PRE-CONFERENCE WORKSHOPS*

A9:00am – 12:30pm (Registration begins at 8:30 AM)

Novel Therapeutic Modalities and Gene Therapies: Developing a Successful Patent Prosecution Portfolio

Harnessing new capabilities such as AI, automation, and data analytics, as well as the manipulation of mRNA, CAR T and CRISPR technologies are critical to how companies will commercialize innovation and ensure success of the business unit. Securing IP rights to these technologies and leveraging or licensing these rights appropriately is essential to successful commercialization, growth, and future development of these innovations. This workshop will examine recent IP controversies with new technologies such as mRNA, CAR T and CRISPR and provide a comprehensive analysis of how patent prosecutors should rethink their prosecution strategies to obtain and enforce patent rights in the new “biotech era”

Points of discussion will include:

• Survey and analysis of current mRNA, CAR T and CRISPR patent challenges

• Thinking about delivery methods ahead of time as part of your portfolio strategy

» E.g., Deciding whether to in-license lipid nanoparticle (LPN) technologies v. patent protection on novel technologies

• Reviewing the regulatory pathways for these technologies

• Being mindful of freedom to operate parameters with these technologies as well as peripheral patent rights

• Addressing ownership and inventorship and considering Thaler’s petition for writ of certiorari to the U.S. Supreme Court following the decision in Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022)

• How to appropriately leverage patent rights for new biotech inventions: when does a license make sense over a lawsuit?

• Looking at future uses of mRNA, CAR T and CRISPR technologies, while being cognizant of current and potential IP challenges

» Analyzing the future market opportunities and emerging biotechnological trends on a global level

B1:00pm – 4:30pm (Registration begins at 12:30 PM)

Licenses, Research and Collaboration Bootcamp: Leveraging the IP Due Diligence Process to Identify Additional Patent Prosecution Efforts

For life sciences companies, intellectual property often represents most of their value. Securing investment, licensing opportunities, and partnerships is dependent upon the strength and valuation of the patent portfolio. Now is the right time to learn, or refresh your knowledge, of expansion through collaboration and licensing. In this bootcamp, leading patent practitioners will cover the ins and outs of what is known as IP due diligence. Topics to be discussed include:

• Understanding how the evaluation of the breadth, strength, and validity of the patents at issue is used to calculate the commercial viability of the IP

• The freedom to operate analysis: ensuring that the commercialization of new products or modalities will not infringe any existing patent rights of third parties

» Understanding how extensive search sequencing should be during FTO

» Learning the best strategies for FTO relating to biologic patents

» Considering regulatory versus patent exclusivity

• Methods to uncover and resolve hidden issues with ownership rights, inventorship, and obligations under prior contractual agreements

• Protecting and preserving confidentiality and privilege during the IP due diligence process