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Overview
Why You Should Attend
Patent law is an ever-changing battlefield. The Federal Circuit and the U.S. Patent and Trademark Office (PTO) are continually reshaping it every year. This program will teach you about some of the key developments from 2021 and 2022, important trends and strategies that can be made to work for you. An experienced faculty will cover developments in district court litigation, appellate practice, the USPTO and ethics considerations.
The program will cover recent developments in indefiniteness, negative limitations, inducement and venue and pleading requirements in ANDA cases. Many pharma and biotech cases are litigated in Delaware. You will review recent ANDA cases in the district, hear about visiting judges, new judges and new procedures, and explore the use of magistrates.
Method of treatment claims play an important role in pharma and biotech enforcement actions. You will learn about recent inducement decisions, how to think about strategic considerations, explore FDA listing and labeling issues and skinny labels. The program will also cover patent issues confronting cell and gene therapy products, including under the BCPIA and sections 101 and 112.
The program will also cover recent developments in the doctrine of patent eligibility that has been the subject of much recent litigation involving life sciences patents, including both at the district court and Federal Circuit levels, as well as the use of expert testimony in patent litigation. Because expert testimony may be determinative, courts following the Supreme Court’s Daubert decision have developed safeguards to guard against the admission of unreliable expert opinions or expert opinions premised on unreliable scientific principles. Attendees will learn about the standards and procedures used in deciding challenges to the admissibility of expert testimony in patent cases.
Lastly, you will learn about important ethical considerations when representing clients before the PTO, when preparing joint development agreements and in litigation while earning CLE ethics credits.
What You Will Learn
- Review recent important decisions by the Federal Circuit
- Learn about developments in the law of inducement
- Learn about litigating life sciences cases in Delaware
- Find out about patent issues confronting cell and gene therapy products
- Explore ethics issues that impact patent practice
Who Should Attend
Attorneys who will find this program helpful include: in-house attorneys who want to understand the latest developments in biotech and pharmaceutical patent law including changes in the substantive law, future trends and strategic considerations; and, litigators who need to understand how to best make use of developing law relating to therapeutic antibodies, generic challenges to branded drug products, patent clearance best practices and strategies, patent eligibility for life sciences patents, and things to be aware of when litigating in the District of Delaware.
Program Level: Overview
Prerequisites: An interest in the latest developments in pharmaceutical and biotech patent law.
Advanced Preparation: None