Pharma Symposium 2026
Pharma Symposium 2026
Pharmaceutical, Biotechnology and Chemical Patents: U.S., Europe, China and India
An intensive, advanced-level symposium on the legal and strategic forces reshaping global pharmaceutical IP, from AI-driven drug discovery and patent cliffs to biosimilar litigation and cross-border enforcement. Two days, eight expert-led sessions, held across two cities.
Global pharmaceutical IP: key trends, challenges, and strategic considerations
The global pharmaceutical industry is witnessing unprecedented change, driven by increasingly complex patent landscapes, evolving regulatory exclusivities, biosimilar competition, artificial-intelligence-driven drug discovery, and major legislative reforms across key markets.
As pharmaceutical innovation becomes more globalized, companies must navigate a sophisticated interplay of patent rights, regulatory protections, litigation risks, and commercialization strategies across multiple jurisdictions. For Indian pharmaceutical companies, understanding developments in the United States, Europe, and China is no longer optional: it is critical for successful global product development, market entry, lifecycle management, licensing, investment, and dispute resolution.
This intensive, advanced-level symposium has been designed specifically for experienced pharmaceutical IP professionals, in-house counsel, patent attorneys, R&D leaders, regulatory experts, and business executives who seek practical, commercially relevant insight into the latest global developments affecting pharmaceutical innovation and market exclusivity. Through expert-led sessions, comparative legal analysis, and real-world case studies, participants, including innovators, generic manufacturers, biosimilar developers, and investors, will gain a strategic, comprehensive understanding of the evolving pharmaceutical IP ecosystem and its implications.
"AI, patent cliffs, and biosimilar litigation are reshaping the pharmaceutical IP landscape. This symposium brings together the practitioners navigating it first-hand."
Highlights and who should attend
The sector is under growing pressure on multiple fronts. This symposium addresses the critical legal and strategic insight needed for sustained innovation and market leadership.
The sector faces increasing pressure from
- Intensifying generic and biosimilar competition
- Higher patent invalidation rates in major jurisdictions
- Increased scrutiny of pharmaceutical patent quality
- Growing reliance on regulatory exclusivities
- AI-driven innovation disrupting traditional drug discovery models
- Expanding biologics and advanced-therapy markets
- China's emergence as a major pharmaceutical innovation hub
- Cross-border patent enforcement and litigation complexities
Who should attend
- IP and patent management teams
- R&D scientists and technical experts
- Patent agents and practising patent attorneys
- IP and pharmaceutical litigators
- Legal and business professionals in the pharma, biotech, and chemical sectors
Session outline
Two full days of practical, case-led sessions. Day 1 is a deep dive into U.S. patent strategy; Day 2 turns to the Europe, China, and India perspective.
U.S. Pharmaceutical Patent Litigation: 2025 to 2026 developments, decisions, and trends
The U.S. pharmaceutical patent litigation landscape has undergone consequential shifts over the past two years, driven by landmark Supreme Court and Federal Circuit decisions, evolving Hatch-Waxman and ANDA practice, and intensifying antitrust scrutiny of brand-name lifecycle strategies. A rigorous, current account of where U.S. pharmaceutical patent litigation stands today.
Part 1: Litigation landscape, filing, settlement, and decision trends (2025 to 2026)
- Statistical overview of ANDA and biologic litigation filing, settlement, and trial trends
- District court forum dynamics
- Settlement structures: at-risk launch trends, authorized generic economics, and negotiating leverage
Part 2: U.S. Supreme Court and Federal Circuit decisions, practical implications
- Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (U.S. Supreme Court, June 2026): unanimous reversal of the Federal Circuit on whether a skinny label plus public statements constitutes active inducement under 35 U.S.C. Section 271(b); carve-out strategies and practical lessons
- In re Entresto (Fed. Cir. 2025): written description and invalidity developments for drug-combination patents
- Myrbetriq, Astellas v. Ascent (D. Del. 2026): claim construction for an overactive-bladder formulation and the reduced food-effect claim term
- Obviousness based on clinical trial disclosures, and inherency arguments in formulation patents
- AI-assisted prior-art searching in ANDA litigation, and how courts are treating its reliability and scope
Key takeaways
- The Supreme Court's Hikma decision raises the pleading bar for brand-side induced-infringement claims
- Federal Circuit decisions continue to shape litigation strategy
- The FTC's sustained Orange Book delisting campaign signals a new era of antitrust risk for routine lifecycle practices, with antitrust scrutiny after In re Amitiza
The changing post-grant landscape at the USPTO: updates and insights for generic and biosimilar developers
The post-grant challenge landscape at the U.S. Patent Office, spanning inter partes review (IPR), post-grant review (PGR), and ex parte reexamination (EPR), has shifted significantly over the past year and continues to evolve rapidly. This session reviews the key changes, highlights emerging trends, and examines the case law shaping current practice, with practical, up-to-date guidance on deploying post-grant challenges as part of a generic or biosimilar development strategy.
