19th Advanced Summit on Life Sciences Patents - WEB

EARN CLE/ETHICS CREDITS

July 21–22, 2021 | Virtual Conference

19th 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

Benefit from the Insights of Our Distinguished Conference Co-Chairs:

Learn from Key Industry Leaders:

Dr. Leslie Fischer Principal Patent Attorney Sandoz Duane Marks Assistant General Patent Counsel Eli Lilly and Company

Microphone-alt Keynote Speaker: Andrew Faile Acting Commissioner for Patents U.S. Patent and Trademark Office

Cara Coburn Associate General Counsel, Patent Law Genentech

Donna Meuth Associate General Counsel, Intellectual Property Eisai

Sarah Hooson Counsel, Patents Merck

Brendan M. O’Malley Vice President, Head of Legal & IP Corporate Secretary Abeona Therapeutics Inc.

Jenny Papatolis Johnson Intellectual Property Executive Director Endo Pharmaceuticals Mythili Markowski Senior Patent Attorney Novartis

Meaghan Richmond Assistant General Counsel AstraZeneca Laura Wine Associate General Counsel, Intellectual Property Arena Pharmaceuticals, Inc.

CONFERENCE HIGHLIGHTS INCLUDE: » An International Global Patent Strategy Think Tank » An Analysis of PTAB Developments Impacting Patent Prosecution and Litigation » Focus Session on the Future Landscape of §101 » An Assessment of Global Perspectives on Written Description and Enablement in Antibody Patent Claims Supporting Sponsors:

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» Life Sciences Litigator Think Tank: “What I Wish the Patent Prosecutor Would Have Done” » A Retrospective on International Strategies for Obtaining Method of Treatment/Second Medical Use Patents » Round Table Discussion: Incorporating the Latest Doctrine of Equivalents Decisions into Your Global Patent Prosecution Strategy

Associate Sponsors:

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ACI’s 19th Global Summit on Life Sciences Patents virtual conference this July will provide practical insights on how to implement bullet-proof patent prosecution tactics, maximize patent life cycles, and develop strategies to enhance protections for your patent portfolio.

By bringing together the collective knowledge and practical experiences of leading in-house IP counsel, patent prosecutors and litigators, the USPTO, and policy experts 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.

Interactive Virtual Conference Experience This program is designed to bring the dynamic, in-person conference experience to you virtually with multiple ways to engage with speakers, stay connected with industry peers and expand your professional network through 1-on-1 conversations.

VIRTUAL NETWORKING OPPORTUNITIES

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Take advantage of 1:1 speed networking, exhibit hall meetups and direct video chats with fellow conference participants. Your next legal team, business partner, or client could be right in one of our virtual networking rooms — it is up to you to find them!

POLLING Weigh in and seize the opportunity to benchmark with industry peers in real-time on leading issues such as sensitive, complex hypothetical scenarios.

VIRTUAL SPEAKER MEET AND GREETS Come camera ready and engage in an interactive think-tank with some of our key patent litigators about “what they wish the patent prosecutor would have done.” Take advantage of the opportunity to meet our speakers face-to-face, ask targeted questions, receive real time answers and share your own thoughts on how decisions during the patent prosecution stages can impact future litigation.

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DISTINGUISHED FACULTY CO-CHAIRS Dr. Leslie Fischer Principal Patent Attorney Sandoz Duane Marks Assistant General Patent Counsel Eli Lilly and Company DISTINGUISHED SPEAKERS Takanori Abe Managing Partner ABE & Partners Brenton Babcock Chair, PTAB Trials Practice Group Loeb & Loeb LLP Poopak (Paki) Banky IP Litigation Counsel Novartis Adrian Bradley Partner Cleveland Scott York (Thames Valley Reading, UK) Cara Coburn Associate General Counsel, Patent Law Genentech Jim Czaban Partner Loeb & Loeb LLP Tina Dorr, Ph.D. Partner Cantor Colburn LLP Briana Erickson, Ph.D. Partner Womble Bond Dickinson (US) LLP Andrew Faile Acting Commissioner for Patents U.S. Patent and Trademark Office (USPTO) Dr. Leslie Fischer Principal Patent Attorney Sandoz Kathleen Kahler Fonda Senior Legal Advisor, Office of Patent Legal Administration U.S. Patent and Trademark Office (USPTO) Wanda French-Brown Partner Loeb & Loeb LLP

