Agenda
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Day 1 — Main Conference
October 14, 2026
Breakfast and Registration
The Impact of Current US Regulatory Policy on Pharma Biotech Patent Litigation: Present Day Status and Future Forecasts
David KornVice President IP and Law Pharmaceutical Research & Manufacturers of America
Joshua KreshResearch Professor and Executive DirectorIPPI: The IP Policy Institute | The University of Akron School of Law
Jonathan StroudGeneral CounselUnified Patents Inc.
The US regulatory scheme governing biopharmaceutical products and their related IP protections is experiencing significant change. Agency turnover, legislative focus on drug pricing, and access, questions surrounding IP protections, as well as enforcement activity have created an atmosphere of instability for long- time practitioners.
This session will explore these current trends, as well as forecasts and predictions for the next year.
Points for discussion will include:
- Examining how leadership changes at key agencies are impacting the biopharmaceutical industry
- Assessing key agency activity and their related impact on pharma and biotech patents
- The continued threat of march in rights
- FDA enforcement activity and notice letters
- Clinical trials
- USPTO/PTAB activity
- Terminal disclaimers
- PTEs and PTRs
- FTC
- Most favored nations pricing
- Inflation Reduction Act
- Drug value under TrumpRx and other Rx direct to patient platforms
Case In Point
Claire FundakowskiPartnerWinston Taylor LLP
Emer SimicPartnerNeal, Gerber & Eisenberg LLP
Thomas WallsSenior Vice President - Head of Global Intellectual Property and LitigationBausch Health Companies Inc.
On June 4, 2026, the Supreme Court unanimously held that Amarin failed to state a claim for induced patent infringement based on Hikma’s “skinny label” and marketing statements, finding that Amarin alleged no “more than a sheer possibility” that Hikma induced infringement. The decision caps a years-long battle: the District Court dismissed Amarin’s case in 2022 for failure to adequately plead inducement; the Federal Circuit reversed, holding that a physician could plausibly interpret Hikma’s skinny label and marketing statements as encouragement to infringe; and the Supreme Court granted certiorari to decide whether Amarin had stated a plausible inducement claim under Twombly/Iqbal.
At its core, the case tested whether generics can ever reliably pursue the Section viii pathway to avoid liability—and what constitutes active inducement of infringement in this context. By siding with Hikma, the Supreme Court affirmed the viability of the Section viii pathway and clarified the standard for active inducement of infringement.
This session will unpack the key takeaways from Hikma v. Amarin and explore the decision’s implications for skinny labeling and beyond.
Morning Coffee Break
Daniel J. KleinPartnerGroombridge, Wu, Baughman & Stone LLP
Nick MitrokostasPartnerWhite & Case LLP
Michelle NyeinSenior Counsel, IPEisai
Amgen v. Sanofi changed the shape of written description and enablement in the US, and the courts are still in the throes of interpreting and applying these decisions to new cases.
Recently, Teva Pharms. Int’l GmbH v. Eli Lilly & Company has become part of the §112 conversation, with a federal panel stating that a method-of-treatment (MOT) claim reciting the use of a genus of antibodies differs from a composition-of-matter (COM) claim to the genus itself, thereby providing new opportunities for MOT claims to survive §112 invalidity challenges.
- Understanding the status of written description and enablement challenges following Amgen v. Sanofi
- Anticipating the outcomes and impact of current and pending post-Amgen §112 cases
- Teva Pharms. Int’l GmbH v. Eli Lilly & Company
- Seagen Inc. v. Daiichi Sankyo Co., Ltd.
- OssiFi-Mab LLC v. Amgen Inc.
- Brita LP v. Int’l Trade Comm’n
- Identifying strategic arguments to preserve challenged MOT claims via §112
- Claim stretching
Lunch
Tales from Before the Bench
Ching-Lee FukudaPartnerMorrison & Foerster LLP
Priya PatelPartnerDechert LLP
Eric DittmannPartner, Litigation DepartmentPaul Hastings, LLP
Jesse FeckerVice President, Intellectual PropertyZymeworks
Jeremy LowePartnerSpencer Fane
Christina SchwarzPartnerVenable LLP
After Cellect and Allergan v. MSN Labs., ODP seemed to be settling into a new equilibrium. But the Patent Trial and Appeal Board decisions in Ex parte Baurin and Ex parte Baumeister, Director Squires’s precedential Appeals Review Panel decision in Ex parte Baurin and the pending Federal Circuit appeals in In re Ablynx (appeal of Ex parte Baumeister) and Ex parte Baurin now threaten to reshape the doctrine yet again.
