Pre-Conference Workshops

Workshop A – Patents Around the World Working Group: How to Execute a Cohesive International Patent Prosecution Strategy

May 15, 2019 9:00am – 12:30pm

Speakers

Tjibbe Douma
Partner
Dentons (Amsterdam, Netherlands)

Robert Sullivan
Managing Principal
Fish & Richardson (New York, NY)

Workshop B – Antibody Claims Drafting Master Class: Strategies for Ensuring Success in U.S.

May 15, 2019 1:30pm – 5:00pm

Speakers

Forrester Liddle
Senior Director of Intellectual Property
Jounce Therapeutics (Cambridge, MA)

Christopher Loh
Partner
Venable LLP

Larry Coury
Vice President, Associate general Counsel
Regeneron Pharmaceuticals

Day 1 - Thursday, May 16, 2019

7:45
Registration Begins
8:30
Co-Chairs’ Opening Remarks
8:45
Inter-Continental Considerations for Patent Portfolios: Devising Bullet Proof Strategies to Secure Patent Ownership in U.S., Europe and China
9:30

USPTO Keynote Address

Examining the PTAB’s Latest Priorities, Review Procedures and New Developments Impacting IPR?
10:30
Networking Coffee Break
10:45
New §101 Landscape: Exploring the Latest Developments at the PTO and District Court Relative to Patent Eligibility
11:45
Obviousness-Type Double Patenting: Safeguarding Patent Ownership Now and Facilitating the Success of Future Patent Applications
12:45
Networking Luncheon
1:45

FIRESIDE CHAT

Exploring the Controversy over The Use of Printed Publications in Patent Prosecution at the PTAB
2:15
Freedom to Operate: Evaluating Current Strategies to Avoid Future Findings of Infringement
3:15
Networking Refreshment Break
3:30
Patent Extensions: Prolonging Your Patent Lifecycles in the U.S. — Europe — Canada
4:30
Revisiting the Doctrine of Equivalence: How to Utilize It to Prevent Patent Infringement
5:30
Conference Adjourns to Cocktail Reception Sponsored by: Loeb & Loeb LLP

Day 2 - Friday, May 17, 2019

9:00
Co-Chair’s Opening Remarks and Recap of Day One
9:15

Focus on Antibodies

Antibody Patent Review: Global Perspectives on Enhancing Biologic Assets Protections
10:45
Networking Break
11:00

Focus on Antibodies

§112 Written Description Properly Circumscribing the Scope of Claims to Monoclonal Antibodies
12:00
Networking Luncheon
1:00
Europe — Post Brexit Effect: Update on the Unified Patent Court and the Future of the Unitary Patent
2:00
Exploring the Intersection Between High Tech AI, Data Mining, Discovery and Patent Protection
3:00
Networking Break
3:30
Ethical Considerations for Life Sciences Patent Prosecution
4:30
Conference Concludes

Day 1 - Thursday, May 16, 2019

7:45
Registration Begins
8:30
Co-Chairs’ Opening Remarks
Karine Crepin

Karine Crepin
VP Head of Biologics Patents
Sanofi (Paris, France)

Dr. Leslie Fischer

Dr. Leslie Fischer
Principal Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

8:45
Inter-Continental Considerations for Patent Portfolios: Devising Bullet Proof Strategies to Secure Patent Ownership in U.S., Europe and China
Stephanie Monaco

Stephanie Monaco
Assistant General Counsel
Pfizer (Secaucus, NJ)

Jordan Olsen
Partner
Stoel Rives

Marina Volin

Marina Volin
Head of Legal and Intellectual Property
Kintai Therapeutics (Cambridge, MA)

Yang Xu

Yang Xu
Assistant General Counsel, IP
BeiGene Ltd (Cambridge, MA)

This exclusive panel, brings together leading Patent Attorneys from both sides of the Atlantic to provide best practice strategies in securing patent ownership, assigning patent priorities documents and addressing vital considerations for patent processing at both USPTO and European Patent Office. Points of Discussion will include:

  • Developing strategies to achieving patent protection in the U.S. and Europe within one-year time frame
  • Discussing cost effective processes in patent applications in U.S. and Europe