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James M. Gould Counsel RatnerPrestia

Amir Naini Senior Counsel Proskauer Rose LLP

Felicity E. Groth Partner BakerHostetler

Honorable Michelle NerozziAnkenbrand Lead Administrative Patent Judge U.S. Patent and Trademark Office (USPTO) Patent Trial and Appeal Board

Miriam Gundt Partner Hogan Lovells International LLP (Dusseldorf, Germany) Siegmund (“Sige”) Gutman Partner Chair, Life Sciences Patent Practice Proskauer Rose LLP Sarah Hooson Counsel, Patents Merck Dr. Sebastian Höpfner Partner German and European Patent and Trademark Attorney Bird & Bird (Munich, Germany) Charlotte Jacobsen Partner Ropes & Gray LLP Jenny Papatolis Johnson Intellectual Property Executive Director Endo Pharmaceuticals Thomas J. Kowalski Partner Duane Morris LLP

Katie Nolan-Stevaux Assistant General Counsel, Litigation Genentech Kevin Noonan Partner McDonnell Boehnen Hulbert & Berghoff LLP Ricardo Nunes Partner Daniel Law (Rio de Janeiro, Brazil) Brendan M. O’Malley Vice President, Head of Legal & IP Corporate Secretary Abeona Therapeutics Inc. Filko Prugo Partner Chair, Life Sciences IP Litigation Ropes & Gray LLP Guido Pontremoli, Ph.D. Global IP Head Corp. Intellectual Property-Patents Chiesi Farmaceutici S.p.A (Parma, Italy)

Mythili Markowski Senior Patent Attorney Novartis

Honorable Teresa Rea Partner Crowell & Moring LLP (Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)

Duane Marks Assistant General Patent Counsel Eli Lilly and Company

Meaghan Richmond Assistant General Counsel AstraZeneca

Catherine McCarty Partner Goodwin Procter LLP

MaCharri Vorndran-Jones Assistant General Patent Counsel Eli Lilly and Company

Donna Meuth Associate General Counsel, Intellectual Property Eisai

Sharon Walker, Ph.D. Director Legal Translate Bio

John Livingstone Managing Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Rachel Mumby Partner Bristows LLP (London, UK)

AmericanConference.com/LSPatents • 888 224 2480

Laura Wine Associate General Counsel, Intellectual Property Arena Pharmaceuticals, Inc.

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

day 1 • Wednesday, July 21, 2021 10:00

12:00 Break

Co-Chairs Opening Remarks

12:15

Microphone Dr. Leslie Fischer, Principal Patent Attorney, Sandoz

Keynote Address

Duane Marks, Assistant General Patent Counsel, Eli Lilly and Company

Microphone Andrew Faile, Acting Commissioner for Patents, U.S. Patent and Trademark Office (USPTO)

10:15

Redefining Your Global Patent Prosecution Strategy for 2021: Addressing the Top Challenges Companies are Currently Facing in Securing Patent Ownership in the U.S., Europe, China and Brazil Microphone Miriam Gundt, Partner, Hogan Lovells International LLP

12:45

PTAB Year in Review: Examining the Latest PTAB Developments Impacting Patent Prosecution and Litigation, Key Federal Circuit Cases Involving the PTAB in the Last Year and an Update on Arthrex

Mythili Markowski, Senior Patent Attorney, Novartis

Catherine McCarty, Partner, Goodwin Procter LLP

Microphone Honorable Michelle Nerozzi-Ankenbrand, Lead Administrative Patent Judge, U.S. Patent and Trademark Office (USPTO), Patent Trial and Appeal Board

Ricardo Nunes, Partner, Daniel Law, (Rio de Janeiro, Brazil)

Brenton Babcock, Chair, PTAB Trials Practice Group, Loeb & Loeb LLP

Brendan M. O’Malley, Vice President, Head of Legal & IP, Corporate Secretary, Abeona Therapeutics Inc.

