to quality of patents, including opposition systems. If anybody wishes to speak to the summary please do so the summary will of course be included in tomorrow's complete summary. As I said, we will continue with patents and health. We will continue with publicly accessible databases of patent status information concerning medicines and vaccines, we have Got presentations from Pat-INFORMED and the Eurasian patent office first of all, I will give the floor to Charles Randolph who is Deputy Director of industrial relations and NGOs. Within the global challenge section of the Global Challenges Department of WIPO, Mr. Randolph you have the floor. Good day and thank you very much for you to present on the Pat-INFORMED initiative, I will be speaking relatively briefly to introduce the initiative and then My colleague from the International pharmaceutical manufacturers association gear of central will be continuing with a little bit more in depth on how it functions, can we go to the second slide, please? And the next, please, yes, what is Pat-INFORMED, it is a public private initiative that we started in 2017 together with the IF PMA to facilitate the access to patent information, notably pharmaceutical patent information, and the goal of this program was to or is To facilitate the procurement agencies use in determining whether or not a medicine is patented, how the program functions is that the data is Provided directly by the bio pharmaceutical companies and WIPO hosts the database where we aim to make this information available in very clear basic terms next slide, please, the What Pat-INFORMED is not and we have had to clarify this at various points in the 12 months initially following the launch, it is not an one-stop shop for All information, Pat-INFORMED is intended to be an additional source of information, a part of the due diligence that agencies would go through, but certainly not the only one, It is also not a linkage system, Pat-INFORMED makes no pretension to patent linkage in any way, and in that sense, patent form is not a freedom to operate tool. It is not a sole source of all the relevant information it is designed again to insist and improve efficiency in the patent information process next slide, please. Why did we engage in this, partly because of our Development Agenda, the WIPO 2007 Development Agenda that called on the organization to make better access? To patent information, make it available publicly. And as a UN member institution, we also are working to promote the Sustainable Development Goals. So this initiative responds at least To the goal number 3 on health and goal number 17 on partnerships, next slide, please. Here you can see the therapeutic areas that Are covered by Pat-INFORMED and also in addition to these six areas, it includes all the products on the World Health Organization, essential medicines list, and And it covers small molecule therapeutic areas, so at present our companies, the member companies, are in the process of uploading all their small molecule medicine, and Patents to the database and some of the larger companies have already completed this. Many people have asked us. Are we including covert related medicines in this database, and They would fall at present in part under the respiratory conditions, but we are also looking in gear, can comment on this, we are working with MSD to try to get the patent And status listed for its new therapeutic COVID-19 therapeutic, as well as with visor to get the patent status listed for its COVID-19 oral antiviral treatment. Next slide, the database who can use it, it is accessible to everyone, but, again, it was primarily designed to help procurement agencies, NGOs, That are engaged in the procurement process, access this information. We also built into the initiative a follow-on inquiry, possibility that Procurement agencies accredited procurement agencies if they have specific questions they can pose them via this platform and get direct responses from the member companies on the status. I would also add that we also have within the database an opportunity for anyone to report inaccuracies if they see that the status is listed incorrectly or has since Hired or been overturned. Next slide, please. Here you just have some of the information, 20 companies we have grown in terms of The listings of the international nonproprietary names added 60 patent families since the 2017 launch and the current number of patents in the database, next slide, please, This just is an overview and I hope that is well to everyone via the slides of our visits in 2021, just some of the analytics we have had little over 8,000 visits and over 10,000 closer going on 11,000 page views during the year, next slide, please, this gives an idea of the geographic distribution of With the darker areas having stronger or higher use of the platform and those also tend to be areas where there are stronger manufacturing. The infrastructures as well, and then on the next slide, it just gives kind of a listing by visitors from place of origin so we have India, the United States, Russia, the United Kingdom, and Switzerland among the top users of the database, so with that, I will thank you for your Time and attention and turn the floor over to Mr. Center. Thank you, Charles and thanks for the invitation it is good to be back here after long time I will go a little bit more in the details of how the database works and happy to take any Questions that we may have after that. If you can go on the next slide, the database is actually two products. One is the public database that anyone can use. That lists the All sorts of information relating to the patent families. So you can just go to the WIPO website and just type the name of the INN and then you are going to see a lot of information. But there is also a tool that the option For procurement agencies to ask direct questions to the companies, as you may be aware, our companies are very large, and sometimes it is not that easy to find the right person that knows about the patent portfolio. Or even license the opportunities. So you could-- you just register as a procurement agency, you make a question and a question about straight to the company. So if we can go on the next slide, please, then This is the landing page of the database itself, extremely simple, you just have to type the number, the name of the INN, and you can future by country, if next slide, and then once you are sorry, typing. Here when I see the hit, so if you can see it is the INN, then the company, the participant company, and then the patent families, a product may have different patent families associated with. Usually from one to five or six, depending on the complexity of the technology, so this is an example, so it is a fiber product, so one INN to patent families, and then if you click, On the patent family, you are going to see all the jurisdictions that are covered by this patent family, there is a big squamour, saying that this is provided on best Effort basis and by no means it is a linkage system or we are making any claims to that. And there is also this tool that has been inserted if There is any inaccuracy, you can flag next slide, so yeah, we took the example of China, you can you have this information on the application filing grant. To give an idea of how the patent is, and the most excite one is you can click on open and patent scope, and then it links to the WIPO infrastructures if you can just quick next. So this example you click in to go straight to the PatentScope, you can have this as China's application and one more and you can use WIPO's very good IT for Translating the patent. It looks simple, but it is extremely complex software behind and a big thanks to the WIPO for the infrastructure on that. There is like around 20 big Multinationals that fire information differently, some of them have purchased other companies, others legacy databases, putting all that together and making to work is a challenge, but a You have a court class IT talents here that managed to put this together, so we are very pleased with the partner with WIPO on this. So this is just like further extremism on the patent. If you are procurement agents you have a very simple option of contacting either or whichever company and asking a question, the next one, it is very simple, please. Could you clarify this or I may see something around this, it is a very open question, and whichever answer the company gives to you, it is Not confidential, so there is absolutely no presumption of confidentiality if you want to send to a patent attorney or to an NGO or do whoever to verify that, you are completely free to one more. So again, Charles already mentioned, but it is always important to highlight that we see Pat-INFORMED, it is not meant to be a freedom to operate, there may be patents that generics May have filed that are not covered here. There may be other aspects of technology. It is not there or free. We have put a lot of effort to make sure that the database is as correct as possible. But I So we are not asking you to keep anything confidential, one more's light, please, so this is a living product, and We are always trying to improve it, we have hosted a seminar with WIPO and different members of the Geneva community on feedback. The one of the feedback is that it should be very clear that the database is not a linkage system and though we have as a response to that added disclaimers everywhere and we are making this extremely It is clear in all of our presentations and also added this tool of reporting and actresses that anything happened, and we are now working with the WIPO IT folks to further improve the links, because again, those are very complex The futures make sure that it leads to the right patent application and especially when you have options filing either in a regional office like the region or the At the national level. So just make sure that all that works, there is a lot of background work happening. But it is a very large database, 22,000 patents, it is a wealth of information. It covers a The ambition is to cover all of the monolities that our members have and it is the vast majority of the patented products that exist everywhere in the world, including the developed countries, but it is The global database, it is not meant only for developing countries. So it is a database of high ambition. And we are very proud of that. And again, thanks very much to WIPO for the partnership. And we always end, we will look a commercial to assist a database of the medicines patent pool, MedsPaL, that also provides similar information with different methodology, but if you are Your main agency, I always recommend you to look at both, they will give you different aspects of the information you are looking for, and with that I am happy to have any questions. Thank you, Mr. CINTRA for that presentation, it is interesting to see the developments at the Pat-INFORMED platform which has been presented in the past. The Center is Chairman of the President of the Innovation Sector of the IFPA. I have a list of speakers, Mr. Bouroni, Director of Medicines Patent. Pool based in Geneva. And I believe you will be joining us remotely. Mr. Chair, Mr. Chair, Esteban, can you confirm whether you can hear me, Sisi, Libre and Lesotho, you have the Yes we can hear you thank you thank you very much yes as mentioned I am the head of policy at the medicines patent pool and it is a pleasure to be here again to day. Thank you to WIPO and thank you to Member States for giving us the opportunity to briefly present again to this Committee our database MedsPaL and the work we have been doing, your recent developments To further improve this tool which is today a wider youth tool to understand the patent status of essential medicines in law and middle-income countries and if I could please have the slides. I am not sure if there is a technical Which I could please confirm whether you are how here we go