Baianat Intellectual Property’s Post

💊 𝗖𝗝𝗘𝗨 𝗖𝗹𝗮𝗿𝗶𝗳𝗶𝗲𝘀 "𝗙𝗶𝗿𝘀𝘁" 𝗠𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗦𝗣𝗖 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 In its 16 July 2024 decision, the Court of Justice of the European Union ruled that the earliest Marketing Authorization (MA) granted for a product, even if withdrawn, is decisive in Supplementary Protection Certificates (SPCs). The chronological order of MAs for the same product is crucial when applying for an SPC. ⚖️ This ruling carries significant implications for pharmaceutical companies navigating patent extensions in Europe. 🔍 Discover how this landmark decision impacts SPC interpretation in the compelling article by our partner, Fernand de Visscher, and associate Marie-Ysaline Lannoye. Dive into the details here: https://lnkd.in/eT_rtJiT 📧 Further questions or need for guidance on patent and SPC protection? Don’t hesitate to reach out our experienced team : IP@simontbraun.eu   #IntellectualProperty #SPC #Pharma #PatentLaw #CJEU #Marketingauthorization

🚀 Fovea IP now offers patents on its global intellectual property data in a single platform. With data from over 170 authorities, we provide the largest collection of patent information available.  Discover how Fovea IP can help you with your IP needs. Request your free trial today by clicking this link:  👉 https://lnkd.in/et7QyY7g #intellectualproperty #IP #patents #trademarks #designs #domainnames #pharmainuse #pharmaceuticals #lighthouseip #innovation #freetrial #IPdata

Make sure to secure your place at Maiwald Intellectual Property's upcoming free masterclass (https://lnkd.in/d4GCi4fp), taking place on 27 November 2024 at 2pm UTC. Themed around the SPC waiver, Marco Stief, one of Europe’s most prominent experts and litigators in the field of SPC, will address the following: - The scope of application of the SPC waiver - Requirements to be met by generics and biosimilars companies in order to be able to rely on the SPC waiver - Recent German and Dutch case law on the topic There is much legal uncertainty and many potential pitfalls attaching to the application of the waiver, with recent court decisions from Munich and The Hague only complicating the matter further instead of clarifying it. This session will discuss key aspects of the SPC Waiver Regulation and will also include a discussion of recent case law in the Netherlands and Germany. #SPCWaiver #Pharmaceuticals #LifeSciences

Excellent reporting by Investigate Europe’s Maxence Peigné on how pharmaceutical companies have turned the patent system into a system of exploitation for maximising profits at the expense of the public. First, drugmakers game the patent system to amass patents and extend their monopolies far beyond what the patent system intended. Then, they harbour their IP portfolios in tax havens, diverting what would otherwise be taxes to their shareholders. This is the actual kind of "innovation" a hyper-financialised medicines system promotes. https://lnkd.in/e8Nq5GSE

Lowenstein Life Sciences and Chemical Patent Chair Robert Paradiso explores U.S. patent law and exclusivity in the pharmaceutical industry in IAM, offering essential guidance for senior life sciences executives navigating patent prosecution, regulatory hurdles, and exclusivity requirements in order to protect significant investments in drug development. Read the full chapter: https://bit.ly/4eImD6Q Read Robert’s bio: https://bit.ly/3KXbnWu #lifesciences #patentlaw #iplaw #intellectualproperty #lawyers

At the core of the legal challenge was the existing process, which resulted in a time gap between the grant of a patent and the issue of the patent certificate. The court held that the date of the grant of a patent is the date on which the controller passes an order to that effect on the file i.e. on the day in which the Controller makes a decision to grant a patent. The issue of a certificate at a later date is then nothing more than a mere formality. The court also came down strongly against the practice of filing serial pre-grant oppositions. through aliases, a practice now fairly common in most pharmaceutical patent cases. Therefore, the decision taken by the Controller on the file is the determining event for ascertaining the date of grant of patent and the acts of sealing of the patent and entering the same in the Register are ministerial acts evidencing the grant of patent. #caselaw#Trademarkinfrigment #copyrighinfringement #newcaselaw #legalservices #Navkarassociates #Ipr #Adv.vijaysoni#Adv.namratajain

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

What kind of tactics do pharma companies use to delay or limit generic competition? --- Last week, the Senate Committee on the Judiciary dove into the various ways #pharma utilizes the patent system to delay or limit #GenericDrugs (article in the comments). The primary tactics discussed: -Pay-for-delay = pay generic drug manufacturers to delay entry into the market -Product hopping = move the patent from an old drug version to a new one -Patent thickets = overlapping network of patents that generic drug manufacturers have to navigate for entry -Sham citizen petitions = requests submitted to the FDA to interfere with a generic application -Improperly listing patents = listing updated or new #patents in the Orange Book to extend patent expiration --- The committee has already passed bills addressing most of these specific tactics (exact bills in the second link in the comments) Including establishing a task force between the Patent and Trademark Office and the FDA to better share information and collaborate. However, none of these have received a full Senate vote yet. --- We know there's a balance here between innovation and stifling competition. Would these bills improve the balance? Or impede innovation too much to be worth the benefit?

🔴 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

In today's highly regulated industries like pharmaceuticals, biotech, and healthcare, maintaining compliance with 21 CFR Part 11 is paramount. This regulation sets the standards for the use of electronic records and signatures in FDA-regulated environments, ensuring data integrity, security, and authenticity. https://lnkd.in/gmFxzyXa #FDACompliance #RegulatoryCompliance #ElectronicDocumentation #DataIntegrity #DigitalSecurity #PharmaRegulation #BiotechCompliance #HealthcareTech #DigitalTransformation #eSignature #QualityAssurance