21st Advanced Summit on Life Sciences Patents - DS

May 18–19, 2023 • New York Bar Association

21st Advanced Summit on

LIFE SCIENCES PATENTS

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

2023 Chairs

David Diamond

Vice President and Head of IP Capstan Therapeutics

Rajiv Shah

Assistant General Counsel, Patents Johnson & Johnson

Anita Varma Partner, Chair of IP Group White & Case LLP

Attend and engage in face to face discussions with leading stakeholders on best practices for filing and defending patent portfolios, including:

Angle-Right Establishing sound and successful protocols to procure and enforce life sciences patents in the U.S. and internationally

Angle-Right Developing new standards of drafting successful genus claims in anticipation of the U.S. Supreme Court review of enablement in Amgen v. Sanofi

Supporting Sponsor

Associate Sponsors

Angle-Right Evaluating the “pros and cons” of opting-into the EU’s new Unitary Patent system and the Unified Patent Court for your global pharmaceutical patent portfolio

Angle-Right Bullet-proofing your patent portfolio against skinny labelling claims and safe harbor exemptions

Angle-Right Obtaining and enforcing patent rights for novel therapeutics and gene therapies

Media Partners

ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May. Join us as we provide practical insights on how to maximize patent term and enhance global protections for your patent portfolio.

Effectively and strategically prosecuting patents is critical to business. In the face of district court litigations, inter-partes review and post-grant proceedings, a granted patent, no matter its content and history, remains vulnerable to attack. Therefore, learning how to better prepare patent portfolios by keeping future litigation concerns in mind at the prosecution stage is mission critical and our faculty of global thought leaders will help you develop forward-thinking strategies through our sophisticated and practical workshops and panels.

The carefully crafted modules will help attendees navigate international developments in life sciences patent law as they impact your global patent prosecution strategy, from the new Unitary Patent and Unified Patent Court in Europe, Safe Harbor exemptions around the world, or the role of AI as an inventor.

Equally, as we enter an era of increased biotech innovation and transformation, this advanced summit will help you examine recent life sciences IP controversies and patent rights with new technologies such as mRNA, CAR T and CRISPR. 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 May, join the “who’s who” of the global pharmaceutical, biotech and medtech industries as they gather in person for ACI’s 21st Advanced Summit on Life Sciences Patents, and learn how to thrive in increasingly challenging and globalized times.

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EARN CLE CREDITS

CONTINUING LEGAL EDUCATION CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing 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/

Distinguished Faculty

CHAIRS

David Diamond

Vice President and Head of IP Capstan Therapeutics

Rajiv Shah

Assistant General Counsel, Patents Johnson & Johnson

Anita Varma

Partner, Chair of IP Group White & Case LLP

GOVERNMENT

Hon. Jacqueline Wright Bonilla Deputy Chief Judge Patent Trial and Appeal Board

U.S. Patent and Trademark Office

Mary Till Senior Legal Advisor

U.S Patent and Trademark Office

Hon. Rian Kalden

Presiding Judge, Court of Appeal Unified Patent Court

Daniel Kolker, Ph.D.

Supervisory Patent Examiner

U.S. Patent and Trademark Office

Nalini Mummalaneni

Legal Advisor

U.S. Patent and Trademark Office

IN-HOUSE

Jennifer Burdman

VP, Chief Counsel Technology & Therapeutics, Chief IP Officer, Deputy General Counsel

Valo

Karen Day

Senior Counsel Pfizer

Mary Ferguson, Ph.D.

Senior Vice President, Head of IP Intellia Therapeutics

Emily Gardel, Ph.D.

Associate Director, Patent Attorney Dyno Therapeutics

Henry Gu SVP, Head of IP Zentalis Pharmaceuticals

Hilary J. Libka

Chief IP Counsel, Associate General Counsel Memorial Sloan Kettering Cancer Center

Forrester Liddle, Ph.D. Head of IP and Legal R&D (US) Novo Nordisk

Eric Majchrzak Counsel, Intellectual Property Litigation Merck Sharp & Dohme LLC

Kiera Mathey

Assistant General Counsel, Patents Johnson & Johnson

Donna Meuth Associate General Counsel, Intellectual Property Eisai

Adam Mossof

Professor of Law, Antonin Scalia Law School George Mason University

Huong T. Nguyen General Counsel Fosun Pharma USA Inc.