thank you so much perhaps they can be put in in slight show mode. Wonderful thank you very much so I will be presenting to you yes MedsPaL which is the two that we have presented to this committee before in the past and that continues to develop. Now adding all the COVID-19 therapeutics, they are in the pipeline, but also a sister tool that we have launched very recently, which is called Vaxpa, it is a Looks at patent status of COVID-19 vaccines, so I think that is also something that is possibly of great interest to this Committee, so the liberty to not just focus on method but also bring to you information relating to backstop. So just two words on all one on whom we are the medicines time for the organization I work for, if you have got the next slide, please, for MSSF, it is a public health organization where we are heading in Geneva. Would-- as a public health organization what we do, we try to facilitate access to new treatments, you patented treatments in low and middle income countries, we started in 2010, doing this For HIV medicines over time succeeded in getting a number of important licenses on WHO recommended products and extended our mandate gradually to other Therapeutic areas including Hepatitis C and tuberculosis in 2016 to other patented essential medicines in 2018 and last year. And we expanded to work on COVID-19 as well on any health technologies that are relevant to COVID-19 treatment or our work is therefore primarily essentially around licensing and around. Licensing with innovators with patent holders, but as a result of all that work, we do your licensing, we started collecting patent data and that patent data on a wide range of essential medicines and We realize what is information that was highly important for a lot of other stakeholders and we began to make that public and so working very closely with the WHO in identifying relevant products Mapping the hands on those products and then making it available through the metal database which was launched in its current form in the year 2016 but had pre-existed in other In other formats since 2011, so it is something that we have been regularly doing, and that is today a database that has been relied upon by a lot of the leading procurement agencies are procuring medicines on behalf of Low and middle income countries, including global fund UNICEF, UNDP, IDA foundation, et cetera. You have the next slide, please. So You could please carry on to the next slide, so this is a key description of some of the main features of metal, at the moment we have 13,700. Or patent applications in there, we have regularly been expanding the number of products that we have, the number of patents covering those products, a number of licenses and number of Are covered by their exclusivity, so what we really try to do, where possible, is to try and have a platform that enables the user to understand what is the IP status of a given. From a physical product medicine essentially essential medicine in a given country and you can search by INNs or name of the product and you can search by country. And really provided it says not just whether there are patents granted but also whether patents are being filed, patterns of being expired are rejected and also whether no patent has been filed on a given product because we understand that thus Information if often databases focus on only the data that is in the database, where there is a patent, but if there is no patent, it simply goes black. And I think it is often very important for a user to know when a given patent family has not been filed in a specific country and so we do where we can try and flag that as well we also have information on licenses. We ourselves negotiated like negotiating licenses that enable generic manufacturers to enter certain countries, but there are also many other licenses out there between patent holders and engineering manufacturers. Et cetera, and so we include all that information because we think that from the perspective of a user, it is not just where there is a patent or not, but if there is a patent there may be licenses in place, and that may enable, for example, the procurement of a generic In a given country, so we are trying to provide a picture that is as complete as possible and finally, of course, maybe they are exclusivity in the given countries or they may not be patent but that product may be covered by data exclusivity. Of course, we do always advise as was mentioned also for Pat-INFORMED and to double check with other sorts of data and, of course, go to national patent offices, national patent offices, ultimately, the other key is Institution that can provide ultimate information on whether a given patent is granted or is in force in a given country if you can please move to the next slide. And this is how it looks when you have done it so, so here we are doing a search for the product, do not take a vessel, you can search by different criteria even search by country by product, and This area, if you know what that number is, it would a trade name or the product, if that is all you know or other such information, and therefore, and then you get the Information as you see here highlighted in general, including the other status, and when that was last updated, so you are in a sense of whether you know how recent that data is, you get the application numbers, and You also get the data exclusivity and unlicense information that you see that you see there and all that information is available when you click on each thing, you get additional information as it is often the case in these kinds of databases, yes. Next slide. So we are trying not zooming, you know, what is covered by method. So we have 140 priority medicines. Could we click again and this approximately 260 formulations also quite a A lot of progress covered here, so first we cover-- Jonas, how really how we started with patent treatments for HIV, hepatitis C and tuberculosis and these are three therapeutic areas that we have been working on since 2015. We include those are recommended by WHO but also some that are still in the pipeline that are under development that may come to market soon so in these three therapeutic areas we will go. And quite beyond was from the essential medicines list of WHO or was recommended and beyond that we look at the full WHO essential medicines list and really focus on all the products within that that have are patented. And I would like to stress that our focus was on small molecules initially, but we are now also adding biologics through biotherapeutics that are including the WHO essential medicines list and we also provide patent data for that. And interestingly last year we got a request from the World Health Organization to consider including within the COVID-19. I am sorry, within MedsPaL, products that were being tested against COVID-19. So medicines a whole range of medicines that already had approval for a different indication were being tested against COVID-19. I saw The drugs for HIV for cancer for TB for rheumatorite and so we say it made sense to start tracking those and really highlighting the patent status of Of all the progress that we are in in Phase II or Phase 3 development trials for COVID-19. In addition, we greatly started adding new treatments that were being developed specifically to address COVID-19 and added patent data on a number of those and that has been going on since early 2020 next light. Now in terms of the patent status, how do we get that and what do we what kind of information do we provide there, so you can move on to the next slide, for that you will we do it with. Is three steps here. The first step is and identifying the relevant patent families. So to do that, you know, this world will Let's start with, I should first day is on identifying your relevant patents on that product and there we rely on a number of sources, two of which you can see that little robot there, shows our database as Automated, the collection of information from these databases, and these are the US FTA orange book and the health Canada patent register, so in these two cases, we We do very thorough and undetailed data collection to reidentify which other patents are relevant to a given product is approved by the US food and drug administration, the The holder of the microtribe authorization Hoar is required to submit the list of patents of US patents are relevant to that product and you have a similar system in health Canada and so that enables us to identify the equivalent Canadian and American. Patents now once you have that we can go a look for other patents in that same family and we do that by relying on in patent family which is a European Patent Office. Database but also WIPO patent scope and also WIPO and the IFPMA put a pat informed which we are very active users of and there is a number of other Tools that we use to identify which other relevant patents on a given, other members of that patent family, for which we identify that initial patent through US FDA or health Canada. We also use Not the Indian Patent Office has a two call form three that includes the listing of all the equivalent patents that have been filed in other countries that are equivalent to the one that is been filed in In the Indian Patent Office so that is another tool that we use quite a bit that once we do all that we do not untake the status country by country and again we can rely on some of those databases I mentioned earlier but we can also. Have direct interactions with many patent offices and we do, you know, very active users of online databases of various patent offices around the world. So this is a really important point that is This is data as collected patent by patent country by country brought up by product, and it is a huge amount of work, but really, you know, we think that Having put it to like this out there we need to make sure that it is as accurate as possible and so it is a big responsibility I am really trying to keep it up to date and having a tool that can be of a Use to a whole range of different stakeholders, I do want to stress that this is a free database, anybody can access no fees, nothing at all, you go in there and you can search without any problem next slide. So what have been the latest developments and I wanted to resume in here because since the last time we presented to this Committee is a number of additional things that we have done so in terms of sheer volume of new for us you have there yet. 5,700 new patent applications have been added, 40 new priority medicines for each priority medicines need to identify all the relevant patent families and all the national applications are of. And to check the status for each one et cetera then we have 20 new licenses have also been added as since the last time we will be presented to this committee next life. Yes I thought you the slide is it is a little longer than the screen here so cannot fit too well but just to flag that these are all the new products that we have been adding over the last Since the last time that we have presented to this committee, you see that there is a lot of new products that were added to the WTO essential medicines list, in particular a number of biologic products, we have also added several COVID-19 candidates and you can see which ones they are here, some biologics and some are small molecules, some of these have already proven to be effective against COVID-19 others. In development so may not have data approving effectiveness, and I highlighted in green those products on which the medicines patent pool also holds licenses for, which will facilitate a Access in low and middle income countries and you see the top two was are mentioned among the purier and PF332 are two products for which for COVID-19 to antivirals that have very promising data. And for both of these products MPP has licenses so from an access perspective of something that could be of great interest to many of your countries but