Day 1 - Wednesday, February 21, 2018

7:45
Registration and Continental Breakfast
8:30
Co-Chairs’ Opening Remarks
8:45
Living Large: Filing and Protecting Big Portfolios while Avoiding Double- Patenting Issues
10:00
Morning Coffee Break
10:30
IPR Investigation: Diving into IPR Dos and Don’ts
12:00
Networking Lunch
1:30
Beyond Sandoz v. Amgen: Future of the Biologics Marketplace and Evolving Biosimilars Development
2:45
Around the World in 30 Months: Developing a Robust International Portfolio
3:45
Afternoon Refreshment Break
4:00
Advancing your Portfolio: Patenting Cutting-Edge Life Sciences Technologies
5:30
Day One Adjourns to Cocktail Reception Sponsored by:

Day 2 - Thursday, February 22, 2018

8:15
Continental Breakfast
9:00
Co-Chairs’ Opening Remarks and Recap of Day One
9:15
§101 Developments: Exploring Legislative Initiatives
10:45
Morning Coffee Break
11:00
Working with the PTO to Obtain (and Extend) Life Sciences Patents
12:30
Networking Luncheon
1:45
Leveraging your Life Sciences Assets: Best Practices for Licensing and IP Due Diligence
2:45
Anti-Antibody Climate? Pursuing Protection for Antibodies in Today’s Environment
3:45
Afternoon Networking Break
4:00
Ethical Considerations for Prosecuting Life Sciences Patents: Avoiding Inequitable Conduct
5:00
Conference Adjourns

Day 1 - Wednesday, February 21, 2018

7:45
Registration and Continental Breakfast
8:30
Co-Chairs’ Opening Remarks

Leslie Fischer
Senior Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

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

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

Mark E. Waddell
Chair, Patent Litigation and Counseling
Loeb & Loeb LLP (New York, NY)

8:45
Living Large: Filing and Protecting Big Portfolios while Avoiding Double- Patenting Issues

Maureen Bresnahan
Assistant General Counsel
Eisai Inc. (Andover, MA)

Leslie Fischer
Senior Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

Anita Varma
Partner
White & Case LLP (Boston, MA • London, UK)

This unique and interactive session will track a hypothetical life sciences patent portfolio and will delve into post-Gilead filing strategies and tactics to implement to maximize the strength of the portfolio while steering clear of double patenting challenges.The panel will also review the status of Gilead-style ODP in District Courts and the Federal Circuit, including the impact on PTA and PTE, and ways to mitigate risk to patent term.

10:00
Morning Coffee Break
10:30
IPR Investigation: Diving into IPR Dos and Don’ts

Charlotte Jacobsen
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Kerry Taylor
Partner
Knobbe Martens (San Diego, CA)

Evan Weitz
Managing Director Head of Controls, Europe and Americas Financial Crime Compliance
Standard Chartered Bank (Newark, NJ)

Over the past year, there has been a distinctive uptick in the use of IPRs in the life sciences industry. This session will explore several of these IPRs and will discuss the decisions made at each step of the process. Our panel will dive into why the parties made certain choices, pros and cons of the choices made, and risk-benefits of IPRs vs. District Court. The session will also cover relevant case law such as Phigenix, (IPR strategies without concurrent litigation) and the up-to-date status of Oil States (constitutionality of IPRs). At the time of print of this brochure, briefing is scheduled to conclude by November 20, 2017, and there is no date set for oral argument. Our panelists will also discuss best practices and strategies to consider for IPR filings in light of these cases as well as effects of Allergan’s deal with the St. Regis Mohawk tribe.

12:00
Networking Lunch
1:30
Beyond Sandoz v. Amgen: Future of the Biologics Marketplace and Evolving Biosimilars Development

Gloria M. Fuentes
Managing Counsel – Intellectual Property
Merck & Co., Inc. (Rahway, NJ)

John Labbé
Partner, IP Litigation
Marshall, Gerstein & Borun LLP (Chicago, IL)

Jennifer Scarpati
Director, Legal Counsel – Intellectual Property
Dr. Reddy’s Laboratories, Inc. (Princeton, NJ)

  • Strategies for giving notice of commercial marketing and satisfying production requirements under the BPCIA after Sandoz v. Amgen
  • Patent dance strategies in view of recent cases (Amgen v. Hospira)
  • Update on current biosimilar litigation concerning Humira, Remicade, Neupogen, Epogen, and others
  • Use of IPRs in biosimilar cases
  • Creatively drafting claims to obtain greatest protection
  • Comparing “highly similar” biosimilars to “bioequivalent” small molecule drugs
  • Addressing FDA’s current stance on interchangeability
  • Reviewing the current biosimilar pipeline
  • Parsing the PGR process: Exploring the risks and rewards of filing PGRs during the patent dance

2:45
Around the World in 30 Months: Developing a Robust International Portfolio

Otto Licks
Partner
Licks Attorneys (Rio de Janeiro, Brazil)

Amy Mills
Vice President, Intellectual Property
Juno Therapeutics (Seattle, WA)

  • Update on Unified Court and unitary patents
  • Strategically setting up filing order and determining when PCT filing is advantageous
  • Surviving simultaneous patenting and international patent oppositions
    • Managing conflicting arguments and coordinating oppositions and IPRs
  • Interpreting the impact of Actavis v. Eli Lilly on doctrine of equivalents
  • Understanding unique challenges for obtaining patents in third-world countries
  • Planning for parallel imports: protecting your biopharmaceutical products

