Monika Lazickaitė’s Post

🚀Get ahead of the curve and ensure your CASP business is primed for MiCA licensing. Dive into our engaging self-questionnaire to assess your readiness and equip your business for seamless licensing under the new regulations. 📝 Let's pave the way to regulatory excellence together! 🛣 Why Take the MiCA-Ready Self-Questionnaire? 📋 Stay Ahead of Regulatory Changes: By completing this self-questionnaire, you can proactively assess your CASP's readiness for MiCA licensing, ensuring compliance with the latest regulations. 🔍 Identify Gaps and Areas for Improvement: The questionnaire will highlight any potential gaps in your current practices, allowing you to address deficiencies and strengthen your regulatory framework. 🤝 Enhance Trust and Credibility: Undertaking this assessment demonstrates your commitment to regulatory compliance, and building trust with customers, partners, and regulators. 🌱 Prepare for Future Growth: By evaluating your readiness for MiCA licensing, you can position your CASP for sustainable growth in a rapidly evolving regulatory landscape. Take the first step towards MiCA compliance and regulatory excellence by engaging with our self-questionnaire today. ✅ 📧 To receive Meta Guards UAB comprehensive self-assessment Questionnaire, please provide your email address, and we will promptly send it to you.

🚀 To receive Meta Guards UAB comprehensive MiCA self-assessment Questionnaire, please send a DM to Gabija V. with your email address, and we will promptly send it to you.🚀 #mica #micar #casp #regulations

ACMA/Australia has opened a new consultation: Proposed new framework for licensing radio navigation-satellite service retransmission technologies. Submissions close at 5 pm (AEST) on Wednesday, 17 July 2024.  https://lnkd.in/gjgyQ2Tp #typeapproval #compliance #Regulatory #GMA #homologation #ACMA #Australia

Navigating the complex regulatory landscape of SaMD development can be daunting. With over 60% of SaMD projects encountering regulatory delays, understanding the regulatory requirements is crucial for success. But where to start? Swipe through to uncover the key regulations you must master for successful SaMD development! 👉

Are you trying to determine how strong your #patent is? Find out how AcclaimIP's Patent Scores can support your decisions through this new blog: https://bit.ly/3UPF8yA

What is #patent scoring and how can it guide your IP decisions? Learn how AcclaimIP determines patent scores to help your evaluation and analysis. #patentability #patentpruning https://bit.ly/3NTrC8L

Preliminary measures were denied by the Local Division The Hague of the UPC regarding Abbott’s EP283 patent on a continuous glucose monitoring device in a judgement of 19 June 2024 in proceedings against Sibio: https://lnkd.in/gkXb4dEX Noteworthy seems in particular that the Court wholeheartedly embraced the so-called “gold standard” disclosure test of the Boards of Appeal of the EPO for added matter. That test and case law was also relied upon by the parties, but the Court held no reservations, also noting that it is also the standard used in many Contracting Member States of the UPC.  Claim 1 was found to be the result of an unallowable intermediate generalization. In that context the Court held that for intermediate generalization to be considered allowable (in the sense that it does not result in added matter), it should be (clearly) established that there is no structural and functional relationship between the omitted feature and the other features incorporated into the claim.    The Court did not rule on whether it has international jurisdiction regarding Ireland because Abbott dropped that claim during the hearing. Abbott was ordered to pay the legal costs and other expenses incurred by Defendants in these preliminary proceedings – instead of awaiting the outcome of proceedings on the merits – because the Court argued that even if the Abbott were to be successful in the proceedings on the merits, it will still have to bear the costs of these proceedings as the unsuccessful party.    On the same day the Court granted Abbott provisional measures against the same parties for its related patent EP879 because of breaches of a unilateral cease-and-desist-declaration: https://lnkd.in/gAKgu8-f For case law on provisional measures (article 62 UPCA): https://lnkd.in/eRxmF8gp   #upc, #upcnugget

🔍 First decisions by the UPC confirm a sober, fresh look at patent validity. Lessons on claim interpretation and priority determination are key takeaways. #UPC #PatentValidity #ClaimInterpretation #PriorityDetermination

Struggling with regulatory submission challenges? Check out our latest blog posts on regulatory operations and eCTD publishing to gain valuable insights and accelerate your submission success. Learn more: http://ow.ly/2J7P50OvHhz

The Council of the EU adopted its position on the Regulation for compulsory licensing for crisis management. The negotiating mandate: ➡ Defines the scope of the Regulation ➡ Re-formulates the decision-making procedure ➡ Strengthens the rights of rights-holders ➡ Curtails the number of legislative acts that could lead to the issuance of compulsory licenses The compromise text formalizes the Council's negotiating position, providing the Council presidency with a mandate for negotiations with the European Parliament > https://hubs.li/Q02DRtT30 #Pharma #Medtech