from the perspective of MedsPaL we have made available these data on the patent data on these products. On the DMPP on method next life so user interface so what is about what we wanted to to. Like another important change we have made here, we used to rely on what is called in Padoc extended patent families for MedsPaL. That is a very helpful tool because the input in Beryl has not so whilst you have identified a patent you can find other patents are part of that and family but there are different ways in which you can define a patent family and in Paddock extended patent family. We found that for our purposes was too broad and so we worked quite a bit to try and break that down into more specific patent families because there was a risk that we were flagging Patents that may have been relevant there may not have been relevant to a given product but we are being shown in metal as being and relevant to that product so we we brought that down we created our ill. Or small patent families and you have an example that is shown here with Ruberin where initially we had one big patent family co-appearing compound and combinations, finally we brought out down into four smaller And families, one of which no longer seemed relevant to the real people in medicine which is what we wanted to show patents for so we took it out of MedsPaL, two others that were. Perfectly fine and stayed in there and a third one that yes was relevant but was only rather than for a specific formulation of Repuerni that the combination of repuring with enough of air so again is a lot of work that is gone into really trying to. Are dived down to the specific for this specific formulation that I as a procurement agency I am interested in whether patents are relevant to that I suppose to you were all the patents that may be relevant to RELPERING compound and that. Really takes quite a bit of further work, but I think it is essential if we want to provide data that is relevant to users next slide. Thing that we have done since we last presented to this Committee, we added the function of being able to search by disease, and what this means is that you can now, you know. You are interested in identifying, for example, here as highlighted show me patent status of medicines are being tested against COVID-19 in a country in this case India and you can do that so you can really select those. By disease area and I think that it could be diabetes it could be HIV, it could be any other therapeutic area for which there are patent medicines in the central medicines list of WHO and within thus A useful tool for stakeholders in the case of covert, it is not just those that are actually approved against covert but those are being tested for covert because we understand that there are drugs that still do not have the data but Are currently undergoing technical trials, next life, and one of the things that we did is also particularly important for covert is added. PCT applications as a new jurisdiction, so now you also get to WIPO, while our PCT appears as a separate jurisdiction, and why was it important because what we realize is happening in Cobo, that is for many of the covert products. I am the part of the national patents is not being filed yet, most of the patent applications are still in international phase and so if you are looking for patents in a given country say South Africa and you for South Africa. So you look anywhere in the world in fact, you will not find any patents, yet there is a PCT patent application has already been filed, so we needed to be able to fly in to national patent applications. For a specific process that is why we included this new feature which is particularly important in covered where in other products are, you know, have approval will soon be potentially may be approved for comment. Are still in the international phase and I have not yet reached the national phase and therefore needed to be able to check to look for them at the international level next slide. Is all the patent office with whom we have agreements is 14 at the moment, including some regional patent offices and these are patent offices from which, you know, have agreed through a collaboration agreement to exchange information with us, We are needed and so we resout to them from time to time when we are facing challenges in identifying the patent status of a given product and it is being extremely helpful. And so we did want to to highlight that but there are many other patent offices with whom we communicate and we seek data at times that for which we may not have a formal formalized agreement. But that has been of course extremely helpful and therefore many patent offices we just use their national, you know, the database, the online database too, to search for the relevant information, next life, so briefly, passing on to vaxpal. Vanuatu is the system product to MedsPaL, and you know, we are all very familiar with the discussions on going around vaccines. COVID-19 and patents and COVID-19, and we felt that there was a strong need for data, I think, always find it very frustrating where discussions are happening or a given issue and they are happening. Any evidence phase without any data to indicate what the actual situation, where things patent are patents on this vaccine on that vaccine, et cetera, et cetera, so we set out to start collecting that and if you can move on to the next slide. And this has been a relatively long process because, you know, really started in February 2021 when we started commissioned the first patent landscape on specific vaccines working with a A firm in India that supported those initial searches and in complementing that with searches through a wide range of other sources that have enabled us to be put together quite a comprehensive and Analysis of the patents and patent families are relevant to a number of COVID-19 vaccines we went live with that back in June as an Excel sheet and I will see that it was already called back foul but was essentially big Excel sheet that was not. Particularly user friendly and I was very pleased at last week we were able to issue it as a proper database and a school backstyle and is available in Bagstadt org and. And really there is the same format as that style we use the similar interface and you can search by companies you can see what we will just go to the next slide I can show you how that searches can be done. All this is providing you a little bit further information I was developed and unfortunate is hard to read with it with this format of slide and clearly we are not using the format that this screen enables I do want a flag that it is That in this case of vexed power was showing patent data worldwide so not just in the middle income countries that is a key point I do want to stress and are we really focusing on the patent families up. That we have identified and in exchange with several experts and I am relying on a number of sources that are particularly relevant to specific vaccines. And most of them are the patterns that were filed by the entity that developed those vaccines so you are typically for the fizer by antique vaccine we will be highlighting in particular those. Patterns that were filed can buy by untack a nature by fizer there may be there are in that specific case a few other more. More patents that are relevant to M R and a vaccines more generally and therefore are also relevant to that to that vaccine but by and large the majority of the patents that we would identify are those that have been filed by the developers of those vaccines. Themselves, but I do want to flag one important point, is that any patent that has been filed over the past 18 months, any patent application that has been followed in the past 18 months are We do not have visibility on it because they have not been published with some exceptions when there are cases as you as you know when patent applications may be published earlier but by and large we do not have. Access those public patent applications have not been filed so if you think of that patent applications filed post June 2020 you would not really have visibility on those so a lot of the patent. Applications that are there on vaccine are on the underlying technologies that were used to develop vaccines and some of the early patent applications that are specific to those vaccines, but there may be other patent applications. They are still not public and that we will be adding as they become public overtime next night. Oh, thank you, I realize I was not using the full screen mode, and I can see the full-slide apologies, it was my, so how do we select the vaccines that were mapping? So we wanted to be as comprehensive as possible on this because we thought we needed to try and map a range of different vaccines our being used in different parts of the world and saw what we are. Generally been doing is that in the approval at least one country where possible we have been mapping those and the other more that are coming so you may be aware of additional vaccines. That are not here in the RB of Renewi's one country and we are in the process of searching for those as well but also those vaccines are being reviewed by WHO in the context of their emergency use listing of the plant prequalification programmes so they have a. They have a link where you can see which other drugs that sorry the vaccines for COVID-19 that are being assessed so it is quite a comprehensive I think set of vaccines but as I said. We have at least three more that we are now going in the process of mapping as well, next slide, if you can keep on clicking, there is a few more. Yes so it was just to give you a sense of of the range of different patents or patent families are relevant to given vaccine and I am not going to get into the details but for the files that by and take your fourteen families that we have identified. I saw the 14 patent families, and that appear to be relevant to the-- to the fizer biotech vaccine, and you can see what each one of them covers from Antigua and I take asset lipid. Et cetera, the processes and if we put some of the key claims or independent claims are relevant here just to give a flavor of the different types of patents that would be relevant to that specific. Vaccine, but you would not find this, this information will not appear that what you will find in Vanuatu is a brief description of what each patent family covers, and they also, of course, find the status and the And the expected date of expiry under et cetera. Next slide. So I am just to give you a very small demo on that also. Is how you can search and what you can see here is that you is very similar to that, but it is like change, one of them is that we were putting the names of products from people, you are going to search, By a product, most people in the case of the COVID-19 vaccines know them, as the fizer by and take vaccine or the modern vaccine, as opposed to the actual product, so we give the possibility to search by originator because that is probably Useful for most users who know may not be familiar with the official name of each vaccine. And you can of course set shared all searches you can download the data into an exile in the same ways you can in MedsPaL as such was said for next life so this gives you. Is, you know, an example, it is the Astro, the University, I have seen in Australia just showing the status of those two patents that were identified, the expected expiry date and the The patent application number and here's a point I was saying I go at most people would not know this as the Chad Ox one and Cove Nineteen vexing but would know it as the Azrazenic vaccine or the Oxford Maxine et cetera so that is how that would work. Side, and you can, of course, change the kind of data that you would like to see on your screen on your interface and you can add things if you are interested in understanding. Additional geographic data and you are going to be showing you also can do that next