Vondst Advocaten’s Post

🔬 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 Nadège Beynon, Sophie Skidmore #CMSlaw #intellectualproperty #clinicaltrials #patentlaw

Join me and my Goodwin colleagues Emily Rapalino, Molly Grammel, Madeline Bordynoski, and Olivia D. Uitto, Ph.D, J.D. as we explore The Fate of the Therapeutic Dosing Regimen! Pharmaceutical patents often claim methods of administering a therapeutic according to a specific dosing regimen, and the validity of these therapeutic dosing regimen claims have been challenged at the district courts and at the US Patent Trial and Appeal Board with mixed results. This #webinar analyzes the state of the law in district courts, the Federal Circuit, and at the PTAB regarding validity of patents claiming therapeutic dosing regimens. Join us as we discuss the trends and analyze relevant decisions across forums over the past several years and identify considerations for patent drafting and patent challenges involving dosing claims. Register at the link below! #iplaw #patentlaw #iplitigation #pharma #genericdrugs #biosimilars #cle

The latest ‘year in review’ publication from our pharmaceutical industry group provides insight and discussion on some of 2023's major developments in pharmaceutical patent law in Australia, ranging from the Sanofi Commonwealth damages judgement to Sandoz v Bayer, the ToolGen CRISPR patent dispute and patent term extensions.   Head of Spruson & Ferguson Lawyers, Katrina Crooks, notes that "We continue to see pharmaceutical patent cases making their way to trial, and legal issues which have seen recent attention, such as the validity of patent term extensions and the best method requirement, show no let up with a number of these cases currently before the Courts."   Read the report to ensure you’re across the latest developments in Australia, and reach out to our IP legal experts for advice or assistance. Authors: Katrina Crooks, Andrew Rankine, Elizabeth Barrett, Daniel Sieveking, Duncan Longstaff, Michael Christie, Lucy Hartland, Fiona Deng, James Beckett #pharmaceutical #patents #patentlaw #IP #IPlaw https://lnkd.in/gMscCD9q

For a global analysis of the regulatory compliance landscape around scientific and medical communications, read our cross-border team’s chapter in the International Comparative Legal Guide – Pharmaceutical Advertising Laws and Regulations 2024. In this chapter, attorneys Lincoln Tsang, Kellie Branson Combs and Katherine Wang, with contributions from Michael Purcell and Jenny Z., explore recent regulatory developments, as well as the regulators’ perspective. #lifesciences #clinicaltrials Read more here: https://bit.ly/46TwAe4

https://lnkd.in/eTXM5TCv Takeaway: Senators on both sides of the aisle agreed that patent reform is needed to stop pharmaceutical companies from extending patents on minor modifications to products and linked this problem to high prescription drug prices. Witnesses at a Senate Judiciary Committee hearing suggested one way to address patent reform is to have greater coordination between the Food and Drug Administration and the US Patent and Trade Office (USPTO) on patents listed in the Orange Book.

🔍 Mylan Settles Patent Litigation with Novo Nordisk Over Generic Ozempic 💊 In a significant development in the pharmaceutical industry, Mylan has reached a settlement with Novo Nordisk regarding the patent litigation over the generic version of Ozempic, a medication widely used for diabetes management and weight loss. This settlement paves the way for increased access to affordable medication for patients in the United States. As the demand for diabetes treatments continues to rise, this resolution highlights the ongoing challenges and complexities within pharmaceutical patent law and the importance of ensuring that vital medications are accessible to those in need. For more insights into this landmark settlement and its implications for the healthcare landscape, read the full article in Financial Express. 👇 Sushmita Panda Sakshi Kuchroo Sumana Sarkar NATCO Pharma Roshun Povaiah Syed Fazal Bari #Pharmaceuticals #Healthcare #PatentLitigation #Ozempic #Mylan #NovoNordisk #GenericDrugs #HealthcareAccess #FinancialExpress

Join Life Sciences expert Alison Dennis at the Informa Connect Life Sciences's EU Pharmaceutical Law Forum 2024 on 22 May.   Alison will be joining a panel discussion with George Pickering and Beverly Rubin, sharing insights through discussion of a case study which will cover: ◾ Why sponsors might choose to conduct a study on a decentralised basis.   Regulatory frameworks and guidance for decentralised, direct to patient clinical trials in the EU and USA. ◾ Privacy considerations including data flows and management, issues of privacy and consent, including e-consent. ◾ Practical legal considerations: from remote pharmacy to the provision of solutions by providers.   #LifeSciences #DigitalHealth #PharmaceuticalIndustry #Medicines #DecentralisedClinicalTrials #MedicalDevices #ClinicalTrials 

With 100+ attendees who have now secured their pass to the EU Pharmaceutical Law Forum 2024, make sure you get yours before they run out! 📅 21-23 May 📍 Steigenberger Wiltcher's, Brussels 📜 Accredited with 18 IJE Points 💲 Save £200, Book By April 19th 🌐 https://bit.ly/3NWNEYe This is your chance to attend Europe's #1 Pharmaceutical Law hub, and get your essential policy and regulatory updates, along with networking with the who's who of pharma law. Also, our event is now accredited with 18 IJE points for you to claim as an attendee. Once signed up, we'll handle all the admin, and you'll automatically receive your points post-event. Along with our expert lineup of speakers from the biggest hitters in EU Law such as the EU Commission, EMA, and European Parliament, we also have attendees from Pharma/Biotech and Legal powerhouses. Sign up today to join the likes of Johnson & Johnson, Teva, Fresenius, GSK, BioNTech, Jazz Pharmaceuticals, Novartis, Pfizer and over 100 more! https://bit.ly/3NWNEYe #eupharmaceuticallaw #eupharma #eucommission #pharmaceuticals #pharmaceuticalindustry #pharmaceuticallaw #pharma #pharmalaw #informa #informaconnect #pharmaregulations #reguationsandcompliance #competitionlaw #spcs #regulatoryframeworks #conference #event #hybridevent #hybridconference #brussels

Patent Thickets Won’t Be Stopped Until FDA and USPTO Collaborate Better, Say Senators and Experts: Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. #fda #financial #lifesciences

Novo Nordisk has long dominated the GLP-1 receptor market, but as generic competitors challenge their patents, the stakes are higher than ever. In his recent article for Law360, Pedram Sameni—Patexia’s CEO and an expert in the intellectual property landscape—delves into Novo Nordisk’s legal defense strategies, focusing on ANDA litigation, patent challenges, and the risks in this multibillion-dollar battle. 💡 Key Takeaways: ◾ With 37 patents protecting blockbuster drugs like Ozempic and Wegovy, Novo Nordisk is under mounting legal pressure as the Type 2 diabetes and obesity treatment market expands. ◾ Competitors like Viatris and Sun Pharma are using ANDA litigation and IPR filings to challenge patent validity, which could reshape the market landscape. ◾ A loss could mean billions in revenue, with up to 70-80% of market share slipping to generics within the first year of their entry. 📖 To uncover the legal strategies behind one of the most significant pharmaceutical battles of today, read the full article. #PatentLaw #ANDA #IPR #Pharmaceuticals #NovoNordisk #LegalInsights #IPTrends #PatentLitigation