What’s in a name? The use of product or sponsor codes in clinical trial related documents is common practice in the pharmaceutical space. However, such codes may not always be sufficient to disregard a publication as relevant prior art against patent claims. Sophie Skidmore and I review recent EPO Board of Appeal decision T 1255/21, in which the Board finds that the use of a product code or sponsor code for a compound or composition in a clinical trial protocol does not affect the status of the protocol as prior art if the skilled person would have been able to identify the compound or composition based on the description of the components of the product code in the protocol combined with their common general knowledge. This was the case despite the product code not being directly equated to a particular compound or composition in the art. Find out more here: https://lnkd.in/ewAqV_wc #patents #clinicaltrial #intellectualproperty #EPO #lifesciences #healthcare #CMSlaw
Nadège Beynon’s Post
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Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial. At a time when the European Medicines Agency (EMA) is requiring increased transparency for EU clinical trials, this case law is of increasing importance to those operating in the pharmaceutical space. In brief, this decision further supports the position that the disclosure of a clinical trial protocol does not always mean there is a reasonable expectation of success of achieving treatment. Find out more here: https://lnkd.in/gk4ir7g9 If you have any questions, contact Nadège Beynon and Sophie Skidmore #CMSlaw #law #ip #intellectualproperty #patents #cmspatentattorneys #lifesciences #healthcare
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In a recent article, Sophie Skidmore and I review recent EPO Board of Appeal decision T 1437/21 in which the Board found that positive phase III clinical trial results did not provide a "reasonable expectation of success" for the claimed sub-population of patients. This decision now sits among a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial. https://lnkd.in/gk4ir7g9 #patents #intellectualproperty #EPO #lifesciences #clinicaltrial
Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial. At a time when the European Medicines Agency (EMA) is requiring increased transparency for EU clinical trials, this case law is of increasing importance to those operating in the pharmaceutical space. In brief, this decision further supports the position that the disclosure of a clinical trial protocol does not always mean there is a reasonable expectation of success of achieving treatment. Find out more here: https://lnkd.in/gk4ir7g9 If you have any questions, contact Nadège Beynon and Sophie Skidmore #CMSlaw #law #ip #intellectualproperty #patents #cmspatentattorneys #lifesciences #healthcare
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Useful article on inventive step when navigating prior art clinical trial disclosures. The comments from Board 3.3.08 in T3165/19 in the antibody space also support that the SKP can be dissuaded from the expectation of success by the prior art where an active is being tested in a clinical study (Reasons 22). https://lnkd.in/eWNwPrtb #EPO #antibodies
Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial. At a time when the European Medicines Agency (EMA) is requiring increased transparency for EU clinical trials, this case law is of increasing importance to those operating in the pharmaceutical space. In brief, this decision further supports the position that the disclosure of a clinical trial protocol does not always mean there is a reasonable expectation of success of achieving treatment. Find out more here: https://lnkd.in/gk4ir7g9 If you have any questions, contact Nadège Beynon and Sophie Skidmore #CMSlaw #law #ip #intellectualproperty #patents #cmspatentattorneys #lifesciences #healthcare
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🔴 BREAKING NEWS 🔴 UK Courts Revokes Bayer's Rivaroxaban Patent - A Triumph for Generics! In a significant victory for generic pharmaceutical companies, the UK courts have revoked Bayer's patent on Rivaroxaban, a widely used anticoagulant. This decision marks a pivotal moment in the realm of intellectual property rights and accessibility of healthcare. The revocation of Bayer's patent opens the door for generic versions of Rivaroxaban to enter the market, potentially leading to increased competition, affordability, and accessibility of this crucial medication for patients worldwide. This landmark ruling underscores the importance of a balanced approach to patent law, ensuring that innovation is incentivized while also safeguarding public health and promoting fair competition. At Signicent, our dedication lies in propelling forward the healthcare sector and intellectual property landscape. Therefore, we wholeheartedly commend this decision as a significant stride towards realizing these objectives. Read more about the ruling here: https://lnkd.in/gjT3WJg6 #Healthcare #PatentLaw #GenericMedicines #Innovation #AccessToMedicine #UKCourts #Bayer #Rivaroxaban #PharmaceuticalIndustry #Signicent #Patents #Intellectualproperty