slide. If you click on the specific patent that you are interested in getting more information on you get the This patent card, that pattern, it gives you the patent description, and that gives you the status and the patent application date and lost loss of relevant information, equivalent PCT application, and Priority application, and then also a link to the patent application from ESPASNE, so in similarly, as we have done for MedsPaL, you have a direct link from here to, to look at the full patent application, In there this is something that exists for all the patents that are flagging back fell and all the patents are flagging in metal where that information is available on as fast as it is, and then that will not be available. Next side. So just to conclude essentially to say that, and similar to what was mentioned by GIM in relation to Pat-INFORMED, we should not see this as a neither method for as a complete Authoritative source of patent information, it is not a freedom to operate analysis, it provides a snapshot of data that was available to the medicine standard pool at a given point in time and we do advise every time any user to Go to the relevant national or regional patent office or to consult patent council to obtain specific patent data for a given product in a given country however this can provide a very useful snapshot and it. And it also often provides you the relevant patent numbers and therefore you can then go to the national patent office with a very specific request on a very specific patent to find out the most recent status or use their online database if that is the case. So it is easy to use for public health players because they can search by the production name the INN, that is what makes it particularly helpful which is not usually the case in national patent office databases but at once you have that patent number. Could go to the national patent office to get the latest, all of these activities are of the MPP or are funded by unitaid, the Swiss Government of the Japanese government, I am very grateful for For their support were a non profit organization we were very closely with the WHO with WIPO and with the UN agencies generally in supporting affordable access to treatment, thank you very much and I hope this has been useful. Thank you very much for that presentation, several years have gone by since Med Pass gave a presentation in the Committee and it is also satisfied. Action to see how the coverage has improved and also there are new products such as vexpower. We will now have a presentation in connection with the Pharmaceutical register of Yaple, pharmaceutical register, this will be by oralia, Saban who is the director of it and also the director of examinations in The section chemicals and medicines, you have the floor. First of all, I wish to thank the WIPO Secretariat for having made it possible to inform us of the EIPO pharmaceutical register. First of all and in just a couple of words I should like to remind you of who we are so that you can better understand the functioning of this register. It is a regional organization which is intergovernmental and was created in 1994 pursuant to the Eurasian. Patent Convention and which became operational in August 1995. We were thus able to establish a regional system for protecting inventions on the territory of this organization which also functions to protect patents and As we can see on the slide there are a number of governments which are members and they are former republics of the Soviet Union. The Member States are also members of the Eurasian Economic Union and have a single economic Platform with free trade in goods, services, technological ones included, and since 2020, We agreed to have a single drug registration platform according to the common rules, consequently There is a single rule for the Eurasian region as a whole, making it possible to have a Searchable and accessible database which takes account of the registration system and for research. This makes it possible in particular to carry out registrations with a possibility of applying the Rules concerning patents systematically and to obtain information on patents on their status on their date of registration, And on the ingredients therein of course until now obtaining these data was difficult. Because they had to be found in patent databases as also the Eurasian patent registry. You had to find out about all of these elements and their legal status that information is contained in a server which publishes. A bulletin giving an update of resources to which one may have access but of course the principal difficulty is that in the patent document. It is rare for us to be able to have the names of all of the molecules in the composition of a medicine, these molecules, generally speaking, Have not yet been disclosed in the patent and, of course, we do not have the formula or the biochemical structure making it possible to find out So how are the medicine functions that is subject to the patent, so we took the initiative, the In Yaple to carry out research via the patent headings and also by the active molecular composition As you can see on the slide, this database is accessible, making it possible to have access to the Pharmaceutical ingredients systematically according to the INN classification and in this way to have access to the database which was launched on the 1 st of March this year, Making it possible for a whole range of users to have access to it, free of charge. I repeat, no fee is requested for this service. In this way it is possible To find out which molecules are in the composition of the substance. In this slide, you can see which patents are concerned related to Active pharmaceutical ingredients, APIs. You can see that you have chemical compounds and And singled chemicals including those that come under Markush claims. And to the information we find in this register, first of all, you have the Eurasian patents grouped under the INN, their legal status, In the eight WIPO Member States, we have a statutory date of patent Term expiry. We have what is in force and not in force for each Member State and at a rate. Link to the E patent register for a full history on legal status, it is also possible to find out about a patent Mentioned any other Member States plus information on market authorizations in the Member States of the Eurasian Union, As also registered licenses in EIPO Member States and as far as these licenses exist. We have developed our register, first of all, thanks to internal resources that we obtained in the Eurasian offices, we also Make use of external databases which are such as Pat-INFORMED, Medpal which were already described to you to Day for some time already we have been cooperating with these two databases. We have exchanges of information A nation with these excellent data sources, we can also receive information through the Patent holders or because of requests made by patent holders, these are addressed to national or regional offices. As far as the Russian Patent Office is concerned, it cooperates closely in developing A register for active chemical ingredients or substances on the First of December 2021, we had 286 Eurasian patents with 192 INNs and 308. 10 registered drugs, you can see on the right the form that is used, We can also carry out searches according to INN according to the patent number and according to the patent, hunger, This information exists in Russian and in English in most cases we can obtain information in both of these language. Languages and you can see our website listed below, that is how you can accede to our register, I should now like to point out How the interface interface was created, you know the number of the patent, for example, and In that case, you can proceed to do your search using INNs and Obtain full information concerning the medicine concerned that has been patented, you can also choose another means for Obtaining information from this register, information is provided in Russian, We have information on when the patent was granted when its expiry date is due. Any exceptions or limitations in Member States for those who are not Russian speaking, the name of the state can be used You can indicate this in green, green shows that the patent exists in that country and information can be provided concerning the extension of the life span of the Patent by specifying the territory on which this extension is applicable. In blue, we state what the status of registration is For medicines in these states which are member members of the Apple in the case of Russia and Kazakhstan, We indicate the name in which this is produced and sold, lastly, and the last data set, We mention if there have been disagreements concerning the list of questions or the granting of licenses and whether information is obtained from wider sources concerning the Patent and its status, I chose to show you this image because I Green shows the state in which this patent is used and in red you have states where this patent is no longer in use at the bottom. You can see the list and if you click on this register here, you can obtain Information concerning the legal status whether there was an opposition whether there was a challenge concerning this particular patent. You can see if fees have been paid and for how long we You can see A1 B1 indicating declarations that were made concerning these various patents. As to the rest of the information that you can find in our register we have a registration procedure for data. Which means that there are no fees to be paid if a patent holder wants to include information on this list. According to INNs and also a copy of us provided concerning market sales. Our register. It contains the information on the various patents grabs. And the filing, the word in which these patents were obtained is detailed, there is all information concerning the patent. The examination is done by experts who ensure that The information provided is corrupt, there are chemist personages who give their INFORME their opinion of the register and ensure that the information contained in them is correct and. It also states whether this patent is, can be used in all countries or only in some of them a single patent is granted In the apple, and if there is a patent which is used in a single Member State, that patent is contained in the register, We can also exclude some information at the request of the patent owner. Additional information can be added, we receive a certification of the quality of the medicines or Third parties may comment on the patents or the medicines in our registration, the if errors are Are encountered, they can be corrected. I have sought to give you An overview of how we can collect information at April, it is, of course, of concern principally to the eight countries which are members of the Organization, the procedure used, the It is such that we provide information and make The request for the information concerning certain medicines, the register seeks To ensure that the medicines are well known in our regions where in the past there was a lack of information as to the rights of patent The owners and the activities of pharmaceutical companies is a new register, which, of course, will We will amend and improve together with the assistance of national or foreign pharmaceutical companies, I am, of course, ready to answer any questions. You have the floor. I will give the floor to those delegations which may have questions or wish to have I see that Venezuela has asked for the floor, followed by Switzerland, Venezuela, Very interesting presentations and which I think approve positive of the strength of the patent system and that patent IMEC has indeed strengthened it, I have a very concrete question for the representative of medicines patent pool. Who gave a brilliant presentation a few days ago we were able to see on the Internet of Venezuela my country. Is among the Ninety five countries which could benefit