Where do we go from here, and what do these cases mean for the future of ODP litigation?
- Laying out the current status of Cellect and Allergan v. MSN Labs
- Examining the distinctions and similarities between Ex parte Baurin and Ex Parte Baumeister and how the PTAB ruled in each case
- Analyzing the August 2026 precedential Ex parte Baurin Appeals Review Panel decision
- Tracking the Federal Circuit appeals of In re Baumeister (In re Ablynx N.V.) and Ex parte Baurin
- Developing strategies to challenge or protect claims on the basis of ODP in view of recent developments
Litigation Magnifying Glass
Thomas J. KowalskiPartnerDuane Morris LLP
Tony V. PezzanoPartnerLippes Mathias LLP
Edward R. ReinesPartnerJones Day
They’re back… Non-Practicing Entities (NPEs), occasionally called Patent Trolls, are once again a growing concern in the pharma and biotech patent world.
NPEs can bring suit without warning, alleging patent infringement on a potentially broad swath of claims. According to a 2014 study, patent trolls create $29 billion in out-of-pocket costs for target companies each year. NPE filings rose by 21.6% in 2025 when compared to 2026, with NPEs responsible for 55.4% of all patent lawsuits. Yikes!
This at-a-glance session will take a look at the current state of NPEs in the system, assess the threats they pose to biopharma patents – comparing the threats of 2026 to the NPE threats of the past, and will offer systematic and strategic solutions to the patent troll problem.
Jeffrey ColemanPartnerEllenoff Grossman & Schole LLP
Sanya SukduangPartnerNorton Rose Fulbright
Hatch-Waxman and BPCIA were enacted to accelerate and encourage the entry of generic drugs and biosimilars to the market by creating strict timetables for litigation under each legislative schematic.
However, over the last 20 years or so, a new tactic – serial litigation – has been implemented to extend these timetables and deter market entry of generic drugs and biosimilars.
This at-a-glance session will discuss:
- Breaking down the circumstances leading to serial litigation
- Considering the impact of serial litigation on the generic market
- Addressing the policy concerns wrapped up in serial litigation
TRACK 1
Telling the Complicated Story of Science – Utilizing Experts Effectively in Life Sciences Patent Litigation
F. Dominic CerritoPartnerQuinn Emanuel Urquhart & Sullivan, LLP
Eleanor HamiltonVice President, ExpertsDOAR
Victoria SpataroHead of US IP LitigationCSL Behring
Experts are key players in successful litigation, but they also require time, effort, and money. In the life sciences, cases typically involve complex scientific explanations that can go over the head of the layman. With this complexity inherent in pharma and biotech patent cases, experts can be a critical tool for clarity and comprehension by the bench and the jury. Making your case clear is critical to effective and successful arguments, and utilizing experts efficiently is key to using experts effectively.
With this complexity inherent in pharma and biotech patent cases, experts can be a critical tool for clarity and comprehension by the bench and the jury. Making your case clear is critical to effective and successful arguments, and utilizing experts efficiently is key to using experts effectively.
This session will explore:
- Developing failsafe tactics to ensure understanding by the jury and the bench
- Determining where, when, and how to bring experts into the patent litigation fray
- Selecting appropriate experts for clarity and charisma
- Deploying experts to explain present, and demonstrate fundamental information to the courtroom
- Translating complex scientific data into layman’s terms
- Utilizing charts, diagrams, experts, and other tools to explain the science behind the patent
Jocelyn CinquinoSenior Communications ConsultantSalmons Consulting
Hon. Mark FalkPartnerWalsh Pizzi O’Reilly Falanga LLPFormer United States Chief Magistrate Judge for the District of New Jersey
Judge Jose L. LinaresPartnerMcCarter & English, LLPFormer Chief Judge of the United States District Court for the District of New Jersey
Juries have gotten more discerning over the years, with some practitioners claiming an anti-corporate bias among certain populations. Life sciences IP litigation adds layer of concern due to the complex and often confusing subject matter whose nuances are central to the case.
Life sciences IP litigation adds layer of concern due to the complex and often confusing subject matter whose nuances are central to the case.
With growing pressure on big pharma and life sciences companies, the complexity of the material being presented, and upwards of millions of dollars hanging in the balance, ensuring a properly arranged jury could be make or break to the success of your case.