9:30

USPTO Keynote Address

Examining the PTAB’s Latest Priorities, Review Procedures and New Developments Impacting IPR?
Jacqueline Bonilla

Honorable Jacqueline Wright Bonilla
Deputy Chief Administrative Patent Judge
USPTO Patent Trial and Appeal Board

  • Recent PTAB statistics in ex parte appeals and AIA cases
  • Changes to the claim construction standard used in AIA cases
  • PTAB’s new processes for designating Board decisions precedential or informative, and recently designated decisions
  • USPTO’s new motion to amend pilot program
  • A new notice regarding options for reissue or reexam during AIA trials

10:30
Networking Coffee Break
10:45
New §101 Landscape: Exploring the Latest Developments at the PTO and District Court Relative to Patent Eligibility
Charlotte Jacobsen

Charlotte Jacobsen
Partner
Ropes & Gray (New York, NY)

Leon Lum

Leon Lum
Intellectual Property Counsel, Legal & Corporate Affairs
Novo Nordisk Inc (Plainsboro, NJ)

Michael Rueckheim
Partner
Winston & Stawn

Moderator

George Johnston

George Johnston
Counsel
Gibbons P.C. (Newark, NJ) (Former Vice President & Chief Patent Counsel, Hoffman-LaRoche)

  • Analyzing the USPTO’s newly released guidance on §101 and understanding its repercussions for patentability
  • Examine the District Courts’ standard on §101 subject matter eligibility
  • Discover whether a more stringent test is being proposed
  • Exploring the patent eligibility standard for the life sciences industries
    • Exploring outcomes and certainties
  • Developing best practices in drafting patent claims to avoid unpatentable subject matter findings
  • Evaluate the interaction between current subject matter eligibility guidance and the Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Circ. 2018)
  • Discover whether recent decisions are favoring towards the influence of natural derivative

11:45
Obviousness-Type Double Patenting: Safeguarding Patent Ownership Now and Facilitating the Success of Future Patent Applications
Melodie Henderson

Melodie Henderson
VP Intellectual Property
Sigilon Therapeutics (Cambridge, MA)

Forrester Liddle

Forrester Liddle
Senior Director of Intellectual Property
Jounce Therapeutics (Cambridge, MA)

Jason Schigelone
Shareholder
Brinks Gilson & Lione

Mary Till

Mary Till
Senior Legal Advisor
United States Patent and Trademark Office (Alexandria, VA)

Patent Applications

  • Review of recent Federal Circuit cases related to obviousness-type double patenting
  • Examining when a terminal disclaimer can be utilised to overcome an obviousness-type double patenting rejection
  • Analyzing the expectations and interpretations of the patent examiners relative to the rules of obviousness-type double patenting
  • Developing strategies avoid and overcome obviousness-type double patenting rejections in a collaboration setting
Patent Protection
  • Analyzing key point from the Federal Circuit’s decision in Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018):
    • Discover whether the order of patent filing can make a difference relating to obviousness-type double patenting?
    • What happens if the later-expiring patent expires later that initial patent timeline because of a Patent Term Extension (PTE) awarded under 35 U.S.C. § 156
    • Clarifying the position of when are patents enforceable under 35 U.S.C. § 156 in an obviousness-type double patenting case
    • Defining the actual expiring timeline for an obviousness-type double patent with patent term extension (PTE) awarded under 35 U.S.C. § 156

12:45
Networking Luncheon
1:45

FIRESIDE CHAT

Exploring the Controversy over The Use of Printed Publications in Patent Prosecution at the PTAB
Dr. Leslie Fischer

Dr. Leslie Fischer
Principal Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

Interviewer

Filko Prugo

Filko Prugo
Partner
Ropes & Gray (New York, NY)

  • What is considered a printed publication at the PTAB?
  • Exploring the differential treatment of printed publications in PTAB proceedings litigation and prosecution?
  • Printed publications during prosecution: How applicants can leverage PTAB decisions regarding printed publications — the Office cannot have it both ways
    • Should USPTO patent examiners be required to certify printed publications in the same manner as petitioners at the PTAB?