from a voluntary license from Fiser in order to produce a viral appeal. Against COVID-19. That bill is not patented and we have not requested a patent for that pill at capital as I tell you that we have not To grant any patents for many years, but, of course, we need information as to the preparation of this medicine The adviser has a plant in the city of Valencia in the Baromabo state, which is very active, I should like to know that Under what conditions a country like my own can benefit from a license through the patent pool. Thank you, Chairman. I now give the floor first to the delegation of Switzerland for any questions, and then we will allow the The cosponsor of SCP/28/10 Rev Switzerland would like to thank today's presenters for their interesting updates on Publicly accessible databases of patent status information concerning medicines and vaccines. We welcome these initiatives as an important contribution by the patent system to enabling access and affordability of medicines and vaccines. We look Forward to continuing these updates in line with our proposal SCP/28/10 Rev. Thank you, Switzerland. Let's see if the representative of MedsPaL can join us again and respond to Venezuela's question Hello, can you hear me well? Can you hear me. Yes, we can hear you. Thank you. Thank you. I would like to thank the Delegate of Venezuela, I will respond in Spanish, indeed medicines patent pool negotiated A license with ISA which permits the granting of sublicenses to companies throughout the world, But in particular the 95 countries covered by the license, these are low income countries in IMF classification. Lower middle in some countries and some of those middle upper income countries, some of them, Venezuela, Is included and what it means is that once there is a generic version of the product, Venezuela will be able to purchase The generic is currently not a patent for the product in Venezuela, there is not one anywhere, this is a product that was developed. Specifically for covert and it is still at the international phase of PCT countries and some countries who are not Members PG PCT have asked for national patents, so there are no patents present, but there will be some in the near future. This also includes patents include in information which is reserved which is available to the Those who desire it and it might allow them to speed up the development of generics in order to bring the product to the market as quickly as possible. It Generics that currently be worked on, there are many interested companies across the world because the license would be available across the world, I do not know whether that if Venezuela companies have I requested that it is a rigorous election, which is a double-blind completely anonymous, a We have internal and external experts who evaluate all the applications, the list has been closed. And we are currently studying those applications we have received, we want to grant it to the largest possible number of countries. We wish to publicize the license and inform those governments which meet the quality requirements. Established in the license so they can request it if they wish to I hope I will have more information soon as which companies have been selected to produce a The medicine in those countries like Venezuela so they can access the generic other countries made by the product to original product. Directly from Brazil. Thank you. I thank you, Mr. President. Indonesia remotely go ahead. Thank you, Chair, this is the first time for my delegation to take the floor, allow me to go to let you and the Vice-Chair on your election and you like also Express our appreciation to the Secretariat for arranging the meeting and following our important work to proceed, despite this ongoing coffee Netty pandemic, and let me thank you for the presentations and the update on the initiative on public Publicly accessible at the base of patent status information concerning medicines and vaccines indeed our work on the issue of patent and health has become evermore oppressing, recent developments that have only shown. The importance of equitable and affordable access to medical products and health ecologists, but more importantly, how IP and other than hinder access to public health, in this regard, we thank the Secretariat for All the updates provided in the document SCP/31/5 on the review of existing research on patents and access to medical products and how technologies and invite the study to be considered In the spirit of coverage, this opportunity, Indonesia would like to convey its support of the proposal to expand the report under review up to the year of 11. Here. Or in the face of the current health and we can see that the focusing of the objective agenda and the bration of this committee might be wanted after almost two years into the spread of me this committee has unfortunately yet to agree on the searchable. Plan which might have a lot for much needed capacity and improved resources to Member States in response to the ongoing pandemic as point out by several delegations sacking the appropriate balance within IP. The quality transfer will be critical in improving accessibility and affordability of vaccine, the appendix and the diagnostic required to combat COVID-19. In this regard, we note the report, the specific documents see SCP/31/5 and would like to recall that when this Committee agreed for to conduct a view, it was to allow Member States to engage on the public of patents and access to medical products and how technologies and to stop Your own future work within this Committee and stated in para 6 of the document SCP/28/9 rev. In addition to the document SCP/31/5, we would like to reiterate our support Work for the work programme proposed by the African Group as effective in document SCP/24/4 and call for this Committee to fully implement all the elements contained within it. We are of the view that a concrete WIPO work program on IP and health is Law over you. It is time for us to agree on the concrete work programme under this agenda item. To this end, my delegation calls on the important roles of this Committee after the premier forum to discuss IP and how to re-and figure its discussion within this It was the agenda item for concrete works and action in investing the current of crisis thicker. I see there are no further requests for the floor regarding these presentations. Is it on these presentations or are you wishing to speak to the next item on the agenda? Now I have some observations regarding this item on the agenda. Yes, go ahead. I am speaking to the protection of patents for the legal society at large and we have to consider the expert Bence of developing medicines which are then protected by a patent. We, of course, need to remove obstacles to access to medicines, but we nevertheless need to protect the rights of patent Holders and to bear in mind the market, the supply of various products, the Russian Federation, It is looking at this issue with great care and is taking steps to protect invention through a register includes patents And medicines, information is provided on such patents, and Their use and public, there is public access to this database, big And owners, once the patent has been registered, they keep their rights, and We then provide information as to the chemical makeup of the products and these chemical formula, mainly to the A production of ancillary or secondary medicines, particularly salts or solvents. It is important that To bear in mind the users of these medicines and in the event of The complaint, we must, of course, search in order to ensure that the patent is respected, those medicines of Pearing on the register. Are registered from the granting of the patent to their expire to the expiry of the patent, the chemical Formulae in the register, which are commercialized, ensure that the invention is properly used Mr. Bdioui. We, of course, bear in mind the information on patent form and other bases. The steps taken internationally make it possible to use to make the best possible use of medicines which have been created and we would Like to thank all those who made very interesting presentations this afternoon. We will now go to general statements on patents and health which began yesterday afternoons and which were interrupted by the adjourn. And you can, of course, make statements as to document 31/5 as well as general statements. It requires access to medicines and health technologies, I see the request for the floor from the Delegation of Paraguay on behalf of The Delegation of Paraguay speaking on behalf of GRULAC, GRULAC would like To note that relevant debate is under this agenda item, particularly in the current situation, we salute those initiatives Contained in documents such as 31/5 and those undertaken in the trilateral work undertaken by WIPO, WTO, and WHO in order to strengthen cooperation In the areas of trade medicines and Internet Intellectual Property. A number of challenges which Make us aware of the complex links between health and access to innovative technologies, and We need mechanisms which facilitate transfer of technology and access to the benefits of the medicines patented, for example, those are Medicines designed to fight the pandemic covered in 19. The health take Knowledge and the access to medicines and the updated databases of public access should contain information on patents of medicines and vaccines, thank you very much. I now give the floor to the Delegation of Venezuela. Thank you, Chairman, our delegation shares the position of GRULAC and we would all We would like to make a national statement, we would like to congratulate the Secretariat of WIPO for the quality of document 31/5 on patents and access to medicines and health tech Knowledge, as we all know, the patent system has been demonized throughout its history, but has always triumphed and has gone forward, strengthened, rather like The Phoenix rising from its ashes. The Fritz Mac Look made us aware of the fact that if we did not have a patent system we would be irresponsible On the basis of our current knowledge of the economic consequences, but since we have had a patent system for many years, it would be irresponsible to recommend its The abolition, I quote, the system has been strengthened thanks to the pandemic. In Venezuela we believe in the patent system Them. We have re-established the system after 15 year recess. Since we believe that it will contribute to our development encouraging industrial activity in all areas and providing technical information And we are, therefore, implementing the TRIPS Agreement of WTO, and having incorporated it in our national legislation, the We believe that any invention meets the conditions established in our law, the state cannot denounce A number of Delegations spoke to the balance between the private individual rights and Of in order to recognize their innovative and innovation and inventiveness and the rights of the public at large. Through the Committee and under the agenda for this session that has also been discussed if the individual right to a patent if Peace access to knowledge in order to resolve an issue of national emergency or public health crisis, the state should Under the law, suspend that individual's rights for a period in this way, Mr. Chairman, we would have a more justable humane patent system and there's This is what we are seeking to do in the current legislation, which is before the parliament of my country, it is not the case of COVID-19, this pandemic went beyond all acts. Limitations and it is not the patent system which is responsible for the limited access of vaccine in some developing countries, as the delegate of South Africa said yesterday, and We know that the great problem of vaccination has been distribution and production, but we know, Mr. Chairman, that if the deliberations analysis undertaken in this Committee allow us to Achieve a more humane patent system and which will assist the