Tune in as a panel of leading patent attorneys from both sides of the Atlantic provide key strategies for protecting your IP and minimizing risk when filing patents internationally. Engage in a unique opportunity to examine vital considerations for patent prosecution at both the USPTO and European Patent Office, and overcome the latest challenges to patent procurement both in the U.S. and abroad. Topics of discussion will include: • Comparing and contrasting the standards of patentability and related issues in the US and Europe • Developing strategies to achieving patent protection in the U.S., Europe and China within one-year time frame • Discussing the most cost-effective processes in patent applications in the U.S and abroad • How do patent assignments affect ownership and patent prosecution rights in the U.S. vs. the EU? 11:15

Gauging the Continued Impact of the Novel Coronavirus Across the Global IP Market: Compulsory Licensing and March-In Rights in the Age of COVID-19 Microphone Kevin Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP

Meaghan Richmond, Assistant General Counsel, AstraZeneca

• Assessing how the search for a Covid-19 cure has affected drug development and patent prosecution • Examining the measures being undertaken by patent offices around the world with regard to Covid-19 related patents and how they will impact patent prosecution and examination • Exploring the potential impact that government use provisions and Bayh-Dole “march in rights” will have on life science companies developing pharmaceuticals and medical devices to address the current COVID-19 pandemic

Update on Arthrex & Discretionary Denials • Examining the current status of Arthrex: the latest developments in the Supreme Court’s review of the constitutionality of APJ appointments • Assessing the continued surge of discretionary denials of PTAB trials, and new incidences of forums foreclosing PTAB challenges altogether • Analyzing developments in Apple, Google, Cisco and Intel’s litigation with the PTAB challenging it’s IPR discretionary denial precedent — how may developments in this litigation impact similar rulings in the life sciences arena?

Latest PTAB Developments Impacting Prosecution and Litigation • Exploring the latest PTAB statistics in the life sciences arena, as well as recently designated precedential decisions • Analyzing the implications of new PTAB rules and pilot programs (e.g. the Fast Track Appeals pilot) • Examining how the newly clarified standard for indefiniteness is being applied in AIA post-grant proceedings • Assessing the latest trends in PTAB motion to amend practice: how many patent proprietors are successfully amending their claims and what are the outcomes of those amendments?

• How is the PTAB ruling on inherency determinations in contentious proceedings? What kind of data and evidence needs to be shown to establish it?

2:00

1:1 Networking

• Exploration of applicable compulsory licensing laws around the world

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4:15

Written Description and Enablement in Antibody Patent Claims: International Perspectives on Establishing the Scope of Antibody Claims and Incorporating the Latest Developments into Your Patent Prosecution Strategy Microphone Takanori Abe, Managing Partner, ABE & Partners

2:15

Lunch Break

Dr. Sebastian Höpfner, Partner, German and European Patent and Trademark Attorney, Bird & Bird

Duane Marks, Assistant General Patent Counsel, Eli Lilly and Company

moderator: Briana Erickson, Ph.D., Partner, Womble Bond Dickinson (US) LLP

3:00

Determining the Future Landscape of §101: Will We Ever Have Clarity on Patent Subject Matter Eligibility?

Microphone Cara Coburn, Associate General Counsel, Patent Law, Genentech

• How has the recent Federal Circuit decision in Amgen v Sanofi (Fed. Cir. 2021) raised the enablement bar for antibody patents and what will the implications be going forward?

• Creative strategies for claiming monoclonal antibodies in order to secure the broadest claim possible from the patent office

Thomas J. Kowalski, Partner, Duane Morris LLP

Donna Meuth, Associate General Counsel, Intellectual Property, Eisai

Amir Naini, Senior Counsel, Proskauer Rose LLP

• Establishing the scope of claims for obtaining antibody patents at the USPTO, EPO, and JPO: what can be found as valid and enforceable antibody patent in the US vs. EU vs. Japan?