LAW FIRMS

Dorothy Auth, Ph.D. Partner

Cadwalader, Wickersham & Taft

Isobel Barry Partner Carpmaels & Ransford LLP

Shannon K. Clark Partner Venable LLP

Peter Corless Partner

Fox Rothschild LLP

Erin M. Dunston Partner

Panitch Schwarze Intellectual Property Law

Dr. Andreas von Falck, Ph.D. Partner

Hogan Lovells LLP

Micheline Gravelle Partner, Leader of Life Science Bereskin Parr LLP

Lisa Hillman, Ph.D. Partner

Lathrop GPM LLP

Thomas Hoxie Founding Lawyer Hoxie & Associates LLC

Professor Willem Hoyng Partner, Hoyng Rokh Monegier Chairman, Advisory Committee of the UPC, Member, Drafting Committee of the Rules of Proceedings of the UPC

Sharon A. Israel Partner

Shook, Hardy & Bacon LLP

Thomas J. Kowalski Partner Duane Morris LLP

Daniel Kracov Partner Arnold & Porter

Joseph Lucci Partner Baker Hostetler LLP

Tatiana Machado Alves Partner Licks Attorneys

Mercedes Meyer, Ph.D. Partner Banner Witcoff

Kevin E. Noonan, Ph.D. Partner

McDonnell Boehnen Hulbert & Berghoff LLP

Sandra Pohlman Partner df-mp

Stephen S. Rabinowitz Counsel

Wolf, Greenfield & Sacks, P.C.

Jane E. Remillard Partner

Nelson Mullins

Robert N. Sahr, Ph.D. Shareholder

Wolf, Greenfield & Sacks, P.C.

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

Len S. Smith Principal Counsel Transformative Legal

Michael Stern Of Counsel Covington

Joachim Wachenfeld, Ph.D. Partner Vossius & Partner

Ningling Wang

Partner, Manager of Shanghai Office Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Jeffrey A. Wolfson Partner Haynes Boone LLP

7:00am Registration and Breakfast

8:00am

Opening Remarks from Chairs

microphone-alt David Diamond, Vice President and Head of IP, Capstan Therapeutics

Rajiv Shah, Assistant General Counsel, Patents, Johnson & Johnson

Anita Varma, Partner, White & Case LLP

8:15am

Global Patent Prosecution Think Tank: Cost Effective Strategies for Procuring and Enforcing Life Sciences Patents Worldwide

microphone-alt Micheline Gravelle, Partner, Leader of Life Sciences, Bereskin Parr LLP

Tatiana Machado Alves, Partner, Licks Attorneys

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

MODERATOR: Thomas Hoxie, Founding Lawyer, Hoxie & Associates LLC

In this session, leading patent practitioners will provide you with a comprehensive and in-depth global life sciences overview to assist you in protecting your IP and minimizing risk when filing patents internationally.

• Reviewing the major patent prosecution developments around the world and how they can help expand your global portfolio:

» E.g., the substantial patent reforms in Canada throughout 2022

• Comparing patent procurement and maintenance costs in the United States to China

• Analyzing the scope of existing patent protection in various jurisdictions, including the availability of the doctrine of equivalents and preliminary injunctions

» How is each jurisdiction reacting to the new Unified Patent Court?

9:30am

Fireside Chat with UPC Appeals Judge: Weighing Risks and Rewards for Life Sciences IP Practitioners Entering into the Unified Patent Court

microphone-alt

Professor Willem Hoyng, Partner, Hoyng Rokh Monegier Chairman, Advisory Committee of the UPC Member, Drafting Committee of the Rules of Proceedings of the UPC

Isobel Barry, Partner, Carpmaels & Ransford LLP

Hon. Rian Kalden, Presiding Judge, Court of Appeal, Unified Patent Court

• After delays and detours, examining what UPC procedures, including appeals, will look like going forward

• How will UPC judges approach areas of law where there is inconsistency across jurisdictions?

• How will the UPC judges align on handling conundrums including preliminary injunctions, timing/urgency, evidence and the application of discretion?