2:15
Freedom to Operate: Evaluating Current Strategies to Avoid Future Findings of Infringement
Heather Boussios

Heather Boussios
Assistant General Counsel – IP
Aptevo Therapeutics (Seattle, WA)

Amy Fix
Shareholder
Brinks Gilson & Lione

Asha Nadipuram

Asha Nadipuram
Patent Attorney
Novartis Institutes for BioMedical (Cambridge, MA)

  • Assessing the current regulatory landscape for FTO analysis
  • Analyzing when during R&D third party patents discovered through FTO should be of concern
  • Understanding how extensive search sequencing should be during FTO
  • Seeking out the current capabilities of FTO relating to biologic patents
  • Evaluating the most effective process for FTO analysis
    • Should it be in the hands of inhouse or outside counsel?

3:15
Networking Refreshment Break
3:30
Patent Extensions: Prolonging Your Patent Lifecycles in the U.S. — Europe — Canada
Henry Gu

Henry Gu
Vice President, Chief IP Counsel
Akebia Therapeutics (Cambridge, MA)

Paul Inman

Paul Inman
Partner
Gowlings WLG (London, United Kingdom)

Micheline Gravelle
Partner
Bereskin & Parr LLP

U.S.

  • Analyzing case studies to develop best practice strategies for patent term extensions for maximized commercial return
Europe
  • Overview and practice update on Supplementary Protection Certificates
  • Gaining practical insights from Teva UK Ltd & Others v Gilead Sciences Inc (Case C 121/17)
Canada
  • Overview of the recently enacted Certificates of Supplementary Protection (CSPs) regime including the requirements to obtain and the term of extension.

4:30
Revisiting the Doctrine of Equivalence: How to Utilize It to Prevent Patent Infringement
Dominic Adair

Dominic Adair
Partner
Bristows LLP (London, United Kingdom)

Melissa Brand

Melissa Brand
Associate Counsel and Director Intellectual Property Policy
BIO (Washington, DC)

Barbara Ruskin

Barbara Ruskin
President
BA Ruskin Law LLC

Mark Waddell

Mark Waddell
Co-Chair, Life Sciences; Chair, Patent Litigation & Counseling
Loeb & Loeb LLP (New York, NY)

This brand-new Doctrine of Equivalence session will start with a brief refresher presentation on the best practice for utilising the Doctrine of Equivalence rule against patent infringement in the U.S. A panel discussion following this will bring together most practical knowledge from both sides of the Atlantic. USA:

  • Understanding the current scope of DOE and analyzing how it may enhance a company’s claim for patent infringement?
    • Recro Gainesville LLC vs. Actavis Laboratories (D. Del 2017)
  • Discover how to utilize DOE to enhance both infringement and prosecution strategies
  • Considerations for prosecution history estoppel for DOE
Europe: A UK Supreme Court decision in Actavis vs Eli Lilly [2017] UKSC 48 gave guidance on the new approach for the UK patenting process. Now, the UK Supreme Court has adopted a doctrine of equivalence (DOE) standard whereby variations to a patented product falling outside the literal scope of claims may now also be considered as infringements where the variations are “immaterial”. Delegates will benefit from presentations regarding DOE judgements and breakdown of application currently in both USA and Europe. Additionally, receiving benchmarking opportunities:
  • What are the practical results following the decision?
  • Developing industry best practices to construe patents: If a product falls outside the literal scope of patent claim, can it still be considered as infringement due to immaterial variation
  • Understanding whether patents can be found as invalid from novelty claims based on ‘equivalents’ to prior art
  • Discussing whether sufficiency attacks can succeed where the patent does not enable ‘equivalents’

5:30
Conference Adjourns to Cocktail Reception Sponsored by: Loeb & Loeb LLP

Day 2 - Friday, May 17, 2019

9:00
Co-Chair’s Opening Remarks and Recap of Day One
Karine Crepin

Karine Crepin
VP Head of Biologics Patents
Sanofi (Paris, France)

Dr. Leslie Fischer

Dr. Leslie Fischer
Principal Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

9:15

Focus on Antibodies

Antibody Patent Review: Global Perspectives on Enhancing Biologic Assets Protections
Karine Crepin