5:15

The Supreme Court has yet to solve or provide clarity on §101, leaving only confusion resulting from decisions from the last decade. This session will explore topics including:

INTERACTIVE SESSION

Life Sciences Litigator Think Tank: “What I Wish the Patent Prosecutor Would Have Done” Microphone Poopak (Paki) Banky, IP Litigation Counsel, Novartis

• Understanding how Supreme Court Guidance in Am. Axle & Manufacturing could impact how patent prosecutors draft their future claims

Siegmund (“Sige”) Gutman, Partner, Chair, Life Sciences Patent Practice, Proskauer Rose LLP

» Anticipating whether the court will finally provide clarity on 101

Katie Nolan-Stevaux, Assistant General Counsel, Litigation, Genentech

Filko Prugo, Partner, Chair, Life Sciences IP Litigation, Ropes & Gray LLP

• How can biotech companies best protect their diagnostic inventions in the current 101 environment absent a clear roadmap set forth by the court? How could Supreme Court intervention in Illumina change this going forward?

• Assessing the most recent 101 cases applying the Supreme Court’s Alice/Mayo tests before the Federal Circuit – what are we extrapolating from these decisions absent clear guidance from the Supreme Court?

• Examining the Federal Circuit’s treatment and application of the USPTO’s recent patent eligibility (PEG) guidance

This unique session will feature a panel of patent litigators who will share personal accounts of challenges they have faced in IPRs and litigation and reflect on what they wished the prosecutor of the patent would have done in the early stages to prevent or mitigate the issues that developed down the road. The panelists will talk through scenarios where a more favorable outcome could have been achieved in litigation had the prosecutor changed certain language in the claim, argued something differently during prosecution, or even built the portfolio in a different way overall. Attendees will then have the opportunity to come on camera at the end of the session to meet the speakers face-to-face, share their own personal insights and ask questions of our panelists.

4:00

6:15

• Examining the trend of using §101 as a substitute for §112 in policing broad claims: are we missing out on opportunities to further develop the case law on §112?

• Developing best practices for drafting patent claims within the current 101 landscape to avoid unpatentable subject matter findings

Afternoon Break

Conference Adjourns

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day 2 • Thursday, July 22, 2021 10:00

» How is the waiver going to be used and what will the response to using the waiver be?

Co-Chairs’ Opening Remarks and Recap of Day 1

» What requirements and qualifications need to be met to use the waiver?

10:15

Examining the Recent Resurgence of Doctrine of Equivalents: Weighing the Effects of the Latest DoE Decisions on Patent Prosecution and Litigation Strategies in the U.S., Europe and Asia

» What is the scope of the waiver? What acts are specifically excepted from patent infringement? » Who can use the waiver? » What partner activities are exempt from infringement?

Microphone Wanda French-Brown, Partner, Loeb & Loeb LLP

» What will the points of attack be?

John Livingstone, Managing Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Guido Pontremoli, Ph.D., Global IP Head, Corp. Intellectual Property-Patents, Chiesi Farmaceutici S.p.A

1:1 Networking 12:30

Sharon Walker, Ph.D., Director Legal, Translate Bio

Across global jurisdictions, the extent of patent protection is defined by the claims as read literally – or, under the Doctrine of Equivalents. In the U.S., the courts seem to recently be taking a more expansive view on the application of DoE in finding patent infringement. Meanwhile, across Europe, each jurisdiction has its own infringement test, making it difficult to predict the outcomes of infringement proceedings based on DOE. This session will consider the current status of the Doctrine of Equivalents in the U.S. and across Europe, as well as the latest DoE developments in Japan.

• Understanding the practical implications of the latest DoE case law developments in the U.S. • Examining the impact of Eagle Pharmaceuticals v. Slayback Pharma (Fed. Cir. 2020) on the future use of the disclosure-dedication doctrine • How can you draft a claim so you can get the broadest interpretation of Doctrine of Equivalents in a subsequent litigation?

• Analyzing biologics under the Doctrine of Equivalents: How is the DoE being applied for small molecules vs. biologics?

• Comparing and contrasting the latest DoE decisions in the UK, Netherlands, Germany, France and Japan • Developing best practices for drafting patents to ensure DoE claims are covered for UK courts 11:15

Morning Break

Lunch Break

A Focus on Method of Treatment/ Second Medical Use Patents 1:15

Exploring Effective Strategies for Obtaining Method of Treatment/Second Medical Use Patents, Personalized Medicine Patents and Dosage Regimen Patents Microphone Adrian Bradley, Partner, Cleveland Scott York

Felicity E. Groth, Partner, BakerHostetler

Jenny Papatolis Johnson, Intellectual Property Executive Director, Endo Pharmaceuticals

While method of treatment/second medical use patents, personalized medicine patents and dosage regimen patents are all very valuable to a patent portfolio, they often prove to be difficult to obtain as they are viewed rather harshly by global patent offices. Further, what you must show to obtain such patents differs across global jurisdictions, adding additional challenges to a company’s pursuit of them. This panel will examine topics including: • What are the key challenges and hurdles being faced in obtaining these types of patents?