Part 1: How the post-grant landscape has changed this past year
- Recent USPTO policy and rule changes affecting IPR institution rates
- The growing use of ex parte reexamination (EPR) as a strategic alternative
- Review of the data: what the latest statistics reveal
- New Federal Circuit and district court decisions reshaping post-grant practice
Part 2: Strategic considerations and case study updates
- Practical approaches to leveraging post-grant challenges within a broader patent strategy
- Case study updates
Part 3: Future outlook
- Legal challenges to USPTO policy changes affecting IPRs
- Prospects, and likelihood, of legislative action
- What developers should watch for going forward
Key takeaways
- Navigate the evolving post-grant landscape
- Stay ahead of critical case law, with insight into recent Federal Circuit and district court decisions shaping post-grant challenge strategy and practice
- Strengthen generic and biosimilar strategies
Biologics and biosimilars: review and update on recent case law
This session examines the evolving U.S. biosimilars landscape under the BPCIA, focusing on the legal and strategic issues affecting market entry and patent disputes, including exclusivity, the "Patent Dance," patent listing, infringement, injunctions, and launch timing. Recent landmark decisions illustrate developments in enablement, written description, claim construction, and patent eligibility.
Part 1: Brief review of the Biologics Price Competition and Innovation Act (BPCIA)
- Exclusivity
- The "Patent Dance"
- Patent listing and the "Purple Book"
- Infringement and injunctions
- Launch timing
Part 2: Case updates
- Regeneron v. Mylan (EYLEA) (2025): the most significant BPCIA case from the Federal Circuit, covering personal jurisdiction, obviousness-type double patenting, written description, and claim construction
- Enablement and written description under 35 U.S.C. Section 112: background set by Amgen v. Sanofi (2023) on the scope of enablement for antibodies
- Seagen v. Daiichi Sankyo (2025, Fed. Cir.): the application described more than 47 million possible tetrapeptides, with claims covering an 81-member subgenus; the court found the subgenus not enabled where the specification failed to point a skilled person to it
- Teva v. Eli Lilly (2026, Fed. Cir.): the court overturned a finding of invalidity for lack of enablement and written description, distinguishing Seagen based on the use of a known genus of antibodies for a particular therapeutic purpose
- Patent-eligible subject matter under 35 U.S.C. Section 101: Regenxbio v. Sarepta addressed how different a cell must be from one existing in nature to qualify as patentable matter
Key takeaways
- Master the BPCIA framework and the "Patent Dance"
- Understand the latest biosimilar case law
- Navigate Section 101, Section 112, and patentability risks
- Develop effective biosimilar launch strategies
From product selection to U.S. launch: integrated patent, FTO, and lifecycle-management strategy
For in-house patent managers, a successful U.S. pharmaceutical launch depends on coordinated decisions concerning product selection, patent protection, freedom to operate, and commercialization. Using a small-molecule pharmaceutical product as a running case study, this session presents a practical framework for managing those decisions from initial evaluation through U.S. market entry.
Part 1: Product selection and portfolio design
- Align patent strategy with the intended commercial product, regulatory pathway, development timeline, and competitive landscape
- Build commercially meaningful protection around compounds, processes, intermediates, forms, formulations, combinations, and methods of use
- Decide which innovations should be patented, maintained as trade secrets, licensed, or designed around
Part 2: FTO as a continuing process
- Begin FTO during product selection and update it through a stage-gate process at key development and commercialization milestones
- Map third-party claims to the proposed product, manufacturing process, formulation, labeling, and commercial activities
- Convert the analysis into practical options: proceed, redesign, license, challenge, delay, or discontinue
Part 3: Lifecycle management and commercialization
- Coordinate patent protection and FTO with product development, regulatory strategy, sourcing, partnering, and launch planning
- Evaluate proprietary portfolio strength and third-party patent risk together during licensing, investment, and due diligence
- Use a portfolio-coverage map and patent-risk matrix to communicate assumptions, alternatives, timing, and residual risk to management
Key takeaways
- Patent strategy should begin with the intended commercial product and business objective, not merely the invention disclosure
- FTO should be treated as a staged management process, not a one-time pre-launch search
- Effective in-house patent management converts claim-level analysis into timely, actionable business decisions
Recent trends and key developments in European pharmaceutical patent litigation
An in-depth review of the latest pharmaceutical patent decisions across Europe, examining how the EPO, national courts, and the CJEU continue to shape patent enforcement and validity challenges, with practical insight for innovator, generic, and biosimilar companies.
