As the U.S. Patent Trial and Appeal Board (PTAB) recalibrates its approach to discretionary denials under Director Squires' leadership, PTAB strategy is becoming harder to predict and more important to get right. This roundtable will examine how the new standards are playing out in practice and what they mean for challengers and patent owners navigating PTAB proceedings.
This session will examine evolving Environmental, Social and Governance (ESG) obligations affecting the life sciences sector, including the revised Urban Waste Water Treatment Directive and its potential cost-allocation consequences for pharmaceutical manufacturers. Participants will explore the new European ESG legislation and discuss how environmental liability exposure, supply chain transparency requirements and new reporting standards are reshaping risk management frameworks and long-term operational planning across the industry.
Ongoing amendments and transitional extensions are continuing to reshape the practical implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) across the EU. This session will outline the latest updates to these legislations and explore the persisting uncertainties and challenges for legal teams managing medical device and IVD portfolios.
Managing IP ownership transfers following cross-border M&A transactions remains an underestimated challenge for many organisations, with ownership errors creating significant hidden risk across global IP portfolios. This roundtable will explore how to manage multi-jurisdictional portfolio transitions efficiently, covering best practices for reducing risk and ensuring compliance during IP ownership changes. Attendees will discuss the operational and strategic challenges in post-acquisition IP integration, and leave with a clearer picture of how to improve visibility, coordination and efficiency in global IP portfolio transitions.
Ketevan Weissflog, LL.M., is Senior Director, Business Development – EMEA at RWS Group, where she advises global organizations and IP law firms on cross-border portfolio transitions, strategic IP management, and complex intellectual property operations.
With more than 15 years in intellectual property, she has supported corporations and IP law firms in navigating multi-jurisdictional ownership changes, post-M&A IP integrations, and global portfolio transitions across patents, trademarks, renewals, validations, and IP recordals.
As a qualified IP lawyer, Ketevan has held several senior leadership roles in international intellectual property operations and portfolio management.
U.S. product liability continues to represent a material litigation risk for life sciences companies, with multidistrict litigation and escalating jury awards intensifying exposure. This roundtable will examine how pharmaceutical and medical device manufacturers are structuring their defence strategy in this space and mitigating against financial reputational damage.
The recent, high-profile Munich Regional Court decision on aflibercept has brought renewed focus to the application of the Doctrine of Equivalents in pharmaceutical patent disputes. The court’s reasoning has significant implications for the scope of protection available to originators and the freedom-to-operate assessments undertaken by biosimilar entrants in crowded, high-value markets. This session will examine the aflibercept decision, its interaction with established German and European equivalence case law and its potential consequences for generic launch and future pan-European injunction proceedings.
This roundtable will examine the legal and strategic implications of the EU SPC manufacturing waiver, focusing on its “safe harbour” role in enabling export and day-one EU market entry while reshaping originator exclusivity planning in the final phase of IP protection. Participants will assess notification requirements, stockpiling constraints and enforcement exposure, considering how originators and generics are adapting to core challenges and shifting strategies in response to new legislation and case law.
Laila Beynon is Director, Dispute Resolution at Regeneron, responsible for the strategic co-ordination of ex-US patent litigation. She has a PhD in Biochemistry/Molecular Biology, 10 years’ private practice experience in life sciences patent litigation at Herbert Smith Freehills LLP, and prior to her role at Regeneron headed up the Patent Litigation team at BAT.
As scrutiny of inventive step and sufficiency intensifies in Europe under evolving EPO and UPC practice, originators face growing pressure to substantiate broad antibody claims with a credible technical contribution and sufficient data at the point of filing. This pressure is further reinforced post-Amgen v. Sanofi (2023) in the U.S., where the enablement doctrine has tightened the boundaries for broad antibody claims.
This session will examine the core IP challenges in the antibody and biologics space, placing recent high profile European and U.S. case law in the context of practical strategies you can deploy to secure broad and robust protection for biological molecules.
- Are broad functional antibody claims in the U.S. still defensible post-Amgen v. Sanofi (2023)?
- What impact has the landmark UPC Court of Appeal decision in Amgen v. Sanofi & Regeneron (Nov 2025) had on antibody claims in Europe?
- How is inventive step for antibodies being assessed currently by major patent offices, including USPTO, EPO, JPO and CNIPA?
- Is the presumption of obviousness of antibody inventions at the EPO justified? - How does the notion of “routine methods” impact antibody patentability?
- How much data do you need in a patent application to demonstrate inventiveness?
- Is there a middle ground between broad, functionally defined claims and narrowly defined sequence claims?
