Course Calendar | Eastern Standard Time
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Week 1 – Day 1
October 20, 2026
1:00 pm
1:15 pm
Ashley RossPartnerKirkland & Ellis LLP
Howard SuhPartnerFox Rothschild LLP
- Framing the Hatch-Waxman and BPCIA statutory schemes and the balance between innovation incentives, generic and biosimilar entry and commercial planning.
- Defining drugs and biologics
- Labeling: when is a drug a drug and not a biologic
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The Nuts and Bolts of the Hatch-Waxman Act and BPCIA
- Their purpose
- The distinct but interrelated roles of the FDA and the USPTO in drug and biologic development, including approval pathways (NDA/ANDA/BLA) and patent examination.
- Explore how innovators and follow-on sponsors use patents, listings, and timing (e.g., Paragraph IV certifications, patent dancing under BPCIA) to manage entry and competition.
- Assess strategies for extending product life (formulation, dosing, device, method-of-use) versus risks of invalidation or narrow scope.
- Evaluate coordination between regulatory filings and IP prosecution to optimize exclusivity windows.
- Practical hurdles—labeling carve-outs, patent thickets, and regulatory requirements—that affect entry and portfolio value.
- How the Inflation Reduction Act (IRA) affects pricing, negotiation eligibility, launch timing, and lifecycle decisions for both small molecules and biologics.
- Consider the economic trade-offs of early vs. delayed generic/biosimilar entry in light of the IRA and revenue cliffs.
2:45 pm
Coffee Break
3:00 pm
Andrew WassonPartnerHaug Partners LLP
Samantha G. WilsonPartnerYoung Conaway Stargatt & Taylor, LLP
- NDA and 505(b)(2) pathways and the approval standards that drive product strategy.
- Bioequivalence and interchangeability requirements, including sameness, dosage form, route of administration, and labeling considerations.
- Understanding Orange Book listing and certification strategies.
- Understanding Hatch-Waxman exclusivities, including NCE, three-year, orphan, pediatric, and 180-day generic exclusivity.
- The role of patent term extension, patent term adjustment, and second-generation patent planning on regulatory approval timelines.
4:30 pm
Questions and Answers
5:00 pm
Day One Adjourns
Week 1 – Day 2
October 22, 2026
1:00 pm
Krista Hessler CarverPartnerCovington & Burling LLP
Lauren LeskoPartnerRakoczy Molino Mazzochi Siwik LLP
- Comparing biologics and small-molecule pathways, including BLAs, aBLAs, ANDAs, biosimilarity, and interchangeability.
- Understanding Purple Book listings, the Purple Book Act, patent transparency requirements, and reference-product sponsor obligations.
- Examining biosimilar and reference-product exclusivities, substitution, naming, and biologics labeling considerations.
- Identifying issues that affect biosimilar launch strategy and innovator response.
2:30 pm
Break
2:45 pm
The Ins and Outs of the Orange Book, Labeling, Safe Harbor, PIV Certs, Notice Letters, and the 30-Month Stay
Sara KoblitzDirectorHyman, Phelps & McNamara P.C.
Jason WinchesterPartnerJones Day LLP
- Understanding Orange Book listings, de-listings, use codes, and the strategic role of patent listings in lifecycle management.
- Addressing Section viii carve-outs, skinny labeling, patented label information, and label negotiations with FDA.
- Reviewing Paragraph IV certifications, notice letters, the 30-month stay, and the timing consequences for brand and generic litigants.
- Assessing the safe harbor under 35 U.S.C. § 271(e)(1) and how it intersects with development, pre-commercial activity, and litigation strategy.
4:15 pm
Questions and Answers
4:45 pm
Co-Chair Closing Remarks and Week One Adjourns
Week 2 – Day 1
October 27, 2026
1:00 pm
1:15 pm
Developing Early Case Strategy and Mastering Case Management in Hatch-Waxman and BPCIA Litigation (90 minutes)
Scott CunningSenior CounselGemini Law LLP
Sarah SullivanPartnerSaul Ewing LLP
- Translating Paragraph IV notices, BPCIA detailed statements and product-selection challenges into early case strategy.
- Managing scheduling orders, protective orders, and early case-management disputes.
- Comparing practical differences between Delaware and New Jersey Hatch-Waxman practice.
- Addressing initial pleadings, declaratory judgment considerations, multiple ANDA filers, and coordination among related cases.
2:45 pm
Break
3:00 pm
Joshua JamesCounselCrowell & Moring LLP
Raghav KrishnapriyanPartnerOrrick
- Preparing infringement, non-infringement, invalidity, and unenforceability contentions in the ANDA context.
- Developing claim construction strategy and aligning it with technical, regulatory, and commercial themes.
- Managing document discovery, sample discovery, regulatory record issues, and confidentiality concerns.
- Coordinating district court litigation with PTAB proceedings and related patent challenges.
4:30 pm
Questions and Answers
5:00 pm
Day One Adjourns
Week 2 – Day 2
October 29, 2026
1:00 pm
Rachel SchweersCounselKatten Muchin Rosenman LLP
Jenna Rea DeneaultPartnerGroombridge, Wu, Baughman & Stone LLP
- Selecting and preparing experts for pharmaceutical, regulatory, technical, damages, and commercial issues.
- Managing expert reports, depositions, Daubert issues, and coordination between testifying and consulting experts.
- Presenting bioequivalence, formulation, infringement, validity, and damages evidence through expert testimony.
2:30 pm
Break
2:45 pm
Trends to Watch Concerning Dispositive Motions, Trial, Serial Litigation, PTAB Strategy, and Settlement
Chris BrunoPartnerUpadhye Tang LLP
Ryan HagglundPartnerLoeb & Loeb LLP
- Dispositive motions in Hatch-Waxman and BPCIA litigation.
- Trial strategy in Hatch-Waxman and BPCIA cases.
- Addressing serial litigation trends, follow-on filers, parallel PTAB practice, and non-litigation patent challenges.
- Analyzing settlement considerations, including timing, exclusivity impacts, regulatory constraints, and business objectives.
4:15 pm
4:45 pm