Karine Crepin
VP Head of Biologics Patents
Sanofi (Paris, France)

Thomas Kowalski

Thomas J. Kowalski
Partner
Duane Morris LLP

Duane Marks

Duane Marks
Patent Counsel (Biomedicine)
Eli Lilly (Indianapolis, IN)

Casey Thampoe

Immac J. Thampoe (“Casey”)
Assistant General Counsel – IP Portfolio Development
Regeneron Pharmaceuticals Inc. (Tarrytown, NY)

  • Discussing the latest antibody patent case law in the U.S and Europe and interpreting their results
  • Examining the scope and assessment for antibody patent protection in U.S. and Europe
    • Comparing the difference in the meaning of inherent properties
    • Understanding how to avoid issues rising from third party intervention
  • Assessing the interplay between functional and structural features
  • Exploring current prosecution challenges in U.S. and Europe

10:45
Networking Break
11:00

Focus on Antibodies

§112 Written Description Properly Circumscribing the Scope of Claims to Monoclonal Antibodies

Aisha Hasan
Intellectual Property Attorney
Brinks Gilson & Lione

Nicole Woods

Nicole Woods
Vice President – Assistant General Patent Counsel
Lilly Oncology (Branchburg, NJ)

PCSK9 Antibodies Update:

  • Examining the Federal Circuit and District Court decisions in Amgen vs. Regeneron
  • Understanding why the European Patent Office has rejected the validity of Amgen’s European patent covering PCSK9 antibodies
  • Clarifying what the fundamental difference between the two different jurisdictions
Enforcement Challenges:
  • Clarify the scope for obtain antibody claims
  • What can be found as valid and enforceable antibody patent in US and Europe
Types of Antibody Claims:
  • Understanding different the types of claims currently available for covering an antibody product from the narrowest to the broadest
  • Examining the vulnerabilities for each scope of claim
  • Examining the latest legal positions and challenges concerning broad and intermediate claims for antibody patents
Antibody Claims in Detail:
  • Can you have a claim that resides in the entire variable antibody region of the heavy and light chain?
  • What types of claims are directed towards a CVR Antibody

12:00
Networking Luncheon
1:00
Europe — Post Brexit Effect: Update on the Unified Patent Court and the Future of the Unitary Patent
James Hayles

James Hayles
European Patent Attorney
Pfizer (Sandwich, United Kingdom)

Paul Inman

Paul Inman
Partner
Gowlings WLG (London, United Kingdom)

Moderator

Teresa Rea

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

Equipped with the most up to date knowledge, our esteemed panellist will discuss, examine and clarify ambiguous areas of patenting and related regulatory processes in the post-Brexit era:

  • Determining whether the UK can still participate in the UPC after its exit from EU?
    • How does this affect U.S. pharma companies seeking patent protection in the U.K?
  • Reviewing the patent prosecution process and utilisation of the UPC
  • What are the expected outcomes of Brexit to the UPC
    • How will this impact patent prosecution strategies for U.S. pharmaceutical companies looking to obtain Unitary Patents?
  • How will IP case law develop resulting from Brexit?
  • Understanding how influential English court decisions are on the international stage?
  • Determining best practice litigation strategies at the Unified Patent Court to obtain a Unitary Patent

2:00
Exploring the Intersection Between High Tech AI, Data Mining, Discovery and Patent Protection
Mike Borella

Mike Borella
Partner
MBHB (Chicago, IL)

FDA is approving an increasing number of mobile apps and digital health systems. This panel will discuss the most current practical strategies in protecting the latest technological advances in the life sciences industry. Detail discussions will address: PART 1: Discovering the Latest Innovations in High Tech AI and Digital Health Patent Protection:

  • A brief overview of what is Machine Learning and AI and what is its position in the Life Sciences Industry
  • Analyzing the latest patent challenges associated with Apps and sensors
  • Determining which parts of the AI and digital health engineering products are patentable
  • How will the future of patent protection be altered due to data being generated through the technology?
PART 2: Demystifying Data Mining, Discovery and the Quality of Patents
  • Discovering the latest data being generated: How this data can be utilized to increase the quality of patent protection
  • Unique Inventions: How to maximize and leverage protection through creative patent protection strategies
  • Setting out a claims strategy for inventions incorporating machine learning