10:30am Networking Break

10:45am

Patent Term Adjustments, Extensions, and the European Supplementary Protection Certificates: Masterful Practice Notes for Extending Global Patent Portfolios

microphone-alt Henry Gu, SVP, Head of IP, Zentalis Pharmaceuticals

Sandra Pohlman, Partner, df-mp

Mary Till, Senior Advisor, U.S. Patent and Trademark Office

SPC CASE LAW AND REFERRALS

• Examining the impact of recent SPC case law and latest referrals for preliminary rulings on the interpretation of Article 3(c) of the SPC Regulation

• Unitary SPCs

» Examining how existing SPCs will operate under the Unified Patent Court, and how the new Unitary Patent will affect SPC filing strategies

» Exploring how the current status of reforms and the plans of the European Commission regarding the introduction of a Unitary SPC

• Comparing European standards to American standards for extensions and adjustments

PATENT TERM ADJUSTMENTS AND EXTENSIONS

• When is it beneficial to seek a PTE on the compound patent in the US?

• Overcoming the hurdle of different definitions of active ingredient at the FDA compared to the USPTO

» What is the active ingredient in a cell-based or gene-therapy based formulation?

• Understanding when and how an extension may undermine claims of prima facie infringement in Australia

• Understanding China’s new patent term extension laws

Good mix of in-house, private practice, and government.

12:00pm

Obviousness-Type Double Patenting: Safeguarding Life Sciences Ownership Now and Facilitating the Success of Future Patent Applications

microphone-alt Robert N. Sahr, Ph.D., Shareholder, Wolf, Greenfield & Sacks, P.C.

Mary Till, Senior Legal Advisor, U.S. Patent and Trademark Office

Jane E. Remillard, Partner, Nelson Mullins

• Review of recent Federal Circuit cases related to obviousness-type double patenting

• Unpacking In Re Cellecte and:

» Whether PTA and PTE should be treated alike for the purposes of OTDP

» Whether it is valid for the patent office to apply OTDP rejections to expired challenged patents that had different expiration dates solely due to PTA periods.

» Examining when a terminal disclaimer can be utilized to overcome an OTDP rejection

1:00pm Networking Lunch

2:15pm

Drug Prices and Patents: Legislative and Policy Trends You Cannot Ignore

microphone-alt

Hilary J. Libka, Chief IP Counsel, Associate General Counsel, Memorial Sloan Kettering Cancer Center

Kiera Mathey, Assistant General Counsel, Patents, Johnson & Johnson

Mercedes Meyer, Ph.D., Partner, Banner Witcoff

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

MODERATOR: Rajiv Shah, Assistant General Counsel, Patents, Johnson & Johnson

• Unpacking the Inflation Reduction Act and its influence on patent litigation and market entry strategies for both brand and generic companies.

• Responding to concerns that patent term extensions and double-patenting creates patent thickets

• Revisiting the Bayh Dole Act and march-in rights as the COVID pandemic continues

• Update on the TRIPS waiver and why the US is no longer supportive

• Tracking the expansion of the 340B Drug Pricing Program

3:30pm Networking Break

3:45pm

Skinny Labelling Claims and Safe Harbor Exemptions Around the World: Bullet-Proofing Your Patent Portfolio

microphone-alt Shannon K. Clark, Partner, Venable LLP

Dr. Andreas von Falck, Partner, Hogan Lovells

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

Eric Majchrzak, Counsel, Intellectual Property Litigation, Merck Sharp & Dohme LLC

The life sciences IP community has been closely following the GSK v Teva saga, with Teva planning to take the case to the U.S. Supreme Court. Until then, brand IP practitioners continue to develop strategies to argue against generic carve outs of non-patented or off-label indications, and this session will get you up to speed on the newest tactics to prevent such carve outs. Topics of discussion include:

• Reviewing recent case law to understand how courts read drug labels for evidence of intent to induce infringement and how generics attempt to carve out indications

» Using the Amarin v Hikma as a roadmap for brand companies to structure their labelling for better chances of success in future skinny labelling cases

» Will Teva serve as an example for future litigation in light of the decision in Hikma?

» Updating your Orange Book listings for the strongest protection against carve outs

• Contrasting the differences in drafting strategy when the skinny label pertains to a patent covering a new indication as opposed to a method of use.

4:45pm

The Freedom to Operate: Evaluating Current Strategies to Avoid Future Findings of Infringement

microphone-alt Dorothy Auth, Ph.D., Partner, Cadwalader, Wickersham & Taft

Jeffrey A. Wolfson, Partner, Haynes Boone LLP

Len S. Smith, Principal Counsel, Transformative Legal

• Understanding how extensive search sequencing should be during FTO

• Evaluating the most effective process for FTO analysis

» Should it be in the hands of inhouse or outside counsel?