Topics of discussion include:
- Identifying relevant biases amongst potential jurors during voir dire
- Anti-corporate/anti-deep pocket bias
- “safetyism” and hindsight bias
- Medical skepticism
- Ensuring a balanced and fair jury
- Understanding of the role of a juror
- Anticipating avenues to convince jurors of your case’s merit
- Assessing jurors for their ability to understand the complex materials presented and the science behind the patent
- Previous jobs
- Advanced education
Break
Jacqueline Wright Bonilla, Ph.D.DirectorSterne, Kessler, Goldstein & Fox P.L.L.C.Former Deputy Chief Administrative Patent Judge at the Patent Trial and Appeal Board (PTAB)
Paul RichterPartner, Co-Chair Pharmaceutical Practice GroupDevlin Law Firm LLC
Samantha G. WilsonPartnerYoung Conaway Stargatt & Taylor, LLP
When filing a patent case, your choice of forum could mean the difference between triumph and disappointment. Each potential forum offers its pros and cons, has its own policies and procedures, and provides a unique set of opportunities and challenges.
This session will discuss:
- Breaking down the considerations to bear in mind when determining where to file
- ITC
- PTAB
- District Court
- Identifying particularities, quirks, and benefits of each forum
- Exploring proper strategies for suit in each forum
End of Day 1
Day 2 — Main Conference
October 15, 2026
Breakfast and Registration
Canadian Crash Course: Everything You Needed to Know about Canadian Life Sciences Patent Litigation but were Too Afraid to Ask
Yael BienenstockPartnerTorys LLP
Shashank UpadhyePartnerUpadhye Tang LLP
Marian WolanskiPartnerBelmore Neidrauer LLP
By and large, the Canadian and US patent systems function the same way, with the CIPO acting in parallel to the USPTO. For practitioners whose life sciences products cross our northern border, however, it is necessary to be aware of some key differences in processes, policies, and timelines, as well as some of the hot topics driving Canadian life sciences patent litigation today.
This session will break down the distinguishing features of Canadian patent law, the current state of Canadian life sciences patent legislation, and the ways these concerns cross into the States, setting you up for success when working on products in the Great White North.
Topics of discussion will include:
- Distinguishing between Canada’s Patented Medicines (Notice of Compliance) Regulations (PM(NOC)) patent linking system and the United States’s Hatch-Waxman Act
- Understanding Canada’s grace period time limit
- Identifying the impact of Canada’s lack of on-sale bar
- Considering ODP without terminal disclaimers in Canada
Quick Look: Top 10 Canadian Concerns in 2026
In this subsection, we will break down the challenges and key developments facing Canadian life sciences patent law practitioners in 2026.
Key points of interest will include:
- Patentable subject matter in Pharmascience v Janssen Inc
- Canadian federal court discussion of the law of anticipation through the lens of disclosure v. document
- Application of overbreadth
- The scope of section 8 damages in cases brought under the Regulations
Aaron PereiraSenior Director or Patents, Global IPFerring Pharmaceuticals
Mark J. Stewart, Ph.D.VP, Head of Global Intellectual Property LitigationMerck Sharp & Dohme LLC
Nicole WilliamsSenior Director of Litigation10x Genomics
Robert CounihanPartnerFenwick & West LLP
As technology evolves, new litigation challenges arise that are specific and particular to the life sciences industry. From continuing CRISPR litigation to mRNA patent infringement to gene therapy, novel science means novel legal challenges.
In this session, we will explore the new litigation challenges and opportunities born out of emerging technologies, including:
- Ongoing CRIPSR litigation
- New challenges to platform technologies
- Gene therapy litigation’s impact on §101
- REGENXBIO Inc. v. Sarepta Therapeutics, Inc.
- Patent challenges regarding mRNA and virus therapies, especially in the context of Covid-19 vaccines
Break
Michael AbernathyPartnerMorgan, Lewis & Bockius LLP
Jason LeonardPartnerMcDermott Will & Schulte
GLP-1s are the hottest product of the century, not only in the life sciences market but across health and wellness, cosmetics, sports, advertising, and more. Market demand isn’t slowing down, and with increased market demand comes increased litigation.
Litigation in the GLP-1 IP space largely focused on “soft IP” until early 2026 when Novo Nordisk filed a patent infringement suit against Hims & Hers Health, Inc. Though the suit ended in settlement and, ultimately, strategic partnership, competition still runs rampant in the industry.
This session will cover:
- Assessing the current IP litigation landscape for GLP-1s
- Comparing GLP-1 litigation to patent litigation in other areas of pharma and biotech
- Identifying the litigation practices, challenges, and foci unique to GLP-1s
- Asking whether GLP-1 IP litigation tactics will set a trend or remain an outlier in pharma & biotech patent litigation
Eric GreenwaldLegal DirectorMerck Sharp & Dohme LLC
Chloe JiangAssociate General Counsel, US Intellectual PropertyAscendis
Ryan JohnsonPartnerFenwick & West LLP
Sona DePartnerSidley Austin LLC
This roundtable discussion brings together in-house patent litigation counsel and their private practice counterparts for a candid discussion on common challenges and key areas of collaboration for successful litigation outcomes in pharma and biotech patent conflicts.
