20th Anniversary Life Sciences Patents - DS

EARN CLE/Ethics CREDITS

June 2–3, 2022 | Harvard Club of New York City | New York, NY TH

ANNIVERSARY

LIFE SCIENCES PATENTS

Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S. and Around the World

2022 Co-Chairs

Celebrate being in-person again with face-to-face networking and direct access to industry thought leaders, as they shed light on critical developments like: » The Current State of Patent Eligibility in the United States and Around the World » Written Description, Enablement, and Obviousness Challenges » Coordinating Global Patent Portfolios

Dr. Leslie Fischer Principal Patent Attorney Sandoz Biopharm Supporting Sponsor:

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Gloria Fuentes VP & Assistant General Counsel Bristol Myers Squibb

» Nuanced IP and Regulatory Challenges Related to Cannabis and Psychedelics » The Role of AI and Tech in Life Sciences Patents » And more!

Associate Sponsor:

AmericanConference.com/LSPatents • 888 224 2480

Luncheon Sponsor:

Cocktail Reception Sponsor:

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

ACI’s 20th Advanced Summit on Life Sciences Patents returns in-person, this June, to provide practical insights on how to maximize your patent term and develop strategies to enhance protections for your patent portfolio.

By bringing the collective knowledge and practical experiences of leading in-house IP counsel, patent prosecutors and litigators, the USPTO, and academics from both sides of the Atlantic, this event will provide you with comprehensive knowledge and benchmarking opportunities to ensure that you are leading the way in patent protection for your company and clients.

Through our sophisticated and practical workshops and panels, you will learn strategic solutions to fundamental prosecution conundrums relating to eligibility, written description and enablement, licensing agreements, and inherency and obviousness.

In addition, ACI proudly introduces new faces to discuss new markets: Cannabis and Psychedelics, Digital Health and AI, and the expanding uses of CRISPR technology.

This June, join the “who’s who” of the pharma, biotech and diagnostic industries as they gather in person for ACI’s 20th Advanced Summit on Life Sciences Patents, and contemplate the impact of these critical developments on your and your clients’ day-to-day practice.

Hear directly from Dr. Leslie Fischer and Gloria Fuentes about why this year’s event is not to be missed.

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“I’m looking forward to ACI’s 20th Life Sciences Patents conference. The agenda and the speakers look great and I can’t wait to gain some insight from other in-house counsel and leading law firm representatives. I’m also hoping to see some old friends and meet some new ones.”

GLORIA FUENTES

VP & Assistant General Counsel, Bristol Myers Squibb

“ACI’s Advanced Summit on Life Sciences Patents is genuinely my favorite patent-related conference of the year. No matter how long I’ve been in this field, I always learn something new (and often times, I learn MANY things new).

The topics are well-thought out, timely, and engaging. And, the speakers and panelists are superb. Really a highlight of my year!”

DR. LESLIE FISCHER

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Hear from Our 2022 Co-Chairs!

Principal Patent Attorney, Sandoz Biopharm

twitter: @ACI_Pharma linkedin: ACI Pharma

Distinguished Faculty GOVERNMENT

LAW FIRMS

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

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

Robin Evans Deputy Commissioner for Patents U.S. Patent and Trademark Office

Matthew Sked Senior Legal Advisor U.S. Patent and Trademark Office

IN-HOUSE Melissa Brand Intellectual Property Counsel Radius Health Jason Derry Associate General Counsel, Intellectual Property Synthego MJ Edwards Senior Associate General Counsel, Intellectual Property Gilead Sciences, Inc Henry Gu VP, Head of Intellectual Property Morphic Therapeutic Sarah Hooson Counsel, Patents Merck & Co Adam Poulin Kerstien Vice President, Head of Intellectual Property Dyno Therapeutics Prahlad Krishnan Founder & CEO Psyber

Adam Mossoff Professor of Law Antonin Scalia Law School, George Mason University Huong T. Nguyen General Counsel Fosun Pharma USA Inc. Jacob Oyloe Senior Director, Patents AstraZeneca Paul Simboli Lead Intellectual Property Counsel Atai Life Sciences Christopher Stabler Associate Corporate Counsel, Intellectual Property Jazz Pharmaceuticals Poorvi Thakur Senior Project Manager PatSnap John Todaro Managing Counsel, Patents Merck & Co., Inc.

