Life Sciences Patents

Registration and Breakfast

Opening Remarks from Chairs

David Diamond
Vice President and Head of IP
Capstan Therapeutics

Rajiv Shah
Assistant General Counsel, Patents
Johnson & Johnson

Anita Varma
Partner
White & Case LLP

Global Patent Prosecution Think Tank

Cost Effective Strategies for Procuring and Enforcing Life Science Patents Worldwide

Tatiana Machado Alves
Partner
Licks Attorneys

Micheline Gravelle
Partner, Leader of Life Science
Bereskin Parr LLP

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 IP overview to assist you in protecting your IP and minimizing risk when filing patents internationally.

• Reviewing the major patent prosecution changes 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, Canada and Brazil
• 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?

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

Isobel Barry
Partner
Carpmaels & Ransford LLP

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

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

Fireside Chat with UPC Appeals Judge:

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

Networking Break

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

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 the 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

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

Jane E. Remillard
Partner
Nelson Mullins

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

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

• 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 ODTP 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 obviousness-type double patenting rejection

Networking Lunch

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

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 Mossoff
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

Networking Break

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

Shannon K. Clark
Partner
Venable LLP

Dr. Andreas von Falck, Ph.D.
Partner
Hogan Lovells LLP

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

Huong Nguyen
General Counsel
Fosun Pharma USA Inc.

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.

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

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

Day One Adjourns

Registration and Breakfast

Opening Remarks from Chairs

David Diamond
Vice President and Head of IP
Capstan Therapeutics

Rajiv Shah
Assistant General Counsel, Patents
Johnson & Johnson

Anita Varma
Partner
White & Case LLP

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

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

Christopher P. Singer, Ph.D
Shareholder
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

Networking Break

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

Jennifer Burdman
VP, Chief Counsel Technology & Therapeutics
Chief IP Officer, Deputy General Counsel
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 patent 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-US 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

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

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

Lisa Hillman, Ph.D.
Partner
Lathrop GPM LLP

Thomas J. Kowalski
Partner
Duane Morris LLP

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

Securing IP 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 the biotech space and then provide an insightful exchange on obtaining and enforcing biotech patents.

• 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-US jurisdictions

Networking Lunch

USPTO Keynote

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

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

Erin M. Dunston
Partner
Panitch Schwarze Intellectual Property Law

Sharon A. Israel
Partner
Shook, Hardy & Bacon LLP

Stephen S. Rabinowitz
Counsel
Wolf, Greenfield & Sacks, P.C.

• Update on the latest Notices of Proposed Rulemaking 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

Networking Break

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

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 US 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

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

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

Conference Concludes