Day 1 - Thursday, June 2, 2022

7:00
Registration and Breakfast
8:00
Opening Remarks from Conference Co-Chairs
8:15
The Current State of Patent Eligibility: Analyzing the Implications of Recent Case Law on Investment, Innovation and Efficiency
9:15
Keynote from the PTAB
9:45
Networking Break
10:15
Dissecting Federal Guidance and Fortifying Written Description and Enablement
11:15
Obviousness-Type Double Patenting: Practice Notes for Patent Applications
12:15
Networking Lunch
1:45
International Think Tank: Masterfully Coordinating Global Patent Portfolios
3:00
If I Knew Then What I Know Now: A Retrospective Understanding of Efficiency and Success
4:00
Networking Break
4:30
Ethical Considerations for Life Sciences Patent Lawyers
5:30
Cocktail Reception

Day 2 - Friday, June 3, 2022

8:00
Registration and Breakfast
9:00
Co-Chair Opening Remarks and Recap of Day 1
9:15
Practical Insights into Exemptions, Extensions, and Carve Outs
10:15
Networking Break
10:45
Drug Price Regulation: What’s Patent Law Got to Do With It?
11:45
Cannabis and Psychedelics: Nuanced IP and Regulatory Challenges, in the US and Abroad
12:45
Networking Lunch
1:45
Standing Out in a Crowded CRISPR World: How to Strengthen Your Portfolios and Patents Utilizing CRISPR Technology
2:45
Digital Health, Artificial Intelligence and Data Mining: The Role of AI and Tech in Life Sciences Patents
3:45
Networking Break
4:00
Diversity, Equity and Inclusion: Implicit Bias in IP and Promoting Bias-Reducing Strategies
5:00
Conference Concludes

Day 1 - Thursday, June 2, 2022

7:00
Registration and Breakfast
8:00
Opening Remarks from Conference Co-Chairs
8:15
The Current State of Patent Eligibility: Analyzing the Implications of Recent Case Law on Investment, Innovation and Efficiency

Matthew Sked
Senior Legal Advisor
USPTO

Brendan Jones
Partner
Foley Hoag LLP

Dr. Grant Shoebridge
Special Counsel
Pearce IP

Christopher P. Singer, Ph.D
Shareholder
McAndrews, Held & Malloy Ltd

The elusive subject matter eligibility (SME): basic, and yet so fundamental to successful patent prosecution. In this session, speakers from around the globe review the nuts and bolts of subject matter eligibility in their regions, toward increasing the chances of obtaining a patent in multiple jurisdictions. Topics of discussion will include:

  • Understanding the differences in global SME, e.g., Canada, Asia (Japan, China, India), the UK, and the EU (Germany)
  • Analyzing the impact of the Deferred Subject Matter Eligibility Project on US patent drafting
  • Outlining practical tips for overcoming ineligibility rejections from the PTO
  • Discussing the future statutory and jurisprudential landscape of section 101
    • Predicting the impact on investment and innovation

9:15
Keynote from the PTAB

Hon. Jacqueline Wright Bonilla
Deputy Chief Administrative Patent Judge
U.S. Patent and Trademark Office

9:45
Networking Break
10:15
Dissecting Federal Guidance and Fortifying Written Description and Enablement

Ryan Hagglund
Partner
Loeb & Loeb LLP

Kevin E. Noonan
Partner
McDonnell Boehnen Hulbert & Berghoff LLP

Jason Derry
Associate General Counsel, Intellectual Property
Synthego

Adam Poulin Kerstien
Vice President, Head of Intellectual Property
Dyno Therapeutics

In this panel, you will learn about important court decisions impacting written description and enablement in the U.S. The panel will also include a special focus on overcoming the unique challenges for protecting antibodies and complex medicines with patents.

Topics of discussion will include:

Written Description and Enablement
  • Reviewing critical case law detailing their impact on patent prosecution strategies
  • Responding to rejections from the USPTO
  • Strategizing in today’s “first-inventor-to-file” system, focusing on how to balance the need to file fast with the need to have sufficient data to support a broad claim

Special Focus: Antibody Claims, Complex Medicines and Platform Inventions
  • Understanding the variety of patent claim types available to maximize the scope of protection
  • Understanding how to walk the fine line between the written description requirement for predictability and the non-obviousness requirement for lack of expected success (the Nuvo squeeze)
  • Learning the written description requirements applicable to complex medicines and platform inventions in new and emerging technology areas
  • Extrapolating the impact of the recent Federal Circuit decision in Juno Therapeutics v. Kite Pharma.