• Understanding patent exclusivity vs regulatory exclusivity

• Analyzing when during R&D third party patents discovered through FTO should be of concern

• Seeking out the current capabilities of FTO relating to biologic patents

5:45pm Day One Adjourns

7:00am Registration and Breakfast

8:00am

Opening Remarks from Chairs

microphone-alt David Diamond, Vice President and Head of IP, Capstan Therapeutics

Rajiv Shah, Assistant General Counsel, Patents, Johnson & Johnson

Anita Varma, Partner, White & Case LLP

8:15am

Hedging your Bets Ahead of Amgen v Sanofi: Satisfying the Requirements of Enablement and Written Description for Genus Claims

microphone-alt Forrester Liddle Ph.D., Head of IP and Legal R&D (US), Novo Nordisk

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

Joseph Lucci, Partner, Baker Hostetler LLP

MODERATOR: David Diamond, Vice President and Head of IP, Capstan Therapeutics

The life sciences IP community waits with bated breath for the U.S. Supreme Court’s decision in Amgen v Sanofi. Whether the Supreme Court upholds the Federal Circuit’s decision or rejects it, life sciences patent prosecution strategies will transform and this session will prepare you for either outcome. Topics of discussion will include:

• Devising alternate strategies for drafting enforceable claims should the scope of appropriate claims for antibodies remain restrictive

• Creating new strategies for drafting enforceable claims should the Supreme Court reverse the federal court’s decision

• Understanding the nuances between written description and enablement

» Why did the Supreme Court decline to hear Kite v Juno?

» Updating prosecution portfolio and litigation strategy if the Supreme Court finds that written description is a fact but enablement a question of law

9:15am Networking Break

9:30am

The Elusive Subject Matter Eligibility Standard in Medtech, Machine Learning and Diagnostics: To Patent or Not to Patent?

microphone-alt Jennifer Burdman, Vice President, Chief Counsel, IP, Valo

Emily Gardel, Ph.D., Associate Director, Patent Attorney, Dyno Therapeutics

Daniel Kolker, Ph.D., Supervisory Patent Examiner, U.S. Patent and Trademark Office

Nalini Mummalaneni, Legal Advisor, U.S. Patent and Trademark Office

• Addressing ownership and inventorship

» 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)

• Learning the newest life sciences prosecution strategies for obtaining patents on medtech, machine learning, and diagnostics

» Understanding whether the goal is to protect the algorithms or conclusions made by your AI or software, compared to protecting the product developed by AI or software

» How to draft claims that comply with USPTO §101 guidance documents while also avoiding divided infringement

• Delineating which non-U.S. jurisdiction are favorable to granting patents involving AI and digital health tech

• Appreciating the advantages and disadvantages of trade secrecy as an alternative form of protection

» Learning how to make and keep a trade secret

10:30am

CRISPR, CAR T and mRNA: Scrutinizing Recent Life Sciences IP Controversies to Develop a New Way Forward

microphone-alt

Lisa Hillman, Ph.D., Partner, Lathrop GPM LLP

Kevin E. Noonan, Ph.D., Partner, McDonnell Boehnen Hulbert & Berghoff LLP

Thomas J. Kowalski, Partner, Duane Morris LLP

Mary Ferguson, Ph.D., Senior Vice President, Head of IP, Intellia Therapeutics

Securing life sciences rights to novel therapeutics and technologies like CRISPR, CAR T and mRNA and leveraging or licensing these rights appropriately is essential to successful commercialization, growth, and future development of these innovations. This session will review the current landmines and hurdles in biotech, and then provide an insightful exchange on obtaining and enforcing biotech patents.

• Reviewing the newest prosecution strategies for CRISPR, CAR T and mNRA therapies and products

» Emphasizing the importance of including a claim on any medical devices incorporated into the biotech invention

» Responding to novelty and subject matter eligibility rejections from the USPTO

• CRISPR licenses: update on the Broad Institute patent legal battle

» Best practices for licensing and collaborations with biotech

• Considering the biotech patent landscape in non-U.S. jurisdictions

11:30pm Networking Lunch

Very enjoyable – wonderful speakers that are well qualified – great content.