Key takeaways
- Convergence and divergence in national court interpretations of pharmaceutical patent law
- Developments in Supplementary Protection Certificate (SPC) jurisprudence and their impact on exclusivity strategy
- Emerging trends in validity, infringement, preliminary injunctions, and launch-at-risk litigation
European regulatory and IP update: data and market exclusivity, skinny labelling, and cross-border patent litigation
A deep dive into data and market exclusivity, skinny labelling, and cross-border patent litigation, including the new legal framework under the European Pharma Package, the most significant revision of EU pharmaceutical legislation in over 20 years.
Covers
- The current legal framework for innovative drugs in Europe, and strategic considerations for innovators and biosimilar developers
- Carve-out strategies under the current EU framework for skinny labelling, and recent case law
- The CJEU's BSH / Electrolux decision and its implementation before national courts and the Unified Patent Court
Patent protection strategies for pharmaceutical and biotechnology innovations in China
Practical patent-protection strategies for pharmaceutical and biotechnology inventions, recent legislative and judicial developments, and the growing impact of China's patent linkage system, patent term adjustment and extension, and drug data exclusivity on lifecycle management and market entry.
Key takeaways
- Claim strategies for new crystal form, second medical use, dosage regimen, and biologics under CNIPA examination practice
- "Method of treatment" claim formats: Swiss-type and purpose-limited product claims
- Polymorphs, salts, and fixed-dose combinations, and evidentiary requirements for unexpected technical effects
- China's patent linkage system compared with the U.S. Hatch-Waxman framework
- Patent term adjustment and extension, and the current drug data exclusivity framework
Pharmaceutical patent prosecution and litigation trends in India
India remains one of the world's most influential pharmaceutical markets, serving as a global hub for generic drug manufacturing while maintaining a unique patent framework that balances innovation and public health. This session examines the latest developments in pharmaceutical patent prosecution, litigation, and enforcement in India.
Key takeaways
- Recent trends in pharmaceutical patent examination before the Indian Patent Office, and patentability challenges under Section 3(d)
- Patent protection strategies for incremental innovations, new forms, formulations, and polymorphs
- Recent High Court and Supreme Court decisions shaping pharmaceutical patent jurisprudence, and the evolving standard for interim injunctions
- Launch-at-risk litigation trends, freedom-to-operate assessments, and generic market-entry planning
Participants will leave with a comprehensive understanding of India's evolving pharmaceutical patent landscape, including key prosecution challenges, litigation trends, enforcement strategies, and commercial considerations affecting pharmaceutical innovation and generic competition, with actionable insight for patent, regulatory, and market-entry strategy in India.
Registration fee
A single fee covers the full two-day programme.
Trusted leaders in IP and legal innovation
IIPRD and Khurana & Khurana bring decades of global experience across patent strategy, litigation, and commercialisation, with a presence across Asia, the US, and the GCC, serving clients from startups to Fortune 100 companies, alongside leading partner firms from the US, Germany, France, and China.
A leading full-service law firm in India, ranked and recommended by international publications including Chambers & Partners, Legal 500, Managing IP, IAM, Asia IP, RSG, Acquisition INTL, Corp INTL, and Benchmark Litigation. With a team of over 350 professionals and offices across India, South-East Asia, the United States, and the UAE and GCC, it focuses comprehensively on intellectual property, corporate transactions, and disputes.
A well-established intellectual property asset management firm specialising in comprehensive patent support, litigation support, and licensing and commercialization mandates for global corporates, law firms, and licensing entities. IIPRD focuses extensively on IP audits, due-diligence exercises, and IP valuations, alongside patent illustration and IDS preparation, docketing, and a full range of patent searches, patentability, validity, freedom-to-operate, and landscape analytics, making it a one-stop solution for complex, cross-jurisdictional IP requirements.