Lunch
Tales from the Bench
Hon. Tonianne BongiovanniMagistrate JudgeUnited States District of New Jersey
Hon. Maryellen NoreikaDistrict JudgeUnited States District Court District of Delaware
Litigation Magnifying Glass
Stanley E. FisherPartnerWilliams & Connolly LLP
Catherine T. MattesPartnerQuinn Emanuel Urquhart & Sullivan, LLP
Life sciences patent litigation discovery is a complex and time-consuming undertaking, and its critical. Effective discovery is the foundation of effective and successful ANDA and BPCIA litigation.
This at-a-glance session will discuss:
- Reviewing recent decisions regarding scope of discovery in ANDA and BPCIA litigation
- Surveying trends in ANDA and BPCIA discovery and assessing where these trends may continue
- Developing effective and efficient strategies for thorough discovery in life sciences patent litigation
- Responding to subpoenas for discovery
- Following proper protocol when filing for discovery
- Limiting discovery costs as much as possible
Annaka NavaPartnerGoodwin Procter LLP
Andrew WassonPartnerHaug Partners LLP
The best way to save when undertaking a litigation is to keep matters brief. Successful dispositive motions can mean a significantly shorter litigation period. In Hatch-Waxman and BPCIA litigation, however, dispositive motions can be a huge challenge.
This session will discuss:
- Assessing avenues available for dispositive motions and early case dismissal
- Determining the appropriate circumstances and timing in which to make a dispositive motion
- Unearthing the barriers to successful dispositive motions in Hatch-Waxman and BPCIA litigation
Break
Sunny Malhotra, Ph.D, J.D.Sr Counsel, IPNovo Nordisk
Lillian WallaceAttorneySteptoe LLP
These days, AI is everywhere, unavoidable, and baked into nearly every system. As lawyers, however, we have certain ethical obligations that AI tools can run afoul of. From patent secrets, to attorney-client confidentiality, these AI systems can present an ethical minefield.
This session will discuss:
- Ensuring your AI usage does not sever attorney-client privilege or patient confidentiality
- Understanding the difference between traditional AI and Generative AI in both drug development and litigation preparation
- Avoiding bad case cites, hallucinations, and other AI-generated pitfalls when looking into patents and case law
- Utilizing AI in a way that is respectful and compliant with professional responsibilities
- Spotting pharma and biotech patent infringement through the use of AI systems without disclosing confidential information
Robert KappersPartnerSteptoe LLP
Rhonda K. SchmidtleinPartnerWilmer Cutler Pickering Hale and Dorr LLP
Cynthia SunDirector Legal CounselVetter Pharma International USA, Inc.
For decades patents have been the primary protection for pharma and biotech innovation. Recently, however, trade secrets have entered the fray as a key component of product protection. The Federal Circuit has even started to take on trade secret cases in the life sciences.
This session will explore:
- the lessons learned from Arcturus v. AbbVie
- Acting proactively to avoid trade secret lawsuits
- Protecting trade secrets internally
- Considering the remedies available in a trade secret theft case
End of Day 2
Day 3 — Main Conference
October 16, 2026
Breakfast and Registration
Hans-Rainer JaenichenPartnerVossius & Partner
Daniel WisePartnerCarpmaels & Ransford LLP
The US may be our patent litigation bread and butter, but activity across the pond can have a major impact on pharma and biotech patent litigation strategies stateside. Preliminary injunctions at the UPC, the Doctrine of Equivalents, differing approaches to claim interpretation, and supplementary protection certificate (SPC) revision are particular to EU practice with residual waves abroad, especially when it comes to generics and biosimilars.
Key points of discussion will include:
- Surveying the current state of pharma and biotech patent litigation at the UPC
- UPC local divisions
- UPC Court of Appeals
- Unpacking the differing applications of the Doctrine of Equivalents across Europe and how substantial equivalence can jeopardize biosimilars and generics
- Comparing US and EU approaches to antibody patents
- Understanding the EU pharma package and its impact on exclusivity, enforcement, and market entry and the product lifecycle on the whole
- Tracking the changing landscape of SPCs
Case In Point
Wouter PorsPartnerWindt Le Grand Leeuwenburgh
Dr. Markus PrägertPartnerdf-mp
The Court of Justice of the European Union’s February 2025 decision in BSH Hausgeräte v Electrolux fundamentally altered global patent litigation by providing the UPC with long-arm jurisdiction over foreign patents, not only increasing the UPC’s reach but also allowing for cross-border injunctions. The impact is major, and your patents are in the crosshairs.