Donna Meuth Associate General Counsel, Intellectual Property Eisai

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AmericanConference.com/LSPatents • 888 224 2480

Dorothy Auth, Ph.D. Partner and Head of Intellectual Property Practice Cadwalader, Wickersham & Taft LLP Isobel Barry Partner Carpmaels & Ransford LLP Miao (Daniel) Cheng President, Founding Partner Cheng & Peng Intellectual Property Law Office Heather Deixler Partner Latham & Watkins LLP Tina Dorr, Ph.D Partner Cantor Colburn LLP Michael Fenwick Partner Bereskin Parr Sophia Gaulkin Attorney Hyman, Phelps and McNamara James Gould Co-Chair of the Pharmaceutical, Biopharma and Life Sciences Industry Group and Counsel RatnerPrestia Ryan Hagglund Partner Loeb & Loeb LLP Judy Jarecki-Black Senior Counsel and Leader, Biotech and Chemical Practice Group Smith, Gambrell & Russell LLP Brendan Jones Partner Foley Hoag LLP Thomas J. Kowalski Partner Duane Morris LLP

Jay Lessler Partner Blank Rome LLP Joseph Matal Partner Haynes & Boone LLP Michael McCabe, Jr. Managing Partner McCabe Ali LLP Mercedes Meyer, Ph.D. Partner Faegre Drinker Biddle & Reath LLP Kevin E. Noonan, Ph.D. Partner McDonnell Boehnen Hulbert & Berghoff LLP Roberto Rodrigues Partner Licks Attorneys Dr. Grant Shoebridge Special Counsel Pearce IP Christopher P. Singer, Ph.D Shareholder McAndrews, Held & Malloy Ltd Malaika D. Tyson, Ph.D. Shareholder McAndrews, Held & Malloy, Ltd. Anita Varma Partner, Chair of the Global IP Practice Group White & Case LLP Ningling Wang Managing Partner, Shanghai Office Finnegan, Henderson, Farabow, Garrett & Dunner LLP Bruce Wexler Partner, Litigation Department Paul Hastings LLP

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

JUNE 2, 2022

10:15

MAIN CONFERENCE DAY ONE 7:00

Registration and Breakfast

8:00

Opening Remarks from Conference Co-Chairs Microphone-alt Dr. Leslie Fischer, Principal Patent Attorney, Sandoz Biopharm Gloria Fuentes, VP & Assistant General Counsel, Bristol Myers Squibb 8:15

The Current State of Patent Eligibility: Analyzing the Implications of Recent Case Law on Investment, Innovation and Efficiency Microphone-alt Matthew Sked, Senior Legal Advisor, U.S Patent and Trademark Office Brendan Jones, Partner, Foley Hoag LLP Dr. Grant Shoebridge, Of Counsel, Pearce IP Law 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

Microphone-alt Hon. Jackie Wright Bonilla, Deputy Chief Administrative Patent Judge, U.S. Patent and Trademark Office Networking Break

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Microphone-alt Jason Derry, Associate General Counsel, Intellectual Property, Synthego Ryan Hagglund, Partner, Loeb & Loeb LLP Adam Poulin Kerstien, Vice President, Head of Intellectual Property, Dyno Therapeutics Kevin E. Noonan, Ph.D., Partner, McDonnell Boehnen Hulbert & Berghoff LLP 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 and 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 and Emerging Complex Medicines • 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) 11:15

Obviousness, Obviousness-Type Double Patenting (OTDP), and Inherent Obviousness: Practice Notes for Patent Applications Microphone-alt Kathleen Fonda, Senior Legal Advisor, USPTO, Office of Patent Legal Administration Jay Lessler, Partner, Blank Rome LLP Joseph Matal, Partner, Haynes & Boone LLP John Todaro, Managing Counsel, Patents, Merck

Keynote from the PTAB

9:45

Dissecting Federal Guidance and Fortifying Written Description and Enablement

twitter: @ACI_Pharma linkedin: ACI Pharma

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

4:30

International Think Tank: Masterfully Coordinating Global Patent Portfolios

Ethical Considerations for Life Sciences Patent Lawyers

Microphone-alt Donna Meuth, Associate General Counsel, Intellectual Property, Eisai Roberto Rodrigues, Partner, Licks Attorneys

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

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

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

Miao (Daniel) Cheng, President, Founding Partner, Cheng & Peng Intellectual Property Law Office Anita Varma, Partner, Chair of the Global IP Practice Group, 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 Microphone-alt Dorothy 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