3:45
Afternoon Refreshment Break
4:00
Advancing your Portfolio: Patenting Cutting-Edge Life Sciences Technologies

Josiah Barbour, J.D.
Patent Attorney
Flagship Biosciences, Inc. (Westminster, CO)

Jeremy Cubert
Partner
Potomac Law Group (Washington, DC)

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

Mark E. Waddell
Chair, Patent Litigation and Counseling
Loeb & Loeb LLP (New York, NY)

This moderated open-floor discussion will cover the development of hot, new technologies and best strategies for protecting these valuable assets. Our panel will spark discussion covering the latest developments in the life sciences space including:

  • Computer-simulations and role of software in diagnostics and methods,
  • Regenerative medicine, cancer immunotherapies, Crispr, personalized medicine, companion diagnostics, and more.
  • Use of Artificial Intelligence for database creation and discovery, large and small molecule drug discovery, predictive analytics and its use in diagnosis and data analysis

5:30
Day One Adjourns to Cocktail Reception Sponsored by:

Day 2 - Thursday, February 22, 2018

8:15
Continental Breakfast
9:00
Co-Chairs’ Opening Remarks and Recap of Day One
9:15
§101 Developments: Exploring Legislative Initiatives

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

Gonzalo Merino, Ph.D., J.D.
Vice President, Chief Intellectual Property Counsel
Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)

Kevin J. Post
Partner
Ropes & Gray LLP (New York, NY)

Join our key policy leaders from Government and industry organizations involved with life sciences as they discuss the evolution of section 101, current initiatives, recent and pending legislation and other happenings on the Hill. Our panelists will present their input into the foreseeable future, when (and if) the “anti-patent” climate will end, and best practices for obtaining patent protection for life sciences inventions.

10:45
Morning Coffee Break
11:00
Working with the PTO to Obtain (and Extend) Life Sciences Patents

Yelee Kim
Partner
Arent Fox LLP (Washington, D.C)

Frederick Krass
Supervisory Patent Examiner Art Unit 1612
United States Patent and Trademark Office (Alexandria, VA)

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

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

  • Knowing your Examiners: Deciding how and when to push back
  • Strategies for communicating with either new or “known-tough” Examiners
  • Utilizing Patent Term Adjustment (PTA) and Patent Term Extensions (“PTE”) to maximize patent life cycles
    • Evaluating the application process
    • Calculating PTO and FDA delays and resulting term extensions
    • Antibody Drug Conjugates: 12-year biologics exclusivity, PTE, and other regulatory issues

12:30
Networking Luncheon
1:45
Leveraging your Life Sciences Assets: Best Practices for Licensing and IP Due Diligence

Trevor Copeland
Shareholder
Brinks Gilson & Lione (Chicago, IL)

Mony R. Ghose
Associate General Counsel – Life Sciences Intellectual Property
Becton, Dickinson and Company (Franklin Lakes, NJ)

Bruce A. Pokras
Senior Corporate Counsel
Pfizer Inc. (Peapack, NJ)

Barbara A. Ruskin
General Counsel and Chief Patent Officer
Molecular Templates, Inc. (Jersey City, NJ)

  • Understanding the roles and positions of the involved parties, both inside and outside your company
  • Getting out of the weeds: Best practices for strategically conducting landscape searches
    • Determining when further in-depth searching is required
  • Focusing on freedom to operate within the biopharmaceutical arena
    • Evaluating existence of infringement searches and written opinions
    • Examining license/assignment agreements, settlement agreements, employment and consulting agreements, and active litigations
  • Learning to share: balancing the amount of IP shared with the overall success of a partnership
  • Managing portfolios when in-licensing or out-licensing to universities

2:45
Anti-Antibody Climate? Pursuing Protection for Antibodies in Today’s Environment

Denise M. Kettelberger
Of Counsel
Patterson Thuente Pedersen, P.A. (Minneapolis, MN)

Nicole S. Woods
Vice President – Assistant General Patent Counsel, Lilly Oncology
Eli Lilly and Company (Branchburg, NJ)

  • How large is your genus? Supporting broad claims and overcoming §112 rejections
    • Reviewing recently-issued antibody claims
  • Obtaining protection for Antibody-Drug Conjugates
  • Analyzing Amgen v. Regeneron and the aftermath

3:45
Afternoon Networking Break
4:00
Ethical Considerations for Prosecuting Life Sciences Patents: Avoiding Inequitable Conduct

Barton W. Giddings
Partner
Stoel Rives LLP (Salt Lake City, UT)

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)

  • Effectively communicating with the PTO: maintaining candor
    • Considering related applications and litigations, foreign-language documents and translations, and prior public use
  • Reviewing relevant jurisprudence (e.g. Gilead Sciences Inc. v. Merck & Co. Inc)
  • Evaluating litigation misconduct and when it rises to the level of “intent”
    • Reviewing Regeneron Pharmaceuticals, Inc. v. Merus N.V. and its repurcussions
  • Determining where Therasense fits in post-Regeneron
  • Balancing the risks and benefits of asserting an inequitable conduct defense
  • Unique attorney-client privilege challenges arising with international companies

5:00
Conference Adjourns