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📢💡 The next edition of 𝐃𝐁𝐒 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 𝐋𝐞𝐠𝐚𝐥 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 – a subjective review of European and Polish life sciences law news prepared by DBS Lawyers – is now available. ✅ This time we present the latest CJEU rulings on the revocation of provisional measures and access to personal data, a summary of the enforcement of EU competition law in the pharmaceutical sector, as well as the latest changes to Polish law on pharmacy acquisitions. Click below for more details. Enjoy reading! ⤵ #pharmaceuticals #healthcare #lifescience #DBSlawfirm
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📣 We are pleased to introduce Calavros Law Firm - Filios - Kloukinas, a renowned Greek law firm among the #LCF Gold Partners! In this all-female panel, the partner Ioanna Vergeti will moderate the session “𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐚𝐛𝐮𝐬𝐞 𝐨𝐟 𝐝𝐨𝐦𝐢𝐧𝐚𝐧𝐜𝐞 𝐢𝐧 𝐭𝐡𝐞 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐚𝐧𝐝 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬 𝐬𝐞𝐜𝐭𝐨𝐫 𝐢𝐧 𝐭𝐡𝐞 𝐆𝐫𝐞𝐞𝐤 𝐉𝐮𝐫𝐢𝐬𝐝𝐢𝐜𝐭𝐢𝐨𝐧” with the participation of Angeliki Rousaki and Iris Ntolaptsi. They will explore the intricate nuances of the Greek legal landscape, with a focus on the pharmaceutical and medical device sectors. Addressing the conflicting approaches of public and private enforcement, they will examine cases involving refusal to supply and parallel export restrictions. Ensure you don't miss this interesting discussion! 👉 Register at https://bit.ly/45K205b and take advantage of the 𝐄𝐚𝐫𝐥𝐲 𝐁𝐢𝐫𝐝 𝐨𝐟𝐟𝐞𝐫 until 𝐉𝐮𝐧𝐞 𝟐𝟖𝐭𝐡. Stay tuned for updates at https://bit.ly/3no2Rah #LCF24 #festival #antitrust #regulation #economics #Calavros #pharmaceutical #abuseofdominance #medicaldevice
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Having a submission blueprint for EU CTR, MDR or IVDR ensures your clinical trial is on the most direct route to regulatory approval. Our whitepaper demystifies EU regulations with case studies and graphics to help you develop your study’s strategy. Get clarity and avoid delays by downloading it here. https://ow.ly/2TEK50TNlgL #regulatoryaffairs #regulatory #regulatorycompliance #pharma #biotech #clinicaltrials #medicaldevices #combinationproducts #europeanmedicinesagency #lifesciences #EUCTR #MDR #IVDR #invitro #EUClinicalTrialRegulation #ClinicalResearch
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As healthcare costs continue to soar, the issue of rising drug prices is a pressing concern for patients, providers, and policymakers alike. The authors delve into the complex world of patent law, pharmacy benefit managers, and regulatory initiatives at the federal and state levels. They also explore some of the innovative approaches being taken to increase transparency and accountability in drug pricing. With so much at stake, policymakers face significant challenges as they seek to balance the needs of patients and the interests of the pharmaceutical industry. Stay informed and engaged on this critical issue! If you're looking for a comprehensive overview of the legal and legislative landscape impacting drug costs, this article is a must-read. Read more here: https://lnkd.in/dPJpgXVk #DrugCosts #HealthcarePolicy #PharmaceuticalIndustry #PatientAccess #HealthcareInnovation
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Life Science Law invites you to join our latest Webinar, please register on the link below to save your spot. Topic: Marketing of Pharmaceutical Drugs & Interactions with Healthcare Professionals in a Digital Era https://lnkd.in/djcc2fiW 📅 Date: Friday, 12th April 2024 ⏰ Time: 12pm (GMT) 🎙️ Co-Speakers: Wendy, Founder & Samantha, Senior Legal Consultant Join us to unravel: ◾ How interactions are sought. ◾ How consent is obtained and documented. ◾ Ensuring content remains of a high standard and is relevant. ◾ The volume of communication is appropriate. Get in touch! Is there an aspect of this subject that you would like covered? What would you ask Wendy and Samantha? Let us know. #webinar #industryinsights #pharmamarketing #healthcare
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📣 Register to our webinar: Drug Device Combinations in the EU & Article 117 👉 Register here: https://lnkd.in/ehY3ZBTY 📅 November 26, 3PM CET Are you planning to submit your Drug Device combination as a medicinal product in the EU? How to address the Medical Device part? What is Article 117 of the Medical Device Regulation and how to use it? Eline Dirven and Tom Manussen will guide through the most important aspects to support you with a successful registration of your Drug Device combination. Save your spot now to our monthly Zwiers Regulatory Consultancy BV, a ProductLife Group company, webinar: #pharma #drug #medicaldevice #drugdevice #healthcare #webinar #lifescience #regulatory #compliance
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