Microphone-alt Michael McCabe, Jr., Managing Partner, McCabe Ali LLP

Networking Break

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

CONTINUING LEGAL EDUCATION CREDITS EARN CLE/Ethics Accreditation will be sought in those jurisdictions requested by the registrants which have continuing CREDITS education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

JUNE 3, 2022

9:00

• 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

Opening Remarks from Conference Co-Chairs

11:45

MAIN CONFERENCE DAY TWO 8:00

Registration and Breakfast

9:15

Practical Insights into Exemptions, Extensions, and Carve Outs Microphone-alt Henry Gu, VP, Head of Intellectual Property, Morphic Therapeutic

Cannabis and Psychedelics: Nuanced IP and Regulatory Challenges, in the US and Abroad Microphone-alt Paul Simboli, Lead Intellectual Property Counsel, Atai Life Sciences

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

Christopher Stabler, Associate Corporate Counsel, Intellectual Property, Jazz Pharmaceuticals

Isobel Barry, Partner, Carpmaels & Ransford LLP

Michael Fenwick, Partner, Bereskin Parr 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:

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 psychedelicbased products face challenges when seeking patent protection. Points 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 in key jurisdictions

• 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

10:15

12:45

Networking Break

10:45

Drug Price Regulation: What’s Patent Law Got to Do with It? Microphone-alt Melissa Brand, Intellectual Property Counsel, Radius Health Sophia Gaulkin, Attorney, Hyman, Phelps and McNamara Adam Mossoff, Professor of Law, Antonin Scalia Law School, George Mason University Jacob Oyloe, Senior Director, Patents, AstraZeneca 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:

6 | #LifeSciencesPatents

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Networking Lunch

Media Partners:

1:45

3:45

Standing Out in a Crowded CRISPR World: How to Strengthen Your Portfolios and Patents Utilizing CRISPR Technology

4:00

Microphone-alt Judy Jarecki-Black, Biotech Patent Team Leader, Smith, Gambrell & Russell LLP Thomas 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

Networking Break

Diversity, Equity, and Inclusion: Implicit Bias in IP and Promoting Bias-Reducing Strategies Microphone-alt Robin Evans, Deputy Commissioner for Patents, U.S. Patent and Trademark Office Tina Dorr, Partner, Cantor Colburn LLP Sarah Hooson, Counsel, Patents, Merck 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 » E.g., efforts which aim to increase the diversity of inventors, and how outside lawyers can better support their clients in these efforts 5:00

Conference Concludes

2:45

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

RELATED EVENTS

Microphone-alt Heather Deixler, Partner, Latham & Watkins LLP Prahlad Krishnan, Founder & CEO, Psyber Poorvi Thakur, Senior Project Manager PatSnap Bruce Wexler, Partner, Litigation Department, Paul Hastings LLP 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

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May 24–25, 2022 | Washington, DC

June 28–29, 2022 | Boston, MA

July 26–27, 2022 | Boston, MA

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Planning Ahead for Live Conferences: C5’s All Secure Safety Plan As American Conference Institute and our partners plan for in-person events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery. In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or location-specific regulations, and will follow the commitments below.

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All attendees will need to assert that at the time that they first attend the conference and for the 14 days prior: y They are not experiencing COVID-19 symptoms. y Have not traveled from an area under a travel health advisory. y Have not provided care for or had close contact with any person with or reasonably suspected of having COVID-19, or with any person who traveled outside of your home country or to an area under a travel health advisory. y Have not been advised by any health authority, government agency or regulation to selfisolate due to possible exposure to COVID-19.

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Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

Increased Cleaning and Sanitation

We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

y Placement of hygiene stations throughout the conference including the registration area, meeting spaces and high frequency areas. y Availability of personal hygiene and safety products including facial coverings where available.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference. y A conference room layout with planned seating for appropriate physical distancing. y We continue to work closely with our venue partners to ensure the safety of our attendees.

Please check back frequently as we monitor and evolve our plan in the weeks ahead.

Bed Venue Information Harvard Club of New York City

ADDRESS: 35 West 44th Street, New York, NY 10036

Reduced Touchpoints y Reduction of the physical distribution of onsite materials. y Food and beverage options that ensure minimal handling and exposure.

Hotel: Sofitel New York Address: 45 West 44th Street, New York, New York 10036 Reservations: 212-782-3021 ACI is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “American Conference Institute”.

Please note that the guest room block cut-off date is May 10, 2022. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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2022 Co-Chairs

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