See Credit Details Below
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 in 2024, as well as 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.
This year’s topics include the impact of AI on the biopharma industry, including on patents protecting biopharma products, IP strategy and life cycle management for biologic drug products, the impact of the Federal Circuit’s decision in In re Cellect on the double patenting doctrine and its effect on protection for life sciences inventions, practice before the PTAB on life sciences patents, proving infringement in ANDA cases, and ethics issues confronting patent lawyers and how to identify and mitigate associated risks in practice. Join us for these important and useful discussions on pressing issues in pharmaceutical and biotech patent law.
What You Will Learn
After completing this program, participants will be able to:
- Understand the impact of artificial intelligence
- Review issues in proving indirect infringement in ANDA cases
- Explore the consequences of In re Cellect on building patent protection
- Review PTAB practice for life sciences patents
- Review key considerations for managing the IP protecting biologic products from both an in-house and outside counsel perspective
- 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, and patent eligibility for life sciences patents.
Program Level: Intermediate
Prerequisites: An interest in the latest developments in pharmaceutical and biotech patent law.
Advanced Preparation: None
Industries
Please note that the views and opinions expressed in this program represent those of individual speakers and do not necessarily reflect the views or positions of PLI.
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Credit Details
Credit Details For All Jurisdictions For This Program
| Jurisdiction | Status | Total | Credit Details |
|---|
Proving Infringement in ANDA Cases: Beyond the Label
Michael F. Autuoro, Angus Chen, Ph.D., Irene E. Hudson, Chad J. Peterman, Jennifer H. Wu0:59:35This session will discuss how to prove infringement in ANDA cases when patent infringement issues are not indisputably resolved by the label including how courts address issues such as intent for indirect infringement, and infringement under Sunovian. After completing this session, participants will have a greater understanding of:
- Evidence of underlying direct infringement for indirect infringement of method claims
- Intent required for contributory infringement and induced infringement of method claims
- Infringement as a technical act versus under a declaratory judgment action claim: differences in proof and remedies
Jennifer H. Wu (Panel Leader), Michael F. Autuoro, Angus Chen, Ph.D., Irene E. Hudson, Chad J. Peterman
Artificial Intelligence and Its Impact on Life Sciences Patents
Lisa A. Samuels, Daniel L. Reisner1:00:50This session will explore the impact of using artificial intelligence during drug discovery and development on obtaining and enforcing patents. After completing this session, participants will have a greater understanding of:
- The application of inventorship and co-inventorship law to inventions made using AI
- How AI impacts the meaning of ordinary skill in the art
- Obviousness risk from inventions made using AI
- Ownership risks to patents arising from use of third-party AI
- Infringement risks from using AI during drug discovery and development
Daniel L. Reisner, Lisa A. Samuels
Double Patenting and the Impact of In re Cellect
James T. Evans, Ph.D., Victoria Reines, David K. Barr1:00:52This session will review the Federal Circuit’s decision in In re Cellect, which for the first time held that a statutory award of Patent Term Adjustment can result in invalidity due to double patenting based on an earlier expiring patent in the same patent family. The Cellect decision has upended the settled expectations of patent owners, especially in the pharmaceutical and biotech industries, and led to conflicting district court interpretations and applications of the decision. Cellect has petitioned for Supreme Court review of this decision and many companies and organizations have filed amicus briefs supporting the petition. The consequences of Cellect on managing and building patent protection are significant. After completing this session, participants will have a greater understanding of:
- The Cellect decision and its implications
- How Cellect has been applied by the district courts
- Consequences of Cellect on building patent protection
- Recent developments respecting Terminal Disclaimers, including (a) the USPTO’s proposed rule that Terminal Disclaimers filed to overcome double patenting include an agreement that the patent will only be enforceable if it has not been tied to a patent any claim of which has been held invalid as anticipated or obvious by a court or the USPTO and (b) the USPTO’s rejection of contingent Terminal Disclaimers filed as a hedge against a possible future double patenting ruling
- Potential ways for pharma and biotech companies to manage their patent strategies in response to Cellect
David K. Barr, James T. Evans, Ph.D., Victoria Reines
PTAB Practice Update
Jessica C. Kaiser, Elizabeth Long1:00:09This session will discuss PTAB activity including PTAB filings, Director activity, and recent notable PTAB decisions. After completing this session, participants will have a greater understanding of:
- Current PTAB filings summary
- Current PTAB rule-making
- PTAB treatment of secondary considerations
- Recent notable PTAB decisions
Jessica C. Kaiser, Elizabeth Long
IP Strategy and Life Cycle Management for Biologics
Julien E. Capers, Alicia A. Russo1:01:31This session will review key considerations for managing the IP protecting biologic products from both an in-house and outside counsel perspective, including developing IP from R&D and acquiring IP through acquisitions and licensing. After completing this session, participants will have a greater understanding of:
- How to build a successful IP portfolio to protect biologic inventions
- Developing IP from R&D
- Acquiring IP through acquisitions and licensing
- Key considerations for managing IP
Julien E. Capers, Alicia A. Russo
Ethical Issues Confronting Patent Lawyers
Sanjay K. Murthy1:00:08This session will review recent caselaw from various jurisdictions and tribunals involving various legal ethics issues for both outside and in-house counsel. After completing this session, participants will be able to:
- Spot ethical issues arising in patent practice through an exploration of caselaw
- Identify and ameliorate the potential risks associated with ethical issues
- Proactively avoid potential conflict of interest problems
- Understand the USPTO/PTAB’s most recent jurisprudence on ethical issues
Sanjay K. Murthy