If your patent is found to be infringing at the UPC, it could significantly impact and limit trading partnerships across the EU, shrinking your market.
This session will cover:
- Discussing the findings and verdict in BSH v Electrolux
- Assessing the impact of BSH v. Electrolux on US-based pharma and biotech patent litigation
- Anticipating threats to US pharma and biotech patents
- Developing strategies to protect US life sciences patents and avoid injunctions overseas
Morning Coffee Break
Litigation Magnifying Glass
Sanjaya MendisPartnerMcCarthy Tétrault
Marc RichardPartnerGowling WLG
Laurah SamuelsAssistant General CounselMemorial Sloan Kettering Cancer Center
Money makes the world go round, and the difference between a damages calculation and a settlement amount can be a determining factor in just how much money must change hands following a suit. With significant costs invested from pre- to post-commercial, damage or settlement amount calculations must be made with recouperation in mind.
Point of discussion will include
- Examining changing global trends in damages and settlement amounts and frequency
- Distinguishing between calculation approaches in different countries and legal systems
- Understanding damages calculations borne out of at-risk launches
- Determining fiscal remedies for willful infringement beyond punitive damages
- Potential damages
- Costs
- Fees
- Attorney’s Fees
- Potential damages
- Assessing pre- and post-commercial actual costs to consider in damages and settlement calculations
- Analyzing the likelihood of triple damages for infringement
- Exploring settlement opportunities
- Calculating settlement offers to avoid damages in the long run
Lunch
Tales from Before the Bench
John LivingstonePartnerFinnegan, Henderson, Farabow, Garrett & Dunner, LLP
Go ahead, brag a little.
In this session, a top trial lawyer will discuss their most successful courtroom moments in the US and abroad, what led to their success, and what they’ve kept in their trial tool bag ever since.
Anne Elise Herold LiPartnerBrownstein Hyatt Farber Schreck, LLP
James S.S. HoltomPartnerMcCarthy Tétrault
Nathaniel LipkusPartner, Intellectual PropertyOsler, Hoskin & Harcourt LLP
Victoria ReinesPrincipal Counsel – Global Patent LitigationSanofi
With parallel but distinguishable processes in Canada, the newly established long-arm of the UPC, and growing international trade concerns, coordinating patent strategies across borders is fundamental to IP protection for pharma and biotech companies.
Points of discussion will include:
- Coordinating prosecution strategies in anticipation of potential litigation challenges
- Considering international threats when building litigation approaches
- Navigating the complex global patent system when undertaking or protecting against suit
Afternoon Break
Melanie BairdPartnerTyr LLP
Judith KrensPartner | Advocaat | UPC Representative| Global Co-Lead IPPinsent Masons Netherlands LLP
Martina Tyreus HufnalPrincipalFish & Richardson P.C.
Dr. Felipe ZillyPartner/Patent AttorneyHogan Lovells Cadwalader
In M&A, start-up companies have an edge, but in litigation? They start off on more challenging footing. The size of legal teams, budgets, and experience can be a stumbling block for smaller pharma & biotech companies trying to take on major players in the space. With international M&A growing, disparate requirements from country to country, and a global market, understanding the proper timing, scale, and approach for your company is fundamental to success.
With international M&A growing, disparate requirements from country to country, and a global market, understanding the proper timing, scale, and approach for your company is fundamental to success.
This session will discuss:
- Distinguishing between approaches to litigation for start-ups vs. established big pharma companies
- Facing litigation challenges head-on while battling economic restrictions
- Applying forum selection knowledge to strategize your global approach to pharma and biotech patent litigation
- Developing efficient and effective patent litigation strategies to avoid breaking the bank
- Considering when, where, and how to employ litigation funding
Michael A. Davitz, M.D. J.D.PartnerLeason Ellis LLP
Juliana NevesPartnerLicks Attorneys
In this final session, panelists will synthesize the learnings of the last 3 days of programming and look ahead at the global pharma and biotech litigation landscape that stretches ahead.
Our speakers will consider the knowns and unknowns facing pharma and biotech patent litigators today to help us prepare for litigation tomorrow.
Topics of discussion will include:
- Reviewing pending litigation to forecast outcomes and identify future potential pitfalls
- Assessing current trends to anticipate how written description, ODP, and more may change in the next 6 months
- Considering what continued changes in federal leadership will mean for the future of life sciences IP
- USPTO
- FDA
- Legislative Branch following the mid-terms