society in overcoming public health crisis. We must do so. Thank you, Venezuela. Well, Argentina has also the floor, Argentina, who will speak remotely, thank you. Yes, thank you very much, can you hear me, thank you very much, since this is the first time I have taken the floor, allow me to Congratulate you for being reelected and also to congratulate the Vice-Chairs. We thank the Secretariat for preparing the meeting and all of those that gave presentations for the information they provided. Mr. Chairman, Argentina agrees with your opening statement about the importance of doing practical and specific work concerning IPRs. And coping with COVID-19 and this Committee, my delegation was one of the proponents of the documents that gave rise to The agenda item, patents and health, and this item is more relevant than ever before, Argentina historically has defended a balanced Intellectual Property system which makes it possible to further development In the light of national needs there should not be obstacles to access to health, particularly in the situation that we are experiencing now when covered vaccines are global public goods. And should be distributed equitably as to vaccines and medicines, it is important to have access to information about the legal status of licenses and patents, this helps promote public Look, disclosure and the transfer of technology. Mr. Chairman, many international organizations are studying the link between Intellectual Property and COVID-19. WIPO should not lie outside these trends, we are interested in future work that will be done in the international level and also multilateral discussions and other fora. Thank you. Thank you, Argentina, the Russian Federation has now asked for the floor. We thank the Secretariat for having prepared the study, the issue of research into medical And technological innovations, this is very topical in connection with patents because COVID-19 is continuing to ravage our society And we need vaccines, we think that the results of this study will make it possible better to understand what this mechanism involves and to find a solution. To the problem of preparing medicines and vaccines in order to find balanced solutions we are in favor of continuing with the study as also updating it while taking In particular care about the current status in different countries because of the pandemic, in fact, it is essential to expedite procedures for examining patent For medicines and vaccines in order to have products on the market for diagnosis and prevention as well as health Care. Currently, in our countries, we see that patents are being filed, Relating to medicines and vaccines against COVID-19. We see that the first patent concerning COVID-19 was Found in Russia, and this was the Spartnek vaccine, this took only three weeks to get validated and to expedite its placement on the market This is not possible without an exchange of information amongst stakeholders, consequently we launch an appeal to all WIPO members to adopt the same Procedures to follow the same paths and approaches in order to support innovation and to make it possible by all means necessary to combat the current Handemic and other health emergencies internationally. This depends essentially upon procedures for examining patents and Structural procedures which are related to that. This is very important. It is also very important to find out when a patent has granted, what the composition And the substance is in molecular terms in this way it should be possible to grant licenses and to Create generic versions, also there is this well-known problem of ever greening. It should be possible to deal with this problem by looking at limits to validity, furthermore, green patents can also cause problems And sometimes there is a need for new ways and means for the denomination of molecules composing them. It must be possible to use them as early as possible without having an expiry date or a validity date, this is particularly important Important so that this practice can become more flexible for users. Of course, this means that new measures are required I had a new context which are sometimes very obscure for nonspecialists. We should also like to remind you that we are interested Dead? In a polar description of the components of patents, this was often raised. This can call into question the whole issue of patentability, we have to adopt a balanced approach for public health. By taking account of practice and experiences in various countries more particularly for issuing licenses. We should also like to inform you that this year we amended the Russian legislation in connection with context, we introduced First Article 31 bis of TRIPS into our national legislation, the delegation of the Russian Federation, the Would we would be very grateful to the Russian Federation if it could read its text more slowly on a subsequent occasion, thank you very much. Thank you very much, Russian Delegation. I do not see any other national requests for the floor. So perhaps the time has come for intergovernmental state And please be concise in your statements, also I wish to remind you of the possibility of handing in your longer statements To the Secretariat who will publish them on the electronic Forum of the Committee. The European Union has asked for the floor. I am taking the floor on behalf of the European Union and its Member States, the EU and its Member States wish to express their understanding for the challenges experienced when the And public health problems and ensuring access to safe, effective, qualitative, and affordable medicines and vaccines for all, this remains some of your challenges and the ongoing COVID-19 pandemic on a key sustainable The development goal that we must all support. Indeed, the COVID-19 pandemic has shown how important medicines and vaccines are for the world; researchers on the pharmaceutical industry supported by extensive public Funding have been put in extraordinary efforts into the development of treatments and vaccines against COVID-19, effective incentives supporting these efforts have been crucial, broad Affordable and equitable global access to safe and effective diagnostics, treatments and vaccines is equally crucial in the fight against COPEC and for such access may be regarded as a global Public good objective, we are committed to continuing to help ensure equitable access to affordable COVID-19 vaccines at global level to enable broad, affordable and equitable global distribution of trade The EU has taken a leading role in the global coronavirus response team Europe has so far pledged around half a billion doses of effective COVID-19 vaccines for the virus. In collaboration with the WHO, the EU and its Member States are actively supporting the access to COVID-19 tools accelerator act A and its vaccine pillar, the cowax facility. By financing more than a quarter of these multilateral structure, and as the biggest donor after the US, the EU and its Member States are living up to their undertakings. For intellectual property rights, including its exceptions and flexibilities, has turned out to be part of the solution; in 2021, we have witnessed hundreds of voluntary partnerships among developers On manufacturers of vaccines in the EU alone 60 factories have been involved at some point in 2021 in key manufacturing steps of the COVID-19 vaccines today, the EU has some On the protection capacity of over 300 million COVID-19 vaccine endorses, and this is continuing to expand even further in October, the EU exported over 80% of its production of COVID-19 Therefore, a careful balance between incentives in favour, both of innovation and of access to medicines, needs to be preserved, including in the discussions within the SCP. The extraordinary situation of the COVID-19 pandemic and the very large amount of public money provided has to be taken into account when addressing this careful balance. Thank you, representative of the EU, if there are no more national or intergovernmental statements, I am sorry, US has asked for the floor. Ramada. Speaking remotely. Thank you Mr. Chair we note that the current pandemic has made this topic like as been mentioned by other Delegations more relevant than has ever been the United States is committed to working with international partners. And identifying practical ways to promote timely, equitable access to safe, effective, affordable, and quality-assured medicines, vaccines and diagnostics around the world, and to support policies that drive the development Of no medicines, then note we merely want to mention are that some Member States have referenced or alluded to TRIPS waiver discussions as this topic is still being or still subject to negotiations at another forum. And pursuant to an international agreement overseen by another body or we just we would like to state that we now do not think that it is appropriate to raise this topic at ESP. Thank you. Thank you, United States. It is now the turn of the non governmental organizations you have the floor. We take note of WIPO's response to COVID-19 as detailed in the program of work and budget for 2022 to 2023, specifically WIPO's COVID-19 response states, and I quote, that WIPO will review, analyze and advise Member States on the specific and systemic measures available that will assist Member States to address COVID-19 and future pandemics including options available to Member States. To implement international treaties in their laws, regulations and other legislative materials, for example, using the TRIPS flexibilities, unquote, providing legislative assistance to its Member States on TRIPS Its flexibilities is important, but for many countries, it is also important to address the challenges of making, importing, exporting and using products under exceptions to exclusive rights when there are by Natural or plurilateral trade agreements. We request WIPO to engage in providing legislative advice on bilateral and plurilateral trade agreements that govern Intellectual Property, pharmaceutical investment and other provisions That are relevant to the scaling of manufacturing of and equitable access to pandemic countermeasures in the COVID-19 response WIPO's legislative advice should address rights in data or access to no How or so lines as they are important factors in scaling the manufacturing of countermeasures as well as the challenges of regulatory pathways that feature linkages to rights in patents, test data, and Protect confidential manufacturing know-how. As part of the Secretariat's update of the review of existing research on patents and access to medical products and health technologies, we would request the international Bureau to include in its review a WHO UNDP publication entitled remuneration guidelines for non-voluntary use of a patent on medical technologies published in 2005 which may Also benefit from an update and WIPO's 2014 study on alternatives to a patent system to support R&D efforts. We reiterate our call for the SCP to discuss the Of patents in the development of and access to new cell and gene therapies, among the topics to be considered are the extent to which patent exceptions for the treatment of human supply as well as the high costs An anti competitive nature of licensing, B, emerging, thickets of patents for these treatments. Thank you, Mr. Chair. Thank you very much, knowledge, Ecology international. And now we have a remote participant, you are me. See as we can hear you thank you are the international federation of pharmaceutical manufacturers and associations would like to thank you for the opportunity to provide input on the important discussions within the SCT. We would also like to extend our congratulations on your reelection and to the newly elected wasteers IFPMA represents the leading research base by pharmaceutical companies as well as national and regional investor associations. Across all five honours we are grateful to the Secretariat too for they continue to