12:45pm

USPTO Keynote

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

1:15pm

What to Expect from the USPTO in 2024: Bolstering your Life Sciences Patent Prosecution and Litigation Strategies Following Recent Developments at the PTAB

microphone-alt Erin M. Dunston, Partner, Panitch Schwarze Intellectual Property Law

Sharon A. Israel, Partner, Shook, Hardy & Bacon LLP

Stephen S. Rabinowitz, Counsel, Wolf, Greenfield & Sacks LLP

• Update on the latest legislative proposals addressing PTAB proceedings and unpacking their potential impact on prosecution and litigation strategy

• Navigating the estoppel effect in IPR proceedings

• Anticipating what the discretionary powers of the Director and the PTAB review process means for your IPR and PGR strategy:

» Discussing the implications of Fintiv, now remanded back to District Court

» Addressing how non practicing entities may be treated as abusing the IPR process as in the cases of Patent Quality Assurance v VLSI and OpenSky v VLSI

» Understanding when and how the USPTO can assert prosecution laches as a defense

2:15pm Networking Break

2:30pm

Novelty, Non-Obviousness and Inventive Step: Interpreting Recent Case Law and Improving Prosecution Strategies

microphone-alt Peter Corless, Partner, Fox Rothschild LLP

Donna Meuth, Associate General Counsel, Intellectual Property, Eisai

Joachim Wachenfeld, Ph.D., Partner, Vossius & Partner

MODERATOR: Anita Varma, Partner, White & Case LLP

• Comparing non-obviousness and inventive step differences in the U.S. versus the EU towards satisfying the both domestic and international statutory requirements

• Unpacking recent case law in the U.S. and abroad on prior art

» Addressing whether “applicant admitted prior art” can form the prior art basis for an IPR: Apple v. Qualcomm

• Developing new strategies for meeting the non-obvious and inventive step requirements

• Reviewing new and uncommon methods of conducting prior art searches

3:30pm

Don’t Forget the Regulator: Recent FDA Developments That Patent Attorneys and Cannot Ignore

microphone-alt Daniel Kracov, Partner, Arnold & Porter

Michael Stern, Of Counsel, Covington

Karen Day, Senior Counsel, Pfizer

• Appreciating how FDA determinations impact CMS’s selection of drugs or biologics for price negotiations under the Inflation Reduction Act

• Revisiting your R&D strategy (timing, submissions) and investor relations

• Unpacking how FDORA will trickle down into your regulatory strategies:

• How the amendments touching on the uses of real-world data (RWD) and real-world evidence (RWE) can be used for products approved under emergency use authorization

• What the modernizing of accelerated approval means for your drug pipeline

• Understanding important updates to exclusivity:

• The scope of orphan drug exclusivity following the Catalyst decision

• Exclusivity for interchangeable biosimilars

• Meeting your duties of disclosure and reasonable inquiry and considering the potential impact of the proposed USPTO-FDA collaboration on those duties

4:30pm Conference Concludes

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Register and pay to lock in your early rate and be eligible for a full refund until May 4, 2023.

If you are unable to attend for any reason, you will have the following options:

y A full credit note for you, or a colleague to attend another event.

y A full refund.

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Venue & Accommodation

VENUE: New York Bar Association

ADDRESS: 42 West, 44th Street, New York, NY 10036-6689

ACCOMMODATIONS: Sofitel New York Hotel

ADDRESS: 45 West, 44th Street, New York, NY

RESERVATIONS: 1-212-782-3015

Interested

If you choose to attend via livestream you can expect true interaction virtually from start to finish. Contact our customer service team at 1-888-224-2480 or customerservice@americanconference.com to learn more about this option.

American Conference Institute 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 “Life Science Patents”

Please note that the guest room block cut-off date is April 17th, 2023 After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

PLEASE NOTE THE FOLLOWING PANDEMIC-RELATED PROTOCOLS:

ACI conferences and events will be organized in accordance with the latest health and safety regulations, guidelines, and recommendations, directed by the CDC and local government authorities. Attendees are advised to consider their personal health needs.

Attendees are asked to self-screen in the days leading up to, before and after attending an ACI event and/or conference.

We will continue to monitor the health situation and relevant authorities. Changes to health and safety measures may be made by ACI at any time as required.