3:00
Networking Break
3:30
Ethical Considerations for Life Sciences Patent Prosecution
Bart Giddings

Bart W. Giddings
Partner
Stoel Rives

MaCharri Vorndran-Jones

MaCharri Vorndran-Jones
Assistant General Patent Counsel
Eli Lilly and Company (Indianapolis, IN)

  • Understanding how to maintain candid communication with the PTO
  • Analyzing how to maintain an equitable balance between risks and benefits of asserting an inequitable conduct defence
  • Exploring best practices to avoid inequitable conduct in the life sciences space: what is reasonable to disclose to the PTO going forward?
    • Related prosecution applications in the US and abroad?
    • Foreign language documents post-patent reform?
    • Related litigation, applications, and Office Actions?
    • Prior sales and prior public uses?

4:30
Conference Concludes

Workshop A – Patents Around the World Working Group: How to Execute a Cohesive International Patent Prosecution Strategy

May 15, 2019 9:00am – 12:30pm

Tjibbe Douma
Partner
Dentons (Amsterdam, Netherlands)

Robert Sullivan
Managing Principal
Fish & Richardson (New York, NY)

What is it about?

(Registration begins at 8:00 – Continental Breakfast will be served)

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. Benefit from our session leaders in-depth analysis of patent laws around the world on a region-by-region basis. Topics to be discussed include:
  • Comparing and contrasting the standards of patentability and related issues in the US and Europe
    • Patent eligibility
    • Availability of patent extensions – PTEs and SPCs
    • Compulsory licensing
    • Bolar-type safe harbor provisions
    • Plausibility and Enablement
    • Inventive Step and Obviousness
  • Procuring and enforcing life sciences patents worldwide on a cost-effective basis
    • Timing and logistics of filing: When to file to maximize exclusivity and what are the expected costs?
    • Determining the locations where it is most and least important to have patent protection in place
    • Drafting applications that satisfy the requirements of different locations
    • Coordinating between lawyers on the ground internationally and with your U.S. teams
  • Spotlight on the EU
    • How will Brexit impact Life Sciences companies
    • How will the establishment of a Unified Patent Court impact life sciences IP strategies?
      • How will the Court work?
      • What actions should companies take now to prepare for implementation?
    • EU Trade Secret Directive and its implementation in 2018 and 2019
    • EU trend on subgroup patents
    • What are the possibilities for an SPC for subgroup patents and new indications following the recent CJEU SPC decision in the Abraxis case?
Luncheon will be served at 12:30 pm for attendees participating in both Workshops A and B

Workshop B – Antibody Claims Drafting Master Class: Strategies for Ensuring Success in U.S.

May 15, 2019 1:30pm – 5:00pm

Forrester Liddle
Senior Director of Intellectual Property
Jounce Therapeutics (Cambridge, MA)

Christopher Loh
Partner
Venable LLP

Larry Coury
Vice President, Associate general Counsel
Regeneron Pharmaceuticals

What is it about?

(Registration begins at 1:00)

Drafting antibody claims is a complex and nuanced endeavour. Questions surrounding which claims are patentable in the United States as well as Europe are becoming increasingly difficult to navigate. This workshop will help cut through the complexity and offer solutions for successful patenting strategies as well as global commercialization. Points of discussion will include:
  • Survey and review of antibody patent practice throughout the world
  • Understanding different patent office’s interpretation for antibody claims
  • Drafting claims for protection across differentjurisdictions
  • Discussing latest case law in relevant jurisdictionsand interpreting their results
  • Developing strategies for effectively drafting antibodyclaims in different international jurisdictions
  • Best practices in the U.S. and Europe
  • Understanding the variety of options available tomaximise the scope of protection
  • Practical guides and experiences
  • Understanding how this process varies from country to country and office to office in certain multinational companies
  • Examining the corporate in-house process for drafting claims
  • Real life case-study and discussing possible solutions to common drafting dilemmas
Luncheon will be served at 12:30 pm for attendees participating in both Workshops A and B