work on this topic that have enriched the debates in this committee the Corporanai pandemic has had a profound help social. And economic impact around the world the bio pharmaceutical industry has made addressing the pandemic in stock priority devoting its resources expertise know how and intellectual assets to developing treatments diagnostics. Vaccines of an unprecedented base all the while committing to and engaging in unprecedented levels of international corroboration and coordination through initiatives such as the act to ensure equitable access to products being developed. A stable predictable and effective IP framework has been a critical enambler it is because of previous investments and continued R&D that has been laid possible by the IP system. That we were able to bring to market several safe and effective vaccines and creetles including new antivirals and more clung and underbodies in recording technology transfer for vaccines especially is a highly complex process. Requiring a range of special skill sets and capacities that notwithstanding to achieve the mass of massive scale up companies have ended into voluntary collaboration with partners across all five continents this. By huge challenges of managing their own production ramp up, companies are waterly engaged in 325 voluntary collaborations for vaccines and 116 with therapeutics, we are on track. Use 12 billion endorses by the end of this year and 24 billion by 2020 to June lastly we would like to thank the Secretariat for inviting us to speak on the patent information initiative of medicines. The PRESIDENT Thank you very much, International Federation of pharmaceutical manufacturer services. The PRESIDENT Thank you. Can we now have JIPA speaking remote? I am sorry, you have got it down there. No? Applause). Thank you. I am very sorry, representative. JIPA, but there was a problem with the connection, would you mind submitting your statements in writing if possible, thank you. If there are no other statements under this item, I would like to remind you that you can always send in your statements and writing, we shall now move on to the next agenda item. Venezuela, did you want to take the floor? Thank you for giving me the floor, Mr. Chairman, the Venezuelan delegation wishes to state that according to the reports and what we have heard, Discussions on patents would go by contents according to contents, and we would like to say that often the system has been criticized, This is a system which is meant to be in the service of the human rights as also transfer of technology, we are mentioning that because we know that many countries would be in favor of canceling the system without further A consequence, but we would like to remind you that ultimately there is a contract between society and an individual with an exchange of information Concerning claims, patents as such have not gained their position without conditions, they can be threatened by public opinion if we want to promote the system And we want to keep a system which is favorable to innovation and to technological development, we have to bear very much in mind that the ultimate goal of a patent is social well-being and Progress and the development of technology for society. This is the approach of Venezuela and this is its approach to patents for them to be relevant. We believe There should be a context of limitations on this right in order to make progress in these discussions in connection with the pandemic. Thank you, Mr. Chair, I wanted to ask you, Mr. Chair, that Nigeria requested the Secretariat that probably the SCP could invite the WHO For guidance on how WIPO could keep in to the set up initiative to assist Member States to have concerted efforts to tackle these public challenges so we are expecting probably the Secretariat to To respond in that regard and also quickly, Mr. Chair, we are also requesting the Secretariat to update the meeting of the Committee on studies on patent flexibilities for public and public health in cooperating country Its legislation such as our exclusions and exceptions. Also, in addition, we are expecting the Secretariat to talk about a probably updated meeting on the recommendations on the review of existing research by international organizations on patent General access to medical products and health technologies. I recall that this matter was presented in the 21 st session of SCP as December 2019 and we would appreciate if the Secretariat could Briefer, the meeting on these matters, thank you so much, Mr. You have the floor, please. The main sense of haunteers. Thank you, Chair, for giving us the floor. Men to some countries we would like to continue sharing our with these and observations on the role of intellectual property, particularly to patents and confidential information of a protected and literacy creative category. Ireland has had a tremendous and material impact on achieving equitable and universal access to commun19 medical tools in two years into the pandemic. So we would like to share and reconnect some of the key issues that we have observed in the past two years of panic, Point of the massive public funding and support to generate the scientific breakthrough bringing multiple vaccines to the words, and with growing headline of promising Therapeutics antiviral or treatment due words, we have not seen any promising and concrete outcome and an impromising kind of past way so that the universal and equitable access. Could be guaranteed through an uninterrupted production and supply by many as many as possible countries in words and as many as possible regions who have a capacity to produce the Industry voluntary action has been limited, we have a recent example when Mercosur goes aside about the license, Ms. Medicines Patent Pool will not without any transformative term and conditions. Falling the same pattern of off a license even practice his real pandemic and we do not think that this is a solution that we are looking for when the call for open licensing global coverage. Non-exclusive licensing has been repeatedly reiterated since last year by many of the public health other organizations, WHO and so on, we have not seen anything changed in this panic when the new therapeutics Potentially bring a signature in many of the developing countries, so we really call for this Committee and the members of Member States Recognizing the instrumental rule that Anky has pledged in hindering the universal access to COVID-19 medical tools and realizing that using the existing mechanism is. Very importance are particularly overcoming the patent barrier by using compulsory licenses and restricting patentability criteria streamlining a patent examination to make sure that the essential. Tools for the pandemic are not subject to private monopoly in this pandemic, realizing those important, but also realizing all of the tools are not enough as we are sitting in the very important Initiatives led by South Africa in India, supported by many members of the World Trade Organization to have a temporary river, not abolishment of the patent system, but a temporary waiver from certain obligations, So that is the countries where needed, they can use that weaver to have a more expenditure and comprehensive addressing of multiple area of barrier for IP related to COVID-19 true. We really call for this Committee and the Member States to recognize the need, which is very unprecedented in the panic, also recognizing the lessons learned from this panic shows that We are not enough for the ending of the future Panama preparedness and response, members need more additional tools in order to make sure public health needs are prioritized. We now wish the global economy trade and any other socio-economic orders will not be back to normal as we are or are anticipating thank you. Thank you very much, Mr. Chair, and thank you very much for the Distinguished Delegate of Nigeria for your questions, I note that the Delegation of Nigeria. So to present the issues that read to the technical assistance, I also note that the Delegation of Nigeria requests the Secretariat to conduct studies on patent And flexibilities, including exceptions and limitations. Now I understand that these requests or suggestions are made as the activities under this Committee. And therefore, What this is a bit going beyond the capacity and the mandate of the Secretariat, but it is rather the issues to be decided by the members of this Committee whether the We wish to conduct and carry out these kind of activities in the Committee, so I think the answer will be in the hands of the members of this Committee, and I would like to note this since the studies on the exceptions and limitations is mentioned by the Delegation, as we have also had some discussions at the first day of this Committee, the exceptions and limitations to patent right is one of the standing agenda items of this committee, and the Committee have had prepared quite some amount of studies, collective The information together with the members of this Committee and I believe that these information and existing studies, if the Delegations have not had a Had seen it. It will be very useful for your delegation and we are ready to refer to you to these studies. It is true that it is not always easy to find these that These somehow, lost in a huge WIPO website, but we are ready to be happy to indicate that to you. Now, finally, in connection with the View of the existing research on patent and access to medical product and health technologies. This is the document which is submitted at the 31 st session Of the SCP with the number SCP/31/5. So the document has been discussed during the last two sessions of this meeting, the Records of these discussions of the last two sessions they are also available under WIPO website and again I am very happy to. I am to guide you to these previous Delegations. I think that concludes this agenda. The first thing tomorrow, no, Nigeria wishes to take the floor, Nigeria. Thank you so much for indulging, Mr. Chair, and I really appreciate the Secretariat for the response given on this matter. I must mention a The issue that was raised, of course, everybody will be there, we have issues with public health emergency in developing countries, especially COVID-19, which no contrast is an exception, and I would just like we read him Mentioned yesterday and we propose that the SCP invites the WHO and that is following the fact that there has been a tripartite meeting between the WTO, WHO and WIPO to come up with a synergy. So we can sort out this issue of COVID-19 and also the Delegation of Nigeria would appreciate if the Committee could come up with an action plan because it It is a matter of emergency and we would appreciate more commitment on this matter and that is why we brought up the issue so thank you so much for giving me the flag and thank you. So tomorrow on screen, you will have a The summary of the discussions today or patents else is another delegation asking for the floor. So we do, in fact, move on to the next item on the agenda, confidentiality of communications between clients and their patent Advises. At the previous session, it was decided to continue debate on this subject in order to allow Member States to rebuild all On new developments in the area. So I will give the floor to Delegations to make general statements, first of all, regional coordinators, and Then any other Delegations wishing to tell us about any new developments. France on behalf of Group B, you have the floor. Thank you, Chairman, Group B continues to attach importance to the issue of confidentiality of communications between a patent ISIS and their clients and we are delighted that the Committee continues to pay attention to this important subject, despite the pandemic patent filing activities as returned to Growth, 1.6%, indeed, from 3,22600 patent applications in 2019 to 3,276,720 Well, wide patents in force has grown by 5.9%, a total number of PCT applications grew by 4%, bed to 2019. 