11:15
Obviousness-Type Double Patenting: Practice Notes for Patent Applications

John Todaro
Managing Counsel, Patents
Merck & Co

Joseph Matal
Partner
Haynes and Boone LLP

Jay Lessler
Partner
Blank Rome LLP

Kathleen Fonda
Senior Legal Advisor
USPTO, Office of Patent Legal Administration

In this comprehensive session, industry thought leaders will share filing strategies and tactics to implement to maximize the strength of your portfolio. Topics of discussion will include:

  • Analyzing recent US case law on obviousness, inherent obviousness, and OTDP in the life sciences
  • Understanding how the doctrine of inherency is used in the obviousness context
  • Developing strategies for avoiding and overcoming OTDP, inherent obviousness and inherent anticipation rejections
  • Fleshing out the interplay between patent term adjustments and OTDP, including the status of Gilead-style OTDP

12:15
Networking Lunch
1:45
International Think Tank: Masterfully Coordinating Global Patent Portfolios

Donna Meuth
Associate General Counsel, Intellectual Property
Eisai

Roberto Rodrigues

Roberto Rodrigues
Partner
Licks Attorneys

MJ Edwards
Senior Associate General Counsel, Intellectual Property
Gilead Sciences, Inc

Miao (Daniel) Cheng
President, Founding Partner
Cheng & Peng Intellectual Property Law Office

Anita Varma
Partner
White & Case LLP

There is a balance to be struck between having a patent in many jurisdictions and patent procurement (and maintenance) costs. The decision must be strategic. In this interactive discussion, lawyers from different jurisdictions, and lawyers practicing in multiple jurisdictions, will give rapid pitches about a specific country followed by a group discussion on best practices for coordinating global portfolios. Points of discussion will include:

  • Learning what patents are the most profitable in their country and why
  • Understanding the process of patent application filing, prosecution, and maintenance fees; and the average wait time to obtain a patent
  • Analyzing the scope of patent protection in various jurisdictions, including the availability of the doctrine of equivalents and preliminary injunctions
  • Strategies for filing and prosecuting patent applications in multiple countries – where to file and pitfalls to beware of

3:00
If I Knew Then What I Know Now: A Retrospective Understanding of Efficiency and Success

Dorothy R. Auth Ph.D.
Partner and Head of Intellectual Property Practice
Cadwalader, Wickersham & Taft LLP

Malaika D. Tyson, Ph.D.
Shareholder
McAndrews, Held & Malloy, Ltd.

If only we could go back in time with what we know now…in this panel, you can! This retrospective panel will feature prosecution, litigation and IP transactional tips that may make the difference in winning your next case or having a successful deal. Topics of discussion include:

  • Learning how to better prepare IP portfolios by keeping future litigation concerns in mind at the prosecution stage
  • Understanding how portfolio management and prosecution strategies may create unexpected consequences for IP transactions

4:00
Networking Break
4:30
Ethical Considerations for Life Sciences Patent Lawyers

Huong Nguyen
General Counsel & Compliance Officer
Fosun Pharma USA Inc.

Mercedes Meyer, Ph.D.
Partner
Faegre Drinker Biddle & Reath LLP

Michael McCabe, Jr.
Managing Partner
McCabe Ali LLP

In this interactive session, our leaders will review common ethical dilemmas in Life Sciences patent prosecution. Attendees will then reflect critically on hypothetical situations posed by the panelists, discuss in groups, and then review their conclusions.

  • Understanding how to maintain candid communication with the USPTO and fulfilling disclosure obligations
  • Exploring best practices to avoid inequitable conduct in the life sciences space
  • Reviewing leading cases on ethical concerns in life sciences patent prosecution

5:30
Cocktail Reception

Day 2 - Friday, June 3, 2022

8:00
Registration and Breakfast
9:00
Co-Chair Opening Remarks and Recap of Day 1
9:15
Practical Insights into Exemptions, Extensions, and Carve Outs

Henry Gu
Vice President, Head of Intellectual Property
Morphic Therapeutic

James M. Gould
Co-Chair of the Pharmaceutical, Biopharma and Life Sciences Industry Group and Counsel
RatnerPrestia

Isobel Barry
Partner
Carpmaels & Ransford LLP

Ningling Wang
Managing Partner, Shanghai Office
Finnegan, Henderson, Farabow, Garrett & Dunner LLP

In the pharmaceutical industry, the largest profits can occur near the end of a patent’s life – making patent term extensions one of the most critical considerations in the patent lifecycle. Hear from the panelists, in a cross global perspective, their practical insights into the strategic value and availability of patent extensions, Safe Harbour exemptions, and label carve outs. Topis of discussion will include:

  • Thinking strategically: what patent(s) to extend and how to prosecute to maximize term extension
  • Analyzing recent developments in the EU regarding the supplementary protection certificate, including how the SPC waiver may be used by brands and generics.
  • Understanding the patent term extensions available in China under China’s new patent linkage system
  • Reviewing Safe Harbour exemptions and label carve outs

10:15
Networking Break
10:45
Drug Price Regulation: What’s Patent Law Got to Do With It?