- How can you curate an antibody development and IP strategy that is adaptable to a changing prior art and reference antibody landscape?
Anish Desai is a first-chair trial lawyer who leads complex competitor life science and technology cases in federal district courts, the U.S. International Trade Commission, the U.S. Court of Appeals for the Federal Circuit, the Patent and Trial Appeal Board, and in arbitration proceedings. IAM Patent 1000 described Mr. Desai as a “smart attorney who is excellent at simplifying technical detail for judges and juries and great on his feet,” while Chambers USA notes that he “provides thoughtful, strategic advice” and “is excellent in court and a rising star; he is the next generation” in the patent litigation area.
Richard Page is a European Patent Attorney and a UPC Representative, specialising in life science patents. Drawing on his solid technical background as a researcher in the UK and Germany and fourteen years of IP experience, he advises clients across a broad range of life science technologies. He has particular expertise in antibody-related inventions, vaccines and second medical uses. Richard has a strong track record in opposition and appeal proceedings before the European Patent Office, and he brings his contentious insights into his drafting and prosecution work to help clients secure strategically robust and commercially valuable patent protection.
Tamaris is a Principal Patent Attorney at Novartis. She has gained extensive experience in pharmaceuticals in her almost ten years at Novartis, as well as from a previous role at a patent law firm in Basel.
She specialises in patent matters relating to antibody technology and cell & gene therapies. She has expertise in patent prosecution and SPC issues, as well as a keen interest in following legal developments in these areas.
Tamaris is both a registered European Patent Attorney and Swiss Patent Attorney. Additionally, she has a background in Australian patent law, having completed a Master of Industrial Property at the University of Technology, Sydney.
Once viewed as a defensive, compliance-driven function, regulatory engagement is increasingly being integrated into broader corporate strategies for long-term product protection. In the context of MFN initiatives and intensifying commercial pressures, regulatory tools are becoming an important strategic lever for shaping market entry and influencing pricing dynamics, bringing regulatory activity into closer alignment with IP, competition and commercial decision-making.
Using FDA citizen petitions as a case study, this session will examine how often underutilised regulatory mechanisms can be deployed to influence market access and shape competitive positioning, and explore how these engagement tools intersect with IP strategy and antitrust risk.
- How are companies using regulatory tools, such as FDA citizen petitions, to complement IP strategy and support long-term product protection?
- To what extent can regulatory mechanisms be deployed to influence generic market entry without crossing the line into anti-competitive conduct?
- How does the timing and sequencing of regulatory interventions dictate competitive outcomes and antitrust exposure, particularly in the context of generic and biosimilar entry?
- How do regulatory strategies that influence competitive entry translate into pricing dynamics and broader market access outcomes?
- How are regulators, courts and competition authorities assessing and responding to the use of regulatory tools, such as citizen petitions?
Ha Kung Wong has over 20 years of experience practicing general intellectual property law with an emphasis on complex patent and trade secret litigation as well as IP transactions and contract negotiations for mergers, acquisitions, and collaborations in pharmaceuticals, biologics, and chemistry. Cases Mr. Wong has litigated include those related to proton pump inhibitors, allergy eye drops, anti-epileptic drugs, anti-tussive, injectable microspheres, RNAi products, and other pharmaceuticals. Mr. Wong also has extensive experience with Inter Partes Review, Post Grant Review, intellectual property counseling, pharmaceutical regulatory counseling, pre-suit investigations, licensing, and due diligence.
Mr. Wong has his BS with high distinction in Chemistry and his BS in Biochemistry from the University of Illinois Urbana-Champaign and his JD, cum laude, from the University of Notre Dame. Mr. Wong is currently an elected member of the Venable Board, is an Advisory Board Member for the Center for Biosimilars, is Treasurer, Executive Committee member, and Board Trustee for the Foundation for Advancement of Diversity in IP Law (FADIPL) and serves as faculty for the National Institute of Trial Advocacy (NITA) and Lawline.
In the modern era of AI-driven in silico approaches for target selection and lead compound identification, companies must navigate nuanced and unresolved patentability issues, centred on inventorship, disclosure, novelty and non-obviousness. In parallel, regulatory agencies are scrutinising AI algorithms, data provenance and transparency within MA dossiers. To combat this, companies must tightly align their IP and regulatory strategies to secure defensible IP and exclusivity positions for their AI-assisted inventions.
This session will address the key unanswered questions surrounding AI patentability and examine the strategies available to you for securing comprehensive patent protection and straightforward regulatory approval for your latest AI-assisted inventions.
- Should you disclose the use of AI in generating a lead compound on a patent application?