20 with the 11 consecutive year of growth applicants from 125 countries across the world for our PCT applications at 84 receiving offices. Users of The patent system are increasingly active in cross-border activities with the economic destruction caused by the health crisis, patent Delegation may well increase in the near future. A trend already observed in a number of countries for users of the system. This emphasizes the importance of an Not facing the risk of an unexpected and unjustified breach of confidentiality from one country to another, patent applicants or owners need to be able to Save cross-border legal advice without risk of forced disclosure of the communication received from their advisors. This is particularly true when the disclosure Could involve communications which are privileged under the jurisdiction under which the communication was made. The absence or lack of clarity of regimes in this area causes legal uncertainty and unpredictability and negatively impacts innovation. The continued SCP work in this area would be of great benefit, Group B notes that the protection of confidentiality does not To affect the disclosure of an invention, patent laws worldwide require that a patent application disclose an invention in a manner sufficient for a person's Skilled in the art to put the invention into practice, patentability requirement is not compromised by a client patent adviser privilege. The confidentiality of Communication between clients and advisers does not affect the level of prior art for patent examiners. Group B continues to believe that this Committee should take a Steps to address the matter at the international level in a manner that provides Member States with appropriate flexibilities to adapt a common mutually agreeable Approach to the specific legal systems, this has been shown abundantly in a large number of countries where various forms of client patent advisory confidentiality privilege has existed for Many years without in any way interfering with patent disclosure requirements. Group B looks forward to discussing the issue, including on the basis of Member States ' Variance, in order to inform the way ahead on this important topic, Group B works of the input of Member States who have recently introduced confidentiality of communications with Between patent applicants and ages and have some early experience to share with the Committee with a view to fruitful exchanges in future. Thank you, Mr. Chairman. Thank you, France, on behalf of Group B, is there any other Delegation who wishes to take the floor? Yeah. Georgia, on behalf of CEBS. Microphone, please. Thank you very much. Chair, CEBS Group continues to attach great importance to the discussions under this agenda item, research and development Projects and corresponding inventions are conceived at the international level, consequently requiring cross-border services of patent advisors; therefore, the cross-border service of patent advisors to their clients is a common Practice. One of the concerns the inventors have, one seeking for the protection of their inventions is a treatment of the information they have to disclose and the potential risk of This disclosure. When dealing with many jurisdictions, together with concerns, the risks are increasing. Often even the legal definition of confidential information differs drastically. In many jurisdictions the claims of privilege may during the litigation process can be challenged. In addition to this in many jurisdictions there are only few precedent setting court decisions on this issue. And all this creates legal uncertainties, mitigation of these risks and challenges requires a global response, as underlined on previous occasions on this matter, We believe that the time is ripe enough to start the development of the harmonized international approach, the creation of legal certainty and predictability through setting minimum standards in the This area and harmonized international approach to protecting confidential client patent advisor communications from forced disclosures will positively influence innovation and bans and the overall patent system. Mr. Chair, CEBS looks forward to further discussions and hopes that better understanding of the differences among the Member States would lead our Committee towards a meaningful outcome, thank you very much Thank you, now the delegation of Switzerland. Chairman, thank you for giving me the floor again, Switzerland supports the statement made by our colleague from the Delegation of France on behalf of Group B We would be in favor of multilateral agreement And on the question of confidentiality between patent advisors and their clients on cross-border situation, we believe that this is an essential condition for the optimal functioning Of the international patent system, it responds to a need and particularly in the light of the increased disputes but Switzerland has been in favor of the coordination of a group, a Working Group B plus, 78 countries which have a It makes the legal systems common law systems and relevant law systems seeking to find a multilateral agreement and have then sought common denominators in all Order to arrive at a flexible solution which we believe should be acceptable to most people, the Working Group on this agreement is currently finalizing this document, We are also including a plenary document for those who are less familiar with the problem and it should allow them to understand the subject better, these documents will be We published the issue, we have to have public hearings in a number of countries, together with the users of the system, the advisers, IP offices and clients, And indeed the specialized patent legal bodies, Switzerland and other members of B plus group would be happy to present To these projects at our next meeting in August of 2022, both the report and its planetary attachment and would then be able to report on the Public hearings and the intermediary results. We hope to have informal exchanges here in Geneva. Thank you. At Thank you, Switzerland. Slovenia, you have the floor. I am speaking on behalf of the European Union and its Member States, the topic of The confidentiality of communications between clients and their patent advisors remains of great importance to the EU and its Member States and we welcome the initiative to keep this item on the agenda. In the absence of protected environment where patent applicants or owners are able to receive legal advice without the risk of forced disclosure of the communication with the patent advisor, the quality of patents. As well as the enforcement of patents might be adversely affected. The EU and its Member States still believe that the convergence of the different legal frameworks in the four Mentioned feel among WIPO Member States irrespective of their legal level of development would benefit users of the patent system. On this issue, our preferences for the An approach that would enable the necessary flexibility in light of the differences in the legal systems which aim at the conferring the same protection to communications between a client and its patent advisor We look forward to the continued discussion on this matter as it will increase awareness and give us a possibility to hear the experiences of practitioners and Member States regarding Development and experience covering policy and practical issues with a particular attention to cross-border elements. We thus look forward to further exchange of views about this important matter and would be pleased to see a sharing Session being organized during SCP/34. Thank you, Slovenia. Delegations of Canada and Spain have asked for the floor remotely, Canada. Thank you Mr. Chair Canada would like to take this opportunity to note some recent domestic developments in the area of confidentiality of communications between clients and their patent advisors. Canada notes that on June Twenty eighth Twenty Twenty one ten of this college of patent agents and trademark agents commenced full operations as members of this committee may recall this development follows from the entry into force of Canada's college of. Agents and trademark agents act in December 2018, which created a governance regime for patents to support the provision of quality advice from IP professionals and ensure that professional and ethical standards, including age and client, Are maintained. The recent launch of the college was also accompanied by the introduction of a code of professional conduct for patent agents. The new code of conduct includes a duty for patent agents to preserve the confidences Secrets of their clients, and rules specifically requiring an agent to hold in strict confidence all information concerning the business and affairs of the client, the college will be responsible for enforcing these rules Has the ability to investigate and discipline agents for breaches of the code. Mr. Chair, given the complexity of the patent system it remains important that inventors, small businesses and other applicants are able to Trust the advisers that they rely on to help them navigate the patent system ensuring confidentiality can help ensure that clients can rely on their advisors to protect their interests and that any information that they disclose will not be revealed without As well, by ensuring that advisers can have frank discussions with clients and that clients feel comfortable providing relevant information to their advisers, agents will be more informed about their client situation Will be able to provide better quality patent advice which can lead to higher quality patents, while privilege can be protected through national legislation, the patent system is global in nature, once confidential information is released In one jurisdiction, confidentiality is lost everywhere, given the international scope of this issue, Canada therefore remains of the view that the SCP can provide an important forum to discuss these issues. With this in mind Canada looks forward to further exchanges within the SCP in this regard and supports the proposal by Switzerland to present on the B plus Working Group on client-attorney privilege during SCP 34. Thank you. I now give the floor to the Delegation of Spain and this will be the last speaker for today. Tomorrow it will be possible to make a few more statements at the beginning of the session. Thank you, Mr. Chairman, I shall try and be brief given that time is getting on at I would like to comment that currently the patent law that was adopted in 2015 includes an Article which expressly takes up the notion of confidential confidentiality between patent advisors and their Clients in March 2020, we also adopted the statute of attorneys for IP in which there was the obligation for patent advisors to keep to confidentiality But in the collegial body of agents of intellectual property, it is not obligatory and we want it nevertheless to include some obligations of representatives. The legislation for patents in order to strengthen confidentiality, as I said at the beginning of this session, we are currently reviewing the patent law and it is now intentional Chairperson, to bring this agreement into line as commented by Switzerland in the group. Thank you. The B plus group So we now conclude today's meeting tomorrow, we shall begin at 12: 00 on the dot. This will be our last day's work on our 30th Third session of SCP, we will continue to deal with the issue of confidentiality of communications since some other participants may be To take the floor subsequently, we will move on to item 10, transfer of technology, following which we should look at our future work. Thank you very much for your cooperation and for your participation. I Issue a very pleasant day or a pleasant afternoon or a pleasant evening until tomorrow. Yes, I wanted to ask the regional coordinators Is to come up to the podium so that we can have a small meeting. Thank you. [[powered by WIPO S2T]]