Jacob Oyloe
Senior Director, Patents
AstraZeneca

Adam Mossoff
Professor of Law
Antonin Scalia Law School, George Mason University

Melissa Brand
Intellectual Property Counsel
Radius Health

Sophia Gaulkin
Attorney
Hyman, Phelps and McNamara

The correlation between a patent system and the costs and logistics of drug development is an issue that will trickle down to your daily patent prosecution practice. Our panelist will get you up to speed on the necessary backdrop and then extrapolate the impact on patent prosecution. Points of discussion will include:

  • A brief overview of drug pricing and how it works in the US and EU
  • How the world is currently reacting to escalating drug costs and access issues (e.g., price controls, compulsory licensing)
  • Current US and Global legislative and other reform efforts that aim to impact the type of portfolio you can build and how it can be asserted (e.g., the TRIPS Waiver)
    • Redeveloping patent prosecution strategies in light of these developments
  • Negotiating compulsory licensing to your advantage

11:45
Cannabis and Psychedelics: Nuanced IP and Regulatory Challenges, in the US and Abroad

Paul Simboli
Lead Intellectual Property Counsel
Atai Life Sciences

Christopher Stabler
Associate Corporate Counsel, Intellectual Property
Jazz Pharmaceuticals

Michael Fenwick
Partner
Bereskin Parr

There has been a resurgence of interest in re-purposing psychedelics for a variety of disorders. Further, medical and recreational cannabis development and commercialization is experiencing a surge worldwide. Cannabis products face unique challenges in the regulatory landscape because they do not comprise a single defined compound. So too do developers of cannabis and psychedelic- based products face challenges when seeking patent protection. Points of discussion will include:

  • Overview of cannabis and psychedelic use in development, regulation, and commercialization in the pharmaceutical arena
  • Building a cannabis patent portfolio: plants, methods of cultivating and processing, medical use and cannabis products (e.g., extracts)
  • Understanding special issues in cannabis patenting, e.g., subject matter eligibility and inherency
  • Exploring successful strategies for drafting claims and obtaining cannabis and psychedelic-based patents worldwide
  • Case Study: Epidiolex

12:45
Networking Lunch
1:45
Standing Out in a Crowded CRISPR World: How to Strengthen Your Portfolios and Patents Utilizing CRISPR Technology

Judy Jarecki-Black
Senior Counsel and Leader, Biotech and Chemical Practice Group
Smith, Gambrell & Russell LLP

Thomas J. Kowalski
Partner
Duane Morris LLP

Despite the legal uncertainty over who owned CRISPR technology, patent applications utilizing CRISPR technology were being filed at an unprecedented rate. The PTAB has now ruled in favor of the Broad Institute. In this pre-patent litigation bubble (which may soon burst), extra strategizing is needed to be both profitable and protected. Our panelists, which include the lawyers representing the Broad Institute, will discuss:

  • What the PTAB’s decision could mean for your patent portfolio
  • The traditional vs newer utilizations of CRISPR technology and important factors to consider when drafting claims
  • Licensing CRISPR technology
  • Practical issues to review with clients on the verge of launch, including FTOs
  • Reviewing the differences of mRNA, CRISPR, and vector technology in gene editing with a focus on costs and efficiency
    • A special look into the use of CRISPR in Animal Health, and why collaboration with Animal Health may save you and your client significant costs

2:45
Digital Health, Artificial Intelligence and Data Mining: The Role of AI and Tech in Life Sciences Patents

Heather Deixler
Partner
Latham & Watkins LLP

Bruce Wexler
Partner, Litigation Department
Paul Hastings LLP

Prahlad Krishnan
Founder & CEO
Psyber

Poorvi Thakur
Senior Project Manager
PatSnap

The onset of COVID-19 marked the beginning of a massive digital transformation of healthcare, and biopharma is embracing the digital innovation trend. Understanding how to integrate digital innovation into your practice will give you a competitive edge, both in terms of how biopharma products are developed, and how you prepare your patent prosecution strategy. Points of discussion will include:

  • Understanding how AI and data mining can accelerate drug discovery and development:
    • The extent to which data might be mined from previous clinical trials toward finding new uses for known drugs
    • Whether the increased collection of real-world-data (RWD) from wearables and mobile health will replace clinical trials and the impact on your prosecution strategy
  • Learning best practices for drafting claims to inventions that use AI or other data technology:
    • How and when to begin building a “digital” portfolio
    • Special considerations for digital inventions, including freedom-to-operate, navigating partnerships, inventorship concerns, and subject matter eligibility

3:45
Networking Break
4:00
Diversity, Equity and Inclusion: Implicit Bias in IP and Promoting Bias-Reducing Strategies

Tina Dorr, Ph.D.
Partner
Cantor Colburn LLP

Sarah Hooson
Counsel, Patents
Merck

Robin Evans
Deputy Commissioner for Patents
US Patent and Trademark Office

Implicit bias refers to the unconscious attitudes or stereotypes that affect our understanding, actions, and decisions. In this interactive session, our panelists will introduce the topic of implicit bias in life sciences IP, share bias-reducing strategies, and will invite attendees to share their thoughts and perceptions on implicit bias. Topics of discussion will include:

  • Reviewing the tests for determining implicit bias
  • Understanding the economic and other costs of implicit bias
  • Recommending strategies for reducing or eliminating bias

5:00
Conference Concludes