- What are the potential consequences of not disclosing AI use for downstream litigation?
- How are patent offices evaluating key issues around inventorship, disclosure, novelty and non-obviousness for AI-assisted inventions?
- How are regulatory authorities handling AI use during drug discovery processes?
- How should patent drafting strategies for AI-assisted invention be shaped to align with downstream regulatory requirements?
- To what extent should human decision-making be documented during the AI-assisted drug discovery process?
- How and to what extent should IP and Regulatory leads brief R&D teams on their use of AI?
Daphné DEROUANE is a qualified European Patent Attorney and holds a Ph.D. in Organic Chemistry from UCLouvain in Belgium. She has over 25 years of experience as in-house patent counsel in industry. Currently, she serves as Associate General Patent Counsel at UCB Biopharma in Belgium, where she leads the IP support for the Research Organization.
Her expertise encompasses defining the overall IP strategy of UCB’s early-stage assets and technologies, patent drafting & prosecution, providing freedom-to-operate opinions, and the negotiation of a variety of agreements. She also closely monitors external IP developments which are relevant to the pharmaceutical industry to ensure the UCB IP strategies remain fit-for-purpose.
Frank Landolt is Chief Counsel, Intellectual Property and Legal at Confo Therapeutics, a privately held biopharmaceutical start-up based in Ghent, Belgium specializing in GPCR-targeted therapeutics.
After studying chemistry and law at the University of Leiden in the Netherlands, Frank worked for almost ten years on pharmaceutical and biotechological patents and licensing in private practice in the Netherlands, where his clients included major pharmaceutical companies as well as some of the top biotech firms and research institutions in the Netherlands.
Prior to joining Confo in 2018, Frank worked for fifteen years in Ablynx N.V. (now a wholly owned Sanofi company), where he was a member of the management team and headed an integrated IP and legal group of four lawyers and five patent professionals. At Ablynx, Frank was involved in negotiating Ablynx’s strategic partnerships and licensing deals with AbbVie, Boehringer-Ingelheim, MSD, Merck-Serono, Novartis, Novo Nordisk, Sanofi and Wyeth.
From 2000 to 2004, Frank was director of IP and legal counsel at Devgen N.V. (now part of Syngenta), another Ghent-based biotechnology company, where he was involved in negotiating Devgen’s strategic collaborations with Sumitomo, Monsanto and DuPont Pioneer.
Frank is a Dutch and European patent attorney, and also holds a degree in business law from the University of Antwerp. He is a member of the Dutch association of patent attorneys (where he is a tutor for the professional qualification course), EPI and LES Benelux (where he is involved in the LES Licensing Course). He is a regular speaker on a range of topics relating to IP and licensing in the (bio)pharmaceutical sector. Frank was named as one of Managing IP’s ‘Corporate IP stars’ for four years in a row (2015-2018).
Dr. Keisha Hylton-Rodić is a U.S. patent attorney and Founder of Hylton-Rodic Law, an IP boutique based in Washington, D.C. She holds a Ph.D. in Organic Chemistry and is registered to practice before the United States Patent and Trademark Office (USPTO).
Dr. Hylton-Rodić advises European and global life sciences companies on navigating the complexities of U.S. patent law with precision and efficiency. Her practice focuses on strategic IP portfolio development and optimization for biotech and pharmaceutical innovators—helping clients build, protect, and leverage their U.S. and international patent assets.
She regularly counsels clients on freedom-to-operate analyses, API clearances, due diligence, patentability, infringement, and validity assessments, with a pragmatic approach that aligns with commercial objectives and regulatory realities.
Her technical expertise spans small molecules, biologics, formulations, and delivery systems—including injectables, inhalation forms, transdermals, and oral dosage technologies—as well as related materials and manufacturing chemistry.
What sets Hylton-Rodic Law apart is its combination of deep scientific understanding, U.S. regulatory insight, and partner-level responsiveness—delivering the caliber of representation expected from large U.S. firms, with the agility and cost-efficiency of a focused boutique.
Specialties: U.S. patent strategy and prosecution, portfolio management, due diligence, freedom-to-operate and risk mitigation, infringement and validity opinions, life sciences IP, biotechnology, pharmaceuticals.
Wouter Mooij is Head of Chemistry & Life Sciences at De Vries & Metman. He oversees the prosecution of patent portfolios covering small molecule therapeutics, drawing on his background in medicinal chemistry and his extensive experience in patent litigation. His clients range from early‑stage spin‑outs to global pharmaceutical companies. Wouter brings a practical, strategic perspective to this panel on AI‑discovered therapeutics.