Founded in 2003 and based in Minneapolis, Carlson Caspers is known for excellence in intellectual property litigation and counseling, serving clients from individuals to Fortune 500 companies. Its attorneys, who are scientists, engineers, chemists, technologists, and pharmacists, are recognized by the American College of Trial Lawyers, Chambers USA, IAM Patent 1000, IP Stars, Best Lawyers, and Super Lawyers.
A boutique intellectual property and patent law firm with offices in Germany and France, recognized for its strategic, client-focused approach to complex IP matters, with deep expertise in the pharmaceutical, biotechnology, chemical, and life sciences sectors. Bonabry is particularly renowned for advising generic pharmaceutical companies on product launches in challenging patent landscapes, including freedom-to-operate assessments, launch strategies, patent litigation, and proceedings before German courts and the Unified Patent Court.
Tee & Howe Intellectual Property Attorneys, established in 1995, is one of China's pioneering intellectual property firms licensed by the China National Intellectual Property Administration (CNIPA) to handle both domestic and international IP matters. The firm provides comprehensive IP services across patents, trademarks, copyrights, licensing, prosecution, enforcement, and litigation, and is an active member of leading international IP organizations, including AIPPI, INTA, FICPI, LES, and AIPLA.
Our faculty
Practitioners from the US, Europe, China, and India, each litigating and advising at the front line of pharmaceutical IP.
A registered U.S. patent attorney focused on the life sciences sector, Gary is a patent litigator who conducts pre-suit investigations, IP valuations, and due diligence, and provides freedom-to-operate opinions and patent-prosecution strategy across domestic and international jurisdictions. He has been involved in numerous post-grant proceedings before the USPTO across medical devices, drug delivery systems, and pharmaceuticals.
Peter practices in intellectual property with a focus on high-stakes patent litigation and post-grant proceedings, spanning medical devices, automotive technology, pharmaceuticals, and telecommunications. He has extensive experience before the USPTO's Patent Trial and Appeal Board, including frequently delivering successful oral arguments.
Nate is a registered patent attorney with experience counseling clients from various industries in intellectual property disputes. He is a zealous advocate who takes pride in identifying a winning argument and clearly articulating it in briefing and oral arguments, and enjoys managing complex cases with many interrelated factual and legal issues.
Iain conducts pre-suit investigations and IP due diligence, provides freedom-to-operate and validity opinions, and litigates patent infringement cases. He also drafts and negotiates patent licenses and develops patent procurement and prosecution strategies. He has practiced before the USPTO for over 25 years, with extensive experience preparing and prosecuting applications and in post-grant procedures.
Based in Bonabry's Hamburg office, Alexander represents clients in German, European, and US intellectual property law, including patent prosecution, oppositions, nullity and infringement proceedings, and relevance and validity opinions in general chemistry, biochemistry, and pharmaceuticals. A qualified German and European Patent Attorney, European Patent Litigator, and US Patent Agent, he has assisted Indian clients for more than 20 years and represents them before the EPO, the German Patent Court, and the Unified Patent Court.
Sarah advises pharmaceutical-industry clients and represents them in court across intellectual property, pharmaceutical, healthcare advertising, medical devices, and unfair competition law. Her particular focus is on pharma patents, SPCs, and related regulatory issues such as data and market exclusivity and carve-out possibilities. She regularly advises on launch strategies for generic and biosimilar products before German courts and the Unified Patent Court.
An experienced patent professional with over 10 years of expertise in patent and design law, Toby is a deal finder for US patent investment, a committee member of the IPO, and a past co-chair of AIPLA committees on IP practice in China and the Far East. One of the authors of "Patent Law in Greater China," he holds a PhD in chemistry, trained under the UK system, and works in Chinese (Mandarin and Cantonese) and English.
With over 23 years of experience across IP subject matters, Tarun is ranked among India's top patent practitioners by IAM 1000 and IAM 300 Strategists, focusing on patent portfolio management, litigation, valuation, and IP commercialization for clients ranging from startups to Fortune 500 companies.
With more than 15 years of experience in patents and related IP rights, Tapan holds a Master's in Medicinal Chemistry from NIPER, Mohali, and has assisted Fortune 500 pharmaceutical and chemical companies, U.S. and European law firms, and in-house patent counsel on product and process development and commercialization.
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