Kisaco Global Biologics Cell and Gene Legal Summit 2023

Fish's Martina Hufnal, Doug McCann, and Jon Singer will speak at the Kisaco Global Biologics Cell and Gene Legal Summit on June 13-14.

Fish is proud to support the Kisaco Global Biologics Cell and Gene Legal Summit, a premier industry event gathering leading industry experts across the intellectual property, regulatory, and commercial fields to discuss the evolving market and dynamic changes in the generic, biosimilar, and innovative biopharma landscapes.

Biosimilar and Biologic Litigation: Practical Strategy Approach to Launching Products in Different Jurisdictions
Tuesday, June 13, 2023 | 2:30 p.m. UTC +2

Biosimilar and biologics litigation is an emerging battleground across the globe, with cases increasing in number. These cases give us firsthand and practical insights into the future of IP disputes and demonstrate the possible avenues for commercialization with the biologic product marketplace. This exclusive panel session of litigators and in-house counsel will explore these fundamental trends.

Part 1 – Europe

• Understand the best practical approach to launching a biosimilar.
  • Preliminary injunction relief
  • Where are the manufacturing hubs?
  • Where is the best jurisdiction to launch?
  • What is the impact of the UPC?
  • Preliminary injunction practice

Part 2 – USA

• Determine the current stance of application of the written description requirement to claims that recite functional limitations.
• Understand the implications for biosimilar production with:
  • Regeneron v. Mylan (2022)
  • Genentech v. Tanvex (2022)
• Preliminary injunctions
  • What can we learn from trastuzumab and bevacizumab?
  • What implications does small molecule PI practice have on the biologics industry?

Part 3 – Rest of the World

• Examine the latest biosimilar litigation in the Asian continent.
• Determine the latest preliminary injunction criteria in Asia and
• Latin America and how they affect a successful product launch.

Speakers:

• Martina Hufnal, Principal, Fish & Richardson
• Sherry Yao, Partner, King & Wood Mallesons
• Sharada Devarasetty, Head of Biopharmaceutical Patents, Sandoz

Biologic Products Roundtable Series: Skinny Labelling in the Biosimilar Realm
Tuesday, June 13, 2023 | 4:00 p.m. UTC +2

Each individually curated roundtable will be led by an industry expert. In-depth discussions, practical findings, and best-practice strategies will be evaluated and unearthed.

Speaker:

• Jon Singer, Senior Principal, Fish & Richardson
• Christoff Bull, Assistant General Patent Counsel, UCB

The Patenting and Enforcement of Cell and Gene Therapies
Wednesday, June 14, 2023 | 9:10 a.m. UTC +2

It is fundamentally important for the biologics industry to stay updated on legal developments within the cell and gene fields. Additionally, as the cell and gene therapy industry becomes a more crowded marketplace, there is growing competition and litigation within the field. This industry-led panel will explore these pressing questions so that you can build a commercially successful biologics product portfolio.

• Understand the key questions with regards to the patenting of stem cells:
  • How do you define and claim cells?
  • How can you curate the optimum cell and gene therapy portfolio in view of recent case law?
  • Learn the patent prosecution landscape of European Car T Cell Therapies.
• Understand the challenges to tackling multi-factorial diseases within gene therapy:
  • Learn the regulatory and ethical considerations associated with these treatments.

Speakers:

• Doug McCann, Principal, Fish & Richardson
• Christoph Rehfuess, Head of IP, SOTIO
• Paki Banky, Senior IP Counsel (IP Lead Cell & Gene), Novartis
• Kirsten Broeckers, Vice President & Head Legal Affairs EMEA, Novartis Gene Therapies GmbH

To learn more, click here.