• What strategies can be employed to help succeed in procuring such patents?

11:30

Patent Term Extension Developments in the U.S. and Europe: Examining the Implications of Biogen v. Banner and Deciphering Europe’s SPC Manufacturing Waiver Microphone Charlotte Jacobsen, Partner, Ropes & Gray LLP

12:15

• Analyzing different approaches you can take to writing these claims which may yield success in the US and abroad • What do you have to show in the US, EU, Japan and China in order to obtain Second Medical Use, Personalized Medicine and Dosage Regimen patents?

Rachel Mumby, Partner, Bristows LLP

• Understanding how the Federal Circuit’s decision in Biogen Int’l GmbH v.

Banner Life Scis. LLC (Fe. Cir. 2020) may influence the future application of patent term extensions in the U.S. • Taking a closer look at Europe’s Supplementary Protection Certificate Waiver: this legislation provides a patent term extension during which European generic and biosimilar manufacturers can continue to produce protected medicines for export or stockpiling. Examining pressing questions including:

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2:15

INTERACTIVE CASE STUDY

Evaluating the Consequence of a Skinny Label: Implications of GSK v. Teva Microphone Jim Czaban, Partner, Loeb & Loeb LLP

James M. Gould, Counsel, RatnerPrestia

Sarah Hooson, Counsel, Patents, Merck

This panel will analyze GSK v. Teva – a case which epitomizes the major challenges that can arise with method of treatment/second medical use patents. Following the recent decision of the Federal Circuit to vacate its prior finding that Teva induced infringement, both brand and generic drug manufacturers are currently awaiting an outcome which will have a profound impact on the future use of skinny label carve outs. Topics of discussion will include: • Understanding the role of skinny labeling in the FDA’s regulation of innovative and generic drug products • Understanding the significant implications of the Federal Circuit striking down label carve outs

3:00

Afternoon Break

3:30

Navigating the Current Obviousness Landscape: Integrating the Latest Developments in ObviousnessType Double Patenting and Inherency into Your Patent Prosecution Approach Microphone Tina M. Dorr, Ph.D., Partner, Cantor Colburn LLP

Kathleen Kahler Fonda, Senior Legal Advisor, Office of Patent Legal Administration, U.S. Patent and Trademark Office (USPTO)

Laura Wine, Associate General Counsel, Intellectual Property, Arena Pharmaceuticals, Inc.

• Analyzing the latest obviousness-type double patenting case law developments in the U.S. • Examining the implications of Immunex v. Sandoz (Fed. Cir. 2020) on the standard for determining common ownership in applying ODP • What is the status of current legislation being proposed around ODP?

• Reconciling whether launching with a skinny label that carves out infringing methods violates a patented method of use

• Developing strategies for avoiding and overcoming obviousness-type double patenting rejections

• What impact will GSK v. Teva have on prosecution strategies and tactics for drafting claim language and label language?

• Inherency and Obviousness Development Updates

• Examining the impact on future drug development and FDA regulatory strategies

4:15

• Incorporating skinny labeling considerations into your patent prosecution strategy in light of GSK v. Teva » When to start thinking about these issues in the early stages of planning your patent protection

EARN CLE/ETHICS

Microphone Honorable Teresa Rea, Partner, Crowell & Moring LLP, (Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)

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.

LIVE POLLING

Interactive Ethics Lab: Overcoming Common Challenges and Ethical Dilemmas in Patent Prosecution

MaCharri Vorndran-Jones, Assistant General Patent Counsel, Eli Lilly and Company

Test your ethical skills with a series of anonymous polling questions on sensitive hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in patent prosecution compares to your peers and benefit from a practical discussion of the polling results and important takeaways for your practice.

5:15

Conference Concludes

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.

For more information on ACI’s CLE process for virtual events visit: www.americanconference.com/accreditationinstructions-for-virtual-attendance/

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